chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: Developed Covid symptoms 19May2022, positive home test 20May2022; Developed Covid symptoms 19May2022, positive home test 20May2022; 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 06Feb2021 at 12:45 as dose 1, single (Lot number: EN5318), on 08Mar2021 at 10:00 as dose 2, single (Lot number: EL9269) and on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 67 years for covid-19 immunization. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: May2019; CETIRIZINE HYDROCHLORIDE, start date: Mar2012; NASACORT, start date: May2018; HCTZ, start date: 15Nov2021; AMLODIPINE, start date: 08Feb2022; LUTEIN ZEAXANTHIN; VITAMIN D3; CALCIUM WITH VITAMIN D [CALCIUM CARBONATE; COLECALCIFEROL]; MAGNESIUM; MELATONIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "unknown" and all described as "Developed Covid symptoms 19May2022, positive home test 20May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive; (26May2022) Positive, notes: very light positive line; (27May2022) Positive, notes: very light positive line; (31May2022) very dark line, notes: very dark line. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course Developed Covid symptoms 19May2022, positive home test 20May2022, ill on 19May2022, 20May2022, 21May2022. Took Paxlovid on 20May2022 - 25May2022. Home test on 26May2022 or 27May2022, very light positive line.Cold /allergy symptoms on 29 May2022, 30 May2022 and 31 May2022. Home test on 31May2022 very dark line. No Known allergies were reported. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: ill 19May, 20May, 21May; 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 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure. Concomitant medication(s) included: LOSARTAN, start date: May2019; CETIRIZINE HYDROCHLORIDE, start date: Mar2012; NASACORT, start date: May2018. Vaccination history included: pfizer / biontech (Dose Number: 2, Batch/Lot No: EL9269, Vaccine Administration Time: 10:00 AM), administration date: 08Mar2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; pfizer / biontech (Dose Number: 1, Batch/Lot No: EN5318, Vaccine Administration Time: 12:45 PM), administration date: 06Feb2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: ILLNESS (non-serious) with onset May2022, outcome "unknown", described as "ill 19May, 20May, 21May".  Additional information: Adverse event: Developed COVID symptoms 19May2022, positive home test 20May2022, ill 19May, 20May, 21May. Took Paxlovid 20May- 25May. Home test 26May or 27May very light positive line. Cold /allergy symptoms 29May, 30May, 31May. Home test 31May, very dark line.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: ill 19May, 20May, 21May; 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 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure. Concomitant medication(s) included: LOSARTAN, start date: May2019; CETIRIZINE HYDROCHLORIDE, start date: Mar2012; NASACORT, start date: May2018. Vaccination history included: pfizer / biontech (Dose Number: 2, Batch/Lot No: EL9269, Vaccine Administration Time: 10:00 AM), administration date: 08Mar2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; pfizer / biontech (Dose Number: 1, Batch/Lot No: EN5318, Vaccine Administration Time: 12:45 PM), administration date: 06Feb2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: ILLNESS (non-serious) with onset May2022, outcome "unknown", described as "ill 19May, 20May, 21May".  Additional information: Adverse event: Developed COVID symptoms 19May2022, positive home test 20May2022, ill 19May, 20May, 21May. Took Paxlovid 20May- 25May. Home test 26May or 27May very light positive line. Cold /allergy symptoms 29May, 30May, 31May. Home test 31May, very dark line.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Headache, SARS-CoV-2 test
Clinical narrative: tested positive for Covid yesterday (30May2022) one week after receiving her Pfizer booster/ She was asymptomatic; tested positive for Covid yesterday (30May2022) one week after receiving her Pfizer booster/ She was asymptomatic; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 8-year-old female patient received BNT162b2 (BNT162B2), in May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: HEADACHE (non-serious) with onset May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30May2022, outcome "unknown" and all described as "tested positive for Covid yesterday (30May2022) one week after receiving her Pfizer booster/ She was asymptomatic". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) positive, notes: tested positive for Covid yesterday (30May2022). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Sick with COVID; Sick with COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4414172-00.  A 29-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 29 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "Sick with COVID". The action taken for adalimumab was unknown. The reporter considered "sick with covid" related to BNT162b2. Additional information: Solicited report by a consumer of an adult male with an event of non-serious sick with COVID with Humira (Adalimumab). On an unknown date, the patient experienced sick with COVID. 