chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of 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 16-year-old male patient received BNT162b2 (BNT162B2), on 09Jan2022 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 15 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Treatment of COVID-19"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Acute kidney injury, Death, Dementia, Investigation
Clinical narrative: He died on the 11May; I would say may be a week or two later his dementia got a lot worse; Acute renal failure; He started developing twitches, big twitches; He started acting strange; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ6369), in arm for covid-19 immunisation. The patient's relevant medical history included: "He had an underlying neurologic disease that's called Cadasil" (unspecified if ongoing), notes: he had an underlying neurologic disease that's called Cadasil. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization; Bnt162b2 (Dose 2, single), for COVID-19 Immunization; Bnt162b2 (Dose 3 (Booster), single), for COVID-19 Immunization. The following information was reported: ACUTE KIDNEY INJURY (medically significant) with onset 05Feb2021, outcome "unknown", described as "Acute renal failure"; ABNORMAL BEHAVIOUR (non-serious) with onset 05Feb2021, outcome "unknown", described as "He started acting strange"; MUSCLE TWITCHING (non-serious) with onset 05Feb2021, outcome "unknown", described as "He started developing twitches, big twitches"; DEMENTIA (medically significant) with onset 05Feb2021, outcome "unknown", described as "I would say may be a week or two later his dementia got a lot worse"; DEATH (death) with onset 11May2022, outcome "fatal", described as "He died on the 11May". The events "i would say may be a week or two later his dementia got a lot worse", "acute renal failure", "he started developing twitches, big twitches" and "he started acting strange" required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab Work: Unknown results, notes: Doctor stated, He had a lot of it at the hospital. Therapeutic measures were not taken as a result of dementia, acute kidney injury, muscle twitching, abnormal behaviour. The patient date of death was 11May2022. The reported cause of death was unknown. No autopsy was performed.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events death, dementia, acute kidney injury and the use of suspect product BNT162B2 cannot be fully excluded. 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.; Reported Cause(s) of Death: He died on the 11May
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: He died on the 11May; I would say may be a week or two later his dementia got a lot worse; Acute renal failure; He started developing twitches, big twitches; He started acting strange; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: FJ6369), in arm for covid-19 immunisation. The patient's relevant medical history included: "He had an underlying neurologic disease that's called Cadasil" (unspecified if ongoing), notes: he had an underlying neurologic disease that's called Cadasil. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization; Bnt162b2 (Dose 2, single), for COVID-19 Immunization; Bnt162b2 (Dose 3 (Booster), single), for COVID-19 Immunization. The following information was reported: ACUTE KIDNEY INJURY (medically significant) with onset 05Feb2021, outcome "unknown", described as "Acute renal failure"; ABNORMAL BEHAVIOUR (non-serious) with onset 05Feb2021, outcome "unknown", described as "He started acting strange"; MUSCLE TWITCHING (non-serious) with onset 05Feb2021, outcome "unknown", described as "He started developing twitches, big twitches"; DEMENTIA (medically significant) with onset 05Feb2021, outcome "unknown", described as "I would say may be a week or two later his dementia got a lot worse"; DEATH (death) with onset 11May2022, outcome "fatal", described as "He died on the 11May". The events "i would say may be a week or two later his dementia got a lot worse", "acute renal failure", "he started developing twitches, big twitches" and "he started acting strange" required emergency room visit. The patient underwent the following laboratory tests and procedures: Lab Work: Unknown results, notes: Doctor stated, He had a lot of it at the hospital. Therapeutic measures were not taken as a result of dementia, acute kidney injury, muscle twitching, abnormal behaviour. The patient date of death was 11May2022. The reported cause of death was unknown. No autopsy was performed.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events death, dementia, acute kidney injury and the use of suspect product BNT162B2 cannot be fully excluded. 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.; Reported Cause(s) of Death: He died on the 11May
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She had covid in may 2020 and got covid this year after 3 pfizer shots; She had covid in may 2020 and got covid this year after 3 pfizer shots; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 43-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 was not reported. The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Allergies: Codeine"; Ibuprofen, reaction(s): "Allergies: Ibuprofen"; Lactose, reaction(s): "Allergies: Lactose"; Norco, reaction(s): "Allergies: Norco"; Vancomycin, reaction(s): "Allergies: Vancomycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had covid in may 2020 and got covid this year after 3 pfizer shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2020) Positive; (19May2022) Positive. Clinical course: patient states she had covid on May 19 and had to stop RA meds for 5 days. Patient states she had sinus pain, headache and fatigue during that time. Doctor aware. Patient also states she had covid in May 2020 and got covid this year after 3 Pfizer shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia, Rash, Swelling
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 59-year-old female patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EW0150) at the age of 58 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "thyroid condition", start date: 2016 (ongoing), notes: States she does have a thyroid condition. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Fever"; RASH (non-serious) with onset Apr2021, outcome "recovered" (Apr2021); PAIN (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Severe pain/would say joint pain but the pain was everywhere and not just the joints"; SWELLING (non-serious) with onset Apr2021, outcome "recovered" (Apr2021); LYMPHADENOPATHY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Swollen lymph nodes". Therapeutic measures were not taken as a result of lymphadenopathy, pain, rash, swelling, pyrexia.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller has had 3 doses of the Pfizer COVID 19 vaccine, tested positive for COVID 19 2 days ago; Caller has had 3 doses of the Pfizer COVID 19 vaccine, tested positive for COVID 19 2 days ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: I have Gerd and take famotidine; "Hiatal hernia" (unspecified if ongoing), notes: I have hiatal hernia. Concomitant medication(s) included: FAMOTIDINE taken for gastrooesophageal reflux disease. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022, outcome "unknown" and all described as "Caller has had 3 doses of the Pfizer COVID 19 vaccine, tested positive for COVID 19 2 days ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Positive, notes: Tested positive for COVID 19 2 days ago. 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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 11Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 19Jun2022, treatment stop date: 20Jun2022, 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.
