chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 13Oct2021 at 13:15 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 60 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient didn't taken other medication in 2weeks. Patient didn't have any known allergies. Paxlovid was taken as treatment for covid-19. Treatment started from 19Jun2022 to 24Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 31Aug2021 as dose 3 (booster) , single (Batch/Lot number: unknown), in left arm and on 30Mar2022 as dose 4 (booster) , single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: All well controlled with medicine; "high blood pressure" (unspecified if ongoing), notes: All well controlled with medicine; "high cholesterol" (unspecified if ongoing), notes: All well controlled with medicine; "hypothyroidism" (unspecified if ongoing), notes: All well controlled with medicine. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; LOSARTAN; ROSUVASTATIN; LEVOTHYROXINE; INSULIN; VITAMIN B COMPLEX; VITAMIN D [VITAMIN D NOS]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (Jun2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information:Rebound Covid case 8 days after tested negative following Paxlovid treatment  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech: Dose Number: 3; rebound covid 19 positive binaxnow test after receiving paxlovid; Pfizer / BioNTech: Dose Number: 3; rebound covid 19 positive binaxnow test after receiving paxlovid; This is a spontaneous report received from contactable reporter(s) (Nurse).  An 100-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2022 as dose 3 (booster), single (Lot number: FM0698) at the age of 100 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 14Jun2022 as dose 1, single (Batch/Lot number: unknown) and on 18Jun2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "Pfizer / BioNTech: Dose Number: 3; rebound covid 19 positive binaxnow test after receiving paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) positive, notes: Patient had rebound covid 19 positive binaxnow test after receiving paxlovid 300 mg. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that, No known drug allergy. Patient had rebound covid 19 positive binaxnow test after receiving paxlovid 300 mg. Other medication in 2weeks was None.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2022 as dose 3 (booster), single (Lot number: EL9267) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). 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". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient had no other medication in 2 weeks since vaccination. Patient received treatment with Paxlovid from 10Jun2022 till Jun2022  No follow-up attempts are possible. No further information is expected.
Age: 51.0
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) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 09:45 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Oct2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY taken for hypersensitivity, start date: 31Dec2021; MUCINEX, start date: 08May2022, stop date: 09Jun2022; VITAMIN C, start date: 31Dec2021; ZINC, start date: 31Dec2021. 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: (unspecified date) Unknown Results; (May2022) Negative, notes: I tested negative on day 7, 2 days after the dose of Plavoxid ended; (May2022) Positive, notes: On day 13, I took another test as symptoms were persisting and I tested positive 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.
Age: 68.0
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) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2021 as dose 1, single (Lot number: EW0178), in left arm and on 23May2021 as dose 2, single (Lot number: EW0167) at the age of 68 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), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: I contracted Covid again. Therapeutic measures were taken as a result of vaccination failure, covid-19.Patient had started taking Paxlovid on 24Apr2022  for the treatment of COVID 19 and stopped on 28Apr2022  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: Ew0151), in left arm, on 21Apr2021 as dose 2, single (Lot number: Ew0165), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: Ff2587), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: Fj4989) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension. Concomitant medication(s) included: AMLODIPINE; LISOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: It was reported that, patient took Paxlovid from 14Jun2022 to 18Jun2022 for COVID 19 Treatment. Adverse event reported as Rebound of Covid symptoms after taking Paxlovid on 26Jun2022 at 12:00 PM and the events were recovering and no treatment for AE. Patient had no known allergies.
Age: 100.0
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 contactable reporter(s) (Nurse).  An 101-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 100 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: "known allergies Penicillin" (unspecified if ongoing), notes: known allergies Penicillin. The patient's concomitant medications were not reported. Past drug history included: Phenergan, reaction(s): "Drug Allergy:Phenergan".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; positive, notes: rebound positive covid 19 test via binaxnow, placed back on covid 19 isolation precautions and quarantine. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received paxlovid 300 mg oral treatment start date 09Jun2022, treatment stop date13Jun2022, Indication for Treatment of COVID-19, and had rebound positive covid 19 test via binaxnow, placed back on covid 19 isolation precautions and quarantine. ; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Loss of consciousness, Neck pain, Pain
Clinical narrative: unconscious; fell down and hit bench; pain behind the neck/tried to move neck around in any direction, it would hurt; pain when moving the leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 17-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2022 at 09:00 as dose 3 (booster), single (Lot number: F51614) at the age of 17 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose, Lot EW973 or 0173, expiration is unknown, injected in left arm), administration date: 17May2021, when the patient was 17-year-old, for COVID-19 Immunization; BNT162b2 (2nd dose, Lot EW0196, injected in left arm, expiration is unknown), administration date: 21Jun2021, when the patient was 17-year-old, for COVID-19 Immunization. The following information was reported: FALL (non-serious) with onset 16Jan2022, outcome "recovered" (2022), described as "fell down and hit bench"; NECK PAIN (non-serious) with onset 16Jan2022, outcome "not recovered", described as "pain behind the neck/tried to move neck around in any direction, it would hurt"; LOSS OF CONSCIOUSNESS (medically significant) with onset 16Jan2022, outcome "unknown", described as "unconscious"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "pain when moving the leg". The events "unconscious", "fell down and hit bench", "pain behind the neck/tried to move neck around in any direction, it would hurt" and "pain when moving the leg" required physician office visit and emergency room visit. Clinical course: The consumer's son received booster dose of the Pfizer COVID 19 vaccine on 16Jan2022, from Pharmacy and after his son received it, he fell down and hit bench. It was behind the cabinet and his son was brought to the hospital; however, insurance only covered half of the hospital bill. He thought would cover it and they would not. They called the ambulance, and he was taken to the hospital where he spent 2 1/2 hours and was released. When he hit bench, he got pain behind the neck. After a while, he was feeling better, and the muscle was better. At this moment he did not have any lasting effects. Around 1 month, pain when moving the leg. His son came on the line and clarified. He was not sure what happened, he was unconscious. When he tried to move neck around in any direction, it would hurt. Around 1 month after, he was still having pain in the neck not the leg. AE(s) require a visit to Emergency Room. They called ambulance 911 and the ambulance came. He did not know what medical treatment was offered, but he just had the hospital bill. AE(s) require a visit to Physician Office. After 1 month, went to family physician. No treatment offered. At the time, he said he was ok. The patient was not hospitalized. No family Medical History Relevant to AE(s).
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dyspnoea, Electrocardiogram, Fall, Heart rate decreased
Clinical narrative: unconscious; fell down and hit bench; pain behind the neck/tried to move neck around in any direction, it would hurt; pain when moving the leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 17-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2022 at 09:00 as dose 3 (booster), single (Lot number: F51614) at the age of 17 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose, Lot EW973 or 0173, expiration is unknown, injected in left arm), administration date: 17May2021, when the patient was 17-year-old, for COVID-19 Immunization; BNT162b2 (2nd dose, Lot EW0196, injected in left arm, expiration is unknown), administration date: 21Jun2021, when the patient was 17-year-old, for COVID-19 Immunization. The following information was reported: FALL (non-serious) with onset 16Jan2022, outcome "recovered" (2022), described as "fell down and hit bench"; NECK PAIN (non-serious) with onset 16Jan2022, outcome "not recovered", described as "pain behind the neck/tried to move neck around in any direction, it would hurt"; LOSS OF CONSCIOUSNESS (medically significant) with onset 16Jan2022, outcome "unknown", described as "unconscious"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "pain when moving the leg". The events "unconscious", "fell down and hit bench", "pain behind the neck/tried to move neck around in any direction, it would hurt" and "pain when moving the leg" required physician office visit and emergency room visit. Clinical course: The consumer's son received booster dose of the Pfizer COVID 19 vaccine on 16Jan2022, from Pharmacy and after his son received it, he fell down and hit bench. It was behind the cabinet and his son was brought to the hospital; however, insurance only covered half of the hospital bill. He thought would cover it and they would not. They called the ambulance, and he was taken to the hospital where he spent 2 1/2 hours and was released. When he hit bench, he got pain behind the neck. After a while, he was feeling better, and the muscle was better. At this moment he did not have any lasting effects. Around 1 month, pain when moving the leg. His son came on the line and clarified. He was not sure what happened, he was unconscious. When he tried to move neck around in any direction, it would hurt. Around 1 month after, he was still having pain in the neck not the leg. AE(s) require a visit to Emergency Room. They called ambulance 911 and the ambulance came. He did not know what medical treatment was offered, but he just had the hospital bill. AE(s) require a visit to Physician Office. After 1 month, went to family physician. No treatment offered. At the time, he said he was ok. The patient was not hospitalized. No family Medical History Relevant to AE(s).
