chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose given beyond 30-day expiration date; Dose given beyond 30-day expiration date; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose given beyond 30-day expiration date) and PRODUCT STORAGE ERROR (Dose given beyond 30-day expiration date).    Concomitant products were not reported.  It was reported the vial was initially stored in the refrigerator on 13-Sep-2022 and administered on 18-Oct, 25-Oct, 01-Nov, 02-Nov and 08-Nov. The vial did not underwent any temperature excursion. It was unknown if individual vials or unbroken cartons were used. The vial size was unknown.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: dose given beyond 30-day expiration date; dose given beyond 30-day expiration date; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date) and NO ADVERSE EVENT (No adverse event) outcome 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 EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date) and PRODUCT STORAGE ERROR (dose given beyond 30-day expiration date).    Concomitant medications were not reported.  It was reported the vial was initially stored in the refrigerator on 13-Sep-2022 and was administered on 18-Oct, 25-Oct, 01-Nov, 02-Nov and 08-Nov.  The vial did not underwent any temperature excursion. It was unknown if individual vials or unbroken cartons were used. The vial size was unknown.  Treatment information was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: side effects of headache; achiness; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced headache and pain. On an unknown date, the outcome of the headache and pain were not recovered/not resolved.   It was unknown if the reporter considered the headache and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 05 Nov 2022 Reporter comment: This case was reported by a patient via interactive digital media. The patient was experiencing side effects of headache and achiness. Additional supportive information:  No follow up attempts possible as no contact information available.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 08Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Irritable Bowel Syndrome" (unspecified if ongoing); "Spastic colon" (unspecified if ongoing); "Seasonal Allergies" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Chronic Eustachian Tube Dysfunction" (unspecified if ongoing); "shellfish" (unspecified if ongoing); "High Blood" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ZETIA; HYDRALAZINE; ESTRADIOL TRANSDERMAL; OMEPRAZOLE; LIVALO; SINGULAIR; FLONASE [FLUTICASONE PROPIONATE]; CALCIUM CITRATE; VIT D3; MAGNESIUM; ZINC; VIT E [TOCOPHEROL]; VIT C; SUPER B COMPLEX [VITAMIN B COMPLEX]; VIT B2; QUERCETIN; TART CHERRY. Past drug history included: Macrodantin, reaction(s): "Known allergy: Macrodantin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2022) Positive; (20Oct2022) Positive; (21Oct2022) Positive; (22Oct2022) Positive; (23Oct2022) Positive; (24Oct2022) Positive; (25Oct2022) Positive; (26Oct2022) Positive; (27Oct2022) Positive; (28Oct2022) Positive; (29Oct2022) Positive; (30Oct2022) Positive; (31Oct2022) Positive; (01Nov2022) Positive; (02Nov2022) Positive; (03Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: PNC13
Symptoms: Diabetes mellitus
Clinical narrative: diabetes; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 58-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2015 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes". Additional information: Pharmacist calling about Prevnar 20 who has a patient that got Prevnar 13 back in 2015. Patient is 58 years old and diabetic and reporter is looking to see would Prevnar 20 be better for him to get than the 23 would be, since usually they do Prevnar 13 and then a year later do Pneumovax 23.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: The association between the event diabetes mellitus with PREVNAR 13 can not be fully excluded based on the limited information and unclear timeline.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Additional information: reporter's family got Pfizer Covid vaccine primary series and boosters and all four of them still got Covid, but they did not have long term problems with it or didn't get that sick with it. 3 shots of Pfizer Covid-19 vaccine and she had no problem with the vaccine but was wondering if Bivalent and the old vaccine are just the same.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): PFIZER INC-202201287003 same reporter/event/products, different patient.
