chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: received a larger dose than recommended of the Pfizer Covid-19 vaccine with a purple cap; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 66 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 02Dec2021 (Lot number: FF2590, Expiration Date: Dec2021) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "Hypertension" (ongoing); "Insulin resistance" (ongoing); "Eczema" (ongoing). Concomitant medication(s) included: FLOVENT taken for asthma (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing); METFORMIN taken for insulin resistance (ongoing); LISINOPRIL taken for hypertension (ongoing); AMLODIPINE taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (Dose 01, Left deltoid, Intramuscular, EN6198), administration date: 03Mar2021, for Covid-19 immunization; Bnt162b2 (Dose 02, Left deltoid, Intramuscular, ER8732), administration date: 24Mar2021, for Covid-19 immunization; Influenza (Batch/Lot: 312875, Manufacturer: Unknown, Route: IM, Anatomical location: Left arm, No of previous dose: Unknown), administration date: 16Oct2021.  The following information was reported: OVERDOSE (hospitalization) with onset 02Dec2021 14:00, described as "received a larger dose than recommended of the Pfizer Covid-19 vaccine with a purple cap". The patient was hospitalized for overdose (hospitalization duration: 1 day(s)). The event "received a larger dose than recommended of the pfizer covid-19 vaccine with a purple cap" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of overdose.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the Hospitalized event Overdose and the suspect BNT162B2 cannot be excluded.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Pleural effusion, Pulmonary embolism
Clinical narrative: pulmonary emboli; pleural effusion; chest tightness; shortness of breath; dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 27Aug2021 (Lot number: EW0178) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BABY ASPIRIN. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: Morphine. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number: EW0191, Intramuscular, in right arm), administration date: 06Aug2021, when the patient was 43 years old, for Covid-19 immunization. No other vaccine was given in four weeks.  The following information was reported: PULMONARY EMBOLISM (medically significant) with onset 11Nov2021, outcome "unknown", described as "pulmonary emboli"; PLEURAL EFFUSION (non-serious) with onset 11Nov2021, outcome "unknown", described as "pleural effusion"; CHEST DISCOMFORT (non-serious) with onset 30Oct2021, outcome "unknown", described as "chest tightness"; DYSPNOEA (non-serious) with onset 30Oct2021, outcome "unknown", described as "shortness of breath"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "dizziness". The events "pulmonary emboli", "pleural effusion", "chest tightness", "shortness of breath" and "dizziness" were evaluated at the physician office visit and emergency room visit on 11Nov2021. The patient has since been experiencing dizziness/ lag since discharged from hospital to the time of report. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Nov2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pulmonary embolism, pleural effusion, chest discomfort, dyspnoea, dizziness.; Sender's Comments: Based on the available information in the case provided, the causal association between the events pulmonary embolism, pleural effusion, chest discomfort, dyspnoea, dizziness and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal association. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: pulmonary emboli; pleural effusion; chest tightness; shortness of breath; dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 27Aug2021 (Lot number: EW0178) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BABY ASPIRIN. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: Morphine. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number: EW0191, Intramuscular, in right arm), administration date: 06Aug2021, when the patient was 43 years old, for Covid-19 immunization. No other vaccine was given in four weeks.  The following information was reported: PULMONARY EMBOLISM (medically significant) with onset 11Nov2021, outcome "unknown", described as "pulmonary emboli"; PLEURAL EFFUSION (non-serious) with onset 11Nov2021, outcome "unknown", described as "pleural effusion"; CHEST DISCOMFORT (non-serious) with onset 30Oct2021, outcome "unknown", described as "chest tightness"; DYSPNOEA (non-serious) with onset 30Oct2021, outcome "unknown", described as "shortness of breath"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "dizziness". The events "pulmonary emboli", "pleural effusion", "chest tightness", "shortness of breath" and "dizziness" were evaluated at the physician office visit and emergency room visit on 11Nov2021. The patient has since been experiencing dizziness/ lag since discharged from hospital to the time of report. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Nov2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pulmonary embolism, pleural effusion, chest discomfort, dyspnoea, dizziness.; Sender's Comments: Based on the available information in the case provided, the causal association between the events pulmonary embolism, pleural effusion, chest discomfort, dyspnoea, dizziness and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal association. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Neuropathy peripheral, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Peripheral neuropathy; pain was terrible in both feet; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01May2021 (Lot number: ER8730) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "migraines" (unspecified if ongoing), notes: migraines; "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LEXAPRO; PROBIOTICS; KLONOPIN; VISTARIL [HYDROXYZINE EMBONATE]. Past drug history included: Macrobid, reaction(s): "Drug Allergy", notes: Macrobid; Erythromycin, reaction(s): "Drug Allergy", notes: Erythromycin; Keflex, reaction(s): "Drug Allergy", notes: Keflex; Bactrim, reaction(s): "Drug Allergy", notes: Bactrim. Vaccination history included: Pfizer (DOSE 1, SINGLE, Batch/Lot No: EW0170, Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 50 years old, for Covid-19 immunization, reaction(s): "right big toe pain. Then it moved to all". No other vaccine was given in four weeks. The following information was reported: NEUROPATHY PERIPHERAL (disability, medically significant) with onset May2021, outcome "not recovered", described as "Peripheral neuropathy"; PAIN IN EXTREMITY (disability) with onset May2021, outcome "not recovered", described as "pain was terrible in both feet". Right after the first dose, the patient started having right big toe pain. Then it moved to all toes, after second injection pain was terrible in both feet. She was tested for all possible causes and there was none. It was directly after Covid shots. The events "peripheral neuropathy" and "pain was terrible in both feet" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: electromyogram: peripheral neuropathy; sars-cov-2 test: negative. Therapeutic measures were taken as a result of neuropathy peripheral, pain in extremity and it included Toe injection and medications.; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration BNT162B2 to the reported events neuropathy peripheral, pain in extremity cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Cough, Immunisation
Clinical narrative: increased asthma symptoms which brought me into the red zone; tightness of chest; coughing; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 13:15 (Lot number: FH8027) at the age of 54 years as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Relevant medical history included: "Asthma (allergy and non-allergy triggered)" (unspecified if ongoing); "Known allergies: sulpha based antibiotics" (unspecified if ongoing). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication(s) included: QVAR; ALBUTEROL [SALBUTAMOL SULFATE], Nasal spray and antihistamines. Vaccination history included: Bnt162b2 (DOSE 2, lot number: EP6955, ARM LEFT), administration date: 01Apr2021, when the patient was 53 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, lot number: EL3247, ARM LEFT), administration date: 11Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 13Dec2021 13:15, outcome "recovering", described as "booster"; ASTHMA (medically significant) with onset 14Dec2021 01:30, outcome "recovering", described as "increased asthma symptoms which brought me into the red zone"; CONDITION AGGRAVATED (medically significant) with onset 14Dec2021 01:30, outcome "recovering", described as "increased asthma symptoms"; CHEST DISCOMFORT (non-serious) with onset 14Dec2021 01:30, outcome "recovering", described as "tightness of chest"; COUGH (non-serious) with onset 14Dec2021 01:30, outcome "recovering", described as "coughing". Therapeutic measures were not taken as a result of immunisation, asthma, condition aggravated, chest discomfort, cough.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: This is a spontaneous report received from contactable reporter, Consumer from medical information team. The reporter is the patient. A 73-year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: diabetic (unspecified if ongoing), notes: was diagnosed with diabetes about 10 or 11 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), administration date: Apr2021, when the patient was 73 years old, for COVID-19 immunization. The following information was reported: seizure (hospitalization, medically significant) with onset May2021, outcome unknown. The patient was hospitalized for seizure (start date: May2021, discharge date: 2021,: hospitalization duration 7 days). The event was evaluated at the physician office visit and emergency room visit. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Investigation, Lymphoma, Pain, Pulmonary oedema
