chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
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 33-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in May2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "ulcerative colitis" (unspecified if ongoing); "ADHD" (unspecified if ongoing), notes: ADHD. Concomitant medication(s) included: SULFASALAZINE, start date: Jan2010; ADDERALL, start date: Nov2021; MIRENA, start date: Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) COVID rebound, notes: COVID rebound 4 days after completing Paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication Mirena and IUD in 2 weeks product. COVID rebound 4 days after completing Paxlovid course.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
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.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL5265), on 19Feb2021 as dose 2, single (Lot number: EN6201), on 24Sep2021 as dose 3 (booster), single (Lot number: FC3182) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "mild hyperlipidemia" (unspecified if ongoing), notes: mild hyperlipidemia; "mildly enlarged prostate" (unspecified if ongoing), notes: mildly enlarged prostate; "thyroid disease" (unspecified if ongoing), notes: thyroid disease; "Known Allergy: penicillin" (unspecified if ongoing), notes: Known Allergy: penicillin. Concomitant medication(s) included: UNITHROID taken for thyroid disorder, start date: 01Jan2022; FINASTERIDE taken for prostatomegaly, start date: 01Jan2022; ATORVASTATIN taken for hyperlipidaemia, start date: 01Jan2022, stop date: 20Jun2022. Past drug history included: Aspirin, reaction(s): "Known Allergy: aspirin".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Negative, notes: Day after treatment ended/ asymptomatic; (Jul2022) Positive, notes: Day 4, after treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course:The patient took other medications/products within 2 weeks of starting COVID-19 treatment and Paxlovid from 23Jun2022 to 28Jun2022. The patient previously received a COVID-19 Vaccine. Day after treatment ended his rapid test was negative and he was asymptomatic. On Day 3 after treatment ended, he was symptomatic. On Day 4, tested positive on unspecified date in Jul2022, and received a second course of Paxlovid with outcome of Recovering.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN61996130121), in left arm, on 26Mar2021 as dose 2, single (Lot number: EP75346130121), in left arm, on 21Oct2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 19May2022 as dose 4 (booster), single (Lot number: FJU989) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "known allergies Sulfa" (unspecified if ongoing); "gerd" (unspecified if ongoing); "General allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "known allergies cipro". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient took Anti-viral drug Paxlovid from 31May2022 to 07Jun2022 for COVID 19 treatment.  No follow-up attempts are possible. No further information is expected.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2021 as dose 1, single (Batch/Lot number: unknown), on 17May2021 as dose 2, single (Batch/Lot number: unknown) and on 01Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Jun2022) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Anti viral details: product=COVID-19 Treatment, brand Paxlovid, treatment start date 12Jun2022, treatment stop date 17Jun2022. Other medication details: other medication in 2weeks product Fluoxetine, other medication in 2weeks product Adderall, other medication in 2weeks product Birth Control. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Took Paxlovid as prescribed for 5 days while I had COVID-19. Tested negative after the 6th day of having COVID-19. 2.5 weeks after, started coughing a little and am testing positive again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: on the 24, I got 4th dose, the second booster of Pfizer (Pfizer COVID-19 booster shot) I don't know if that anything has to do then on 28 I tested positive then I take the Paxlovid on; on the 24 I got 4th dose the second booster of Pfizer (Pfizer COVID-19 booster shot) I don't know if that anything has to do then on 28 I tested positive then I take the Paxlovid on/ minor cough; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: E1685), as dose 2, single (Lot number: EP7534), as dose 3 (booster), single (Lot number: 3OT308A) and on 24Jun2022 as dose 4 (booster), single (Lot number: PF4554) 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 28Jun2022, outcome "not recovered", described as "on the 24 I got 4th dose the second booster of Pfizer (Pfizer COVID-19 booster shot) I don't know if that anything has to do then on 28 I tested positive then I take the Paxlovid on/ minor cough"; DRUG INEFFECTIVE (medically significant) with onset 28Jun2022, outcome "unknown", described as "on the 24, I got 4th dose, the second booster of Pfizer (Pfizer COVID-19 booster shot) I don't know if that anything has to do then on 28 I tested positive then I take the Paxlovid on". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jul2022) Positive; (28Jun2022) Positive; (03Jul2022) Positive; (07Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Consumer stated, I had been tested positive since 28Jun, I was at first two days it was bad so my doctor prescribed Paxlovid they want me take like pack of 30 4 to 5 days but the past 4 days I didn't have any symptoms, but the problem was like I kept testing positive, tested this morning and it was the home test, the instant but I didn't have any symptoms. It really, I had like it was minor cough, but it was not its minor cough like other wise I am good I didn't have any symptoms at all. It was already ten days I was still positive, and I want to know why because if you were taking and I did. I think on the 24, I got 4th dose, the second booster of Pfizer (Pfizer COVID-19 booster shot) I didn't know if that anything had to do then on 28, I tested positive then I take the Paxlovid on, I started taking the Paxlovid on 29 I finished it like on like 3. I don't have Paxlovid anymore.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events.
