chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive with Covid-19; tested positive with Covid-19; extreme diarrhea; high fever; sore throat; cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years for covid-19 immunisation. The patient's relevant medical history included: "CKD" (unspecified if ongoing), notes: Optional Information:, (Name withheld) has CKD, diabetes, atrial fibrillation.; "diabetes" (unspecified if ongoing), notes: Optional Information:, (Name withheld) has CKD, diabetes, atrial fibrillation.; "atrial fibrillation" (unspecified if ongoing), notes: Optional Information:, (Name withheld) has CKD, diabetes, atrial fibrillation.; "monoclonal antibody infusion", start date: 17Jun2022, stop date: 17Jun2022, notes: (Name withheld) received a monoclonal antibody infusion on 17Jun. Concomitant medication(s) included: COUMADIN; INSULIN. The following information was reported: COUGH (hospitalization) with onset 17Jul2022, outcome "unknown"; DIARRHOEA (hospitalization) with onset 17Jul2022, outcome "unknown", described as "extreme diarrhea"; PYREXIA (hospitalization) with onset 17Jul2022, outcome "unknown", described as "high fever"; OROPHARYNGEAL PAIN (hospitalization) with onset 17Jul2022, outcome "unknown", described as "sore throat"; DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 17Jul2022, outcome "unknown" and all described as "tested positive with Covid-19". The patient was hospitalized for drug ineffective, covid-19, diarrhoea, pyrexia, oropharyngeal pain, cough (start date: 18Jul2022). The patient underwent the following laboratory tests and procedures: Pyrexia: (17Jul2022) high, notes: (Name withheld) tested positive for Covid-19 on 17Jul. His symptoms included extreme diarrhea, sore throat, cough, and high fever; SARS-CoV-2 test: (17Jul2022) Positive, notes: tested positive for Covid-19 on 17Jul.  Clinical course:(Name withheld) tested positive for Covid-19 on 17Jul. His symptoms included extreme diarrhea, sore throat, cough, and high fever. (Name withheld) also received four Pfizer Covid-19 vaccination shots. (Name withheld) DOB is (DOB withheld). He is 6'1 and approximately 360 pounds. (Name withheld) received a monoclonal antibody infusion on 17Jun, and was hospitalized on 18Jul. (Name withheld) has CKD, diabetes, atrial fibrillation, He is also on Coumadin, insulin shots, and numerous other co-morbid medications. 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: Linked Report(s) : US-PFIZER INC-PV202200026265 same reporter/product/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rls" (unspecified if ongoing), notes: Rls. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Prolonged duration of testing Positive 19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had increased blood glucose levels, Increased night sweats and Prolonged duration of testing Positive 19. This report was about COVID-19 treatment. Patient did receive the vaccine. Patient did not receive other medications in 2 weeks. Patient received treatment for COVID-19 as Paxlovid from 28May2022 to 22May2022. It was reported that patient had no known allergies. For treatment Prescribed Metformon.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 16May2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Nov2021 as dose 3, (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "low hemoglobin (possibly mild Thalassemia)" (unspecified if ongoing). Concomitant medication(s) included: NUVARING; VITAMIN B12 [CYANOCOBALAMIN]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2weeks: Yes; Anti viral details: product=COVID 19 Treatment, treatment start date=02Jul2022, treatment stop date=06Jul2022, indication=Treatment of COVID-19. Other medication details, other medication in 2weeks product=Nuvaring, other medication in 2weeks product=B12 supplements. Known allergies: no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 04Apr2021 as dose 2, single (Lot number: ER8737) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Dec2021 as dose 3 (booster), single (Lot number: 012H21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: indication, treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected. Anti viral details [{product=COVID 19 Treatment, brand=Paxlovid, treatment start date=19Jul2022, indication=Treatment of COVID-19, administrator route=Oral. Covid vaccine details [{vaccine brand=Other, vaccine brand other=Moderna, vaccine brand unknown=False, vaccine administration date=03Dec2021, vaccine lot number=012H21A, vaccine lot unknown=False, vaccine dose number=3, vaccine dose number unknown=False, vaccine location=Left arm}, {vaccine brand=Pfizer / BioNTech, vaccine brand unknown=False, vaccine administration date=04Apr2021, vaccine lot number=ER8737, vaccine lot unknown=False, vaccine dose number=2, vaccine dose number unknown=False, vaccine location=Left arm}, {vaccine brand=Pfizer / BioNTech, vaccine brand unknown=False, vaccine administration date=11Mar2021, vaccine lot number=EN6208, vaccine lot unknown=False, vaccine dose number=1, vaccine dose number unknown=False, vaccine location=Left arm}] Adverse event: A bad taste in mouth. Adverse event start date: 19Jul2022. AE resulted in: [None of the above]. If patient recovered: Not recovered. If treatment AE: No. Known allergies: no. Other medical history: none.