Age: 58.0
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) from product quality group. 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 28Sep2022 at 12:30 as dose 5 (booster), single (Lot number: GJ6742) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 at 14:30 as dose 1, single (Lot number: EL3247), in left arm, on 25Mar2021 at 14:45 as dose 2, single (Lot number: EL3247), in left arm, on 30Nov2021 at 12:15 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 05Apr2022 at 12:15 as dose 4 (booster), single (Lot number: FL3197), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL, start date: 15Oct2022; PROGESTERONE, start date: 15Oct2022; BUPROPION HCL ER; SYNTHROID. 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body height decreased, Head discomfort, Headache, Palpitations
Clinical narrative: periodic headaches; It is like a heaviness in the head; It was like a night after she didn't realize it was a symptom of the medication, but she did have palpitations; Her height is decreasing  and she has lost weight.; Her height is decreasing  and she has lost weight.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 87-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 at 09:51 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 87 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "sulfa allergies" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE; ATENOLOL; LOVASTATIN. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch number: EN6200), administration date: 16Feb2021, when the patient was 85-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Batch number: EN6206), administration date: 10Mar2021, when the patient was 85-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch number:FF2589), administration date: 28Sep2021, when the patient was 85-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch number:FK9893), administration date: 11May2022, when the patient was 86-year-old, for COVID-19 Immunization; flu vaccine (Dose Number Unknown, Single, manufacturer: Unknown), administration date: 17Sep2022, when the patient was 86-year-old, for Immunization.  The following information was reported: BODY HEIGHT DECREASED (non-serious), WEIGHT DECREASED (non-serious) all with onset Nov2022, outcome "unknown" and all described as "Her height is decreasing  and she has lost weight."; HEAD DISCOMFORT (non-serious) with onset Nov2022, outcome "unknown", described as "It is like a heaviness in the head"; PALPITATIONS (non-serious) with onset Nov2022, outcome "recovered" (Nov2022), described as "It was like a night after she didn't realize it was a symptom of the medication, but she did have palpitations"; HEADACHE (non-serious) with onset Nov2022, outcome "not recovered", described as "periodic headaches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Other Conditions: No, Investigations: No, Other Products: No. She had no reactions after first two primary or first two boosters. She was taking high blood pressure pills, but she has taken those for years. There were no emergency or physician office room visit. Prior Vaccinations (within 4 weeks): flu vaccine but weeks apart. maybe 3-4 weeks before administered on 17Sep2022.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: periodic headaches; It is like a heaviness in the head; It was like a night after she didn't realize it was a symptom of the medication, but she did have palpitations; Her height is decreasing  and she has lost weight.; Her height is decreasing  and she has lost weight.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 87-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 at 09:51 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 87 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "sulfa allergies" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE; ATENOLOL; LOVASTATIN. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch number: EN6200), administration date: 16Feb2021, when the patient was 85-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Batch number: EN6206), administration date: 10Mar2021, when the patient was 85-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch number:FF2589), administration date: 28Sep2021, when the patient was 85-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Batch number:FK9893), administration date: 11May2022, when the patient was 86-year-old, for COVID-19 Immunization; flu vaccine (Dose Number Unknown, Single, manufacturer: Unknown), administration date: 17Sep2022, when the patient was 86-year-old, for Immunization.  The following information was reported: BODY HEIGHT DECREASED (non-serious), WEIGHT DECREASED (non-serious) all with onset Nov2022, outcome "unknown" and all described as "Her height is decreasing  and she has lost weight."; HEAD DISCOMFORT (non-serious) with onset Nov2022, outcome "unknown", described as "It is like a heaviness in the head"; PALPITATIONS (non-serious) with onset Nov2022, outcome "recovered" (Nov2022), described as "It was like a night after she didn't realize it was a symptom of the medication, but she did have palpitations"; HEADACHE (non-serious) with onset Nov2022, outcome "not recovered", described as "periodic headaches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Other Conditions: No, Investigations: No, Other Products: No. She had no reactions after first two primary or first two boosters. She was taking high blood pressure pills, but she has taken those for years. There were no emergency or physician office room visit. Prior Vaccinations (within 4 weeks): flu vaccine but weeks apart. maybe 3-4 weeks before administered on 17Sep2022.
