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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
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bad fever; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 2, single (Lot number: EW0170) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot: ER8733; anatomical location:Upper arm, pretty sure right arm.), administration date: 30Mar2021, when the patient was 59-year-old, for COVID-19 Immunization, reaction(s): "heart palpitations". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "bad fever". Additional information: Patient takes vitamins but stopped for a while. Caller stated well now, but nothing back in 2021 doesn't believe. Did the patient receive any other vaccines on the same date as the Pfizer vaccine reported as No. Did the patient receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine reported as No.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
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second time testing positive for Covid; second time testing positive for Covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid for COVID-19, reaction(s): "Dysgeusia (metal taste)"; Paxlovid for COVID-19, reaction(s): "diarrhea"; Paxlovid for COVID-19, reaction(s): "Felt nauseated but didn't vomit"; Paxlovid for COVID-19, reaction(s): "lost his appetite". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Flu vaccine (flu vaccine decades ago, got a shot in the arm), administration date: 2000, when the patient was 49 years old, for Immunization, reaction(s): "AMPPE"; Flu vaccine (After treatment with high dose steroids, I was able to regain my vision, got a shot in the arm, Name of steroids unknown.), administration date: 2000, when the patient was 49 years old, for Immunization, reaction(s): "lost my central vision"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "second time testing positive for Covid". The patient underwent the following laboratory tests and procedures: Body temperature: maybe .1 or .2 increase; SARS-CoV-2 test: Positive, notes: The second time. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient had original 2 doses and believed he had had 3 boosters. He had contracted Covid twice after the Covid vaccine and boosters. The second time testing positive for Covid, the patient called his doctor on a Friday and he called in script for child dosage of Paxlovid, but he was unable to obtain it. On Monday he called his doctor back and said no one had Paxlovid and can't get it. The doctor asked him how he felt and his temperature was maybe .1 or .2 increase. His doctor said if you are not running a high fever and feel ok don't bother taking it and caller didn't take it the second time. Then he was fine after and his symptoms improved. He didn't need any other treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166339 same patient/event, different dose;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
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body became very cold; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 (BNT162B2), in 2021 as dose number 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING COLD (non-serious) with onset 2021, outcome "recovered" (2021), described as "body became very cold". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. Additional information: The consumer told company representative about her experience with Pfizer Covid vaccine from 2021. Felt like he would just call it in, to be safe. When asked to provide experience reporter had reported to caller, he states, she relayed that, pretty immediately after she received her vaccination, her body became very cold for about 2 minutes, then subsided. That was really the only detail that was provided. Caller had asked her if she felt like it was chills, said it was not really chills, whole body felt cold. Caller did not know how to describe that. Reporter was mentally having to recall when this occurred. Was with her first Covid vaccine, which became available in 2021, caller believed. Clarified, as previously stated, was from 4 years ago, was not a recent event.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: Fasciitis
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fasciitis in her lower leg; This is a spontaneous report received from a Nurse from medical information team. A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, lot unknown), administration date: 07Mar2021, for covid-19 immunisation; Bnt162b2 (dose 2, lot unknown), for covid-19 immunisation; Bnt162b2 (dose 3, lot unknown), for covid-19 immunisation; Bnt162b2 (dose 4, lot unknown), for covid-19 immunisation; Bnt162b2 (dose 5, lot unknown), for covid-19 immunisation; Bnt162b2 (dose 6, lot unknown), for covid-19 immunisation. Her first Pfizer COVID-19 vaccine was on 07Mar2021 and stated that she already had at least seven Pfizer COVID-19 vaccines. The following information was reported: FASCIITIS (non-serious) with onset Oct2024, 1 week after the suspect product(s) administration, outcome "unknown", described as "fasciitis in her lower leg". The event "fasciitis in her lower leg" required physician office visit. Therapeutic measures were taken as a result of fasciitis. She also stated that she had Physical therapy and anti-inflammatory medications. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 73-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Weight
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had actual Covid - bad case but not hospitalized; had actual Covid - bad case but not hospitalized; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: EW0164), in arm, on 07May2021 as dose 2, single (Lot number: EW0165), in arm and on 26Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 59 years, in arm, all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2023 as dose number unknown (booster), single intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Strong Menopause symptoms" (unspecified if ongoing). There were no concomitant medications (the patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine, and did not receive any other vaccines on the same date as the Pfizer vaccine). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "had actual Covid - bad case but not hospitalized". The patient underwent the following laboratory tests and procedures: Weight: 160. Clinical course: had actual Covid-bad case but not hospitalized in early 2023.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Barrel chest, Cough, Rash, Rash erythematous, Rash macular
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The patient presented to Clinic on 08/18/2025 at approximately 0800 for routine immunizations. ProQuad was administered in the left thigh and Kinrix in the right thigh. The patient tolerated the injections without complication and departed the clinic at approximately 0910. At 0915, the patient?s father called reporting a new onset rash and cough. He was advised to return to the clinic for further evaluation. Upon arrival, the patient was noted to be in respiratory distress. Dr. and FNP-BC evaluated the patient. Oxygen saturation was 92% on room air. Examination revealed barrel chest, retracted breathing, and a splotchy erythematous rash across the torso. The patient also demonstrated tachypnea and vomiting. At 0950, Dr. administered Epinephrine 0.15 mg IM to the left thigh, followed by Decadron 4 mg/mL and Diphenhydramine 50 mg/mL. The patient showed an adequate response to treatment with improvement in oxygen saturation to 98% on room air and a pulse of 132 bpm. An ambulance was dispatched for transfer to Emergency Department for continued monitoring. The patient arrived at approximately 1043. He remained stable throughout observation and was prescribed Prednisolone 15 mg/5 mL for home use. The patient was discharged in stable condition at 1252.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Respiratory distress, Tachypnoea, Use of accessory respiratory muscles, Vomiting
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The patient presented to Clinic on 08/18/2025 at approximately 0800 for routine immunizations. ProQuad was administered in the left thigh and Kinrix in the right thigh. The patient tolerated the injections without complication and departed the clinic at approximately 0910. At 0915, the patient?s father called reporting a new onset rash and cough. He was advised to return to the clinic for further evaluation. Upon arrival, the patient was noted to be in respiratory distress. Dr. and FNP-BC evaluated the patient. Oxygen saturation was 92% on room air. Examination revealed barrel chest, retracted breathing, and a splotchy erythematous rash across the torso. The patient also demonstrated tachypnea and vomiting. At 0950, Dr. administered Epinephrine 0.15 mg IM to the left thigh, followed by Decadron 4 mg/mL and Diphenhydramine 50 mg/mL. The patient showed an adequate response to treatment with improvement in oxygen saturation to 98% on room air and a pulse of 132 bpm. An ambulance was dispatched for transfer to Emergency Department for continued monitoring. The patient arrived at approximately 1043. He remained stable throughout observation and was prescribed Prednisolone 15 mg/5 mL for home use. The patient was discharged in stable condition at 1252.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
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Since 2 months post vax, my hair fell out in copious amounts. The first year, I lost at least 1/3 of my hair. Now, still, in 2025, I lose hair in cycles. So does my 18 year old daughter who was 14 at time of "vaccination" thus making it unlikely to be a hormonal thing related to menopause. There are many of us out there- who lost a lot of hair. Please research.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
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Patient given Arexvy instead of Abrysvo. Pt reports EGA 35+2. Patient at risk of adverse event due to side effects of pregnant patient receiving Arexvy. Patient remained at clinic for one hour after event. Patient did not report any s/s of preterm labor. Patient's OB provider made aware of incident. Pt reports that her OB provider would call her to discuss what happened, possible side effects, precautions, and next steps. Incident also reported to (withheld) Clinical Consult Team (phone# withheld opt.1).
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 37.0
Sex: F
Vaccine: COVID19, HEP, HPV9
Symptoms: Lip swelling, Urticaria
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Many hours after the shot, I developed hives, which eventually covered about 80% of my body. My top lip swelled but I did not have any breathing trouble. My doctor sent a steroid and now they are starting to go away, 2 days later.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
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Vaccine give after 10 week expiration date. No reactions or illness symptoms took place.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cardiac amyloidosis, Cerebrovascular accident, Menstrual disorder, Myocarditis
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myocarditis; thrombosis; cerebrovascular accident; amyloidogenesis; arthralgia; menstrual disorders; reproductive concerns; This case has been considered invalid as Duplicate Case. This is a literature report from License Party for the following literature source(s): An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; THROMBOSIS (medically significant), outcome "unknown"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown"; CARDIAC AMYLOIDOSIS (medically significant), outcome "unknown", described as "amyloidogenesis"; ARTHRALGIA (non-serious), outcome "unknown"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "menstrual disorders"; REPRODUCTIVE TRACT DISORDER (non-serious), outcome "unknown", described as "reproductive concerns". Synthetic mRNA vaccines have introduced a novel platform in human immunization by encoding viral antigens Within lipid nanoparticle encapsulated, chemically modified mRNA molecules. While initially promoted for their rapid production and strong immunogenicity, a growing body of evidence has identified a range of adverse events, including myocarditis, thrombosis, cerebrovascular accidents, amyloidogenesis, arthralgia, menstrual disorders, reproductive concerns, and new-onset malignancies. These events have prompted renewed scrutiny of the molecular mechanisms triggered by synthetic mRNA constructs and their intracellular fate. Unlike endogenous mRNA, vaccine-derived transcripts incorporate non-natural features such as NI-methylpseudouridine substitution, extended poly(A) tails, and optimized untranslated regions (UTRs) to enhance stability and translational efficiency. These same modifications may alter RNA metabolism and surveillance, contributing to ribosomal infidelity, +1 frameshifting, and defective protein folding. Independent studies have reported reverse transcription of vaccine mRNA into DNA via endogenous LINE-I elements, highlighting issues over genomic integration and persistent expression. Recent analyses of BNT162b2 vaccine vials revealed residual plasmid DNA, including SV40 enhancer and antibiotic resistance genes, raising concerns over potential oncogenic risk from unintended genomic exposure. Moreover, recent research has shown that spike protein translated from mRNA vaccines can persist in the circulation for extended periods, far beyond initial pharmacokinetic expectations, potentially sustaining Inflammatory signalling and Immune activation. Finally, some studies suggest that SARS-CoV-2 bears molecular signatures consistent with synthetic genome assembly, raising further concerns about engineered RNA platforms and their unforeseen biological consequences. These features collectively raise concerns regarding unintended cellular consequences of synthetic mRNA exposure. To address this gap, the authors conducted a comparative transcriptomic analysis using bulk RNA-sequencing data from whole blood of patients with new-onset adverse events (Group 1) and patients with new-onset cancers (Group 2) following COVID-19 mRNA vaccination, alongside healthy controls. Differential expression analysis and Gene Set Enrichment Analysis (GSEA) were performed to identify hallmark-specific molecular pathways perturbed in each group. By comparing these two profiles, this study aims to highlight potential transcriptomic disturbances associated with vaccine-related pathology and explore whether distinct or shared molecular hallmarks may underlie different post-vaccination clinical trajectories. The authors enrolled adult