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: One child's father said his child dropped dead after getting 2nd dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER: UNKNOWN), for Covid-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "One child's father said his child dropped dead after getting 2nd dose.". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical Course: It was reported that reporter had a product complaint. Pfizer was using social media and trying to get parents to get 5 year olds vaccinated. Reporter had several children in the (name-withheld) die after getting the doses. There was not news coverage, and she goes to local town meetings. One child's father said his child dropped dead after getting 2nd dose. These are young healthy children. Reporter did not have any specific information to provide on any of these children to complete a report for.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: One child's father said his child dropped dead after getting 2nd dose.
Sex: U
Vaccine: COVID19
Symptoms: Death, Myocarditis
Clinical narrative: dropped dead on the soccer field; Another child has Myocarditis after getting it and dropped dead on the soccer field.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "dropped dead on the soccer field"; MYOCARDITIS (medically significant), outcome "unknown", described as "Another child has Myocarditis after getting it and dropped dead on the soccer field.". The patient date of death was unknown. Reported cause of death: "dropped dead on the soccer field". It was not reported if an autopsy was performed.  Clinical Course: It was reported that, reporter had a caller on the line to complain about the Pfizer COVID 19 vaccine. She did not specify the complaint. Caller stated she had a product complaint. Pfizer was using social media and trying to get parents to get 5 year old vaccinated. She had several children in the (name-withheld) die after getting the doses. There was not news coverage and she goes to local town meetings. One child's father said his child dropped dead after getting 2nd dose. Another child had Myocarditis after getting it and dropped dead on the soccer field. These were young healthy children. She did not had any specific information to provide on any of these children to complete a report for. She was genuinely disgusted for people to gave their children something like sacrificial lambs. She does not know how call handler sleeps at night working for this company. She had a friend who works at (name-withheld) and said that people were sick in ICU after getting vaccine with complications from it. She did not had any specific information to provide on any of these patients to complete a report for. She did not wish to provide an address or email. If someone calls with an adverse event, she said do not censor it and make it count. She does not trust Pfizer. She just does not understand why Pfizer was pushing to vaccinate these young children when the virus does not even affect them.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: dropped dead on the soccer field
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21May2021 at 17:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 26Aug2021 at 16:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28May2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing); "Multiple Sclerosis" (unspecified if ongoing). Concomitant medication(s) included: CEFDINIR, start date: 07Jul2022, stop date: 13Jul2022; EZETIMIBE; PRAVASTATIN; RITUXIMAB, start date: 06Jul2022, stop date: 06Jul2022. The following information was reported: COVID-19 (medically significant) with onset 19Jul2022, outcome "not recovered", described as "SARS-CoV-2 infection"; VACCINATION FAILURE (medically significant) with onset 19Jul2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I was still testing negative at this time; (19Jul2022) positive, notes: tested today 19Jul2022 and I am positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient in his 20's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for Covid". The event "positive for covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Ultrasound scan: 3 blocked veins, notes: one going from liver to heart, another from intestines to liver, and one other one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8737), in right arm, on 22Apr2021 as dose 2, single (Lot number: ER8735), in right arm, on 18Dec2021 as dose 3 (booster), single (Lot number: FD7218), in left arm and on 13May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2022) Negative, notes: Tested neg on (Test Kit Name withheld) molecular 11Jul2022; (17Jul2022) Positive, notes: Tested positive on (Test Kit Name withheld) molecular 17Jul, 18Jul and still positive on 19Jul; (18Jul2022) Positive, notes: Tested positive on (Test Kit Name withheld) molecular 17Jul, 18Jul and still positive on 19Jul; (19Jul2022) Positive, notes: Tested positive on (Test Kit Name withheld) molecular 17Jul, 18Jul and still positive on 19Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical Course:Anti-viral details Product COVID 19 Treatment, Brand Paxlovid, Treatment start date Jul2022. Treatment stop date: Jul2022. Indication: Treatment of COVID-19. Adverse events start date was 17Jul2022. AE resulted in none of the above.  