chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Poor quality product administered; series of temperature excursions; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (series of temperature excursions) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (series of temperature excursions) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (series of temperature excursions) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (series of temperature excursions).    No concomitant product reported by reporter.  It was reported that series of temperature excursion occurred  over the past 5 months since 10-Aug-2022. There were 4 instances where temperatures were out of range which included both the Monovalent adult and Bivalent booster for adults. Excursion details for monovalent vaccine were reported as follow. First excursion occurred on 10-Aug-2022 with maximum temperature of 8.5 degrees Celsius for 34 minutes and vaccine was taken out of the freezer to refrigerator when it was used on 10-Aug-2022. Second excursion occurred on 07-Oct-2022 with maximum temperature of 12.3 degrees Celsius for 90 minutes and vaccine was taken out of the freezer to refrigerator when it was used on 07-Oct-2022. Third excursion occurred on 09-Nov-2022 with maximum temperature of 8.6 degrees Celsius for 29 minutes and vaccine was taken out of the freezer to refrigerator when it was used on 09-Nov-2022. Fourth excursion occurred on 11-Nov-2022 with maximum temperature of 8.6 degrees Celsius for 29 minutes and vaccine was taken out of the freezer to refrigerator when it was used on 11-Nov-2022. Storage condition at the time of the excursion was refrigerated storage and vial size was 5.5 ml. No visual changes were observed in the vial. Reporter was not sure exactly how many patients received doses from these vials following the temperature excursions but does believe the doses have been administered.  No treatment medication reported by reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: He died from clotting in his lungs due to Moderna vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY THROMBOSIS (He died from clotting in his lungs due to Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced PULMONARY THROMBOSIS (He died from clotting in his lungs due to Moderna vaccine) (seriousness criteria death and medically significant). The reported cause of death was he died from clotting in his lungs due to moderna vaccine. It is unknown if an autopsy was performed.            Concomitant and treatment medications were not reported. Patient died in the hospital. He was forced to take vaccine. He died from clotting in his lungs due to vaccine.  Company comment: This spontaneous case concerns a male patient of unspecified age, with no medical history reported, who experienced the Fatal, unexpected serious (Death and medically significant) AESI event of Pulmonary thrombosis that occurred on unspecified day in context to a dose of mRNA-1273 bivalent BA.4/BA.5 vaccination. Vaccination dose number and vaccination schedule was not disclosed. The reported cause of death was he died from clotting in his lungs due to Moderna vaccine. It is unknown if an autopsy was performed. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, concomitant medication, and treatment received were available for review. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unspecified age, with no medical history reported, who experienced the Fatal, unexpected serious (Death and medically significant) AESI event of Pulmonary thrombosis that occurred on unspecified day in context to a dose of mRNA-1273 bivalent BA.4/BA.5 vaccination. Vaccination dose number and vaccination schedule was not disclosed. The reported cause of death was he died from clotting in his lungs due to Moderna vaccine. It is unknown if an autopsy was performed. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, concomitant medication, and treatment received were available for review. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.; Reported Cause(s) of Death: He died from clotting in his lungs due to Moderna vaccine
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Foetal exposure during pregnancy
Clinical narrative: COVID-19; Fetal exposure during pregnancy; The mother of the infant of unknown ethnic origin and unknown gender was participating in Moderna mRNA-1273 Study and patient developed COVID-19(COVID-19). Additionally, the patient had FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy).  The subject's mother medical history was concurrent conditions included Caffeine consumption (caffeinated beverages less than 3 per day).  No medical history was reported for the subject.   The subject received the dose of mRNA-1273 for COVID-19 vaccination on an unknown date. On an unknown date, the subject experienced COVID-19(COVID-19) (seriousness criteria hospitalization). Additionally, the subject had FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy). The delivery occurred on 04-Jul-2022, which was reported as Unknown. The outcome was reported as Delivered NOS.  No treatment information was reported by the reporter.  