participants (ages 18-70) who developed either new-onset symptoms following administration of mRNA-based COVID-19 vaccines (BNT162b2 [Pfizer] or mRNA-1273 [Moderna]). All participants provided written informed consent prior to inclusion in the study. Among the symptomatic individuals with nonmalignant adverse events, reported manifestations included cardiovascular injury, thrombosis, chronic fatigue, and neurological dysfunction, emerging shortly after vaccination. Another group of participants was diagnosed with cancer as a new-onset condition within a short time frame following mRNA vaccine administration. The study population was divided into two groups: the first consisted of three individuals who developed new-onset post-vaccination symptoms (group 1), and the second included seven individuals with new-onset cancer diagnoses (group 2). A cohort of 803 healthy individuals was used as the reference control group. Peripheral blood samples were collected in accordance with institutional biosafety guidelines by licensed nurses at clinical sites affiliated with Neo7Bioscience. Venipuncture was performed using standard sterile technique. Whole blood was drawn into pre-labelled Streck tubes, stored at 4 degree C, and transported the same day in cooled containers to the Genomics Center at the University for processing. No follow-up attempts are possible. Follow-up (11Aug2025): This is a literature report for the following literature source(s): This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Updated information: Market Authorization Holder of MODERNA COVID-19 VACCINE added, Digital Object Identifier updated, Causality assessment updated, and case downgraded to invalid as it was inclusion criteria for this study. Follow-up (18Aug2025): This is a follow-up report to notify that the case PV202500092384 and 202500165734 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202500165734. Amendment: case 202500165734 is being deleted from the database as erroneously submitted to certain regulators with no reportable ADRs and duplicate to 202500167447 (created for reporting to other regulators as well as aggregate and risk management purposes). All subsequent follow-up information will be reported under manufacturer report number 202500167447. This case is being deleted from the database for the following reason: duplicate case. No further follow-up information has been received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19, COVID19
Symptoms: Reproductive tract disorder, Thrombosis
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myocarditis; thrombosis; cerebrovascular accident; amyloidogenesis; arthralgia; menstrual disorders; reproductive concerns; This case has been considered invalid as Duplicate Case. This is a literature report from License Party for the following literature source(s): An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; THROMBOSIS (medically significant), outcome "unknown"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown"; CARDIAC AMYLOIDOSIS (medically significant), outcome "unknown", described as "amyloidogenesis"; ARTHRALGIA (non-serious), outcome "unknown"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "menstrual disorders"; REPRODUCTIVE TRACT DISORDER (non-serious), outcome "unknown", described as "reproductive concerns". Synthetic mRNA vaccines have introduced a novel platform in human immunization by encoding viral antigens Within lipid nanoparticle encapsulated, chemically modified mRNA molecules. While initially promoted for their rapid production and strong immunogenicity, a growing body of evidence has identified a range of adverse events, including myocarditis, thrombosis, cerebrovascular accidents, amyloidogenesis, arthralgia, menstrual disorders, reproductive concerns, and new-onset malignancies. These events have prompted renewed scrutiny of the molecular mechanisms triggered by synthetic mRNA constructs and their intracellular fate. Unlike endogenous mRNA, vaccine-derived transcripts incorporate non-natural features such as NI-methylpseudouridine substitution, extended poly(A) tails, and optimized untranslated regions (UTRs) to enhance stability and translational efficiency. These same modifications may alter RNA metabolism and surveillance, contributing to ribosomal infidelity, +1 frameshifting, and defective protein folding. Independent studies have reported reverse transcription of vaccine mRNA into DNA via endogenous LINE-I elements, highlighting issues over genomic integration and persistent expression. Recent analyses of BNT162b2 vaccine vials revealed residual plasmid DNA, including SV40 enhancer and antibiotic resistance genes, raising concerns over potential oncogenic risk from unintended genomic exposure. Moreover, recent research has shown that spike protein translated from mRNA vaccines can persist in the circulation for extended periods, far beyond initial pharmacokinetic expectations, potentially sustaining Inflammatory signalling and Immune activation. Finally, some studies suggest that SARS-CoV-2 bears molecular signatures consistent with synthetic genome assembly, raising further concerns about engineered RNA platforms and their unforeseen biological consequences. These features collectively raise concerns regarding unintended cellular consequences of synthetic mRNA exposure. To address this gap, the authors conducted a comparative transcriptomic analysis using bulk RNA-sequencing data from whole blood of patients with new-onset adverse events (Group 1) and patients with new-onset cancers (Group 2) following COVID-19 mRNA vaccination, alongside healthy controls. Differential expression analysis and Gene Set Enrichment Analysis (GSEA) were performed to identify hallmark-specific molecular pathways perturbed in each group. By comparing these two profiles, this study aims to highlight potential transcriptomic disturbances associated with vaccine-related pathology and explore whether distinct or shared molecular hallmarks may underlie different post-vaccination clinical trajectories. The authors enrolled adult participants (ages 18-70) who developed either new-onset symptoms following administration of mRNA-based COVID-19 vaccines (BNT162b2 [Pfizer] or mRNA-1273 [Moderna]). All participants provided written informed consent prior to inclusion in the study. Among the symptomatic individuals with nonmalignant adverse events, reported manifestations included cardiovascular injury, thrombosis, chronic fatigue, and neurological dysfunction, emerging shortly after vaccination. Another group of participants was diagnosed with cancer as a new-onset condition within a short time frame following mRNA vaccine administration. The study population was divided into two groups: the first consisted of three individuals who developed new-onset post-vaccination symptoms (group 1), and the second included seven individuals with new-onset cancer diagnoses (group 2). A cohort of 803 healthy individuals was used as the reference control group. Peripheral blood samples were collected in accordance with institutional biosafety guidelines by licensed nurses at clinical sites affiliated with Neo7Bioscience. Venipuncture was performed using standard sterile technique. Whole blood was drawn into pre-labelled Streck tubes, stored at 4 degree C, and transported the same day in cooled containers to the Genomics Center at the University for processing. No follow-up attempts are possible. Follow-up (11Aug2025): This is a literature report for the following literature source(s): This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Updated information: Market Authorization Holder of MODERNA COVID-19 VACCINE added, Digital Object Identifier updated, Causality assessment updated, and case downgraded to invalid as it was inclusion criteria for this study. Follow-up (18Aug2025): This is a follow-up report to notify that the case PV202500092384 and 202500165734 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202500165734. Amendment: case 202500165734 is being deleted from the database as erroneously submitted to certain regulators with no reportable ADRs and duplicate to 202500167447 (created for reporting to other regulators as well as aggregate and risk management purposes). All subsequent follow-up information will be reported under manufacturer report number 202500167447. This case is being deleted from the database for the following reason: duplicate case. No further follow-up information has been received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased
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Chest pain heart beats fast fatigue shortness of breath.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 0.08
Sex: M
Vaccine: DTPPVHBHPB, RV1, UNK
Symptoms: Death, Sudden infant death syndrome
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My son passed away on May 11th 2024 his cause of death has been ruled SUID undetermined
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
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Patient had pain, redness, and heat coming from injection site, as well as the presence of a hard lump. Patient was treated with ibuprofen and Benadryl and was told that if symptoms do improve over the course of 24 hours, to go to the doctor.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis
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spondyloarthropathy with ankylosing attributes or conditions; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 70-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "mild fibromyalgia" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 17Sep2021, for COVID-19 immunization, reaction(s): "Ankylosing Spondylitis". The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "spondyloarthropathy with ankylosing attributes or conditions". Therapeutic measures were taken as a result of ankylosing spondylitis. Clinical course: She has lots of things that happened after the vaccination that has now caused her lots of health problems and is on lots of medications. She wants to tell Pfizer what the vaccine did to her and her health for the last two, three or four years, clarifies as since 2021 since she got the second vaccination. She has very mild fibromyalgia intermittently that only affected her arm joint that was she confirms was diagnosed prior to the covid vaccine. She did not have immediate issues after first dose then states she cannot delineate since the doses were weeks apart but immediately after the second dose, her entire body was on fire on the inside and every joint in her body awakened with pain, joints that she had never felt before. Her primary doctor had never heard of this. She went to the fibromyalgia website and there were hundreds of reports of fibromyalgia patients experiencing the same thing. No further details provided. Treatment: did not know what treatment to get. When querying outcome states she was taking biologic medication now since the covid vaccine caused spondyloarthropathy with ankylosing attributes or conditions, states she does not know what it was called. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: UNK
Symptoms: Syringe issue
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No AE; Finger Flange Broken - During or After Injection; following administration while applying needle safety cover , the glass PFS broke; This spontaneous report was received from a Nurse on 15-AUG-2025. The complaint description was reported as follow: Health care professional (HCP) called to report a product quality complaint (PQC) for Hepatitis B Vaccine (Recombinant) (RECOMBIVAX H) Suspension for injection (lot #Z004729, has been verified to be valid lot #, expiration date was provided and confirmed as: 04-Sep-2027). Caller reported that on 15-AUG-2025, following administration while applying needle safety cover, the glass pre-filled syringe (PFS) broke (Syringe issue). Caller stated that "it broke in half and shards were everyone". Finger flange broken, it broken into 2 pieces with multiple shards. No patient involved. No injury to patient or HCP. Product available for retrieval. No adverse event (AE) was reported. No additional PQC. Date PQC observed: 15-AUG-2025.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Allergy test, Food allergy
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Patient became allergic to peanuts. He first had peanuts when he was just over a year old in September of 2014.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Myocarditis
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myocarditis
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
|
Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
|
Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
|
Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Enema administration, Fatigue, Intussusception, Lethargy, Ultrasound abdomen abnormal
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Patient with sudden onset of fatigue and lethargy on 07/17/25, with multiple episodes of bilious vomiting. Patient seen in ED where workup was completed; ultrasound remarkable for large colonic to colonic intussusception. Patient received barium enema which reduced the majority of the intussusception; admitted for observation and received additional enemas to reduce intussusception.; no surgery. Seen in office 07/20/25 and was noted to be doing well and is followed by pediatric surgery.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Vomiting
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Patient with sudden onset of fatigue and lethargy on 07/17/25, with multiple episodes of bilious vomiting. Patient seen in ED where workup was completed; ultrasound remarkable for large colonic to colonic intussusception. Patient received barium enema which reduced the majority of the intussusception; admitted for observation and received additional enemas to reduce intussusception.; no surgery. Seen in office 07/20/25 and was noted to be doing well and is followed by pediatric surgery.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
|
Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
|
Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
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Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
|
Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 78.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site inflammation, Injection site pruritus
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Patient had injection site reaction. Injection site was inflamed and itchy - about 2 inches x 4 inches patch on 8/22/25. Started roughly 5 days after vaccine administration (on 8/21/25).