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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Negative; (06Jul2022) 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.
Age: 71.0
Sex: M
Vaccine: 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) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 10Jan2021 as dose 2, single (Lot number: FJ1686), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Failure" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "single functioning kidney" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID; METOPROLOL TARTRATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication (Metoprolol tartrate, Synthyroid) in 2 weeks. Patient took Paxlovid as a anti viral Treatment. Patient had no allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 07Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 27Oct2021 as dose 3 (booster), single (Lot number: Ew0183) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Crohns" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE, start date: 01Aug2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I took another at home rapid test and was positive again; (23Jun2022) Positive, notes: I tested positive by rapid test on 23Jun2022; (24Jun2022) Positive, notes: confirmed by PCR on 24Jun2022; (02Jul2022) Negative, notes: I tested negative by two rapid home tests on 02Jul2022; (02Jul2022) Negative, notes: I tested negative by two rapid home tests on 02Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient did not have any known allergies. Patient was treated with anti viral drug Paxlovid from 24Jun2022 to 29Jun2022, for COVID-19. Patient received other medication in 2 weeks. Patient tested positive by rapid test on 23Jun2022 and confirmed by PCR on 24Jun2022. Patient started paxlovid 5-day dose that evening. Patient tested negative by two rapid home tests on 02Jul2022 and ended her isolation with mild runny nose. She masked most of 02Jul and 03Jul, and her symptoms worsened the afternoon of 03Jul. Patient took another at home rapid test and was positive again.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rebound of covid symptoms in 7 days after ending Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that patient took other medication in 2 weeks. Patient took COVID 19 Treatment (Paxlovid) from 25Jun2022 to 29Jun2022.  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 in the case report and a plausible temporal relationship, a possible causal association between the events Covid 19 and Drug ineffective and suspect drug BNT162B2 cannot be excluded.
Age: 69.0
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) (Nurse).  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "latex" (unspecified if ongoing); "CAD" (unspecified if ongoing). Concomitant medication(s) included: TOPROL oral, start date: 24Jun2022, stop date: 28Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: Negative; Negative; Positive, notes: PCR CT values at 22. 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.  Clinical course: Patient received vaccine and also she was on other medication in 2 weeks.Patient was on Anti-viral treatment with Paxlovid. Treatment start date was 24Jun2022 and stop date was 8Jun2022 with indication COVID 19 treatment, Oral. Patient completed full course of treatment. felt better, tested negative on antigen. 2 days after finishing course and testing negative, developed fever, cough. Tested positive on antigen and PCR CT values at 22.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
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 57-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multi organ sarcoidosis" (unspecified if ongoing); "Heart block" (unspecified if ongoing); "Cardiomyopathy CNS" (unspecified if ongoing). Concomitant medications included: MYCOPHENOLATE; PREDNISONE; RITUXAN; MELATONIN; VITAMIN B COMPLEX; MAGNESIUM; DULOXETINE; EVUSHELD, VITAMIN D and SULPHATE ANTIBIOTIC. 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 antibody test: Unknown Results, notes: Initial Covid; Unknown Results, notes: Rebound Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient started treatment with paxlovid from 20Jun2022 till 25Jun2022 for initial Covid. Patient reported rebound Covid (onset date 01Jul2022). Worse than initial Covid prior (onset date unspecified) to paxlovid. No treatment was received for rebound Covid. The patient received chemo in 2 weeks of product administration.  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; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Lot number: Ff2588) 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 included: "Asthma" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Known allergies: Penicillins" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: cefalosporins" (unspecified if ongoing). Concomitant medication(s) included: QVAR, start date: 11Apr2017; ALBUTEROL [SALBUTAMOL], start date: 06Apr1993; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 05Jun2017; SINGULAIR, start date: 04Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19: PAXLOVID.; Sender's Comments: The causal association of lack of effect  and Covid 19 infection in relation to suspected vaccine BNT162B2 cannot be totally exluded.  Case will be reassess pending investigation.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurry Vision in Both Eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 18-year-old female patient received BNT162b2 (BNT162B2), on 29Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 18 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VISION BLURRED (non-serious) with onset 30Jun2022, outcome "recovering", described as "Blurry Vision in Both Eyes". Therapeutic measures were not taken as a result of vision blurred.  Additional information: Reason for no lot number: of Covid 19 Vaccine: Complainant does not have the product with them at the time of call. Vaccination facility type was Pharmacy/Drug Store. There was no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines was administered on same date of the Pfizer Suspect. The time of onset of AE'S was 12 Hours later. Patient did not require any AE(s) to a visit to Emergency Room. Prior Vaccinations (within 4 weeks): None. Patient did not had any AE(s) following prior vaccinations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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): 21K-163-4034481-00.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, all intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), on 07Oct2020 (ongoing) as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2021, outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was dosage not changed.  The reporter considered "covid-19" related to BNT162b2.  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 in the case report and a plausible temporal relationship, a possible causal association between the reported events and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202200936734 same reporter/patient, different drug dose/event;US-PFIZER INC-202200936733 same reporter/patient, different drug dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diplopia, Muscular weakness
