chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Optic neuritis
Clinical narrative: Diagnosed with an autoimmune reaction chronic idopathic optic neuritis; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: Apr2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: OPTIC NEURITIS (hospitalization, medically significant) with onset 17Oct2021, outcome "unknown", described as "Diagnosed with an autoimmune reaction chronic idopathic optic neuritis". The event "diagnosed with an autoimmune reaction chronic idopathic optic neuritis" required emergency room visit. The patient underwent the following laboratory tests and procedures: lab test: unknown results, notes: all lab tests has ruled out the other auto immune causes. Therapeutic measures were taken as a result of optic neuritis.  Clinical Course: Patient did not receive any other vaccines within 4 weeks. No other medications the patient received within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 post vaccination. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Military facility. The patient received BNT162B2 dose 2 on May2021 at 09:00 AM. Reported Event: Diagnosed with an autoimmune reaction chronic idiopathic optic neuritis with the first even in Oct2021, subsequent Apr2022 and Aug2022. All lab tests have ruled out the other auto immune causes. The patient received Plasmapheresis and steroids as a treatment for event.  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 given in narrative, the causal relationship between the event optic neuritis and the suspect drug BNT162B2 cannot be excluded. Statement-The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: No" (unspecified if ongoing), notes: Known allergies: No. 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: (2022) Positive, notes: I tested positive for COVID again with all the symptoms; (Aug2022) Positive, notes: Treatment of COVID-19. Antiviral drug was taken as therapeutic measures for drug ineffective, covid-19 from 24Aug2022 to 28Aug2022. Patient took no other medication within 2 weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
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) (Physician) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2022 as dose 1, single (Lot number: FK9895) at the age of 72 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: History of asthma. Concomitant medication(s) included: TAMSULOSIN; ADVAIR HFA; LEVOTHYROXINE; FINASTERIDE; VALSARTAN; PRAVASTATIN; ALENDRONATE; ALBUTEROL [SALBUTAMOL]. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Therapeutic measures included, Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment started on 24Aug2022 and treatment stop date: 29Aug2022, Indication: Treatment of COVID-19. The reporter considered the events as non-serious. Hospitalization prolonged reported as no.  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 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Nasal congestion, SARS-CoV-2 test
Clinical narrative: mental fogginess; tiredness; stuffy nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FG3527) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, EN6201), administration date: 11Feb2021, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, EN6200), administration date: 04Mar2021, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "mental fogginess"; NASAL CONGESTION (non-serious) with onset 2022, outcome "unknown", described as "stuffy nose"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "tiredness". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: Patient's symptom started Wednesday night (24Aug2022) as a sore throat and progressed to a fever of 101F, stuffy nose, coughing, tiredness and mental fogginess. She received two Pfizer Covid-19 vaccines and booster.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: COVID-19 VACCINE taken for covid-19 immunisation as dose 1, single as dose 2, single as dose 3 (booster), single; ATORVASTATIN, stop date: 25Aug2022; TAMSULOSIN; SYNTHROID; VIT D3. 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: (unspecified date) Positive; (02Sep2022) Negative, notes: tested negative 02Sep2022; (05Sep2022) Positive, notes: Paxlovid rebound, tested positive 05Sep2022,. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies was reported as none. Other medication in 2weeks were reported as yes.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Condition aggravated, Fear, Memory impairment, Myalgia
Clinical narrative: tremendous pain to my muscles/got worse after the booster; all joints and nerve pain/got worse after the booster; nerve pain; nerve pain/got worse after the booster; suffering so much pain in daily bases; memories are getting worse; horrifying; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "all joints and nerve pain", "tremendous pain to my muscles", "all joints and nerve pain"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "memories are getting worse"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "horrifying"; Covid-19 vaccine (Dose number unknown, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "tremendous pain to my muscles/got worse after the booster"; ARTHRALGIA (non-serious), outcome "unknown", described as "all joints and nerve pain/got worse after the booster"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "nerve pain/got worse after the booster"; PAIN (non-serious), outcome "unknown", described as "suffering so much pain in daily bases"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "memories are getting worse"; FEAR (non-serious), outcome "unknown", described as "horrifying".  Additional information: Patient had been experiencing tremendous pain to muscles, all joints and nerve pain ever since received first dose of vaccine and got worse after the booster. Patient was suffering so much pain in daily bases. Patient never had pain in the life before the vaccine. Also memories were getting worse. Patient was horrified.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200057825 same reporter/patient/AE, different drug dose;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Pain
