chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Off label use, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; vaccine dose number=4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19"; OFF LABEL USE (non-serious), outcome "unknown", described as "vaccine dose number=4". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive on PCR; Tested positive on PCR; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 10Jan2021 as dose 2, single (Lot number: EL0140), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Apr2022 as dose 4 (booster), single (Lot number: 003J21-2A), 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 14Jun2022, outcome "not recovered" and all described as "Tested positive on PCR". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: Tested positive on PCR on 14Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had taken oral paxlovid, as COVID 19 treatment dated start date: 15Jun2022, to stop date: 19Jun2022, with lot number: NDC: 00069-1085-30. The patient received other medications in 2 weeks Bupropion HCL SR 100mg with lot number NDC: 43547-288-50 from 31Dec2010 to 27Jun2022 via oral route. Fexofenadine HCl tablet 180 mg with lot number 21K716 from 31May2022 to 27Jun2022 via oral route.  No follow-up attempts are possible. No further information is expected.; 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 vaccination failure (LOE) cannot be ruled out.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Depression, Fatigue, Nausea, Oropharyngeal pain
Clinical narrative: fever; vomiting; nauseau; fatigue; cough; depression; sore throat; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose number 3 (booster), single (Lot number: FF8839) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "cold agglutenin syndrome" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION HCL oral, start date: 31Dec2010, stop date: 27Jun2022; FEXOFENADINE HCL oral, start date: 31May2022, stop date: 27Jun2022. Vaccination history included: BNT162b2 (Pfizer / BioNTech vaccine dose 2; lot number: EL0140, Vaccine location: Left arm), administration date: 10Jan2021, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Pfizer / BioNTech vaccine dose 1, lot number: EJ1685, Vaccine location: Left arm), administration date: 20Dec2020, for Covid-19 immunization, reaction(s): "COVID-19". The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 13Jun2022, outcome "recovering", described as "sore throat"; COUGH (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering"; DEPRESSION (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering"; FATIGUE (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering"; PYREXIA (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering", described as "nauseau"; VOMITING (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vomiting, nausea, fatigue, cough, oropharyngeal pain, depression.  Additional information: The patient had symptoms of sore throat starting on 13Jun2022. Antigen was negative on the 13Jun2022. Tested positive on PCR on 14Jun2022. Symptoms were increased and included elevated fever, vomiting, nausea, fatigue, cough, sore throat, depression. As symptoms resolved, tested antigen negative on 23Jun2022 and 24Jun2022. Rebound of nasal congestion and sore throat symptoms and positive antigen test on 27Jun2022. The patient did receive other medications in 2 weeks prior to vaccine. Patient has Moderna covid vaccine as 4th dose with lot number 003J21-2A on 07Apr2022 in left arm. Patient had taken oral paxlovid, as COVID 19 treatment dated start date: 15Jun2022, to stop date: 19Jun2022, with lot number: NDC: 00069-1085-30.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: fever; vomiting; nauseau; fatigue; cough; depression; sore throat; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose number 3 (booster), single (Lot number: FF8839) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "cold agglutenin syndrome" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION HCL oral, start date: 31Dec2010, stop date: 27Jun2022; FEXOFENADINE HCL oral, start date: 31May2022, stop date: 27Jun2022. Vaccination history included: BNT162b2 (Pfizer / BioNTech vaccine dose 2; lot number: EL0140, Vaccine location: Left arm), administration date: 10Jan2021, for Covid-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Pfizer / BioNTech vaccine dose 1, lot number: EJ1685, Vaccine location: Left arm), administration date: 20Dec2020, for Covid-19 immunization, reaction(s): "COVID-19". The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 13Jun2022, outcome "recovering", described as "sore throat"; COUGH (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering"; DEPRESSION (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering"; FATIGUE (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering"; PYREXIA (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering", described as "fever"; NAUSEA (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering", described as "nauseau"; VOMITING (non-serious) with onset 26Jun2022 at 07:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vomiting, nausea, fatigue, cough, oropharyngeal pain, depression.  Additional information: The patient had symptoms of sore throat starting on 13Jun2022. Antigen was negative on the 13Jun2022. Tested positive on PCR on 14Jun2022. Symptoms were increased and included elevated fever, vomiting, nausea, fatigue, cough, sore throat, depression. As symptoms resolved, tested antigen negative on 23Jun2022 and 24Jun2022. Rebound of nasal congestion and sore throat symptoms and positive antigen test on 27Jun2022. The patient did receive other medications in 2 weeks prior to vaccine. Patient has Moderna covid vaccine as 4th dose with lot number 003J21-2A on 07Apr2022 in left arm. Patient had taken oral paxlovid, as COVID 19 treatment dated start date: 15Jun2022, to stop date: 19Jun2022, with lot number: NDC: 00069-1085-30.
