chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6207), on 07Apr2021 as dose 2, single (Lot number: EW0150) and on 21Oct2021 as dose 3 (booster), single (Lot number: FF2582) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history included: "Antihistamine" (unspecified if ongoing); "Anti-acid" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; NEXIUM [ESOMEPRAZOLE SODIUM] taken for gastrooesophageal reflux disease; ZYRTEK taken for antiallergic therapy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Negative, notes: By 13May2022 I was testing negative,; (May2022) Negative, notes: testing twice daily on Antigen tests for the next full week; (10May2022) positive, notes: on 10May2022 I tested positive and began Paxlovid that evening; (20May2022) positive, notes: On first text 20May2022, I began to test positive again for Covid. Been testing positive for Covid since 20May2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Conclusion- The complaint for lack of effect of the Pfizerbiontech Covid-19 Vaccine lot EN6207 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 EN6207, fill lot EN5340, and the formulated drug product lot EN5328. A complaint sample was not returned. No related quality issues were identified during the investigation. There was 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.  Clinical course- The patient started exhibiting Covid symptoms on 08May2022, on 10May2022  tested positive and began Paxlovid that evening. By 13May2022 the patient was testing negative, testing twice daily on Antigen tests for the next full week. The patient completed Paxlovid dose the morning 15May2022. On first text 20May2022, the patient began to test positive again for Covid. The patient receive other vaccines within 4 weeks prior to the COVID vaccine. There was list of other medications the patient received within 2 weeks of vaccination.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID illness; COVID illness; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "T1 Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "known allergies: Amoxicillin" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG taken for blood insulin abnormal; LEVOTHYROXINE; INSULIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24May2022 at 18:00, outcome "unknown" and all described as "COVID illness". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical courses: Other medication in 2 weeks: Insulin, Humalog, Levothyroxine. AE treatment: Advil.  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: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.  ,Linked Report(s) : US-PFIZER INC-202200770433 Same patient, different product and event
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: not feeling right with each Pfizer COVID vaccine; Sore arm; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL8982) at the age of 79 years, in left arm and on 09Feb2021 as dose 2, single (Lot number: EL9267), in left arm for covid-19 immunization. The patient's relevant medical history included: "Heart failure", start date: Aug2018 (unspecified if ongoing); "Asthma", start date: Aug2018 (unspecified if ongoing), notes: She does inhalers; "COPD", start date: Aug2018 (unspecified if ongoing), notes: She does inhalers; "scoliosis" (unspecified if ongoing), notes: She has had scoliosis for many years.; "Pacemaker placed", start date: 2018 (unspecified if ongoing). Concomitant medication(s) included: ENTRESTO; DIGOXIN; SPIRONOLACTONE. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovering", described as "not feeling right with each Pfizer COVID vaccine"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Sore arm"; PYREXIA (non-serious), outcome "recovering", described as "low grade fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No additional vaccines were administered on same date of the Pfizer suspect. No AE require a visit to Emergency Room and Physician Office. Patient did not take any prior vaccinations (within 4 weeks). Patient did not receive any medical treatment for events sore arm, low-grade fever and not feeling right with each Pfizer COVID vaccine and all improved within the 2nd day. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200756211 similar report from same reporter.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: covid 19; covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: CUS5815) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Known allergies: Banana" (unspecified if ongoing); "Known allergies: Papaya" (unspecified if ongoing); "Known allergies: Kiwi" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Positive; (18May2022) Negative; (27May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: got her period and her period is not supposed to start for another 18 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A 27-year-old female patient received BNT162b2 (BNT162B2), in May2022 as dose 1, single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset May2022, outcome "not recovered", described as "got her period and her period is not supposed to start for another 18 days".  