chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Plasma cell myeloma, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 41-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 17Feb2021, when the patient was 39-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 28Jan2021, when the patient was 39-year-old, for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset 22Apr2022, outcome "unknown", described as "ST cough"; PLASMA CELL MYELOMA (medically significant) with onset 22Apr2022, outcome "unknown", described as "mm aches". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Apr2022) Positive, notes: Covid test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of plasma cell myeloma. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event plasma cell myeloma 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.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 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: "Asthma" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "celiac artery compression syndrome" (unspecified if ongoing); "Reaction: Allergy" (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 22Apr2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 with Paxlovid for treatment of COVID-19 (Batch/Lot number FT5400).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 37.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; 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-163-4365970-00 (Agency).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1157583) at 80 mg 1x/day (citrate free day 1 (1 in 1 d)), second regimen (Lot number: 115783) at 40 mg 1x/day (citrate free day 8 (1 in 1 d)) and third regimen (Lot number: 115783) at 40 mg (citrate free (40 mg,1 in 2 wk)), all subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2021, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: UNKNOWN. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid 19" 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and Suspected COVID - 19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: After 5-day course of Paxlovid I tested negative for COVID on Day 6/7.Continued to test negative until Day 12 when I tested positive again.; After 5-day course of Paxlovid I tested negative for COVID on Day 6/7.Continued to test negative until Day 12 when I tested positive again.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 39 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PAXLOVID taken for covid-19, start date: 13Apr2022, stop date: 18Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Apr2022 at 09:30, outcome "not recovered" and all described as "After 5-day course of Paxlovid I tested negative for COVID on Day 6/7.Continued to test negative until Day 12 when I tested positive again.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. No other medication in 2weeks. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknow, 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: BLINDNESS (medically significant), outcome "unknown", described as "slowly I lost my eyesight". Clinical course: I had your COVID vaccine and it was good but slowly I lost my eyesight. I don't know what should I do. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Near death experience, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the parent. A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "got omicron Covid"; NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "almost died". The patient underwent the following laboratory tests and procedures: Oxygen saturation: Unknown results, notes: Hospitalized on oxygen; SARS-CoV-2 test: Positive for omicron. Therapeutic measures were taken as a result of Covid-19. Clinical information: Patient consider the Pfizer product had a casual effect to adverse event(s). P.S Son (Name withheld) - had same two Pfizer vaccine and 3rd booster and got omicron Covid and hospitalized on oxygen and almost died. 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 available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of Covid-19 and drug ineffective is: expected. The case will be reassessed further upon receipt of additional information. Based on available information and the drug temporal relationship, the causality between the event "near death experience" and the suspect drug "BNT162B2" cannot be completely 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.
Sex: F
Vaccine: COVID19
Symptoms: Spinal operation
Clinical narrative: 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-163-4367626-00 (RA). A 67-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unknown (citrate free), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPINAL OPERATION (medically significant), outcome "unknown", described as "back surgery". The action taken for adalimumab was dosage permanently withdrawn. Clinical course: Solicited report by a consumer of an elderly female with an event of back surgery with Humira (Adalimumab). On an unknown date, the experienced back surgery. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient stopped Humira for back surgery. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Did event abate after stopping drug? Yes. Causality for Humira (Adalimumab): The reporter's causality for the event (s) of back surgery with Humira (Adalimumab) was a reasonable possibility. Causality as per reporter (Drug/Vaccine) of Humira (Solution For Injection In Pre-Filled Pen) (Adalimumab) for event Back surgery (Spinal operation) was Probable and of Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran) for event Back surgery (Spinal operation) was Possible. The reporter considered "back surgery" related to BNT162b2. 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 currently available, The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely 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.
Age: 67.0
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 at 14:30 as dose 3 (booster), single (Lot number: Ff2539) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, Dose Number: 1,2), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 21Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Apr2022) Negative, notes: I initially felt better and tested negative for Covid 19 on Tuesday 4/19/22; (21Apr2022) Positive, notes: tested positive for Covid 19 Thursday evening 4/21/22. Therapeutic measures were not taken as a result of covid-19. Clinical course: patient initially felt better and tested negative for Covid 19 on Tuesday 19Apr2022. Wednesday 20Apr2022 my symptoms returned and  tested positive for Covid 19. Thursday evening 21Apr22. Patient had not have any known allergy. And no other medication in 2weeks
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Off label use, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID; COVID; off label use; Dose 4 Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE], start date: Oct2009. Vaccination history included: Covid-19 vaccine (DOSE 1, 2 and 3 , Manufacturer Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 21Feb2022 at 12:00, outcome "unknown", described as "Dose 4 Booster"; OFF LABEL USE (medically significant) with onset 21Feb2022 at 12:00, outcome "unknown"; COVID-19 (medically significant) with onset 23Apr2022, outcome "recovering", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: began testing positive again on rapid covid test. Therapeutic measures were not taken as a result of immunisation, covid-19, off label use. Clinical course: On 15Apr2022 to 20Apr2022 (Lot No: fx4466), the patient was treated with Paxlovid for Covid-19. The patient had rebound of Covid symptoms after last dose of Paxlovid. Tested negative after antiviral treatment for 2 days then symptoms came back and began, testing positive again on rapid Covid test. Device timestamp was reported as, 25Apr2022.  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: Arrhythmia, Condition aggravated, Heart rate irregular, Palpitations
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 13:30 as dose 2, single (Lot number: EN6203) at the age of 68 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Mild PVCs" (unspecified if ongoing); "Mild PACs" (unspecified if ongoing); "Infrequent SVT" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Contrast dye" (unspecified if ongoing). The patient had mild PVCs, PACs and 3 occasions of SVT in the past 30 yrs. so on Acebutolol. Concomitant medication(s) included: ACEBUTOLOL; ALENDRONATE. Other medications in two weeks were Acebutolol, Alendronate. Vaccination history included: BNT162b2 (Dose:1, Dose administration time: 14:30, Vaccine location: Left arm, Lot number: EL9267), administration date: 11Feb2021, when the patient was 68-year-old, for Covid-19 immunization. Facility type vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient did not have Covid prior vaccination. The patient was not tested for Covid post vaccination. The following information was reported: CONDITION AGGRAVATED (medically significant), HEART RATE IRREGULAR (non-serious) all with onset Mar2021, outcome "recovering" and all described as "About 3 weeks after 2nd dose felt extreme increase in frequency, duration and intensity of arrhythmias"; ARRHYTHMIA (medically significant) with onset Mar2021, outcome "recovering", described as "About 3 weeks. After 2nd dose felt extreme increase in frequency, duration and intensity of arrhythmias"; PALPITATIONS (non-serious) with onset Mar2021, outcome "recovering", described as "Heart thumping kept me awake. Abated some by 6 months when I got 3rd. 15 days later it all started again. Abating some now but still more frequent and intense than before shots." The events "about 3 weeks after 2nd dose felt extreme increase in frequency, duration and intensity of arrhythmias", "about 3 weeks after 2nd dose felt extreme increase in frequency, duration and intensity of arrhythmias" and "heart thumping kept me awake. abated some by 6 months when I got 3rd. 15 days later it all started again. Abating some now but still more frequent and intense than before shots". Required physician office visit. Therapeutic measures were not taken as a result of arrhythmia, condition aggravated, palpitations, and heart rate irregular.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Confirmed case of covid 19; Confirmed case of covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 1, single (Lot number: FE3590) and in Dec2021 as dose 2, single (Lot number: FH8027) at the age of 13 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination. Covid tested post vaccination was reported as yes. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "Confirmed case of covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. An adolescent female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. Medical history included "a lot of allergies" (unspecified if ongoing). Concomitant medications not reported. The patient experienced illness/sickness, with outcome of unknown. Additional info: Patient had a violent reaction to the first two shots. The information on the batch/lot number for BNT162B2 requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: ill with Covid 19 virus; ill with Covid 19 virus; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "ill with Covid 19 virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Covid 19 virus, notes: has received 2 doses of Pfizer vaccine and booster. Became ill with Covid 19 virus. Clinical course: The patient became ill with COVID 19 virus. Symptoms included severe fatigue, cough, and loss of appetite. No underlying conditions. Patient was in good health.  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 current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the events Drug Ineffective and Coivd19 cannot be totally excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle swelling, Tendon rupture
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Aug2021 at 08:00 as dose 2, single (Lot number: EW0167) at the age of 62 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; MELOXICAM; DULOXETINE. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0164, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 10Aug2021, when the patient was 62-year-old, for Covid-19 Immunization. The following information was reported: MUSCLE SWELLING (disability), TENDON RUPTURE (disability) all with onset 20Jan2022 at 04:00, outcome "not recovered" and all described as "Torn deltoid tendon, resulting in "Popeye arm"". The event "torn deltoid tendon, resulting in "Popeye arm"" required physician office visit. Therapeutic measures were not taken as a result of muscle swelling, and tendon rupture. Clinical course: No other Vaccine in four weeks. Patient had no known allergies. Patient did not had Covid prior vaccination and not Covid tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive covid 19 case; positive covid 19 case; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Lot number: EP6955), in Apr2021 as dose 2, single (Lot number: EP6955) and in Dec2021 as dose 3 (booster), single (Lot number: FL3197) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 26Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "positive covid 19 case". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive.  Clinical course: It was reported to be non serious. Not resulted in death, was not life threatening, had not caused/prolonged hospitalization, was not caused Disabling/Incapacitating, had not resulted in anomaly/birth defect. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EP6955), on 07Apr2021 as dose 2, single (Lot number: EP6955) and on 22Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 44 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 25Apr2022, outcome "not recovered" and all described as "tested positive for covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: COVID test post vaccination COVID test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Device timestamp: 26Apr2022, no COVID prior vaccination. COVID was tested post vaccination.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 11-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Nov2021 as dose 1, single (Lot number: FK5127), in left arm and on 26Nov2021 as dose 2, single (Lot number: FK5127) at the age of 10 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "not recovered" and all described as "Tested positive for COVID". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not have COVID prior vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Electrocardiogram ST segment, Electrocardiogram ST segment normal, Nasal congestion, Nasopharyngitis
Clinical narrative: Ag test 25Apr positive; Ag test 25Apr positive; cold symptoms congestion; cold symptoms congestion; travel to NYC by plane returned 4/21, then cold sx congestion and ST started 4/23 then Ag test 4/25 positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 43-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL3247), on 23Feb2021 as dose 2, single (Lot number: EL3247) and on 19Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), NASAL CONGESTION (non-serious) all with onset 23Apr2022, outcome "recovering" and all described as "cold symptoms congestion"; ELECTROCARDIOGRAM ST SEGMENT NORMAL (non-serious) with onset 23Apr2022, outcome "recovering", described as "travel to NYC by plane returned 4/21, then cold sx congestion and ST started 4/23 then Ag test 4/25 positive"; VACCINATION FAILURE (medically significant) with onset 25Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 25Apr2022, outcome "recovering" and all described as "Ag test 25Apr positive". The patient underwent the following laboratory tests and procedures: Electrocardiogram ST segment: (23Apr2022) Unknown; SARS-CoV-2 test: (25Apr2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, nasopharyngitis, nasal congestion, electrocardiogram st segment normal.Clinical course: Unknown the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown the patient diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported events of vaccination failure,covid-19. 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
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Ag test 25Apr positive; Ag test 25Apr positive; cold symptoms congestion; cold symptoms congestion; travel to NYC by plane returned 4/21, then cold sx congestion and ST started 4/23 then Ag test 4/25 positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 43-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL3247), on 23Feb2021 as dose 2, single (Lot number: EL3247) and on 19Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), NASAL CONGESTION (non-serious) all with onset 23Apr2022, outcome "recovering" and all described as "cold symptoms congestion"; ELECTROCARDIOGRAM ST SEGMENT NORMAL (non-serious) with onset 23Apr2022, outcome "recovering", described as "travel to NYC by plane returned 4/21, then cold sx congestion and ST started 4/23 then Ag test 4/25 positive"; VACCINATION FAILURE (medically significant) with onset 25Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 25Apr2022, outcome "recovering" and all described as "Ag test 25Apr positive". The patient underwent the following laboratory tests and procedures: Electrocardiogram ST segment: (23Apr2022) Unknown; SARS-CoV-2 test: (25Apr2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, nasopharyngitis, nasal congestion, electrocardiogram st segment normal.Clinical course: Unknown the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown the patient diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported events of vaccination failure,covid-19. 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
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID infection/tested positive for COVID 19; COVID infection/tested positive for COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER2613), on 09Apr2021 as dose 2, single (Lot number: ER8729) and on 03Sep2021 as dose 3 (booster), single (Lot number: FA6780) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02Apr2022 as dose 4 (booster), single (Lot number: 002m21A) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Interchange of vaccine products" (unspecified if ongoing), notes: Vaccine brand other: Moderna,. Concomitant medication(s) included: HYDROXYCHLOROQUIN; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; OMEPRAZOL; LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID infection/tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Apr2022) Negative, notes: I tested negative for infection on 13Apr2022; (15Apr2022) Positive, notes: On 15Apr2022 I tested positive for COVID 19; (26Apr2022) Positive, notes: still remain positive for COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient received Paxlovid on 08Apr2022 for a COVID infection. Patient took the full, five day course. Her symptoms resolved and she tested negative for infection on 13Apr2022. On 14Apr2022 her symptoms began to return. On 15Apr2022 she tested positive for COVID 19. Today was 26Apr2022 and she still remain positive for COVID-19. Her symptoms were mild, however, she cannot seem to clear the infection post-Paxlovid. No known allergies were present.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extreme fatigue for 3 days with doses 1, 2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2022-535874 (moderna).  A 59-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8733) at the age of 59 years, in arm and on 23Apr2021 as dose 2, single (Lot number: EW0172), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered" (2021), described as "extreme fatigue for 3 days with doses 1, 2".  Additional information: Patient received Dose 3 (Moderna, Lot/Batch #: Moderna 052E21A) on 29Oct2021, Route and body site: Arm. Patient received Dose 4 (Moderna, Lot/Batch #: Moderna 025L218) on 30Mar2022, Route and body site: Arm, Dose/volume: 25ml. Patient had not been diagnosed with/tested positive for Covid-19. Patient did not had acute illness at the time of vaccination and up to one month before. Patient did not had chronic or long-standing health conditions. With previous Covid-19 vaccines, never felt Sick-Patient just had extreme fatigue for 3 days with doses 1, 2 and 3.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Memory impairment
Clinical narrative: issue with her eye's; short-term memory issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US064130_NC (Agency).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE DISORDER (non-serious), outcome "unknown", described as "issue with her eye's"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "short-term memory issues".  Additional information:As you may be aware, the FDA Guidelines for Post marketing Reporting of Adverse Drug Reactions require that:"Reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant."Additionally, the requirements concerning the submission of post-marketing 15-day Alert reports, also apply to any person other than the applicant whose name appears on the label of an approved drug product as a manufacturer, packer, or distributor (non-applicant). To avoid unnecessary duplication in the submission to FDA of reports, obligations of a non-applicant may be met by submission of all reports of serious adverse drug experiences to the applicant. If a non-applicant elects to submit adverse drug experience reports to the applicant rather than to FDA, the non-applicant must submit, by any appropriate means, each report to the applicant within 5 calendar days of initial receipt of the information by the non-applicant, and the applicant must then comply with the requirements of this section.We are, therefore, forwarding the information below relating to your product which was obtained by one of our staff during the normal course of business  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Knee operation, Somnolence
