chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 37-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 07Apr2021 as dose 2, single (Lot number: ER8737) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Dec2021 as dose 3 (booster), single (Lot number: 032H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing), notes: ADHD. The patient did not had any known allergies. Concomitant medication(s) included: SERTRALINE, start date: 01Jan1999; ADDERALL, start date: 01Jan1999. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: fully vaccinated and had 2 booster shots and got covid; fully vaccinated and had 2 booster shots and got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: ER2613) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "fully vaccinated and had 2 booster shots and got covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Investigation, Skin hyperpigmentation, Vitiligo
Clinical narrative: Hyperpigmentation white spots on inner thighs, anus, and leg folds of child; Diagnosis is vitiligo; Its flush with skin; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 5-year-old female patient received BNT162b2 (BNT162B2), on 27May2022 as dose 1, single (Lot number: F18095) 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: SKIN HYPERPIGMENTATION (non-serious) with onset 09Jun2022, outcome "not recovered", described as "Hyperpigmentation white spots on inner thighs, anus, and leg folds of child"; VITILIGO (non-serious) with onset Jun2022, outcome "not recovered", described as "Diagnosis is vitiligo"; FLUSHING (non-serious) with onset Jun2022, outcome "not recovered", described as "Its flush with skin". The events "hyperpigmentation white spots on inner thighs, anus, and leg folds of child", "diagnosis is vitiligo" and "its flush with skin" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter was calling in regards to the COVID vaccination for a 05-year-old. This was the fourth nurse she has spoken with in the last 45 minutes. Spent 30 minutes on the phone with another call handler doing a report. Caller now has some pieces to add to the case that she didn't have originally. She was transferred to medical information person who was of no use at all. It was granddaughter's first dose. The reporter daughter (the mother of the patient) gave the child a bath on 09Jun2022 and noticed hyperpigmentation white spots on inner thighs, anus, and leg folds of child. The child was half samoan, so the spots are very pronounced. There was no exudate, no pain, its flush with skin. Took her to pediatrician and the preliminary diagnosis was vitiligo. Had a whole slew of lab work down to check for everything. Awaiting those results. Looked that up this morning to see if it was a problem with COVID and kids. Found two articles that said that there were hyperpigmentation problems and vitiligo concerns in children about two weeks after getting the vaccine. Wanted to let Pfizer know what was going on. Had provided her daughter's information (the mother of the child) in the original report as well. The mom was very anxious right now, so the grandmother decided to make the call to Pfizer for her. Have no family history of this. It would be so horrific and devastating that it could be caused by the vaccination a couple weeks ago. She was very upset about the possibility of the COVID Vaccination causing hyperpigmentation in her skin.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left 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), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Rebound; (Jun2022) Negative, notes: then tested negative for 2 days using at home tests; (Jun2022) positive, notes: then tested positive again on 4th day after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for 5 days for the treatment of COVID-19, then tested negative for 2 days using at home tests, then tested positive again on 4th day after completing Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted Covid; Contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3247) and on 25Mar2021 as dose 2, single (Lot number: EL3247) at the age of 65 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 06Jun2022, outcome "recovering" and all described as "Contracted Covid". The event "contracted covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Unknown results, notes: Since the vaccination, has the patient been tested for COVID-19:Yes. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Device Date : 16Jun2022.  No follow-up attempts are possible. 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 and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Palpitations, Rash, SARS-CoV-2 test
Clinical narrative: Rash; racing heart rate; hot flash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2021 at 12:00 as dose 1, single (Lot number: Ew0172) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 27Apr2021 at 12:00, outcome "recovered" (2022); HOT FLUSH (non-serious) with onset 27Apr2021 at 12:00, outcome "recovered" (2022), described as "hot flash"; PALPITATIONS (non-serious) with onset 27Apr2021 at 12:00, outcome "recovered" (2022), described as "racing heart rate". The events "rash", "racing heart rate" and "hot flash" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: covid prior vaccination No, known allergies Yes.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted Covid; Contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 38-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 16Feb2021 as dose 2, single (Lot number: EL3247) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 37 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) with onset 16Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 16Jun2022, outcome "recovering" and all described as "Contracted Covid". The event "contracted covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2022) Unknown Result, notes: COVID test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Serious, Seriousness criteria-results in death, Seriousness criteria-life threatening, Seriousness criteria- caused/prolonged hospitalization, Seriousness criteria- disabling/incapacitating and Seriousness criteria-congenital anomaly/birth defect reported as No. Report about COVID vaccine was Yes. If other vaccine in four weeks reported as Unknown. Adverse event Contracted COVID. If treatment ae reported as Yes. Ae treatment reported as Paxlovid. COVID prior vaccination reported as Unknown.  No follow-up attempts are possible. 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 and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Papilloma viral infection, SARS-CoV-2 test
