chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 at 18:00 as dose 3 (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's relevant medical history included: "high blood pressure" (unspecified if ongoing); "gout" (unspecified if ongoing); "obesity" (unspecified if ongoing); "sickle cell trait" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received paxlovid from 08Jun2022 to 13Jun2022 for treatment of COVID-19. It was reported that strange taste in mouth, persistent cough, COVID symptoms reappeared 4-6 days after stopping paxlovid. COVID symptoms included fever, sneezing, coughing, malaise. The patient also received treatment with tylenol, chestall cough syrup, citrizine, nasalspr.  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: gotten two doses of Pfizer-BioNTech COVID-19 Vaccine and a booster shot/thought that she tested positive; gotten two doses of Pfizer-BioNTech COVID-19 Vaccine and a booster shot/thought that she tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "gotten two doses of Pfizer-BioNTech COVID-19 Vaccine and a booster shot/thought that she tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Caller stated that that she has gotten two doses of  Pfizer-BioNTech COVID-19 Vaccine and a booster shot ,recently came in contact with Covid and thought that she tested positive because per caller she "freak  out and threw the test in the garbage "caller stated" I have no symptoms"  wanted to  know if she needed to quarantine. Stated that she was wearing a mask in public.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Double vaccinated with the Pfizer Covid 19 vaccine but not boosted. She tested positive for Covid tonight; Double vaccinated with the Pfizer Covid 19 vaccine but not boosted. She tested positive for Covid tonight; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the parent.  A 14-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2022, outcome "unknown" and all described as "Double vaccinated with the Pfizer Covid 19 vaccine but not boosted. She tested positive for Covid tonight". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Positive, notes: She tested positive for Covid tonight. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The caller stated his 14 year old daughter is double vaccinated with the Pfizer Covid 19 vaccine but not boosted. The patient tested positive for Covid tonight and developed symptoms at afternoon of nausea, fever, and headache so reporter tested for patient. Reporter understands Paxlovid should not be crushed, however asked if there is any additional information on crushing the medication. Patient hasn't learned how to swallow pills yet.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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 drug ineffective / COVID-19 cannot be ruled out
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 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 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid 20Jun2022.  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 drug ineffective / COVID-19 cannot be ruled out
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "chronic pain" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Pfizer product for treatment of COVID-19 from 11Jun2022 to 16Jun2022. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient started to feel better after finishing Paxlovid, but just a couple days later started having COVID symptoms again from 18Jan2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 non-contactable reporter(s) (Other HCP).  A 42-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN XL; ADVAIR; ALBUTEROL HFA. 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. From 15Jun2022 to 19Jun2022, the patient was treated with Paxlovid for the COVID-19. The had patient previously receive a COVID-19 Vaccine.  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 drug ineffective / COVID-19 cannot be ruled out
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 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: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: 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 covid-19, drug ineffective.Clinical course : If vaccine received: Yes. Other medication in 2weeks: No. Anti viral details: Product=COVID 19 Treatment, Brand =Paxlovid, Treatment start date=10Jun2022, Treatment stop date=14Jun2022, Indication=Treatment of COVID-19. 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.  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: Seizure
Clinical narrative: seizure; The initial case was missing the following minimum criteria: Identifiable reporter. Upon receipt of follow-up information on 15Jun2022, this case now contains all required information to be considered valid.  This is a literature report.  A 13-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "Seizure"; Bnt162b2 (Dose 2, Got the second vaccine in December, had another seizure.), for Covid-19 Immunization, reaction(s): "Seizure". The following information was reported: SEIZURE (medically significant), outcome "not recovered". Clinical course information: Pfizer dose had a seizure within 30 days. Got the second vaccine in Dec, had another seizure. Had the third booster, now has 4-6 seizures a day. She was an active soccer player and a good student, unable to play sports or attend class in person.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events.   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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 14Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anklylosing spondylitis" (unspecified if ongoing). Concomitant medication(s) included: COSENTYX; HYDROCHLOROTHIAZIDE; LISINOPRIL; NALTREXONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: am still testing positive for covid; Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient received Paxlovid from 15Jun2022 to 20Jun2022 for treatment of COVID-19. She just finished her Paxlovid series. She started having a reoccurrence of heavy cough congestion and malaise after the 3rd to 4th dosing in the series. She finished her last morning dose this morning and she had very heavy flu-like symptoms. She was still testing positive for covid. Patient experienced above symptoms from 20Jun2022 and was recovering but did not receive any treatment medication for the same.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 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 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 12Jun2022 to 16Jun2022. The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. After finishing Paxlovid course on day 6 of initial symptoms, new symptoms developed on day 8 and positive antigen result.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pyrexia