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 1.0
Sex: M
Vaccine: HEPA, MMR, UNK, VARCEL
Symptoms: Altered state of consciousness, Diarrhoea, Irritability, Pyrexia
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getting his vaccines along with dupixent; fever and diarrhea after getting his vaccines; fever ans diarrhea after getting his vaccines; more fussy and "not like self after getting the vaccine"; more fussy and "not like self after getting the vaccine"/ cranky; fussiness and crankiness to patient teething; This spontaneous report was received from a consumer via other company and refers to a 1-year-old male patient. His medical history was not reported. The patient's concurrent conditions included ongoing multiple food allergies. Concomitant therapies were not reported. On 31-Dec-2024, the patient started therapy with Dupixent (Dupilumab) solution for injection 200 mg (strength 200mg), administered by subcutaneous route for the treatment of eczema (lot # and expiration date were not reported). On 08-Jun-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), administered by unknown route as prophylaxis (lot # and expiration date were not reported); Varicella Virus Vaccine Live (Oka-Merck) (manufacturer unknown), administered by unknown route as prophylaxis (lot # and expiration date were not reported); Hepatitis A Vaccine, Inactivated (manufacturer unknown), administered by unknown route as prophylaxis (lot # and expiration date were not reported); and with Typhoid Conjugate Vaccine (reported as TCV vaccine) administered by unknown route (lot # and expiration date were not reported). Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and Varicella Virus Vaccine Live (Oka-Merck) (manufacturer unknown) were reconstituted with sterile diluent (no details provided). On 08 -JUN-2025, per mom, the patient had a fever and diarrhea after getting his vaccines. They did not know about avoiding live vaccines regarding Dupixent injection (contraindicated product administered). She stated patient did seem more fussy and "not like self" after getting the vaccines (altered state of consciousness) (onset: 2025), fever and diarrhea had resolved the next day, on 09-JUN-2025 (reported also as 7/9/2025, discrepancy). The patient was administered Tylenol (date unknown). He was still a little fussy and cranky (irritability) (onset: 2025) but better, the fussiness and crankiness were attributed to the patient's teething (irritability) (onset: 2025). The action taken was not applicable for all of the vaccines. Dupilumab was continued for all events. The patient recovered from the event of fever and diarrhea after getting his vaccines on 09-Jun-2025. At the reporting time, the patient was recovering from irritability. The outcome of the patient's teething and altered state of consciousness was unknown. The causal relationship between the events and the suspect vaccines was not provided. Upon internal review, all of the events were determined to be medically significant.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: VARZOS
Symptoms: Bell's palsy
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Bells palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: Bells palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. The company considered the bell's palsy to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 09-AUG-2025 This case was reported by a patient via interactive digital media. Bell's palsy had been his/her reward for getting the shingles vaccine.; Sender's Comments: A case of Bell's palsy, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Vaccination failure
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passed away 2 years ago; Suspected vaccination failure; worst case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: passed away 2 years ago) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: worst case of shingles). The outcome of the vaccination failure and shingles were not reported. The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine. The company considered the unknown cause of death and vaccination failure to be unrelated to Shingles vaccine. The company considered the shingles to be possibly related to Shingles vaccine. Additional Information: GSK Receipt Date: 12-AUG-2025 This case was reported by son-in-law or daughter-in-law of the patient via interactive digital media. The reporter reported his/her father-in-law (patient) got the jab and came down with the worst case of shingles he/she had ever seen. In reporter's opinion the jab caused. Further reporter said, sadly the patient passed away 2 years ago (from the date of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Death, unknown time after receiving Shingles vaccine in a male patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.; Reported Cause(s) of Death: Unknown cause of death
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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contracted COVID twice after vaccination and boosters; contracted COVID twice after vaccination and boosters; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (got a shot in the arm), administration date: 2000, when the patient was 49 years old, for Immunization, reaction(s): "lost central vision", "AMPPE", a decade ago he got a flu vaccine, the flu vaccine threw his immune system into overdrive, 3 months later he developed AMPPE (Acute Multifocal Placoid Pigment Epitheliopathy) where he lost his central vision. It was gradual, plague builds up in layers of retina and gradually expands. Where central vision was focused goes into shadow, if you move vision to left side and couldn't see the left side. Move to right side and could't see right side. His was more prominent in central vision. As a result of that, he was on massive doses of steroids for probably 6-7 months. As a result of the AMPPE he now has adorated macular degeneration which he gets injections into his eyes every 12 weeks. When he was first in the hospital his dose was 100mg a day and he was in hospital for about 3-4 days. When released from hospital was on 80mg a day. That lasted at least 6 months. It took another month to lower the dosage of steroids it was either 10 or 20mg decrease per week so another month to wean off the steroids. After treatment with high dose steroids, he was able to regain his vision, although his stomach still reels from side effects. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID twice after vaccination and boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Patient received total 2 original doses of Pfizer Covid vaccines and 3 boosters, he got Covid after the 1st booster. Therapeutic measures included paxlovid were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166730 same patient, different dose/event;US-PFIZER INC-202500166729 same patient/event, different dose;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body height, Drug ineffective, Suspected COVID-19, Vertigo, Vomiting
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contracted COVID twice after vaccination and boosters; contracted COVID twice after vaccination and boosters; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (got a shot in the arm), administration date: 2000, when the patient was 49 years old, for Immunization, reaction(s): "lost central vision", "AMPPE", a decade ago he got a flu vaccine, the flu vaccine threw his immune system into overdrive, 3 months later he developed AMPPE (Acute Multifocal Placoid Pigment Epitheliopathy) where he lost his central vision. It was gradual, plague builds up in layers of retina and gradually expands. Where central vision was focused goes into shadow, if you move vision to left side and couldn't see the left side. Move to right side and could't see right side. His was more prominent in central vision. As a result of that, he was on massive doses of steroids for probably 6-7 months. As a result of the AMPPE he now has adorated macular degeneration which he gets injections into his eyes every 12 weeks. When he was first in the hospital his dose was 100mg a day and he was in hospital for about 3-4 days. When released from hospital was on 80mg a day. That lasted at least 6 months. It took another month to lower the dosage of steroids it was either 10 or 20mg decrease per week so another month to wean off the steroids. After treatment with high dose steroids, he was able to regain his vision, although his stomach still reels from side effects. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID twice after vaccination and boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Patient received total 2 original doses of Pfizer Covid vaccines and 3 boosters, he got Covid after the 1st booster. Therapeutic measures included paxlovid were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166730 same patient, different dose/event;US-PFIZER INC-202500166729 same patient/event, different dose;
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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suspect it may have been COVID/didn't have a test to check so didn't know; suspect it may have been COVID/didn't have a test to check so didn't know; a virulent episode of vertigo where the patient could not stand up; vomiting; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid for Covid-19 treatment, reaction(s): "metal taste"; Paxlovid for Covid-19 treatment, reaction(s): "diarrhea"; Paxlovid for Covid-19 treatment, reaction(s): "Felt nauseated but didn't vomit"; Paxlovid for Covid-19 treatment, reaction(s): "lost his appetite". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Comirnaty (2024-2025 formula) (DOSE 1, SINGLE), for Covid-19 immunization; Flu vaccine (flu vaccine decades ago, got a shot in the arm), administration date: 2000, when the patient was 49 years old, for immunization, reaction(s): "AMPPE"; Flu vaccine (flu vaccine decades ago, got a shot in the arm, After treatment with high dose steroids, I was able to regain my vision), administration date: 2000, when the patient was 49 years old, for immunization, reaction(s): "lost my central vision". The following information was reported: VERTIGO (non-serious) with onset May2025, outcome "recovered" (2025), described as "a virulent episode of vertigo where the patient could not stand up"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2025, outcome "recovered" (2025) and all described as "suspect it may have been COVID/didn't have a test to check so didn't know"; VOMITING (non-serious) with onset May2025, outcome "recovered" (2025). Clinical course: The patient had 2 original doses and believed he had had 3 boosters. He had contracted Covid twice after the Covid vaccine and boosters. Back in May2025, the patient developed a virulent episode of vertigo where the patient could not stand up so the patient's daughter had to come over to walk dog. The vertigo lasted 2 days. The patient checked the website and found that vertigo was a possible side effect of COVID 19 but the patient did not have a COVID test at home to confirm if the patient had COVID again for the third time but suspect it may have been COVID. He thought maybe that was a sign so he searched and found this could be potential sign of Covid but didn't have a test to check so didn't know. Other than that episode of vertigo, the patient had no other symptoms. The patient's daughter brought a pill for nausea that let dissolve under tongue and swallow. She brought 2 pills but the patient took 1 and the vomiting stopped. Wanted to say around the middle of the month this happened. Was laying down watching TV not feeling well and was going to get water and sat up and just started vomiting. That was when the patient noticed he couldn't stand up. At first thought it was ear infection but didn't have any ear pain. Name of medication was printed really small. It is in a foil pack and says Ondansetron orally disintegrating and has Pheny and a bunch of other letters are on there also. Manufacturer starts with an A and the letters are blurred out. Lot B/N000823024A Expiry May2027. The patient underwent the following laboratory tests and procedures: Body height: 6', notes: 6 feet; 5'10.5", notes: 5 feet 10 and a half; 5'11", notes: 5 feet 11. Therapeutic measures were taken as a result of vertigo, vomiting. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166339 same patient, different dose/event;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body height, Drug ineffective, Suspected COVID-19, Vertigo, Vomiting
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suspect it may have been COVID/didn't have a test to check so didn't know; suspect it may have been COVID/didn't have a test to check so didn't know; a virulent episode of vertigo where the patient could not stand up; vomiting; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid for Covid-19 treatment, reaction(s): "metal taste"; Paxlovid for Covid-19 treatment, reaction(s): "diarrhea"; Paxlovid for Covid-19 treatment, reaction(s): "Felt nauseated but didn't vomit"; Paxlovid for Covid-19 treatment, reaction(s): "lost his appetite". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Comirnaty (2024-2025 formula) (DOSE 1, SINGLE), for Covid-19 immunization; Flu vaccine (flu vaccine decades ago, got a shot in the arm), administration date: 2000, when the patient was 49 years old, for immunization, reaction(s): "AMPPE"; Flu vaccine (flu vaccine decades ago, got a shot in the arm, After treatment with high dose steroids, I was able to regain my vision), administration date: 2000, when the patient was 49 years old, for immunization, reaction(s): "lost my central vision". The following information was reported: VERTIGO (non-serious) with onset May2025, outcome "recovered" (2025), described as "a virulent episode of vertigo where the patient could not stand up"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2025, outcome "recovered" (2025) and all described as "suspect it may have been COVID/didn't have a test to check so didn't know"; VOMITING (non-serious) with onset May2025, outcome "recovered" (2025). Clinical course: The patient had 2 original doses and believed he had had 3 boosters. He had contracted Covid twice after the Covid vaccine and boosters. Back in May2025, the patient developed a virulent episode of vertigo where the patient could not stand up so the patient's daughter had to come over to walk dog. The vertigo lasted 2 days. The patient checked the website and found that vertigo was a possible side effect of COVID 19 but the patient did not have a COVID test at home to confirm if the patient had COVID again for the third time but suspect it may have been COVID. He thought maybe that was a sign so he searched and found this could be potential sign of Covid but didn't have a test to check so didn't know. Other than that episode of vertigo, the patient had no other symptoms. The patient's daughter brought a pill for nausea that let dissolve under tongue and swallow. She brought 2 pills but the patient took 1 and the vomiting stopped. Wanted to say around the middle of the month this happened. Was laying down watching TV not feeling well and was going to get water and sat up and just started vomiting. That was when the patient noticed he couldn't stand up. At first thought it was ear infection but didn't have any ear pain. Name of medication was printed really small. It is in a foil pack and says Ondansetron orally disintegrating and has Pheny and a bunch of other letters are on there also. Manufacturer starts with an A and the letters are blurred out. Lot B/N000823024A Expiry May2027. The patient underwent the following laboratory tests and procedures: Body height: 6', notes: 6 feet; 5'10.5", notes: 5 feet 10 and a half; 5'11", notes: 5 feet 11. Therapeutic measures were taken as a result of vertigo, vomiting. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166339 same patient, different dose/event;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
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heart palpitations; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset Mar2021, outcome "unknown", described as "heart palpitations". Additional information: first couple of shots caller was sick the next day with heart palpitations.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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took her last injection of the Pfizer Covid 19 vaccine on Sep2024/was recently, last week, diagnosed with covid; took her last injection of the Pfizer Covid 19 vaccine on Sep2024/was recently, last week, diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Symbicort. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2025, outcome "unknown" and all described as "took her last injection of the Pfizer Covid 19 vaccine on Sep2024/was recently, last week, diagnosed with covid". The clinical course was reported as follows: The patient had not received any recent immunizations since last year (2024). The patient took her last injection of the Pfizer Covid 19 vaccine on Sep2024 and wanted to know if there was a new immunization available, with a different variant. Most of her injections were Pfizer, except for the first one that was Moderna. The patient was recently, last week, diagnosed with covid and, where she got her medication, they told her they run out of medication because it seemed everybody was getting covid. The patient never had covid since 2020 until last week. She didn't have it before, and she was not exposed to it. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: M
