chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered 3 vaccine doses past 30 days beyond use by date after being thawed.; administered 3 vaccine doses past 30 days beyond use by date after being thawed.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 3 vaccine doses past 30 days beyond use by date after being thawed.) and PRODUCT STORAGE ERROR (administered 3 vaccine doses past 30 days beyond use by date after being thawed.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 3 vaccine doses past 30 days beyond use by date after being thawed.). In May 2022, the patient experienced PRODUCT STORAGE ERROR (administered 3 vaccine doses past 30 days beyond use by date after being thawed.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 3 vaccine doses past 30 days beyond use by date after being thawed.) and PRODUCT STORAGE ERROR (administered 3 vaccine doses past 30 days beyond use by date after being thawed.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Expired vaccine doses administered to 3 patients. The HCP stated that they were 2 booster doses and one regular (0.5mL) dose. The HCP stated that they had administered 3 vaccine doses past 30 days beyond use by date after being thawed. There were 2 different vials with same Lot number and expiration date however 1 dose was administered from 1 vial and 2 doses were administered from 2nd vial.  2 vials but 3 doses were administered from 2 separate vials. The vial was initially stored in the refrigerator on 07Apr2022. 2 doses were administered on 10May2022 and 1 dose was administered on 11May2022. The vial did not undergo any temperature excursions. Patient took second booster dose 10May2022.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Had swollen in the arm  in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Had swollen in the arm  in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049021a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GINKGO BILOBA (GINKO BILOBA [GINKGO BILOBA]) for an unknown indication.   On 13-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced VACCINATION SITE SWELLING (Had swollen in the arm  in the injection site). At the time of the report, VACCINATION SITE SWELLING (Had swollen in the arm  in the injection site) outcome was unknown.            Concomitant medications also included some other undisclosed medications.  It was reported that patient did not lost her vaccination card, but that in her vaccination card she had 4 shots when she only had 3 shots. On 13 May 2022 patient had first booster dose.  Treatment medication was not provided by the reporter.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: In general did not feel good; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (In general did not feel good), HEADACHE (Headache) and FATIGUE (Tired) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MALAISE (In general did not feel good), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, MALAISE (In general did not feel good), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported. Patient had no adverse reactions or side effects from first dose. The patient received his first Moderna COVID-19 vaccine booster dose on 02-Nov-2021, lot number 01721A, expiration date was not provided. Patient received his booster dose in his right arm shoulder deltoid muscle. The patient reported no adverse reactions or side effects.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced HEADACHE (slight headache). At the time of the report, HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant were reported. No treatment were reported.   This case was linked to MOD-2022-569890 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 29 Apr 2022 and stored upto 10 May 2022 (expired vaccine stored and then administered); expired doses administered to 8 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered to 8 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 29 Apr 2022 and stored upto 10 May 2022 (expired vaccine stored and then administered)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Johnson and Johnson COVID-19 Vaccine on 07-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID-19 Vaccine.   On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered to 8 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 29 Apr 2022 and stored upto 10 May 2022 (expired vaccine stored and then administered)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses administered to 8 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 29 Apr 2022 and stored upto 10 May 2022 (expired vaccine stored and then administered)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported. Patient received first booster dose on 15 Nov 2021 and second booster dose on 10 May 2022.  It was reported that the vial was initially stored in the refrigerator at the same date that the dose was administered. The vial did not undergo any temperature excursions.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered to 8 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 8 patients) in a 53-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 16-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 8 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 8 patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Gingival injury, Illness, Immunisation reaction, Tooth disorder