Clinical narrative: tremendous pain to my muscles/got worse after the booster; all joints and nerve pain/got worse after the booster; nerve pain; nerve pain/got worse after the booster; suffering so much pain in daily bases; memories are getting worse; horrifying; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "all joints and nerve pain", "tremendous pain to my muscles", "all joints and nerve pain"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "memories are getting worse"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "horrifying"; Covid-19 vaccine (Dose number unknown, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "tremendous pain to my muscles/got worse after the booster"; ARTHRALGIA (non-serious), outcome "unknown", described as "all joints and nerve pain/got worse after the booster"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "nerve pain/got worse after the booster"; PAIN (non-serious), outcome "unknown", described as "suffering so much pain in daily bases"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "memories are getting worse"; FEAR (non-serious), outcome "unknown", described as "horrifying".  Additional information: Patient had been experiencing tremendous pain to muscles, all joints and nerve pain ever since received first dose of vaccine and got worse after the booster. Patient was suffering so much pain in daily bases. Patient never had pain in the life before the vaccine. Also memories were getting worse. Patient was horrified.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200057825 same reporter/patient/AE, different drug dose;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fear, Memory impairment, Myalgia, Neuralgia
Clinical narrative: tremendous pain to my muscles/got worse after the booster; all joints and nerve pain/got worse after the booster; nerve pain; nerve pain/got worse after the booster; suffering so much pain in daily bases; memories are getting worse; horrifying; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "all joints and nerve pain", "tremendous pain to my muscles", "all joints and nerve pain"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "memories are getting worse"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "horrifying"; Covid-19 vaccine (Dose number unknown, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "tremendous pain to my muscles/got worse after the booster"; ARTHRALGIA (non-serious), outcome "unknown", described as "all joints and nerve pain/got worse after the booster"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "nerve pain/got worse after the booster"; PAIN (non-serious), outcome "unknown", described as "suffering so much pain in daily bases"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "memories are getting worse"; FEAR (non-serious), outcome "unknown", described as "horrifying".  Additional information: Patient had been experiencing tremendous pain to muscles, all joints and nerve pain ever since received first dose of vaccine and got worse after the booster. Patient was suffering so much pain in daily bases. Patient never had pain in the life before the vaccine. Also memories were getting worse. Patient was horrified.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200057825 same reporter/patient/AE, different drug dose;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Condition aggravated, Fear, Memory impairment, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "tremendous pain to my muscles"; ARTHRALGIA (non-serious), NEURALGIA (non-serious), outcome "unknown" and all described as "all joints and nerve pain"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "memories are getting worse"; FEAR (non-serious), outcome "unknown", described as "horrifying". Additional information: Patient was experiencing tremendous pain to muscles, all joints and nerve pain ever since patient received first dose of vaccine and got worse after the booster. Patient was  suffering so much pain on daily basis. Patient never had pain in life before the vaccine. Also patient's memories was getting worse  Patient was horrifying. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202201130835 same reporter/patient/AE, different drug dose;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "tremendous pain to my muscles"; ARTHRALGIA (non-serious), NEURALGIA (non-serious), outcome "unknown" and all described as "all joints and nerve pain"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "memories are getting worse"; FEAR (non-serious), outcome "unknown", described as "horrifying". Additional information: Patient was experiencing tremendous pain to muscles, all joints and nerve pain ever since patient received first dose of vaccine and got worse after the booster. Patient was  suffering so much pain on daily basis. Patient never had pain in life before the vaccine. Also patient's memories was getting worse  Patient was horrifying. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202201130835 same reporter/patient/AE, different drug dose;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fear, Memory impairment, Myalgia, Neuralgia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "tremendous pain to my muscles"; ARTHRALGIA (non-serious), NEURALGIA (non-serious), outcome "unknown" and all described as "all joints and nerve pain"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "memories are getting worse"; FEAR (non-serious), outcome "unknown", described as "horrifying". Additional information: Patient was experiencing tremendous pain to muscles, all joints and nerve pain ever since patient received first dose of vaccine and got worse after the booster. Patient was  suffering so much pain on daily basis. Patient never had pain in life before the vaccine. Also patient's memories was getting worse  Patient was horrifying. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202201130835 same reporter/patient/AE, different drug dose;