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Pain in extremity, Vaccination site pain, Vaccination site pruritus
Clinical narrative: slight arm pain; localized in her injection site including itching and slight arm pain; localized in her injection site including itching and slight arm pain; acid reflux; 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 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: GH9702, Expiration Date: 30Jul2023), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single), administration date: 25Feb2021, for COVID-19 immunization, reaction(s): "urine was cloudy and had a smell", "urine was cloudy and had a smell", "acid reflux"; Covid-19 vaccine (Dose 2, Manufacture unknown), for COVID-19 immunization, reaction(s): "Acid reflux", "her arms hurt for a good couple of months after the second COVID-19 shot"; Covid-19 vaccine (Dose 3, Manufacture unknown), for COVID-19 immunization, reaction(s): "arm pain"; Flu shot, for immunization, reaction(s): "arm pain"; Pneumonia shot, for immunization, reaction(s): "arm pain". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "slight arm pain"; VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "localized in her injection site including itching and slight arm pain"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "acid reflux".  Additional information: Patient stated that the only side effect that she experienced is a slight arm pain that was closer to the muscle locking rather than pain. Caller stated that in comparison to her flu shot every year, pneumonia shot and 3 other COVID shots, Caller described her symptoms as more localized in her injection site including itching and slight arm pain but also thinks it may be because she does physical therapy. Caller also stated that her arms hurt for a good couple of months after the second COVID-19 shot.Caller stated for the first time in her life she had no side effects. She called her doctor, and her doctor told her that it was normal and that some people do not get side effects. She is just concerned about the efficacy of the product. Caller has acid reflux.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose number unknown (booster), single (Lot number: GH9694) at the age of 52 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's relevant medical history included: "Asthma" (unspecified if ongoing); "occasional flare up of diverticulitis" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (29Oct2022) Positive, notes: I tested positive for COVID on 10/29/22 (first known time contracting COVID); (08Nov2022) Positive, notes: On 11/8/22, I became symptomatic again with cold like symptoms and testing positive for COVID. It appears to be a rebound of symptoms for me. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient tested positive for COVID on 29Oct2022 (first known time contracting COVID). Provider prescribed Paxlovid on 29Oct2022. Patient began first dose evening of 20Oct22 and completed last dose morning of 04Nov22. She was symptomatic with COVID through 06Nov2022.  She was asymptomatic on 07Nov2022. On 08Nov22, she became symptomatic again with cold like symptoms and testing positive for COVID. It appears to be a rebound of symptoms for her.
Sex: U
Vaccine: COVID19
Symptoms: Ill-defined disorder
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILL-DEFINED DISORDER (medically significant), outcome "unknown", described as "a cousin dying from it".  Clinical information: Reporter stated they have a cousin dying from it and they want to know why. Caller declined to provide any information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Food allergy
Clinical narrative: Diagnosed with Alpha Gal Syndrome/allergy from a tick bite; 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 female patient received BNT162b2 (BNT162B2), in Nov2021 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: FOOD ALLERGY (non-serious) with onset Apr2022, outcome "unknown", described as "Diagnosed with Alpha Gal Syndrome/allergy from a tick bite ".  Additional information: Patient stated that, she has previously received 3 total doses of the Pfizer-BioNTech COVID-19 Vaccine. Patient was diagnosed with Alpha Gal Syndrome in Apr2022, following a tick bite. Patient wanted to know if they were animal byproduct on the Bivalent Vaccine because she had alpha gal syndrome and acquired the redneck allergy from a tick bite.  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: Gastrooesophageal reflux disease, Pain in extremity
Clinical narrative: acid reflux; arms hurt; 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.  An elderly female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "physical therapy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single.), for COVID-19 immunization, reaction(s): "injection site including itching"; Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "slight arm pain"; Flu shot (Dose number unknown, Manufacturer unknown.), for Immunisation, reaction(s): "injection site including itching", "slight arm pain"; Pneumonia shot (Dose number unknown, Manufacturer unknown.), for Immunisation, reaction(s): "injection site including itching", "slight arm pain". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arms hurt"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "acid reflux".  Additional information: Caller is a consumer that was calling about side effects and lack thereof with the Pfizer Covid-19 Bivalent Booster. For the first time in her life, she had no side effects. She called her doctor, and her doctor told her that it was normal and that some people do not get side effects. She is just concerned about the efficacy of the product. Caller has acid reflux. No email to provide. Caller declined to complete a report at this time and requested to be transferred to (Withheld) to have her questions addressed. Warm transfer to (Withheld). Caller declined report. Report was filed with the information provided by the caller. Caller provided the number to (Withheld) prior to transfer, (Withheld) option 3.