The subjects last dose date prior to the event and the action taken with mRNA-1273 was unknown.  The outcome of the COVID-19(COVID-19) was reported as unknown, and for the event FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy) it was reported as resolved.  The reporter did not provide the causality for event COVID-19(COVID-19) and FOETAL EXPOSURE DURING PREGNANCY (Fetal exposure during pregnancy).  Company Comment:  This is a sponsored case concerning an unknown-year-old infant patient with no medical history, who was exposed to a dose of mRNA-1273 during mother´s pregnancy .  Foetal exposure during pregnancy was considered in this case. The infant experienced the unexpected seriousness criteria hospitalization event of Covid-19. No further clinical information was available for medical review. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The event of COVID-19 was assessed as not applicable to mRNA-1273 vaccine due to lack of biological plausibility. The event might be explained by current pandemic outbreak.; Sender's Comments: Company Comment:  This is a sponsored case concerning an unknown-year-old infant patient with no medical history, who was exposed to a dose of mRNA-1273 during mother´s pregnancy .  Foetal exposure during pregnancy was considered in this case. The infant experienced the unexpected seriousness criteria hospitalization event of Covid-19. No further clinical information was available for medical review. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The event of COVID-19 was assessed as not applicable to mRNA-1273 vaccine due to lack of biological plausibility. The event might be explained by current pandemic outbreak.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Left arm sore; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm sore), FATIGUE (Tired) and HEADACHE (Headache) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    There was no reported medical history.    On 24-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm sore), FATIGUE (Tired) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Left arm sore), FATIGUE (Tired) and HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter causality for co-suspect Humira for all the events was reported as not related.  No concomitant medication reported. No treatment medication reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Hypertension
Clinical narrative: Shortness of breath; High blood pressure; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), HYPERTENSION (High blood pressure) and CHEST PAIN (Chest pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Sep-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Single-Dose Prefilled Syringe. On 19-Sep-2022, the patient experienced DYSPNOEA (Shortness of breath), HYPERTENSION (High blood pressure) and CHEST PAIN (Chest pain). At the time of the report, DYSPNOEA (Shortness of breath), HYPERTENSION (High blood pressure) and CHEST PAIN (Chest pain) had resolved.     No concomitant medications were reported.  It was reported that, the reporter did not have the lot number information, because the packaging was discarded.  No treatment medications were reported.  The reporter's causality for the events of chest paint, high blood pressure and shortness of breath with adalimumab was not provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: vaccines have surfer multiple temperature excursions; No adverse event; vaccines have surfer multiple temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vaccines have surfer multiple temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Nov-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (vaccines have surfer multiple temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (vaccines have surfer multiple temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (vaccines have surfer multiple temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines have surfer multiple temperature excursions).    No concomitant medications were reported. It was reported as unknown whether the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine No treatment medications were reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Diarrhoea, Flatulence
Clinical narrative: GI upset; diarrhea; extreme abdominal cramping; bloating; gas; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 24-year-old female patient received BNT162b2 (BNT162B2), on 14Jan2021 at 16:00 as dose 1, single (Lot number: EL0142) at the age of 24 years intramuscular, in right deltoid for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 15Jan2021, outcome "recovered" (16Jan2021), described as "GI upset"; ABDOMINAL DISTENSION (non-serious) with onset 15Jan2021, outcome "recovered" (16Jan2021), described as "bloating"; DIARRHOEA (non-serious) with onset 15Jan2021, outcome "recovered" (16Jan2021), described as "diarrhea"; ABDOMINAL PAIN (non-serious) with onset 15Jan2021, outcome "recovered" (16Jan2021), described as "extreme abdominal cramping"; FLATULENCE (non-serious) with onset 15Jan2021, outcome "recovered" (16Jan2021), described as "gas". Therapeutic measures were taken as a result of abdominal discomfort, diarrhoea, abdominal pain, abdominal distension, flatulence.  