Clinical narrative: Recurrence of HPV; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2022 as dose 3 (booster), single (Lot number: 33130BA) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing), notes: Allergies; "Asthma" (unspecified if ongoing); "Soy allergy" (unspecified if ongoing); "Egg allergy" (unspecified if ongoing); "HPV" (unspecified if ongoing), notes: Had a recurrence of HPV which had been dormant for over 10 years prior to booster. Concomitant medication(s) included: ALLEGRA D; SINGULAIR; NUVARING; OMEPRAZOLE. Vaccination history included: pfizer (DOSE NUMBER; 2, Batch/Lot No: FC3180, Location of injection: Arm Left), administration date: 22Aug2021, for COVID-19 immunization; pfizer (DOSE NUMBER: 1, Batch/Lot No: EW0181, Location of injection: Arm Right), administration date: 31Jul2021, for COVID-19 immunization. The following information was reported: PAPILLOMA VIRAL INFECTION (non-serious) with onset 25Jan2022, outcome "recovering", described as "Recurrence of HPV". The event "recurrence of hpv" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of papilloma viral infection.  Additional information: No any other vaccine in four weeks. Patient did not experience COVID prior vaccination. If COVID tested post vaccination: Yes. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination,patient been tested for COVID-19. Device date: 16Jun2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Fully vaccinated and had 2 booster shots and got COVID; Fully vaccinated and had 2 booster shots and got COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: ER2613), on 12Apr2021 as dose 2, single (Lot number: EW0150) and on 19Oct2021 as dose 3 (booster), single (Lot number: FE3590) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Apr2022 as dose 4 (booster), single (Lot number: 002MZ1A) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing), notes: Psoriasis diagnosed 25 years ago; "Allergies" (unspecified if ongoing), notes: Allergies diagnosed 30 years ago. The patient's family history included: "Asthma" (unspecified if ongoing), notes: Asthma diagnosed 25-30 years ago, Had a family history of asthma, (patient's mom died of asthma at the age of 50 years). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Fully vaccinated and had 2 booster shots and got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Positive, notes: Unit: Not Provided; (15Jun2022) Positive, notes: Unit: Not Provided. Therapeutic measures were taken as a result of covid-19, vaccination failure.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Jun2022, outcome "recovering" 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 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: reinfection despite boosted; reinfection despite boosted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 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 was not reported. Concomitant medication(s) included: IBUPROFEN; LEXAPRO. Past drug history included: Bactrim, reaction(s): "allergies: bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 15Jun2022, outcome "not recovered" and all described as "reinfection despite boosted". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Other medication in 2weeks was reported as Yes. Antiviral details: product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 07Jun2022, Treatment stop date: 11Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 at 09:00 as dose 1, single (Lot number: EL9265), in left arm, on 19Feb2021 at 10:00 as dose 2, single (Lot number: EN6203), in left arm and on 25Sep2021 at 09:00 as dose 3 (booster), single (Lot number: Ew0185) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 003j212a) for covid-19 immunisation. The patient's relevant medical history included: "known allergies Penicillen" (unspecified if ongoing), notes: known allergies Penicillen. Concomitant medication(s) included: FOSAMAX, start date: 03Sep2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
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) (Nurse). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 29Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 301708A) 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: "DM" (unspecified if ongoing), notes: other medical history: DM; "HTN" (unspecified if ongoing), notes: other medical history: HTN; "hypothyroid" (unspecified if ongoing), notes: other medical history: hypothyroid; "GERD" (unspecified if ongoing), notes: other medical history: GERD; "insomnia" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Known Allergy: Bactrim", notes: Known Allergy: Bactrim; Lisinopril, reaction(s): "Known Allergy: Lisinopril", notes: Known Allergy: Lisinopril. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive antigen (home) test after repeated negative antigen tests; positive antigen (home) test after repeated negative antigen tests; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 1, single (Lot number: ER8733), on 24Apr2021 as dose 2, single (Lot number: EW0172) and on 06Dec2021 as dose 3 (booster), single (Lot number: FT1670) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 10Jun2022. The following information was reported: COVID-19 (medically significant) with onset 16Jun2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "positive antigen (home) test after repeated negative antigen tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive antigen home test after repeated negative antigen tests; Negative, notes: positive antigen home test after repeated negative antigen tests. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 21Feb2021 as dose 2, single (Lot number: EME201), in left arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she is still testing positive for COVID; she is still testing positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "she is still testing positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she is still testing positive for COVID. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Caller stated that she was still testing positive for COVID. Caller was asking "am I still contagious?" and "do I still need to isolate?"  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Decreased appetite, Malaise, Nausea, Photosensitivity reaction