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Neck pain, Pain, Vision blurred
Clinical narrative: unconscious; fell down and hit bench; pain behind the neck/tried to move neck around in any direction, it would hurt; pain when moving the leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A 17-year-old male patient received BNT162b2 (BNT162B2), on 16Jan2022 at 09:00 as dose 3 (booster), single (Lot number: F51614) at the age of 17 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose, Lot EW973 or 0173, expiration is unknown, injected in left arm), administration date: 17May2021, when the patient was 17-year-old, for COVID-19 Immunization; BNT162b2 (2nd dose, Lot EW0196, injected in left arm, expiration is unknown), administration date: 21Jun2021, when the patient was 17-year-old, for COVID-19 Immunization. The following information was reported: FALL (non-serious) with onset 16Jan2022, outcome "recovered" (2022), described as "fell down and hit bench"; NECK PAIN (non-serious) with onset 16Jan2022, outcome "not recovered", described as "pain behind the neck/tried to move neck around in any direction, it would hurt"; LOSS OF CONSCIOUSNESS (medically significant) with onset 16Jan2022, outcome "unknown", described as "unconscious"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "pain when moving the leg". The events "unconscious", "fell down and hit bench", "pain behind the neck/tried to move neck around in any direction, it would hurt" and "pain when moving the leg" required physician office visit and emergency room visit. Clinical course: The consumer's son received booster dose of the Pfizer COVID 19 vaccine on 16Jan2022, from Pharmacy and after his son received it, he fell down and hit bench. It was behind the cabinet and his son was brought to the hospital; however, insurance only covered half of the hospital bill. He thought would cover it and they would not. They called the ambulance, and he was taken to the hospital where he spent 2 1/2 hours and was released. When he hit bench, he got pain behind the neck. After a while, he was feeling better, and the muscle was better. At this moment he did not have any lasting effects. Around 1 month, pain when moving the leg. His son came on the line and clarified. He was not sure what happened, he was unconscious. When he tried to move neck around in any direction, it would hurt. Around 1 month after, he was still having pain in the neck not the leg. AE(s) require a visit to Emergency Room. They called ambulance 911 and the ambulance came. He did not know what medical treatment was offered, but he just had the hospital bill. AE(s) require a visit to Physician Office. After 1 month, went to family physician. No treatment offered. At the time, he said he was ok. The patient was not hospitalized. No family Medical History Relevant to AE(s).
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 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 included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR, start date: 31Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was not pregnant. Other medication in 2weeks reported as yes. Anti-viral details: covid 19 treatment start date was 19jun2022 and stop date was 23jun2022. Adverse event was rebound on day 12. Positive test. Mild headache and body aches. Congestion and coughing. Mild fatigue. Adverse events start date was 29jun2022. Patient was not recovered. Treatment ae and known allergies were reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EWO162), in left arm, on 29Apr2021 as dose 2, single (Lot number: EWO165), in left arm and on 15Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 32 years, in right arm for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "exercise-induced asthma" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Sulfa Drugs" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs. Concomitant medication(s) included: SERTRALINE, start date: Jul2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medication in 2 weeks of vaccination, Sertraline, brand: Au-robindo, start date: Jul2018. Rebound case of Covid-19 5 days after completion of Paxlovid course. Anti-viral for COVID 19 Treatment was Paxlovid, Treatment start date was 19Jun2022 and Treat-ment stop date was 24Jun2022. Patient known allergies: sulfa drugs and other medical history: de-pression, anxiety, exercise-induced asthma, high cholesterol.  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: tested positive on 21Jun2022/ her son had all of the Pfizer covid vaccines/ had four booster all of the Pfizer covid vaccine; tested positive on 21Jun2022/ her son had all of the Pfizer covid vaccines/ had four booster all of the Pfizer covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 18-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2022, outcome "unknown" and all described as "tested positive on 21Jun2022/ her son had all of the Pfizer covid vaccines/ had four booster all of the Pfizer covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Positive.  Clinical course: Reporter Stated her son tested positive on 21Jun2022; he is age 18 and does not know legally whether or not she would report on him, declined report and states her son is protective about his health information. Stated her son had all of the Pfizer covid vaccines and does not have the lots, dates, expiry dates, or NDC numbers of his Pfizer covid vaccines to provide as that information is not with her and is in her son's wallet. Caller stated she is assuming he can go online to report this. Her son who lives with her and is age 18 has ulcerative colitis and he is considered mildly immunosuppressive and had four booster all of the Pfizer covid vaccine.  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: Body mass index, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: fully vaccinated and boosted with mRNA vaccine who tested positive for COVID-19; fully vaccinated and boosted with mRNA vaccine who tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the parent.  