Clinical narrative: vaccine given beyond expiration date; Fever; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A male patient received BNT162b2 (BNT162B2), on 09May2022 as dose number unknown, single (Lot number: FK9729) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 09May2022, outcome "unknown", described as "vaccine given beyond expiration date"; PYREXIA (non-serious) with onset May2022, outcome "unknown", described as "Fever". Additional information: This reporter came on the phone after a previous reporter from the same location had finished receiving her requested information. The reporter confirmed that doses of the Pfizer BioNTech COVID-19 vaccine, gray cap formulation, was given after it's 10 week Beyond Use Date. The reporter stated that the 10 week BUD was on 23Mar2022 and there were doses administered on 09May2022. The reporter stated that she received correspondence from (Name withheld) with Pfizer's team who provided documentation that this vaccine, specifically lot# FK9729, that was administered past its BUD was not a supported excursion. The reporter was asking what the recommendations are for administering an unsupported/invalid dose and would the invalid dose be reflected in the Health Department's records. This AE had been filed previously, however, the reporter reported that she and her husband both received doses from this vial. This was the reporter 4th Pfizer COVID-19 vaccine dose. She stated that her and her husband both had a fever for 3 days and felt like she was "hit with a truck." Later in the call the reported stated that she had a fever for 2 days after receiving the 4th dose. The reporter stated that she had the exact same side effects to this dose as all of the other doses she had received so she felt like the dose was still valid. I had been trying to get in touch with Pfizer Medical for two weeks now without success. I need further clarification on the Letter you sent to me on 07Jun2022. In the letter you had the expiry date listed as Sept2022 but you also had Stability data does not support the use of this product, and then you go on to say that the decision to release the impacted products was my responsibility. Please clarify to me if these patients vaccines are considered valid or not, or if they all need to be re vaccinated. If you are saying the expiration was really Sept2022, then all the vaccines given are valid. I personally received the vaccine and had the same reaction with a fever that I did with all my other vaccines, so I believed that the vaccine was still stable. Please advise me on what I need to tell all of these patients. Sender's Comments: Linked Report(s) : PFIZER INC-202200759951 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: been on Paxlovid since Friday 17Jun /had 2 Pfizer vaccines and 2 Pfizer booster; been on Paxlovid since Friday 17Jun/had 2 Pfizer vaccines and 2 Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), 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; cilgavimab, tixagevimab (EVUSHELD), 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), outcome "not recovered", described as "been on Paxlovid since Friday 17Jun /had 2 Pfizer vaccines and 2 Pfizer booster"; COVID-19 (medically significant), outcome "not recovered", described as "been on Paxlovid since Friday 17Jun/had 2 Pfizer vaccines and 2 Pfizer booster". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient had been on Paxlovid since Friday 17Jun. Patient didn't feel better. Patient did think a second round of another 5 days would work. Maybe just wishful thinking. Patient had 2 Pfizer vaccines and 2 Pfizer booster s plus the Evusheld.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 54-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 2, single (Lot number: FG-3527) at the age of 54 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: PCN" (unspecified if ongoing), notes: known allergies: PCN. 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 "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 03Jun2022 to 08Jun2022 for the treatment of COVID-19. Rebound symptoms on 13Jun2022 after Paxlovid treatment was reported.
Sex: M
Vaccine: COVID19, 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 a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL9261), on 17Feb2021 as dose 2, single (Lot number: EN6200) and on 05Oct2021 as dose 3 (booster), single (Lot number: 30130BA) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 4 (booster), single (Lot number: 003K21-2A) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN, start date: Dec2021; ALLER FLO, start date: Dec2021; ALENDRONATE SODIUM, start date: Mar2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: continue to test positive 16 days after my initial positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid from 06Jun2022 to 11Jun2022 as Covid-19 treatment. Other medication in two weeks included unspecified medication from Mar2022. Adverse event 3 days after completing Paxlovid, patient started having symptoms again. Patient was feeling better after 4 days, but never tested negative and continue to test positive 16 days after initial positive test.