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 12:00 as dose 5 (booster), single (Lot number: G75342) at the age of 59 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 31Dec2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 19Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient had no relevant medical history. Patient has no known allergies. Concomitant medication(s) included: LOVASTATIN, start date: Jan2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid on 25Oct2022 to 30Oct2022 for treatment of COVID-19.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Fatigue; headache; foot pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 at 10:00 as dose 2, single (Lot number: EN6200) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number=EL9264; Administration time: 10:00 AM; Anatomical location: left arm), administration date: 27Jan2021, when the patient was 70-year-old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Feb2021, outcome "not recovered"; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "not recovered", described as "foot pain"; HEADACHE (non-serious) with onset Feb2021, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of fatigue, headache, pain in extremity.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. No known allergies were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Hot flush, Menopausal symptoms
Clinical narrative: Hot flashes; loss of period; menopausal symptoms within hours after injection and since then; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HOT FLUSH (non-serious) with onset 12Oct2022, outcome "not recovered", described as "Hot flashes"; AMENORRHOEA (non-serious) with onset 12Oct2022, outcome "not recovered", described as "loss of period"; MENOPAUSAL SYMPTOMS (non-serious) with onset 12Oct2022, outcome "not recovered", described as "menopausal symptoms within hours after injection and since then".  Additional information: It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. It was unknown the patient had been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Aspartate aminotransferase, Chest X-ray, Ejection fraction, Electrocardiogram, Influenza A virus test
Clinical narrative: a diagnosis of pericarditis was made, and myocarditis was suspected; a diagnosis of pericarditis was made, and myocarditis was suspected; This is a literature report for the following literature source(s): A 19-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, DOSE 1), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening), PERICARDITIS (hospitalization, medically significant, life threatening), all with latency 2 days after the suspect product(s) administration, outcome "recovered", and all described as "a diagnosis of pericarditis was made, and myocarditis was suspected". The events "a diagnosis of pericarditis was made, and myocarditis was suspected" required emergency room visit. The patient underwent the following laboratory tests and procedures: Aspartate aminotransferase: 106 IU/l; Chest X-ray: negative for any acute process; Ejection fraction: 45 %; 50 %; Electrocardiogram: diffuse ST elevation without reciprocal depression; a diagnosis of pericarditis was made, notes: and myocarditis was suspected; normalized; significant for a decreased, notes: left ventricular function with an ejection fraction estimated to be 45% to 50% and evidence of right heart strain consistent  with myocarditis with no prior echocardiogram for comparison; had no breakthrough chest pain for over, notes: 24 hours prior to discharge and did not develop any arrhythmias during admission; was no evidence of reduced ejection, notes: fraction or right heart strain; Influenza A virus test: Negative; Influenza B virus test: Negative; labs: pericarditis was made and, notes: myocarditis was suspected; SARS-CoV-2 test: Negative; Streptococcus test: Negative; Troponin: 1338 ng/L; White blood cell count: 10.91, notes: K/uL Elevated. Therapeutic measures were taken as a result of myocarditis, pericarditis.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate., Linked Report(s): PFIZER INC-202201292766 Same article/drug/event and different patient.
Sex: M
Vaccine: COVID19
Symptoms: Influenza B virus test, Laboratory test, Myocarditis, Pericarditis, SARS-CoV-2 test
Clinical narrative: a diagnosis of pericarditis was made, and myocarditis was suspected; a diagnosis of pericarditis was made, and myocarditis was suspected; This is a literature report for the following literature source(s): A 19-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, DOSE 1), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening), PERICARDITIS (hospitalization, medically significant, life threatening), all with latency 2 days after the suspect product(s) administration, outcome "recovered", and all described as "a diagnosis of pericarditis was made, and myocarditis was suspected". The events "a diagnosis of pericarditis was made, and myocarditis was suspected" required emergency room visit. The patient underwent the following laboratory tests and procedures: Aspartate aminotransferase: 106 IU/l; Chest X-ray: negative for any acute process; Ejection fraction: 45 %; 50 %; Electrocardiogram: diffuse ST elevation without reciprocal depression; a diagnosis of pericarditis was made, notes: and myocarditis was suspected; normalized; significant for a decreased, notes: left ventricular function with an ejection fraction estimated to be 45% to 50% and evidence of right heart strain consistent  with myocarditis with no prior echocardiogram for comparison; had no breakthrough chest pain for over, notes: 24 hours prior to discharge and did not develop any arrhythmias during admission; was no evidence of reduced ejection, notes: fraction or right heart strain; Influenza A virus test: Negative; Influenza B virus test: Negative; labs: pericarditis was made and, notes: myocarditis was suspected; SARS-CoV-2 test: Negative; Streptococcus test: Negative; Troponin: 1338 ng/L; White blood cell count: 10.91, notes: K/uL Elevated. Therapeutic measures were taken as a result of myocarditis, pericarditis.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate., Linked Report(s): PFIZER INC-202201292766 Same article/drug/event and different patient.
