chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient reported tingling sensation in arm after vaccination. Later reported numbness in fingers
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Fatigue, Malaise
Clinical narrative: After this vaccine, I cought COVID for the first time.  Since, I have been sick four times each lasting more then a week with lingering coughs and tiredness.  Prior to the vaccine it would be unsual for me to get sick once a year and have any sickness last more.then a few days.  I never had lingering coughs prior to this vaccine.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Off label use, Overdose, Product administered to patient of inappropriate age
Clinical narrative: mild headache + fatigue; mild headache + fatigue; 4 year old female received 1st dose of Pfizer COVID 19 Vaccine. They gave the child the orange cap formulation, Pfizer COVID 19 Vaccine instead of the maroon cap; 4 year old female received 1st dose of Pfizer COVID 19 Vaccine. They gave the child the orange cap formulation, Pfizer COVID 19 Vaccine instead of the maroon cap; Vaccine Name: Proquad, Date: 01Aug2022/Vaccine Name: Kinrix, Date: 01Aug2022; Vaccine Name: Proquad, Date: 01Aug2022/Vaccine Name: Kinrix, Date: 01Aug2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID: (159558).  A 4-year-old female patient received BNT162b2 (BNT162B2), on 01Aug2022 as dose 1 (orange cap), single (Lot number: FL8094, Expiration Date: 31Aug2022) at the age of 4 years intramuscular, in left arm for covid-19 immunisation; measles vaccine live (enderS-edmonston), mumps vaccine live, rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (PROQUAD), on 01Aug2022 as dose number unknown, single (Lot number: W004028) subcutaneous, in left arm for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), on 01Aug2022 as dose number unknown, single (Lot number: H9917) intramuscular, in right arm for immunisation. The patient's relevant medical history included: "COVID", start date: 17Jul2022, stop date: 17Jul2022, notes: Brief illness-totally resolved prior to visit. There were no concomitant medications.  The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 01Aug2022, outcome "unknown" and all described as "4 year old female received 1st dose of Pfizer COVID 19 Vaccine. They gave the child the orange cap formulation, Pfizer COVID 19 Vaccine instead of the maroon cap"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 01Aug2022, outcome "unknown" and all described as "Vaccine Name: Proquad, Date: 01Aug2022/Vaccine Name: Kinrix, Date: 01Aug2022"; HEADACHE (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "mild headache + fatigue".  Additional information: It was reported that the patient had mild headache and fatigue for 1-2 days after administration.  Follow-Up (23Aug2022): Follow-up attempts are completed. No further information is expected.  Follow up (06Sep2022): This is a spontaneous follow-up report from a contactable Physician. This Physician reported in response to HCP follow-up letter sent that included: Updated Information Included: Reporter Information, facility information, dosage regimen, RMH and New adverse events.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: mild headache + fatigue; mild headache + fatigue; 4 year old female received 1st dose of Pfizer COVID 19 Vaccine. They gave the child the orange cap formulation, Pfizer COVID 19 Vaccine instead of the maroon cap; 4 year old female received 1st dose of Pfizer COVID 19 Vaccine. They gave the child the orange cap formulation, Pfizer COVID 19 Vaccine instead of the maroon cap; Vaccine Name: Proquad, Date: 01Aug2022/Vaccine Name: Kinrix, Date: 01Aug2022; Vaccine Name: Proquad, Date: 01Aug2022/Vaccine Name: Kinrix, Date: 01Aug2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID: (159558).  A 4-year-old female patient received BNT162b2 (BNT162B2), on 01Aug2022 as dose 1 (orange cap), single (Lot number: FL8094, Expiration Date: 31Aug2022) at the age of 4 years intramuscular, in left arm for covid-19 immunisation; measles vaccine live (enderS-edmonston), mumps vaccine live, rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (PROQUAD), on 01Aug2022 as dose number unknown, single (Lot number: W004028) subcutaneous, in left arm for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), on 01Aug2022 as dose number unknown, single (Lot number: H9917) intramuscular, in right arm for immunisation. The patient's relevant medical history included: "COVID", start date: 17Jul2022, stop date: 17Jul2022, notes: Brief illness-totally resolved prior to visit. There were no concomitant medications.  The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 01Aug2022, outcome "unknown" and all described as "4 year old female received 1st dose of Pfizer COVID 19 Vaccine. They gave the child the orange cap formulation, Pfizer COVID 19 Vaccine instead of the maroon cap"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 01Aug2022, outcome "unknown" and all described as "Vaccine Name: Proquad, Date: 01Aug2022/Vaccine Name: Kinrix, Date: 01Aug2022"; HEADACHE (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "mild headache + fatigue".  Additional information: It was reported that the patient had mild headache and fatigue for 1-2 days after administration.  Follow-Up (23Aug2022): Follow-up attempts are completed. No further information is expected.  Follow up (06Sep2022): This is a spontaneous follow-up report from a contactable Physician. This Physician reported in response to HCP follow-up letter sent that included: Updated Information Included: Reporter Information, facility information, dosage regimen, RMH and New adverse events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: She did poorly with 2nd Covid shot, she started passing out; light headed/dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (086396). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 12Feb2021 at early afternoon as dose 2, single (Lot number: E19269) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Asthmatic" (ongoing), notes: takes medication as needed diagnosed as a kid, Continuing: True; "Labyrinthitis" (unspecified if ongoing), notes: takes Anitvert as neeed. Was diagnosed years ago.; "Slipped disc in back L4-L5" (unspecified if ongoing), notes: take Nabumetone; "Acid reflux sometimes will take something like Tums that is over the counter" (unspecified if ongoing), notes: Acid reflux sometimes will take something like Tums that is over the counter; "Lactose intolerant" (unspecified if ongoing), notes: Lactose intolerant will take a Lactaid pill before something with milk; "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Menopause" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Preventative for heart" (unspecified if ongoing); "Dry eyes" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased (started years ago; 10mg daily) ; LEVOTHYROXINE taken for hypothyroidism (started years ago; 25mcg daily) ; PREMPRO oral taken for menopause (started years ago keeps her sane. she wasn't sleeping, concentrating she was shivering sweating, was a mess; 0.3mg/1.5mg three times a week orally); RAMIPRIL taken for hypertension (started years ago; 10mg once daily); ECOTRIN taken for cardiac disorder (started years ago; 81mg once a day); RESTASIS taken for dry eye (started years ago; 0.05% 1 drop each eye daily); FAMOTIDINE taken for reflux gastritis, NABUMETONE taken for pain, intervertebral disc protrusion. Vaccination history included: BNT162b2 (Dose: 1; lot: E13247), administration date: 22Jan2021, when the patient was 73-year-old, for Covid-19 immunization.  The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 12Feb2021, outcome "unknown", described as "She did poorly with 2nd Covid shot, she started passing out"; DIZZINESS (non-serious) with onset 12Feb2021, outcome "unknown", described as "light headed/dizzy".  Clinical summery: She did poorly with 2nd Covid shot, she started passing out. She had had to drive to beach for the shot and as soon as she got it she got light headed and dizzy. They asked if they needed to call EMS to look at her and she said no and put her head down and waited half hour and felt better was able to drive home.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Accidental exposure to product, Exposure during pregnancy, Exposure via eye contact
Clinical narrative: The caller mentioned the patient's mother is pregnant; some patient's mother that somehow got some Prevnar 13 in her eye; some patient's mother that somehow got some Prevnar 13 in her eye; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A female patient (pregnant) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE DURING PREGNANCY (intervention required), described as "The caller mentioned the patient's mother is pregnant"; ACCIDENTAL EXPOSURE TO PRODUCT (intervention required), EXPOSURE VIA EYE CONTACT (intervention required) and all described as "some patient's mother that somehow got some Prevnar 13 in her eye". Caller mentioned that "we hot some patient's mother that somehow got some Prevnar 13 in her eye. I was calling to see if there should be any extra concern besides flushing the eye out". The caller mentioned the patient's mother is pregnant.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 38.0
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) (Other HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 38 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included in 2 weeks: ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Aug2022, stop date: 31Aug2022. The patient had no known allergies. The patient was not pregnant at time of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Aug2022, outcome "unknown", COVID-19 (medically significant) with onset Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Rebound infection beginning on 26Aug. Therapeutic measures were taken as a result of covid-19. Clinical course: Therapeutic measures included, Anti-viral details: Product: COVID 19 Treatment, Brand: Pfizer, Treatment started on 17Aug2022 and stopped on 22Aug2022, Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got COVID again after doing the full course of the treatment; Got COVID again after doing the full course of the treatment; Got COVID again after doing the full course of the treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL3246), on 29Jan2021 as dose 2, single (Lot number: EL8982) and on 24Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 85 years for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 13Apr2022 as dose 4 (booster), single (Lot number: 046LZ14) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE, start date: Jan2000; METFORMIN HCL, start date: Jan2000; NIFEDIPINE, start date: Jan2000; IRBESARTAN, start date: Jan2000; PRESERVISION, start date: Jan2010; HESPERIDIN, start date: Jan2010. Past drug history included: Ibuprofen, reaction(s): "allergies: ibuprofen". The following information was reported: DISEASE RECURRENCE (medically significant) with onset 27Aug2022, outcome "recovered with sequelae" (31Aug2022), VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered with sequelae" and all described as "Got COVID again after doing the full course of the treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Got