Age: 34.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: FC3183) 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks reporter as No. Paxlovid used as COVID 19 Treatment started on 11Jun2022 and stopped on 15Jun2022. Tested negative for 3 straight days after Paxlovid and on day 4 I developed a strong cough. Retested and the result was strong positive and immediate on a PCR.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: he can't walk; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT INABILITY (non-serious), outcome "unknown", described as "he can't walk". Additional information: It was reported that the patients daughter (name withheld) called for assistance with colestipol. She stated "my mom has C diff and she's taking colestipol hydrochloride but at this point my dad is in the living room in a hospital bed because he cant walk since covid even though he got all 3 of your vaccines and than she yeah he's a whole another ball game but meanwhile my mom has C diff and colestipol the only thing stopping it and we can't afford to buy it anymore." Advised we help with the Colestid (name withheld) stated mother is taking colestipol hydrochloride greenstone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Lamb" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: 31May2022, stop date: 20Jun2022; VITAMIN D NOS, start date: 31May2022, stop date: 20Jun2022; VITAMIN B [VITAMIN B COMPLEX], start date: 31May2022, stop date: 20Jun2022; ACIDOPHILUS, start date: 31May2022, stop date: 20Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Horrible metallic taste in mouth noted 24/7.Rebound COVID a week after finishing Paxlovid reported. Tested positive and having all the symptoms come back (slight fever, tearing eyes, sinuses clogged, runny nose, sore throat & cough. Symptoms started on 18Jun2022 at 07:00 PM, outcome reported not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: Rebound COVID; Rebound COVID; pregnant last menstrual date 17Feb2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 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 had no relevant medical history. Date of last menstrual period: 17Feb2022. The patient is expected to deliver a baby(s) on 23Nov2022. Concomitant medication(s) included: PROZAC. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 2021, outcome "unknown", described as "pregnant last menstrual date 17Feb2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Rebound COVID". 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.  Clinical Information:Patient received treatment for Covid-19 with Anti viral from 08Jun2022.to 13Jun2022. Patient received Prozac in 2weeks. Device timestamp: 21Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 via rapid antigen test on 20Jun2022; Tested positive for COVID-19 via rapid antigen test on 20Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EL9262), in left arm, on 14Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 23Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022, outcome "recovering" and all described as "Tested positive for COVID-19 via rapid antigen test on 20Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2021) Positive, notes: Nasal Swab; (19Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: There was no other vaccine in four weeks. Tested positive for COVID-19 via rapid antigen test on 20Jun2022. There was no covid prior vaccination. There was covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP6955), on 04Apr2021 as dose 2, single (Batch/Lot number: unknown), on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 08Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing); "lupus" (unspecified if ongoing); "hypogammaglobulinemia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Hashimoto's hypothyroidism" (unspecified if ongoing); "chronic bronchitis" (unspecified if ongoing); "spina bifida" (unspecified if ongoing); "Club foot" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LORATADINE; SERTRALINE; VALACYCLOVIR HCL. Past drug history included: Cefaclor, reaction(s): "Allergies: Cefaclor"; Fioricet, reaction(s): "Allergies: fioricet"; Ceclor, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 19Jun2022, lot number: GC2132, indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid a very mild case; tested positive for Covid a very mild case; 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 patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid a very mild case". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive for Covid a very mild case.  Clinical information: Patient have received two Covid shots and two Pfizer boosters. Patient had a very sore arm and also tested positive for Covid a very mild case. Unfortunately, soon after Patient had a bad rash on my back and stomach which was diagnosed by his Dermatologist as Bullous Pemphigoid a rare skin disorder but potentially very dangerous to get. patient have read that a few other people have had this same reaction.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pemphigoid, Rash, SARS-CoV-2 test
Clinical narrative: tested positive for Covid a very mild case; tested positive for Covid a very mild case; 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 patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid a very mild case". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: tested positive for Covid a very mild case.  Clinical information: Patient have received two Covid shots and two Pfizer boosters. Patient had a very sore arm and also tested positive for Covid a very mild case. Unfortunately, soon after Patient had a bad rash on my back and stomach which was diagnosed by his Dermatologist as Bullous Pemphigoid a rare skin disorder but potentially very dangerous to get. patient have read that a few other people have had this same reaction.