A 23-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing), notes: obese. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "fully vaccinated and boosted with mRNA vaccine who tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: Body mass index: >35; SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient obese (BMI >35), fully vaccinated and boosted with mRNA vaccine who tested positive for COVID-19 and went to a test-to-treat site for therapy. Was prescribed Paxlovid but stopped taking after 4 days due to metallic taste.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody 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 55-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 14Apr2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022 at 18:00, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown results, notes: 4 days after taking the full course of Paxlovid, most of my COVID symptoms returned. 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: vaccination failure; COVID 19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 22Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "celiac" (unspecified if ongoing); "hypertriglyceremia" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; JARDIANCE; FENOFIBRATE; ATORVASTATIN; TOUJEO; PRANDIN; WELLBUTRIN; ALLEGRA; OMEPRAZOLE. Past drug history included: Nickel, reaction(s): "Known allergies: nickel". The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) negative; (2022) positive; (unspecified date) Unknown result. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Rebound Covid on day 10 of initial isolation. 4 days after completing Paxlovid. Have negative antigen test on day 9. Day 10 developed mild symptoms and tested positive on antigen test. Other medication in 2 weeks product included Metformin, Jardiance, Fenofibrate, Atorvastatin, Toujeo, Prandin, Wellbutrin, Allegra and Omeprazole.   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 provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 27.0
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) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 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: "Asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies:Yes" (unspecified if ongoing), notes: Known allergies:Yes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Dec2021 at 12:00, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (29Jun2022) Positive, notes: Took a at home test and was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient no Other medication in 2weeks.The treatment medications Paxlovid on start date 16Jun2022 and stop date 20Jun2022.The Dose 3 Vaccine administration date 11Dec2021 12:00 PM and vaccine location left arm and Lot was unknown. The Adverse event were Woke up with stuffy nose and tired, just felt off. Took a at home test and was positive reported. The AE start date 29Jun2022 12:00AM patient recovered- Recovering. The Known allergies Other medical history- Asthma, anxiety were reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Neuropathy peripheral, Scan
Clinical narrative: Since her last scan she started to complain about neuropathy pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 19Sep2021 as dose 3 (booster), single (Lot number: 7485) at the age of 81 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Lung Cancer" (unspecified if ongoing); "Thyroid" (unspecified if ongoing), notes: Levothyroxine for her thyroid. Levothyroxine 112 mg; "Allergies" (unspecified if ongoing); "Compromised immune status" (unspecified if ongoing); "Respiratory illness" (unspecified if ongoing); "Genetic/chromosomal abnormalities" (unspecified if ongoing); "Endocrine abnormalities (including diabetes)" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: TAGRISSO taken for neoplasm malignant; LEVOTHYROXINE taken for thyroid therapy. Vaccination history included: BNT162b2 (First vaccine, Lot: EL9267, Time given: 9:15 Morning, She said whatever was required and they put a needle in her.  Anatomical Location: Left arm and she said she was driving.), administration date: 19Feb2021, when the patient was 80-year-old, for COVID-19 immunization; BNT162b2 (Second vaccine, Lot: EN6207, Time given: 9:15 morning, Anatomical Location: Right arm and she was not driving), administration date: 12Mar2021, when the patient was 80-year-old, for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Since her last scan she started to complain about neuropathy pain". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results, notes: They did special blood work and there will be no results for 6 to 7 days; Scan: (28Jun2022) 3 month scans the new spots showed up. Therapeutic measures were taken as a result of neuropathy peripheral.  Clinical information: The patient also received Covid-19 fourth vaccine (Lot: FP4554) on 13Apr2022 in the afternoon for COVID -19 immunisation. The patient cannot remember if the right or left arm because she was driving, she received at arm. The patient did not administer any additional Vaccines on Same Date of the Pfizer Suspect. The patient did not receive any prior vaccinations within 4 weeks to the first administration date of the suspect vaccine. The patient don't go to the doctor except of scans every 3 months and if she goes to doctor is for something silly like an ingrown toe nail and goes to podiatrist. The patient had other relatives that had cancer but not lung. She said she is a cancer patient and she said lung cancer for 8 years next month.  She has been stable and only taking Tagrisso.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Ingrowing nail