Age: 63.0
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) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, Report about covid treatment: Yes, if vaccine received: Yes. Other medication in 2weeks was Yes. Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, Treatment start date: 16Jun2022, Treatment stop date: 19Jun2022, Indication: Treatment of COVID-19. covid vaccine details: Vaccine brand Pfizer/BioNTech, Vaccine administration date:27Apr2022. Adverse event: Rebound Covid 10 7 days post completion of Paxlovid, Adverse event country: Adverse event start date: 26Jun2022, Adverse event start time: 11:00 PM, ae resulted in: None of the above, If patient recovered: Recovering, If treatment ae: No.   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 limited information in the case , a possible causal association between   the reported  events Drug ineffective , covid 19 and the suspect drug cannot be excluded
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red rash on hand covering 1/5th of left hand between index and middle finger and hand, Still see signs of the healing today; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 39-year-old male patient received BNT162b2 (BNT162B2), on 16Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; METFORMIN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 19Jun2022, outcome "recovering", described as "Red rash on hand covering 1/5th of left hand between index and middle finger and hand, Still see signs of the healing today" (as reported). Therapeutic measures were not taken as a result of rash erythematous.  Additional information: It was reported that if other vaccine in four weeks: unknown; If covid prior vaccination: no; If covid tested post vaccination: unknown and known allergies: unknown.  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; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-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 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 "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 63 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: "Bronchiectasis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications (no other medications in 2 weeks). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course (including laboratory tests and procedures): Anti-viral details: COVID-19 treatment (Brand: Pfizer, Lot Number: GA5109) from 16Jun2022 to 20Jun2022. First bout of COVID resolved on 23Jun2022. Patient felt well 22Jun2022- Sunday 27Jun2022. She had a negative BINAX test on 24Jun2022. Bounce back COVID (from 26Jun2022 01:00 am; resulted in none of the above; not recovered; no treatment) was documented with positive BINAX test taken at 7:00 am on 27Jun2022. Prior night felt a little funny but no symptoms. Strong symptoms began on 27Jun2022 with fever up to 100.4, sneezing, runny nose, coughing, slight headache, aches. Symptoms somewhat better on 28Jun2022 fever sub normal, still have sneezing, cough, poor appetite. Oxygen 92-98.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of Covid-19; Treatment of COVID-19; . This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 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: "DM" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; MUCINEX D; ACETAMINOPHEN. Past drug history included: Nsaids, reaction(s): "Intolerance to NSAIDs". The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown", described as "Treatment of COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", described as "Treatment of Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Drug ineffective; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 71-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown), on 02Feb2021 as dose 2, single (Batch/Lot number: unknown), on 23Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: other medical history: hypertension, RLS, sleep apnea,, Metabolic syndrome, Obesity,, hyperlipidemia, insomnia; "RLS" (unspecified if ongoing), notes: other medical history: hypertension, RLS, sleep apnea,, Metabolic syndrome, Obesity,, hyperlipidemia, insomnia; "sleep apnea" (unspecified if ongoing), notes: other medical history: hypertension, RLS, sleep apnea,, Metabolic syndrome, Obesity,, hyperlipidemia, insomnia; "Metabolic syndrome" (unspecified if ongoing), notes: other medical history: hypertension, RLS, sleep apnea,, Metabolic syndrome, Obesity,, hyperlipidemia, insomnia; "Obesity" (unspecified if ongoing), notes: other medical history: hypertension, RLS, sleep apnea,, Metabolic syndrome, Obesity,, hyperlipidemia, insomnia; "hyperlipidemia" (unspecified if ongoing), notes: other medical history: hypertension, RLS, sleep apnea,, Metabolic syndrome, Obesity,, hyperlipidemia, insomnia; "insomnia" (unspecified if ongoing), notes: other medical history: hypertension, RLS, sleep apnea,, Metabolic syndrome, Obesity,, hyperlipidemia, insomnia; "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Positive, notes: Patient tested positive for COVID on 04Jun2022; (17Jun2022) Negative, notes: Then on June 17th, patient started having COVID symptoms again; (19Jun2022) Positive, notes: On June 19th, patient tested positive for Covid again. 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.; 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 vaccination failure (LOE) cannot be ruled out.
