chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Tiredness; headache; muscle pain; chills; feverish without a fever; joint pain; nausea; swollen throat; diarrhea; vomiting; brand Pfizer-BioNTech COVID-19 Bivalent/ dose number=1; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 1, single (Lot number: GL0446) at the age of 58 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 15Dec2022, outcome "recovered", described as "Tiredness"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 15Dec2022, outcome "unknown", described as "brand Pfizer-BioNTech COVID-19 Bivalent/ dose number=1"; CHILLS (non-serious) with onset 15Dec2022, outcome "recovered"; DIARRHOEA (non-serious) with onset 15Dec2022, outcome "recovered", described as "diarrhea"; PYREXIA (non-serious) with onset 15Dec2022, outcome "recovered", described as "feverish without a fever"; HEADACHE (non-serious) with onset 15Dec2022, outcome "recovered"; ARTHRALGIA (non-serious) with onset 15Dec2022, outcome "recovered", described as "joint pain"; MYALGIA (non-serious) with onset 15Dec2022, outcome "recovered", described as "muscle pain"; NAUSEA (non-serious) with onset 15Dec2022, outcome "recovered"; PHARYNGEAL OEDEMA (non-serious) with onset 15Dec2022, outcome "recovered", described as "swollen throat"; VOMITING (non-serious) with onset 15Dec2022, outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient did not receive other vaccine in four weeks. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was tested post vaccination on 16Dec2022 vial nasal swab with negative result.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pharyngeal oedema, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tiredness; headache; muscle pain; chills; feverish without a fever; joint pain; nausea; swollen throat; diarrhea; vomiting; brand Pfizer-BioNTech COVID-19 Bivalent/ dose number=1; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 1, single (Lot number: GL0446) at the age of 58 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 15Dec2022, outcome "recovered", described as "Tiredness"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 15Dec2022, outcome "unknown", described as "brand Pfizer-BioNTech COVID-19 Bivalent/ dose number=1"; CHILLS (non-serious) with onset 15Dec2022, outcome "recovered"; DIARRHOEA (non-serious) with onset 15Dec2022, outcome "recovered", described as "diarrhea"; PYREXIA (non-serious) with onset 15Dec2022, outcome "recovered", described as "feverish without a fever"; HEADACHE (non-serious) with onset 15Dec2022, outcome "recovered"; ARTHRALGIA (non-serious) with onset 15Dec2022, outcome "recovered", described as "joint pain"; MYALGIA (non-serious) with onset 15Dec2022, outcome "recovered", described as "muscle pain"; NAUSEA (non-serious) with onset 15Dec2022, outcome "recovered"; PHARYNGEAL OEDEMA (non-serious) with onset 15Dec2022, outcome "recovered", described as "swollen throat"; VOMITING (non-serious) with onset 15Dec2022, outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient did not receive other vaccine in four weeks. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was tested post vaccination on 16Dec2022 vial nasal swab with negative result.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Wrong product administered
Clinical narrative: Tiredness; headache; muscle pain; chills; feverish without a fever; joint pain; nausea; swollen throat; diarrhea; vomiting; brand Pfizer-BioNTech COVID-19 Bivalent/ dose number=1; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Dec2022 as dose 1, single (Lot number: GL0446) at the age of 58 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 15Dec2022, outcome "recovered", described as "Tiredness"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 15Dec2022, outcome "unknown", described as "brand Pfizer-BioNTech COVID-19 Bivalent/ dose number=1"; CHILLS (non-serious) with onset 15Dec2022, outcome "recovered"; DIARRHOEA (non-serious) with onset 15Dec2022, outcome "recovered", described as "diarrhea"; PYREXIA (non-serious) with onset 15Dec2022, outcome "recovered", described as "feverish without a fever"; HEADACHE (non-serious) with onset 15Dec2022, outcome "recovered"; ARTHRALGIA (non-serious) with onset 15Dec2022, outcome "recovered", described as "joint pain"; MYALGIA (non-serious) with onset 15Dec2022, outcome "recovered", described as "muscle pain"; NAUSEA (non-serious) with onset 15Dec2022, outcome "recovered"; PHARYNGEAL OEDEMA (non-serious) with onset 15Dec2022, outcome "recovered", described as "swollen throat"; VOMITING (non-serious) with onset 15Dec2022, outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient did not receive other vaccine in four weeks. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was tested post vaccination on 16Dec2022 vial nasal swab with negative result.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure during pregnancy
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Exposure during pregnancy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 37-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 37 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 was 40 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 10Dec2022. 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 "not recovered" and all described as "COVID 19 Treatment"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Exposure during pregnancy". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was unknown if patient received other medication in two weeks. Patient received Paxlovid from 09Dec2022 to 14Dec2022 for COVID-19 treatment.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the reported event and BNT162B2.
