chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Batch/Lot number: unknown), on 14Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies codeine", notes: known allergies codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Postive, notes: pos. Covid antigen test on 24May2022; (29May2022) Negative, notes: Patient had neg antigen test on 29May2022; (08Jun2022) Positive, notes: Tested positive again on 08Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Unknown if patient received Other medication in 2 weeks. Anti-viral details: Brand was Paxlovid, Treatment start date was 24May2022, Treatment stop date was 29May2022, Indication was Treatment of COVID-19, Administration route was Oral. For dose 1, dose 2 and dose 3, vaccine lot unknown reason was Not available/provided to reporter at the time of report completion. Adverse event: COVID-19 Rebound: pos. covid antigen test on 24May2022 followed by a 5-day dose pack of Paxlovid. Patient had neg antigen test on 29May2022. Became symptomatic 07Jun2022 and tested positive again on 08Jun2022.   The lot number for [BNT162b2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2022 as dose 4 (booster), single (Lot number: 331308A) at the age of 52 years 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's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19. Clinical course: Therapeutic measures were taken as a result of covid-19. Anti-viral details: Product = COVID 19 Treatment, Brand = Paxlovid, Treatment start date= 27May2022, Treatment start date= 31May2022, Indication=Treatment of COVID-19. No other medication in 2 weeks. Patient had no known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic kidney disease stage 3a" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Drug Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) Positive, notes: Took PCR Covid test on 07Jun222 and tested POSITIVE on 08Jun2022; (31May2022) Positive; (04Jun2022) Positive; (06Jun2022) Negative, notes: On 06Jun2022 no temp, and rapid test shows Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 31May2022 to 05Jun2022.  Clinical information: Reported as, the patient did not receive other medication in two weeks. Symptoms began 28May2022, thought it was allergy. Rapid test positive on 31May2022, and started Paxlovid with an evening dose for the treatment of COVID-19. Took all five doses, still had congestion and mild temperature. Retested with rapid test on 04Jun2022, results Positive, congestion and intermittent mild fever. The patient stopped Paxlovid on 05Jun2022. On 06Jun2022, no temp, and rapid test shows Negative. Took PCR Covid test on 07Jun2022 and tested positive on 08Jun2022. The patient was still congested and messed up sleep patterns, some loose bowels.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart failure" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Coronary heart dz" (unspecified if ongoing); "Some antibiotics" (unspecified if ongoing). The patient took concomitant medications. 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: Negative, notes: I tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid for COVID-19 treatment from 26May2022 to 31May2022. Patient was taking many different meds for heart disease and heart failure from 01Jan2019 to 01Jun2022 (lot number was Unknown).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "In remission from mucosal melanoma" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were not taken as a result of covid-19, drug ineffective.  Antiviral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 28May2022 and stop date: 01Jun2022, indication is used for treatment of COVID-19, Administrator route: Oral. The patient did not receive other medication in 2 weeks. The patient experienced adverse event on 07Jun2022 Routine monthly labs done post cancer treatment were done on 07Jun22 and the ALK was elevated (134). The outcome of events was not recovered. The patient did not receive treatment.  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: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: eng198), in left arm, on 24Mar2021 as dose 2, single (Lot number: ep7534), in right arm, on 02Oct2021 as dose 3 (booster), single (Lot number: 30130ba), in left arm and on 20Apr2022 as dose 4 (booster), single (Lot number: fk9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing), notes: Diabetes type 2; "Mild COPD" (unspecified if ongoing), notes: Mild COPD. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 22May2022, outcome "unknown", COVID-19 (medically significant) with onset 22May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive; (28May2022) Negative; (07Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical information: Other medication in 2weeks was Unknown. Patient has taken COVID 19 treatment with Paxlovid .Treatment start date 23May2022 and stop date: 27May2022. Rebound Covid after taking Paxlovid. Positive on 22May, started Paxlovid on 23May2022. Neg. tested on 28May2022 with improved symptoms. Symptoms back but less intense on 05Jun2022 and tested positive again on 07May2022.