Vaccine: COVID19
Symptoms: Anosmia
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has no sense of smell post Covid vaccine in 2021; This is a spontaneous report received from an Other HCP. A 55-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious) with onset Jun2025, outcome "unknown", described as "has no sense of smell post Covid vaccine in 2021". It was unknown if therapeutic measures were taken as a result of anosmia.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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Positive for COVID-19; Positive for COVID-19; This is a spontaneous report received from a consumer, Program ID. A 42-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive for COVID-19". The event "positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. A day before the reporting, the patient's husband got a prescription to get nirmatrelvir/ritonavir (PAXLOVID) tablet for the patient. She got positive for COVID-19, and they had an appointment with the health provider, and he prescribed PAXLOVID tablet. The patient was really sick, she actually needs this medicine and that's why the provider prescribed it last night; the medicine is prescribed for 15 days. Now that the patient is already detected with COVID-19, the patient's husband asked after how many days they can take the COVID-19 vaccine again, because they missed it for the last two years, and in 2023 they had all the Pfizer vaccines, you know taken correctly with the booster, but for 2024 and 2025 they didn't take any vaccines, and looks like she just got diagnosed with COVID-19. So now, after this medicine course has been completed, the patient's husband asked if they could take the vaccine immediately, or they have to wait for maybe 16 or 30 days. The patient's husband thinks he will get the medicine now, because the patient was already having trouble, and then he'll talk to his healthcare provider.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity
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Gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP. A 17-year-old female patient received BNT162b2 (BNT162B2), on 30Jun2021 as dose 1, single (Lot number: EW0196) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased. Additional information: The reporter stated that every time the patient takes the vaccine, she gets a fever of around 103 and has always pain in arm. The patient is 21 (at the time of report). Every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and the reporter massaged it as gently as she could, not really pushing, just trying to make her feel better. When they came home from getting the vaccine, the patient was generally okay at first and then a couple of hours will go by and then she started getting really hot and flushed and her arm would hurt a lot; she was having a more of extreme pain in her arm and it was always in her left arm but the fever that she would get ranged somewhere between 102 and 104. She did go to 105 but was able to get it down pretty quickly with Tylenol. So, within half an hour she got down, but the fever has held on for a while.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167459 same patient, drug, and event, different dose;US-PFIZER INC-202500167457 same patient, drug, and event, different dose;US-PFIZER INC-202500167458 same reporter, patient, product, event; different dose;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
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Gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP. A 17-year-old female patient received BNT162b2 (BNT162B2), on 30Jun2021 as dose 1, single (Lot number: EW0196) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased. Additional information: The reporter stated that every time the patient takes the vaccine, she gets a fever of around 103 and has always pain in arm. The patient is 21 (at the time of report). Every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and the reporter massaged it as gently as she could, not really pushing, just trying to make her feel better. When they came home from getting the vaccine, the patient was generally okay at first and then a couple of hours will go by and then she started getting really hot and flushed and her arm would hurt a lot; she was having a more of extreme pain in her arm and it was always in her left arm but the fever that she would get ranged somewhere between 102 and 104. She did go to 105 but was able to get it down pretty quickly with Tylenol. So, within half an hour she got down, but the fever has held on for a while.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167459 same patient, drug, and event, different dose;US-PFIZER INC-202500167457 same patient, drug, and event, different dose;US-PFIZER INC-202500167458 same reporter, patient, product, event; different dose;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity
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Every time that she has ever gotten the vaccine, she has gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP. A 21-year-old female patient received BNT162b2 (BNT162B2), on 21Jul2021 as dose 2, single (Lot number: EW0181) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1; Lot: EW0196), administration date: 30Jun2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in arm", "Pain in her arm; Very hard for her to move it", "hot and flush", "hot and flush". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Every time that she has ever gotten the vaccine, she has gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased. Additional information: The patient has been receiving the Pfizer vaccine since COVID began, but every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and mother massaged it as gently as she could, trying to make her feel better. She was feeling tortured basically by getting the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167445 same reporter, patient, product, event; different dose;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
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Every time that she has ever gotten the vaccine, she has gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP. A 21-year-old female patient received BNT162b2 (BNT162B2), on 21Jul2021 as dose 2, single (Lot number: EW0181) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1; Lot: EW0196), administration date: 30Jun2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in arm", "Pain in her arm; Very hard for her to move it", "hot and flush", "hot and flush". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Every time that she has ever gotten the vaccine, she has gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased. Additional information: The patient has been receiving the Pfizer vaccine since COVID began, but every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and mother massaged it as gently as she could, trying to make her feel better. She was feeling tortured basically by getting the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167445 same reporter, patient, product, event; different dose;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity
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Every time that she has ever gotten the vaccine, she has gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP. A 21-year-old female patient received BNT162b2 (BNT162B2), on 06May2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 18 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1; Lot: EW0196), administration date: 30Jun2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "hot and flush", "hot and flush"; BNT162b2 (Dose: 2; Lot: EW0181), administration date: 21Jul2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "hot and flush", "hot and flush". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Every time that she has ever gotten the vaccine, she has gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased. Additional information: The patient has been receiving the Pfizer vaccine since COVID began, but every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and mother massaged it as gently as she could, trying to make her feel better. She was feeling tortured basically by getting the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167445 same reporter, patient, product, event; different dose;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
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Every time that she has ever gotten the vaccine, she has gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP. A 21-year-old female patient received BNT162b2 (BNT162B2), on 06May2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 18 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1; Lot: EW0196), administration date: 30Jun2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "hot and flush", "hot and flush"; BNT162b2 (Dose: 2; Lot: EW0181), administration date: 21Jul2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "hot and flush", "hot and flush". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Every time that she has ever gotten the vaccine, she has gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased. Additional information: The patient has been receiving the Pfizer vaccine since COVID began, but every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and mother massaged it as gently as she could, trying to make her feel better. She was feeling tortured basically by getting the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167445 same reporter, patient, product, event; different dose;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity
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Very high fever; between 102 and 104; fever of around 103; 105; Pain in her arm; very hard for her to move it; having a more of extreme pain in her arm; Pain in her arm; very hard for her to move it; having a more of extreme pain in her arm; Hot; Flush; This is a spontaneous report received from a consumer. A 19-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Mar2023 as dose 4 (booster), single (Lot number: GL0447) at the age of 19 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EW0196), administration date: 30Jun2021, when the patient was 17-year-old, for COVID-19 immunization, reaction(s): "Very high fever", "Pain in her arm", "Hot", "Flush", "Hard for her to move it (arm)"; BNT162b2 (DOSE 2; Lot Number: EW0181), administration date: 21Jul2021, when the patient was 17-year-old, for COVID-19 immunization, reaction(s): "Very high fever", "Pain in her arm", "Hot", "Flush", "Hard for her to move it (arm)"; BNT162b2 (DOSE 3 (BOOSTER); Lot Number: FM9992), administration date: 06May2022, when the patient was 18-year-old, for COVID-19 immunization, reaction(s): "Very high fever", "Pain in her arm", "Hot", "Flush", "Hard for her to move it (arm)". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Very high fever; between 102 and 104; fever of around 103; 105"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; very hard for her to move it; having a more of extreme pain in her arm"; FEELING HOT (non-serious), outcome "unknown", described as "Hot"; FLUSHING (non-serious), outcome "unknown", described as "Flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased. Additional Information: She is healthy, no other medication. The patient has taken the Comirnaty vaccine (Pfizer COVID-19 Vaccine) before or the Boosters (Pfizer COVID-19 Vaccine) and they said that every time she takes the vaccine, she gets a fever of around 103 and she was always in pain, her arm. So, the patient's mother wanted to go ahead and report that. The patient has been taking the Pfizer vaccine since COVID began, when they first started in Jun2021, but every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was at 104 and it's two days in bed. Even with naproxen or paracetamol (TYLENOL), the pain in her arm never ceased for the whole two days. It's very hard for her to move it and the patient's mother massaged it as gently as she could, not really pushing, just trying to make her feel better kind of thing. When they came home from getting the vaccine, she was generally okay at first and then a couple of hours will go by and then the patient started getting really hot and flush and her arm would hurt a lot more than the patient's mother. She was having a more of extreme pain in her arm and to the mother's memory it was always in her left arm but the fever that she would get ranged somewhere between 102 and 104. She did go to 105, but the mother was able to get it down pretty quickly when she gave the patient TYLENOL. So, within half an hour she got down, but the fever has held on for a while. She was feeling tortured basically by getting the vaccine, but the patient's mother had autoimmune diseases, so the patient knows that she has to take it. Financially, the patient is now in a different situation, she is currently 21 but she is in an appointment where they are not giving her medical insurance. So, she has no coverage, and she was trying to figure out, do they really fight to try and find help for her to getting the Pfizer vaccine or should she change vaccine at this point because this is what's happening every time the patient gets home.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167445 Same patient and product; different event and dose;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
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Very high fever; between 102 and 104; fever of around 103; 105; Pain in her arm; very hard for her to move it; having a more of extreme pain in her arm; Pain in her arm; very hard for her to move it; having a more of extreme pain in her arm; Hot; Flush; This is a spontaneous report received from a consumer. A 19-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Mar2023 as dose 4 (booster), single (Lot number: GL0447) at the age of 19 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EW0196), administration date: 30Jun2021, when the patient was 17-year-old, for COVID-19 immunization, reaction(s): "Very high fever", "Pain in her arm", "Hot", "Flush", "Hard for her to move it (arm)"; BNT162b2 (DOSE 2; Lot Number: EW0181), administration date: 21Jul2021, when the patient was 17-year-old, for COVID-19 immunization, reaction(s): "Very high fever", "Pain in her arm", "Hot", "Flush", "Hard for her to move it (arm)"; BNT162b2 (DOSE 3 (BOOSTER); Lot Number: FM9992), administration date: 06May2022, when the patient was 18-year-old, for COVID-19 immunization, reaction(s): "Very high fever", "Pain in her arm", "Hot", "Flush", "Hard for her to move it (arm)". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Very high fever; between 102 and 104; fever of around 103; 105"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; very hard for her to move it; having a more of extreme pain in her arm"; FEELING HOT (non-serious), outcome "unknown", described as "Hot"; FLUSHING (non-serious), outcome "unknown", described as "Flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased. Additional Information: She is healthy, no other medication. The patient has taken the Comirnaty vaccine (Pfizer COVID-19 Vaccine) before or the Boosters (Pfizer COVID-19 Vaccine) and they said that every time she takes the vaccine, she gets a fever of around 103 and she was always in pain, her arm. So, the patient's mother wanted to go ahead and report that. The patient has been taking the Pfizer vaccine since COVID began, when they first started in Jun2021, but every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was at 104 and it's two days in bed. Even with naproxen or paracetamol (TYLENOL), the pain in her arm never ceased for the whole two days. It's very hard for her to move it and the patient's mother massaged it as gently as she could, not really pushing, just trying to make her feel better kind of thing. When they came home from getting the vaccine, she was generally okay at first and then a couple of hours will go by and then the patient started getting really hot and flush and her arm would hurt a lot more than the patient's mother. She was having a more of extreme pain in her arm and to the mother's memory it was always in her left arm but the fever that she would get ranged somewhere between 102 and 104. She did go to 105, but the mother was able to get it down pretty quickly when she gave the patient TYLENOL. So, within half an hour she got down, but the fever has held on for a while. She was feeling tortured basically by getting the vaccine, but the patient's mother had autoimmune diseases, so the patient knows that she has to take it. Financially, the patient is now in a different situation, she is currently 21 but she is in an appointment where they are not giving her medical insurance. So, she has no coverage, and she was trying to figure out, do they really fight to try and find help for her to getting the Pfizer vaccine or should she change vaccine at this point because this is what's happening every time the patient gets home.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167445 Same patient and product; different event and dose;
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
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her arm would hurt a lot more than 'mine'; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune diseases" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm would hurt a lot more than 'mine'".
