chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: 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) (Other HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VENLAFAXINE. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening) all with onset Jan2022, outcome "not recovered" and all described as "Covid-19". The patient was hospitalized for drug ineffective, covid-19 (hospitalization duration: 1 day(s)). The event "covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab. 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: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Age: 74.0
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 75-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: FV6202), in left arm, on 16Mar2021 as dose 2, single (Lot number: EP7534), in left arm, on 09Nov2021 at 12:00 as dose 3 (booster), single (Lot number: WG3912), in left arm and on 22May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (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: (06Aug2022) Negative; (10Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No other medication in 2 weeks. Patient received Anti-viral treatment for COVID-19 with Paxlovid from 28Jul2022 to 06Aug2022. Original Covid 19 Symptoms 28Jul2022, Aching muscles on 29Jul2022, Took Paxlovid on 30Jul2022.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 at 10:00 as dose 1, single (Lot number: en5318), in right arm, on 26Feb2021 at 12:00 as dose 2, single (Lot number: en6203), in right arm, on 06Oct2021 at 12:00 as dose 3 (booster), single (Lot number: ff8841), in right arm and on 11Apr2022 at 12:00 as dose 4 (booster), single (Lot number: fl3209), in right arm 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 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Paxlovid (Lot number: 00069108530) was started on 29Jun2022 and stopped on 01Jul2022 for the treatment of COVID-19. Other medications in 2 weeks was reported to be unknown. There were no known allergies.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive 5 days after testing negative after taking the Paxlovid antiviral for 5 days; Tested positive 5 days after testing negative after taking the Paxlovid antiviral for 5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: En6199), in left arm, on 24Mar2021 as dose 2, single (Lot number: Er2613), in left arm and on 18Sep2021 as dose 3 (booster), single (Lot number: Ff2589) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Tested positive 5 days after testing negative after taking the Paxlovid antiviral for 5 days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive 5 days after testing negative after taking the Paxlovid antiviral for 5 days; Negative, notes: Tested positive 5 days after testing negative after taking the Paxlovid antiviral for 5 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid treatment received from 31Jul2022 to 04Aug2022 for covid-19. No known allergies were reported.
Age: 37.0
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) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: EW0162), in left arm, on 09May2021 as dose 2, single (Lot number: EW0183), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 37 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: Z-PAK, start date: 27Jul2022, stop date: 31Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Adverse event: After testing negative and feeling fine on last day of taking Paxlovid, I've had a return of COVID symptoms and am testing positive again. Have a sore throat, nasal drip, and a headache. Brand-Paxlovid (start date-01Aug2022, stop date-05Aug2022), indication=Treatment of COVID-19. Known allergies: None, Other medical history: None. Other medication in 2 weeks product=Z-pack (azithromycin) start date=27Jul2022, stop date=31Jul2022.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: FK9894), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Jan2021 as dose 1, single (Lot number: 042L201), in right arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "pollen allergies" (unspecified if ongoing). Concomitant medication(s) included: PERRIGO, start date: Jul2022, stop date: Aug2022. The following information was reported: DRUG INEFFECTIVE (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-1 test: (2022) Positive; (10Aug2022) Positive, notes: I have mild symptoms and am Ag(+) again. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 01Aug2022 to 06Aug2022, the patient had paxlovid as treatment of COVID-19.  Clinical Course: The other medical history was reported as none. Paxlovid rebound. Patient was Covid+ and symptomatic, and started Paxlovid on Aug 1. Patient was nearly symptom free and Ag(-) on Aug. 6. Today, Aug 10 patient have mild symptoms and am Ag(+) again.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
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 45-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Lot number: FG3521) at the age of 45 years, in left arm 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: "MS" (unspecified if ongoing). The patient's 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: there never was a negative COVID test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: the patient was given Paxlovid was treatment.