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 39 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergy: Sulfa drug" (unspecified if ongoing), notes: Allergy. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: No other medication received in 2weeks. Received treatment Paxlovid start date=23May2022 stop date=27May2022. Reported as COVID rebound symptoms extended to day 17. Felt well at day five and then poorly again on day 10. Felt better on day 12, then back to original symptoms on day 13. Patient received urgent care. Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Sick on 17May  Positive Covid on 17May Took Paxlovid starting 5/18. Fever and chills for 2 days. Covid test negative on 5/26.; Sick on 17May  Positive Covid on 17May Took Paxlovid starting 5/18. Fever and chills for 2 days. Covid test negative on 5/26.; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 71-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 at 08:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 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 known allergies. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "recovered" (07Jun2022) and all described as "Sick on 17May Positive Covid on 17May Took Paxlovid starting 5/18. Fever and chills for 2 days. Covid test negative on 5/26.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) positive, notes: positive; (26May2022) negative, notes: negative; (29May2022) positive, notes: positive; (07Jun2022) negative, notes: negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 18May2022 to 22May2022, the patient was treated with Paxlovid (oral) for COVID-19. Clinical course: Patient was sick on 17May and was covid positive on 18May. Took Paxlovid starting 18May. Fever and chills for 2 days. Covid test negative on 26May. Patient developed runny nose on 27May. Covid test was positive on 29May. Runny nose for a few days. Covid test negative on 07Jun. No symptoms on 07Jun. Patient had no known allergies. Patient had not received any Other medication in 2 weeks.  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 reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EK5730) and on 09Jan2021 as dose 2, single (Lot number: EL3246) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 31Jul2021 as dose 3 (booster), single (Lot number: 024C21A) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT (GSK). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) positive; (02Jun2022) Negative; (09Jun2022) Positive. Therapeutic measures were taken as a result of covid-19 with Paxlovid from 26May2022 to 30May2022 for 5 days, first negative antigen test on day 9 of infection (02Jun2022). Now with nasal congestion and newly positive antigen test 7 days later (09Jun2022).; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and vaccination failure, Covid 19 cannot be completely excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 at 10:00 as dose 1, single (Lot number: ER8733), in left arm, on 15Apr2021 at 10:00 as dose 2, single (Lot number: ER8731), in right arm and on 10Dec2021 at 09:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 51 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. If vaccine received was yes The following information was reported: SUSPECTED COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient had COVID in Feb2022; patient had COVID in Feb2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), 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'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 Feb2022, outcome "recovered" (2022) and all described as "patient had COVID in Feb2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) positive, notes: only lasted about 7 days.  Clinical Course: On 25May2022, it was reported that a patient started treatment on unspecified dates with 3 COVID-19 "shots" (Pfizer) for COVID-19 vaccination. It was reported the she had a very mild case. The patient anticipated getting a 4th booster (unspecified manufacturer) the last week of May2022 or first week of Jun2022. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: M
Vaccine: COVID19, 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "heart problems" (unspecified if ongoing); "over weight" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE. 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: (unspecified date) Unknown results, notes: COVID 19 Treatment; (08Jun2002) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had received Anti-viral as a treatment for COVID-19 which included Paxlovid, treatment start date: 30May2022 and stop date: 03Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies- Penicillin" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE. Past drug history included: Cephelexin, reaction(s): "known allergies: Cefalexin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.Ae treatment Diphenhydramine  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 plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events. Linked Report(s) : US-PFIZER INC-202200821473 Same patient, different product and event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jan2021 at 12:00 as dose 1, single (Lot number: EL3246), in left arm, on 06Feb2021 at 16:00 as dose 2, single (Lot number: EL9262), in left arm and on 17Aug2021 at 12:00 as dose 3 (booster), single (Lot number: FC3180), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Unknown results, notes: COVID 19 Treatment; (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Covid returned about a week later. Not as sick but after 19 days I'm still testing positive and have a head cold.