Age: 36.0
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) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EJ1686), in right arm and on 28Jan2021 as dose 2, single (Lot number: EL9261) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lung nodules and being monitored for sarcoidosis or lymphoma" (unspecified if ongoing), notes: Other medical history: Lung nodules and being monitored for sarcoidosis or lymphoma; "Lung nodules and being monitored for sarcoidosis or lymphoma" (unspecified if ongoing), notes: Other medical history: Lung nodules and being monitored for sarcoidosis or lymphoma; "Lung nodules and being monitored for sarcoidosis or lymphoma" (unspecified if ongoing), notes: Other medical history: Lung nodules and being monitored for sarcoidosis or lymphoma; "Known allergies: Shellfish" (unspecified if ongoing). There were no concomitant medications. 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: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 89.0
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 a contactable reporter(s) (Other HCP).  An 89-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single at the age of 89 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Feb2021 as dose 1, single (Batch/Lot number: unknown), on 09Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CKD, stage 3" (unspecified if ongoing), notes: Stage 3; "HTN" (unspecified if ongoing); "type 2 DM" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing); "obesity" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: GLIPIZIDE oral; CITALOPRAM oral; FOSAMAX oral; LEVOTHYROXINE oral; LISINOPRIL oral; MAGNESIA [MAGNESIUM OXIDE] oral; Multivitamin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient received anti viral details product-COVID 19 Treatment orally from 14Jun2022 to 19Jun2022. Adverse event covid rebound on 24Jun2022; completed paxlovid 20Jun2022, renal dosing, and felt improved while taking, then normal for 2 to 3 days, then full symptom recurrence 25Jun2022 and repeat covid testing was positive 25Jun22 by antigen. Patient received treatment including telemedicine follow up, extended home isolation.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the available information in the case, the causal association between the event Drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 77.0
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) (Nurse).  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 01May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years for COVID-19 immunisation. The patient's relevant medical history included: "Diverticulosis" (unspecified if ongoing); "scolisis" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "depression" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "allergics" (unspecified if ongoing); "malignant neoplasm of uterus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "recovering" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, COVID-19 and included Paxlovid. Clinical course (including laboratory tests and procedures): Patient tested positive for COVID on 17May2022. Dr. prescribed Paxlovid (orally from 16May2022 to 21Jun2022 for treatment of COVID-19). Then on 31May2002 patient started having COVID symptoms again. Tested negative that day on 30May2022, patient tested positive for COVID again. Therefore had a case of rebound COVID (start date reported as 30May2022, recovering, no treatment received, resulted in none of the above) after finishing the Paxlovid.  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 Vaccination Failure (LOE) and COVID-19 cannot be ruled out.
Age: 70.0
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) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EJ1685), in left arm, on 16Feb2021 as dose 2, single (Lot number: EL9261), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: FF2087), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Occasional asthma" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 14Jun2022 to 18Jun2022. No other medication in 2 weeks with treatment of Paxlovid.