Additional Information:On 04Feb2021, 16:00, Dose 2, Anatomical site of injection: R deltoid, Route of Administration: Intramuscular, Lot number: ZM9809. On 07Dec2021, 18:00, Anatomical site of injection: R deltoid, Route of Administration: Intramuscular, Lot number: Moderna: 058H21A, exp: 26Mar2022. COVID Shot 1: Received from as an employee. Felt no symptoms the day of, but almost exactly 18 hours later suffered from quick onset, intense diarrhea, extreme abdominal cramping, bloating, and gas for approx. 12 hours. Simethicone was taken but did not provide relief. With both initial doses, the side effects were so bad I was unable to carry on daily tasks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200115252 same patient, different vaccine doses.;US-PFIZER INC-202201344425 same patient, different vaccine doses/events;
Sex: M
Vaccine: COVID19
Symptoms: Cardiomyopathy, Ejection fraction, Heart rate, Heart rate irregular, Pericardial disease
Clinical narrative: myocardial/pericardial infection; myocardial/pericardial infection; some irregular heart beats; 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 male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for covid-19 immunization. The following information was reported: CARDIOMYOPATHY (medically significant), PERICARDIAL DISEASE (medically significant), outcome "unknown" and all described as "myocardial/pericardial infection"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "some irregular heart beats". The patient underwent the following laboratory tests and procedures: Ejection fraction: dropping low after each rituximab treatment; 15%; 5% to 10%; Heart rate: irregular, notes: some irregular heart beats. Therapeutic measures were taken as a result of cardiomyopathy, pericardial disease, heart rate irregular. Clinical course: Caller asking if Ruxience was indicated for treatment of heart failure/low ejection fraction. Caller asking if Pfizer has any record of ejection fraction dropping significantly after treatment with Ruxience. Caller states he takes rituximab for cancer treatment but was not sure which branded product he uses. Caller states he experienced his ejection fraction dropping low after each treatment. Caller states he experienced a growth appear around his heart and aorta which grew from 2cm to 4cm in 2 to 3 weeks. Caller states he received immunotherapy in the hospital by the time it was 5cm. Caller states his ejection fraction dropped shortly after and was now only at 5% to 10%. Caller states his doctor did not seem concerned until it dropped to 15%. Caller states he also experienced cardiac side effects after taking 2 doses of the Pfizer BioNTech Covid-19 vaccine. Caller states he went to a specialist in Canada City and his study showed he had "some irregular heart beats and [myocardial/pericardial] infection." Caller states he took methotrexate for 3 months and "that took care of that."  Caller states, otherwise, his rituximab has "knocked the cancer back really quick and really well."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: FC3180) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: FA6780), for COVID-19 immunization.  The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 11Sep2022, outcome "unknown", described as "heart attack".  Clinical information: It was reported that the patient received the first two doses of the Covid Pfizer vaccine. The patient had no symptoms when she received the vaccine. On 11Sep2022, she suffered a heart attack known as the widow maker in which she was a 30 year old female. She never had any issues with health. The patient inquires if was there a study on her age group having a heart attack a year after vaccine and could the vaccine have caused that heart attack.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little bit of a sore arm/like I've had on the other Pfizer shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9269) at the age of 69 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Blood Pressure" (unspecified if ongoing), notes: he takes a blood pressure pill and a tablet for urinating; "Urinating" (unspecified if ongoing), notes: he takes a blood pressure pill and a tablet for urinating. Concomitant medication(s) included: SERTRALINE. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "little bit of a sore arm/like I've had on the other Pfizer shots". Therapeutic measures were taken as a result of pain in extremity.  Additional Information: When he had sore arm he took some Tylenol and Ibuprofen, which was 500mg for Tylenol, which he took a couple of times as needed. For the Ibuprofen dose would have been 200mg, which he took the same as the Tylenol, a couple of times as needed. Ibuprofen was taken at same time as Tylenol. His sore arm got better. Concomitant Medications: He takes his regular medications, like he takes a blood pressure pill and a tablet for urinating, and he takes Sertraline.  Reporter said he does not feel those are relevant, he had been taking all of them for 4-5 years and did not have neck spasms.