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Bullous Pemphigoid; My 2nd booster was on 11Apr2022. I had a very sore arm; I had a bad rash on my back and stomach; 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 patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid -19 vaccine (DOSE: 01, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid -19 vaccine (DOSE: 02, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Bnt162b2 (DOSE: 03 (Booster dose)), for COVID-19 Immunization. The following information was reported: PEMPHIGOID (medically significant), outcome "unknown", described as "Bullous Pemphigoid"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My 2nd booster was on 11Apr2022. I had a very sore arm"; RASH (non-serious), outcome "unknown", described as "I had a bad rash on my back and stomach". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: The patient had received two Covid shots and two Pfizer boosters. The 2nd booster was on 11Apr2022. The patient had a very sore arm and also tested positive for Covid a very mild case. Unfortunately, soon after patient had a bad rash on the back and stomach which was diagnosed by the Dermatologist as Bullous Pemphigoid a rare skin disorder but potentially very dangerous to get. The patient read that a few other people had this same reaction.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pemphigoid, Rash, SARS-CoV-2 test
Clinical narrative: Bullous Pemphigoid; My 2nd booster was on 11Apr2022. I had a very sore arm; I had a bad rash on my back and stomach; 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 patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid -19 vaccine (DOSE: 01, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid -19 vaccine (DOSE: 02, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Bnt162b2 (DOSE: 03 (Booster dose)), for COVID-19 Immunization. The following information was reported: PEMPHIGOID (medically significant), outcome "unknown", described as "Bullous Pemphigoid"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My 2nd booster was on 11Apr2022. I had a very sore arm"; RASH (non-serious), outcome "unknown", described as "I had a bad rash on my back and stomach". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: The patient had received two Covid shots and two Pfizer boosters. The 2nd booster was on 11Apr2022. The patient had a very sore arm and also tested positive for Covid a very mild case. Unfortunately, soon after patient had a bad rash on the back and stomach which was diagnosed by the Dermatologist as Bullous Pemphigoid a rare skin disorder but potentially very dangerous to get. The patient read that a few other people had this same reaction.   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: Anorectal disorder, Furuncle, Perineal disorder, Vulval disorder
Clinical narrative: I exploded in boils all over my buttocks and in the crease with my thigh; have also found smaller noodles in the vulva, perineum and anus; have also found smaller noodles in the vulva, perineum and anus; have also found smaller noodles in the vulva, perineum and anus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2022 as dose 3 (booster), single (Lot number: 330308D) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HEDS" (unspecified if ongoing); "CLL" (unspecified if ongoing); "MDD" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "many issues with spine & skeletal anatomy" (unspecified if ongoing); "idiopathic retinopathy" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "known allergies: bee sting" (unspecified if ongoing); "Hidradenitis Suppurativa" (ongoing), notes: I have Hidradenitis Suppurativa and have been in remission for some time; "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; LITHIUM; PROZAC; TRIPHALA; XANAX; ZOLOFT. Past drug history included: Demerol for known allergies: Demerol; Tetracycline for known allergies: Tetracycline; Erythromycin for known allergies:Erythromycin. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0179, Location of injection: Arm Right), administration date: 08Jun2021, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0180, Location of injection: Arm Right), administration date: 29Jun2021, for COVID-19 immunization. Patient received vaccine at pharmacy or drug store. No other vaccine in four weeks. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The following information was reported: FURUNCLE (disability) with onset 14Mar2022, outcome "unknown", described as "I exploded in boils all over my buttocks and in the crease with my thigh"; VULVAL DISORDER (disability), PERINEAL DISORDER (disability), ANORECTAL DISORDER (disability) all with onset 14Mar2022, outcome "unknown" and all described as "have also found smaller noodles in the vulva, perineum and anus". The events "i exploded in boils all over my buttocks and in the crease with my thigh" and "have also found smaller noodles in the vulva, perineum and anus" required physician office visit. Therapeutic measures were taken as a result of furuncle, vulval disorder, perineal disorder, anorectal disorder. Clinical course: It was reported that, she have Hidradenitis Suppurativa and have been in remission for some time. Soon after the booster, she exploded in boils all over her buttocks and in the crease with her thigh. She have also found smaller noodles in the vulva, perineum and anus. Those are not areas she ever had problems with - her disease expresses as Murphys boils to the inside of the thigh which appears unaffected.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted 8-9 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 39-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "fainted 8-9 times". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Clinical course: The doctors tried to say its all in her head. She is very upset with them.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Valdecoxib, reaction(s): "Known allergies: Valdecoxib".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient did not received other medication in 2weeks. COVID 19 treatment, brand: Paxlovid. Patient administered paxlovid on 08Jun2022 and stopped on 12Jun2022, indication for treatment of COVID-19. Adverse event: recurrence of sore throat day 4 after finishing Paxlovid. Adverse event started on 18Jun2022; 08:00 AM. Patient was recovering form AE. It was unknow if patient received treatment for adverse event. known allergies: Valdecoxib. Other medical history: None. Patient was not pregnant at time of vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.