Clinical narrative: Patient had a lot of dental work and the provider cut the gum a lot; Patient had a lot of dental work and the provider cut the gum a lot; Patient was sick for 2 weeks; Patient had every possible side effect; This spontaneous case was reported by a patient and describes the occurrence of TOOTH DISORDER (Patient had a lot of dental work and the provider cut the gum a lot), GINGIVAL INJURY (Patient had a lot of dental work and the provider cut the gum a lot), ILLNESS (Patient was sick for 2 weeks) and IMMUNISATION REACTION (Patient had every possible side effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, the patient experienced TOOTH DISORDER (Patient had a lot of dental work and the provider cut the gum a lot) and GINGIVAL INJURY (Patient had a lot of dental work and the provider cut the gum a lot). On an unknown date, the patient experienced ILLNESS (Patient was sick for 2 weeks) and IMMUNISATION REACTION (Patient had every possible side effect). At the time of the report, TOOTH DISORDER (Patient had a lot of dental work and the provider cut the gum a lot) and GINGIVAL INJURY (Patient had a lot of dental work and the provider cut the gum a lot) outcome was unknown and ILLNESS (Patient was sick for 2 weeks) and IMMUNISATION REACTION (Patient had every possible side effect) had resolved.            No concomitant medications were reported.  Patient reported that she was due for her 2nd booster the next day. She also reported that she had a lot of dental work on the day of this report and the provider had cut the gum a lot.  No treatment medications were reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got extremely ill off the first shot; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Got extremely ill off the first shot) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     Family history included Colon cancer since an unknown date and Leukemia since an unknown date. Concurrent medical conditions included Drug allergy (Allergy to Codeine).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got extremely ill off the first shot). At the time of the report, ILLNESS (Got extremely ill off the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient Height: 5'4 No concomitant medications were reported. No treatment details were reported.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: Side effects were mild for all three shots; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Side effects were mild for all three shots) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects were mild for all three shots). At the time of the report, IMMUNISATION REACTION (Side effects were mild for all three shots) outcome was unknown.            No concomitant medications were reported. It was reported that the patient took the first two Moderna shots and third booster shot with Pfizer and the patient was wondering which shot the patient should take when the patient would be eligible. No treatment medications were reported.   This case was linked to MOD-2022-570187 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: Side effects were mild for all three shots; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Side effects were mild for all three shots) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects were mild for all three shots). At the time of the report, IMMUNISATION REACTION (Side effects were mild for all three shots) outcome was unknown.            No concomitant medications were reported. It was reported that the patient took the first two Moderna shots and third booster shot with Pfizer and the patient was wondering which shot the patient should take when the patient would be eligible. No treatment medications were reported.   This case was linked to MOD-2022-570187 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: My side effects are mild for all three shots.; 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 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: Moderna covid-19 vaccine (Dose 1, Single), for COVID-19 Immunization, reaction(s): "side effects are mild for all three shots"; Moderna covid-19 vaccine (Dose 2, Single), for COVID-19 Immunization, reaction(s): "side effects are mild for all three shots".  The following information was reported: ADVERSE EVENT FOLLOWING IMMUNISATION (non-serious), outcome "unknown", described as "My side effects are mild for all three shots.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: My side effects are mild for all three shots.; 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 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: Moderna covid-19 vaccine (Dose 1, Single), for COVID-19 Immunization, reaction(s): "side effects are mild for all three shots"; Moderna covid-19 vaccine (Dose 2, Single), for COVID-19 Immunization, reaction(s): "side effects are mild for all three shots".  The following information was reported: ADVERSE EVENT FOLLOWING IMMUNISATION (non-serious), outcome "unknown", described as "My side effects are mild for all three shots.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated
Clinical narrative: Flare up of symptoms; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Flare up of symptoms) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   In March 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) at an unspecified dose. In March 2022, the patient experienced CONDITION AGGRAVATED (Flare up of symptoms). At the time of the report, CONDITION AGGRAVATED (Flare up of symptoms) had not resolved.            It was unknown if patient was enrolled in a covid 19 vaccine trial. Concomitant drug not reported. No relevant medical history reported.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Full blood count abnormal, Nasopharyngitis, Pyrexia