COVID again after doing the full course of the treatment; (27Aug2022) Positive, notes: Got COVID again after doing the full course of the treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: Paxlovid start date: 17Aug2022, Treatment stop date: 21Aug2022 Indication:COVID 19 Treatment, Administrator route: Oral  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine_brand=Pfizer / BioNTech;vaccine_brand_other=ModernaModerna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 04Jun2022 as dose 4 (booster), single (Lot number: FM0173) for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 24Feb2021 as dose 1, single (Lot number: 010A21A), on 24Mar2021 as dose 2, single (Lot number: 045A21A) and on 29Nov2021 as dose 3 (booster), single (Lot number: 013F21A) for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "kidney disease" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; LEVOTHYROXINE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 04Jun2022, outcome "unknown", described as "vaccine_brand=Pfizer / BioNTech;vaccine_brand_other=ModernaModerna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Aug2022) Positive, notes: Finished the Paxlovid yesterday. Tested positive today. Therapeutic measures were taken as a result of drug ineffective, covid-19. with Paxlovid from 25Aug2022 to 30Aug2022.  Clinical course: It was reported that paxlovid completed yesterday and again tested positive today.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine_brand=Pfizer / BioNTech;vaccine_brand_other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Mar2021 as dose 1, single (Lot number: 030A21A), in left arm, on 15Apr2021 as dose 2, single (Lot number: 021B21A), in left arm and on 25Oct2021 as dose 3 (booster), single (Lot number: 006D21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Non-radiographic Axial Spondylarthropothy" (unspecified if ongoing); "Pain" (unspecified if ongoing), notes: Maintenance med for pain; "Back pain" (unspecified if ongoing), notes: Back pain medication. Concomitant medication(s) included: ENALAPRIL MALEATE taken for hypertension, start date: Jan2022; HYDROCODONE/ACETAMINOPHEN taken for pain, start date: Jan2022; VOLTAREN [DICLOFENAC DIETHYLAMINE] taken for back pain, start date: Jan2015; MAGNESIUM OXIDE. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 14Apr2022, outcome "unknown", described as "vaccine_brand=Pfizer / BioNTech;vaccine_brand_other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Positive; (19Aug2022) Negative, notes: rapid test; (22Aug2022) Positive; (31Aug2022) Negative, notes: Rapid antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that COVID symptoms started on 13Aug and then tested positive on 14Aug2022. Started first round of paxlovid same day on 14Aug2022. Took the entire five doses with final dose on 19Aug2022 in the a.m. Felt better and tested negative with rapid test on 19Aug2022. Rebound occurred and tested again on 22Aug2022 and was positive.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; Vaccine_brand=Pfizer / BioNTech;vaccine_brand_other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Batch/Lot number: unknown), on 13Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing), notes: Known allergies: sulfa; "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 18May2022, outcome "unknown", described as "Vaccine_brand=Pfizer / BioNTech;vaccine_brand_other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxovid from 19Aug2022 to 23Aug2022.  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 vaccination failure, Covid-19 and interchange of vaccine products with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8729), in right arm and on 03Dec2021 as dose 3 (booster), single (Lot number: FH8036) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Mild asthma. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti viral details: Product: COVID 19 treatment. COVID vaccine details: Vaccine brand: Pfizer / BioNTech. No known allergies reported.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 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: "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) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had Antiviral treatment for COVID-19 on 23Aug2022 to 28Aug2022 and patient had Rebound of symptoms 3 days after completing treatment. Mostly sore throat and exhaustion has returned, but also increased congestion too.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4375465-00.  A 55-year-old female patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) Unknown Results.  Clinical information: In 2021, the patient experienced COVID. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality with Covid-19 vaccine was reported as possible as per the reporter for events of covid-19 and 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 available information the events Drug ineffective and suspected  Covid-19 assessed as related to the suspect drug BNT162b2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, Pyrexia