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 non-contactable reporter(s) (Nurse).  A 72-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; 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 immunization. The patient's relevant medical history was not reported. The patient took concomitant medications. Other medications in two weeks was reported as yes. The following information was reported: DRUG INEFFECTIVE (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: Unknown results. Therapeutic measures were taken as a result of covid-19. Therapeutic measures included Anti-viral details: Product: Covid-19 treatment, Brand: Paxlovid, Treatment started on 18Jul2022 and stopped on 22Jul2022, Administrator route: Oral, Indication: Treatment of COVID-19.  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 in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got infected with COVID-19; got infected with COVID-19; 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.  An 84-year-old female patient received BNT162b2 (COMIRNATY), 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 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 "got infected with COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she got infected with COVID-19 and was prescribed Paxlovid. 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jul2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 50 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03May2021 as dose 1, single (Lot number: EW0176), in left arm, on 24May2021 as dose 2, single (Lot number: EW0187), in left arm and on 17Dec2021 as dose 3 (booster), single (Lot number: FE3594), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: latex" (unspecified if ongoing); "Known allergies: Wellbutrin, Benadryl" (unspecified if ongoing). Concomitant medication(s) included: TRETINOIN, start date: Apr2021; ALLERTEC [CETIRIZINE], start date: Jan2021; NEXIUM [ESOMEPRAZOLE MAGNESIUM], start date: May2022. The following information was reported: VACCINATION FAILURE (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: Body mass index: 29.5. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment included Paxlovid.
Age: 33.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 33 years, in left arm 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: "Hemochromatosis" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: Carrot, celery, cucumber" (unspecified if ongoing); "known allergies: Cats, horses" (unspecified if ongoing); "known allergies: tree nuts" (unspecified if ongoing); "Known allergies: Cantaloupe" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Aug2022, 05:30) Positive. Therapeutic measures were taken as a result of covid-19 included Paxlovid. Additional information: allergy to Cantaloupe, carrot, celery, cucumber, tree nuts, cats, horses. There is no Hospitalization Prolonged, no treatment received. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested negative on day 6, but rebounded 6 days later after taking several antigen tests; 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 65-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 18Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 01Apr2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 11Nov2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 16Dec2019, stop date: 28Jul2022. Past drug history included: Aleve, reaction(s): "Known allergies:Aleve". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 07Aug2022 at 12:00, outcome "recovering", described as "Tested negative on day 6, but rebounded 6 days later after taking several antigen tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) Negative; (07Aug2022) Positive, notes: Rebounded 6 days later after taking several antigen tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included took Paxlovid for 5 days from 28Jul2022 to 01Aug2022. Therapeutic measures were not taken as a result of disease recurrence.  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, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; rebound COVID; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 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 and concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 10Aug2022, outcome "recovered", described as "rebound COVID"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient received paxlovid from 10Aug2022 as COVID 19 treatment, then experienced rebound COVID on 10Aug2022. 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 currently available, a causal association between the reported events and BNT162b2 cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 at 07:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jul2022, outcome "recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19, drug ineffective. Patient received Paxlovid as COVID 19 treatment from 26Jul2022 to 30Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: 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 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Dec2021 at 11:00 as dose 2 (booster), single (Lot number: Fh8027) at the age of 35 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 03Apr2021 at 12:00 as dose 1, single (Lot number: 043A2IA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: bees" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Acetaminophen, reaction(s): "Known allergies: Acetaminophen".  The following information was reported: DRUG INEFFECTIVE (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) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 08Aug2022 to 09Aug2022).  Clinical course: Patient did not received other medication in 2 weeks. Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 08Aug2022 and Treatment stop date: 09Aug2022, Lot number: NDC 0069-1085-30, for the Treatment of Covid-19. Patient having known allergies with Acetaminophen and bees.  No follow-up attempts are possible. No further information is expected.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), 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: "Overweight" (unspecified if ongoing); "ex-smoker" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "known allergies: Keflex"; Septra, reaction(s): "known allergies: Septra". Vaccination history included: Pneumovax23, reaction(s): "known allergies: PneumoVax23". 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. Patient received anti-viral treatment nirmatrelvir/ritonavir (PAXLOVID) from 25Jul2022 to 30Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Blood glucose, COVID-19, Hypoglycaemia, Insulinoma
Clinical narrative: hypoglycemia / blood sugar dropped; Husband tested positive /took Paxlovid; Husband tested positive /took Paxlovid; insulinoma; This is a spontaneous report received from contactable consumer (patient's wife). An 86-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6198), on 19Mar2021 as dose 2, single (Lot number: EP7534) and on 22Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 86 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: SIMVASTATIN. Patient's wife reported that in Mar2022 patient had surgery for an insulinoma which is a begin tumor on the pancreas that causes the pancreas to secrete too much insulin. Took that off and didn't take much of the pancreas. Everything was clear and the biopsy was good. Has been getting along fine since then. Currently, it's August and he had Covid last week (in Aug2022), took Paxlovid from 30Jul2022 to 03Aug2022, and yesterday (09Aug2022) his blood sugar dropped to 29 and had to be taken to the hospital. Timing seems rather interesting that the Covid, Paxlovid, and then blood sugar drop when there hadn't been any problems with his blood sugar since March until now. Patient's wife is wondering about the possibility of hypoglycemia as a result of the Covid or Paxlovid. She has read where it is a possible side effect of both Covid and Paxlovid. Patient tested positive and was given Paxlovid. Finished Paxlovid a week ago today, 03Aug2022 and his blood sugar dropped yesterday (09Aug2022) and he is in the hospital. Patient's wife is wondering if this is a valid situation. She knew that not a whole lot is known about covid. patient got the Pfizer vaccines. Patient's wife did as well. She has not had covid. Wondering about the timing of this blood sugar drop though. She also reported patient's blood sugar was better as of 10Aug2022. Still hospitalized while the doctors try to figure out why this happened. On an IV that was stabilizing his blood sugar. He's not diabetic. The patient underwent the following laboratory tests and procedures: Biopsy: (Mar2022) Everything was clear and the biopsy was good; Blood glucose: (09Aug2022) 29, notes: Unit Not Provided; (Aug2022) better; SARS-CoV-2 test: (Aug2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, hypoglycaemia, insulinoma. Outcome of hypoglycemia and insulinoma was recovering, outcome of other events was unknown.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: hypoglycemia / blood sugar dropped; Husband tested positive /took Paxlovid; Husband tested positive /took Paxlovid; insulinoma; This is a spontaneous report received from contactable consumer (patient's wife). An 86-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6198), on 19Mar2021 as dose 2, single (Lot number: EP7534) and on 22Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 86 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: SIMVASTATIN. Patient's wife reported that in Mar2022 patient had surgery for an insulinoma which is a begin tumor on the pancreas that causes the pancreas to secrete too much insulin. Took that off and didn't take much of the pancreas. Everything was clear and the biopsy was good. Has been getting along fine since then. Currently, it's August and he had Covid last week (in Aug2022), took Paxlovid from 30Jul2022 to 03Aug2022, and yesterday (09Aug2022) his blood sugar dropped to 29 and had to be taken to the hospital. Timing seems rather interesting that the Covid, Paxlovid, and then blood sugar drop when there hadn't been any problems with his blood sugar since March until now. Patient's wife is wondering about the possibility of hypoglycemia as a result of the Covid or Paxlovid. She has read where it is a possible side effect of both Covid and Paxlovid. Patient tested positive and was given Paxlovid. Finished Paxlovid a week ago today, 03Aug2022 and his blood sugar dropped yesterday (09Aug2022) and he is in the hospital. Patient's wife is wondering if this is a valid situation. She knew that not a whole lot is known about covid. patient got the Pfizer vaccines. Patient's wife did as well. She has not had covid. Wondering about the timing of this blood sugar drop though. She also reported patient's blood sugar was better as of 10Aug2022. Still hospitalized while the doctors try to figure out why this happened. On an IV that was stabilizing his blood sugar. He's not diabetic. The patient underwent the following laboratory tests and procedures: Biopsy: (Mar2022) Everything was clear and the biopsy was good; Blood glucose: (09Aug2022) 29, notes: Unit Not Provided; (Aug2022) better; SARS-CoV-2 test: (Aug2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, hypoglycaemia, insulinoma. Outcome of hypoglycemia and insulinoma was recovering, outcome of other events was unknown.
