chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 10Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 28Mar2022 at 15:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentum". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 24Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Negative, notes: tested COVIID negative Monday 20Jun; (25Jun2022) Positive, notes: COVID positive Saturday 25Jun. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Completed Paxlovid regimen on Sunday 19Jun2022, tested COVIID negative Monday 20Jun2022. Runny nose and slight fever began Friday 24Jun2022. Tested COVID positive Saturday 25Jun2022.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 , in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FINASTERID, start date: 10Nov2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "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, covid-19.  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, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Lot number: FF2587) 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 "COVID 19 Treatment". 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 course: The patient took other medications in 2 weeks. The patient was treated with Paxlovid for COVD-19 from 14Jun2022 to 18Jun2022. Rebound COVID-19 infection following Paxlovid treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 40.0
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 contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-years-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications.  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: (22Jun2002) positive; (20Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Adverse event Paxlovid rebound. Finished course on Sunday, on Tuesday tested negative on a PCR and was symptom free. Symptoms returned on Thursday, strong positive on PCR next day with full symptom return. The patient had no known allergies and no other medications in 2 weeks. No treatment was received for adverse events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillins" (unspecified if ongoing), notes: known allergies: penicillins. Concomitant medication(s) included: GABAPENTIN; SOLIFENACIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Three days later I tested positive; Unknown results, notes: Treatment of COVID-19; Negative, notes: tested negative on a rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: I tested negative on a rapid test. Three days later I tested positive. Had a stuffy nose and sore throat but no fever. Also have a rash on my forehead that may a or met not be related.   Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), in Aug2021 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 included: "Diabetes" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "rls" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received no other medication in 2 weeks. Patient had no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EP7533), on 15Apr2021 as dose 2, single (Lot number: ER8731), on 02Dec2021 as dose 3 (booster), single (Lot number: Fj8762) and on 12May2022 as dose 4 (booster), single (Lot number: FN9222) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Parkinson" (unspecified if ongoing), notes: other medical history: Parkinson. Concomitant medication(s) included: SINEMET, start date: 29Sep2019; EFFEXOR, start date: 31May2021; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MELATONIN, start date: 31May2021. Past drug history included: Sensitive to codeine, reaction(s): "Allergy", notes: known allergies: Sensitive to codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Report about covid treatment reported as Yes. if vaccine received reported Yes. other medication in 2weeks reported as Yes. Anti viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 14Jun2022, treatment stop date: 18Jun2022, indication: Treatment of COVID-19. Adverse event reported as Rebound case of Covid 6 days after completion of course of Paxlovid.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Fatigue, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; fatigue; lingering cough; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Postpartum depression" (unspecified if ongoing), notes: Postpartum depression (I'm 9 months postpartum); "asthma" (unspecified if ongoing), notes: I also had asthma for a, couple of years when I was a kid.; "Allergy" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 27Feb2022; IBUPROFEN, start date: 12Jun2022, stop date: 17Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; FATIGUE (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "lingering cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, fatigue, cough.  