chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Emotional distress, Fungal infection, Vaccination failure
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EMOTIONAL DISTRESS (Emotional distress), COVID-19 (COVID-19), FUNGAL INFECTION (Yeast infection) and VACCINATION FAILURE (Vaccination failure) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis. Patient had no known allergies. No Medical History information was reported.  On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In June 2022, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure). In 2022, the patient experienced EMOTIONAL DISTRESS (Emotional distress) and FUNGAL INFECTION (Yeast infection). At the time of the report, EMOTIONAL DISTRESS (Emotional distress), COVID-19 (COVID-19), FUNGAL INFECTION (Yeast infection) and VACCINATION FAILURE (Vaccination failure) outcome was unknown. Concomitant medications were not provided by the reporter. Humira was taken for Non-infectious intermediate, Posterior and Panuveitis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment information was not provided. Company Comment: This spontaneous case concerns a 74-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious of COVID-19 which occurred approximately 14 months after the second dose of mRNA-1273 vaccine. Additionally, vaccination failure is also noted in this case. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 74-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious of COVID-19 which occurred approximately 14 months after the second dose of mRNA-1273 vaccine. Additionally, vaccination failure is also noted in this case. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (patient had an anaphylactic reaction to the Moderna shot) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (patient had an anaphylactic reaction to the Moderna shot) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (patient had an anaphylactic reaction to the Moderna shot) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the serious (medically significant)expected event anaphylactic reaction, on an unknown date after receiving an unspecified dose of RNA-1273. Patient details, clinical course, diagnostic tests and treatment details were not provided. It was reported that the patient was tested at the allergist and could not have any injections that have PEG. Events seriousness captured as per local list. Further information is not expected. The benefit-risk relationship of mRNA-1273 is not affected by this report. Concomitant medication information was not provided by the reporter. It was reported that the patient was tested at the allergist and could not have any injections that have PEG. Treatment information was not provided by the reporter. Sender's Comments: Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the serious (medically significant)expected event anaphylactic reaction, on an unknown date after receiving an unspecified dose of RNA-1273. Patient details, clinical course, diagnostic tests and treatment details were not provided. It was reported that the patient was tested at the allergist and could not have any injections that have PEG. Events seriousness captured as per local list. Further information is not expected. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease
Clinical narrative: GERD; This spontaneous case was reported by an other health care professional and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (GERD) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 prophylaxis.     It was unknown if the patient has ever been diagnosed with/tested positive for COVID-19. It was unknown if there was acute illnesses at the time of vaccination and up to one moth before.  Concurrent medical conditions included Allergy since 19-Dec-2019, Hyperlipidemia since 22-May-2018, Osteoporosis since 14-Mar-2019 and GERD since 22-Feb-2021. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) from 14-Mar-2019 to an unknown date, ATORVASTATIN from 22-May-2018 to an unknown date, LORATADINE from 19-Dec-2019 to an unknown date, FAMOTIDINE from 22-Feb-2021 to an unknown date and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) from 19-Dec-2018 to an unknown date for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Feb-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (GERD). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (GERD) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received first dose at 14:09. Patient received second dose on 25-Feb-2021 at 10:58 am of 0.5 dose with lot number (006M20A) in left deltoid. Patient received third dose on 21-Dec-2021 at 11:56 am of 0.5 dose with lot number (078J21a) in right deltoid. Patient did not have any adverse event including signs symptoms, clinical course and or treatment with dates/timelines. No treatment information was provided.   This case was linked to MOD-2022-503571 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Hypertension; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERTENSION (Hypertension) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 002A21A) for COVID-19 prophylaxis.     It was unknown if the patient has ever been diagnosed with/tested positive for COVID-19.  It was reported as unknown if there was acute illnesses  at the time of vaccination and upto one month before.  Concurrent medical conditions included Blood pressure high since 29-Nov-2019, Hypertension since 29-Nov-2018 and Type 2 diabetes mellitus since 09-Jan-2020. Concomitant products included AMLODIPINE from 29-Nov-2019 to an unknown date, LISINOPRIL from 29-Nov-2019 to an unknown date, LOSARTAN from 24-Nov-2021 to an unknown date and METFORMIN from 09-Jan-2020 to an unknown date for an unknown indication.   On 09-Mar-2021 at 5:32 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Apr-2021 at 1:25 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 24-Nov-2021, the patient experienced HYPERTENSION (Hypertension). At the time of the report, HYPERTENSION (Hypertension) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPERTENSION (Hypertension) to be not related.    Patient received third dose on 06-Dec-2021 at 13:25 pm of 0.5 dose with lot number (069F21A) in left deltoid. No treatment information was provided.  Patient did not have any adverse event including signs symptoms, clinical course  and or treatment with dates/timelines.   