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 26May2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 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) 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), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication in 2 weeks. Paxlovid was taken for treatment from 29May2022 to 02Jun2022. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 46.0
Sex: M
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) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 at 13:30 as dose 1, single (Lot number: EN6208), on 07Apr2021 at 13:30 as dose 2, single (Lot number: EW0151), in left arm and on 07Oct2021 at 15:15 as dose 3 (booster), single (Lot number: EW0187) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing); "Sleep apnea (treated with CPAP)" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "overweight" (unspecified if ongoing); "IB" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: 30May2022; TRUVADA; MIRTAZAPINE; ALVESCO; CETRIZINE; FLUTICASONE, start date: 31May2022. Past drug history included: Metformin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical significance: Patient received PF-07321332, ritonavir (PAXLOVID), from 31May2022 to 04Jun2022 for covid-19 treatment.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cystitis interstitial
Clinical narrative: Interstitial cystitis patient. Very bad flare up; Interstitial cystitis patient. Very bad flare up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jun2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interstitial cystitis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; LEVOTHYROXINE; B12 [CYANOCOBALAMIN]; TYLENOL WITH CODEINE NO. 3; BENADRYL. Past drug history included: Zithromax, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Batch/lot number: E13246, Dose Number: 1), for COVID-19 immunization; Bnt162b2 (Batch/lot number: EL9263, Dose Number: 2), for COVID-19 immunization; Bnt162b2 (Batch/lot number: FC3184, Dose Number: 3), for COVID-19 immunization. The following information was reported: CYSTITIS INTERSTITIAL (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 07Jun2022 at 16:00, outcome "not recovered" and all described as "Interstitial cystitis patient. Very bad flare up". Therapeutic measures were not taken as a result of cystitis interstitial, condition aggravated.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: After all 3 of Pfizer's Covid shots I got Covid on a cruise; After all 3 of Pfizer's Covid shots I got Covid on a cruise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "After all 3 of Pfizer's Covid shots I got Covid on a cruise".  Clinical course: After all 3 of Pfizers Covid shots consumer got Covid on a cruise, getting well now after 15 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0175), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "primary dysthymia" (unspecified if ongoing); "migraine with aura" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION (brand: Dr), start date: 01Aug2020; PHENYLEPHRINE (brand: Wal-phed), start date: 02Jun2022, stop date: 05Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid treatment, Lot number: GC0490, from 03Jun2022 to 08Jun2022). Symptoms returned before paxlovid treatment was finished (reported as 07Jun2022 at 17:00). All doses taken on time 12-14 hours apart. Symptoms (headache, cough) returned on day 4.5 and day 5 of treatment.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Diagnosed with COVID after having been administered 3 doses of Pfizer for Covid.; Diagnosed with COVID after having been administered 3 doses of Pfizer for Covid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9264), on 25Feb2021 as dose 2, single (Lot number: EN6200) and on 11Oct2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Type II diabetes mellitus", start date: 2015 (ongoing), notes: Type II Diabetes Onset date roughly about 7 years ago.; "High blood pressure" (unspecified if ongoing); "he had COVID" (unspecified if ongoing), notes: he had COVID and he did have COVID. Concomitant medication(s) included: TRESIBA taken for type 2 diabetes mellitus; METFORMIN taken for type 2 diabetes mellitus; LISINOPRIL taken for hypertension. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with COVID after having been administered 3 doses of Pfizer for Covid.". The event "diagnosed with covid after having been administered 3 doses of pfizer for covid." required physician office visit.  Clinical course: This consumer is the patient who called to report abdominal pain with Paxlovid. In the evening, after starting Paxlovid he had onset of abdominal pain. He wasn't having any kind of diarrhea, just hurting in the abdomen.  