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.  An adult male patient received BNT162b2 (BNT162B2), on 11Dec2021 at 15:45 as dose 3 (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) and on 03Mar2021 as dose 2, single (Lot number: EN6205), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate sleep apnea," (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; ROSUVASTATIN. Past drug history included: Erythromycin, reaction(s): "Known allergies: erythromycin", notes: Oral flora ins and erythromycin-flutters not anaphylaxis. 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. 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: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 76-year-old female patient (not pregnant) received BNT162B2, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "h/o cancer" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: rebound covid symptoms with new positive test 7 days after completing Paxlovid with cough, runny nose. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: COVID 19 Treatment (Paxlovid) was from 13Jun2022 to 18Jun2022. The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: dx of covid 19; dx of covid 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 79-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Batch/Lot number: unknown), on 03Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "nonrheumatic AV insufficiency" (unspecified if ongoing); "nonmelanoma skin cancer" (unspecified if ongoing); "cataracts bilaterally" (unspecified if ongoing); "Rosacea" (unspecified if ongoing); "AK" (unspecified if ongoing); "mitral regurg" (unspecified if ongoing); "HLD Aneurysm of aorta" (unspecified if ongoing); "HLD" (unspecified if ongoing); "thyroid nodule" (unspecified if ongoing); "essential hypertension" (unspecified if ongoing); "Known allergies: grasses" (unspecified if ongoing); "Known allergies: Trees" (unspecified if ongoing); "Known allergies: Ragweed" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "not recovered" and all described as "dx of covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Negative, notes: Tested negative for covid on 23Jun2022; (23Jun2022) Positive, notes: Repeated home test that was positive for Covid on 23Jun2022; (23Jun2022) Positive, notes: Repeated home test that was positive for Covid on 23Jun2022 and also from spit test at the (Lab name withheld) that same day. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Symptoms started on 16Jun2022 and dx of covid 19. Started paxlovid on 17Jun2022 and took until gone on 22Jun2022 and felt just a bit of residual symptoms with great improvement. Tested negative for covid on 23Jun2022 and then on 25Jun2022 started to develop new mild symptoms of cough, increased phlegm in chest and nasal passages, resurgence of fatigue. Repeated home test that was positive for Covid on 23Jun2022 and also from spit test at the (Lab name withheld) that same day.  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 available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
Age: 64.0
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 a non-contactable reporter(s) (Nurse).  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown), on 07Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 27Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: re-testing positive 11 days after initial infection. Therapeutic measures were taken as a result of drug ineffective, covid-19. From 14Jun2022 to 19Jun2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19. On 25Jun2022, the patient experienced rebound covid with re-testing positive 11 days after initial infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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) and COVID-19 cannot be ruled out.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid home test which came up positive/COVID 19 Treatment; covid home test which came up positive/COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 18Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancer" (unspecified if ongoing); "Allergy to bee stings" (unspecified if ongoing), notes: Known allergies: none known other than bee stings. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid home test which came up positive/COVID 19 Treatment". Having finished the full treatment, the patient began to feel unwell about 26Jun2022. Sneezing, runny nose. Today (on 28Jun2022) symptoms worsened with aches, low grade fever, headache. Took covid home test which came up positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jun2022) Positive, notes: covid home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 12Jun2022 to 17Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid-19 positive; covid-19 positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL3247), on 16Mar2021 as dose 2, single (Lot number: EL3247) and on 03Nov2021 as dose 3 (booster), single (Lot number: EW0217) 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 27Jun2022, outcome "not recovered" and all described as "covid-19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 positive; COVID 19 positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult 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 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 25Jun2022, outcome "not recovered" and all described as "COVID 19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If covid prior vaccination reported as no. If covid tested post vaccination reported as yes. Paxlovid used for the treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Rash