Age: 56.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing). There were no 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; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included nirmatrelvir/ritonavir (PAXLOVID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: Positive for COVID/ before her second booster dose; Positive for COVID/ before her second booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 01Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 83 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Allergies to Penicillin" (unspecified if ongoing). Concomitant medications (all started years before) included: OLMESARTAN; BYSTOLIC; ZOCOR; CETIRIZINE taken for hypersensitivity; FLUTICASONE nasal; IPRATROPIUM BROMIDE nasal; OMEPRAZOLE; LORAZEPAM; DILTIAZEM. Past drug history included: Clonidine, reaction(s): "Allergies to Clonidine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Dec2021, outcome "recovered" (20Dec2021) and all described as "Positive for COVID/ before her second booster dose". The event "positive for covid/ before her second booster dose" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Dec2021) Positive; (20Dec2021) Negative; Weight: (unspecified date) 115-117 lbs. Therapeutic measures were taken as a result of vaccination failure, COVID-19 and included an antibiotic.  Clinical course: The patient had 4 doses of Pfizer BioNTech Covid-19 Vaccine including 2 standard doses and 2 booster doses. She has had COVID twice since getting Pfizer COVID-19 Vaccine; the first was before her second booster dose. Since the first series of the vaccine she has had itchy rash all over her legs, arms and body that's like getting hives. Her doctor gave her antibiotic but it wouldn't go away. Doctor gave her the antibiotic in Dec2021 when she had COVID thinking it was hives and it didn't work. She does not know the name of the antibiotic, she only had it for a week or so in Dec2021. Patient stated, "The itchy rash gets worse when you get COVID."
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Dysphonia, Illness
Clinical narrative: COVID; COVID; very sick after getting her covid vaccination; had a bad cough; sore throat; was under the weather; voice was hoarse; 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-163-4476548-00.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 08Jul2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHONIA (non-serious) with onset 2022, outcome "unknown", described as "voice was hoarse"; MALAISE (non-serious) with onset 2022, outcome "not recovered", described as "was under the weather"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID"; ILLNESS (non-serious), outcome "unknown", described as "very sick after getting her covid vaccination"; COUGH (non-serious), outcome "unknown", described as "had a bad cough"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". The action taken for risankizumab was unknown. The patient was very sick after getting her covid vaccination. She was under the weather and had a bad cough and sore throat and voice was hoarse.  Causality for Skyrizi (Risankizumab): The reporter's causality for the events of COVID and Under The Weather with Skyrizi (Risankizumab) was no reasonable possibility. The reporter's causality for the event of Hoarse Voice was not provided.   The reporter considered "covid", "was under the weather", "voice was hoarse" and "very sick after getting her covid vaccination" not related to BNT162b2. The reporter's assessment of the causal relationship of "had a bad cough" and "sore throat" 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 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 available information and considering the temporal chronological association  the Company considers these adverse events as not related to study drug BNT162b2. Potential confounding factor for cough, malaise and oropharyngeal pain (included in the safety profile of the drug) represented by risankizumab although treatment detail are missing in the report.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain
Clinical narrative: COVID; COVID; very sick after getting her covid vaccination; had a bad cough; sore throat; was under the weather; voice was hoarse; 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-163-4476548-00.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 08Jul2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHONIA (non-serious) with onset 2022, outcome "unknown", described as "voice was hoarse"; MALAISE (non-serious) with onset 2022, outcome "not recovered", described as "was under the weather"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID"; ILLNESS (non-serious), outcome "unknown", described as "very sick after getting her covid vaccination"; COUGH (non-serious), outcome "unknown", described as "had a bad cough"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". The action taken for risankizumab was unknown. The patient was very sick after getting her covid vaccination. She was under the weather and had a bad cough and sore throat and voice was hoarse.  Causality for Skyrizi (Risankizumab): The reporter's causality for the events of COVID and Under The Weather with Skyrizi (Risankizumab) was no reasonable possibility. The reporter's causality for the event of Hoarse Voice was not provided.   