chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 at 13:30 as dose 4 (booster), single (Lot number: FM9992) 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's relevant medical history included: "Multiple myeloma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Other medication in 2weeks is Yes. On 27Jun2022 patient started other medication in 2 weeks and brand is Revlimid. On Jul2022 patient stopped taking it. No any treatment an dno allergies were reported.  No follow-up attempts are possible. No further information is expected.
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 15May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) 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 had no relevant medical history. 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results; positive, notes: recurrence of fatigue and positive SARS-CoV-2 antigen test 7 days after finishing paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2weeks. Anti viral details was paxlovid, treatment start date was 28Jun2022, stop date was 02Jul2022, Indication=Treatment of COVID-19. No treatment for AE. No Known allergies. No Other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
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) (Other HCP) from product quality group. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 2, single (Lot number: Ek4176) and on 11Oct2021 as dose 3 (booster), single (Lot number: Ff2590) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUSPIRONE; FLUOXETINE. 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No known allergies. Patient received other medication in two weeks. Paxlovid for treatment of COVID-19, started on 02Jul2022 and stopped on 07Jul2022. On 10Jul2022, she experienced the event Rebound infection. No treatment given.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cerebrovascular accident, Headache, Lethargy
Clinical narrative: ended up hospitalized due to stroke symptoms; She has been having side effects still to this day including weakness, headaches, and lethargy; She has been having side effects still to this day including weakness, headaches, and lethargy; She has been having side effects still to this day including weakness, headaches, and lethargy; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), in 2022 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: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 3), for COVID-19 immunization.  The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant), outcome "recovering", described as "ended up hospitalized due to stroke symptoms"; ASTHENIA (hospitalization), HEADACHE (hospitalization), LETHARGY (hospitalization), outcome "recovering" and all described as "She has been having side effects still to this day including weakness, headaches, and lethargy". The events "ended up hospitalized due to stroke symptoms" and "she has been having side effects still to this day including weakness, headaches, and lethargy" required physician office visit. It was unknown if therapeutic measures were taken as a result of cerebrovascular accident, asthenia, headache, lethargy. Clinical course: Reporter was told by friend that her mother had been having extended side effects after her second booster. Reporter ascertained that all 4 vaccinations have been Pfizer. She said that she got the vaccine at the end of May2022 or beginning of Jun2022 and ended up hospitalized due to stroke symptoms. She had been having side effects still to this day including weakness, headaches, and lethargy. This was the extent of information.  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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event cerebrovascular accident, asthenia, headache, lethargy Cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: COVID rebound with symptoms starting July 10; COVID rebound with symptoms starting July 10; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 31-year-old male patient received BNT162b2 (BNT162B2), on 18Oct2021 at 16:00 as dose 3, (booster), single (Lot number: FH8027) at the age of 30 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). 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) all with onset 10Jul2022, outcome "not recovered" and all described as "COVID rebound with symptoms starting July 10". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (10Jul2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. COVID rebound with symptoms starting July 10, antigen was positive and turned positive faster than the same brand of test prior to beginning paxlovid, suggesting a higher viral load. Symptoms thus far are less severe though, no fever unlike prior to paxlovid.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in left arm pit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2022 at 12:00 as dose 1, single (Lot number: FM7773) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; OXYBUTYN. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Jul2022 at 23:00, outcome "not recovered", described as "Swollen lymph node in left arm pit". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: Other medications in two weeks was supplements. No covid Prior vaccination, no covid tested post vaccination. Known allergies were none and other medical history were none.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Felt normal and tested negative day 9 of covid; day 10 tested positive and return of headache/stuffy nose; Felt normal and tested negative day 9 of covid; day 10 tested positive and return of headache/stuffy nose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booser), single (Batch/Lot number: unknown) at the age of 47 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: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; SINGULAIR; ALLEGRA; MAGNESIUM OXIDE; ESOMEPRAZOLE; GENTLE IRON [FERROUS BISGLYCINATE]; ATARAX [ALPRAZOLAM]; PROBIOTIC [BIFIDOBACTERIUM LACTIS]. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Felt normal and tested negative day 9 of covid; day 10 tested positive and return of headache/stuffy nose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (09Jul2022) Negative, notes: tested negative day 9 of covid; (10Jul2022) Positive, notes: day 10 tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: It was reported that Anti viral details: product: COVID 19 Treatment. Treatment start date: 01Jul2022. Treatment stop date: 06Jul2022. Indication: Treatment of COVID-19. Adverse event: Felt normal and tested negative day 9 of covid; day 10 tested positive and return of headache/stuffy nose. Adverse event start date 10Jul2022. Adverse event start time: 12:00 AM. AE resulted in: None of the above. If patient recovered: Recovering. If treatment AE: Yes. AE treatment: Otc cold meds.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: test shows that I am positive; I have COVID-19; test shows that I am positive; I have COVID-19; 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), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "test shows that I am positive; I have COVID-19". 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 included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he would test still positive; He had all the Pfizer immunization, he have all the vaccinations done; he would test still positive; He had all the Pfizer immunization, he have all the vaccinations done; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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 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 "he would test still positive; He had all the Pfizer immunization, he have all the vaccinations done". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: My husband had test for the positive; Positive, notes: after 10 days continuously is, we just check it just if the test was still positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Reporter stated, She asking about, the medication was Paxlovid. Her husband had test for the positive, Covid positive, so they got the Paxlovid, the medication, Pfizer's. After that, after 10 days continuously, They just check it just if the test was still positive. He does not have a lot of symptom but he still does had a lot of sputum was coming out and basically that was what it was. He pulped it out and spit them, he does not have fever, he does not have anything precise of whatsoever. She just wondering since he would test still positive, he was still contagious? Yes? He had all the Pfizer immunization, he had a booster two times, he had a vaccination two times (Later clarified as Pfizer COVID- 19 Vaccine), he got everything done. reporter just kind of wondering was that, can be possible if they ask about the urgent care doctor to ask about monoclonal antibody, was that a name or somebody says 'that Paxlovid may had possible' and even though he had Paxlovid, can they had another shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: 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) (Physician) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2022 at 10:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 09Mar2021 at 09:00 as dose 1, single (Lot number: 032M20A), in left arm, on 07Apr2021 at 10:00 as dose 2, single (Lot number: 016B21A), in right arm and on 18Nov2021 at 09:00 as dose 3 (booster), single (Lot number: 039F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Celebrex, reaction(s): "Known allergies: Celebrex". No other medication in 2 weeks.  The following information was reported: DRUG INEFFECTIVE (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: Unknown results, notes: Rebound 3-4 days after last dose with increase nasal congestion and cough. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received anti viral treatment Paxlovid (lot number: 00079-1085-30) from 29Jun2022 to 03Jul2022 for treatment of COVID-19.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 62.0
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). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 18:00 as dose 1, single (Lot number: En6202), in right arm, on 31Mar2021 at 18:00 as dose 2, single (Lot number: Ep6955), in right arm and on 16Jun2022 at 10:00 as dose 4 (booster), single (Lot number: Fn2908) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 10Nov2021 at 19:00 as dose 3 (booster), single (Lot number: 034f21a), in right arm 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive; Unknown Result.
Sex: F
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: It's for injuries for vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), 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: INJURY (non-serious), outcome "unknown", described as "It's for injuries for vaccines".  Additional Information: Reporter stated was calling regarding Pfizer vaccine (unspecified vaccine) for grandmother. When paraphrased, Reporter stated called  for vaccine. When probed if reporter had any query. Reporter stated injuries for vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, 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) (Other HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 04Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), (Batch/Lot number: unknown) at 3 single (dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Moderna, start date: 08Dec2021, stop date: 08Dec2021, for Covid-19 Immunization, reaction(s): "COVID-19", notes: Dose Number: 3, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right; Pfizer / biontech, start date: 04Apr2021, stop date: 04Apr2021, for Covid-19 Immunization, reaction(s): "COVID-19", notes: Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right; Pfizer / biontech, start date: 17Mar2021, stop date: 17Mar2021, for Covid-19 Immunization, reaction(s): "COVID-19", notes: Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right. If Vaccine Received: Yes. Other Medication in 2weeks: No. 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: Unknown Results. Anti Viral Details Product: COVID 19 Treatment, Brand: Paxlovid, Treatment Start Date: 01Jul2022, Treatment Stop Date: 06Jul2022, and Indication: Treatment of COVID-19. Adverse event: Rebound of Ag-positive symptoms 4 days after completion of Paxlovid treatment. Adverse event start date: 11Jul2022. Adverse event start time: 01:30 AM.   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 in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid Infection; Covid Infection; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 22Apr2021 as dose 2, single (Lot number: ER8735), in left arm and on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "SVT" (unspecified if ongoing); "HTN" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Drug Allergy: Demerol"; Darvon, reaction(s): "Drug Allergy: Darvon"; Darvocet, reaction(s): "Drug Allergy: Darvocet". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Jul2022 at 19:00, outcome "recovering" and all described as "Covid Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Negative, notes: Nasal Swab; (07Jul2022) Positive, notes: Nasal Swab; (09Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: No other vaccine in four weeks. No other medications in two weeks. No Covid prior vaccination. Covid tested positive post vaccination. Facility type vaccine: Pharmacy or Drug Store.  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, 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 41-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 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 Result. Therapeutic measures were taken as a result of covid-19. Clinical course: Anti-viral details: Product: COVID 19 Treatment. Brand: Paxlovid. Treatment start date: 03Jul2022. Treatment stop date: 07Jul2022. Indication: Treatment of COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 non-contactable reporter(s) (Pharmacist).  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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 covid-19, drug ineffective.  No Follow-up attempts are Possible. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 71-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "blood pressure abnormal" (unspecified if ongoing), notes: High blood pressure; "Blood cholesterol" (unspecified if ongoing), notes: high cholesterol. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment".anti viral details :product: COVID 19 Treatment. brand: Paxlovid, treatment start date:01Jul2022, treatment stop date:06Jul2022,indication: Treatment of COVID-19   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 08Feb2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "POCS" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; ALBUTEROL HFA; SINGULAIR; CITALOPRAM; TELMISARTAN; METFORMIN ER; POTASSIUM CHLORIDE; NAPROXEN; ATORVASTATIN. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". 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, notes: after testing negative on the 5th day on the medication; Positive, notes: got two positive test; Positive, notes: got two positive test; Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Adverse event: Took the Paxlovid and now having rebound symptoms and got two positive test after testing negative on the 5th day on the medication.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
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) (Physician) from product quality group. The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 32 years intramuscular, 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 had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovering" and all described as "Treatment of COVID-19". It was reported that patient contracted covid and was started PAXLOVID on day 4 of symptoms. Covid test was negative on day 11 (06Jul2022). On day 14 (08Jul2022), symptoms returned and my rapid test was positive again. Therapeutic measures taken as a result of drug ineffective, covid-19 included anti-viral PAXLOVID from 29Jun2022 to 04Jul2022.  Product Quality Group provided investigational results on 12Jul2022 for BNT162b2: Conclusion of Previously Completed Investigation (FCISIOffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FF2587 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2587, fill lot FF2556, and the formulated drug product lot FE5315. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Based on the available information available, there is causal association between the events drug ineffective, covid-19 and the suspect drug BNT162b2 cannot be excluded . The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2022 as dose 3 (booster), single (Lot number: FG3527) at the age of 72 years intramuscular, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Lot number: 016M20A), in right arm, on 10Mar2021 as dose 2, single (Lot number: 032M20A), in right arm and on 03Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sesame, reaction(s): "known allergies: sesame"; Sunflower seed, reaction(s): "known allergies: Sunflower seed". 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: (08Jul2022) Negative; (11Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 02Jul2022 to 07Jul2022 as treatment of COVID-19. COVID rebound. One day after finishing Paxlovid, COVID test was negative. Two days later new symptoms developed. Retest for COVID was positive (11Jul2022).  This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process according to in PQS Q1215 and or Q1252. Refer to the below table for details: Product Description (CR): COMPOUND BNT 162 COVID 19 VACCINE SUSPENSION FOR INTRAMUSCUL AR 2ML MULTIPLE DOSE VIAL X 1. Lot-# (CR): FG3527. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FG3527 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FG3527, fill lot FG3512, and the formulated drug product lot FJ8500. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Aug2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV infection - long term" (unspecified if ongoing), notes: HIV infection - long term. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete- unknown manufacturer), for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had anti-viral therapy of Paxlovid from 26Jun2022 to 30Jun2022 for treatment of COVID-19 and had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 37.0
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) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 at 15:00 as dose 3 (booster), single (Lot number: EL9264) at the age of 37 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: "known allergies: Latex" (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: (11Jul2022) Positive; (08Jul2022) Negative; (10Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 02Jul2022 to 07Jul2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19. After testing negative for Covid on 08Jul2022 and 10Jul2022.  On 11Jul2022 at 06:00 am, the patient woke up with a new sore throat and tested positive for Covid on a rapid test. The patient assumed she had "Paxlovid rebound". Product Quality Group provided investigational results on 12Jul2022 for bnt162b2: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL9264 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EL9264, fill lot EL9255, and the formulated drug product lot EL9246. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) and from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 08Sep2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 14Apr2022 at 09:30 as dose 4 (booster), single (Lot number: FM9992) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history (patient had no known allergies and no other medical history). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included received anti-viral product Paxlovid from 30Jun2022 to 05Jul2022. Investigation result conclusion: Lot-# (CR): FM9992. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): "For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 7142695 (see File attachment in this investigation record) The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM9992. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Manufacturing facility  concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 29.0
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 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 at 09:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 24Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (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 "unknown" and all described as "COVID 19 Treatment".  Additional information: Rebound infection after taking Paxlovid. No Other medication was received within 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
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) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Dec2021 at 10:00 as dose 3 (booster), single (Lot number: 33130BA) at the age of 44 years, in right 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: "known allergies: Penicillin" (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: (unspecified date) Positive, notes: Treatment of COVID-19; (unspecified date) Negative, notes: after days of testing negative; (11Jul2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Anti-viral details included: Product: COVID 19 Treatment, Brand was Paxlovid. Treatment start date was on 02Jul2022, Treatment stop date was on 06Jul2022, Indication was for Treatment of COVID-19. 6 days after completing course of Paxlovid, patient feel sick and tested positive again, after days of testing negative.  No follow-up attempts possible. No further information expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 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: "chronic PVC's" (unspecified if ongoing); "vertigo" (unspecified if ongoing). Concomitant medication(s) included: VALIUM, start date: Nov2020, stop date: Jul2022; METOPROLOL, start date: Jan2015, stop date: Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (11Jul2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (03Jul2022) Positive, notes: Tested positive(via home test) on 03Jul2022. for Covid-19; (11Jul2022) Negative, notes: Symptoms cleared in 4 days. Tested negative on 11Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events