Clinical narrative: This is a solicited report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4159698-00 (RA). A 72-year-old female patient received BNT162b2 (BNT162B2), on 12Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), since 2021 (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose; 2, Manufacture: Pfizer, Lot Number: Not Provided, Route of administration: Intramuscular), administration date: 30Mar2021, for Covid-19 immunization; BNT162b2 (Dose; 1, Manufacture: Pfizer, Lot Number: Not Provided, Route of administration: Intramuscular), administration date: 01Mar2021, for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset Aug2021, outcome "recovered", described as "Sleepy"; KNEE OPERATION (medically significant) with onset 12Oct2021, outcome "recovering", described as "Knee surgery on right knee". The action taken for adalimumab was unknown. Clinical course: She was stopped Humira for six weeks, two weeks before the surgery for four weeks after. She had administered Covid booster 12Aug2021 and had some sleepy side effects of that vaccine. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's assessment of the causal relationship of "knee surgery on right knee" and "sleepy" 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event Knee operation and somnolence and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: then I took the booster also then I realized that the COVID; Then I took the booster also then I realized that the COVID; 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, NDC number, UPC number and Expiry Date are Unknown), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "then I took the booster also then I realized that the COVID"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Then I took the booster also then I realized that the COVID".  Additional information: The report did not relate to a study or programme. When probed to spell name: The reporter stated, had the symptoms after having  first and second dose (clarified as COVID-19 Vaccine) and then took booster also was getting this situation and the side effects for tinnitus and they sent the patient form, it is 3 and more and month and a half, the patient had sent it back (Hence Report type captured as Follow-up Report). The patient never heard from anybody. The patient did not know who to talk to because now it is the second booster. The patient was  not sure what it is but the patient had this tinnitus situation right after the patient took the first and second and which the patient ignored and thought maybe it will go away then found out it is a tinnitus, then took the booster also then the patient realized that the COVID (not paraphrased and confirmed if the consumer experienced COVID, hence not captured as event) sometimes have that aspect and then the patient realized it happened after that (vaccination). Now, second booster has come back and so the patient was not sure what is the right thing. The reporter was informed to contact Pfizer Medical Information for the queries and was provided with the number of Pfizer Medical Information. Product details (LOT#, Expiration Date, NDC# and UPC#) and Pharmacy details could not be probed as consumer hung up the call abruptly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Swelling face
Clinical narrative: face was nice and swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-042422-10642 (Agency).  A 44-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; poly-L-lactic acid (SCULPTRA), (Batch/Lot number: unknown); botulinum toxin type a (BOTOX), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Patient had Pfizer Covid-19 vaccines on Aug2021 and Sep2021), administration date: Aug2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: SWELLING FACE (non-serious), outcome "unknown", described as "face was nice and swollen".  Additional information: The clinical course was reported as on an unknown date at the end of Dec2021 or the beginning of Jan2022, the consumer was injected with 2 vials of sculptra-1 vial on each side of the face- into the marionette lines, under the eyes, and upper cheeks The lot number and expiration are unknown to the consumer. The consumer reported that the injecting HCP stated she would not need any more treatments after the initial one, because the sagging of her skin was not that bad. The consumer additionally reported that the HCP stated that maybe she would need another treatment after 3 months. The consumer stated she did not go for a 3rd treatment because she was fasting and was going to go after fasting. The consumer additionally stated that after the first treatment, her face was nice and swollen, and she thought, this was going to work. The consumer stated after that, she never saw anything, and did not want to go for a third treatment if it was not working. Appointment with HCP is scheduled on an unknown date in May2022. Additionally, the consumer was treated with botox in the eyebrow, at the same time she was treated with sculptra, at the end of Dec2021 or the beginning of Jan2022. She had Pfizer Covid-19 vaccines on: Aug2021 and Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: muscle aches; Pain at injection site; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 03:00 as dose 4 (booster), single (Lot number: 330368D), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Apr2022 at 06:00, outcome "recovering", described as "Pain at injection site"; HEADACHE (non-serious) with onset 27Apr2022 at 06:00, outcome "recovering"; MYALGIA (non-serious) with onset 27Apr2022 at 06:00, outcome "recovering", described as "muscle aches". Therapeutic measures were not taken as a result of myalgia, vaccination site pain, headache.  No follow-up attempts are possible. No further information is expected.