The reporter considered "covid", "was under the weather", "voice was hoarse" and "very sick after getting her covid vaccination" not related to BNT162b2. The reporter's assessment of the causal relationship of "had a bad cough" and "sore throat" 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 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 available information and considering the temporal chronological association  the Company considers these adverse events as not related to study drug BNT162b2. Potential confounding factor for cough, malaise and oropharyngeal pain (included in the safety profile of the drug) represented by risankizumab although treatment detail are missing in the report.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; 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-163-4496042-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Intramuscular), administration date: 01Jan2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Intramuscular), administration date: 01Feb2021, for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up". On an unknown date, the patient experienced rheumatoid arthritis flare ups. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect. The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "rheumatoid arthritis flare up" related (possible) to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted covid; contracted covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 26Jul2022, outcome "unknown" and all described as "contracted covid". 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: Facial paralysis, Joint stiffness, Lyme disease, Musculoskeletal stiffness
Clinical narrative: diagnosed with Lyme's, rash, fever; facial palsy on right side; neck stiffness; Stiff joints; 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 50-year-old patient received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: LYME DISEASE (medically significant), outcome "unknown", described as "diagnosed with Lyme's, rash, fever"; FACIAL PARALYSIS (medically significant), outcome "not recovered", described as "facial palsy on right side"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "neck stiffness"; JOINT STIFFNESS (non-serious), outcome "unknown", described as "Stiff joints". Therapeutic measures were taken as a result of lyme disease. The patient had COVID shot and booster. Also, patient was just recently diagnosed with Lyme's and just took the last pill this am. The patient always outside for work and can't have it disrupt work again. Stiff joints, rash, fever, not fun! Currently have facial palsy, right side. Can't eat a hamburger unless cut the meat. The patient submitted a request to possibly get in on the Lymes trial. The patient recently came down with Lyme's and finished the last pill of the 14 got Monday. This was a nasty experience of which the patient didn't want to go through again! The patient just turned 50 and was in great health, great shape and fit. Work outside and was an avid hunter and fisherman. This disease was real and something that hit patient hard was the stiffness patient endured. The patient felt like the Tin man! That's the best way to put it. Fever, and very bad neck stiffness were hitting hard. The patient currently has facial palsy on right side. It's hard to even drink water, need a straw.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; 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-163-4497950-00.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Intramuscular), for covid-19 immunisation; Bnt162b2 (DOSE 2, Intramuscular), for covid-19 immunisation. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset Dec2021, outcome "recovering", described as "Heart attack". The action taken for adalimumab was unknown.  Solicited report by a consumer of a 63 year old male with an event of Heart Attack with Humira (Adalimumab). There was no reported medical history. In Dec2021, the patient experienced heart attack. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect.  The reporter's causality for the event(s) of heart attack was not provided for Adalimumab, the opinion is that the event of heart attack is not assessable for Adalimumab. The reporter's causality for the event(s) of heart attack was possible for Pfizer BioNTech COVID19 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 available information, a possible contributory role of BNT162B2 vaccine cannot be totally excluded for the reported event of Myocardial infarction. 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: COVID19
Symptoms: Cerebrovascular accident, Incorrect dose administered
Clinical narrative: had a stroke 3 days after receiving a 5th dose of Comirnaty; Inappropriate dose of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An 85-year-old patient received BNT162b2 (COMIRNATY), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "at a long-term care facility, nursing home" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (dose 3 (booster), manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (dose 4 (booster), manufacturer unknown), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "unknown", described as "had a stroke 3 days after receiving a 5th dose of Comirnaty"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Inappropriate dose of vaccine administered". Event took place after use of product.  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 available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Cerebrovascular accident. 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.