Patient was not recovered, no treatment AE.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 39-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 38 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: "Depression" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Cephalosporin and Penicillin. Concomitant medication(s) included: CITALOPRAM. Past drug history included: Cephalosporin, reaction(s): "Known allergies: Cephalosporin", notes: Known allergies: Cephalosporin and Penicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Product: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Age: 58.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 58 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 had no relevant medical history. Concomitant medication(s) included: BIJUVA, start date: 10Jul2022, stop date: 14Jul2022; SERTRALINE, start date: 10Jul2022, stop date: 14Jul2022; HYDROCHLOROTHIAZIDE, start date: 10Jul2022, stop date: 14Jul2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 19Jul2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Positive. Therapeutic measures were not taken as a result of covid-19, drug ineffective. Clinical course: It was reported that the patient had symptoms including cough, congestion, fatigue.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: contracted Covid-19; contracted Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 02Apr2021 as dose 2, single (Lot number: EW0150), in left arm and on 02Jun2022 as dose 3 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing), notes: High Blood Pressure. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "unknown" and all described as "contracted Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2022) Positive, notes: He was diagnosed on 11Jul2022./ Date of start of reaction/event: 11Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: While reporting on herself the caller mentioned that the person that lives in the house where she lives is fully vaccinated and that is who she contracted Covid-19 from. The caller said that he also took Paxlovid with her. He took the same medication Paxlovid also. He was more ill than his wife was even though he was vaccinated. He was sicker than she was. He was diagnosed on 11Jul2022 with Covid and started taking Paxlovid on 12Jul2022.   No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 33-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. Concomitant medication(s) included: MOTRIN [IBUPROFEN]. 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 34.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, 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: "Breast cancer" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing); "Known allergies: Nut allergy" (unspecified if ongoing), notes: Known allergies: Nut allergy. Concomitant medication(s) included: ALLEGRA; CALCIUM; CRANBERRY; FLONASE [FLUTICASONE PROPIONATE]; VITAMIN B 12 [CYANOCOBALAMIN]; VITAMIN D [COLECALCIFEROL]; ZINC; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had taken other medication in 2weeks.Treatment start date provided as 23Jun2022 and treatment stop date 27Jun2022. Vaccine lot unknown reason were not available/provided to reporter at the time of report completion. Adverse event reported that Patient had diarrhea for 5 days and patient recovered. Reported as treatment adverse event. Adverse event treatment given as Imodium.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid symptoms on 05Jul2022. Covid antigen positive; disease recurrence; Covid symptoms on 05Jul2022. Covid antigen positive; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 07Jan2021 as dose 2, single (Lot number: EL1284), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: 3013584) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Celiac Disease" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Known allergies : PCN" (unspecified if ongoing). Concomitant medication(s) included: CABERGOLINE; COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; VITAMIN D [VITAMIN D NOS]; ZINC. Past drug history included: C-clor, reaction(s): "Known allergies : C-clor", notes: Known allergies : C-Clor.  The following information was reported: COVID-19 (medically significant) with onset 05Jul2022, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "Covid symptoms on 05Jul2022. Covid antigen positive"; DISEASE RECURRENCE (medically significant) with onset 18Jul2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Covid Antigen Positive; (07Jul2022) Positive; (12Jul2022) Negative, notes: No Covid symptoms and negative covid antigen test on12Jul2022; (19Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence.  Clinical course: Covid symptoms on 05Jul2022. Covid antigen positive and Paxlovid started on 06Jul2022. Covid per positive on 07Jul2022. No Covid symptoms and negative covid antigen teston12Jul2022.Covid symptoms restarted on 18Jul2022. Covid antigen positive on 19Jul2022. Ae treatment was Z-Pack for sinus infection.  No follow-up attempts are possible; No further information is expected.
