chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: COVID-19; Suspected COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 09May2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "COVID-19"; SUSPECTED COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  It was reported that Rebound of COVID-19 symptoms. High level on antigen test after having been tested negative after treatment. Chest congestion came back after being cured by Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EJ1685), in left arm and on 07Jan2021 as dose 2, single (Lot number: EJ1685) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Nov2021 as dose 3 (booster), single (Lot number: O13FZ1A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 18May2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) positive. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: she fainted at her home; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old female patient received BNT162b2 (COMIRNATY), on 21May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: SYNCOPE (medically significant) with onset 22May2022, outcome "unknown", described as "she fainted at her home". The event "she fainted at her home" required physician office visit.   Clinical information: The reporter reported that after receiving booster dose. The next morning, she fainted at her home. Her parents took her to the (name withheld). The pediatrician on call said it was potentially a side effect from booster. They did an overall evaluation and sent her home.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: her husband (72 y/o male) also tested positive for Covid; her husband (72 y/o male) also tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 08Oct2021 as dose 3 (booster), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "unknown" and all described as "her husband (72 y/o male) also tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No just down feathers" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM, start date: Dec2018; LEVOTHYROXINE SODIUM; DICLOFENAC SODIUM, start date: Dec2018; ASPIRIN 81, start date: Jun2016; FISH OIL, start date: May2013; HYDROXYZINE HCL, start date: Oct2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received other medication (Multivitamin) in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received the original 2 shots in Mar2021 and was boosted 01Nov2021 (all Pfizer)/ tested Covid; received the original 2 shots in Mar2021 and was boosted 01Nov2021 (all Pfizer)/ tested Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown), on 01Nov2021 as dose 3 (booster) single (Batch/Lot number: unknown) and on 20May2022 as dose 4 (booster) 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 21May2022, outcome "unknown" and all described as "received the original 2 shots in Mar2021 and was boosted 01Nov2021 (all Pfizer)/ tested Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Negative; (21May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  Clinical Course: Reported as, Patient received the original 2 shots in Mar2021 and was boosted 01Nov2021 (all Pfizer). Thursday 19May2022 patient had a tickle in throat and performed an at home test (negative result). Patient set a 2nd booster appointment for 20May2022, informed that patient had a tickle but a negative test result. They said it was ok and received the 2nd booster (Pfizer). On Saturday 21May tested Covid and contacted the local Doctor who prescribed Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Extra dose administered, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; vaccine dose number= 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hi blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "stress" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EXTRA DOSE ADMINISTERED (non-serious) with onset 25Feb2022, outcome "unknown", described as "vaccine dose number= 5"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective. Clinical course: The patient received Paxlovid treatment from 16May2022 to 20May2022 for covid-19 treatment. After taking the Paxlovid Patient felt exhausted, short tempered, dizzy, lethargic. Felt better prior to taking the medication. Patient lost taste and generally did not feel good at all.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown), on 16Feb2021 as dose 2, single (Batch/Lot number: unknown), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 09Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "psoriasis" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HCTZ; AMLODIPINE; LIPITOR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID - no symptoms.  Required to take test for entrance to a baby shower; Tested positive for COVID - no symptoms.  Required to take test for entrance to a baby shower; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), in right arm, on 24Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 19Jan2022 as dose 3 (booster), single (Lot number: FL3197) at the age of 64 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), ASYMPTOMATIC COVID-19 (medically significant) all with onset 22May2022 at 11:30, outcome "recovered" (May2022) and all described as "Tested positive for COVID - no symptoms. Required to take test for entrance to a baby shower". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, asymptomatic covid-19. Clinical information: Facility type vaccine was workplace clinic. No known allergies. No other vaccine in four weeks. No covid prior and post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Developed covid; Developed covid; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 64-year-old patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6202), on 01Apr2021 as dose 2, single (Lot number: EN6207) and on 29Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 64 years, in right deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "blood thinner" (unspecified if ongoing), notes: blood thinner. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "Developed covid". The event "developed covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jan2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event vaccination failure and Covid 19 and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4256835-00.