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 of sick with COVID with Humira (Adalimumab)was no reasonable possibility . Causality: 1)COVID-19 (COVID-19): Causality as per reporter (Drug/Vaccine) : possible  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "known allergies:  PCN" (unspecified if ongoing), notes: known allergies:  PCN. There were no concomitant medications. Past drug history included: Plaquenil, reaction(s): "known allergies: plaquenil", notes: known allergies: plaquenil. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: other medication in 2weeks: No 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 reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: The patient experienced COVID; The patient experienced COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4407091-00 (AbbVie).  A 53-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis. 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 2022, outcome "recovered" (May2022) and all described as "The patient experienced COVID". The action taken for risankizumab was unknown. Clinical course of the events: Solicited report from the USA by a consumer with an event of non-serious COVID with Skyrizi (Risankizumab). There was no reported medical history. In 2022, the patient experienced COVID. In May2022, the COVID resolved. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. In May2022, the patient recovered from COVID. Patient did not agree to have physician contacted. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Skyrizi (Risankizumab): The reporter's causality for the event(s) of COVID with Skyrizi (Risankizumab) was no reasonable possibility. Did event abate after stopping drug: NA. Drug: Skyrizi (Risankizumab) Causality: covid-19 (covid-19): action(s) taken with drug : unknown. causality as per reporter (drug/vaccine) : not related. drug: pfizer biontech covid-19 vaccine (tozinameran) (tozinameran), unknown, unknown, unknown: causality. covid-19 (covid-19) causality as per reporter (drug/vaccine) : not reported.  The reporter's assessment of the causal relationship of "the patient experienced covid" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The 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 reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID/She has no symptoms; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient received BNT162b2 (BNT162B2), in May2022 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: DRUG INEFFECTIVE (medically significant) with onset 31May2022, outcome "unknown", described as "Tested positive for COVID"; ASYMPTOMATIC COVID-19 (medically significant) with onset 31May2022, outcome "unknown", described as "Tested positive for COVID/She has no symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) positive, notes: tested positive for COVID on 31May and 30May respectively.  Additional Information: Patient was vaccinated with Pfizer COVID vaccine. Reporter asked for pics of their COVID cards and will send shortly.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 22Jan2021 at 08:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 24Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "3 doses: Moderna/ 1 dose: Pfizer" (unspecified if ongoing), notes: 3 doses: Moderna/ 1 dose: Pfizer. Concomitant medication(s) included: SIMVASTATIN, start date: Jan2014, stop date: 25May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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 drug ineffective, covid-19 included Paxlovid, treatment start date=27May2022, treatment stop date=29May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 07May2022 at 11:00 as dose 4 (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), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: product=COVID-19 Treatment, brand=Paxlovid, treatment start date=17May2022, treatment stop date=21May2022, indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 83.0
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 83-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2021 at 15:45 as dose 1, single (Lot number: EL0140), in left arm, on 02Mar2021 at 13:30 as dose 2, single (Lot number: EN6205), in left arm, on 02Oct2021 at 14:15 as dose 3 (booster), single (Lot number: BA30135), in left arm and on 07Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing), notes: Mild hypertension; "Emphysematous lung changes due to 2nd hand smoke" (unspecified if ongoing), notes: Emphysematous lung changes due to 2nd hand smoke; "Emphysematous lung changes due to 2nd hand smoke" (unspecified if ongoing), notes: Emphysematous lung changes due to 2nd hand smoke; "Hypogonadism" (unspecified if ongoing); "Macular degeneration" (unspecified if ongoing); "Fall", start date: 12Mar2022 (unspecified if ongoing), notes: Fall 12Mar2022 resulting in hospitalization; "T7-8 fracture" (unspecified if ongoing), notes: T7-8 fracture & remains in full upper body clam shell that restricts respirations.; "T7-8 fracture" (unspecified if ongoing), notes: T7-8 fracture & remains in full upper body clam shell that restricts respirations.; "Restricts respirations" (unspecified if ongoing), notes: full upper body clam shell that restricts respirations.; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: BYSTOLIC; DEPO-TESTOSTERONE; CALCIUM; FISH OIL; VITAMIN C [ASCORBIC ACID]; PRESERVISION; TRAZODONE, stop date: 16May2022; EYLEA. The following information was reported: VACCINATION