Clinical narrative: Rashes; a lump in her forehead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), 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 (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (1st Booster), Manufacturer unknown), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rashes"; MASS (non-serious), outcome "unknown", described as "a lump in her forehead". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Sep2021 at 14:00 as dose 3 (booster) single (Batch/Lot number: unknown), in right arm and on 17Feb2022 at 14:00 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetic" (unspecified if ongoing); "arthritis" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Negative, notes: tested negative on 3rd day; (25Jun2022) Positive, notes: tested positive on day 5, again. 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: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; 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 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Peanuts allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had no other medication in 2 weeks. The patient received Paxlovid as treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: after the first shot, it took a month for the side effects to start, but she had a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: States she already had high blood pressure. The patient's concomitant medications were not reported. Vaccination history included: Flu (she took the Flu and Shingles shots and she broke out with a rash under her breasts.), administration date: 2021, for immunization, reaction(s): "she broke out with a rash under her breasts"; Shingles (she took the Flu and Shingles shots and she broke out with a rash under her breasts.), administration date: 2021, for immunization, reaction(s): "she broke out with a rash under her breasts". The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "after the first shot, it took a month for the side effects to start, but she had a headache". Therapeutic measures were taken as a result of headache. Additional Information: Lot number was not provided as complainant does not have the product with them at the time of call. Expiry date of Covid 19 vaccine was unknown. Caller stated she took the first shot and she had no rash, she was just fine. Caller clarified , after the first shot, it took a month for the side effects to start, but she had a headache and she took pills for that aspirin.Caller stated she thought she would go ahead and take the second Pfizer shot because she did not break out with a rash with the first shot. Caller stated she does not like taking medication. Stated she stopped taking her blood pressure medication and her muscle relaxer before she started the Pfizer vaccines because she did not want to mix those up with the vaccines. Stated the blood pressure medication was not doing any good anyhow, her blood pressure kept going up and down and up and down. Treatment included Aspirin for High blood pressure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 04Feb2021 as dose 2, single (Lot number: EL9264), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: EW0183) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "ulcerative colitis" (unspecified if ongoing). Concomitant medication(s) included: XYZAL; ALBUTEROL [SALBUTAMOL]; SYMBICORT. 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: (unspecified date) Unknown Results; (22Jun2022) Negative; (28Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I had a positive test on the morning of 18Jun2022. I began my Paxlovid on 18Jun2022; I had a positive test on the morning of 18Jun2022. I began my Paxlovid on 18Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 at 15:00 as dose 1, single (Lot number: EL1283), in left arm, on 02Feb2021 at 14:00 as dose 2, single (Lot number: EL9262), in left arm and on 23Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FC3183) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022, outcome "not recovered" and all described as "I had a positive test on the morning of 18Jun2022. I began my Paxlovid on 18Jun2022". The patient underwent the following laboratory tests and procedures: Body temperature: (27Jun2022) 100.3; SARS-CoV-2 test: (18Jun2022) Positive; (22Jun2022) Negative, notes: I tested negative again on the 22nd at 8am; (27Jun2022) Positive; (29Jun2022) Positive, notes: Still testing positive on a home rapid test; (21Jun2022) Negative, notes: I tested negative at 6:45pm (I have the documents) . Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not have known allergies. The patient had a positive test on the morning of 18Jun2022. She began Paxlovid (lot no: ga2851) on 18Jun2022. Felt better by Monday 20Jun2022. The patient had  PCR test on Tuesday the 21st. She had tested negative at 6:45pm (She has the documents). Then she finished her Paxlovid on wed 22nd. The patient tested negative again on the 22nd at 8am. The patient had no symptoms or fever. The patient started feeling bad on Sunday night 26Jun2022. She tested on Monday the 27th and she was positive. She was running a fever of 100.3 had a runny nose and headache. No cough or trouble breathing, just like a sinus infection. On Wed 29Jun2022, She was better with a low grade fever. Still testing positive on a home rapid test. Her doctor gave her a prescription for Tamiflu but she has not taken it yet. She was hesitant because she was doing better. She has no underlying health problems.  She was doing work out regular.