Sex: M
Vaccine: COVID19
Symptoms: Streptococcus test, Troponin, White blood cell count
Clinical narrative: a diagnosis of pericarditis was made, and myocarditis was suspected; a diagnosis of pericarditis was made, and myocarditis was suspected; This is a literature report for the following literature source(s): A 19-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, DOSE 1), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening), PERICARDITIS (hospitalization, medically significant, life threatening), all with latency 2 days after the suspect product(s) administration, outcome "recovered", and all described as "a diagnosis of pericarditis was made, and myocarditis was suspected". The events "a diagnosis of pericarditis was made, and myocarditis was suspected" required emergency room visit. The patient underwent the following laboratory tests and procedures: Aspartate aminotransferase: 106 IU/l; Chest X-ray: negative for any acute process; Ejection fraction: 45 %; 50 %; Electrocardiogram: diffuse ST elevation without reciprocal depression; a diagnosis of pericarditis was made, notes: and myocarditis was suspected; normalized; significant for a decreased, notes: left ventricular function with an ejection fraction estimated to be 45% to 50% and evidence of right heart strain consistent  with myocarditis with no prior echocardiogram for comparison; had no breakthrough chest pain for over, notes: 24 hours prior to discharge and did not develop any arrhythmias during admission; was no evidence of reduced ejection, notes: fraction or right heart strain; Influenza A virus test: Negative; Influenza B virus test: Negative; labs: pericarditis was made and, notes: myocarditis was suspected; SARS-CoV-2 test: Negative; Streptococcus test: Negative; Troponin: 1338 ng/L; White blood cell count: 10.91, notes: K/uL Elevated. Therapeutic measures were taken as a result of myocarditis, pericarditis.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate., Linked Report(s): PFIZER INC-202201292766 Same article/drug/event and different patient.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a literature report for the following literature source:   A 22-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant, life threatening), 2 days after the suspect product administration, outcome "unknown". Additional information: Within a few weeks of this (master) case, the author's inpatient cardiology service had 2 other cases of myocarditis that occurred within 2 days following the second doses of mRNA COVID-19 vaccines. Myocarditis developed within 2 days of the second dose, and the 3 patients tolerated the first doses of mRNA vaccination well, with arm soreness being the only notable symptom.; Sender's Comments: Based on limited information in the case , a possible causal association between  the reported event Myocarditis and the suspect drug cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201292682 same article, drug, and event; different patient;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller seeking recommendation for a patient who has covid on when to retest if they are fully vaccinated; Caller seeking recommendation for a patient who has covid on when to retest if they are fully vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller seeking recommendation for a patient who has covid on when to retest if they are fully vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: seeking recommendation for patient who has covid on when to retest.  Clinical course: Reporter was seeking recommendation for a patient who has covid on when to retest if they are fully vaccinated, stated their symptoms had worsened.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: woke up with short mild vertigo like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 10:00 as dose 5 (booster), single (Lot number: GJ3275), in right arm for covid-19 immunisation. The patient's relevant medical history included: "pulmonary embolism" (unspecified if ongoing); "factor V leiden" (unspecified if ongoing), notes: Other medical history: factor V leiden; "type II diabetes" (unspecified if ongoing), notes: Other medical history: type II diabetes; "morbid obesity" (unspecified if ongoing); "bilateral lymphedema legs" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN SODIUM; ALLOPURINOL; CRESTOR; LASIX [FUROSEMIDE SODIUM]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: PHIZEREW0162, Anatomical location:, Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 11Mar2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: PHIZERER8727, Anatomical location:, Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 21Mar2021, when the patient was 60-year-old, for COVID-19 immunization, reaction(s): "Dose 1: 11Mar2021; Dose 2: 21Mar2021"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: PHIZERFH8027, Anatomical location: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 19Oct2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot number: PHIZERFK9893, Anatomical location: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 22Apr2022, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: VERTIGO (non-serious) with onset 29Oct2022 at 07:00, outcome "not recovered", described as "woke up with short mild vertigo like symptoms". Therapeutic measures were not taken as a result of vertigo.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient was not tested for COVID.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Still has arm pain today; 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 07Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "not recovered", described as "Still has arm pain today".  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.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: fever; chills; booster made him feel horrible half a day or a day; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; CHILLS (non-serious), outcome "recovered"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "booster made him feel horrible half a day or a day".  Additional information: The event started right after the patient received booster. He felt horrible half a day or a day. He felt bad with fever and chills for half a day. The patient did not have any investigations. The caller was assuming everything was good regarding outcome. The patient completely blamed his symptoms on that Pfizer COVID-19 Booster.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201292854 Same reporter, different drug, different patient;