Abdominal pains: He had recovered completely from this event probably later in the day on 01Jun2022 after having stopped the Paxlovid; maybe within 6-8 hours of product stop. Prior to starting Paxlovid he went to the doctor thinking he had COVID and he did have COVID. He had already had the first 2 shots and the booster shot of the Pfizer for Covid, but they prescribed the Paxlovid for him to help him with his symptoms. He never had anything really severe, but the doctor thought because he had already had the Pfizer for Covid shots and booster that the doctor wanted him to have the Paxlovid to help. Paxlovid: Took a total of 3 doses, 9 tablets overall prior to stop. Caller verified that there has been no relevant testing, treatment or medical interventions performed relative to this event. NDC/Expiry: Unknown, not on CDC vaccine record card. Description of Product Complaint: PC is not on suspect product. Description of complaint: Diagnosed with COVID after having been administered 3 doses of Pfizer for Covid. Product strength and count size dispensed: Additional lot numbers: EL9264; EN6200; 301358A Expiries: Unknown, not on CDC vaccine record card. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: He caught a seizure and he suffers from seizures.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "He caught a seizure and he suffers from seizures.". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Illness
Clinical narrative: Was really sick for 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "Was really sick for 3 days".  Additional Context: The report is cross referenced to report ID: Withheld  Warm transfer from withheld with Pfizer Medical Information: Withheld. Caller was told by the CDC to contact Pfizer. She had her first Pfizer BioNTech COVID-19 Vaccine at the end of August and 10 days later she had the second dose administered. She states her sister got the basic vaccine and her husband got the vaccine and was really sick for 3 days. Her sister went religiously right after she remembers her getting very sick. She told her sister the flu shots are brought around and she read in the paper the flu shots wasn't effective. Her sister and her brother in law are both 90-year-old and have dementia problems. Her sister is the only one she has left of 7. She can't understand what you are saying anymore and her husband is in the same boat. She states this is a very sad way to live this long only for your brain to go.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Drug ineffective, Fatigue, Pain
Clinical narrative: COVID-19 positive; COVID-19 positive; fever; tired; poor appetite; ache; 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-163-4426706-00 (Company).  A 12-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160991) at weekly (unk, weekly), subcutaneous for crohn's disease. 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), outcome "not recovered" and all described as "COVID-19 positive"; PYREXIA (non-serious), outcome "not recovered", described as "fever"; FATIGUE (non-serious), outcome "not recovered", described as "tired"; DECREASED APPETITE (non-serious), outcome "not recovered", described as "poor appetite"; PAIN (non-serious), outcome "not recovered", described as "ache". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: On an unknown date, the patient experienced covid positive. The action taken for adalimumab was unknown.  The reporter considered "covid-19 positive", "fever", "tired", "poor appetite" and "ache" related to BNT162b2.  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 known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19 positive; COVID-19 positive; fever; tired; poor appetite; ache; 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-163-4426706-00 (Company).  A 12-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160991) at weekly (unk, weekly), subcutaneous for crohn's disease. 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), outcome "not recovered" and all described as "COVID-19 positive"; PYREXIA (non-serious), outcome "not recovered", described as "fever"; FATIGUE (non-serious), outcome "not recovered", described as "tired"; DECREASED APPETITE (non-serious), outcome "not recovered", described as "poor appetite"; PAIN (non-serious), outcome "not recovered", described as "ache". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: On an unknown date, the patient experienced covid positive. The action taken for adalimumab was unknown.  The reporter considered "covid-19 positive", "fever", "tired", "poor appetite" and "ache" related to BNT162b2.  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 known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: full body rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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. Vaccination history included: Moderna (Dose 1, Moderna Vaxx with no AEs), for COVID-19 Immunization; Moderna (Dose 2, Moderna Vaxx with no AEs), for COVID-19 Immunization; Moderna (Dose 3, Moderna Vaxx with no AEs), for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "full body rash".  Additional information: Patient experienced full body rash after getting Covid Vaccine 2nd booster. Previously patient had received 3 doses of Moderna Vaccine with no AEs.  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: Muscle contractions involuntary, Noninfective encephalitis