Age: 50.0
Sex: M
Vaccine: PNC20
Symptoms: Vaccination site pain
Clinical narrative: injection site hurt for a day / last night it started hurting as much as it did right after the injection; This is a spontaneous report received from contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 50-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 05Dec2022 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for immunisation. The patient's relevant medical history included: "pneumonia", start date: Feb2022 (unspecified if ongoing), notes: got pneumonia last February which put caller in the hospital for 4 days, was on oxygen for a month. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Dec2022, outcome "not recovered", described as "injection site hurt for a day / last night it started hurting as much as it did right after the injection". Additional information: The patient stated he received Prevnar 20 two weeks ago and the injection site hurt for a day or so and went away. Patient stated that last night it started hurting as much as it did right after the injection.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) 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: 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 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 included: "Asthma" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing). The patient took concomitant medications (other medication in 2weeks: Yes). 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 treatment from 05Dec2022 to 10Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 10Dec2022 to 16Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 43 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EM9810), on 04Mar2021 as dose 2, single (Lot number: EN6202), on 23Aug2021 as dose 3 (booster), single (Lot number: FC3182) and on 14Mar2022 as dose 4 (booster), single (Lot number: FJ8762), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Imuran, reaction(s): "Known allergies: Allergic to Imuran". 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid (COVID 19 treatment) from 08Dec2022 to 13Dec2022.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: had 3 shingle shots, then shingles/suspected vaccination failure; 2 bouts of shingles after the shots; had 3 shingle shots; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 17-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had 3 shots and have had 2 bouts of shingles after the shots. The patient stated not good. The reporter denied to follow-up. Additional supportive information: The patient received 3 shots of Shingrix, which led to extra dose administered. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired Havrix  administered; This case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 14-Dec-2022 Reporter's comment: The reporter wanted to know if the patient needed to be revaccinated. The reporter connected with the agency. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose April, 2nd not  yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose at the end of April).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-Dec-2022 Reporter's comment: The patient stated that he just learned  that it was a 2 dose series.  The patient asked that if he should get his second dose now. Education provided per content.  Medical disclaimer was provided. Mailing package insert and referred to health care professional. Did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Received Infanrix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a child male patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022138671   Additional Information: GSK Receipt Date:14 DEC 2022 Reporter's comment: LPN reported a patient was inadvertently administered a dose of Infanrix instead of Boostrix. The vaccine administration facility was the same as primary reporter. Consented to follow up via email. Additional supportive information: LPN reported a patient was inadvertently administered a dose of Infanrix instead of Boostrix, which led to wrong vaccine administered.; Sender's Comments:  US-GSK-US2022138671:Possible same patient
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Hyperglycaemia
Clinical narrative: increased blood glucose level in 300s - daily - since administration of 2nd booster on 12/13/22; an increased blood glucose level in 300s - daily - since administration of 2nd booster on 12/13/22/the vaccine induced hyperglycemia; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (increased blood glucose level in 300s - daily - since administration of 2nd booster on 12/13/22) and HYPERGLYCAEMIA (an increased blood glucose level in 300s - daily - since administration of 2nd booster on 12/13/22/the vaccine induced hyperglycemia) in a 71-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Dec-2022, the patient experienced BLOOD GLUCOSE INCREASED (increased blood glucose level in 300s - daily - since administration of 2nd booster on 12/13/22) and HYPERGLYCAEMIA (an increased blood glucose level in 300s - daily - since administration of 2nd booster on 12/13/22/the vaccine induced hyperglycemia). At the time of the report, BLOOD GLUCOSE INCREASED (increased blood glucose level in 300s - daily - since administration of 2nd booster on 12/13/22) and HYPERGLYCAEMIA (an increased blood glucose level in 300s - daily - since administration of 2nd booster on 12/13/22/the vaccine induced hyperglycemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2022, Blood glucose: blood glucose level in 300s - daily - since administration of 2nd booster on 12/13/22.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. No treatment medicine were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2022: Significant follow-up received and additional reporter and contains new event.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Dec-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine).    Concomitant medication was not provided. It was unknown if any other vaccines were received within the 4 weeks prior to COVID-19 vaccine. Patient had no information about previous COVID-19 vaccination doses. Treatment information was not reported.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine administered beyond use date 07Jul2022; This spontaneous case was reported by a non-health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date 07Jul2022) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date 07Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date 07Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not provided. Vaccine received on 07-Jun-2022. Treatment medication information was not provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=Moderna, Vaccine brand: Pfizer / BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hx of stroke" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; MAGNESIUM GLYCINATE; B12 [CYANOCOBALAMIN] sublingual; RIBOFLAVIN; TYLENOL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Oct2022 at 14:00, outcome "unknown", described as "Vaccine brand other=Moderna, Vaccine brand: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 09Dec2022 to 14Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case, a possible causal association between the reported events and the suspect drug cannot be excluded.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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 included: "High BP" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing). Concomitant medication(s) included: LOPRESSOR, start date: 01Jan2019; NORVASC; KEPPRA [LEVETIRACETAM]; FINASTERIDE; ALFUZOSIN; NEXIUM [ESOMEPRAZOLE SODIUM].  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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 14Dec2022 to 19Dec2022. Lot number= GA9816.
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) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: BASAGLAR; NOVOLOG; NOVOLIN R. 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about Covid treatment. Other medication in 2 weeks. Anti-viral details: Paxlovid (Treatment start date: 16Dec2022, Treatment stop date: 20Dec2022). Extreme high blood sugars I have been type 1 diabetic for 20+ years with excellent control. Upon starting Paxlovid, my blood sugars shot into the 300s and higher. I worked with my endocrinologist and had to triple the calculation on all my insulin doses during Paxlovid use to bring my blood sugars under 200. Upon finishing Paxlovid, my blood sugars returned to normal approximately 12-24 later and I was able to resume my normal insulin dosing. For reference the only medication I took was paxlovid during this 5 day period. Nothing over the counter and only insulin as prescribed. I also continued to test positive for 5 days after completing paxlovid so the virus itself cannot be blamed for the high blood sugar as it was present in my system when paxlovid was not and I maintained stable blood sugars after completing Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
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; dose #1: Moderna/ dose #2: Moderna / dose #3: Moderna / dose #4 Moderna / dose #5 Pfizer; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Lot number: 031L20A), on 12Mar2021 as dose 2, single (Lot number: 044A21A), on 24Oct2021 as dose 3 (booster), single (Lot number: 026D21A), in right arm and on 29Apr2022 as dose 4 (booster), single (Lot number: 056M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes, type 2" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; BABY ASPIRIN; CARVEDILOL; CHLORTHALIDONE; GLIMEPIRIDE; LEVOTHYROXINE; METFORMIN; OMEGA 3 FATTY ACID; RAMIPRIL; ROSUVASTATIN; TADALAFIL; VICTOZA; VITAMIN D3. Past drug history included: Known_allergies:malarone, reaction(s): "known allergies: Malarone", notes: known allergies: Malarone. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022, outcome "unknown", described as "dose #1: Moderna/ dose #2: Moderna / dose #3: Moderna / dose #4 Moderna / dose #5 Pfizer"; DRUG INEFFECTIVE (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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Other medication in 2weeks: Yes. COVID 19 Treatment, Brand Paxlovid, Treatment start date 08Dec2022, Treatment stop date 12Dec2022, Indication Treatment of COVID-19. Rebound symptoms within 2 days: increased bronchitic cough with clear sputum, head congestion.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia
Clinical narrative: he had 103 fever; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 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: Moderna (Dose Number Unknown), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 18Dec2022, outcome "not recovered", described as "Diarrhea"; PYREXIA (non-serious) with onset 18Dec2022, outcome "not recovered", described as "he had 103 fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Reporter stated, "Well my husband got the Pfizer Shot on Friday and he is 69 years old and he got, it is the Booster the last booster was available and the prior one was a Moderna (Moderna COVID-19 Vaccine) but he had done it somewhere else (withheld) and they did not have Moderna so, they gave him Pfizer (Pfizer COVID-19 Vaccine). Anyway by Saturday he was feeling pretty crappy which is normal and but last night he had 103 fever and he had diarrhea since Saturday and he still have the fever and he still has diarrhea." When probed for if reporter have any question regarding the concern: Reporter stated, "Is the diarrhea normal, I mean is this a normal reaction?" Reporter was provided with the number of Pfizer Medical Information as #1-#, Option#3 and informed about the timings. In response to further probing: Reporter stated, "No, not right now, I get to the end some of stuff, it is not the right time. Reporter was unwilling to complete the report. Thus further probing was not done.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; 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 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose number unknown (booster), single (Lot number: GH9703) at the age of 33 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ASHWAGANDHA; MOUNJARO. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19: Brand: Paxlovid, Treatment start date: 07Dec2022, Treatment stop date: 11Dec2022. The other medication in 2 weeks product brand was goli. The patient had no known allergies.