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis, psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 vaccination. The following information was reported: LYMPHADENOPATHY (medically significant) with onset 2021, outcome "recovered" (2022), described as "Swollen lymph nodes". The action taken for risankizumab was unknown.  The reporter considered "swollen lymph nodes" related to BNT162b2.  Additional information: The patient had swollen lymph nodes off. After her second covid vaccine booster she noticed her lymph nodes stayed swollen for about one month just like they did after her first vaccine booster. She know that the lymph node swelling was related to Covid booster and not the Skyrizi. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Change History On 18May2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The event of Swollen lymph nodes is now considered serious. Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event (s) of Swollen lymph nodes with SKYRIZI (RISANKIZUMAD) was no reasonable possibility.  Suspect product information: Drug: SKYRIZI(RISANKIZUMAB) 1)Swollen lymph nodes: (Lymphadenopathy) Causality as per reporter (Drug/Vaccine): Not related Drug:  PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)  1)Swollen lymph nodes: (Lymphadenopathy) Causality as per reporter (Drug/Vaccine): Probable  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis from 2nd dose of initial Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2021 at 09:00 as dose 2, single (Batch/Lot number: unknown) at the age of 26 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, vaccine administration time: 09:00 AM, Lot number: EL0140,, Anatomical Location : Left arm), administration date: 19Dec2020, when the patient was 26-year-old, for Covid-19 Immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis from 2nd dose of initial Pfizer vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported event Myocarditis and the administration of the vaccine cannot be 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.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Drug interaction, Immunodeficiency, Psoriatic arthropathy, Therapeutic response shortened
Clinical narrative: compromised immune system/immune system was down; covid vaccination and humira were fighting each other with humira; flare ups seemed to have occurred between humira injection; Wearing off effect; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4392189-00 (Agency).  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159929) at unk (citrate free), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "recovering", described as "compromised immune system/immune system was down"; DRUG INTERACTION (non-serious), outcome "unknown", described as "covid vaccination and humira were fighting each other with humira"; CONDITION AGGRAVATED (non-serious), outcome "recovering", described as "flare ups seemed to have occurred between humira injection"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "unknown", described as "Wearing off effect". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial  The reporter's assessment of the causal relationship of "compromised immune system/immune system was down", "covid vaccination and humira were fighting each other with humira" and "wearing off effect" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "flare ups seemed to have occurred between humira injection" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of immunodeficiency, drug interaction,condition aggravated,therapeutic response shortened. 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
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; chills; headache; 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.   Concurrent medical conditions included penicillin allergy.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced fever, chills and headache. On an unknown date, the outcome of the fever, chills and headache were unknown.   It was unknown if the reporter considered the fever, chills and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-MAY-2022 Reporter's Comments: The case was self reported by the patient via interactive digital media. The patient had the shot and got sick within about 18 hours of having it (fever, chills and headache).  The patient's physician warned saying that several people get this kind of a reaction. The follow-up would not possible as no contact details were available. On 25th May 2022, the case US2022AMR084987 was identified as duplicate case of US2022AMR084996.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR084996:Same reporter
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received a two days expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th May 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 26th May 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   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: 26-May-2020 Reporter's Comments: A nurse reported that the patient received a two days expired dose of Havrix. Reporter consented to follow up. Additional Supportive Information: The patient received Havrix which was already expired 2 days back, which led to expired vaccine used.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient herself a other health professional via other manufacturer (Pfizer Inc) concerned a 52 year old female. Initial information was processed along with the additional information received on 26-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Name of drug not reported). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administartion, and batch number were not reported) dose was not reported, 1 total administered in right arm on 08-MAR-2021 at 12:00 for prophylactic vaccination. Age at time of vaccination 51 years old. The batch number was not reported and has been requested. No concomitant medications were reported. The patient additionally received two doses of non-company suspect vaccine included: Moderna covid-19 vaccine (Elasomeran) (Dose number in series 2) ( form of admin, route of admin, and batch number were not reported) doses were not reported, administered in right arm on 22-OCT-2021 at 15:00 (first dose) and in right arm on 25-APR-2022 at 12:00 (second dose) for prophylactic vaccination.  