This case was linked to MOD-2022-503629 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in fridge greater then 12 hours post puncture; No adverse event; Dose administered greater then 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (The vial was stored in fridge greater then 12 hours post puncture), EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 049L21A) for COVID-19 vaccination. No Medical History information was reported. On 19-May-2022 at 9:45 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-May-2022 at 9:45 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in fridge greater then 12 hours post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (The vial was stored in fridge greater then 12 hours post puncture), EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (The vial was stored in fridge greater then 12 hours post puncture) and EXPIRED PRODUCT ADMINISTERED (Dose administered greater then 12 hours post puncture). No relevant concomitant medications were reported. It was unknown whether the vial was initially stored in the refrigerator. The vial was first punctured on 13-May-2022 at 8.15 am. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. It was unknown whether the vial was exposed to room temperature range (8° to 25°C, 46° to 77°F). Was stored in freezer until 13-May-2022 and then in fridge the entire time. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2022: Follow up received: no new information. On 16-Aug-2022: Follow up received: vaccination start date updated.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Caller says because the messenger in the vaccine this is happening) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Caller says because the messenger in the vaccine this is happening). At the time of the report, IMMUNISATION REACTION (Caller says because the messenger in the vaccine this is happening) outcome was unknown. No concomitant medications was reported. The reporter was forced to get the vaccine to keep on job and informed that because of the messenger in the vaccine this was happening. The reporter wanted to know how to get the vaccine out of their body. No treatment drug details was reported. Reporter did not allow further contact.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: No adverse event; The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago.; Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2022 at 3:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours) 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 (The Moderna Covid-19 vaccine vial had also been punctured more than 12 hours ago.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that was opened on 15AUG2022 and left at room temperature for 25 hours). No concomitant medication was reported. On 19-JUL-2022 the vial was initially stored in the refrigerator. On 15-AUG-2022 at 2:30PM vial was first punctured and for 25 hours the vial was exposed to room temperature before being administered on 16-AUG-2022 at 3:15 PM. No treatment medication was reported.
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: received 2 doses of Prevnar 20 within 24 hours; Drug(s) Information Characterization of drug role: Suspect Proprietary medicinal product name: Prevnar 20    Active Substance Information Active Drug substance names: pneumococcal 20-valent conjugate vaccine  Narrative case summary and further information: Case narrative: Originating AE Request: REQ-885366  Attachments: 1 Patient Age: 82 years of age  Reporter Subtype: Pharmacist  PQC Present: No  AE Present: Yes   Request Name: REQ-885366 Product: Prevnar 20  Question: Caller is calling from a Nursing Home. She mentioned one of the residents received 2 doses of Prevnar 20 within 24 hours.  Caller asked if they should "watch for anything specific" and to report this event.  Patient is a female with birthday (DOB withheld).  AE e-transmitted. Caller was transferred to (Name withheld). REPORTUM GMCU0IBP. No NTID was provided.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Blood urine, Haematuria, Urine protein/creatinine ratio
Clinical narrative: Gross Hematuria; This is a literature report.  A 50-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 included: "IgA nephropathy" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 immunization. The following information was reported: HAEMATURIA (medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "Gross Hematuria". The patient underwent the following laboratory tests and procedures: Blood creatinine: 1.54 mg/dl, notes: Presentation after second dose; 1.24 mg/dl, notes: Follow-up after second dose; 1/17 mg/dl, notes: baseline; Blood urine: greater than 50, notes: Presentation after second dose; 11 to 25, notes: Follow-up after second dose; 11-25, notes: baseline; Urine protein/creatinine ratio: 3.56, notes: g/g; Presentation after second dose; 2.20, notes: g/g; Follow-up after second dose; 2.40, notes: g/g; baseline.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Aphthous ulcer, Cytomegalovirus test, Epstein-Barr virus test, Physical examination, Vulval ulceration
Clinical narrative: Post COVID-19 Vaccination vulvar aphthous ulcers; Post COVID-19 Vaccination vulvar aphthous ulcers; This is a literature report for the following literature source(s): Journal of Pediatric and Adolescent Gynecology, 2022; pgs:226, DOI:10.1016/j.jpag.2022.01.089.  An adolescent 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: Bnt162b2 (Dose 1, Single), for covid-19 immunization, reaction(s): "Without complications". The following information was reported: VULVAL ULCERATION (medically significant), APHTHOUS ULCER (medically significant) all with onset 2020, latency 2 days after the suspect product(s) administration, outcome "recovered" and all described as "Post COVID-19 Vaccination vulvar aphthous ulcers". The event "post covid-19 vaccination vulvar aphthous ulcers" required emergency room visit. The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: Negative; Epstein-Barr virus test: Negative; Physical exam: was consistent with a diagnosis, notes: of vulvar aphthous ulcers with no exceptional characteristics.; Sender's Comments: Based on the available limited information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events vulval ulceration, aphthous ulcer which cannot be fully excluded. The case will be reassessed if additional information becomes available. 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) : US-PFIZER INC-PV202200042326 Same article/drug/event and different patient:;US-PFIZER INC-202201056247 Same article/drug/event and different patient:;