Clinical narrative: she is still testing positive for COVID; she is still testing positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "she is still testing positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she is still testing positive for COVID. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Caller stated that she was still testing positive for COVID. Caller was asking "am I still contagious?" and "do I still need to isolate?"  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Swelling, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: she is still testing positive for COVID; she is still testing positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "she is still testing positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she is still testing positive for COVID. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Caller stated that she was still testing positive for COVID. Caller was asking "am I still contagious?" and "do I still need to isolate?"  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: Both received Pfizer COVID-19 vaccines and boosters./taking Paxlovid; Both received Pfizer COVID-19 vaccines and boosters./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), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Both received Pfizer COVID-19 vaccines and boosters./taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. The reporter stated that her husband is also now taking Paxlovid and has no side effects.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "hashimotos thyroiditis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LISINOPRIL; HCTZ; PRILOSEC; LEXAPRO. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin", notes: Augmentin; Biaxin, reaction(s): "Known allergies: biaxin"; Quinolones, reaction(s): "Known allergies: quinolones". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Suspect drug (Pfizer), Indication is used for treatment of COVID-19, start date: 15Jun2022, Date of last administration: 16Jun2022. Active Drug substance names: COVID 19 Treatment. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was previously received a COVID-19 Vaccine. Reported Event: Rash on my face and neck, hot to touch, tingling in lips. The treatment received for the adverse event with Benadryl on 16Jun2022 10:00. The outcome of event was Recovering. No Hospitalization Prolonged. The patient was received treatment as yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: Reporter reported that the patient had an adult niece and an adult nephew who both recently tested positive for Covid. They had received the Pfizer vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200004383 Different patients, Same reporter, drug, event.;
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID19 positive test; COVID19 positive test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0150), in left arm and on 01Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "thyroid nodules" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: Jan2016, stop date: 07Jun2022; BENAZEPRIL, start date: Jan2016, stop date: 07Jun2022. Past drug history included: No, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant) with onset 07Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 07Jun2022, outcome "recovering" and all described as "COVID19 positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jun2022) Positive, notes: Initial COVID19 positive test (antigen, confirmed by NAAT test) on 07Jun2022, also mild symptoms; (12Jun2022) Negative, notes: antigen tested negative each day 12Jun-15Jun; (13Jun2022) Negative, notes: antigen tested negative each day 12Jun-15Jun; (14Jun2022) Negative, notes: antigen tested negative each day 12Jun-15Jun; (15Jun2022) Negative, notes: antigen tested negative each day 12Jun-15Jun; (16Jun2022) Positive, notes: tested positive again with antigen test morning of 16Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 09Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Tree nuts" (unspecified if ongoing), notes: known allergies: Tree nuts; "Interchange of vaccine products" (unspecified if ongoing), notes: Dose 3: Pfizer / BioNTech/Dose 2: Moderna/Dose 1: Moderna. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Anti-viral details: product=COVID 19 Treatment, Treatment start date-02Jun2022, Treatment stop date-07Jun2022, Indication-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. Reported Event: Rebound Covid. Adverse events start date: 12Jun2022. If patient recovered was not recovered. If treatment ae was no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3247), on 09Feb2021 as dose 2, single (Lot number: EM9810) and on 13Oct2021 as dose 3 (booster), single (Lot number: BT5196248) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Low sodium" (unspecified if ongoing), notes: Low sodium. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid dx 06Jun; Covid dx 06Jun; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Apr2022 at 12:00 as dose 4 (booster), single (Lot number: 071F21A) at the age of 68 years, in left arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient 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) all with onset 06Jun2022, outcome "unknown" and all described as "Covid dx 06Jun". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Covid diagnosed; (13Jun2022) Negative, notes: Day 8; (14Jun2022) Negative, notes: Day 9; (14Jun2022) Positive, notes: Day 10. Therapeutic measures were taken as a result of drug ineffective, covid-19; patient had received treatment with start of drug 06Jun2022 and date of last administration was 11Jun2022.