Clinical narrative: B Cell Lymphoma; Foam in her lungs; brain injury; pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non healthcare professional) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: LYMPHOMA (medically significant), outcome "unknown", described as "B Cell Lymphoma"; PULMONARY OEDEMA (medically significant), outcome "unknown", described as "Foam in her lungs"; BRAIN INJURY (medically significant), outcome "unknown", described as "brain injury"; PAIN (non-serious), outcome "unknown", described as "pain". The patient underwent the following laboratory tests and procedures: investigation: negative. Therapeutic measures were not taken as a result of lymphoma, pulmonary oedema, brain injury, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced fever and chills The patient commented that, he/she thought that the symptoms were ok than what they read. The follow-up would not possible as no contact details were available. For 2nd dose tolerance, refer linked case US2021AMR260656, reported by the same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR260656:Same reporter, same product, same patient, case for different dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had a severe case and even after the shots/Suspected vaccination failure; Shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingles shot and had severe case of shingles and still got pain. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: itch real bad; had shingles, Got first shot and second/Suspected vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In February 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. In November 2021, between 1 and 2 years after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the vaccination failure, shingles and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got first Shingles shot on 15th December 2021 and 2nd Shingles shot in February 2020 and had shingles back in first part in November 2021. The patient was not in pain at all and just itch really bad. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. Note: Discrepancy in 1st dose date (Year), hence not updated in product tab only mentioned in narrative.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: 9 months old received adult dose; 9 months old received adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 9-month-old female patient who received HBV (Engerix B adult) (batch number T2S4Z, expiry date 20th November 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st December 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 21st December 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A nurse reported that a pediatric patient, received an adult engerix-B dose, which led to overdose and adult product administered to child. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose over 4 years ago, has not received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: Age at vaccination was not reported. Pharmacist reported that patient received the first dose of Shingrix over 4 years before reporting  and had not received second dose, which led to incomplete course of vaccination. Consent to follow up granted.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: 3 PEOPLE I KNOW DIED FROM COVID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative concerned multiple patients (03) of unspecified race and ethnicity. No past medical history or concurrent conditions were reported. On an unspecified date, the patients previously received covid-19 vaccine ad26.cov2.s vaccination (unspecified manufacturer) (dose number in series: 1), (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported, 1 total, administered for prophylactic vaccination. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series:1). The patients received covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, following administration of covid-19 vaccine ad26.cov2.s, the patients experienced coronavirus disease (Covid-19) although they were fully vaccinated and boostered (captured as: suspected covid-19 and suspected clinical vaccination failure) (dose number in series 2).  On an unspecified date, the patients died due to Covid-19. It was unknown if autopsy was performed or not (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for 3 people died from Covid was fatal, and the outcome of the suspected clinical vaccination failure was unknown/not reported. This report was serious (Death, and Other Medically Important Condition) This report was associated with product quality complaint: 90000207716. This case, from the same reporter is linked to 20211243153.; Sender's Comments: V0: 20211240566-covid-19 vaccine ad26.cov2.s-3 people i know died from Covid. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211240566-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: 3 PEOPLE I KNOW DIED FROM COVID
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Lacrimation increased, Nasal discomfort, SARS-CoV-2 test, Vaccination failure