Clinical narrative: Since her last scan she started to complain about neuropathy pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), on 19Sep2021 as dose 3 (booster), single (Lot number: 7485) at the age of 81 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Lung Cancer" (unspecified if ongoing); "Thyroid" (unspecified if ongoing), notes: Levothyroxine for her thyroid. Levothyroxine 112 mg; "Allergies" (unspecified if ongoing); "Compromised immune status" (unspecified if ongoing); "Respiratory illness" (unspecified if ongoing); "Genetic/chromosomal abnormalities" (unspecified if ongoing); "Endocrine abnormalities (including diabetes)" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: TAGRISSO taken for neoplasm malignant; LEVOTHYROXINE taken for thyroid therapy. Vaccination history included: BNT162b2 (First vaccine, Lot: EL9267, Time given: 9:15 Morning, She said whatever was required and they put a needle in her.  Anatomical Location: Left arm and she said she was driving.), administration date: 19Feb2021, when the patient was 80-year-old, for COVID-19 immunization; BNT162b2 (Second vaccine, Lot: EN6207, Time given: 9:15 morning, Anatomical Location: Right arm and she was not driving), administration date: 12Mar2021, when the patient was 80-year-old, for COVID-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Since her last scan she started to complain about neuropathy pain". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results, notes: They did special blood work and there will be no results for 6 to 7 days; Scan: (28Jun2022) 3 month scans the new spots showed up. Therapeutic measures were taken as a result of neuropathy peripheral.  Clinical information: The patient also received Covid-19 fourth vaccine (Lot: FP4554) on 13Apr2022 in the afternoon for COVID -19 immunisation. The patient cannot remember if the right or left arm because she was driving, she received at arm. The patient did not administer any additional Vaccines on Same Date of the Pfizer Suspect. The patient did not receive any prior vaccinations within 4 weeks to the first administration date of the suspect vaccine. The patient don't go to the doctor except of scans every 3 months and if she goes to doctor is for something silly like an ingrown toe nail and goes to podiatrist. The patient had other relatives that had cancer but not lung. She said she is a cancer patient and she said lung cancer for 8 years next month.  She has been stable and only taking Tagrisso.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing), notes: Other medical history: Migraine; "Known allergies: Eye numbing drops" (unspecified if ongoing), notes: Known allergies: Eye numbing drops. Concomitant medication(s) included: TOPIRAMATE, start date: Nov2021; FAMOTIDINE, start date: Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: She took topiramate 50mg daily for migraine headache prevention. At first she had lots of side effects from topiramate, which went away after several months. While she took Paxlovid the side effects came roaring back: paresthesia, brain fog, word-finding difficulties. They stopped after the Paxlovid course ended. She was on other medication in 2 weeks.  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: 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 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown), on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; AVIANE; SINGULAIR; ZYRTEC ALLERGY. Past drug history included: Ceclor, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid rebound 5 days after finishing Paxlovid and 3 days after a negative test result; Negative, notes: Covid rebound 5 days after finishing Paxlovid and 3 days after a negative test result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included yes patient received other medication in 2weeks. Covid rebound 5 days after finishing Paxlovid and 3 days after a negative test result. Other medical history: Psoriasis, asthma.  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 contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, solution for injection), on 06Jan2021 as dose 1, single (Lot number: EK9231), in right arm, on 27Jan2021 as dose 2, single (Lot number: EL3247), in right arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FF2587), in right arm and on 28Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: Other medical history: History of breast cancer. Psoriasis. Gluten Intolerance.; "Psoriasis" (unspecified if ongoing), notes: Other medical history: History of breast cancer. Psoriasis. Gluten Intolerance.; "Gluten Intolerance" (unspecified if ongoing), notes: Other medical history: History of breast cancer. Psoriasis. Gluten Intolerance. Concomitant medication(s) included: LETROZOLE, start date: 07Apr2020; ATENOLOL.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 18Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Positive, notes: Symptoms more severe than first round of Covid (18Jun2022); (26Jun2022) Positive, notes: Symptoms returned 6/26/2022 with positive antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: It was reported that, the patient received vaccine. Received other medication in 2weeks. Covid Rebound after finishing Paxlovid RX. Finished on 22jun2022. Symptoms returned 26Jun2022 with positive antigen test. Symptoms more severe than first round of Covid (18Jun2022). Had Known allergies.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech: Dose Number: 3; positive Covid; Pfizer / BioNTech: Dose Number: 3; positive Covid; 35 weeks pregnant; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 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: "Known Allergies: Pecans and walnuts" (unspecified if ongoing). The patient was 35 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 28Jul2022. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (Jun2022) and all described as "Pfizer / BioNTech: Dose Number: 3; positive Covid"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "35 weeks pregnant". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Developed new Covid symptoms and positive Covid antigens test 18 days after first infection. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.