Age: 27.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 2, single (Lot number: Fh8028) at the age of 27 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Major depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2 Weeks was No. Patient reported that she had no known allergies. The patient received anti-viral COVID 19 Treatment from 30Jun2022 to 04Jul2022.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, 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) (Physician).  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2022 as dose 1, single (Lot number: EN6199) and on 13Apr2022 as dose 2, single (Lot number: ER8732) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE oral, start date: 16Jul2022, stop date: Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: 30-35; SARS-CoV-2 test: Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
Age: 63.0
Sex: F
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 a contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 17Mar2021 as dose 2, single (Lot number: EN6207), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Apr2022 at 15:15 as dose 4 (booster), single (Lot number: 033K21214), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulphate" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: asa, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Antigenic test slightly positive the days ago; (unspecified date) Unknown result, notes: Treatment of COVID-19; (19Jul2022) Positive, notes: today very positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received treatment with Paxlovid, treatment start date: 08Jul2022, treatment stop date: 12Jul2022,; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of vaccination failure, covid-19..
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 contactable reporter(s) (Other HCP).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing), notes: Other medical history: Htn; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results, notes: Rebound Covid after Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid administrator route Oral. Treatment start date 10Jul2022, Treatment top date 14Jul2022.  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 events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have ringing in my ears after getting the vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jul2022 at 17:00 as dose 4 (booster), single (Lot number: FN2908) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: None" (unspecified if ongoing), notes: Known allergies: No. Concomitant medication(s) included: RESTASIS; FISH OIL. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "I have ringing in my ears after getting the vaccine.". Therapeutic measures were not taken as a result of tinnitus.
Age: 63.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: ER8737), on 21Apr2021 as dose 2, single (Lot number: EW0170), on 23Nov2021 as dose 3 (booster), single (Lot number: FD0809) and on 03May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "total knee replacement", start date: Jan2022 (unspecified if ongoing); "Allergy: Sulfa drugs" (unspecified if ongoing), notes: Allergy: Sulfa drugs; "Allergy: gluten intolerance" (unspecified if ongoing), notes: Allergy: gluten intolerance. The patient took concomitant medications.Past drug history included: Cephalosporins, reaction(s): "Allergy: cephalosporins", notes: Allergy: cephalosporins. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jul2022) Negative; (19Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient took other medication in 2weeks details included too many supplements to list, other medication in 2weeks start date: 01Jul2020, other medication in 2weeks stop date: 20Jul2022. Anti viral details: [product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 06Jul2022, treatment stop date: 10Jul2022, indication:Treatment of COVID-19].Paxlovid rebound after full recovery. Tested negative on 16Jul2022 (antigen test). Started feeling bad again (marked increase in coughing and fatigue). Tested positive again on 19Jul2022 (antigen test).Known allergies included sulfa drugs, cephalosporins, and gluten intolerance and Other medical history: total knee replacement Jan2022.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chills, Pyrexia, Vomiting
Clinical narrative: Fever; Chills; Vomiting; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the parent.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 17Jun2022 as dose number unknown (orange cap; booster), single (Lot number: FL8095, Expiration Date: 30Aug2022) 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: PYREXIA (non-serious), outcome "recovered", described as "Fever"; CHILLS (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The report was not related to a study or programme. The patient is not also the reporter. The person that reported it to caller is a doctor and it was the doctor's child that had an adverse event. The adverse events that were reported were fever, chills, and vomiting that lasted a day and a half and then resolved. This was the patient's booster dose. It was given on 17Jun2022. Caller states he is unsure when the fever, chills, and vomiting started, but he assumes it started the same day the patient got the booster dose, but reporter doesn't know for