Clinical narrative: BURNING NOSE; WATERY EYES; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 54 year old male. Initial information was processed along with additional information received on 22-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068, expiry: 23-AUG-2022) dose was not reported, 1 total, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient received additional non-company suspect vaccine MRNA 1273 (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination. No concomitant medications were reported. On 14-DEC-2021, the patient experienced headache, runny nose, fatigue, nasal congestion and patient felt only congestion until 20-DEC-2021 (subsumed under suspect covid-19 infection). On 15-DEC-2021, the patient also experienced burning nose, and watery eyes. On 17-DEC-2021, headache was resolved. On 18-DEC-2021, the patient had done home antigen test and for covid 19 tested as positive, hence had suspected clinical vaccination failure (Dose number in series 1 and 2).  The action taken with covid-19 vaccine ad26.cov2.s and MRNA 1273 was not applicable. The patient recovered from burning nose, and watery eyes on 18-DEC-2021, and the outcome of suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint : 90000207979 The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211244606-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: DIED; BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a 44 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter stated that, on 03-AUG-2021, the patient experienced blood clot and next day on 04-AUG-2021, she died from unknown cause of death (dose number in series was 1). It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 04-AUG-2021 from unknown cause of death, and the outcome of blood clot was not reported.  This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20211254542 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death, Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: INCREASED NEUROPATHY IN LEGS AND FEET; This spontaneous report received from a patient via  concerned a patient of unspecified age and sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The dose number in series was 1. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced increased neuropathy in legs and feet. The patient reported as "Why don't you do something about the increased neuropathy your J&J shot caused in my legs and feet was no problem till I took your shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of increased neuropathy in legs and feet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211256340-Covid-19 vaccine ad26.cov2.s-Increased neuropathy in legs and feet . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, C-reactive protein, Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03BB2UA, 04212OA and O22M2OA) for COVID-19 vaccination.     The patient's past medical history included Hematuria (Hematuria, unspecified), Carotid artery stenosis (Carotid artery stenasis, right mid), Hyperlipidemia, Dizziness, Visual disturbance, Dyspepsia (Dyspepsia), Osteoarthritis, Carpal tunnel syndrome (Carpal tunnel! syndrome; left), Shoulder pain (Shoulder pain, right), Sciatica, Urinary incontinence (Urinary incontinence, urgency), Knee pain (Knee pain, right medial), UTI, Diverticulitis, Mitral regurgitation, Carotid bruit, Cervical radiculopathy, Constipation, Keratosis (Keratosis, actinic), Osteopenia, Hip discomfort (HIP PAIN, RIGHT, CHRONIC), Osteoporosis (SCREEN, OSTEOPOROSIS), Skin cancer (SCREEN SKIN CANCER), Shingles, Dyspnea, Vitamin D (VITAMIN D, DEFICINECY), Colon cancer, Breast cancer, Heart disease, unspecified, Diabetes, High cholesterol, Ovarian cancer and Lung cancer. Previously administered products included for Product used for unknown indication: Influenza Vaccine on 02-Oct-2018, Influenza vaccine on 14-Sep-2021, Influenza vaccine on 18-Sep-2021 and Influenza vaccine on 21-Oct-2021. Past adverse reactions to the above products included No adverse event with Influenza Vaccine, Influenza vaccine, Influenza vaccine and Influenza vaccine. Concomitant products included CALCIUM CARBONATE, CHOLECALCIFEROL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and AMLODIPINE BESYLATE for an unknown indication, CHONDROITIN SULFATE, GLUCOSAMINE SULFATE, METHYLSULFONYLMETHANE (GLUCOSAMINE CHONDROITIN & MSM), CYANOCOBALAMIN, LOSARTAN POTASSIUM, SIMVASTATIN, CELECOXIB and SOLIFENACIN SUCCINATE.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (EXPIRED VACCINE USED) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: impaired (abnormal) Glucose - Impaired. On an unknown date, C-reactive protein: high (High) C-reactive protein - elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient past medical history includes - Lab exam, Observation and evaluation for suspected exposure to other biological  product, physical exam routine and cervical strain   Pre operative examination   Treatment information not provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chills, Dizziness, Electrocardiogram