FAILURE (medically significant) with onset 17May2022, outcome "unknown", COVID-19 (medically significant) with onset 17May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: + on antigen test on 17May; (25May2022) Negative, notes: Antigen test negative on 25May; (28May2022) Positive, notes: Tested + on 28May. Therapeutic measures were taken as a result of covid-19. This report was about COVID-19 treatment. Patient did receive the vaccine. Patient received other medications in 2 weeks. Patient received treatment for COVID-19 as Paxlovid from 17May2022 to 22May2022. Patient was positive on antigen test on 17May2022, as symptomatic after which wife was positive on PCR several days earlier. Took 5 days Paxlovid from 17May2022 to 21May2022. Symptom free and antigen test was negative on 25May2022.  No follow up attempts are possible. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Inspiratory capacity decreased, Thoracic vertebral fracture
Clinical narrative: Fall; T7-8 fracture; restricts respirations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 02Oct2021 at 14:15 as dose 3 (booster), single (Lot number: BA30135) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing), notes: Mild hypertension; "empysematous lung changes due to 2nd hand smoke" (unspecified if ongoing), notes: empysematous lung changes due to 2nd hand smoke; "hypogonadism" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "known allergies:Sulfa" (unspecified if ongoing), notes: known allergies:Sulfa; "2nd hand smoke" (unspecified if ongoing), notes: empysematous lung changes due to 2nd hand smoke. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1, vaccine administration time=03:45 PM, vaccine lot  number=EL0140, vaccine location=Left arm), administration date: 09Feb2021, when the patient was 82-year-old, for Covid-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose:2, vaccine administration time=01:30 PM, vaccine lot  number=EN6205,, vaccine location=Left arm), administration date: 02Mar2021, when the patient was 82-year-old, for Covid-19 Immunization, reaction(s): "COVID-19". The following information was reported: FALL (hospitalization) with onset 12Mar2022, outcome "unknown"; THORACIC VERTEBRAL FRACTURE (hospitalization) with onset 12Mar2022, outcome "unknown", described as "T7-8 fracture"; INSPIRATORY CAPACITY DECREASED (non-serious) with onset 12Mar2022, outcome "unknown", described as "restricts respirations".  Anti-viral details [product=COVID 19 Treatment (Paxlovid), treatment start date=17May2022 and stop date=22May2022, Indication is used for treatment of COVID-19. covid vaccine details [vaccine brand=Pfizer BioNTech, administration on 07Apr2022, at 01:00PM, lot number=FK9894, on dose number unknown reason=UNKNOWN, location=Left arm. other medication details [other medication in 2weeks product=Bystolic, Trazadone, stop date=16May2022, Depo-testosterone, Multiple Vitamin, Calcium, Fish Oil, Vitamin C, Preservision, Eyeleainjections. Reported Event: + on antigen test on 17May, as symptomatic & after wife positive on PCR several days earlier. Took 5 days Paxlovid 17May - 21May.Symptom free & antigen test negative on 25May.27May 07:00 AM at return Covid symptoms of sore throat, cold & lung congestion with cough, low grade fever & fatigue. & tested + on 28May). On 31May remains symptomatic with only minimal improvement in symptoms. The outcome of events was not recovered without any treatment.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive test for COVID/COVID 19 Treatment; Positive test for COVID/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.  An elderly male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer" (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 May2022, outcome "unknown" and all described as "Positive test for COVID/COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Overdose, Pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Pediatric Patient that was administered a Vaccination on Saturday which was given the adult dose; Pediatric Patient that was administered a Vaccination on Saturday which was given the adult dose; Lymph node is swollen under her armpit; lymph nodes have been swollen after they received vaccination; Fever; Pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An 11-year-old female patient received BNT162b2 (BNT162B2), on 28May2022 as dose 3 (booster), single (Lot number: FP4554, Expiration Date: 14Jun2022) at the age of 11 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (First dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; Bnt162b2 (Second dose), administration date: 2022, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset May2022, outcome "unknown", described as "Fever"; LYMPHADENOPATHY (non-serious) with onset May2022, outcome "unknown", described as "Lymph node is swollen under her armpit; lymph nodes have been swollen after they received vaccination"; PAIN (non-serious) with onset May2022, outcome "unknown"; OVERDOSE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 28May2022, outcome "unknown" and all described as "Pediatric Patient that was administered a Vaccination on Saturday which was given the adult dose". Therapeutic measures were taken as a result of pyrexia, pain.  Additional information: Pharmacist stated, He was actually filing in for another pharmacist today and he was noticed something when he was going back with paperwork. One of the Pediatric Patient that was administered a Vaccination on Saturday which was given the adult dose. The young  lady happened to be born (withheld) so she was scheduled to turn 12 in this year. But unfortunately she was under the age of 12. She should have received her booster under the orange cap the children dose but the patient in experiencing her Lymph node was swollen under her armpit. She got her vaccination with her mom. The Pharmacist stated treatment included Tylenol and Ibuprofen, Tylenol for the Pain and he guess the Fever, using the Tylenol.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2020 as dose 1, single (Lot number: EL1284), in left arm, on 21Jan2021 as dose 2, single (Lot number: EK9231), in left arm, on 04Sep2021 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 24Jan2022 as dose 4 (booster), single (Lot number: 33036BD) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "Type 2 Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN [METFORMIN HYDROCHLORIDE], start date: Mar2017; LISINOPRIL, start date: Mar2008. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin", notes: Known allergies: amoxicillin; Iodine for Known allergies: Iodine, notes: Known allergies: Iodine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: I have a positive COVID test after six days with negative results; (May2022) Positive, notes: I have a positive COVID test after six days with negative results. Therapeutic measures were taken as a result of vaccination failure, covid-19.Product:COVID 19 Treatment, Brand: Paxlovid, Treatment start date:20May2022,Treatment stop date:24May2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Nasopharyngitis, Oropharyngeal pain, Pain
Clinical narrative: mild sore throat; sinus pain; headache; cold s/s; Treatment of COVID-19; Treatment of COVID-19; fever; body aches; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jan2021 as dose 1, single (Batch/Lot number: unknown), on 22Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for COVID-19 immunization. The patient's relevant medical history included: "Cancer" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; LANREOTIDE, start date: 16May2022, stop date: 16May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; SINUS PAIN (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold s/s"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "mild sore throat"; PAIN (non-serious), outcome "recovered", described as "body aches"; PYREXIA (non-serious), outcome "recovered", described as "fever". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive. Therapeutic measures were taken as a result of covid-19, sinus pain, headache, nasopharyngitis, oropharyngeal pain. Clinical course: It was reported that, day 7 after completing Paxlovid patient started with her prev COVID s/s; sinus pain, headache, and then cold s/s, mild sore throat. These symptoms were mild compared to her initial COVID course. With her initial COVID course she also had body aches, and fever for 24 hrs. She tested on 31May2022, 2 days after rebound s/s and her home test was quickly positive. Patient received Paxlovid as treatment of COVID-19; start of drug: 17May2022 and date of last administration: 21May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Sinus pain, Vaccination failure
Clinical narrative: mild sore throat; sinus pain; headache; cold s/s; Treatment of COVID-19; Treatment of COVID-19; fever; body aches; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jan2021 as dose 1, single (Batch/Lot number: unknown), on 22Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for COVID-19 immunization. The patient's relevant medical history included: "Cancer" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; LANREOTIDE, start date: 16May2022, stop date: 16May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; SINUS PAIN (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold s/s"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "mild sore throat"; PAIN (non-serious), outcome "recovered", described as "body aches"; PYREXIA (non-serious), outcome "recovered", described as "fever". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive. Therapeutic measures were taken as a result of covid-19, sinus pain, headache, nasopharyngitis, oropharyngeal pain. Clinical course: It was reported that, day 7 after completing Paxlovid patient started with her prev COVID s/s; sinus pain, headache, and then cold s/s, mild sore throat. These symptoms were mild compared to her initial COVID course. With her initial COVID course she also had body aches, and fever for 24 hrs. She tested on 31May2022, 2 days after rebound s/s and her home test was quickly positive. Patient received Paxlovid as treatment of COVID-19; start of drug: 17May2022 and date of last administration: 21May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Echocardiogram, Gait disturbance, Investigation, Pulmonary hypertension