Additional Information: Patient received the Pfizer COVID-19 vaccine Wednesday night and got her period and her period is not supposed to start for another 18 days. Her period is irregular or right on time. She is supposed to get it for 18 days. Is this normal to get her period after getting the vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EN6201), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 11Nov2021 at 13:00 as dose 3 (booster) , single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "TAVR" (unspecified if ongoing); "Lupus" (unspecified if ongoing); "Reflux" (unspecified if ongoing); "Pleuralefusion" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE, start date: Apr2019, stop date: 27May2022; LOSARTAN, start date: 21Nov2021, stop date: 27May2022; HYDROCHLOROTHIAZID, start date: Jun2010, stop date: 27May2022; HYDROXYCHLOROQUINE, start date: Jun2005, stop date: 27May2022; PREDNISONE, start date: May2001, stop date: 27May2022; ASPIRIN 81, start date: Aug2001, stop date: 27May2022; NEXIUM [ESOMEPRAZOLE SODIUM], start date: Aug2010, stop date: 27May2022; RED YEAST RICE, start date: Sep2018, stop date: 27May2022; FLAXSEED OIL [LINUM USITATISSIMUM OIL], start date: Oct2009, stop date: 27May2022; PROBIOTICS, start date: Mar2018, stop date: 27May2022; VITAMIN C [ASCORBIC ACID], start date: Jan2015, stop date: 27May2022; VITAMIN B-12, start date: Jan2010, stop date: 27May2022; VITAMIN D NOS, start date: Jan2010, stop date: 27May2022; TUMS ULTRA, start date: Nov2020, stop date: 27May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2022 as dose 1, single (Lot number: Er8737), on 03May2022 as dose 2, single (Lot number: Ew0176) and on 22Nov2021 as dose number 3 (booster), single (Lot number: Fj1620) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: FINGOLIMOD, start date: 15Feb2018; GILENYA, start date: 15Feb2018. Past drug history included: Bnt162b2, start date: 03May2021, stop date: 03May2021, for COVID-19 Immunization, reaction(s): "Covid-19", notes: Dose Number: 2, Batch/Lot No: Ew0176; Bnt162b2, start date: 06Apr2022, stop date: 06Apr2022, for covid-19 immunization, reaction(s): "Covid-19", notes: Dose Number: 1, Batch/Lot No: Er8737. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Covid rebound. Consumer started Anti-viral treatment Paxlovid on 16May2022 for COVID 19 Treatment, stopped on 21May2022 (Lot number=FP6522).
Age: 64.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 19Aug2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 31Dec2021 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 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 had relevant medical history (not specified). The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive, notes: Tested positive on 18May2022; (23May2022) Negative, notes: Tested Negative on 23May2022; (27May2022) Positive, notes: Tested Positive on 27May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient started Paxlovid (5-day course) on 18May2022 as a treatment for COVID-19 and completed Paxlovid course on 23May2022.  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
Clinical narrative: a man that had both doses of the PBCV and the 2 booster doses then 13 days later he got COVID and is now taking PAXLOVID; a man that had both doses of the PBCV and the 2 booster doses then 13 days later he got COVID and is now taking PAXLOVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2, solution for injection), 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 "unknown" and all described as "a man that had both doses of the PBCV and the 2 booster doses then 13 days later he got COVID and is now taking PAXLOVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 with PAXLOVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity
Clinical narrative: entire multi-dose vial of vaccination/she was given up to 10 doses; a lot of arm pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  An 8-year-old female patient received BNT162b2 (BNT162B2), on 27May2022 as dose number unknown, single (Lot number: FL809) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2022, outcome "unknown", described as "a lot of arm pain"; OVERDOSE (non-serious) with onset 27May2022, outcome "unknown", described as "entire multi-dose vial of vaccination/she was given up to 10 doses".  Additional information: Question: On 28MAY2022 after hours VM left at 1:39PM EST: verbatim: Hi, my name is (name withheld), I am calling, I am not in the office today, apologize it is raining here. My phone number to call me back is (phone number withheld). I am calling because I have been notified by a patient that a local pharmacy inadvertently gave a child, an 8-year-old Female, an entire multi-dose vial of vaccination, rather than just one dose. They are not 100 percent sure how much she was given, they have just said that she was given up to 10 doses. So, um, if somebody could call me back and guide me on what I should tell this patient as far as, on if they have any information on suspected or reported effects. I would just appreciate any guidance that could be offered. Again, my name is (name withheld). I am a Nurse Practitioner, and my phone number is (phone number withheld). Thank you. Hi, I apologize, I am camping and in a rain storm. The pharmacy called the patient's parent this morning and said they gave the entire vial to the patient, but they did not indicate it was the wrong formulation. The patient's Father texted me a photo of the LOT# Pfizer FL809. If they have a low threshold, they may take the child to the Emergency Room. They did note that the child has a lot of arm pain. She received the dose yesterday and they didn't know it happened until the pharmacy called today. The caller is asking for guidance and what to tell the parents to expect. The caller would like to wait and check with the parents. They are understandably now vaccine hesitant and very upset. The caller is pretty sure the pharmacy will report. They better report. They will be filing the information that this happened. Caller added that having this information is helpful, if they end up going to the Emergency Room, they have something to bring with them.