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; I have rebound covid now, five days after completing paxlovid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "not recovered", described as "I have rebound covid now, five days after completing paxlovid."; 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: Pyrexia: (Aug2022) slight fever, notes: I have a slight fever, and cough and cold symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: No, Other medication in 2 weeks. Anti-viral medication for COVID-19 Treatment, brand Paxlovid, Treatment started on 02Aug2022 and stop on 06Aug2022. No, treatment for AE. No known allergies. patient had rebound covid now, five days after completing paxlovid. Patient had a slight fever, and cough and cold symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine headaches after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years 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, reaction(s): "COVID-19". The following information was reported: MIGRAINE (non-serious) with onset 19Jan2021, outcome "not recovered", described as "migraine headaches after receiving the vaccine". The event "migraine headaches after receiving the vaccine" required physician office visit. Therapeutic measures were taken as a result of migraine.  Additional information: It was reported that the patient had ongoing migraine headaches after receiving the vaccine. Stated that 3 hours after the second dose of Pfizer Covid Vaccine on 19Jan2021, she started having migraines. Migraines ran all day. She could sleep but when she woke, she had them. She was seeing a neurologist. She worked at Hospital, that's why she was able to get it so soon; although she was not clinical. The migraines were exacerbated by loud noise and high-pitched sounds; like if the fire alarm went off at work she had to leave. They had tried a multitude of things but she had no relief. She saw the neurologist and told them she had run out of options, asked what they could do and the neurologist told her they could try surgery. She had tried 13 medicines. It was not easy to work, but she had to work. She did have the booster dose of Pfizer Covid Vaccine she thought in the fall and her symptoms did not change after the booster; but she was still (at the time of this report) suffering. Onset latency of event Migraine headache was 3 hours after vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 72-year-old male patient 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: ATORVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID]; LIPITOR; multivitamin (unspecified). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (26Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19; COVID 19 Treatment included Paxlovid from 21Aug2022 to 26Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The contribution of the suspect drug to the onset of event "COVID 19 treatment" cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Apr2021 at 15:00 as dose 2, single (Lot number: EW0173), in left arm and on 14Dec2021 at 16:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D3, start date: 17Feb2020; OMEGA-3 [OMEGA-3 NOS], start date: 17Feb2020; LIPOSOMAL VITAMIN C, start date: 17Feb2020; ADREN ALL, start date: Jan2019; BONE UP, start date: Jan2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Sep2022 at 06:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2022) Positive, notes: Rebound symptoms and Covid-positive test 7 days after completion of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti viral treatment with Paxlovid was started on 19Aug2022 and stopped on 24Aug2022. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: Em9809), in left arm and on 24Feb2021 as dose 2, single (Lot number: En6203) at the age of 42 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Dec2021 as dose 3 (booster), single (Lot number: 012h21b), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure and covid-19 included Paxlovid started on 21Aug2022 and stopped on 26Aug2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the reported events and suspect cannot be excluded .The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 71-year-old female 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) 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 31Aug2022, outcome "recovering" and all described as "Tested positive for Covid". The event "tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Aug2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: The patient had no covid prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: hearing loss; tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "hearing loss"; TINNITUS (non-serious), outcome "unknown".   Clinical course: He wants to know the prevalence of tinnitus and seeks recommendations to tell the patient. Caller said he does not have the information right now regarding which vaccine formulation or color of vaccine cap was administered. He wants to know the frequency of reports with tinnitus. He also wants to know if there are any reports of hearing loss. He also asked for the number of subjects for each study arm who reported hearing loss. Caller states that they have a patient who had a reaction to the vaccine. Caller states that they are curious about any guidance for this case? What is the prevalence of tinnitus with this vaccine?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, Inappropriate schedule of product administration, Magnetic resonance imaging head, SARS-CoV-2 test