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bursitis, Shoulder injury related to vaccine administration
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Patient started having shoulder pain within 24 hours after receiving the shot. She took Ibuprofen by mouth as needed expecting it to get better. Pain continued so she sought medical attention on 12/31/2024 was diagnosed with bursitis (and was given a steroid shot in the left shoulder that helped for about 2 months then stared to ware off. Now her pain is back to being 10 /10 with no pain meds usually first thing in the morning after immobility for few hours. On good days with shoulder movement is 4/10. Patient has history of shoulder surgery but the pain experienced after the shot was sudden, severe and of a different nature suggesting it is SIRVA.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 79.0
Sex: M
Vaccine: COVID19, FLU3, TDAP, VARZOS
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Monoplegia, Neurological symptom
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ANCA-associated vasculitis, paralyzed left foot, stroke like symptoms (stroke was ruled out), hospitalized for multiple months
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
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Auto immune disease lupus doctor has prescribed me, methotrexate, hydroxychloroquine, and clobetasol
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: COVID19
Symptoms: Alopecia
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alopecia; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 14-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number ,unknown,single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "recovering". Batch/lot number is not provided, and it cannot be obtained. Additional information: Additional information: Caregiver stated that her daughter has alopecia and she was thinking maybe it was caused by Pfizer Covid19 vaccine but she can't prove it. She would like to know if there was any evidence that it can be caused by Pfizer Covid shot. Caregiver wanted to know the duration of treatment for Litfulo. She stated her daughter was taking Litfulo going on 2 years, should she continue taking it for for life. At Week 48: 43% of people taking LITFULO saw 80% or more scalp hair coverage." Caller is the mother of the patient her daughter was taking Litfulo going on for 2 years because she has alopecia. Caller mentioned that may be the alopecia was caused by the Pfizer Covid-19 vaccine. The caller verified the information provided by the transferring agent. Caller said that a doctor mentioned and said that alopecia can be caused by vaccines. She got the vaccine less than a year before developing alopecia. Alopecia started in October or Nov2022, and her went on Litfulo in 2024. She received the Covid-19 Vaccine in 2021 and never had alopecia before that or any health issues prior to that. Caller said that Litfulo is working great. Her daughter only has one place in the back of her head that is not growing back. If it was the covid shot that could cause alopecia, can it be reversed. She spoke to authority about this and there was nothing that they have found and nothing has been reported. Her daughter never had covid and never had anything health related. The report was filed with the information provided by the transferring agent and the caller.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 60.0
Sex: M
Vaccine: PNC21
Symptoms: Blood test, Chest X-ray normal, Computerised tomogram head normal, Gait disturbance, Guillain-Barre syndrome
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Muscles in my legs gave out, unable to walk without crutches or walker; hospitalized and diagnosed with GBS, given IVIG treatment over three days and have started improving with 10 days on in patient rehab
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 60.0
Sex: M
Vaccine: PNC21
Symptoms: Immunoglobulin therapy, Laboratory test, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Muscular weakness
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Muscles in my legs gave out, unable to walk without crutches or walker; hospitalized and diagnosed with GBS, given IVIG treatment over three days and have started improving with 10 days on in patient rehab
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 60.0
Sex: M
Vaccine: PNC21
Symptoms: Reflex test, Vibration test, Walking aid user
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Muscles in my legs gave out, unable to walk without crutches or walker; hospitalized and diagnosed with GBS, given IVIG treatment over three days and have started improving with 10 days on in patient rehab
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 77.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Pain in extremity
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Patient received a second dose of Arexvy outside of current CDC recommendations. They did not have any side effects other than a sore arm.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute left ventricular failure, Asthenia, Atrial fibrillation, Breast cancer stage IV, Cardiac ablation
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5/3/2021 - Saw patient for diagnosed dyspenea on exertion. Rx for 5 mg Lisinopril. 7/24/2021 - Urgent care for fatigue. cough, and congestion. 7/30/21 - Urgent care for fatigue. cough, and congestion. 8/19/2021 - Increase Rx for depression. 2/1/2022 - Ejection fraction still low, so Cardiology Referral. 2/18/2022 - Dr. at hospital. Acute systolic CHF and 1 year fatigue. Rx for Toprol 25 mg. 3/16/2022 - Fall with head split open. ER noted patient was in AFIB. May 2022 - Patient had a heart monitor installed. Dr. at hospital. 8/28/2023 - Biventricular PPM and AV node ablation. Pacemaker installed. 3/11/2024 - 3/18/2024 - Hospital pacemaker upgrade to biventricular CRT on 3/15/2024. Hospital inpatient stay. Low energy and fatigue. 3/25/2024 - 3/26/2024 - Dislodged pacemaker lead extracted and replaced. Hospital inpatient stay. 4/25/2024 - 4/27/2024 - Hospitalization for heart medication changes since still low energy and fatigued. 5/7/2024 - 5/13/2024 - Hospitalization for procedures and heart medication changes since still low energy and fatigued. 5/20/2024 - 5/23/2024 - Diagnosed with BLE Edema for lower extremities. Given Lasix as blood thinner. Low energy and fatigue. 7/1/2025 - 7/3/2025 - Chest wall mass identified and suspected as a hematoma from pacemaker lead drips. Surgery scheduled to wash away the hematoma. 7/11/2025 - 7/12/2025 - During surgery chest wall mass identified as a tumor and cut-out by heart surgeon. July 2025 - Tumor identified as Triple Negative Breast Cancer. August of 2025 - No chemo or radiation suggested at 87 years old, so sent to palliative care with diagnosis of Stage 4 Breast Cancer.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac monitoring, Cardiac resynchronisation therapy, Chest X-ray normal, Chest wall mass, Cough
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5/3/2021 - Saw patient for diagnosed dyspenea on exertion. Rx for 5 mg Lisinopril. 7/24/2021 - Urgent care for fatigue. cough, and congestion. 7/30/21 - Urgent care for fatigue. cough, and congestion. 8/19/2021 - Increase Rx for depression. 2/1/2022 - Ejection fraction still low, so Cardiology Referral. 2/18/2022 - Dr. at hospital. Acute systolic CHF and 1 year fatigue. Rx for Toprol 25 mg. 3/16/2022 - Fall with head split open. ER noted patient was in AFIB. May 2022 - Patient had a heart monitor installed. Dr. at hospital. 8/28/2023 - Biventricular PPM and AV node ablation. Pacemaker installed. 3/11/2024 - 3/18/2024 - Hospital pacemaker upgrade to biventricular CRT on 3/15/2024. Hospital inpatient stay. Low energy and fatigue. 3/25/2024 - 3/26/2024 - Dislodged pacemaker lead extracted and replaced. Hospital inpatient stay. 4/25/2024 - 4/27/2024 - Hospitalization for heart medication changes since still low energy and fatigued. 5/7/2024 - 5/13/2024 - Hospitalization for procedures and heart medication changes since still low energy and fatigued. 5/20/2024 - 5/23/2024 - Diagnosed with BLE Edema for lower extremities. Given Lasix as blood thinner. Low energy and fatigue. 7/1/2025 - 7/3/2025 - Chest wall mass identified and suspected as a hematoma from pacemaker lead drips. Surgery scheduled to wash away the hematoma. 7/11/2025 - 7/12/2025 - During surgery chest wall mass identified as a tumor and cut-out by heart surgeon. July 2025 - Tumor identified as Triple Negative Breast Cancer. August of 2025 - No chemo or radiation suggested at 87 years old, so sent to palliative care with diagnosis of Stage 4 Breast Cancer.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Depression, Dyspnoea exertional, Ejection fraction decreased, Fall, Fatigue
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5/3/2021 - Saw patient for diagnosed dyspenea on exertion. Rx for 5 mg Lisinopril. 7/24/2021 - Urgent care for fatigue. cough, and congestion. 7/30/21 - Urgent care for fatigue. cough, and congestion. 8/19/2021 - Increase Rx for depression. 2/1/2022 - Ejection fraction still low, so Cardiology Referral. 2/18/2022 - Dr. at hospital. Acute systolic CHF and 1 year fatigue. Rx for Toprol 25 mg. 3/16/2022 - Fall with head split open. ER noted patient was in AFIB. May 2022 - Patient had a heart monitor installed. Dr. at hospital. 8/28/2023 - Biventricular PPM and AV node ablation. Pacemaker installed. 3/11/2024 - 3/18/2024 - Hospital pacemaker upgrade to biventricular CRT on 3/15/2024. Hospital inpatient stay. Low energy and fatigue. 3/25/2024 - 3/26/2024 - Dislodged pacemaker lead extracted and replaced. Hospital inpatient stay. 4/25/2024 - 4/27/2024 - Hospitalization for heart medication changes since still low energy and fatigued. 5/7/2024 - 5/13/2024 - Hospitalization for procedures and heart medication changes since still low energy and fatigued. 5/20/2024 - 5/23/2024 - Diagnosed with BLE Edema for lower extremities. Given Lasix as blood thinner. Low energy and fatigue. 7/1/2025 - 7/3/2025 - Chest wall mass identified and suspected as a hematoma from pacemaker lead drips. Surgery scheduled to wash away the hematoma. 7/11/2025 - 7/12/2025 - During surgery chest wall mass identified as a tumor and cut-out by heart surgeon. July 2025 - Tumor identified as Triple Negative Breast Cancer. August of 2025 - No chemo or radiation suggested at 87 years old, so sent to palliative care with diagnosis of Stage 4 Breast Cancer.