sure. The reporter clarified that the patient received the Pfizer BioNTech Covid Vaccine, orange cap. The reporter stated he also had product misuse or product storage issue to report for the Pfizer BioNTech Covid Vaccine. The reporter's office was told by the Health Department that once they get it shipped to them it could stay in freezer for 2 weeks and then be use after that. The reporter stated the product can't be frozen. The office was going to probably have to discard everything. The office called the person at the Health Department who thought the office's freezer was an ultra-low freezer, but it wasn't. Someone had told them it was good for 2 weeks in freezer. The reporter stated that it was specifically the orange cap Pfizer BioNTech Covid Vaccine, but may have effected the maroon cap, and possibly the purple and gray cap too. Basically anything they had. Patient Involvement: it is all of the doctor's patients and reporter didn't have a number. The reporter is not sure how many they gave. The doctor's daughter who had the adverse events of fever, chills, and vomiting would have been one of the patients involved. The doctor tested her daughter for antibodies and her daughter did have antibodies.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: contracted covid; contracted covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) received via COVID-19.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: 037A21B), in left arm, on 30Apr2021 as dose 2, single (Lot number: 006C21A), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 32 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient received other vaccine in four weeks.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jul2022, outcome "recovering" and all described as "contracted covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. It was unknown if patient had covid prior vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had the Pfizer shots and a booster last year and tested positive two weeks ago; Had the Pfizer shots and a booster last year and tested positive two weeks ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Had the Pfizer shots and a booster last year and tested positive two weeks ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. Clinical course: It was reported that when queried which Pfizer product he was calling regarding he stated he is actually not. Patient clarified that "he had the Pfizer shots and a booster last year and tested positive two weeks ago". Patient wants to know how long does this thing last or is there anything he can take. Patient stated after a week it is usually over. Patient said it isn't bad it just a cold, like getting a cold. He can't smell, can't taste. Should he call his local doctor. Patient declined to proceed with the report and stated he will call his personal doctor.  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: Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First Booster dose, unknown manufacturer), for covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 19Jul2022, outcome "unknown". Additional information: The reporter's wife got the second booster today (19Jul2022) and she is experiencing chills.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity, Peripheral swelling, Seizure, Vomiting
Clinical narrative: I was feeling like I was having a seizure; I threw up and had the diarrhea; I threw up and had the diarrhea; pain and swelling in the extremities.; pain and swelling in the extremities.; 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 69-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for covid 19 immunization.  The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "I was feeling like I was having a seizure"; VOMITING (non-serious), DIARRHOEA (non-serious), outcome "unknown" and all described as "I threw up and had the diarrhea"; PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), outcome "unknown" and all described as "pain and swelling in the extremities.". Follow-up attempts are completed. No further information is expected.  Clinical course: The reporter stated that after receiving the Pfizer covid 2nd and 1st booster shots exactly after 12hours the patient arms flew around uncontrollably (less than a minute). she had the common effect of throwing up with diahhrea but the arms scared me enough that I'm concerned about getting the last booster. Has this been a common reaction ? My doctor didn't know." Reporter stated that her arms started swinging around like crazy besides throwing up and diarrhea after receiving the Pfizer COVID-19 Vaccine. Reporter described it as like having a seizure. Reporter stated that her doctor wasn't aware of anything. Reporter stated that she was told that the only information we had were pain and swelling in the extremities. Caller mentioned that she might not get the next booster dose.  No follow-up attempts are possible; iformation about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 34-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 25Apr2021 as dose 2, single (Lot number: EW0176), in left arm and on 13Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 33 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19".  Clinical course :No other medication in 2 weeks of Covid-19 vaccination.