Clinical narrative: hypertension in lungs; it is hard to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Lot number: FF2587) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "knee replacement", start date: 11Aug2021 (unspecified if ongoing), notes: Caller clarified surgery as a complete knee replacement on left leg. She had cortisone in left knee then he did the surgery on 11Aug2021.; "Hypertension" (unspecified if ongoing), notes: she had hypertension because of lungs. Concomitant medication(s) included: VITAMIN D3. Vaccination history included: BNT162b2 (First dose, On the card it says Pfizer, 0.3ml, 6 hours, lot number: EL3247), administration date: 23Jan2021, for COVID-19 Immunization; BNT162b2 (Second dose, Lot Number: EL3251), administration date: 13Feb2021, for COVID-19 Immunization, reaction(s): "swelling in both feet", "swelling in left leg". The following information was reported: PULMONARY HYPERTENSION (medically significant) with onset 2021, outcome "unknown", described as "hypertension in lungs"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "it is hard to walk". The patient underwent the following laboratory tests and procedures: Blood test: Improved, notes: her blood tests improved; Echocardiogram: noticed hypertension, notes: showed something about right side of heart enlarged a little bit then noticed hypertension; Tests: Normal, notes: did all kinds of test on her and everything looked normal; Renal function test: little lower, notes: but had improved from prior month. Therapeutic measures were taken as a result of pulmonary hypertension, gait disturbance.  Follow-Up (02Jun2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Renal function test
Clinical narrative: hypertension in lungs; it is hard to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Lot number: FF2587) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "knee replacement", start date: 11Aug2021 (unspecified if ongoing), notes: Caller clarified surgery as a complete knee replacement on left leg. She had cortisone in left knee then he did the surgery on 11Aug2021.; "Hypertension" (unspecified if ongoing), notes: she had hypertension because of lungs. Concomitant medication(s) included: VITAMIN D3. Vaccination history included: BNT162b2 (First dose, On the card it says Pfizer, 0.3ml, 6 hours, lot number: EL3247), administration date: 23Jan2021, for COVID-19 Immunization; BNT162b2 (Second dose, Lot Number: EL3251), administration date: 13Feb2021, for COVID-19 Immunization, reaction(s): "swelling in both feet", "swelling in left leg". The following information was reported: PULMONARY HYPERTENSION (medically significant) with onset 2021, outcome "unknown", described as "hypertension in lungs"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "it is hard to walk". The patient underwent the following laboratory tests and procedures: Blood test: Improved, notes: her blood tests improved; Echocardiogram: noticed hypertension, notes: showed something about right side of heart enlarged a little bit then noticed hypertension; Tests: Normal, notes: did all kinds of test on her and everything looked normal; Renal function test: little lower, notes: but had improved from prior month. Therapeutic measures were taken as a result of pulmonary hypertension, gait disturbance.  Follow-Up (02Jun2022): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Eczema" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid 19 and drug ineffective.
Age: 43.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Oct2021 at 10:45 as dose 3 (booster), single (Lot number: 30125) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "blood clotting disorder" (unspecified if ongoing), notes: other medical history: blood clotting disorder. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: on Day 10; (2022) Positive, notes: On Day 13; (2022) Positive, notes: on Day 17. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Consumer took all 10 doses of Paxlovid as scheduled. Symptoms mostly resolved. Consumer had a negative antigen test on day 10. On Day 13 upper respiratory symptoms began again and she tested positive on an antigen test. Consumer still testing positive on day 17. Consumer started anti-viral Paxlovid on 15May2022 for COVID 19 Treatment, treatment stop date was 20May2022. Other medication in 2 weeks included Wellbutrin, started on 05May2022.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Goitre
Clinical narrative: Her thyroid got bigger; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GOITRE (non-serious), outcome "unknown", described as "Her thyroid got bigger". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Condition aggravated, Crying, Discomfort
Clinical narrative: The few days leading up to the getting the 2nd dose of the Covid vaccine I had tweaked my neck and had some pain. I took ibuprofen, which helped it; however, the day of the vaccine I did not take it because I had heard that it was probably a good idea to not take ibuprofen with the vaccine. I received the vaccine at 11AM on March 24, 2021  and later that day my neck pain started to get worse (maybe around 2 or 3 I started feeling it worsen). I tried to stretch it out and relieve it without medication. But that night the pain progressively got worse. I couldn't sleep. Pain was radiating in my neck and down my back. I felt chills and body aches (I did not have a fever though). It was a constant pain. When describing it to people I recall saying it was similar to labor pains, but without the relief a break between contractions (I've delivered three babies without any pain medication or epidural). I was literally crying and screaming