Clinical narrative: diplopia in the right eye/aggravated; diplopia in the right eye/aggravated; muscle weakness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diplopia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: DIPLOPIA (non-serious), CONDITION AGGRAVATED (non-serious), outcome "recovered" and all described as "diplopia in the right eye/aggravated"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness". Therapeutic measures were not taken as a result of diplopia, condition aggravated.  Additional information: Patient received the first booster of Pfizer Covid-19 vaccine. Experienced diplopia in the right eye along with muscle weakness. Diplopia lasted for a couple of days. Diplopia resolved on its own without any other interventions. Patient reported she had diplopia prior but the booster dose aggravated it. Event took place after use of product.  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: Pericarditis
Clinical narrative: developed pericarditis after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "developed pericarditis after receiving the vaccine".  Clinical course: Reporters wife developed pericarditis after receiving the vaccine. This adverse event was reported within the 24 hour time frame. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "pericarditis" and the suspect drug "BNT162B2" 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.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; 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-163-4458098-00.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Lot number: 1160837) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was dosage not changed.  The reporter considered "rheumatoid arthritis flare up" 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 in the case report and a plausible temporal relationship, a possible causal association between the event 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain, Rheumatoid arthritis
Clinical narrative: breakthrough of COVID after being vaccinated; breakthrough of COVID after being vaccinated; Rheumatoid arthritis flare up; Pain; 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-163-4407148-00 (AbbVie).  A 71-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 01Jan2020 (ongoing) (Lot number: 1153557), subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", COVID-19 (medically significant), outcome "recovered" and all described as "breakthrough of COVID after being vaccinated"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; PAIN (non-serious), outcome "recovered". It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "breakthrough of covid after being vaccinated", "rheumatoid arthritis flare up" and "pain" 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 causality for the event(s) of pain with HUMIRA(Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of breakthrough of covid after being vaccinated and rheumatoid arthritis flare ups was not provided."  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 in the case report and a plausible temporal relationship, a possible causal association between the reported events  and suspect drug BNT162B2 cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Drug ineffective, Pain of skin
Clinical narrative: Medication Not Relieving The Pain In Joints And Skin With Humira (Adalimumab); Flare Ups Twice a Week; Pain In Joints And Skin; Pain In Joints And Skin; 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-163-4451143-00 (AbbVie).  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1154441), subcutaneous. 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 "Medication Not Relieving The Pain In Joints And Skin With Humira (Adalimumab)"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Flare Ups Twice a Week"; ARTHRALGIA (non-serious), PAIN OF SKIN (non-serious), outcome "not recovered" and all described as "Pain In Joints And Skin". The action taken for adalimumab was unknown. Clinical course: An adult male with events of non-serious Flare Ups Twice a Week, Pain In Joints And Skin And Medication Not Relieving The Pain In Joints And Skin With Humira (Adalimumab). There was no reported medical history.  On unknown dates, the patient experienced flare ups twice a week, pain in joints and skin and medication not relieving the pain in joints and skin. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira(Adalimumab) The reporter's causality for the event(s) of Flare Ups Twice a Week, Pain In Joints And Skin unknown onset and Pain In Joints And Skin Unknown Onset With Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of Medication Not Relieving The Pain In Joints And Skin was not provided.  The reporter considered "medication not relieving the pain in joints and skin with humira (adalimumab)", "flare ups twice a week" and "pain in joints and skin" 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 provided in the narrative , a possible contributory role of the suspect vaccine  to reported event of  condition aggravated, arthralgia, skin pain, condition aggravated and drug ineffective    cannot be excluded.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata
Clinical narrative: huge bald spot on the side of her head/she has spots all around her head; alopecia Areta; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the parent.  A 6-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "huge bald spot on the side of her head/she has spots all around her head"; ALOPECIA AREATA (non-serious), outcome "unknown", described as "alopecia Areta". The events "huge bald spot on the side of her head/she has spots all around her head" and "alopecia areta" required physician office visit.  Additional information: The reporter wanted to know her daughter who is 6, she was 5 at the time of vaccination, now has alopecia Areta as a result of taking the vaccine. Her daughter has always had thick full hair and a just a few days after receiving the vaccine, she got 1 huge bald spot on the side of her head. Soon after and as of today she has spots all around her head. She saw a dermatologist, and it's so severe she has to see an Alopecia specialist.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Insomnia
Clinical narrative: Spondylitis ankylosing aggravated; Difficulty sleeping; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), on 02Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 2021, outcome "not recovered", described as "Difficulty sleeping"; ANKYLOSING SPONDYLITIS (medically significant) with onset 2021, outcome "not recovered", described as "Spondylitis ankylosing aggravated". The action taken for adalimumab was dosage permanently withdrawn.  The reporter considered "spondylitis ankylosing aggravated" and "difficulty sleeping" 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 available, the causal relationship between the reported 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,Linked Report(s) : 22K-163-4453517-00 AbbVie;
Age: 1.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: The patient was not supposed to receive any vaccines at all, The doses were pulled for another patient and then mistakenly were administered to the affected patient with no adverse event; Initial information received on 29-Jun-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 months old and unknown gender patient who was not supposed to receive any vaccines at all, the doses were pulled for another patient and then mistakenly were administered to the affected patient with no adverse event while receiving vaccines diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] and meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect meningococcal A-C-Y-W135 (D CONJ) vaccine and diphtheria-2/tetanus/5 AC pertussis vaccine at an unknown dose (lot number, expiry date, form: not reported) via unknown route in unknown administration site for immunisation.  On an unknown date the patient was not supposed to receive any vaccines at all, the doses were pulled for another patient and then mistakenly were administered to the affected patient with no adverse event (wrong patient received product) (unknown latency) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine and (unknown latency) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01168900: 01168833:
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Ipol administered after the excursion with no reported adverse event; The condition was 1.6C for approximately 35 hours due to a refrigerator malfunction with no reported adverse event; Initial information received on 05-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient to whom Ipol administered after the excursion with no reported adverse event and the condition was 1.6 Celsius (C)  for approximately 35 hours due to a refrigerator malfunction with no reported adverse event , and it involved punctured  vaccine IPV (VERO) [IPOL].   The patient's past medical history, medical treatment(s),  and family history were not provided. The patient was not given any other vaccine    The caller sated that on an unknown date, the condition was 1.6 C for approximately 35 hours due to a refrigerator malfunction with no reported adverse event (product storage error) (latency : unknown)  On 14-Jun-2022, the patient received 0.5 ml   dose of suspect IPV (VERO) once,  (lot : T1E871M ; expiry date: 10-Oct-2022) via intramuscular route in the left deltoid for immunization. It was reported that Ipol administered after the excursion with no reported adverse event (poor quality product administered) (latency: same day)   Action taken : not applicable for both the events.  Outcome: unknown for both the events    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: refrigerator door was left open; low Temperature reached: 8.56 C; Duration out of labelled range: 45 minutes (punctured IPOL) with no reported adverse event; was administered with vaccines that was exposed to excursion with no reported adverse event; Initial information received on 05-Jul-2022 regarding an unsolicited valid  non-serious case received from nurse.   This case involves a 18 years old female patient who was administered with vaccines that was exposed to excursion with no reported adverse event and reported Product storage error (refrigerator door was left open; low temperature reached: 8.56 c; duration out of labelled range: 45 minutes (punctured ipol) with no reported adverse event) while receiving vaccine IPV (VERO) [IPOL].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) for Immunisation; MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO); MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO); and HEPATITIS A VACCINE INACT (HAVRIX) all for Immunisation.   On 29-Apr-2022, the patient received suspect IPV (VERO) at a dose of 0.5 ml (lot U1A601M, expiry date: 27-Feb-2023, strength, form: not reported) via subcutaneous route in the left arm for immunisation.   On an unknown date the patient refrigerator door was left open; low temperature reached: 8.56 c; duration out of labelled range: 45 minutes (punctured ipol) with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).   On 29-Apr-2022 the patient developed a non-serious was administered with vaccines that was exposed to excursion with no reported adverse event (poor quality product administered) latency same day following the administration of IPV (VERO). Nurse also inquired if they need to revaccinate patients that was administered with vaccines that was exposed to excursion.    Action taken: Not applicable.   Outcome: Unknown for both the events.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01176068: 01176149: