chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: vaccine expired on 29Apr2022 and stored in the refrigerator the same date that the dose was administered; expired doses administered to patient; The patient received his first dose of Moderna on 01Jan2021, second Moderna dose on 07Feb2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first dose of Moderna on 01Jan2021, second Moderna dose on 07Feb2021), EXPIRED PRODUCT ADMINISTERED (expired doses administered to patient) and PRODUCT STORAGE ERROR (vaccine expired on 29Apr2022 and stored in the refrigerator the same date that the dose was administered) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 07-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first dose of Moderna on 01Jan2021, second Moderna dose on 07Feb2021). On 17-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine expired on 29Apr2022 and stored in the refrigerator the same date that the dose was administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received his first dose of Moderna on 01Jan2021, second Moderna dose on 07Feb2021), EXPIRED PRODUCT ADMINISTERED (expired doses administered to patient) and PRODUCT STORAGE ERROR (vaccine expired on 29Apr2022 and stored in the refrigerator the same date that the dose was administered) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that vial was initially stored in the refrigerator on the same day of administration. It was reported that the vial did not undergo temperature excursion. The Lot 042J21A expired on 29-Apr-2022. Treatment information was not provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 64-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported.  The daily dose of Moderna was reported as 1 in 1 once.  Patient had discontinued RINVOQ for two weeks and no dechallenge. Causality is not reported for drug RINVOQ  It was unknown if patient was enrolled in COVID-19 vaccine trial.  Treatment information was not provided by the reporter.  Company comment: This spontaneous case reported by a consumer concerns a 64-year-old-female patient, with medical history of Rheumatoid arthritis in treatment with Upadacitinib, who experienced the unexpected non-serious AESI of COVID-19. Onset date of vaccination with mRNA-1273 vaccine and date of event were not provided; hence, latency cannot be assessed. Vaccination schedule and interval between doses was not reported. It was reported that patient discontinued Upadacitinib for two weeks after COVID19 was diagnosed. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer concerns a 64-year-old-female patient, with medical history of Rheumatoid arthritis in treatment with Upadacitinib, who experienced the unexpected non-serious AESI of COVID-19. Onset date of vaccination with mRNA-1273 vaccine and date of event were not provided; hence, latency cannot be assessed. Vaccination schedule and interval between doses was not reported. It was reported that patient discontinued Upadacitinib for two weeks after COVID19 was diagnosed. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: side effects are mild for ll three shots; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (side effects are mild for ll three shots) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     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, the patient experienced IMMUNISATION REACTION (side effects are mild for ll three shots). At the time of the report, IMMUNISATION REACTION (side effects are mild for ll three shots) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   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-2022-570194 (Patient Link).
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Nasopharyngitis
Clinical narrative: COVID-19; Cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold symptoms) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Ulcerative colitis and Ankylosing spondylitis.    No known allergies reported.  Concurrent medical conditions included Ulcerative colitis (Moderate to severe ulcerative colitis) and Ankylosing spondylitis.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Pre filled injection. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Unknown regimen. On an unknown date, the patient experienced COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold symptoms). At the time of the report, COVID-19 (COVID-19) and NASOPHARYNGITIS (Cold symptoms) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No Concomitant medication was reported  Patient took Second dose and third dose booster via intramuscular route with no associated events reported. No Treatment medication was reported Company comment This spontaneous case reported by a consumer, concerns a male patient of unknown age, with concurrent illness with Ulcerative colitis and Ankylosing spondylitis, on treatment with Adalimumab (Humira), who experienced the unexpected, non-serious AESI of covid 19 Infection, unknown days after receiving the 1 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Details of clinical course, labs, diagnostic investigations and treatment were not provided. Ongoing Covid 19 pandemia and concomitant use of Adalimumab could be considered as confounders to the event. Patient took Second dose and third dose booster via intramuscular route with no associated events reported. Event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case reported by a consumer, concerns a male patient of unknown age, with concurrent illness with Ulcerative colitis and Ankylosing spondylitis, on treatment with Adalimumab (Humira), who experienced the unexpected, non-serious AESI of covid 19 Infection, unknown days after receiving the 1 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Details of clinical course, labs, diagnostic investigations and treatment were not provided. Ongoing Covid 19 pandemia and concomitant use of Adalimumab could be considered as confounders to the event. Patient took Second dose and third dose booster via intramuscular route with no associated events reported. Event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction
Clinical narrative: Medical Information Potential AE; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Medical Information Potential AE) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (Medical Information Potential AE). At the time of the report, IMMUNISATION REACTION (Medical Information Potential AE) outcome was unknown.            No concomitant medications was reported. Patient received second booster dose 2 week ago and was querying was it still okay to take Paxlovid.  Paitient was taking Paxlovid and would like to ask for information regarding use with the antibiotic Doxycycline. No treatment medications was reported.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid mass
Clinical narrative: Nodules on my Thyroid, that weren't there prior to the vaccine. This is causing health complications.; This spontaneous case was reported by a consumer and describes the occurrence of THYROID MASS (Nodules on my Thyroid, that weren't there prior to the vaccine. This is causing health complications.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A and 051F21A) for COVID-19 vaccination.     The patient was not diagnosed with COVID Prior to vaccination.  Concurrent medical conditions included AFib and Allergy to antibiotic (cleocin). Concomitant products included METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.   On 29-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, the patient experienced THYROID MASS (Nodules on my Thyroid, that weren't there prior to the vaccine. This is causing health complications.). At the time of the report, THYROID MASS (Nodules on my Thyroid, that weren't there prior to the vaccine. This is causing health complications.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    No treatment medications were provided.
Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Symptoms returned and tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Symptoms returned and tested positive) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Concurrent medical conditions included Gout and Allergy NOS. Concomitant products included PRAVASTATIN from an unknown date to 17-May-2022 for an unknown indication.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 05-May-2022, the patient experienced COVID-19 (Symptoms returned and tested positive). At the time of the report, COVID-19 (Symptoms returned and tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive with symptoms on May 5. On 13-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative on May 13. On 17-May-2022, SARS-CoV-2 test: positive (Positive) Symptoms returned and tested positive May 17.         No information on treatment medications was reported. Company comment: This spontaneous case concerns a patient of a 55-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 approximately 7 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per narrative of the source document, she experienced symptoms with a positive test, and the symptoms cleared in treatment with Paxlovid (ritonavir), but he reported after eight days the symptoms returned and tested positive again. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of a 55-year-old male patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 approximately 7 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per narrative of the source document, she experienced symptoms with a positive test, and the symptoms cleared in treatment with Paxlovid (ritonavir), but he reported after eight days the symptoms returned and tested positive again. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received a Moderna vaccine in error at age 17; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a Moderna vaccine in error at age 17) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a Moderna vaccine in error at age 17). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received a Moderna vaccine in error at age 17) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  It was reported that the parent never gave patient an additional dose.   Treatment information was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Patient complains of fatigue; sore left injection site arm; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Patient complains of fatigue) and VACCINATION SITE PAIN (sore left injection site arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced FATIGUE (Patient complains of fatigue) and VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, FATIGUE (Patient complains of fatigue) and VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.      It was reported that patient was not immunocompromised. No treatment details were reported.   This case was linked to MOD-2022-570986, MOD-2022-571008, MOD-2022-570966, MOD-2022-570982, MOD-2022-570996 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Apr-2022 and the vaccine was administered on 17-May-2022; administered an expired vaccine, 6 days after beyond use day; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine, 6 days after beyond use day ) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2022 and the vaccine was administered on 17-May-2022) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 005M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine, 6 days after beyond use day ). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2022 and the vaccine was administered on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine, 6 days after beyond use day ) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Apr-2022 and the vaccine was administered on 17-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Live follow-up contains significant information which included addition of secondary reporter, patient demographics (initial, age and gender), suspect product details (date of administration and batch number) and new event (product storage error). Also primary reporter details (address and city) and event description was updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 06-Sep-2021 and removed from the fridge on 04-Jan-2022; administered vaccines past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 06-Sep-2021 and removed from the fridge on 04-Jan-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 06-Sep-2021 and removed from the fridge on 04-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 06-Sep-2021 and removed from the fridge on 04-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  On 04-Jan-2022, the vial was removed from fridge.  Reportedly, By Used Date was 06-Sep-2021. The vaccines were stored in the freezer and only removed as needed to thaw and then administered. It was mentioned that vials were taken out at a time and thawed as they did not thawed an entire box.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 24-Apr-2022 and removed from the fridge on 25-Apr-2022 and administred on 25-Apr-2022; administered vaccines past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 24-Apr-2022 and removed from the fridge on 25-Apr-2022 and administred on 25-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 24-Apr-2022 and removed from the fridge on 25-Apr-2022 and administred on 25-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 24-Apr-2022 and removed from the fridge on 25-Apr-2022 and administred on 25-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Reportedly, by used date was mentioned as 24-Apr-2022. The vaccines were stored in the freezer and only removed as needed to thaw and then administered. It was mentioned that vials were taken out at a time and thawed as they did not thawed an entire box.  Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 24-Apr-2022 and removed from the fridge on 27-Apr-2022; administered vaccines past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 24-Apr-2022 and removed from the fridge on 27-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 24-Apr-2022 and removed from the fridge on 27-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 24-Apr-2022 and removed from the fridge on 27-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  Reportedly, the by used date was mentioned as 24-Apr-2022. The vaccines were stored in the freezer and only removed as needed to thaw and then administered. It was mentioned that vials were taken out at a time and thawed as they did not thawed an entire box. On 27-Apr-2022, the vaccine was removed from the Fridge.  No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Culture, Urticaria
Clinical narrative: The vaccine has been making break out in hives since Jun2021; 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 received BNT162b2 (BNT162B2), on 04Jun2021 as dose 1, single (Lot number: ER8735), in left arm and on 26Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 06Jun2021, outcome "not recovered", described as "The vaccine has been making break out in hives since Jun2021". The event "the vaccine has been making break out in hives since jun2021" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria.  Additional information: No. issues with Pfizer product and reported issue does not occur after use of Pfizer product. Dec2021, hives stopped for a month and then started up during the day and at random times. May have been infected by COVID. No serotyping done. No prior vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: vaccinated with a Covid-19 vaccine has been diagnosed with mild Covid-19; vaccinated with a Covid-19 vaccine has been diagnosed with mild Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number (unknown), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "vaccinated with a Covid-19 vaccine has been diagnosed with mild Covid-19".The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Clinical course: The reporter stated that the patient was vaccinated with a Covid-19 vaccine and has been diagnosed with mild Covid-19. The physician would prescribe Paxlovid if the patient's condition worsened.  No follow-up attempts are possible. No further information is expected
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: developed nose bleeding/waking up at night with his bed full of blood/The patient is saying it took a very very very long time to stop the bleeding this morning, like 30 minutes; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), 0.3 ml single (Lot number: FM9992) at the age of 53 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2;  unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (booster); Unknown manufacturer), for COVID-19 Immunization. The following information was reported: EPISTAXIS (medically significant) with onset 11May2022, outcome "unknown", described as "developed nose bleeding/waking up at night with his bed full of blood/The patient is saying it took a very very very long time to stop the bleeding this morning, like 30 minutes". Therapeutic measures were taken as a result of epistaxis. Clinical course: The report was not related to a study or programme. NDC number of COVID-19 vaccine: 59267102504. Caller is a pharmacist reporting an adverse event on behalf of a patient who received their second booster dose of the Pfizer Covid vaccine on 11May2022. That evening after receiving the vaccine, the patient developed nose bleeding. The patient reported waking up at night with his bed full of blood and it took a long time to stop the bleeding. This happened again the following night (12May2022). Patient told that it was related, patient has never had a nose bleed before in his life. Patient was thinking of going to the urgent care for the nose bleeding event. The patient said that it took a very long time to stop the bleeding that morning, like 30 minutes. Patient said the bleeding had stopped already yesterday, and caller instructed the patient to not take patient's baby Aspirin, but then the nose bleeding happened again last night, 12May2022. Caller was going to tell patient to get some of the bleed stop product, but patient was very angry and upset. Patient picked up the baby Aspirin over the counter, patient told the caller over the phone that he takes baby Aspirin. NDC number, lot number, expiration date: Unknown. Manufacturer date: Oct2021. Beyond use date: 31Jan2023.; Sender's Comments: Based on the information provided in the narrative , a possible contributory role of the suspect vaccine  to reported event of  epistaxis    cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 09:00 as dose 3 (booster), single (Lot number: FE3590), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ciprofloxacin, reaction(s): "Known allergies: Ciprofloxacin"; Midazolam, reaction(s): "Known allergies: Midazolam". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment from 02May2022 to 07May2022. No other medication in 2 weeks of vaccination. Three days after completing my treatment course, the initial Covid symptoms returned. Start date of events was 10May2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Device Date was documented as 13May2022.  No follow-up attempts are possible. 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Head discomfort, Rhinorrhoea, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Heavy chest; runny nose; clogged head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM9810), in right arm, on 28Feb2021 as dose 2, single (Lot number: EN6198), in right arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Treating high blood pressure" (unspecified if ongoing). There were no concomitant medications in 2weeks. Past drug history included: Ampicillin, reaction(s): "known allergies: Ampicillin". The following information was reported: CHEST DISCOMFORT (non-serious) with onset 12May2022, outcome "not recovered", described as "Heavy chest"; HEAD DISCOMFORT (non-serious) with onset 12May2022, outcome "not recovered", described as "clogged head"; RHINORRHOEA (non-serious) with onset 12May2022, out-come "not recovered", described as "runny nose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of chest discomfort. Anti viral details, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 03May2022, Treatment stop date: 08May2022, Indication: Treatment of COVID-19. No treatment for adverse event.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Oropharyngeal pain, Productive cough