Clinical narrative: Multi organ inflammation (including the brain); arm pulsing; 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), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization complete., Manufacturer unknown), for COVID-19 IMMUNIZATION. The following information was reported: NONINFECTIVE ENCEPHALITIS (medically significant), outcome "unknown", described as "Multi organ inflammation (including the brain)"; MUSCLE CONTRACTIONS INVOLUNTARY (non-serious), outcome "unknown", described as "arm pulsing".  Addition information: I was experiencing an interesting case of post vaccine kind of natural booster (10 months). I was my self a scientist and since I had pretty bad side effects, like Multi organ inflammation (including the brain) I become really carefull on what was happening to my body. So basically if I got in contact with positive persons, I had my arm pulsing, like after the vaccine shot.  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: Arthropathy, Emotional distress, Insomnia, Malaise, Tremor
Clinical narrative: body tremors; joint issues with my hands, neck, face, knees and shoulder's; insomnia; don't feel well overall; distress; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 23-year-old patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "body tremors"; ARTHROPATHY (non-serious), outcome "unknown", described as "joint issues with my hands, neck, face, knees and shoulder's"; INSOMNIA (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "don't feel well overall"; EMOTIONAL DISTRESS (non-serious), outcome "unknown", described as "distress". Additional information: The patient reported that "I started having health issues. I was a healthy 23 year old graduating from college. I received the shot in Apr about a month before graduation. Within two weeks I began to experience body tremors all over. These persisted for the better part of 9 months and then I began having joint issues with my hands, neck, face, knees and shoulder's. I have insomnia and don't feel well overall. It has caused great distress to me".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Myalgia, Swelling, Vaccination site pain
Clinical narrative: had abdominal cramping. I've had about 3 episodes this morning; swelling in my armpit; some muscle soreness; soreness at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 56-year-old patient received BNT162b2 (COMIRNATY), on 07Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 56 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; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First Booster ; unknown manufacturer), for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious) with onset 08Jun2022, outcome "unknown", described as "some muscle soreness"; VACCINATION SITE PAIN (non-serious) with onset 08Jun2022, outcome "unknown", described as "soreness at the injection site"; SWELLING (non-serious) with onset 08Jun2022, outcome "unknown", described as "swelling in my armpit"; ABDOMINAL PAIN (non-serious) with onset 09Jun2022, outcome "unknown", described as "had abdominal cramping. I've had about 3 episodes this morning".  Additional information: I got my 2nd booster of Comirnaty on 07Jun2022.Patient weight was reported as 113. Patient tried to use the app for this but it kept losing information. Patient also called the toll-free number and it was a fax.~  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Illness, Nasal congestion, Suspected COVID-19
Clinical narrative: Received 2nd booster about a month ago, Got COVID again about a month after and it was their worst case of COVID; Received 2nd booster about a month ago, Got COVID again about a month after and it was their worst case of COVID; Still ill/They were sicker; Still having mild congestion issues; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Received 2nd booster about a month ago, Got COVID again about a month after and it was their worst case of COVID"; NASAL CONGESTION (non-serious) with onset 2022, outcome "not recovered", described as "Still having mild congestion issues"; ILLNESS (non-serious) with onset 2022, outcome "not recovered", described as "Still ill/They were sicker".  Clinical course: Patient learned of another AE yesterday evening. They think this may already have been reported, but until they can confirm I wanted to send along. Patient received 1st booster about 6 months ago, one month later (around Dec) they got COVID. Same patient received 2nd booster about a month ago, Got COVID again about a month after and it was their worst case of COVID. They were sicker then they were the first time, hit harder then before. They are still ill, still having mild congestion issues.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.