Age: 37.0
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) (Physician).  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown whether the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: product=COVID 19 Treatment, Treatment start date- 08May2022, Treatment stop date-13May2022. Reported Event: Covid rebound - tested positive on 20Jun2022. If patient recovered was recovering. If treatment ae was no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Age: 34.0
Sex: M
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-healthcare professional). The reporter is the patient.   A 36-year-old male patient received BNT162b2 (BNT162B2, Solution for injection), on 28Apr2021 as dose 2, single (Batch/Lot number: unknown, Misplaced/discarded, Expiration date: Unknown) at the age of 34 years, in right arm for COVID-19 immunization; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown, Misplaced/discarded, Expiration date: Unknown), in right arm for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown, Expiration date: Unknown) for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Other medication in 2 weeks included None. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient had Covid Rebound symptoms which tested negative on 20Jun2022 and positive again on 22Jun2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Treatment of COVID-19; (20Jun2022) Negative, notes: tested negative on 20Jun2022; (22Jun2022) Positive, notes: positive again on 22Jun2022. Therapeutic measures were taken as a result of drug ineffective and COVID-19 included Paxlovid from 05Jun2022 to 09Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
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 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 at 12:00 as dose 1, single (Lot number: En6202), in left arm, on 15Mar2021 at 13:00 as dose 2, single (Lot number: En6207), in left arm and on 26Dec2021 at 11:00 as dose 3 (booster), single (Lot number: F00809) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (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: (21Jun2022) Negative; (22Jun2022) Positive, notes: took two home tests, both positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: The patient was an adult. Patient received other medications in 2 weeks. Patient received treatment for Covid-19 with Paxlovid from 13Jun2022 to 17Jun2022. Adverse event: Last dose of Paxlovid taken Saturday 18Jun2022. Tested negative and felt better on Tuesday 21Jun2022. Woke up congested and achy, with stomach issues, on Wednesday 22Jun2022, took two home tests, both positive and one at urgent care. The events were started on 21Jun2022 at 06:00 AM; the patient not received treatment and outcome of the event was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), first regimen at single (dose 2, single) and second regimen at single (dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: MELATONIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid Treatment start date: 17Jun2022, Treatment stop date: 21Jun2022, Lot number: 1914705A.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 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: "Ankilosing Spondylitis" (unspecified if ongoing), notes: Ankilosing Spondylitis- NOT on, immuno supppresant medications. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; NALTREXONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OMEPRAZOLE; LIVALO; ZETIA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course:  Anti-viral details: Product is COVID 19 treatment, Brand is Plaxlovid, Treatment start date is 11Jun2022, Treatment stop date is 16Jun2022, Indication was Treatment of COVID-19     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for COVID; Positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Oct2021 as dose 3 (booster), single (Lot number: Fh8020) at the age of 23 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 08Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Possible tuberculosis" (unspecified if ongoing), notes: was treated for 6months. Concomitant medication(s) included: AZITHROMYCIN, start date: 16Jun2022, stop date: 20Jun2022; BENZONATATE, start date: 15Jun2022, stop date: 21Jun2022. Past drug history included: Ceclor, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The patient received treatment of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pfizer / BioNTech: Dose Number: 3; Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 3; 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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 at 17:00 as dose 3 (booster), single (Lot number: FO3527) at the age of 65 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: "No" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE, start date: 31Dec2019; AREDS (Brand name: Bausch lomb), start date: 31Dec2019.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 3; Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID-19 treatment with anti-viral (start date: 21Jun2022).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech : Dose Number: 1, 2, 3; COVID 19 Treatment; Pfizer / BioNTech : Dose Number: 1, 2, 3; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: En6205), on 05Apr2021 as dose 2, single (Lot number: Er8732) and on 14Feb2022 as dose 3 (booster), single (Lot number: Fk9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Other medication in two weeks: No.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "recovered" (17Jun2022) and all described as "Pfizer / BioNTech : Dose Number: 1, 2, 3; COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Positive, notes: I took a covid test June 10 was positive; (17Jun2022) Negative, notes: Retested June 17 was negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer / BioNTech: Dose Number: 4; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 4; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 23Sep2021 at 11:00 as dose 4 (booster), single (Lot number: 439199), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. 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 "Pfizer / BioNTech: Dose Number: 4; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (22Jun2022) Positive, notes: Home test. Therapeutic measures were taken as a result of drug ineffective,  covid-19.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of COVID-19 ,drug ineffective.