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient. A 48-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: 3209) at the age of 48 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (2022) and all described as "Treatment of COVID-19"; PRODUCTIVE COUGH (non-serious) with onset 10May2022, outcome "not recovered", described as "Cough has become more productive"; FATIGUE (non-serious) with onset 10May2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 10May2022, outcome "unknown", described as "sore throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Negative. Therapeutic measures were taken as a result of Covid-19, productive cough. Other medication in 2weeks was no, Anti-viral details: product was COVID-19 Treatment, brand=Pfizer, treatment start date was 28Apr2022, treatment stop date was 03May2022, indication was Treatment of COVID-19. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was no. Did you/the patient previously receive a COVID-19 Vaccine was yes. Symptoms of cough, fatigue, and sore throat returned significantly on 10May2022.  Rapid at home antigen COVID test was negative 11May2022. Cough has become more productive and remains in 13May2022. What treatment received for the adverse event was  Medication for cough. Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events. The case will be reassessed once new information is available.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient. A 48-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: 3209) at the age of 48 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (2022) and all described as "Treatment of COVID-19"; PRODUCTIVE COUGH (non-serious) with onset 10May2022, outcome "not recovered", described as "Cough has become more productive"; FATIGUE (non-serious) with onset 10May2022, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious) with onset 10May2022, outcome "unknown", described as "sore throat". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Negative. Therapeutic measures were taken as a result of Covid-19, productive cough. Other medication in 2weeks was no, Anti-viral details: product was COVID-19 Treatment, brand=Pfizer, treatment start date was 28Apr2022, treatment stop date was 03May2022, indication was Treatment of COVID-19. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was no. Did you/the patient previously receive a COVID-19 Vaccine was yes. Symptoms of cough, fatigue, and sore throat returned significantly on 10May2022.  Rapid at home antigen COVID test was negative 11May2022. Cough has become more productive and remains in 13May2022. What treatment received for the adverse event was  Medication for cough. Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events. The case will be reassessed once new information is available.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Plasma cell myeloma" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR SODIUM], start date: 07Jan2022; PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE], start date: 15Nov2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional Information: Patient received Paxlovid anti-viral details [{product=COVID 19 Treatment with start date was 04May2022 and stop date 09May2022, other medication in 2weeks product was Zyrtec D other medication in 2weeks start date 04May2022. Adverse event: Symptoms returned today (13May2022). Runny nose, sore throat, and cough. The symptoms had been gone for a few days but I woke up at 4 am with them back and have had them since. Patient had no allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter consumer or other non HCP. The reporter is the patient. A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 12:00 as dose 1, single (Lot number: ER8729), on 05May2021 at 14:00 as dose 2, single (Lot number: EW1072), in left arm and on 08Dec2021 at 11:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 26 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Shellfish" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test was positive. Therapeutic measures were taken as a result of Covid-19. Clinical information: Adverse event includes that I am currently day 5 after finishing my Paxlovid course and I feel just as sick as I did when I tested positive before taking it. I started feeling sick yesterday with congestion and a headache, and today I have that plus sore throat, fatigue, and low fever 100.1. Anti-viral details includes that patient undergone COVID 19 Treatment. Brand was Paxlovid. Treatment start date was 03May2022 and treatment stop date was 08May2022. Patient had no other medication in 2 weeks. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3246), in left arm, on 04Feb2021 as dose 2, single (Lot number: EL9264), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 50 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Chronic migraines" (unspecified if ongoing); "COVID", start date: Nov2020 (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE, start date: 01May2021; CANDESARTAN CILEXETIL, start date: 01Mar2022; EMGALITY [GALCANEZUMAB], start date: 11Apr2022, stop date: 11Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19 with Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2020) diagnosed with long Covid. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Additional information: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 04May2022, treatment stop date: 08May2022, indication: Treatment of COVID-19 with Paxlovid. There was no known allergies. Chronic migraines induced by Covid/ diagnosed with long Covid from first infection Nov2020.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested "positive" with at home test; Tested "positive" with at home test; 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 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 78 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: "diabetes Type 2" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown if patient received other medication in 2 weeks. It was unknown if patient had known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Tested "positive" with at home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Paxlovid from 06May2022 to 11May2022 for COVID-19. 5-day treatment completed 11May2022 continued symptoms of: fatique, cough, headache and congestion. Tested "positive" with at home test 13May2022.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; sore arm; Upset stomach; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4389748-00.  A 44-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Vaccine dose number=3 Pfizer, vaccine dose number=1,2 Moderna" (unspecified if ongoing), notes: Vaccine dose number=3 Pfizer, vaccine dose number=1,2 Moderna. The patient's concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "recovered" (2022), described as "Rheumatoid arthritis flare up"; ABDOMINAL DISCOMFORT (non-serious) with onset 2022, outcome "recovered", described as "Upset stomach"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "recovered", described as "sore arm". The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis flare up", "sore arm" and "upset stomach" related to BNT162b2.  The reporter causality between the events rheumatoid arthritis flares up, sore arm and upset stomach for BNT162b2 and MODERNA COVID-19 VACCINE was reported as possible and for HUMIRA was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: To amend to update event causality result.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events rheumatoid arthritis, abdominal discomfort and pain in extremity cannot be excluded.