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in arm at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 27May2022 at 11:45 as dose 4 (booster), single (Lot number: FL3197) intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27May2022 at 22:00, outcome "recovering", described as "Soreness in arm at injection site". Therapeutic measures were not taken as a result of vaccination site pain. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, 0.3 ml single (Lot number: EW0151, Expiration Date: 31Jul2021), in left arm, on 30Apr2021 as dose 2, 0.3 ml single (Lot number: EW0167, Expiration Date: 31Aug2021), in left arm and on 03Nov2021 as dose 3 (booster), 0.3 ml single (Lot number: FH8020, Expiration Date: 31Jan2022) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Lymphadenopathy, Pyrexia
Clinical narrative: stomach upset; Swollen lymph node left arm pit; fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 3, SINGLE, Location: left arm, Time of administration: 14:45, Route of administration: Intramuscular, Lot number: FD0809), administration date: 01Dec2021, when the patient was 52-year-old, for COVID-19 Immunization, reaction(s): "Malaise", "Swollen Lymph Nodes"; BNT162b2 (DOSE 2, SINGLE, Time of administration: 12:00, Location: Right arm, Lot number: Ep6955), administration date: 25Mar2021, for COVID-19 Immunization, reaction(s): "Fever chills", "About 28 hours post dose 2 headache"; BNT162b2 (DOSE 1, SINGLE, Location: Right arm, Time of administration: 12:30, Lot number: El3248), administration date: 04Mar2021, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 25May2022 at 08:00, outcome "recovering", described as "Swollen lymph node left arm pit"; CHILLS (non-serious) with onset 25May2022 at 08:00, outcome "recovering"; PYREXIA (non-serious) with onset 25May2022 at 08:00, outcome "recovering", described as "fever"; ABDOMINAL DISCOMFORT (non-serious) with onset 25May2022 at 08:00, outcome "recovering", described as "stomach upset". Therapeutic measures were taken as a result of abdominal discomfort, lymphadenopathy, pyrexia, chills. Additional information: AE treatment: Tylenol and motrin. The patient had no COVID prior to vaccination and COVID not tested post vaccination. The patient had no known allergies and other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Off label use, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Booster; Off label use; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 09Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: EW0181) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: 007J21A-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos thyroiditis" (unspecified if ongoing), notes: Hashimotos thyroiditis; "High cholesterol" (unspecified if ongoing), notes: High cholesterol; "Dose 4 Moderna/ dose 1,2 and 3 Pfizer" (unspecified if ongoing), notes: Dose 4 Moderna/ dose 1,2 and 3 Pfizer. Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN, stop date: 12May2022. The following information was reported: IMMUNISATION (medically significant) with onset 05Apr2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 05Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 12May2022, outcome "unknown", COVID-19 (medically significant) with onset 12May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive, notes: Tested positive on an antigen test; (19May2022) Negative, notes: On day 7 I tested negative; (21May2022) Positive, notes: On day 9 tested positive again; (26May2022) Positive, notes: On day 14 still testing positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug BNT162b2  to all the reported events cannot be completely excluded based on temporal association and known drug safety profile 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: 49.0
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) (Nurse) from Regulatory Authority. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FF25B9) 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) 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), notes: known allergies: Latex. The patient's concomitant medications were not reported. Past drug history included: Ancef, reaction(s): "known allergies: Ancef", notes: known allergies: Ancef. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- The patient took Paxlovid and felt better 4-8 hours after. The symptom onset 15. The patient was very sick from COVID and  felt the Paxlovid helped but she still had stuffy nose fatigues then on 19 the patient was done with medication and on 25 started to have a lot of congestion and runny nose and feel sick again but more of a head cold.  