Age: 63.0
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 63-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sleep apnea w" (unspecified if ongoing), notes: sleep apnea w/CPAP. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (vaccine lot number=FF8839, vaccine dose number=3, vaccine location=Left arm), administration date: 08Dec2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (vaccine lot number=EI3302, vaccine dose number=2, vaccine location=Left arm), administration date: 22Apr2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (vaccine lot number=EN5318, vaccine dose number=1, vaccine location=Left arm), administration date: 29Mar2021, when the patient was 61-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jun2022, outcome "recovering" and all described as "Treatment of COVID-19";. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19.  Symptoms include cough, sore throat, congestion, running nose, fatigue and light-headedness.; Tested positive for Covid-19.  Symptoms include cough, sore throat, congestion, running nose, fatigue and light-headedness.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3248), on 22Mar2021 as dose 2, single (Lot number: EL3248) and on 01Dec2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 42 years 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) all with onset 21Jun2022, outcome "recovering" and all described as "Tested positive for Covid-19.  Symptoms include cough, sore throat, congestion, running nose, fatigue and light-headedness.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Positive, notes: Nasal. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Addition information: Known allergies was none. Other vaccine in four weeks was none. Covid prior vaccination was none. Covid tested post vaccination.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Symptomatic for Covid-19 (congestion, aching joints, fever, chills/overheating). Tested positive for covid the following morning (on 22Jun2022, at approximately 5am) via at-home antigen test.; Symptomatic for Covid-19 (congestion, aching joints, fever, chills/overheating). Tested positive for covid the following morning (on 22Jun2022, at approximately 5am) via at-home antigen test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3248), on 23Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 19Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 33 years, in right arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. There were no concomitant medications. The patient did not receive any other vaccine in four weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 21Jun2022, outcome "not recovered" and all described as "Symptomatic for Covid-19 (congestion, aching joints, fever, chills/overheating). Tested positive for covid the following morning (on 22Jun2022, at approximately 5am) via at-home antigen test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) positive; (21Jun2022) Positive. Therapeutic measures were not taken as a result of covid-19.  Clinical course: It was reported that symptomatic for Covid-19 (congestion, aching joints, fever, chills/overheating). Tested positive for covid the following morning (on 22Jun2022, at approximately 5am) via at-home antigen test.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Joint swelling, Joint warmth
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 as dose 3 (booster) , single (Lot number: FD0809) at the age of 62 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "lichen sclerosis et atrophicus" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "atrophic vaginitis" (unspecified if ongoing); "penicillin" (unspecified if ongoing), notes: known allergies: dairy, codeine, penicillin, scallops; "scallops" (unspecified if ongoing), notes: known allergies: dairy, codeine, penicillin, scallops; "known allergies: dairy" (unspecified if ongoing), notes: known allergies: dairy. Concomitant medication(s) included: COMBIPATCH; CLOBETASOL; METRONIDAZOLE; VIT D [VITAMIN D NOS]; CALCIUM; PATANOL. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: dairy, codeine, penicillin, scallops. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious) with onset 16Jun2022 at 03:00, outcome "unknown", described as "joint motion limitation"; JOINT SWELLING (non-serious), JOINT WARMTH (non-serious) all with onset 16Jun2022 at 03:00, outcome "unknown" and all described as "joints very painful, hot, swollen"; ARTHRALGIA (non-serious) with onset 16Jun2022 at 03:00, outcome "unknown", described as "severe arthralgia/ joints very painful". The events "severe arthralgia/ joints very painful", "joint motion limitation" and "joints very painful, hot, swollen" required physician office visit. Therapeutic measures were not taken as a result of arthralgia, joint range of motion decreased, joint swelling, joint warmth. Additional information: No other vaccine in four weeks: No If other vaccine in four weeks. No covid tested prior or post vaccination. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202200887057 Same patient and drug, different event;
Age: 59.0
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 at 10:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 at 10:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 10Oct2021 at 12:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 28Mar2022 at 12:00 as dose 4 (booster), single (Lot number: AC9895) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic inflammation" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". 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: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Start date of treatment for COVID-19 was 13Jun2022. Stop date of treatment for COVID-19 was 17Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2021 as dose 1, single (Lot number: EW0170), on 27May2021 as dose 2, single (Lot number: EW0182), in right arm and on 27Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 12Nov2019, stop date: 05Jun2022. 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) Unknown results, notes: Treatment of COVID-19; (13Jun2022) Negative, notes: Tested negative on a home test on 13Jun2022; (21Jun2022) Positive, notes: Took home test on 21Jun2022 and tested positive; (22Jun2022) Positive, notes: Same result on 22Jun2022 from NAAT test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Known allergy was none. Start date of treatment for COVID-19 was 06Jun2022. Stop date of treatment for COVID-19 was 10Jun2022.
Age: 28.0
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 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FF8020) at the age of 28 years for COVID-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Lot number: 013M20A), in left arm and on 11Mar2021 as dose 2, single (Lot number: 011A21A), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing), notes: Other medical history: Type 1 Diabetes. Concomitant medication(s) included: HUMALOG; ADVIL [IBUPROFEN], start date: 05Jun2022, stop date: 08Jun2022. Past drug history included: Ceclor for Known allergies: Ceclor. 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: antigen test: (unspecified date) positive, notes: Day 13 (today): Persistent cough and congestion and starting to feel very fatigued again. I am also experiencing an increased feeling of brain fog. I took an antigen test at home and it was just slightly darker than day 12 but not by much; (14Jun2022) positive, notes: Days 6-8: I was feeling significantly better because most of my symptoms had lightened up or disappeared completely. I took an antigen test at home on all three days and each test showed a very very faint positive; (15Jun2022) positive, notes: Days 6-8: I was feeling significantly better because most of my symptoms had lightened up or disappeared completely. I took an antigen test at home on all three days and each test showed a very very faint positive; (16Jun2022) positive, notes: Days 6-8: I was feeling significantly better because most of my symptoms had lightened up or disappeared completely. I took an antigen test at home on all three days and each test showed a very very faint positive; (20Jun2022) positive, notes: Day 12: I started to have a more persistent cough in addition to a runny nose. I took an antigen test at home and the positive mark was significantly darker than days 6-8. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Two days later I tested positive for Covid after cold like symptoms appeared/Sore throat, runny nose, and chills; Two days later I tested positive for Covid after cold like symptoms appeared/Sore throat, runny nose, and chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, brand: Pfizer), on 22Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6203), in right arm and on 14Dec2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 56 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "moderate high blood pressure" (unspecified if ongoing). Concomitant medication(s) (Other medications in two weeks) included: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE. No Covid prior vaccination. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2022 at 17:00, outcome "not recovered" and all described as "Two days later I tested positive for Covid after cold like symptoms appeared/Sore throat, runny nose, and chills". Clinical course as follows: Sore throat, runny nose, and chills after being exposed to her husband who tested positive for Covid. Two days later she tested positive for Covid after cold like symptoms appeared. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) positive, notes: Two days later I tested positive for Covid after cold like symptoms appeared; (22Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: General physical health deterioration, Immune system disorder, Peripheral nerve injury
Clinical narrative: I lost my nerves in feet by compromising my immune system; I lost my nerves in feet by compromising my immune system; I lost my health; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL NERVE INJURY (medically significant), IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown" and all described as "I lost my nerves in feet by compromising my immune system"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "I lost my health".  Additional information: The patient was super healthy and prancing for Triathlon. The patient took vaccines and lost health since and also lost his nerves in feet by compromising immune system.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Therapeutic product effect decreased
Clinical narrative: Experienced Humira quit working; Experienced flare after first vaccine for COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4434891-00 (Agency).  A 61-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, on 08Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 06Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE; PREDNISONE. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "Experienced flare after first vaccine for COVID"; THERAPEUTIC PRODUCT EFFECT DECREASED (medically significant), outcome "unknown", described as "Experienced Humira quit working". The action taken for adalimumab was unknown.  Additional information :On an unknown date, the patient experienced Humira quit working. In 2021, the patient experienced flare after first vaccine for COVID. Pfizer Biontech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "experienced humira quit working" and "experienced flare after first vaccine for covid" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's assessment of the causal relationship of "experienced humira quit working" and "experienced flare after first vaccine for covid" with the suspect product(s) Humira (Adalimumab) was Probable at the time of this report.  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 association between the events and suspect drug BNT162B2 cannot be excluded. 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.