in pain. My husband was trying to help, and thought he might have to take me to the emergency room. I did take ibuprofen to try and help relieve the pain and it did not work. I had one dose of flexeril at my house from a previous issue a couple years back, so I took that to try and help. I also took tylenol to try and help relieve it. After a few hours of the extreme pain I was able to fall asleep (still very uncomfortable) and in the morning I went to the urgent care (which is the care provider I listed as the best medical professional to speak to about this. This is a different place than where I received my vaccine). My husband (a nurse), my sister (a physical therapist) and the NP at the urgent care all told me they thought my pain was worsened and that the episode in the night was due to the vaccine. After the urgent care visit I was prescribed a Medrol pack and was told to alternate ibuprofen and tylenol and to ice the area and perform stretches. That all helped and I never experienced the wild pain again. I have been fine since then.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Insomnia, Neck pain, Pain, Screaming
Clinical narrative: The few days leading up to the getting the 2nd dose of the Covid vaccine I had tweaked my neck and had some pain. I took ibuprofen, which helped it; however, the day of the vaccine I did not take it because I had heard that it was probably a good idea to not take ibuprofen with the vaccine. I received the vaccine at 11AM on March 24, 2021  and later that day my neck pain started to get worse (maybe around 2 or 3 I started feeling it worsen). I tried to stretch it out and relieve it without medication. But that night the pain progressively got worse. I couldn't sleep. Pain was radiating in my neck and down my back. I felt chills and body aches (I did not have a fever though). It was a constant pain. When describing it to people I recall saying it was similar to labor pains, but without the relief a break between contractions (I've delivered three babies without any pain medication or epidural). I was literally crying and screaming in pain. My husband was trying to help, and thought he might have to take me to the emergency room. I did take ibuprofen to try and help relieve the pain and it did not work. I had one dose of flexeril at my house from a previous issue a couple years back, so I took that to try and help. I also took tylenol to try and help relieve it. After a few hours of the extreme pain I was able to fall asleep (still very uncomfortable) and in the morning I went to the urgent care (which is the care provider I listed as the best medical professional to speak to about this. This is a different place than where I received my vaccine). My husband (a nurse), my sister (a physical therapist) and the NP at the urgent care all told me they thought my pain was worsened and that the episode in the night was due to the vaccine. After the urgent care visit I was prescribed a Medrol pack and was told to alternate ibuprofen and tylenol and to ice the area and perform stretches. That all helped and I never experienced the wild pain again. I have been fine since then.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure during pregnancy, Road traffic accident, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case  admitted for MVA, COVID was an incidental finding 32 weeks pregnant as of 6/2/22  dose 1 1/6/21 Moderna 026L20A dose 2 2/3/21 Moderna 007M20A
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Axillary pain, Chills, Cough
Clinical narrative: Tuesday: Extreme redness at injection site covering an approximate 9 inch by 12 inch area of upper arm. Injection site turned hot to touch and hard. Pain under arm. Joint pain beginning 8 hours after vaccine and increasing throughout the night. Wednesday: Nausea, headache, dizziness upon waking. Debilitating pain in every joint including fingers, toes, knuckles. Drowsy. Slight cough. Strong chills until approximately 2am Thursday: Tired, slightly dizzy, mild joint pain, increased redness, heat, pain and 'hardness' at the injection site. Mild cough.  Light chills at 9pm.  Friday: Redness has increased at injection site, that area is extremely tender to the touch, body aches and chills and cough gone. Slight headache and dizziness. I have had adverse reactions to all of my Covid vaccines. This was my 2nd booster.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Extra dose administered, Fatigue, Headache, Injection site erythema
Clinical narrative: Tuesday: Extreme redness at injection site covering an approximate 9 inch by 12 inch area of upper arm. Injection site turned hot to touch and hard. Pain under arm. Joint pain beginning 8 hours after vaccine and increasing throughout the night. Wednesday: Nausea, headache, dizziness upon waking. Debilitating pain in every joint including fingers, toes, knuckles. Drowsy. Slight cough. Strong chills until approximately 2am Thursday: Tired, slightly dizzy, mild joint pain, increased redness, heat, pain and 'hardness' at the injection site. Mild cough.  Light chills at 9pm.  Friday: Redness has increased at injection site, that area is extremely tender to the touch, body aches and chills and cough gone. Slight headache and dizziness. I have had adverse reactions to all of my Covid vaccines. This was my 2nd booster.