chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (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 Apr2023, outcome "unknown" and all described as "Treatment of 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. Clinical course: Patient received paxlovid as treatment drug from 22Apr2023 to 26Apr2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182002 same patient, different drug/event;
Sex: F
Vaccine: COVID19, 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) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "sulfa allergy" (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". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: The patient took Paxlovid from 23Apr2023 to 28Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The contributory role of the suspect product to the reported  event drug ineffective and COVID-19 cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency. ,Linked Report(s) : US-PFIZER INC-202300181837 Same reporter/patient, different suspect/event;
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Scar
Clinical narrative: and burning sensation; Rash all over body; scars; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 28-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Lot number: EW0161) at the age of 28 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (ongoing), notes: Epilepsy; "Brain Surgery" (unspecified if ongoing); "Tumor in Stomach" (unspecified if ongoing). Concomitant medication(s) included: VIMPAT taken for epilepsy, start date: 2011 (ongoing); ZONISAMIDE taken for epilepsy, start date: 2011 (ongoing). The following information was reported: RASH (non-serious) with onset 21Apr2021, outcome "recovered", described as "Rash all over body"; BURNING SENSATION (non-serious) with onset 21Apr2021, outcome "recovered", described as "and burning sensation"; SCAR (non-serious) with onset 2021, outcome "unknown", described as "scars". The events "and burning sensation", "rash all over body" and "scars" required emergency room visit. Therapeutic measures were taken as a result of burning sensation, rash, scar. Additional information: The patient got a rash all over her body and a burning sensation and was rushed to the hospital (ER). After 1-2 weeks, it resolved, but she has scars. She did not receive a secondary dose. It was reported that patient was treated and released in the ER. She stated, she saw 3 doctors there and they told her to use cream to put over it.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8733), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: patient received Anti viral COVID 19 Treatment, Paxlovid, from 25Apr2023 to 30Apr2023 as Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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's relevant medical history included: "Known allergies: Penicillin" (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 Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had taken Paxlovid as COVID 19 Treatment from 26Apr2023 to 30Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182610 Same patient, different drug, different event;
Age: 49.0
Sex: M
Vaccine: COVID19, 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 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 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". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: patient treated with Paxlovid from start date 25Apr2023 to end date 29Apr2023, lot number:PAA1888974 for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182508 Same patient, different product, different event;
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: Disease recurrence (Suspected COVID-19); Drug ineffective; Suspected COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN O208) and on 09Apr2021 as dose 2, single (Lot number: EWU153) at the age of 53 years 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) with onset Jan2022, outcome "unknown"; SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "unknown"; DISEASE RECURRENCE (medically significant) with onset 16Jan2023, outcome "unknown", described as "Disease recurrence (Suspected COVID-19)". The events "drug ineffective", "suspected covid-19" and "disease recurrence (suspected covid-19)" required physician office visit. Clinical Course: Patient stated she knew people got Bell's Palsy with reaction to Pfizer covid-19 vaccines, she did not have Pfizer shot since Apr2021. She did not have the boosters, her doctor thought that it was too long ago to be the reason for this. She did get covid herself in Janaury and her upper back and neck were in excruciating pain, then all of a sudden bam. She had covid twice after the second dose of the Pfizer covid 19 vaccine, second dose was in April, she got covid the following Jan2022, and again this 15Jan2023. Patient asked for any data that people who took Pfizer covid vaccine had bell's palsy, or got it at a later date. She got Covid on 16Jan2023 and woke up all nasally, woke up the next day and her upper upper trap muscles, neck and muscles on the right could not move without pain. Her doctor thought it was post viral neuralgia. She had been going to physical therapy 3 times a week since January. She just went down to 2 times a week because her body was feeling better and did not know if it was related. She was also under a lot of stress.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182700 Same patient, different product, different event;
Age: 60.0
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 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Mar2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (03May2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with Paxlovid from 26Apr2023 to 30Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300183026 same reporter/patient, different drug/AE;
Sex: M
Vaccine: COVID19, 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 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 5 (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), 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 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 "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not received other medication in 2weeks. It was reported that patient was treated with Paxlovid from 27Apr2023 to 03May2023. Patient had no Known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300183056 same reporter/patient, different drug/AE;
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), on 12Mar2021 as dose 2, single (Batch/Lot number: unknown), on 31Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 15Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Patient stated that she had no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2023) Positive, notes: Day 1 is when I started taking paxlovid and received my first positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient received paxlovid as treatment drug from 25Apr2023 to 30Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300183094 same reporter/patient, different drug/AE (Paxlovid);
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cardiac disorder, Dyspnoea, Investigation, Loss of personal independence in daily activities
Clinical narrative: I would say and I did end up getting like COVID like three times; I would say and I did end up getting like COVID like three times; 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 52-year-old female patient received BNT162b2 (BNT162B2), on 26Aug2021 as dose 1, single (Lot number: FD8448), in right arm and on 16Sep2021 as dose 2, single (Lot number: 301308A) at the age of 50 years, in right arm 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), outcome "unknown" and all described as "I would say and I did end up getting like COVID like three times". The patient underwent the following laboratory tests and procedures: Laboratory test: (Mar2023) Unknown results, notes: my last lab were Mar of this year that's when I was in the hospital for six days, yes.". Clinical course: Patient did end up getting like COVID like three times. She did get COVID a couple of times and after that it just been downhill. Patient do not have information about for Booster Vaccine. When probed for the dose, consumer stated, she don't had that information. It only has three sections here and one section is to, the first dose it says the maker which is Pfizer then the number she gave you and then the date it was given and then who gave it which is withheld Department of health and then that was all on here there is no information on leader or anything like that. Patient was not able to provide the time of vaccination.  Conclusion: The complaint for lack of effect of the Pfizer BioNTech COVID-19 Vaccine lot FD8448 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FD8448, fill lot EY0548, and the bulk formulated drug product lot EP8652. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300183100 same patient, same product, different events (dose 2);US-PFIZER INC-202300183117 same patient, same product, different events (dose 1);
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pneumonia
Clinical narrative: I would say and I did end up getting like COVID like three times; I would say and I did end up getting like COVID like three times; 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 52-year-old female patient received BNT162b2 (BNT162B2), on 26Aug2021 as dose 1, single (Lot number: FD8448), in right arm and on 16Sep2021 as dose 2, single (Lot number: 301308A) at the age of 50 years, in right arm 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), outcome "unknown" and all described as "I would say and I did end up getting like COVID like three times". The patient underwent the following laboratory tests and procedures: Laboratory test: (Mar2023) Unknown results, notes: my last lab were Mar of this year that's when I was in the hospital for six days, yes.". Clinical course: Patient did end up getting like COVID like three times. She did get COVID a couple of times and after that it just been downhill. Patient do not have information about for Booster Vaccine. When probed for the dose, consumer stated, she don't had that information. It only has three sections here and one section is to, the first dose it says the maker which is Pfizer then the number she gave you and then the date it was given and then who gave it which is withheld Department of health and then that was all on here there is no information on leader or anything like that. Patient was not able to provide the time of vaccination.  Conclusion: The complaint for lack of effect of the Pfizer BioNTech COVID-19 Vaccine lot FD8448 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FD8448, fill lot EY0548, and the bulk formulated drug product lot EP8652. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300183100 same patient, same product, different events (dose 2);US-PFIZER INC-202300183117 same patient, same product, different events (dose 1);
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Investigation, Suspected COVID-19
Clinical narrative: I would say and I did end up getting like COVID like three times; I would say and I did end up getting like COVID like three times; 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 52-year-old female patient received BNT162b2 (BNT162B2), on 26Aug2021 as dose 1, single (Lot number: FD8448), in right arm and on 16Sep2021 as dose 2, single (Lot number: 301308A) at the age of 50 years, in right arm 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), outcome "unknown" and all described as "I would say and I did end up getting like COVID like three times". The patient underwent the following laboratory tests and procedures: Laboratory test: (Mar2023) Unknown results, notes: my last lab were Mar of this year that's when I was in the hospital for six days, yes.". Clinical course: Patient did end up getting like COVID like three times. She did get COVID a couple of times and after that it just been downhill. Patient do not have information about for Booster Vaccine. When probed for the dose, consumer stated, she don't had that information. It only has three sections here and one section is to, the first dose it says the maker which is Pfizer then the number she gave you and then the date it was given and then who gave it which is withheld Department of health and then that was all on here there is no information on leader or anything like that. Patient was not able to provide the time of vaccination.  Conclusion: The complaint for lack of effect of the Pfizer BioNTech COVID-19 Vaccine lot FD8448 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FD8448, fill lot EY0548, and the bulk formulated drug product lot EP8652. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300183100 same patient, same product, different events (dose 2);US-PFIZER INC-202300183117 same patient, same product, different events (dose 1);
Age: 28.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 16May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa allergy" (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 Apr2023, 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 drug ineffective, covid-19. Clinical course: patient received paxlovid on 21Apr2023 to 25Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300183108 same reporter/patient, different drug/AE;
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2 NOS), on 22Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid as treatment drug from 28Apr2023 to 02May2023.  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 current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect product Comirnaty cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300182911 same patient/reporter; different drug/AE;
Age: 60.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Patient had no known drug allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" 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 with paxlovid from 20Apr2023 to 25Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182760 same patient, different product and event;
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Computerised tomogram, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: a positive COVID-19 test; a positive COVID-19 test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 16-year-old male patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 1, single (Lot number: EY0584), in arm, on 04Sep2021 as dose 2, single (Lot number: FC3184), in arm and on 12Apr2022 as dose 3 (booster), single (Lot number: FK9893) at the age of 15 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal Allergies" (unspecified if ongoing), notes: Flonase as needy; "Tree Pollen" (unspecified if ongoing), notes: Flonase as needy; "Cats" (unspecified if ongoing), notes: Flonase as needy; "acute pancreatitis" (unspecified if ongoing), notes: acute pancreatitis was discontinued. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "a positive COVID-19 test". The patient underwent the following laboratory tests and procedures: Blood test: (19Jan2022) Unknown Results; Computerised tomogram: (19Jan2022) Unknown Results; Magnetic resonance imaging: (19Jan2022) Unknown Results; SARS-CoV-2 test: (19Jan2022) Positive, notes: Covid Positive loss of smell & Taste for Months; X-ray: (19Jan2022) Unknown Results.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300019688 same patient/vaccine, diff dose/event;
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure, X-ray
Clinical narrative: a positive COVID-19 test; a positive COVID-19 test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 16-year-old male patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 1, single (Lot number: EY0584), in arm, on 04Sep2021 as dose 2, single (Lot number: FC3184), in arm and on 12Apr2022 as dose 3 (booster), single (Lot number: FK9893) at the age of 15 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal Allergies" (unspecified if ongoing), notes: Flonase as needy; "Tree Pollen" (unspecified if ongoing), notes: Flonase as needy; "Cats" (unspecified if ongoing), notes: Flonase as needy; "acute pancreatitis" (unspecified if ongoing), notes: acute pancreatitis was discontinued. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "a positive COVID-19 test". The patient underwent the following laboratory tests and procedures: Blood test: (19Jan2022) Unknown Results; Computerised tomogram: (19Jan2022) Unknown Results; Magnetic resonance imaging: (19Jan2022) Unknown Results; SARS-CoV-2 test: (19Jan2022) Positive, notes: Covid Positive loss of smell & Taste for Months; X-ray: (19Jan2022) Unknown Results.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300019688 same patient/vaccine, diff dose/event;
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand=Pfizer / BioNTech; vaccine administration date=13Apr2023; vaccine brand other=MODERNA, vaccine administration date=04Mar2021; 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 91-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Apr2023 at 12:30 as dose 3 (booster), single (Lot number: GL0447) at the age of 91 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Feb2021 at 11:15 as dose 1, single (Lot number: 013M20A), in left arm and on 04Mar2021 at 13:15 as dose 2, single (Lot number: 012A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "atrial fibrillation" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "seasonal allergy" (unspecified if ongoing); "mild asthma" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: May1993, stop date: 07May2023; TERAZOSIN, start date: Jul1956, stop date: 07May2023; FINASTERIDE, start date: Jan1980, stop date: 07May2023; METOPROLOL, start date: Feb2021, stop date: 07May2023; APIXABAN, start date: Mar2017, stop date: 30Apr2023; FLUTICASONE, start date: May1984, stop date: 07May2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Apr2023 at 12:30, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech; vaccine administration date=13Apr2023; vaccine brand other=MODERNA, vaccine administration date=04Mar2021"; 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: Positive, notes: COVID 19 Treatment. Therapeutic measures paxlovid from 30Apr2023 to 05May2023 was taken as a result of drug ineffective, covid-19.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown), in right arm, in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "htn" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "recovered"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: after testing negative. Therapeutic measures were taken as a result of drug ineffective, 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 current available limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the use of suspect product cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300182757 same patient, different product and event;US-PFIZER INC-202300183358 same patient, different dose and event (DOSE 2);
Age: 35.0
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) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 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 included: "ectopic atrial tachycardia" (unspecified if ongoing); "depression" (unspecified if ongoing); "hyperhidrosis" (unspecified if ongoing); "IBS" (unspecified if ongoing); "known allergies: Onions" (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 "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (02May2023) Negative; (05May2023) Positive, notes: tested positive starting on Friday 05May (after finishing Paxlovid and testing negative on 02May). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Antiviral details Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 27Apr2023, Treatment stop date: 02May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182899 same reporter/patient, different drug/event;
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic asthma" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "severe skin" (unspecified if ongoing); "respiratory" (unspecified if ongoing); "Medication allergies" (unspecified if ongoing); "food intolerances" (unspecified if ongoing); "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment of Paxlovid for COVID-19 from 27Apr2023 to 02May2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300183864 same patient, different drug and different event;
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 "unknown" and all described as "Treatment of COVID-19". 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 drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182900 same reporter/patient, different drug/AE.;
Age: 70.0
Sex: M
Vaccine: COVID19-2
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 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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. Past drug history included: Gabapentin, reaction(s): "Known allergies: Gabapentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "recovered" (27Apr2023) 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; (27Apr2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 21Apr2023 to 25Apr2023. Clinical course: Patient was not taking any other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182804 same patient, different product and event;
Sex: M
Vaccine: COVID19, 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 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN, start date: 01Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182807 same patient, different product and event;
Sex: F
Vaccine: MENB
Symptoms: Colitis ulcerative
Clinical narrative: diagnosed with Ulcerative Colitis; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An 18-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "unknown", described as "diagnosed with Ulcerative Colitis ". Therapeutic measures were taken as a result of colitis ulcerative. It was reported that patient was diagnosed with Ulcerative Colitis and was on Prednisone. The physician had a quick question about Trumenba. He was asking if it was safe for a patient to be on prednisone and to be due for Trumenba, or should they delay the second dose. He also asked if there were contraindications.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.; Sender's Comments: The association between the event ulcerative colitis with TRUMENBA can not be fully excluded based on the available information.  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.