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 64 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Apr2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I've tested negative using the nasal swab Antigen test; Positive, notes: I've been concerned about my positive PCR covid test for over a month after my initial positive test; Positive, notes: my PCR test is still positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient stated, I have been concerned about my positive PCR covid test for over a month after my initial positive test. I have tested negative using the nasal swab Antigen test but still after a month, my PCR test is still positive.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: experienced symptoms of (primarily cough, fatigue and congestion) and tested positive for covid-19; experienced symptoms of (primarily cough, fatigue and congestion) and tested positive for covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47-year-old male patient received BNT162b2 (COMIRNATY), on 15Nov2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Lot number: O36A21A) and on 09Apr2021 as dose 2, single (Lot number: O32B21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Aug2022, outcome "recovering" and all described as "experienced symptoms of (primarily cough, fatigue and congestion) and tested positive for covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (cough syrup, antihistamines).  Additional information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19
Age: 61.0
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) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Dec2020 at 16:00 as dose 1, single (Lot number: EK9231), in right arm, on 22Jan2021 at 16:00 as dose 2, single (Lot number: 162b2), in left arm, on 29Dec2021 at 16:00 as dose 3 (booster), single (Lot number: 320308D), in right arm and on 15Jul2022 at 17:30 as dose 4 (booster), single (Lot number: FM0173) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Chronic Bronchitis" (unspecified if ongoing); "Known allergies: Shell fish" (unspecified if ongoing); "Known allergies:  latex" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2022) positive; (08Aug2022) Negative; (13Aug2022) positive, notes: Rebound on 13Aug with worsening symptoms. Therapeutic measures were taken as a result of covid-19. Clinical course: COVID positive 03Aug2022. Started Plaxlovid on 04Aug finished 09Aug. Mild to Moderate case. Negative test on Monday 08Aug. Rebound on 13Aug with worsening symptoms, and positive test.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective and covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter (consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose number unknown, single (Lot number: FFJ9943) at the age of 67 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: rebound covid on 7th day after last day of paxlovid; rebound covid on 7th day after last day of paxlovid; 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), on 23Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 26Apr2021 as dose 2, single (Lot number: EW0176), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: FJ8762), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SUMATRIPTAN; FAMOTIDINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "rebound covid on 7th day after last day of paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient taken antiviral (Paxlovid; lot no.FY9928) for treatment of COVID-19 on 26May2022 and stopped on 31May2022.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 2, single (Lot number: EL9266) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hyper- cholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 05Aug2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Batch/Lot No: EL9265; Anatomical location: Arm Left), administration date: 28Jan2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "Pain at the injection site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain at the injection site".  Additional information: The patient received BNT162b2 (BNT162B2) on 29Sep2021 as dose 3 (booster), single (Lot number: 301458A)  in left arm for covid-19 immunisation and on 25Jun2022 as dose 4 (booster), single (Lot number: FP7135)  in left arm for covid-19 immunisation. The patient had no known allergies. It was reported that there were none other than pain at the injection site.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hyper- cholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 05Aug2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EL9265, Anatomical location: Arm Left), administration date: 28Jan2021, when the patient was 64-year-old, for COVID-19 immunisation, reaction(s): "If you were talking about adverse events of the Pfizer vaccine for go series. There were none other than pain add the injection site"; BNT162b2 (DOSE 2, SINGLE, Lot number: EL9266, Anatomical location: Arm Left), administration date: 25Feb2021, when the patient was 64-year-old, for COVID-19 immunisation, reaction(s): "If you were talking about adverse events of the Pfizer vaccine for go series. There were none other than pain add the injection site". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "If you were talking about adverse events of the Pfizer vaccine for go series. There were none other than pain add the injection site". Additional information: Patient received BNT162b2, on 25Jun2022 as dose 4 (booster), single (Lot number: FP7135) in left arm.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: If you were talking about adverse events of the Pfizer vaccine for go series. There were none other than pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hyper- cholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 05Aug2022; DILTIAZEM, start date: 03Aug2022. Vaccination history included: BNT162b2 (DOSE 3, SINGLE; Lot Number: 301458A, Anatomical location: Left arm), administration date: 29Sep2021, when the patient was 65-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot Number: EL9266, Anatomical location: Left arm), administration date: 25Feb2021, when the patient was 64-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 1, SINGLE; Lot Number: EL9265, Anatomical location: Left arm), administration date: 28Jan2021, when the patient was 64-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "If you were talking about adverse events of the Pfizer vaccine for go series. There were none other than pain at the injection site".  Additional information: The patient had no known allergies. The patient received other medication in 2 weeks. It was reported that "If you were talking about adverse events of the Pfizer vaccine for go series", there were none other than pain at the injection site.