Clinical course: Woke up this morning with general malaise, fatigue, sore throat, runny nose, sneezing. These are all new symptoms except for fatigue after feeling better/recovering from initial COVID infection. I also have a lingering cough from my initial COVID infection. As day progressed, general malaise and fatigue worsened. Congestion presented in afternoon and got worse. Took one dose of OTC Zyrtec in the morning thinking it was allergies. Took one dose of Day Quil in the afternoon when still wasn't feeling well. Took my temperature this evening and it read 99.5. Decided to take an antigen test and it came back positive. No known allergies reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 as dose 2, single (Lot number: 301458A) at the age of 47 years 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: "Psoriatic arthropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received anti-viral (Brand=Pfizer) for COVID 19 treatment from 16Jun2022 to 20Jun2022. The patient received Enbrel (brand=Amgen) within two weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 26Nov2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing); "obesity" (unspecified if ongoing); "diverticulosis" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: Yes, sulfa; "Known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: Yes, shellfish. There were no concomitant medications. patient had no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 22Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I Tested positive again; I Tested positive again; This is a spontaneous report received from a non-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 18Jan2021 as dose 1, single (Lot number: EL3249), on 14Feb2021 as dose 2, single (Lot number: EL9269), on 16Aug2021 as dose 3 (booster), single (Lot number: FC3181) and on 19Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "Narcolepsy" (unspecified if ongoing); "Anemia caused by low iron" (unspecified if ongoing), notes: Anemia caused by low iron; "Asthma" (unspecified if ongoing); "Anemia caused by low iron" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; ALLEGRA; SUNOSI; EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL] taken for tension; ALBUTEROL [SALBUTAMOL]; SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]. Past drug history included: Zanaflex, reaction(s): "known allergies: Zanaflex". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I Tested positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (21Jun2022) Negative, notes: I tested negative on 21Jun2022 and 23Jun2022 and my symptoms were gone except for the fatigue; (23Jun2022) Negative, notes: I tested negative on 21Jun2022 and 23Jun2022 and my symptoms were gone except for the fatigue; (25Jun2022) Positive, notes: On 25Jun2022 my sore throat and congestion returned, so I used an at home antigen test and I Tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm, on 14Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 24Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (10Jun2022) Positive, notes: Rebound COVID on day 11 after first initial positive test. This is 5 days after completing paxlovid; (21Jun2022) Positive, notes: Rebound COVID on day 11 after first initial positive test. This is 5 days after completing paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received treatment with paxlovid for covid-19 treatment start date was 11Jun2022 and treatment stop date was 16Jun2022. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162b2 to the development of events vaccination failure and COVID-19 cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Paxlovid indication=Treatment of COVID-19; Paxlovid indication=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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: En6208), in left arm and on 07Apr2021 as dose 2, single (Lot number: Er8731) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Mar2022 as dose 3 (booster), single (Lot number: 026lub), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Roche at home rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:  Tested positive (at home rapid test) for Covid after testing negative 5 days prior. Recurrence/worsening of covid symptoms led to retest. Testing positive (today) 13 days after first positive test. Started paxlovid the day after first Positive test. Timeline: PCR test negative on 10Jun (test12ed at 2pm), antigen test positive 12Jun, started Paxlovid on the 13Jun. Tested negative (at home) on the 17Jun and 18Jun. Felt worse on the 22Jun, and tested positive again on the 23Jun and the 25Jun. if vaccine received. The patient got COVID-19 treatment with antiviral paxlovid from 12Jun2022 to 16Jun2022. The patient had taken other medication in 2weeks were Sudafed, Zyrtec, Tylenol, Dayquil, Vitamin B12.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
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 51-year-old male patient received BNT162b2 (BNT162B2), on 23Sep2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 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 and concomitant medications were not reported. Other medication in 2weeks was unknown. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6206), in left arm, as dose 2, single (Lot number: ER8764), in left arm and on 01Nov2021 as dose 3 (booster), single (Lot number: 3203080) at the age of 37 years, in left arm for covid-19 immunization. The patient's relevant medical history was not reported. The patient took concomitant medications, reported as patient received other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Positive, notes: Positive test 7 days in a row; Negative, notes: Recovered and negative for 3 days; Positive, notes: Now returned symptoms and positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 13Jun2022 and stopped on 18Jun2022. Clinical course was reported as, Covid rebound started on 23Jun2022. patient took paxlovid. Positive test 7 days in a row. Recovered and negative for 3 days. Now returned symptoms and positive test. No treatment received for Covid rebound symptoms treatment and patient was not recovered from symptoms.  