Clinical narrative: Terrified I have a blood clot or something; Tingling; Full Chest feeling; Dizzy when standing up; Extremely anxious; Sinus tachycardia; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUS TACHYCARDIA (Sinus tachycardia), FEELING ABNORMAL (Terrified I have a blood clot or something), PARAESTHESIA (Tingling), CHEST DISCOMFORT (Full Chest feeling) and DIZZINESS (Dizzy when standing up) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 048A21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anxiety (severe anxiety) and Panic attacks.On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 24-Nov-2021, the patient experienced SINUS TACHYCARDIA (Sinus tachycardia). On an unknown date, the patient experienced FEELING ABNORMAL (Terrified I have a blood clot or something), PARAESTHESIA (Tingling), CHEST DISCOMFORT (Full Chest feeling), DIZZINESS (Dizzy when standing up) and ANXIETY (Extremely anxious). The patient was treated with LORAZEPAM for Adverse event, at an unspecified dose and frequency. On 24-Nov-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, SINUS TACHYCARDIA (Sinus tachycardia), FEELING ABNORMAL (Terrified I have a blood clot or something), PARAESTHESIA (Tingling), CHEST DISCOMFORT (Full Chest feeling), DIZZINESS (Dizzy when standing up) and ANXIETY (Extremely anxious) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):In November 2021, Electrocardiogram: sinus tachycardia (abnormal) EKG showed Sinus tachycardia. In November 2021, Heart rate: 100-110 bpm (High) Slightly elevated heart rate 100-110 bpm. In November 2021, Inflammatory marker test: normal (normal) Normal.On 23-Nov-2021, Heart rate: slightly elevated (High) Heart rate has been slightly elevated since.On 29-Nov-2021, Pregnancy test: negative (Negative) Negative.On 29-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. About 4 hours after receiving the booster dose the symptoms started. Patient states that the symptoms are Still continuing.She has experienced symptoms like this before when she has a panic attack, but they have not been this severe. She had seen her medical doctors and they were not overly concerned. She had visited her doctor's office on 24 NOV 2021, 26 NOV 2021 and 29 NOV 2021. No concomitant medication were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Inflammatory marker test, Paraesthesia, Pregnancy test
Clinical narrative: Terrified I have a blood clot or something; Tingling; Full Chest feeling; Dizzy when standing up; Extremely anxious; Sinus tachycardia; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUS TACHYCARDIA (Sinus tachycardia), FEELING ABNORMAL (Terrified I have a blood clot or something), PARAESTHESIA (Tingling), CHEST DISCOMFORT (Full Chest feeling) and DIZZINESS (Dizzy when standing up) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 048A21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anxiety (severe anxiety) and Panic attacks.On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 24-Nov-2021, the patient experienced SINUS TACHYCARDIA (Sinus tachycardia). On an unknown date, the patient experienced FEELING ABNORMAL (Terrified I have a blood clot or something), PARAESTHESIA (Tingling), CHEST DISCOMFORT (Full Chest feeling), DIZZINESS (Dizzy when standing up) and ANXIETY (Extremely anxious). The patient was treated with LORAZEPAM for Adverse event, at an unspecified dose and frequency. On 24-Nov-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, SINUS TACHYCARDIA (Sinus tachycardia), FEELING ABNORMAL (Terrified I have a blood clot or something), PARAESTHESIA (Tingling), CHEST DISCOMFORT (Full Chest feeling), DIZZINESS (Dizzy when standing up) and ANXIETY (Extremely anxious) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):In November 2021, Electrocardiogram: sinus tachycardia (abnormal) EKG showed Sinus tachycardia. In November 2021, Heart rate: 100-110 bpm (High) Slightly elevated heart rate 100-110 bpm. In November 2021, Inflammatory marker test: normal (normal) Normal.On 23-Nov-2021, Heart rate: slightly elevated (High) Heart rate has been slightly elevated since.On 29-Nov-2021, Pregnancy test: negative (Negative) Negative.On 29-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. About 4 hours after receiving the booster dose the symptoms started. Patient states that the symptoms are Still continuing.She has experienced symptoms like this before when she has a panic attack, but they have not been this severe. She had seen her medical doctors and they were not overly concerned. She had visited her doctor's office on 24 NOV 2021, 26 NOV 2021 and 29 NOV 2021. No concomitant medication were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Sinus tachycardia