Clinical narrative: tested positive for covid yesterday; tested positive for covid yesterday; fever 99.6/ felt hot; throat scratchy; continues to have cold like symptoms; decreased blood cell count; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: (060820).  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LETROZOLE; LUPRON. The following information was reported: PYREXIA (non-serious) with onset 02May2022, outcome "recovering", described as "fever 99.6/ felt hot"; THROAT IRRITATION (non-serious) with onset 02May2022, outcome "recovering", described as "throat scratchy"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "unknown" and all described as "tested positive for covid yesterday"; NASOPHARYNGITIS (non-serious) with onset 2022, outcome "not recovered", described as "continues to have cold like symptoms"; FULL BLOOD COUNT ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "decreased blood cell count". The patient underwent the following laboratory tests and procedures: Pyrexia: (02May2022) 99.6; SARS-CoV-2 test: (05May2022) Positive; White blood cell count decreased: (unspecified date) Decreased, notes: decreased blood cell counts. Therapeutic measures were taken as a result of drug ineffective, covid-19, pyrexia. Clinical course: Patient took dose:100 mg capsule daily for 21 days and off 7 days with daily Letrozole and Lupron. patient reports since start of therapy: starting on lowered dose of 100 mg daily for 14 days (20Apr2022, approximate) after being on hold for decreased blood cell counts. after start of therapy, on 02May2022 had fever 99.6, felt hot, throat scratchy. 03May2022, evening started feeling better, fever decreased- Tylenol. Tested positive for covid yesterday, and was advised by md to go on hold 05May2022. was prescribed covid medication (unknown) to take for 5 days then will retest. continues to have cold like symptoms. Patient stated she was vaccinated and boosted for covid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Amendment: This follow-up report is being submitted to amend previously reported information: report type updated to spontaneous.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, White blood cell count decreased
Clinical narrative: tested positive for covid yesterday; tested positive for covid yesterday; fever 99.6/ felt hot; throat scratchy; continues to have cold like symptoms; decreased blood cell count; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: (060820).  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LETROZOLE; LUPRON. The following information was reported: PYREXIA (non-serious) with onset 02May2022, outcome "recovering", described as "fever 99.6/ felt hot"; THROAT IRRITATION (non-serious) with onset 02May2022, outcome "recovering", described as "throat scratchy"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "unknown" and all described as "tested positive for covid yesterday"; NASOPHARYNGITIS (non-serious) with onset 2022, outcome "not recovered", described as "continues to have cold like symptoms"; FULL BLOOD COUNT ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "decreased blood cell count". The patient underwent the following laboratory tests and procedures: Pyrexia: (02May2022) 99.6; SARS-CoV-2 test: (05May2022) Positive; White blood cell count decreased: (unspecified date) Decreased, notes: decreased blood cell counts. Therapeutic measures were taken as a result of drug ineffective, covid-19, pyrexia. Clinical course: Patient took dose:100 mg capsule daily for 21 days and off 7 days with daily Letrozole and Lupron. patient reports since start of therapy: starting on lowered dose of 100 mg daily for 14 days (20Apr2022, approximate) after being on hold for decreased blood cell counts. after start of therapy, on 02May2022 had fever 99.6, felt hot, throat scratchy. 03May2022, evening started feeling better, fever decreased- Tylenol. Tested positive for covid yesterday, and was advised by md to go on hold 05May2022. was prescribed covid medication (unknown) to take for 5 days then will retest. continues to have cold like symptoms. Patient stated she was vaccinated and boosted for covid.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Amendment: This follow-up report is being submitted to amend previously reported information: report type updated to spontaneous.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Influenza like illness, Polymenorrhoea
Clinical narrative: flu like symptoms for 5-6 days; menstrual cycle was abnormal which meant a longer, heavier and earlier cycle; menstrual cycle was abnormal which meant a longer, heavier and earlier cycle; 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 44-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8732), for Covid-19 Immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms for 5-6 days"; POLYMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown" and all described as "menstrual cycle was abnormal which meant a longer, heavier and earlier cycle".  Additional information: The patient received 2 doses and a booster dose (on 04May2022 evening). The patient did have a reaction after the second dose, but it was more concerning what happened after the booster dose. With the second dose she had typical side effects, flu like symptoms for 5-6 days, changes in the menstrual cycle. Reported that her menstrual cycle was abnormal which meant a longer, heavier and earlier cycle that she noticed after the second dose and with the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200700271 same patient/drug, different dose/event