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: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered with sequelae" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (24Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "treated for chronic Lyme disease" (unspecified if ongoing). There were no concomitant medications. The patient did not have any known allergies. The patient received vaccine. The following information was reported: VACCINATION FAILURE (medically significant) with onset 12Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 12Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) positive, notes: 12Jun and tested positive for Covid at an urgent care clinic out of state; (21Jun2022) negative, notes: I felt well but did the 10 day quarantine followed with 2 negative Covid tests on 21Jun and 22Jun; (22Jun2022) negative, notes: I felt well but did the 10 day quarantine followed with 2 negative Covid tests on 21Jun and 22Jun; (23Jun2022) positive, notes: In the evening of 22Jun I began having the same symptoms return and tested positive on 23Jun; (26Jun2022) Positive, notes: My symptoms continue, but improving, and I tested positive today, 26Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: I began having symptoms of headache, sinus, and ear congestion, and diarrhea on 12Jun and tested positive for Covid at an urgent care clinic out of state. I was ordered Paxlovid and had total relief of symptoms in about 48 hours. I felt well but did the 10-day quarantine followed with 2 negative Covid tests on 21Jun and 22Jun. In the evening of 22Jun I began having the same symptoms return and tested positive on 23Jun. My symptoms continue, but improving, and I tested positive today, 26Jun. Adverse event start date: 21Jun2022, Adverse event start time: 08:00 PM, if patient recovered was recovering, if treatment ae was no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Adverse event: Rebound Covid; tested negative day after completing treatment with return of symptoms in 2 days and positive test 4 days after treatment; still testing positive at this time.The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Rebound Covid; (15Jun2022) negative, notes: tested negative day after completing treatment; (17Jun2022) positive, notes: with return of symptoms in 2 days; (18Jun2022) positive, notes: positive test 4 days after treatment; (2022) positive, notes: still testing positive at this time. Therapeutic measures were taken as a result of covid-19, drug ineffective. Antiviral details. Product: COVID 19 Treatment. Brand: Paxlovid .Treatment start date: 09Jun2022.Treatment stop date: 14Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19, 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 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 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's relevant medical history included: "Lupus" (unspecified if ongoing); "Sjogren's" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing); "sulpha drugs allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Allergy". 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: Postive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient other medication in 2 weeks was unknown. Patient had received anti-viral medication; Paxlovid as COVID 19 Treatment. Treatment started on 13Jun2022 and stop date was 18Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, solution for injection), on 15Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Coconut" (unspecified if ongoing), notes: Known allergies: Coconut. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patients adverse events are Vomiting, Metal odor in taste, Harsh xerostomia, Difficulty swallowing on 17Jun2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EK9231), in right arm, on 13Jan2021 as dose 2, single (Lot number: EL3246), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "mitral valve repair" (unspecified if ongoing), notes: mitral valve prolapse with regurgitation (s/p mitral valve repair); "hx of atrial fibrillation" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient did not have any known allergies. Concomitant medication(s) or other medications the patient received in 2 weeks included: LISINOPRIL, start date: 01May1994; ADDERALL, start date: 30Apr2020; ASPIRIN [ACETYLSALICYLIC ACID], start date: 04Sep2012; GABAPENTIN, start date: 07Mar2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 06Jun2022 to 11Jun2022. The initial COVID-19 symptoms completely resolved while the patient was on Paxlovid, but then she had rebound symptoms (cough, myalgia, headache, fatigue) 5 days after end of Paxlovid treatment. They had been improving, but mild cough persisted.; 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.