The patient was prescribed with non-company suspect drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 05-MAY-2022 and last dose on 10-MAY-2022 for covid 19. On 16-MAY-2022 at 6:00, the patient experienced rebound symptoms and positive rapid test (suspected covid-19 infection) (Dose number in series 2) and (suspected clinical vaccination failure) (Dose number in series 1). On 19-MAY-2022, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with elasomeran was not reported. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000232903.; Sender's Comments: V0: 20220551133- COVID-19 VACCINE Ad26.COV2.S- Suspected Clinical Vaccination failure. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after manufacturer date of expiry; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were initially stored in the refrigerator on 09-Apr-2022 and moved from freezer to Room Temperature at time of vaccination. The eight patients received expired Moderna COVID-19 vaccine beyond the manufacturing expiration date.  4 patients received their first shot, 2 patients received booster and 1 patient received the 2nd shot. Lot number was 060H21A and manufacturing expiry date: 28MAR2022 On 09-Apr-2022, the vial was initially stored in the refrigerator for patient 2, 3 and 4.  The vial did not undergo any temperature excursion. Patient did not have any adverse reactions. No treatment  medications were reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022 at 5:00 PM, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-May-2022 to 11-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications was provided by the reporter.  the patient did not taking any other medications/products within 2 weeks of starting COVID-19 treatment and the patient  previously receive a COVID-19 Vaccine.  Patient experienced Covid symptoms again 6 days after ending paxlovid treatment, and are still ongoing.   Company Comment: This is a spontaneous case concerning a 39-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. No details on the previous 2 doses were provided. As reported, the patient had COVID symptoms 6 days after treatment with Paxlovid, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 39-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. No details on the previous 2 doses were provided. As reported, the patient had COVID symptoms 6 days after treatment with Paxlovid, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Linear IgA disease
Clinical narrative: Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis; This literature-non-study case was reported in a literature article and describes the occurrence of LINEAR IGA DISEASE (Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       Concomitant products included TERBINAFINE for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LINEAR IGA DISEASE (Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis) (seriousness criterion medically significant). At the time of the report, LINEAR IGA DISEASE (Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LINEAR IGA DISEASE (Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis) to be related.    Treatment and concomitant medications were not reported. Company comment: This literature-non-study case concerns an 86-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant) unexpected event of LINEAR IGA DISEASE (reported as Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis) after the third dose of mRNA-1273 vaccine in the setting of oral terbinafine. Since dates of vaccination and the exact onset date of the event were not reported, latency cannot be assessed. Concomitant terbinafine remains as a confounder for the event. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This literature-non-study case concerns an 86-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant) unexpected event of LINEAR IGA DISEASE (reported as Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis) after the third dose of mRNA-1273 vaccine in the setting of oral terbinafine. Since dates of vaccination and the exact onset date of the event were not reported, latency cannot be assessed. Concomitant terbinafine remains as a confounder for the event. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID rebound. Negative test after treatment, then positive test on 5/22/22 with new symptoms.; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID rebound. Negative test after treatment, then positive test on 5/22/22 with new symptoms.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No allergic condition reported by the reporter.  Previously administered products included for COVID-19: PAXLOVID from 06-May-2022 to 10-May-2022. Past adverse reactions to the above products included No adverse event with PAXLOVID. Concurrent medical conditions included Hypercholesterolemia.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID rebound. Negative test after treatment, then positive test on 5/22/22 with new symptoms.). At the time of the report, COVID-19 (COVID rebound. Negative test after treatment, then positive test on 5/22/22 with new symptoms.) outcome was unknown. Not provided.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2022, SARS-CoV-2 test: positive (Positive) positive test with new symptoms. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative test after treatment.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided. Company comment: This spontaneous case concerns an 81-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 198 days after administration of third dose of mRNA-1273, the initial two doses were given approximately 8 months prior, the interval between the two doses is 28 days. On May 22, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns an 81-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 198 days after administration of third dose of mRNA-1273, the initial two doses were given approximately 8 months prior, the interval between the two doses is 28 days. On May 22, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Patient received third dose 0.5 ml dose; This spontaneous case was reported by an other health care professional and describes the occurrence of OVERDOSE (Patient received third dose 0.5 ml dose) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 030L20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (fluticasone), Drug allergy (bupropion), Drug allergy (citalopram), Drug allergy (codeine), Penicillin allergy (PNC), Drug allergy (primidone), Hypothyroidism since 12-Feb-2016, Memory loss since 12-Dec-2016, Peripheral neuropathy since 23-Aug-2021, Cystocele on 12-Dec-2016, Rectocele since 12-Dec-2016, Depression, Anxiety and Atrial fibrillation since 08-May-2022. Concomitant products included IPRATROPIUM BROMIDE (ATROVENT ADULTES) from 27-Apr-2022 to an unknown date for Allergy, BUSPIRONE HYDROCHLORIDE (BUSPAR) from 23-Aug-2021 to an unknown date for Anxiety, METOPROLOL from 04-May-2022 to an unknown date for Atrial fibrillation, TRAZODONE from 23-Aug-2021 to an unknown date for Depression, THIAMAZOLE (TAPAZOLE) from 09-May-2022 to an unknown date for Hypothyroidism.