Clinical narrative: Terrified I have a blood clot or something; Tingling; Full Chest feeling; Dizzy when standing up; Extremely anxious; Sinus tachycardia; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUS TACHYCARDIA (Sinus tachycardia), FEELING ABNORMAL (Terrified I have a blood clot or something), PARAESTHESIA (Tingling), CHEST DISCOMFORT (Full Chest feeling) and DIZZINESS (Dizzy when standing up) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 048A21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anxiety (severe anxiety) and Panic attacks.On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 24-Nov-2021, the patient experienced SINUS TACHYCARDIA (Sinus tachycardia). On an unknown date, the patient experienced FEELING ABNORMAL (Terrified I have a blood clot or something), PARAESTHESIA (Tingling), CHEST DISCOMFORT (Full Chest feeling), DIZZINESS (Dizzy when standing up) and ANXIETY (Extremely anxious). The patient was treated with LORAZEPAM for Adverse event, at an unspecified dose and frequency. On 24-Nov-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, SINUS TACHYCARDIA (Sinus tachycardia), FEELING ABNORMAL (Terrified I have a blood clot or something), PARAESTHESIA (Tingling), CHEST DISCOMFORT (Full Chest feeling), DIZZINESS (Dizzy when standing up) and ANXIETY (Extremely anxious) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):In November 2021, Electrocardiogram: sinus tachycardia (abnormal) EKG showed Sinus tachycardia. In November 2021, Heart rate: 100-110 bpm (High) Slightly elevated heart rate 100-110 bpm. In November 2021, Inflammatory marker test: normal (normal) Normal.On 23-Nov-2021, Heart rate: slightly elevated (High) Heart rate has been slightly elevated since.On 29-Nov-2021, Pregnancy test: negative (Negative) Negative.On 29-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. About 4 hours after receiving the booster dose the symptoms started. Patient states that the symptoms are Still continuing.She has experienced symptoms like this before when she has a panic attack, but they have not been this severe. She had seen her medical doctors and they were not overly concerned. She had visited her doctor's office on 24 NOV 2021, 26 NOV 2021 and 29 NOV 2021. No concomitant medication were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Guttate psoriasis, Pyrexia
Clinical narrative: Low grade fever; Guttate psoriasis; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of GUTTATE PSORIASIS (Guttate psoriasis), DIARRHOEA (Diarrhea) and PYREXIA (Low grade fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA) and METHOTREXATE for Psoriasis.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced GUTTATE PSORIASIS (Guttate psoriasis). On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and PYREXIA (Low grade fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, GUTTATE PSORIASIS (Guttate psoriasis), DIARRHOEA (Diarrhea) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received 1 dose of the Moderna Covid-19 vaccine by injection to their arm on 9-MAR-2021 and 8 days after receiving the vaccine, they broke out with a rash over their entire body, but not on their head and neck. The patient also had a low grade fever at this time and had a history of psoriatic arthritis and was told that this rash was a guttate psoriasis. The rash was like chicken pox all over their body. Reportedly, the patient spoke to their dermatologist and a few other doctors, then took Benadryl, and used steroid creams and foams for their rash. The patient was taking Cimzia for their psoriasis at that time and was now taking methotrexate as well. More recently, they had been experiencing 3 weeks of diarrhea.  Treatment medications also reported included steroid creams and foams for the rash.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Headache, Pain in extremity
Clinical narrative: Lost his hearing in his right ear; Sore right arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Lost his hearing in his right ear) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 026B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced DEAFNESS UNILATERAL (Lost his hearing in his right ear) (seriousness criterion medically significant), PAIN IN EXTREMITY (Sore right arm) and HEADACHE (Headache). At the time of the report, DEAFNESS UNILATERAL (Lost his hearing in his right ear), PAIN IN EXTREMITY (Sore right arm) and HEADACHE (Headache) outcome was unknown.            Concomitant medication included an unspecified urinary medication to help the patient urinate. Treatment information was not provided.  The patient reported the events to his healthcare provider and was told to wait for 48 hours to see if his hearing loss resolves and if not call healthcare provider back. Patient stated he hasn't taken anything yet to treat the sore arm or headache but mentioned he planned to take something to treat. Patient had no hearing problems in the past and no known drug or food allergies.  Company Comment: This spontaneous case concerns a 67-year-old, male patient with no medical history reported and no previous hearing problems, who experienced the unexpected, serious event of deafness unilateral and other associated unexpected and expected, non-serious events. The events occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old, male patient with no medical history reported and no previous hearing problems, who experienced the unexpected, serious event of deafness unilateral and other associated unexpected and expected, non-serious events. The events occurred 1 day after administration of the booster dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. The outcomes of the events were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.