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound Covid; 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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 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: "Pacemaker" (unspecified if ongoing). Concomitant medication(s) included (other medication in 2weeks): ATENOLOL; ESCITALOPRAM; TRAZODONE. There was no known drug allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 02Sep2022, outcome "not recovered", described as "Rebound Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Sep2022) Positive, notes: Rebound Covid.  Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 treatment with Paxlovid with indication treatment of COVID-19, treatment started from 22Aug2022 and stopped 27Aug2022.  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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 78 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: "I'm almost 79!  A variety of things (mostly heart)." (unspecified if ongoing), notes: Other medical history: I'm almost 79! A variety of things (mostly heart); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicllin. Concomitant medication(s) included: RANOLAZINE, start date: 01Feb2022, stop date: 24Aug2022; ROSUVASTATIN, start date: 01Jan2010, stop date: 24Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Paxlovid worked great. Things were getting better after the first day-so happy! After 5th day I felt cured and went to normal routine. Day 6-ok. Day 7 started sneezing again. Day 8-had slight fever again. Day 9-cough/running nose. Day 10 worse. Day 12 fainted, daughter called 911. Day 13-a little better. Day 14-today, no improvement. But Paxlovid worked great for 5 days. Guess I'll just ride it out now. Adverse event start date: 29Aug2022. AE resulted in: None of the above. If patient recovered: Not recovered. If treatment ae: No  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: having covid; having covid; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP).  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Aug2022, outcome "unknown" and all described as "having covid".  Clinical course: Patient reported, missed 5 days of Xeljanz last week due to him having Covid, No longer has any symptoms of Covid. Md not aware.   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 given in narrative, the causal relationship between the event Drug ineffective and COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Computerised tomogram, Gastric disorder, Laboratory test, Magnetic resonance imaging
Clinical narrative: stomach issues; 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 received BNT162b2 (BNT162B2), on 01Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure. Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EL9269), administration date: 06Feb2021, when the patient was 65-year-old, for COVID-19 Immunisation, reaction(s): "stomach issues"; BNT162b2 (DOSE 2, SINGLE; Lot number: EL9266), administration date: 27Feb2021, when the patient was 65-year-old, for Covid-19 Immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FF2589), administration date: 09Oct2021, when the patient was 66-year-old, for Covid-19 Immunisation. The following information was reported: GASTRIC DISORDER (non-serious) with onset 2022, outcome "not recovered", described as "stomach issues". The event "stomach issues" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastric disorder.  Additional information: It was reported that she had stomach issues couple of days after the fourth one and had really bad stomach issues, it comes and goes but it would not go away. Had been taking Bentyl (the prescription for it) and trying to get that to work; nothing was helping with it; nothing at all. Consumer stated that, whenever she had the first one back to the first one now, had stomach issues couple of days after, a day or two after and called the other night and asked if that was one of the side effects and they really don't know whole lot about it but they put it down. Then had second and third one and did okay, but had her fourth one and had really bad stomach issues and had been to the doctors and can't find anything wrong with her or anything else because of this problem. The patient had a lot of lab tests in past 3 weeks. She had lab work done on 30Aug and back in 15Aug in the hospital. The patient had an MRI done and a CT scan done (Further not clarified) both with contrast to see if she could find something wrong with her stomach. But can't find anything. No prior vaccinations (within 4 weeks).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201131859 Same reporter/Patient/event; different Dose;
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years 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: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. Concomitant medication(s) included: TRAZODONE; BUPROFEN; TYLENOL; TESSALON; DELSYM; CODEINE; MUCINEX. The patient started Azithromycin on 26Aug2022 and stopped on 01Sep2022. The patient had no known allergies. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19; (2022) Positive, notes: Rebound positive test. Therapeutic measures were taken as a result of covid-19. Therapeutic measures included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment started on 25Aug2022 and treatment stopped on 31Aug2022, Indication: Treatment of Covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; 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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Test positive for covid=10; Test positive for covid=10; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: 2895) at the age of 79 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Pacemaker" (unspecified if ongoing); "Heart valve replacement" (unspecified if ongoing). 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 "Test positive for covid=10". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Test positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: anti viral treatment was received for the events from 23Aug2022 to 27Aug2022. Patient had no known allergies   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: 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) from product quality group. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 30Jan2021 at 14:00 as dose 1, single (Lot number: EL2965), in right arm, on 17Feb2021 at 14:00 as dose 2, single (Lot number: EM9809), in right arm, on 29Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FH8020), in right arm and on 08Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 74 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: Feb1995, stop date: 21Aug2022; PAROXETINE, start date: Jan1998; LISINOPRIL AND HYDROCHLOROTHIAZIDE, start date: Apr2008; MULTIVITAMIN [VITAMINS NOS], start date: Feb1998. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, 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) Positive; (31Aug2022) Negative, notes: Tested negative on day 10; (04Sep2022) Positive, notes: Retested for COVID on day 15 and tested positive (also on day 16, today.); (05Sep2022) Positive, notes: Retested for COVID on day 15 and tested positive (also on day 16, today.). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Paxlovid start date=22Aug2022, stop date=26Aug2022, route: oral. The patient took the 5-day Paxlovid regimen during days 2-6 of covid. Tested negative on day 10.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid 5 days after receiving the gray cap booster.; Tested positive for covid 5 days after receiving the gray cap booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 30Aug2022 at 16:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 35 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: "Multiple sclerosis" (unspecified if ongoing), notes: other medical history: Multiple sclerosis. Concomitant medication(s) included: VUMERITY; TROSPIUM; XYZAL; PROZAC. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04Sep2022, outcome "not recovered", COVID-19 (medically significant) with onset 04Sep2022, outcome "not recovered" and all described as "Tested positive for covid 5 days after receiving the gray cap booster.". The event "tested positive for covid 5 days after receiving the gray cap booster." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Sep2022) Positive, notes: for covid 5 days after receiving the  gray cap booster; (05Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported that, the dose received was more than 3. Patient did not have other vaccine in four weeks. Other medications in two weeks were VUMERITY, trospium, xyzal, Prozac, multivitamin. Adverse event was tested positive for covid 5 days after receiving the gray cap booster. Adverse events start date was 04Sep2022. AE resulted in Emergency room/department or urgent care .The treatment ae was TESSALON. The patient did not have covid prior vaccination, was tested post vaccination with Nasal Swab on 05Sep2022. Covid test result was Positive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 22Apr2022 as dose 4 (bosster), single (Lot number: FP4554) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; METFORMIN; TRAZODONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid (Lot number: GE8686) from 20Aug2022 to 25Aug2022. Patient took other medication in two weeks.  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
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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: Ff8841) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; OMEPRAZOLE. The following information was reported: VACCINATION FAILURE (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: (unspecified date) positive; (unspecified date) Negative; (05Sep2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 26Aug2022 to 31Aug2022.  Clinical Course: It was reported that patient received vaccine was Yes. Other medication in 2weeks was Yes includes Metoprolol and Omeprazole. New positive test was on 05Sep2022. Known allergies was Penicillin. Other medical history was Hypertension, obesity and pre-diabetes.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 25Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "high cholesterol" (unspecified if ongoing). 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 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 08Apr2021 as dose 2, single (Lot number: ER8734), in left arm, on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 31Mar2022 at 10:30 as dose 4 (booster), single (Lot number: FK9894) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BMI of 26" (unspecified if ongoing), notes: Other medical history: BMI of 26. Concomitant medication(s) included: SIMVASTATIN, start date: 01Jan2015, stop date: 21Aug2022. The following information was reported: VACCINATION FAILURE (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: Body mass index: (unspecified date) 26, notes: BMI of 26; SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (01Sep2022) Negative, notes: after negative rapid tests on days 8 and 10; (03Sep2022) Negative, notes: after negative, rapid tests on days 8 and 10; (04Sep2022) Positive, notes: Rebound COVID indicated by a Positive rapid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Rebound COVID indicated by a Positive rapid test and bad head cold symptoms on day 12 after negative rapid tests on days 8 and 10.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with COVID after COVID-19 vaccine; diagnosed with COVID after COVID-19 vaccine; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EL3248, Expiration Date: 21Apr2021), on 26Mar2021 as dose 2, single (Lot number: EP6955, Expiration Date: 30Jun2021) and on 19Nov2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 43 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 29Aug2022 (also reported as 19Aug2022), outcome "unknown" and all described as "diagnosed with COVID after COVID-19 vaccine". Clinical course: the reporter was a Pfizer employee who received the vaccine "in Mar2021, then booster, and a second booster in Nov2021." The reporter was diagnosed with COVID on 29Aug2022.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The adverse event did not require a visit to the emergency room or physician office. There were no additional vaccines administered on the same dates of the Pfizer suspect. There were no adverse events following prior vaccinations. The reporter finally noted that her husband was sick as well. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2022) Positive.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient 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 included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (04Sep2022) Positive, notes: I tested positive for covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treated with Paxlovid started on 28Aug2022, stopped on 01Sep2022. The patient tested positive for covid again and then started having symptoms three days after stopping paxlovid. Event started on: 04Sep2022, Recovering.  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
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EK9231), in right arm, on 30Jan2021 as dose 2, single (Lot number: EL9262), in right arm, on 20Dec2021 as dose 3 (booster), single (Lot number: FE3590), in right arm and on 22Jul2022 at 13:15 as dose 4 (booster), single (Lot number: FM9992) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NORTRIPTYLINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Valicyclovir medication in 2 weeks from 17Aug2022 to 19Aug2022. The patient had no known allergies.