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I was vaccinated and I get COVID; I was vaccinated and I get COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old patient received COVID-19 Vaccine - Manufacturer Unknown, 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 "I was vaccinated and I get COVID". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient had a quick question. Patient was vaccinated (further clarifications unknown hence, captured as unspecified vaccine) and patient got COVID and took a five day course of Paxlovid and they had no adverse reaction, worked very good, worked very well but patient's question was they were 71 years old, their doctor told to stop taking their statin drug (Unspecified medication) for cholesterol. Patient's question was they took the last dosage tonight, five days. How long does patient have to wait before they get start taking their statin drug again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Crohn's disease, Therapeutic response unexpected
Clinical narrative: Arthritis; crohn's disease; Unexpected therapeutic benefit; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, subcutaneous for crohn's disease. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 04Dec2019, outcome "unknown", described as "Unexpected therapeutic benefit"; CROHN'S DISEASE (medically significant) with onset 04Dec2019, outcome "unknown"; ARTHRITIS (non-serious), outcome "unknown". It was reported that patient had unexpected benefit, where Humira helped Arthritis a freckle and Crohn's symptoms. The action taken for adalimumab was dosage permanently withdrawn.  The reporter causal assessment between events "crohn's disease" and "unexpected therapeutic benefit" and BNT162b2 was possible. The reporter's assessment of the causal relationship of "arthritis" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: upper respiratory cough; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient in their 90's received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: COUGH (non-serious), outcome "unknown", described as "upper respiratory cough". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles, Heart rate, Heart rate increased
Clinical narrative: having rapid heart beat and skipping some; having rapid heart beat and skipping some; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76-year-old female patient received BNT162b2 (COMIRNATY), on 10May2022 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: HEART RATE INCREASED (non-serious), EXTRASYSTOLES (non-serious) all with onset 11May2022, outcome "unknown" and all described as "having rapid heart beat and skipping some". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that his wife got a COVID shot on 10May2022 and she was having some symptoms on the next day, having rapid heartbeat and skipping some.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "CAD" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. Past drug history included: Alphagan eye drops, reaction(s): "Known allergies: Alphagan eye drops". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "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 included Paxlovid taken from 26Apr2022 to 30pr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose number unknown, single (Lot number: Fm8028) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic hypersomnia" (unspecified if ongoing); "intracranial cavernous angioma" (unspecified if ongoing), notes: Intracranial cavernous angioma. Concomitant medication(s) included: ADDERALL taken for hypersomnia, start date: 01Nov2021. Past drug history included: Cechlor, reaction(s): "known allergies: Cechlor", notes: known allergies: Cechlor. Known allergies included cephalosporin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". It was reported that when she first came down with covid, she was sleeping all the time anyway, so she didn't take it. On day 3 of Paxlovid, she felt better and took it just one of the two adderall doses. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) came down. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid, treatment start date=09May2022, treatment stop date=12May2022, lot number=GA1513.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Preexisting Tinnitus increased in severity by about 10x; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2021 at 13:15 as dose 2 (initial pfizer dose), single (Lot number: FJ1620) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Tinnitus" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (Dose Number: 1, Batch/Lot No: 011A21A, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 10Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 17Dec2021 at 07:30, outcome "recovering", described as "Preexisting Tinnitus increased in severity by about 10x". The event "preexisting tinnitus increased in severity by about 10x" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus.  Additional information: If other vaccine in four weeks: No, Other medications in two weeks: N/A, If covid prior vaccination: No, If covid tested post vaccination: Yes, Covid test post vaccination: Covid test type post vaccination=Nasal Swab, Covid test name post vaccination=Nina Now, Covid test date=29Dec2021, Covid test result=Negative, Known allergies: N/A, Other medical history: None