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.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 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 immunization. The patient had no relevant medical history. There were no concomitant medications, reported as no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (Anti viral, Batch/Lot number: unknown, Started on 20Jun2022 and stopped on 15Jun2022). Clinical course was reported as, After the 2nd dose of Paxlovid patient started to get hives on forearms started on 21Jun2022. They continued to get worse so she stopped the medication after 6 doses (3 days). Treatment received for symptom Hives included Benadryl. Patient was recovering from symptom.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from 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), on 08Apr2021 at 09:00 as dose 1, single (Lot number: EWO153), in left arm, on 29Apr2021 at 09:00 as dose 2, single (Lot number: EWO167), in left arm and on 16Nov2021 at 09:00 as dose 3 (booster), single (Lot number: EWO173) at the age of 61 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "asthma" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: FLUOXETINE, start date: 08Mar2022; ALBUTEROL HFA, start date: 11Jun2022; ALVESCO, start date: 11Jun2022; VITAMIN D [COLECALCIFEROL], start date: 08Mar2022, also reported as other medication in 2weeks. The following information was reported: VACCINATION FAILURE (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: (13Jun2022) Positive, notes: I tested positive for COVID via PCR and antigen test on 13Jun2022 pm after waking up with a cough; (20Jun2022) Negative, notes: Tested negative on antigen test on 20Jun2022 am with lingering intermittent cough and slight drainage; (23Jun2022) Positive, notes: Woke up morning of 23Jun22 with sinus congestion and sneezing and tested positive on antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started on 13Jun2022 and stopped on 17Jun2022. Clinical course was reported as, Patient was exposed to COVID via husband. She tested positive for COVID via PCR and antigen test on 13Jun2022 pm after waking up with a cough. Began Paxlovid on 14Jun2022 am. Tested negative on antigen test on 20Jun2022 am with lingering intermittent cough and slight drainage. Covid rebound symptoms started on 22Jun2022 at 07:00. Woke up morning of 23Jun2022 with sinus congestion and sneezing and tested positive on antigen test. Continuing symptoms are runny nose, sneezing and light congestion as of 24Jun2022. Patient not received any treatment for symptoms and was recovering from symptoms.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 11Apr2021 as dose 2, single (Lot number: EN6204), in left arm and on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic low back pain" (unspecified if ongoing); "Chronic GERD" (unspecified if ongoing); "Generalized anxiety disorder" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Osteoarthritis of knee" (unspecified if ongoing); "History of severe acute respiratory syndrome" (unspecified if ongoing); "coronavirus 2 (SARS-CoV-2) disease" (unspecified if ongoing); "History of transient ischemic attack" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ASPIRIN (E.C.); FEXOFENADINE;PSEUDOEPHEDRINE; OMEPRAZOLE. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "recovering"; VACCINATION FAILURE (medically significant) with onset 2022, outcome "recovering", described as "Vaccination failure ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Negative, notes: Had negative home antigen test on 20Jun2022; (22Jun2022) Positive, notes: On 22Jun2022 tested positive with home antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Paxlovid treatment start date=09Jun2022, treatment stop date=13Jun2022, administrator route: Oral. Covid illness rebound after Paxlovid therapy. Onset of symptoms: 10Jun2022. Treated with Paxlovid 5-day course 10Jun-14Jun2022. Felt well. The patient had negative home antigen test on 20Jun2022. Next day (21Jun2022) felt ill (URI symptoms). On 22Jun2022 tested positive with home antigen test and returned to home isolation for 5 days.  . The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-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 15Aug2021 as dose 3 (bootser), single (Batch/Lot number: unknown) at the age of 42 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: "Anklosyng spondylitis" (unspecified if ongoing); "chronic Lyme" (unspecified if ongoing); "Alpha-1" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received nebulizer, steroids, oral inhaler after ER visit. The patient had Paxlovid rebound two days after testing negative and the sickness was much worse than while taking Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa drugs" (unspecified if ongoing); "author-immune disease" (unspecified if ongoing). The patient's concomitant medications were not reported and also reported as it was unknown if patient took other medication in 2 weeks. The following information was reported: COVID-19 (medically significant) with onset 19Jun2022, outcome "not recovered", DRUG INEFFECTIVE (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: (16Jun2022) negative, notes: 4 days after starting paxlovid I had a negative home test; (18Jun2022) Negative, notes: another negative test 6 days after starting; (19Jun2022) Positive, notes: Tested positive for Covid again (3 days after Paxlovid finished). Therapeutic measures were taken as a result of drug ineffective, covid-19 covid-19 included Paxlovid started on 12Jun2022 and stopped on 16Jun2022. Clinical course was reported as, 4 days after starting Paxlovid patient had a negative home test and another negative test 6 days after starting. On the 9th day she got a head cold and bad body aches. Tested positive for Covid again (3 days after Paxlovid finished) on 21Jun2022. No treatment received for symptoms and patient was not recovered from symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm is still swelling; it really hurts; Pain, its just real sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "arm is still swelling"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "it really hurts; Pain, its just real sore".  Additional information: Reporter stated that Her arm was still swelling and it really hurts; Pain, its just real sore. Reporter mentioned that she got vaccinated yesterday and as of the moment her arm is still swelling and it really hurts. She wanted to know if she could take any medication to keep the swelling away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.