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Oct-2021, the patient experienced OVERDOSE (Patient received third dose 0.5 ml dose). At the time of the report, OVERDOSE (Patient received third dose 0.5 ml dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.   This case was linked to MOD-2022-574080 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication:  Past adverse reactions to the above products included Allergy. Concurrent medical conditions included Asthma, Blood pressure high and Allergy to nuts.    On 04-Nov-2021 at 4:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 15-May-2022 for COVID-19 immunization, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication of the patient was not reported. It was unknown if the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  On 24-May-2022 at 05:00, the patient had rebound of COVID-19 symptoms/positive COVID test. It was reported that for the rebound of symptoms the patient did not receive any treatments.  Company comment: This is a spontaneous case concerning a 51-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred approximately 6 months after the third dose of mRNA-1273 vaccine administration. The event was described as, approximately 188 days after the third dose of mRNA-1273 vaccine administration patient took Nirmatrelvir + Ritonavir (Paxlovid) for treatment of Covid-19. Approximately 9 days after the last dose of Nirmatrelvir + Ritonavir (Paxlovid) patient experienced rebound symptoms with positive Covid-19 test. No other information surrounding the event was reported. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 51-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious  event of Covid-19. The event occurred approximately 6 months after the third dose of mRNA-1273 vaccine administration. The event was described as, approximately 188 days after the third dose of mRNA-1273 vaccine administration patient took Nirmatrelvir + Ritonavir (Paxlovid) for treatment of Covid-19. Approximately 9 days after the last dose of Nirmatrelvir + Ritonavir (Paxlovid) patient experienced rebound symptoms with positive Covid-19 test. No other information surrounding the event was reported. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slight sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (slight sore arm) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (slight sore arm). At the time of the report, PAIN IN EXTREMITY (slight sore arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that patient declined providing information regarding the side effects because they were so minimal.  No treatment  medications were reported.   This case was linked to MOD-2022-578384 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea
Clinical narrative: COVID-19; Still feeling winded weeks later, labored breathing when exercising; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DYSPNOEA (Still feeling winded weeks later, labored breathing when exercising) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis, Asthma and Allergy NOS. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) from 20-Mar-2022 to 26-May-2022, MIRABEGRON (MYRBETRIQ) from 03-Jan-2022 to 26-May-2022 and SOLIFENACIN SUCCINATE from 01-Mar-2022 to 27-Apr-2022 for an unknown indication.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced DYSPNOEA (Still feeling winded weeks later, labored breathing when exercising). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 27-Apr-2022 to 30-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown and DYSPNOEA (Still feeling winded weeks later, labored breathing when exercising) had not resolved.            The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Patient previously received a COVID-19 Vaccine.  Company Comment:  This spontaneous case concerns a 56-year-old female patient with concurrent Asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19 on an unknown date after receiving mRNA-1273 given as fourth in the COVID-19 vaccination series. Patient had completed COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) and presented with labored breathing during exercises approximately 2 weeks later. No information was provided on the previous 3 doses of COVID-19 vaccination prior to current mRNA-1273 vaccine.  The concurrent asthma could be considered as a contributory factor to COVID-19 including the other non-serious event of dyspnea The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 56-year-old female patient with concurrent Asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19 on an unknown date after receiving mRNA-1273 given as fourth in the COVID-19 vaccination series. Patient had completed COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) and presented with labored breathing during exercises approximately 2 weeks later. No information was provided on the previous 3 doses of COVID-19 vaccination prior to current mRNA-1273 vaccine.  The concurrent asthma could be considered as a contributory factor to COVID-19 including the other non-serious event of dyspnea The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Influenza like illness
Clinical narrative: Having severe flu like symptoms; Had chest pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLUENZA LIKE ILLNESS (Having severe flu like symptoms) and CHEST PAIN (Had chest pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Having severe flu like symptoms) and CHEST PAIN (Had chest pain). At the time of the report, INFLUENZA LIKE ILLNESS (Having severe flu like symptoms) and CHEST PAIN (Had chest pain) outcome was unknown.            No concomitant medication were reported.  No treatment medication were reported.