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Extreme exhaustion; Achy all over; Stiff neck; Hard to hold his head up; Feverish; Felt very warm then very cold; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), 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 Immunization; Covid-19 vaccine (FIRST BOOSTER DOSE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Extreme exhaustion"; PAIN (non-serious), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Achy all over"; MUSCULOSKELETAL STIFFNESS (non-serious), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Stiff neck"; JOINT RANGE OF MOTION DECREASED (non-serious), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Hard to hold his head up"; PYREXIA (non-serious), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Feverish"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Felt very warm then very cold".  Additional information: It was also reported that the symptoms started 2 hrs after the booster, and lasted until about 8AM the next day. Symptoms mimicked COVID-19 symptoms. The HCP/patient think the event might have been related to the drug.  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: Pyrexia
Clinical narrative: Extreme exhaustion; Achy all over; Stiff neck; Hard to hold his head up; Feverish; Felt very warm then very cold; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), 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 Immunization; Covid-19 vaccine (FIRST BOOSTER DOSE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Extreme exhaustion"; PAIN (non-serious), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Achy all over"; MUSCULOSKELETAL STIFFNESS (non-serious), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Stiff neck"; JOINT RANGE OF MOTION DECREASED (non-serious), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Hard to hold his head up"; PYREXIA (non-serious), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Feverish"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), 2 hrs after the suspect product(s) administration, outcome "recovered", described as "Felt very warm then very cold".  Additional information: It was also reported that the symptoms started 2 hrs after the booster, and lasted until about 8AM the next day. Symptoms mimicked COVID-19 symptoms. The HCP/patient think the event might have been related to the drug.  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, Nausea
Clinical narrative: nausea; diarrhea; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), 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; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (FIRST BOOSTER DOSE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  Additional information: The BNT162b2 was also reported as second booster dose. The physician thought the event might have been related to the drug.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound case of COVID; Rebound case of COVID; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENAZEPRIL; ASA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "recovering" and all described as "Rebound case of COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Anti-viral details: Product-COVID 19 Treatment Brand-Paxlovid, Treatment start date-12Apr2022,Treatment stop date-16Apr2022, Indication-Treatment of COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Headache, Intracranial mass
Clinical narrative: brain mass; twitch; sore arm (sensitive to touch); headaches; blurred vision; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTRACRANIAL MASS (medically significant), outcome "unknown", described as "brain mass"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitch"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm (sensitive to touch)"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision"; NAUSEA (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Computerised tomogram: Unknown results; Electrocardiogram: Unknown results; Magnetic resonance imaging: Unknown results; SARS-CoV-2 test: Negative, notes: My 18-year-old granddaughter has had many Covid tests -all of which were negative.   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: Magnetic resonance imaging, Muscle twitching, Nausea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: brain mass; twitch; sore arm (sensitive to touch); headaches; blurred vision; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTRACRANIAL MASS (medically significant), outcome "unknown", described as "brain mass"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitch"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm (sensitive to touch)"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision"; NAUSEA (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Computerised tomogram: Unknown results; Electrocardiogram: Unknown results; Magnetic resonance imaging: Unknown results; SARS-CoV-2 test: Negative, notes: My 18-year-old granddaughter has had many Covid tests -all of which were negative.   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: Vision blurred
Clinical narrative: brain mass; twitch; sore arm (sensitive to touch); headaches; blurred vision; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTRACRANIAL MASS (medically significant), outcome "unknown", described as "brain mass"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitch"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm (sensitive to touch)"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision"; NAUSEA (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Computerised tomogram: Unknown results; Electrocardiogram: Unknown results; Magnetic resonance imaging: Unknown results; SARS-CoV-2 test: Negative, notes: My 18-year-old granddaughter has had many Covid tests -all of which were negative.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.