Age: 50.0
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) (Nurse). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose 2, single (Lot number: EK9231), in left arm and on 04Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 50 years, in left 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: "High cholesterol" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ATORVASTATIN, stop date: 10Dec2022. 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, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itching".  Additional information: The sister of a friends of reporter was going crazy with the itching as well. She was also experiencing this significant itching. Friend mentioned that her sister at times feels like shooting herself because the itching is so bad. That was a hyperbole for sure, but it gets bad.  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, 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 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa antibiotics" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: confirmed by positive home antigen test; (Dec2022) Negative, notes: I tested negative on home antigen test; (Dec2022) Positive, notes: had a bright red positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient does not have other medical history. Treatment received with Paxlovid from 09Dec2022 to 14Dec2022 for covid-19. Rebound Covid - patient tested negative on home antigen test on Day 6 after first infection confirmed by positive home antigen test. By Day 9 patient had a headache and was feeling nasal congestion again and tested and had a bright red positive antigen test. Her current symptoms at Day 11 after first infection are nasal discharge and congestion, sneezing, itchy eyes, fatigue, some dizziness.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had her 2nd booster last Aug 2021/had covid back on Sep; had her 2nd booster last Aug 2021/had covid back on Sep; 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 78-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "had her 2nd booster last Aug 2021/had covid back on Sep".  Clinical Course: It was reported that, In call said she is scheduled for her 3rd booster dose of the Pfizer covid vaccine at 4'oclock today but had covid back on Sep, so she is asking if she needs to wait 6 or 3 months after her recent infection before getting the 3rd booster. Caller says she had her 2nd booster last Aug2021 and that she is 78 years old.  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, Polymerase chain reaction, Vaccination failure
Clinical narrative: PCR test result: Positive(Nasal Swab)/Since the vaccination, has the patient been tested for COVID-19?:Yes; PCR test result: Positive(Nasal Swab)/Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Fibroid" (unspecified if ongoing), notes: Fibroid; "Known allergy: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Oct2022, outcome "unknown" and all described as "PCR test result: Positive(Nasal Swab)/Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (08Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of covid-19.  Clinical course: Report about COVID treatment: Yes. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. After her booster, she developed heart palpitations/ fluttering a few months after. She went to the emergency room twice due to her fast heartbeat. Doctor or other healthcare professional office/clinic visit. Emergency room/department or urgent care. No treatment AE.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Dysgeusia, Off label use, Product use issue
Clinical narrative: Caller says he took his 4th Pfizer covid shot with the flu shot on 14Nov2022; Caller says he took his 4th Pfizer covid shot with the flu shot on 14Nov2022; he experienced the most horrible bitter, sour, salty taste; 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 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 14Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation complete, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Nov2022, outcome "unknown" and all described as "Caller says he took his 4th Pfizer covid shot with the flu shot on 14Nov2022"; DYSGEUSIA (non-serious) with onset Nov2022, outcome "not recovered", described as "he experienced the most horrible bitter, sour, salty taste". The event "he experienced the most horrible bitter, sour, salty taste" required physician office visit. Therapeutic measures were taken as a result of dysgeusia.  Additional information: Caller said he just spoke with someone from Pfizer, a pharmacist, regarding the adverse event he experienced and was directed to call this number for questions. Caller said no reportum number was provided to him. He took his 4th Pfizer COVID shot with the flu shot on 14Nov2022, one and a half or two days later caller says he experienced the most horrible bitter, sour, salty taste (which caller rates was 10 out of 10 and was more leaning to a salty taste). Caller said that it had not gone away and that it was going to 5 weeks at the time of reporting. He already went to his HCP was prescribed Amoxicillin for 10 days after he was prescribed with another antibiotic with steroids for another 10 days but it did not work. Caller at the end of the call demanded that someone higher up call him to talk to him about this and if other patients have reported this as well. Caller said he was perfectly healthy other than what he experienced.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.