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: severe bad cough; 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 female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; epoetin alfa (PROCRIT), from 01Dec2022 (Batch/Lot number: unknown) to 01Dec2022 at 1x/every 4 weeks. 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; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 01Dec2022, outcome "not recovered", described as "severe bad cough". The action taken for epoetin alfa was unknown.  Additional information: Patient had a bad cough after receiving the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent gray cap formula booster shot on 01Dec2022 (reported as yesterday). Stated as her third booster. An hour after receiving the shot; patient had a bad cough; still (at the time of this report) had the cough; further described as severe cough. She inquired if it had been reported as a side effect. Inquired if severe cough be from the vaccine. She also received her Procrit injection, she received it 1x/every 4 weeks, at the same time. The report was not related to a study or programme.  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: 70.0
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 contactable reporter(s) (Other HCP) from product quality group.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 70 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: "hypothyroidism" (unspecified if ongoing); "Hep B carrier" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies opoids, reaction(s): "Known allergies Opoids", notes: known allergies: Opoids.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient previously receive a COVID-19 Vaccine. Paxlovid treatment started from 19Nov2022 to 23Nov2022. Device Date: 02Dec2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Rebound and awful taste in mouth while taking the medication; Rebound and awful taste in mouth while taking the medication; Interchange of vaccine products; 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 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 16:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Mar2021 as dose 1, single (Lot number: 011A21A), in left arm, on 09Apr2021 as dose 2, single (Lot number: 026B21A), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: 020F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer 5 years prior; "Sulfonamide derivatives/ sulfa antibiotics" (unspecified if ongoing); "Known allergies: penicillins" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR MYLAN, start date: 25Aug2022, stop date: 21Nov2022; VIT D [VITAMIN D NOS]; ZINC; VIT C. Past drug history included: Tetracyclines & related, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound and awful taste in mouth while taking the medication". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Concomitant medications included Valacyclovir brand was Mylan, Multi vitamin.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little bit of a sore arm/like I've had on the other Pfizer shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2021 as dose 2, single (Lot number: EL9262) at the age of 69 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Blood Pressure" (unspecified if ongoing); "Urine Disorder" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Vaccination history included: BNT162b2 (Dose 1, Route of Administration: intramuscular. , Batch/Lot number: EL9269), administration date: 13Feb2021, when the patient was 69-year-old, for Covid-19 immunization, reaction(s): "little bit of a sore arm/like I've had on the other Pfizer shots". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "little bit of a sore arm/like I've had on the other Pfizer shots". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The report was not related to a study or programme. He took his regular medications, like taking a blood pressure pill and a tablet for urinating, and he took Sertraline. He doesn't feel those are relevant, he has been taking all of them for 4-5 years and didn't have neck spasms.  The patient had a little bit of a sore arm, like he had on the other Pfizer shots, but nothing major. The patient stated vaccine was not administered at military facility. When he had a sore arm, he took some Tylenol and Ibuprofen, which was 500 mg for Tylenol, which he took a couple of times as needed. For the Ibuprofen dose would have been 200mg, which he took the same as the Tylenol, a couple of times as needed. Ibuprofen was taken at same time as Tylenol. His sore arm got better. The report was considered as non-serious by the reporter.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201348782 same patient, different vaccine dose number/event;