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2022 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 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "obesity" (unspecified if ongoing); "non alcohol fatty liver" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. Past drug history included: Clindamycin, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: in Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid as covid-19 treatment on 12Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 12Apr2021 as dose 2, single (Lot number: EW0161), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 80-year-old patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (First booster dose, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "recovering", described as "felt very tired". Additional information: Reporter stated that his son and he, both received our second Pfizer Booster (COVID-19 Vaccine) so number 4th shot almost 2 weeks ago now and just we little bit felt tired couple of days 2-3 days with it. Then they felt better and but now we felt very tired again. Is that something that you have heard people, report or what because he understood that the side effects can be off and on" No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 57-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. 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: FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "felt very tired". Additional information: Patient received second Pfizer Booster (COVID-19 Vaccine) so number 4th shot on an unknown date in 2022 (reported as almost 2 weeks ago now) and just little bit felt tired couple of days 2-3 days with it. Then felt better and but now (at the time of this report) patient felt very tired again. The reporter understood that side effects could be off and on. 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) : PFIZER INC-202201058024 Same reporter/event/dose, different patient;
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Intermenstrual bleeding, Menstrual disorder, Muscle tightness
Clinical narrative: Heavy flow with large blood clot size of golf ball; Menstrual cycle has lasted 14 days and still going.; Extreme tiredness; loss of appetite; clenching of jaw at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2022 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anaemia" (unspecified if ongoing). Concomitant medication(s) included: IRON; VITAMIN C [ASCORBIC ACID]. The following information was reported: FATIGUE (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "Extreme tiredness"; INTERMENSTRUAL BLEEDING (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "Heavy flow with large blood clot size of golf ball"; MENSTRUAL DISORDER (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "Menstrual cycle has lasted 14 days and still going."; MUSCLE TIGHTNESS (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "clenching of jaw at night"; DECREASED APPETITE (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of intermenstrual bleeding, menstrual disorder, fatigue, decreased appetite, muscle tightness.  Patient not been took any vaccination within four weeks. Patient not had COVID prior to vaccination. Patient tested COVID positive post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Heavy flow with large blood clot size of golf ball; Menstrual cycle has lasted 14 days and still going.; Extreme tiredness; loss of appetite; clenching of jaw at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2022 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anaemia" (unspecified if ongoing). Concomitant medication(s) included: IRON; VITAMIN C [ASCORBIC ACID]. The following information was reported: FATIGUE (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "Extreme tiredness"; INTERMENSTRUAL BLEEDING (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "Heavy flow with large blood clot size of golf ball"; MENSTRUAL DISORDER (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "Menstrual cycle has lasted 14 days and still going."; MUSCLE TIGHTNESS (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "clenching of jaw at night"; DECREASED APPETITE (non-serious) with onset 02Aug2022 at 12:00, outcome "not recovered", described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of intermenstrual bleeding, menstrual disorder, fatigue, decreased appetite, muscle tightness.  Patient not been took any vaccination within four weeks. Patient not had COVID prior to vaccination. Patient tested COVID positive post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A 45-year-old male patient received BNT162b2 (BNT162B2), on 23Aug2021 as dose 1, single (Lot number: FL3181) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "epilepsy" (unspecified if ongoing), notes: he had at age 14, that was it; "depression" (ongoing), notes: was having a lot of depression and anxiety due to loss of fiancé.; "anxiety" (ongoing). The patient's concomitant medications were not reported. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious) with onset 2021, outcome "unknown", described as "when he had his Covid-19 vaccination, his health had worsened".
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 16Mar2021 as dose 2, single (Lot number: EN6708), in left arm, on 30Sep2021 at 10:30 as dose 3 (booster), single (Lot number: EW0179), in left arm and on 03Jun2022 as dose 4 (booster), single (Lot number: EW0179) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing); "Past smoker" (not ongoing), notes: quit 40 years ago. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: previously testing negative; (14Aug2022) Positive, notes: Tested positive 4 days after stopping Paxlovid. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 302580) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (lot number: ER8732, administration time 03:00 PM, vaccine location Left arm), administration date: 15Apr2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "Fluid removed each symptom Started about 1 month after each dose"; BNT162b2 (lot number EW0161, administration time 12:00 PM, vaccine location Left arm), administration date: 18Mar2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "Fluid removed each symptom Started about 1 month after each dose". The following information was reported: FLUID RETENTION (non-serious), outcome "unknown", described as "Fluid removed each symptom Started about 1 month after each dose". The event "fluid removed each symptom started about 1 month after each dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: No Covid prior vaccination, no known allergies, no other medical history. No other vaccine in four weeks.