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Lot number: EL1284), on 16Jan2021 as dose 2, single (Lot number: EL4239) and on 25Apr2022 as dose 3 (booster), single (Lot number: FJ4989) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergy: Yes pain meds" (unspecified if ongoing); "Known allergy: lots of depression meds" (unspecified if ongoing); "Known allergy:all fibromyalgia meds" (unspecified if ongoing); "Known allergy: Yes pain meds, lots of depression meds and all fibromyalgia meds" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "IBS" (unspecified if ongoing); "gastritis" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; METOPROLOL; PANTOPRAZOLE; FAMOTIDINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". 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 in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 49.0
Sex: F
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) (Nurse).  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 03May2021 as dose 2, single (Lot number: EW0158), in left arm and on 26May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 as dose 3 (booster), single (Lot number: 033F), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure. Clinical course: Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: No. Did you/the patient previously receive a COVID-19 Vaccine?: Yes. Reported Event: rash on her legs her hands and her upper arms started 12Jun2022 -seen in emergency room 13Jun2022 urticarial rash on anterior legs dorsal aspect of the hand, upper arms and on the chest. Given prednisone -Seen 14Jun2022 Now some rash on palms and soles, mild oral pruritis. Adverse event start date: 12Jun2022, Adverse event start time: 12:00 PM. Ae resulted in: [None of the above] If patient recovered: Not recovered. If treatment ae: Yes. What treatment received for the adverse event? prednisone, Benadryl, Device Date : 16Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 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: "Hashimoto's Thyroiditis" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL and Thryroid Hormone. Past drug history included: Biaxin, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant) with onset 14Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 14Jun2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive, notes: On 10May2022, I once again became symptomatic and remained symptomatic and positive through 14Jun2022; (07Jun2022) Negative, notes: through 09Jun2022; (14Jun2022) Positive; (15Jun2022) Negative, notes: On 15Jun2022 I once again tested negative and have remained so. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient began Paxlovid on day 1 of her covid illness, 30May2022. She completed the dose and tested negative via RAT on 07Jun2022 through 09Jun2022. On 10May2022, patient once again became symptomatic and remained symptomatic and positive through 14Jun2022. Symptoms were more severe than initial illness and included fever, headache, congestion, cough, sneezing, fatigue. On 15Jun2022, patient once again tested negative and have remained so.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis; 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 male patient received BNT162b2 (BNT162B2), on 07Jan2022 at 12:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing); "Leukemia" (unspecified if ongoing), notes: in remission for 25 years; "Covid" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; LAMICTAL. Past drug history included: Vencomyicin, reaction(s): "Known allergies: Vencomyicin". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9261; Anatomical Location: Left Arm; Time of administration: 12:00 PM), administration date: 20Jan2021, when the patient was 29-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EL2966; Anatomical Location: Left Arm; Time of administration: 12:00 PM), administration date: 10Feb2021, when the patient was 29-year-old, for Covid-19 Immunization. The following information was reported: PSORIASIS (non-serious) with onset 20May2022 at 12:00, outcome "not recovered". The event "psoriasis" required physician office visit. Therapeutic measures were taken as a result of psoriasis.  Additional Information: It was reported that patient did not receive any other vaccine in four weeks and was not tested for COVID post vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Post Paxlovid Rebound; Post Paxlovid Rebound; This is a spontaneous report received from 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 03Apr2021 at 12:00 as dose 1, single (Lot number: EW0150), in left arm, on 24Apr2021 at 17:00 as dose 2, single (Lot number: EW0164), in left arm and on 17Dec2021 at 17:00 as dose 3 (booster), single (Lot number: FE3594) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cerebral Spinal Fluid leak" (unspecified if ongoing), notes: Cerebral Spinal Fluid leak, idiopathic Intracranial Hypertension, depression; "idiopathic Intracranial Hypertension" (unspecified if ongoing), notes: Cerebral Spinal Fluid leak, idiopathic Intracranial Hypertension, depression; "Depression" (unspecified if ongoing), notes: Cerebral Spinal Fluid leak, idiopathic Intracranial Hypertension, depression. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jun2022, outcome "not recovered" and all described as "Post Paxlovid Rebound". Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient received anti viral product for COVID 19 Treatment, brand Paxlovid, treatment start date:01Jun2022, treatment stop date:05Jun2022, lot number:FY8927.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "mild high blood pressure" (unspecified if ongoing), notes: other medical history: mild high blood pressure; "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs. Concomitant medication(s) included: PROGESTERONE. Past drug history included: Iodine, reaction(s): "Allergy: iodine", notes: known allergies: iodine. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.