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little bit of a sore arm/like I've had on the other Pfizer shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 70 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing), notes: He takes his regular medications, like he takes a blood pressure pill and a tablet for urinating; "urinating" (unspecified if ongoing), notes: He takes his regular medications, like he takes a blood pressure pill and a tablet for urinating. Concomitant medication(s) included: SERTRALINE taken for urinary incontinence. Past drug history included: Sertraline, notes: taking all of them for 4-5 years and didn't have neck spasms. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Route of Administration: intramuscular. , Batch/Lot number: EL9269. NDC/EXP not provide on handwritten vaccine card.), administration date: 13Feb2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "little bit of a sore arm/like I've had on the other Pfizer shots"; BNT162b2 (DOSE 2, SINGLE, Route of Administration: intramuscular. , Batch/Lot number: EL9262. , NDC/EXP: not provided on handwritten vaccine card.), administration date: 07Mar2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "little bit of a sore arm/like I've had on the other Pfizer shots". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "little bit of a sore arm/like I've had on the other Pfizer shots". Therapeutic measures were taken as a result of pain in extremity. Additional Information: He takes his regular medications, like he takes a blood pressure pill and a tablet for urinating, and he takes Sertraline. Caller said he doesn't feel those are relevant, he had been taking all of them for 4-5 years and didn't have neck spasms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201348782 same patient, different vaccine dose number/event;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 13:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 70 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19May2022 at 13:30 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6198), in left arm, on 23Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 05Oct2021 at 13:30 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6198), in left arm and on 23Mar2021 as dose 2, single (Lot number: EP6955), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "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. Patient received Paxlovid (Lot number 281523) from 17Nov2022 to 19Nov2022 for COVID 19 Treatment.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Hoshimoto" (unspecified if ongoing), notes: Other medical history: Hoshimoto; "Known allergies: Iodine" (unspecified if ongoing), notes: Known allergies: Iodine. Concomitant medication(s) included: ZOLPIDEM, start date: 01Sep2021, stop date: 21Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (30Nov2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (30Nov2022) Negative, notes: Prior tested negative twice 30Nov2022; (30Nov2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment: Paxlovid from 22Nov2022 to 26Nov2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gastric disorder, Illness, Mutism
Clinical narrative: Diarrhea; he is having some serious gastric issue; Sick; he is unable to talk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer Unkown), for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; GASTRIC DISORDER (non-serious), outcome "unknown", described as "he is having some serious gastric issue"; ILLNESS (non-serious), outcome "unknown", described as "Sick"; MUTISM (non-serious), outcome "unknown", described as "he is unable to talk".  Additional information: Reporter stated "my husband and both received the third covid booster(Clarified as COVID-19 booster shot) this past Monday 30Nov. My husband is now traveling. He is on the plane and he is unable to talk. As of Friday, he had, we don't know if this connected with the booster, it could be a side effect, some serious diarrhea and thankfully not actually travelling but now he was at the airport and he was texting me, he is unable to talk, but he is having some serious gastric issue". Reporter wanted to know if it could be a side effect of the booster or should they think of other reason.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Illness, Incorrect dose administered
Clinical narrative: Sick; Shingles; Patient said he got the 2nd dose of Pfizer COVID vaccine Bivalent dose.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GH9702) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer Unknown), for Covid-19 immunization; Bnt162b2 (1st BOOSTER), for Covid-19 immunization; Bnt162b2 (Patient said he got the 2nd dose of Pfizer COVID vaccine Bivalent dose.), for Covid-19 immunization. The following information was reported: ILLNESS (hospitalization), outcome "unknown", described as "Sick"; HERPES ZOSTER (hospitalization), outcome "unknown", described as "Shingles"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Patient said he got the 2nd dose of Pfizer COVID vaccine Bivalent dose.".  Clinical course: Patient said he got the 2nd dose of Pfizer COVID vaccine Bivalent dose. What happened is he was in good shape but reduced blood level to the point where he caught COVID 19 and upon catching COVID, he wound up with Shingles. He does not want anyone else getting this and getting COVID and you wind up in the hospital and wound with Shingles. Was in good health before.