The patient receive other vaccines within 4 weeks prior to the COVID vaccine. There was list of other medications Ibroprofen the patient received within 2 weeks of vaccination. Device Date: 28May2022  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I took a rapid test and also was Positive; I took a rapid test and also was Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Lot number: FL9264), in left arm, in 2021 as dose 2, single (Lot number: EN6201), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "history of sporadic/rare/non-chronic A-fib" (unspecified if ongoing), notes: history of sporadic/rare/non-chronic A-fib. Concomitant medication(s) included: ROSUVASTATIN, start date: 04Nov2019, stop date: 18May2022. Past drug history included: Codeine, reaction(s): "Known Allergies: Codeine", notes: Known Allergies: Codeine. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "I took a rapid test and also was Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating, Seriousness criteria-Congenital anomaly/birth defect reported as no. Proprietary medicinal product name: Pfizer/Paxlovid, Batch/lot number: N/A, Indication for use in the case: Treatment of COVID-19, Date of start of drug: 19May2022, Date of last administration: 24May2022. Reported Event: Rebound COVID. Took full course of drug (5 days). Only two side effects: 1) foul metallic taste; 2) difficulty sleeping. By day 5 I felt fine and on day 6 registered neg on at-home antigen test. My wife was one day behind me in cycle and sicker during her illness. She also took Paxlovid and was neg on her day 6. But by her day 7/my day 8 she became sick again with severe headache, fatigue, etc. We went to see doc for help. While there she took a PCR test and was positive again. After we got home I took a rapid test and also was positive. My symptoms initially were mild - worst was bad cough, also sneezing/dripping - and are milder yet on this rebound. Her rebound symptoms are a little less bad than first round but worse than mine; no sore throat as with initial illness but splitting headache. Biggest downside for me is having to redo the 5/5 isolation/masking.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: mild sx 25May2022 then plus Ag on 26May2022; mild sx 25May2022 then plus Ag on 26May2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 24-year-old female patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" and all described as "mild sx 25May2022 then plus Ag on 26May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive, notes: COVID test post vaccination COVID test type post vaccination: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Device timestamp: 27May2022.  No follow-up attempts are possible. 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 serious events vaccination failure and COVID-19 cannot be totally excluded.
Age: 53.0
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) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 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: "Metastatic breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: exposed to roomie 24May2022 sx of neck stiffness chills and fever and dry cough 26May. positive Ag test 27May2022; exposed to roomie 24May2022 sx of neck stiffness chills and fever and dry cough 26May. positive Ag test 27May2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from Regulatory Authority.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EL3247), on 18Mar2021 as dose 2, single (Lot number: EL3247) and on 09Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "unknown" and all described as "exposed to roomie 24May2022 sx of neck stiffness chills and fever and dry cough 26May. positive Ag test 27May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: COVID test type post vaccination: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course- Prior to vaccination, was the patient diagnosed with COVID-19 and The patient receive any other vaccines within 4 weeks prior to the COVID vaccine reported as unknown. Since the vaccination, the patient been tested for COVID-19 reported as yes. Device Date: 27May2022.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 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: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical Course: It was reported that, the patient received Paxlovid from 20May2022 to 23May2022 for treatment of COVID-19. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient reported to had Dysgeusia (grapefruit-soap like taste during Paxlovid treatment).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Rash, Rash pruritic
Clinical narrative: rash; low grade temperature of 99.5; itchy rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5-year-old male patient received BNT162b2 (BNT162B2), on 26May2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH PRURITIC (non-serious) with onset May2022, outcome "unknown", described as "itchy rash"; PYREXIA (non-serious) with onset May2022, outcome "unknown", described as "low grade temperature of 99.5"; RASH (non-serious) with onset 26May2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received Paxlovid. Reporter stated, the keys that they had, they have had got reporter the paperwork for the box, so reporter didn't get out of the car that now. Expiry Date of Paxlovid: Unknown. Reporter had 5-year-old child had the shot Thursday he developed a rash; he was got an itchy rash now running a low-grade temperature of 99.5 and reporter wanted to know if reporter should give anything for the Itch or if reporter can take him to the ER.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pericarditis, Pleuritic pain