Clinical narrative: recurrent headaches/ Headache pain; right eye pain; Dose Number: 1: 21Sep2021; Dose Number: 2: 22Sep2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 22Sep2021 at 17:00 as dose 2, single (Lot number: 30130BA) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertentsion" (unspecified if ongoing), notes: Other medical history: Hypertentsion. Concomitant medication(s) included: CARVEDILOL. Vaccination history included: pfizer (Dose Number: 1, Batch/Lot No: FC3182, Location of injection: Arm Right, Vaccine Administration Time: 05:00 PM), administration date: 21Sep2021, when the patient was 40-year-old, for COVID-19 immunization, reaction(s): "right eye pain", "headaches". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Sep2021 at 17:00, outcome "unknown", described as "Dose Number: 1: 21Sep2021; Dose Number: 2: 22Sep2021"; HEADACHE (non-serious) with onset 23Sep2021 at 00:15, outcome "not recovered", described as "recurrent headaches/ Headache pain"; EYE PAIN (non-serious) with onset 23Sep2021 at 00:15, outcome "not recovered", described as "right eye pain". The events "recurrent headaches/ headache pain" and "right eye pain" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, eye pain.  Additional information: It was reported that, patient experienced headaches within days of receiving first dose 21Sep2021, and recurrent headaches, right eye pain ever since until the day. Patient had most days out of the week with headaches, most hours of the day with headaches and never had a history of headaches. Patient had to visit ophthalmologist and had MRI performed on brain. The patient received MRI, daily medications (MEDs) for Headache PAIN. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201112994 Same pateint/vaccine/event, different vaccine dose;
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Musculoskeletal pain, Pain in extremity, Pruritus, Rash
Clinical narrative: itchy; Lost weight; Pain in feet, buttocks; Pain in feet, buttocks; Lose his balance when he stands up; Rash; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: 3014SA) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot Number / Expiry Date: 19EJ1686/ Mar2021), administration date: 15Jan2021, when the patient was 81-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Lot Number / Expiry Date: 19623/ unknown), administration date: 05Feb2021, when the patient was 81-year-old, for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset Dec2021, outcome "recovering"; BALANCE DISORDER (disability, medically significant) with onset Jan2022, outcome "not recovered", described as "Lose his balance when he stands up"; WEIGHT DECREASED (disability) with onset Jan2022, outcome "not recovered", described as "Lost weight"; PAIN IN EXTREMITY (disability), MUSCULOSKELETAL PAIN (disability) all with onset Jan2022, outcome "unknown" and all described as "Pain in feet, buttocks"; PRURITUS (non-serious), outcome "unknown", described as "itchy". The events "rash" and "itchy" required physician office visit. Therapeutic measures were taken as a result of rash.  Clinical course: Patient states he got his third dose, clarified as first booster and had issues. States in December, he got a rash: armpits, neck, shoulder, down his leg, it was streaky and itchy. States his dermatologist said it was due to the vaccine. Patient lost weight: fat off feet, buttocks, chest, lost 12 pounds, pain in feet, bone on bone. He loses his balance when he stands up. The patient will be having an MRI on 19Sep2022. Vaccination Facility Type was reported as pharmacy. Prior vaccinations within 4 weeks were reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: itchy; Lost weight; Pain in feet, buttocks; Pain in feet, buttocks; Lose his balance when he stands up; Rash; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: 3014SA) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot Number / Expiry Date: 19EJ1686/ Mar2021), administration date: 15Jan2021, when the patient was 81-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Lot Number / Expiry Date: 19623/ unknown), administration date: 05Feb2021, when the patient was 81-year-old, for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset Dec2021, outcome "recovering"; BALANCE DISORDER (disability, medically significant) with onset Jan2022, outcome "not recovered", described as "Lose his balance when he stands up"; WEIGHT DECREASED (disability) with onset Jan2022, outcome "not recovered", described as "Lost weight"; PAIN IN EXTREMITY (disability), MUSCULOSKELETAL PAIN (disability) all with onset Jan2022, outcome "unknown" and all described as "Pain in feet, buttocks"; PRURITUS (non-serious), outcome "unknown", described as "itchy". The events "rash" and "itchy" required physician office visit. Therapeutic measures were taken as a result of rash.  Clinical course: Patient states he got his third dose, clarified as first booster and had issues. States in December, he got a rash: armpits, neck, shoulder, down his leg, it was streaky and itchy. States his dermatologist said it was due to the vaccine. Patient lost weight: fat off feet, buttocks, chest, lost 12 pounds, pain in feet, bone on bone. He loses his balance when he stands up. The patient will be having an MRI on 19Sep2022. Vaccination Facility Type was reported as pharmacy. Prior vaccinations within 4 weeks were reported as none. Additional vaccines administered on same date of the Pfizer Suspect was reported as none.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 2 days later it came back and we are again positive; 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 70-year-old male patient received BNT162b2 (BNT162B2), on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 14Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 26Aug2022, outcome "unknown", described as "2 days later it came back and we are again positive". 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 which included paxlovid from 19Aug2022 to 23Aug2022. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course information: Reported as, No other medication within 2 weeks. Both Patient and his wife had Paxlovid. After taken course they were negative however 2 days later it came back and they were again positive.  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-202201114829 Same reporter/vaccine/event, different patient;