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Interchange of vaccine products; Got COVID virus; Got COVID virus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GH9702) and 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), outcome "unknown" and all described as "Got COVID virus"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Clinical course: Received call from consumer who said he got the 2nd dose of Pfizer COVID vaccine Bivalent dose.  What happened is he was in good shape but reduced blood level to the point where he caught COVID 19 and upon catching COVID, he wound up with Shingles. He does not want anyone else getting this and getting COVID and you wind up in the hospital and wound with Shingles. Was in good health before.  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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Interchange of vaccine products; Treatment of COVID-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER8727), in left arm and on 08Apr2021 as dose 2, single (Lot number: EW0151) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 030H21B), in left arm, on 11Jun2022 as dose 4 (booster), single (Lot number: 060A22A), in left arm and on 29Sep2022 as dose 5 (booster), single (Lot number: 027E22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Nov2022, outcome "recovering", described as "Treatment of COVID-19"; COVID-19 (medically significant) with onset Nov2022, outcome "recovering"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) positive. Therapeutic measures were taken as a result of covid-19, vaccination failure  for which included PF-07321332, ritonavir (PAXLOVID) from 21Nov2022 to 26Nov2022.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Nasal Swab: positive; Nasal Swab: positive; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL1284) and on 09Jan2021 as dose 2, single (Lot number: EL1284) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history included: "ammenorhea" (unspecified if ongoing), notes: I have had ammenorhea (absent menstrual cycle) for 6 years.; "Reaction: Allergy" (unspecified if ongoing), notes: Reaction: Allergy. The patient took concomitant medications (patient has received birth control pills within 2 weeks of vaccination). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Nasal Swab: positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive.  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 events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202201342119 same patient, different event, different dose/event;US-PFIZER INC-202201341882 same patient, different event, different dose/event;
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid-19 (home test); tested positive for covid-19 (home test); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 18:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "Ankylosing Spondylitis" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE, start date: Jun2005, stop date: 20Nov2022; HUMIRA, start date: May2021, stop date: 12Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Nov2022 at 05:00, outcome "not recovered" and all described as "tested positive for covid-19 (home test)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Nov2022) Positive, notes: report positive test to Rheumatologist's office; (24Nov2022) Positive; (26Nov2022) Positive; (29Nov2022) Negative; (03Dec2022) Positive; (04Dec2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient was currently on Humira (40mg/2 wks) and Methotrexate (20mg/wk). Symptoms of Covid-19 started 5:00 pm 22Nov2022-hoarseness, fever 100 deg.F, body aches, tiredness. 23Nov2022, 5:00 am, tested positive for Covid-19 (home test), report positive test to Rheumatologist's office, prescribed Paxlovid. Started Paxlovid at 12:00 pm 23Nov2022. At this time, Covid-19 symptoms were mild fever, mild body aches, tiredness. 24Nov2022, 12:00 pm, tested positive for Covid-19 (home test). Continued taking Paxlovid as prescribed. Covid-19 symptoms were very mild to non-existent. 25Nov2022-same. 26Nov2022, tested positive for Covid-19 (home test). 27Nov2022, all doses of Paxlovid were taken as prescribed. 29Nov2022 tested negative for Covid-19 (home test). 02Dec2022 symptoms; watery eyes, runny nose, hoarseness. 03Dec2022 tested positive for Covid-19. 04Dec2022 tested positive for Covid-19, symptoms are near non-existent.  No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore Arm; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Dec2022 at 15:15 as dose 3 (booster), single (Lot number: 6K1657) at the age of 10 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Pfizer BioNTech, lot number: FL8094, dose administration date: 08Jan2022,dose number: 2), administration date: 08Jan2022, when the patient was 9-year-old, for COVID-19 Immunization; BNT162b2 (Pfizer BioNTech, lot number: FK5618, dose administration date: 18Dec2021,  dose number: 1), administration date: 18Dec2021, when the patient was 9-year-old, for COVID-19 Immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Dec2022, outcome "recovering", described as "Sore Arm"; FATIGUE (non-serious) with onset 05Dec2022, outcome "recovering", described as "Tiredness".  No follow-up attempts are possible. No further information is expected.