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lead dislodgement, Mass excision, Oedema peripheral, Respiratory tract congestion, SARS-CoV-2 test negative
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5/3/2021 - Saw patient for diagnosed dyspenea on exertion. Rx for 5 mg Lisinopril. 7/24/2021 - Urgent care for fatigue. cough, and congestion. 7/30/21 - Urgent care for fatigue. cough, and congestion. 8/19/2021 - Increase Rx for depression. 2/1/2022 - Ejection fraction still low, so Cardiology Referral. 2/18/2022 - Dr. at hospital. Acute systolic CHF and 1 year fatigue. Rx for Toprol 25 mg. 3/16/2022 - Fall with head split open. ER noted patient was in AFIB. May 2022 - Patient had a heart monitor installed. Dr. at hospital. 8/28/2023 - Biventricular PPM and AV node ablation. Pacemaker installed. 3/11/2024 - 3/18/2024 - Hospital pacemaker upgrade to biventricular CRT on 3/15/2024. Hospital inpatient stay. Low energy and fatigue. 3/25/2024 - 3/26/2024 - Dislodged pacemaker lead extracted and replaced. Hospital inpatient stay. 4/25/2024 - 4/27/2024 - Hospitalization for heart medication changes since still low energy and fatigued. 5/7/2024 - 5/13/2024 - Hospitalization for procedures and heart medication changes since still low energy and fatigued. 5/20/2024 - 5/23/2024 - Diagnosed with BLE Edema for lower extremities. Given Lasix as blood thinner. Low energy and fatigue. 7/1/2025 - 7/3/2025 - Chest wall mass identified and suspected as a hematoma from pacemaker lead drips. Surgery scheduled to wash away the hematoma. 7/11/2025 - 7/12/2025 - During surgery chest wall mass identified as a tumor and cut-out by heart surgeon. July 2025 - Tumor identified as Triple Negative Breast Cancer. August of 2025 - No chemo or radiation suggested at 87 years old, so sent to palliative care with diagnosis of Stage 4 Breast Cancer.
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Skin laceration, Triple negative breast cancer
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5/3/2021 - Saw patient for diagnosed dyspenea on exertion. Rx for 5 mg Lisinopril. 7/24/2021 - Urgent care for fatigue. cough, and congestion. 7/30/21 - Urgent care for fatigue. cough, and congestion. 8/19/2021 - Increase Rx for depression. 2/1/2022 - Ejection fraction still low, so Cardiology Referral. 2/18/2022 - Dr. at hospital. Acute systolic CHF and 1 year fatigue. Rx for Toprol 25 mg. 3/16/2022 - Fall with head split open. ER noted patient was in AFIB. May 2022 - Patient had a heart monitor installed. Dr. at hospital. 8/28/2023 - Biventricular PPM and AV node ablation. Pacemaker installed. 3/11/2024 - 3/18/2024 - Hospital pacemaker upgrade to biventricular CRT on 3/15/2024. Hospital inpatient stay. Low energy and fatigue. 3/25/2024 - 3/26/2024 - Dislodged pacemaker lead extracted and replaced. Hospital inpatient stay. 4/25/2024 - 4/27/2024 - Hospitalization for heart medication changes since still low energy and fatigued. 5/7/2024 - 5/13/2024 - Hospitalization for procedures and heart medication changes since still low energy and fatigued. 5/20/2024 - 5/23/2024 - Diagnosed with BLE Edema for lower extremities. Given Lasix as blood thinner. Low energy and fatigue. 7/1/2025 - 7/3/2025 - Chest wall mass identified and suspected as a hematoma from pacemaker lead drips. Surgery scheduled to wash away the hematoma. 7/11/2025 - 7/12/2025 - During surgery chest wall mass identified as a tumor and cut-out by heart surgeon. July 2025 - Tumor identified as Triple Negative Breast Cancer. August of 2025 - No chemo or radiation suggested at 87 years old, so sent to palliative care with diagnosis of Stage 4 Breast Cancer.
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Arthralgia, Bladder dysfunction, Computerised tomogram, Dysstasia
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I started to feel something around late October of 2021. My hand was tingling and then is spread throughout my body, my hands, legs were numb, anything brushing up against my skin was extremely painful, I couldn't walk straight, then my left leg went completely limp
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Functional gastrointestinal disorder, Gait disturbance, Hypoaesthesia, Hypotonia
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I started to feel something around late October of 2021. My hand was tingling and then is spread throughout my body, my hands, legs were numb, anything brushing up against my skin was extremely painful, I couldn't walk straight, then my left leg went completely limp
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Lumbar puncture, Magnetic resonance imaging, Monoplegia, Muscular weakness
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I started to feel something around late October of 2021. My hand was tingling and then is spread throughout my body, my hands, legs were numb, anything brushing up against my skin was extremely painful, I couldn't walk straight, then my left leg went completely limp
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myelitis transverse, Necrosis, Nerve injury, Neuralgia, Neuritis
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I started to feel something around late October of 2021. My hand was tingling and then is spread throughout my body, my hands, legs were numb, anything brushing up against my skin was extremely painful, I couldn't walk straight, then my left leg went completely limp
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuromyelitis optica spectrum disorder, Pain, Pain of skin, Paraesthesia, Sjogren's syndrome
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I started to feel something around late October of 2021. My hand was tingling and then is spread throughout my body, my hands, legs were numb, anything brushing up against my skin was extremely painful, I couldn't walk straight, then my left leg went completely limp
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheelchair user, X-ray
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I started to feel something around late October of 2021. My hand was tingling and then is spread throughout my body, my hands, legs were numb, anything brushing up against my skin was extremely painful, I couldn't walk straight, then my left leg went completely limp
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 53.0
Sex: F
Vaccine: COVID19, FLU3, PNC21
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Neck pain
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I'm not sure about my selections above - I received the seasonal flu and COVID vaccines in my left arm and the pneumonia vaccine in my right arm. In the first few hours, I experienced the expected tenderness-to-the-touch in the COVID/flu left arm and in the pneumonia/right arm. Around 1:30AM on Saturday morning, I woke up with pain on the right side of my neck and right shoulder that made it difficult to move or get out of bed. I stayed in bed most of Saturday with pain, getting up only to use the restroom. I took Tylenol for the pain and got up around 4P on Saturday, feeling a little bit better. The neck pain on the right side continued through Saturday night and remains as I write this on Sunday morning. I expect to feel back to normal by Monday. This has been strange because I have never experienced an adverse reaction to a vaccine.
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 88.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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Patient reported soreness after injection. Area started to get red around the size of an egg on the arm on Friday morning, the next day. On Saturday it spread to a bigger area. It was redness, warmth, tenderness, and swollen. Recommendation patient seen by urgent care and/call primary provider.
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Headache, Pain, Pyrexia, Rhinorrhoea
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Starting about 36 hours later, severe body aches and severe headache, 102 fever, runny nose, exhaustion. At 48 hours fever 101.5
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Age: 80.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Extra dose administered, No adverse event
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NO ADVERSE EVENT REPORTED. THE PATIENT HAS ON RECORD 2 RSV Vaccinations. The patient received ABRYSVO on 12/3/23 and AREXVY on 10/28/2024.
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: RAB, RAB
Symptoms: Bacterial test, Computerised tomogram, Confusional state, Contrast echocardiogram, Decreased appetite
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Patient was hospitalized with diagnosis of stroke due to blood clot; Patient received RabAvert vaccine in intragluteal site; Pleocytosis; Case reference number US-BN-2025-001405 is a spontaneous case initially received from a pharmacist via MedComm (reference number: USBAV25-2040) on 15-Aug-2025 and concerns an 82-year-old female patient. The patient's medical history included history of chronic lymphomatic leukemia (CLL) and atrial fibrillation with coagulation. The patient's concomitant medication details included Eliquis for anticoagulation. On 25-Jul-2025, the patient was bitten by a dog. On the same day, the patient received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683; expiration date: 20-Nov-2027), at 1 mL, via unknown route reported as gluteal, for indication post exposure to dog bite. The patient also received wound care and antibiotics, but no immunoglobulin G (IGG). The dog had been vaccinated. (explicitly coded as 'vaccine administered at inappropriate site') On 31-Jul-2025, six days after the first dose of RabAvert, the patient came back to the hospital as her family had concerns of weakness. The family was very concerned that the neurological decline occurred shortly after the patient receiving the vaccine and then the patient continued to decline to the point that they brought the patient in. Patient was transferred to the rehab unit (to be confirmed). CT imaging was performed, and no clot was seen. Subsequent imaging detected a clot. On the same day, the patient experienced a stroke due to blood clot and patient was hospitalized. Providers seem to attribute the stroke to the clot. On 06-Aug-2025, a lumbar puncture was obtained. The report states: Pleocytosis, including many lymphocytes and monocytes and occasional neutrophils with rare glial cells, the patient has a history of CLL (Chronic lymphocytic leukaemia) but it is negative for malignancy. At the time of the initial report, the events of 'stroke', and 'pleocytosis' were still ongoing and the patient remains admitted to the hospital rehab unit. The reporter assessed the events of 'stroke', and 'pleocytosis' as serious due to seriousness criteria of hospitalization. However, event of 'stroke' was assessed as serious due to seriousness criteria of medical significance. The reporter provided causality assessment as unknown. The reporter did hypothesize an alternate explanation for the stroke, as follows: Did the patient stop taking it (Eliquis) when she had been bitten by a dog and her wound was maybe oozing and there was some kind of, you know, not compliance with her anticoagulation. And could that have contributed as well? No further information was provided.; Reporter's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.; Sender's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.
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Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: RAB, RAB
Symptoms: Disorientation, Dizziness, Encephalitis, Fungal test, Insomnia
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Patient was hospitalized with diagnosis of stroke due to blood clot; Patient received RabAvert vaccine in intragluteal site; Pleocytosis; Case reference number US-BN-2025-001405 is a spontaneous case initially received from a pharmacist via MedComm (reference number: USBAV25-2040) on 15-Aug-2025 and concerns an 82-year-old female patient. The patient's medical history included history of chronic lymphomatic leukemia (CLL) and atrial fibrillation with coagulation. The patient's concomitant medication details included Eliquis for anticoagulation. On 25-Jul-2025, the patient was bitten by a dog. On the same day, the patient received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683; expiration date: 20-Nov-2027), at 1 mL, via unknown route reported as gluteal, for indication post exposure to dog bite. The patient also received wound care and antibiotics, but no immunoglobulin G (IGG). The dog had been vaccinated. (explicitly coded as 'vaccine administered at inappropriate site') On 31-Jul-2025, six days after the first dose of RabAvert, the patient came back to the hospital as her family had concerns of weakness. The family was very concerned that the neurological decline occurred shortly after the patient receiving the vaccine and then the patient continued to decline to the point that they brought the patient in. Patient was transferred to the rehab unit (to be confirmed). CT imaging was performed, and no clot was seen. Subsequent imaging detected a clot. On the same day, the patient experienced a stroke due to blood clot and patient was hospitalized. Providers seem to attribute the stroke to the clot. On 06-Aug-2025, a lumbar puncture was obtained. The report states: Pleocytosis, including many lymphocytes and monocytes and occasional neutrophils with rare glial cells, the patient has a history of CLL (Chronic lymphocytic leukaemia) but it is negative for malignancy. At the time of the initial report, the events of 'stroke', and 'pleocytosis' were still ongoing and the patient remains admitted to the hospital rehab unit. The reporter assessed the events of 'stroke', and 'pleocytosis' as serious due to seriousness criteria of hospitalization. However, event of 'stroke' was assessed as serious due to seriousness criteria of medical significance. The reporter provided causality assessment as unknown. The reporter did hypothesize an alternate explanation for the stroke, as follows: Did the patient stop taking it (Eliquis) when she had been bitten by a dog and her wound was maybe oozing and there was some kind of, you know, not compliance with her anticoagulation. And could that have contributed as well? No further information was provided.; Reporter's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.; Sender's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.
|
Generate a clinical symptom description based on the patient and vaccine information provided
|
Sex: F
Vaccine: RAB, RAB
Symptoms: Laboratory test, Lumbar puncture abnormal, Magnetic resonance imaging, Malaise, Mental status changes
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Patient was hospitalized with diagnosis of stroke due to blood clot; Patient received RabAvert vaccine in intragluteal site; Pleocytosis; Case reference number US-BN-2025-001405 is a spontaneous case initially received from a pharmacist via MedComm (reference number: USBAV25-2040) on 15-Aug-2025 and concerns an 82-year-old female patient. The patient's medical history included history of chronic lymphomatic leukemia (CLL) and atrial fibrillation with coagulation. The patient's concomitant medication details included Eliquis for anticoagulation. On 25-Jul-2025, the patient was bitten by a dog. On the same day, the patient received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683; expiration date: 20-Nov-2027), at 1 mL, via unknown route reported as gluteal, for indication post exposure to dog bite. The patient also received wound care and antibiotics, but no immunoglobulin G (IGG). The dog had been vaccinated. (explicitly coded as 'vaccine administered at inappropriate site') On 31-Jul-2025, six days after the first dose of RabAvert, the patient came back to the hospital as her family had concerns of weakness. The family was very concerned that the neurological decline occurred shortly after the patient receiving the vaccine and then the patient continued to decline to the point that they brought the patient in. Patient was transferred to the rehab unit (to be confirmed). CT imaging was performed, and no clot was seen. Subsequent imaging detected a clot. On the same day, the patient experienced a stroke due to blood clot and patient was hospitalized. Providers seem to attribute the stroke to the clot. On 06-Aug-2025, a lumbar puncture was obtained. The report states: Pleocytosis, including many lymphocytes and monocytes and occasional neutrophils with rare glial cells, the patient has a history of CLL (Chronic lymphocytic leukaemia) but it is negative for malignancy. At the time of the initial report, the events of 'stroke', and 'pleocytosis' were still ongoing and the patient remains admitted to the hospital rehab unit. The reporter assessed the events of 'stroke', and 'pleocytosis' as serious due to seriousness criteria of hospitalization. However, event of 'stroke' was assessed as serious due to seriousness criteria of medical significance. The reporter provided causality assessment as unknown. The reporter did hypothesize an alternate explanation for the stroke, as follows: Did the patient stop taking it (Eliquis) when she had been bitten by a dog and her wound was maybe oozing and there was some kind of, you know, not compliance with her anticoagulation. And could that have contributed as well? No further information was provided.; Reporter's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.; Sender's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: RAB, RAB
Symptoms: Product administered at inappropriate site
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Patient was hospitalized with diagnosis of stroke due to blood clot; Patient received RabAvert vaccine in intragluteal site; Pleocytosis; Case reference number US-BN-2025-001405 is a spontaneous case initially received from a pharmacist via MedComm (reference number: USBAV25-2040) on 15-Aug-2025 and concerns an 82-year-old female patient. The patient's medical history included history of chronic lymphomatic leukemia (CLL) and atrial fibrillation with coagulation. The patient's concomitant medication details included Eliquis for anticoagulation. On 25-Jul-2025, the patient was bitten by a dog. On the same day, the patient received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683; expiration date: 20-Nov-2027), at 1 mL, via unknown route reported as gluteal, for indication post exposure to dog bite. The patient also received wound care and antibiotics, but no immunoglobulin G (IGG). The dog had been vaccinated. (explicitly coded as 'vaccine administered at inappropriate site') On 31-Jul-2025, six days after the first dose of RabAvert, the patient came back to the hospital as her family had concerns of weakness. The family was very concerned that the neurological decline occurred shortly after the patient receiving the vaccine and then the patient continued to decline to the point that they brought the patient in. Patient was transferred to the rehab unit (to be confirmed). CT imaging was performed, and no clot was seen. Subsequent imaging detected a clot. On the same day, the patient experienced a stroke due to blood clot and patient was hospitalized. Providers seem to attribute the stroke to the clot. On 06-Aug-2025, a lumbar puncture was obtained. The report states: Pleocytosis, including many lymphocytes and monocytes and occasional neutrophils with rare glial cells, the patient has a history of CLL (Chronic lymphocytic leukaemia) but it is negative for malignancy. At the time of the initial report, the events of 'stroke', and 'pleocytosis' were still ongoing and the patient remains admitted to the hospital rehab unit. The reporter assessed the events of 'stroke', and 'pleocytosis' as serious due to seriousness criteria of hospitalization. However, event of 'stroke' was assessed as serious due to seriousness criteria of medical significance. The reporter provided causality assessment as unknown. The reporter did hypothesize an alternate explanation for the stroke, as follows: Did the patient stop taking it (Eliquis) when she had been bitten by a dog and her wound was maybe oozing and there was some kind of, you know, not compliance with her anticoagulation. And could that have contributed as well? No further information was provided.; Reporter's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.; Sender's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: RAB, RAB
Symptoms: Asthenia, CSF lymphocyte count increased, CSF monocyte count increased, Cerebral thrombosis, Cerebrovascular accident
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Patient was hospitalized with diagnosis of stroke due to blood clot; Patient received RabAvert vaccine in intragluteal site; Pleocytosis; Case reference number US-BN-2025-001405 is a spontaneous case initially received from a pharmacist via MedComm (reference number: USBAV25-2040) on 15-Aug-2025 and concerns an 82-year-old female patient. The patient's medical history included history of chronic lymphomatic leukemia (CLL) and atrial fibrillation with coagulation. The patient's concomitant medication details included Eliquis for anticoagulation. On 25-Jul-2025, the patient was bitten by a dog. On the same day, the patient received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683; expiration date: 20-Nov-2027), at 1 mL, via unknown route reported as gluteal, for indication post exposure to dog bite. The patient also received wound care and antibiotics, but no immunoglobulin G (IGG). The dog had been vaccinated. (explicitly coded as 'vaccine administered at inappropriate site') On 31-Jul-2025, six days after the first dose of RabAvert, the patient came back to the hospital as her family had concerns of weakness. The family was very concerned that the neurological decline occurred shortly after the patient receiving the vaccine and then the patient continued to decline to the point that they brought the patient in. Patient was transferred to the rehab unit (to be confirmed). CT imaging was performed, and no clot was seen. Subsequent imaging detected a clot. On the same day, the patient experienced a stroke due to blood clot and patient was hospitalized. Providers seem to attribute the stroke to the clot. On 06-Aug-2025, a lumbar puncture was obtained. The report states: Pleocytosis, including many lymphocytes and monocytes and occasional neutrophils with rare glial cells, the patient has a history of CLL (Chronic lymphocytic leukaemia) but it is negative for malignancy. At the time of the initial report, the events of 'stroke', and 'pleocytosis' were still ongoing and the patient remains admitted to the hospital rehab unit. The reporter assessed the events of 'stroke', and 'pleocytosis' as serious due to seriousness criteria of hospitalization. However, event of 'stroke' was assessed as serious due to seriousness criteria of medical significance. The reporter provided causality assessment as unknown. The reporter did hypothesize an alternate explanation for the stroke, as follows: Did the patient stop taking it (Eliquis) when she had been bitten by a dog and her wound was maybe oozing and there was some kind of, you know, not compliance with her anticoagulation. And could that have contributed as well? No further information was provided.; Reporter's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.; Sender's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Sex: F
Vaccine: RAB, RAB
Symptoms: Computerised tomogram head abnormal, Lumbar puncture abnormal, Pleocytosis, Product administered at inappropriate site
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Patient was hospitalized with diagnosis of stroke due to blood clot; Patient received RabAvert vaccine in intragluteal site; Pleocytosis; Case reference number US-BN-2025-001405 is a spontaneous case initially received from a pharmacist via MedComm (reference number: USBAV25-2040) on 15-Aug-2025 and concerns an 82-year-old female patient. The patient's medical history included history of chronic lymphomatic leukemia (CLL) and atrial fibrillation with coagulation. The patient's concomitant medication details included Eliquis for anticoagulation. On 25-Jul-2025, the patient was bitten by a dog. On the same day, the patient received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683; expiration date: 20-Nov-2027), at 1 mL, via unknown route reported as gluteal, for indication post exposure to dog bite. The patient also received wound care and antibiotics, but no immunoglobulin G (IGG). The dog had been vaccinated. (explicitly coded as 'vaccine administered at inappropriate site') On 31-Jul-2025, six days after the first dose of RabAvert, the patient came back to the hospital as her family had concerns of weakness. The family was very concerned that the neurological decline occurred shortly after the patient receiving the vaccine and then the patient continued to decline to the point that they brought the patient in. Patient was transferred to the rehab unit (to be confirmed). CT imaging was performed, and no clot was seen. Subsequent imaging detected a clot. On the same day, the patient experienced a stroke due to blood clot and patient was hospitalized. Providers seem to attribute the stroke to the clot. On 06-Aug-2025, a lumbar puncture was obtained. The report states: Pleocytosis, including many lymphocytes and monocytes and occasional neutrophils with rare glial cells, the patient has a history of CLL (Chronic lymphocytic leukaemia) but it is negative for malignancy. At the time of the initial report, the events of 'stroke', and 'pleocytosis' were still ongoing and the patient remains admitted to the hospital rehab unit. The reporter assessed the events of 'stroke', and 'pleocytosis' as serious due to seriousness criteria of hospitalization. However, event of 'stroke' was assessed as serious due to seriousness criteria of medical significance. The reporter provided causality assessment as unknown. The reporter did hypothesize an alternate explanation for the stroke, as follows: Did the patient stop taking it (Eliquis) when she had been bitten by a dog and her wound was maybe oozing and there was some kind of, you know, not compliance with her anticoagulation. And could that have contributed as well? No further information was provided.; Reporter's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.; Sender's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: RVX, RVX
Symptoms: Dysphagia, Gastrointestinal tube insertion, Guillain-Barre syndrome, Movement disorder, Neurological symptom
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Guillain-Barre syndrome; total body paralysis from feet to eyes/ could not move or swallow; Severe nerve reaction; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria GSK medically significant), quadraplegic (Verbatim: total body paralysis from feet to eyes/ could not move or swallow) (serious criteria GSK medically significant) and neurologic reaction (Verbatim: Severe nerve reaction). The outcome of the guillain barre syndrome, quadraplegic and neurologic reaction were not reported. It was unknown if the reporter considered the guillain barre syndrome, quadraplegic and neurologic reaction to be related to RSV vaccine. The company considered the guillain barre syndrome, quadraplegic and neurologic reaction to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine and had a severe nerve reaction. By the end of the week the patient was in the emergency room with Guillain-Barre syndrome. One of the first questions that was asked was if patient had gotten the RSV vaccine. The patient eventually had total body paralysis from his/her feet to his/her eyes. The patient could not move or swallow. The patient used feeding tube and months in rehab to learn how to walk again. The patient advised to not get this vaccine.; Sender's Comments: A case of Guillain-Barre syndrome and Quadriplegia, on an unknown date after receiving RSV vaccine in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: RVX, RVX
Symptoms: Quadriplegia
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Guillain-Barre syndrome; total body paralysis from feet to eyes/ could not move or swallow; Severe nerve reaction; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria GSK medically significant), quadraplegic (Verbatim: total body paralysis from feet to eyes/ could not move or swallow) (serious criteria GSK medically significant) and neurologic reaction (Verbatim: Severe nerve reaction). The outcome of the guillain barre syndrome, quadraplegic and neurologic reaction were not reported. It was unknown if the reporter considered the guillain barre syndrome, quadraplegic and neurologic reaction to be related to RSV vaccine. The company considered the guillain barre syndrome, quadraplegic and neurologic reaction to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine and had a severe nerve reaction. By the end of the week the patient was in the emergency room with Guillain-Barre syndrome. One of the first questions that was asked was if patient had gotten the RSV vaccine. The patient eventually had total body paralysis from his/her feet to his/her eyes. The patient could not move or swallow. The patient used feeding tube and months in rehab to learn how to walk again. The patient advised to not get this vaccine.; Sender's Comments: A case of Guillain-Barre syndrome and Quadriplegia, on an unknown date after receiving RSV vaccine in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: RVX, RVX
Symptoms: Gait inability, Gastrointestinal tube insertion, Guillain-Barre syndrome, Paralysis
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Guillain-Barre syndrome; total body paralysis from feet to eyes/ could not move or swallow; Severe nerve reaction; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria GSK medically significant), quadraplegic (Verbatim: total body paralysis from feet to eyes/ could not move or swallow) (serious criteria GSK medically significant) and neurologic reaction (Verbatim: Severe nerve reaction). The outcome of the guillain barre syndrome, quadraplegic and neurologic reaction were not reported. It was unknown if the reporter considered the guillain barre syndrome, quadraplegic and neurologic reaction to be related to RSV vaccine. The company considered the guillain barre syndrome, quadraplegic and neurologic reaction to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine and had a severe nerve reaction. By the end of the week the patient was in the emergency room with Guillain-Barre syndrome. One of the first questions that was asked was if patient had gotten the RSV vaccine. The patient eventually had total body paralysis from his/her feet to his/her eyes. The patient could not move or swallow. The patient used feeding tube and months in rehab to learn how to walk again. The patient advised to not get this vaccine.; Sender's Comments: A case of Guillain-Barre syndrome and Quadriplegia, on an unknown date after receiving RSV vaccine in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: RVX, RVX
Symptoms: Dysphagia, Gastrointestinal tube insertion, Guillain-Barre syndrome, Movement disorder, Neurological symptom
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Guillian-Barre Syndrome; paralyzed from my eyes to my feet; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 23-DEC-2024, the patient received RSV vaccine. In DEC-2024, less than 2 weeks after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillian-Barre Syndrome) (serious criteria GSK medically significant and life threatening) and paralysis (Verbatim: paralyzed from my eyes to my feet) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome and paralysis were not reported. It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to RSV vaccine. The company considered the guillain barre syndrome and paralysis to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 09-AUG-2025 This case was reported by a patient via interactive digital media. The patient stated the Respiratory Syncytial Virus vaccine almost killed her/him. The patient received Respiratory Syncytial Virus vaccine. and on new year's evening he/she was in the emergency room with severe, near fatal case of guillian-barre syndrome, paralyzed from his/her eyes to feet. The first thing that they asked him/her in the emergency room was if he/she had gotten the Respiratory Syncytial Virus vaccine. Feeding tube and months of rehabilitation later, to learn how to walk again, luckily, he/she survived.; Sender's Comments: A case of Guillain-Barre syndrome, less than 2 weeks after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: RVX, RVX
Symptoms: Quadriplegia
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Guillian-Barre Syndrome; paralyzed from my eyes to my feet; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 23-DEC-2024, the patient received RSV vaccine. In DEC-2024, less than 2 weeks after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillian-Barre Syndrome) (serious criteria GSK medically significant and life threatening) and paralysis (Verbatim: paralyzed from my eyes to my feet) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome and paralysis were not reported. It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to RSV vaccine. The company considered the guillain barre syndrome and paralysis to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 09-AUG-2025 This case was reported by a patient via interactive digital media. The patient stated the Respiratory Syncytial Virus vaccine almost killed her/him. The patient received Respiratory Syncytial Virus vaccine. and on new year's evening he/she was in the emergency room with severe, near fatal case of guillian-barre syndrome, paralyzed from his/her eyes to feet. The first thing that they asked him/her in the emergency room was if he/she had gotten the Respiratory Syncytial Virus vaccine. Feeding tube and months of rehabilitation later, to learn how to walk again, luckily, he/she survived.; Sender's Comments: A case of Guillain-Barre syndrome, less than 2 weeks after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: RVX, RVX
Symptoms: Gait inability, Gastrointestinal tube insertion, Guillain-Barre syndrome, Paralysis
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Guillian-Barre Syndrome; paralyzed from my eyes to my feet; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On 23-DEC-2024, the patient received RSV vaccine. In DEC-2024, less than 2 weeks after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillian-Barre Syndrome) (serious criteria GSK medically significant and life threatening) and paralysis (Verbatim: paralyzed from my eyes to my feet) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome and paralysis were not reported. It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to RSV vaccine. The company considered the guillain barre syndrome and paralysis to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 09-AUG-2025 This case was reported by a patient via interactive digital media. The patient stated the Respiratory Syncytial Virus vaccine almost killed her/him. The patient received Respiratory Syncytial Virus vaccine. and on new year's evening he/she was in the emergency room with severe, near fatal case of guillian-barre syndrome, paralyzed from his/her eyes to feet. The first thing that they asked him/her in the emergency room was if he/she had gotten the Respiratory Syncytial Virus vaccine. Feeding tube and months of rehabilitation later, to learn how to walk again, luckily, he/she survived.; Sender's Comments: A case of Guillain-Barre syndrome, less than 2 weeks after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
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Generate a clinical symptom description based on the patient and vaccine information provided
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Vaccine: COVID19, FLU3, MEN, UNK
Symptoms: Pectus excavatum, Product storage error
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Liquid vaccine was exposed to temperatures greater than 46 degree Fahrenheit with a maximum temperature of 47.91 degree Fahrenheit and was out of range for 16 minutes; Pectus excavatum; This serious case was reported by a nurse via other manufacturer and described the occurrence of pectus excavatum in a patient who received Men B NVS (Meningococcal B vaccine) (batch number B4J4B) for prophylaxis. Co-suspect products included Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 45546) for prophylaxis, Elasomeran (Spikevax) (batch number B0005, expiry date 28-MAY-2025) for prophylaxis and Meningococcal vaccine A/C/Y/W (Men acwy) (batch number ek7D6) for prophylaxis. Concurrent medical conditions included pseudostrabismus, congenital tracheomalacia, asthma and wheezing. Additional patient notes included The patient was not allergic to medications, food, and other products. Concomitant products included salbutamol (Albuterol Hfa) and salbutamol (Albuterol). On 17-DEC-2024, the patient received Meningococcal B vaccine (intramuscular), FluLaval 2024-2025 season (intramuscular), Spikevax (intramuscular) and Men acwy (intramuscular, left deltoid). On 15-APR-2025, 119 days after receiving Meningococcal B vaccine, FluLaval 2024-2025 season, Spikevax and Men acwy, the patient experienced pectus excavatum (Verbatim: Pectus excavatum) (serious criteria other: Serious as per reporter). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: Liquid vaccine was exposed to temperatures greater than 46 degree Fahrenheit with a maximum temperature of 47.91 degree Fahrenheit and was out of range for 16 minutes). The outcome of the pectus excavatum was not resolved and the outcome of the incorrect storage of drug was not applicable. It was unknown if the reporter considered the pectus excavatum to be related to Meningococcal B vaccine, Meningococcal B Vaccine Pre-Filled Syringe Device, FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. The reporter considered the pectus excavatum and incorrect storage of drug to be not reported if related to Spikevax and Men acwy. The company considered the pectus excavatum to be unrelated to Meningococcal B vaccine, Meningococcal B Vaccine Pre-Filled Syringe Device, FluLaval 2024-2025 season and Flulaval Pre-Filled Syringe Device. The company considered the pectus excavatum and incorrect storage of drug to be not reported if related to Spikevax and Men acwy. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-JUL-2025 The nurse reported multiple excursions in their refrigerator over a period ranging from 03rd December 2024. The exact highest temperature and total combined excursion time were reported as 47.91 degrees Fahrenheit and 33 minutes, respectively. On 13th December 2024, the highest temperature was reported as 47.91 degrees Fahrenheit, and minutes out of range was reported as 16 minutes and the vaccines were administered after excursion, which led to incorrect storage of drug. The patient had pectus excavatum after receiving vaccinations. No Moderna geriatric vaccine was stored in their refrigerator after 04th February 2025. No adverse events were reported in relation to the vaccination of 17th December 2024. No treatment medication was reported.; Sender's Comments: A case of Pectus excavatum, 119 days after receiving Meningococcal B vaccine, Meningococcal B vaccine PRE-FILLED SYRINGE DEVICE, FluLaval 2024-2025 season and FluLaval PRE-FILLED SYRINGE DEVICE in a patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (concurrent congenial tracheomalacia).
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Generate a clinical symptom description based on the patient and vaccine information provided
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Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Hypertension, Immediate post-injection reaction, Injected limb mobility decreased, Muscular weakness
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As a 79 year old female, I received my third COVID19 Pfizer vaccine in my left arm on September (27), 2021. Immediately after the COVID19 Vaccine, I had a LARGE HUMERUS on my left arm. As the years past, I had pain in my LEFT ARM. My LEFT ARM became progressively WEAK that I couldn't USE and/or RAISE my LEFT ARM to pick up an empty cup. I was hospitalized on July 12, 2025 for (congestive heart failure/hypertension). While I was hospitalized, I give TWO BLOOD THINNERS in my stomach. Immediately, shrunk to half the size on my LEFT ARM. 9% of the PAIN on the LEFT ARM has gone. I can USE my LEFT ARM again "I think the COVID19 Pfizer Vaccine that I received in my LEFT ARM gave me a TINY BLOOD CLOT in my LEFT ARM which DIDN'T SHOW UP my MRI RESULTS. When I received the BLOOD THINNER while I was in the hospital, the BLOOD THINNER REMOVED the TINY BLOOD CLOT in my LEFT ARM!" I thought that I would have to live with the PAIN in my LEFT ARM after the COVID19 Vaccine. Please research if BLOOD THINNER is the SOLUTIONS to some of the PATIENTS that received COVID 19 Vaccine, and they are in PAIN.
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