Clinical narrative: Acute pericarditis; Severe pleuritic chest pain; Severe pleuritic chest pain; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: Fk9893) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cad" (unspecified if ongoing), notes: Cad; "dm" (unspecified if ongoing), notes: dm; "HTN" (unspecified if ongoing), notes: HTN; "DMD" (unspecified if ongoing), notes: DMD; "dyslipidemia" (unspecified if ongoing); "gerd" (unspecified if ongoing), notes: gerd. Concomitant medication(s) included: METFORMIN; REPATHA; GLYBURIDE; COREG; AMLODIPINE; OLMESAB. Vaccination history included: Bnt162b2 (Dose 3:, Lot number: Fd0810, Vaccine location: LT arm), for COVID-19 immunization; Bnt162b2 (Dose 2:, Lot number: El1284, Vaccine location: LT arm), for COVID-19 immunization; Bnt162b2 (Dose 1:, Lot number: Ek5730, Vaccine location: LT arm), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant) with onset 23May2022 at 09:00, outcome "recovering", described as "Acute pericarditis"; PLEURITIC PAIN (medically significant), CHEST PAIN (medically significant) all with onset 23May2022 at 09:00, outcome "recovering" and all described as "Severe pleuritic chest pain". The events "acute pericarditis" and "severe pleuritic chest pain" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pericarditis, pleuritic pain, chest pain. Clinical course included treatment received for the adverse event was Colchicine and naprosyn. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug BNT162b2  to all the reported events Pericarditis , Pleuritic pain, Chest pain  cannot be completely excluded based on temporal association and known drug safety profile
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing), notes: Graves Disease. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (28May2022) Positive, notes: Tested positive for COVID for second time on 28May. Therapeutic measures were taken as a result of covid-19, drug ineffective. No other medications the patient received within 2 weeks of vaccination. No known allergies. Sick again after course of Paxlovid. Tested positive for COVID for second time on 28May.  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Sinusitis
Clinical narrative: sinus infection; tested positive even though I have had all four shots, the vaccinations against COVID; tested positive even though I have had all four shots, the vaccinations against COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CIPRALEX taken for depression. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "unknown" and all described as "tested positive even though I have had all four shots, the vaccinations against COVID"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27May2022) Positive, notes: I tested positive even though I have had all four shots, vaccination against covid. Clinical information: Patient just talked to Health doctor and he told that patient tested positive even though she have had all four shots, the vaccinations against COVID and he is saying that she could receive the Pfizer drug, Paxlovid.  As it was not clarified over the call if consumer consumed Paxlovid while taking Cipralex hence event captured as per verbatim and both captured as suspect conservatively. Is there a product complaint to report: Yes. The patient who was recently diagnosed with Covid-19 and was advised to take Paxlovid. Stated that she has had four doses of the Covid vaccine. Information confirmed as provided. Stated that this feels like she has a sinus infection. Stated that she was with her family and in the last two weeks her grandchildren came down with Covid. Stated that she had called because one doctor said that she can take Paxlovid and one said not to take it because she has taken an antidepressant Citralex which is called Lexapro for the last 10 years. Stated that the agent stated that her doctor knows best. Event details: Stated that she was diagnosed with Covid 19 today.  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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Lot number: EW0172), in left arm and on 12May2021 as dose 2, single (Lot number: EW0185) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Dec2021 as dose 3 (booster), single (Lot number: 012H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dose number 3 Moderna/ dose 1 and dose 2 Pfizer" (unspecified if ongoing), notes: Dose number 3 Moderna/ dose 1 and dose 2 Pfizer. Concomitant medication(s) included: JUNEL FE, start date: 01Jan2022, stop date: 29May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid (start date: 11May2022, stop date: 16May2022). Clinical course was reported as, during the 5 day course of paxlovid the patient had a horrible, metallic taste in mouth. This cleared up immediately after stopping treatment, but during the course was bad enough to wake her from sleep and to wish she could stop taking the pills early. (However, she finished the course as prescribed). The bigger issue was the resurgence of Covid symptoms (and positive test) a few days after she stopped treatment / tested negative. Patient was recovering from symptoms and received treatment over the counter medicine to treat symptoms.