chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Stored Moderna vaccine in their refrigerator and administered vaccine on 19-Feb-2022 past the BUD date 01-Nov-2021; The patient administered vaccine on 19-Feb-2022 past the BUD date of 01-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered vaccine on 19-Feb-2022 past the BUD date of 01-Nov-2021) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered vaccine on 19-Feb-2022 past the BUD date 01-Nov-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered vaccine on 19-Feb-2022 past the BUD date of 01-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered vaccine on 19-Feb-2022 past the BUD date 01-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered vaccine on 19-Feb-2022 past the BUD date of 01-Nov-2021) and PRODUCT STORAGE ERROR (Stored Moderna vaccine in their refrigerator and administered vaccine on 19-Feb-2022 past the BUD date 01-Nov-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The BUD date was reported as 01-Nov-2021 and CDC expiration was reported as 19-Mar-2022. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Storing Moderna vaccine in their refrigerator and administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021; Patient administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021) and PRODUCT STORAGE ERROR (Storing Moderna vaccine in their refrigerator and administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Storing Moderna vaccine in their refrigerator and administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021) and PRODUCT STORAGE ERROR (Storing Moderna vaccine in their refrigerator and administered vaccine on 22-FEB-2022 past the BUD date 01-Nov-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The BUD date was reported as 01-Nov-2022. and CDC expiration reported as 19-Mar-2022.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: stored Moderna vaccine in their refrigerator and administered past the BUD date; BUD was 01-Nov-2021 but the vaccine was administered on 27-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 27-Feb-2022) and PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 27-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD was 01-Nov-2021 but the vaccine was administered on 27-Feb-2022) and PRODUCT STORAGE ERROR (stored Moderna vaccine in their refrigerator and administered past the BUD date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (received vaccine on Mar 7, 2022 past the BUD date of Nov 1, 2021) and product storage error (stored Moderna vaccine in refrigerator; administered vaccine on Mar 7, 2022; past the BUD date of Nov 1, 2021) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011F21A) for COVID-19 immunization. No medical history reported. On Mar 7, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 7, 2022, patient administered expired product (received vaccine on Mar 7, 2022 past the BUD date of Nov 1, 2021). On an unknown date, patient experienced product storage error (stored Moderna vaccine in refrigerator; administered vaccine on Mar 7, 2022; past the BUD date of Nov 1, 2021). At the time of the report, administered expired product (received vaccine on Mar 7, 2022 past the BUD date of Nov 1, 2021) and product storage error (stored Moderna vaccine in refrigerator; administered vaccine on Mar 7, 2022; past the BUD date of Nov 1, 2021) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Liver disorder
Clinical narrative: he was not the only one with this issues, (liver discomfort) that he had family members, and people in his socials networks that  had the same issue after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of LIVER DISORDER (he was not the only one with this issues, (liver discomfort) that he had family members, and people in his socials networks that  had the same issue after the second dose) in a 22-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER DISORDER (he was not the only one with this issues, (liver discomfort) that he had family members, and people in his socials networks that  had the same issue after the second dose). At the time of the report, LIVER DISORDER (he was not the only one with this issues, (liver discomfort) that he had family members, and people in his socials networks that  had the same issue after the second dose) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  Company Comment: This case concerns a 22-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI of Liver disorder on unspecified days after receiving the second dose of mRNA-1273 vaccine. Its reported that patient is not the only one with this issues of liver discomfort that he have family members, and people in his socials networks that had the same issue after the second dose.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 22-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI of Liver disorder on unspecified days after receiving the second dose of mRNA-1273 vaccine. Its reported that patient is not the only one with this issues of liver discomfort that he have family members, and people in his socials networks that had the same issue after the second dose.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Liver disorder
Clinical narrative: Liver discomfort; This spontaneous case was reported by a consumer and describes the occurrence of LIVER DISORDER (Liver discomfort) in a 15-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER DISORDER (Liver discomfort). At the time of the report, LIVER DISORDER (Liver discomfort) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Company comment: This spontaneous case concerns a 15 year old female patient, with no reported medical history, who experienced the unexpected non serious AESI of Liver disorder (latency unknown), after receiving the second dose of COVID -19 vaccination with mRNA-1273 vaccine. No further information on clinical course and management of the event was available in the report. The outcome of the event was unknown'. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-551822, MOD-2022-551703, MOD-2022-551797, MOD-2022-551805 (Patient Link).; Sender's Comments: This spontaneous case concerns a 15 year old female patient, with no reported medical history, who experienced the unexpected non serious AESI of Liver disorder (latency unknown), after receiving the second dose of COVID -19 vaccination with mRNA-1273 vaccine. No further information on clinical course and management of the event was available in the report. The outcome of the event was unknown'. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 01-April-2022 and administered on 20-April-2022; Expired vaccine given to 6 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to 6 patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-April-2022 and administered on 20-April-2022) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to 6 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-April-2022 and administered on 20-April-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to 6 patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-April-2022 and administered on 20-April-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received second booster dose. The vial initially stored in the refrigerator on 01-Apr-2022. The vaccine expired on17-April-2022. The vial did not undergo any temperature excursions.   No treatment information was provided.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of accidental overdose (received a full dose of the COVID-19 for his first booster dose) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 056A22A) for COVID-19 immunization. No medical history reported. In 2021, patient received the first and second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; .5 milliliter. On an unknown date, patient experienced accidental overdose (received a full dose of the COVID-19 for his first booster dose). At the time of the report, accidental overdose (received a full dose of the COVID-19 for his first booster dose) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Patient received primary series in spring of 2021. Patient took 1st booster dose. Patient did not experience any adverse event.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial expired on 17-Apr-2022, stored in refrigerator on 18-Apr-2022 and administered on 19-Apr-2022.; patient was administered an expired dose of the vaccine for the booster; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of the vaccine for the booster) and PRODUCT STORAGE ERROR (Vial expired on 17-Apr-2022, stored in refrigerator on 18-Apr-2022 and administered on 19-Apr-2022.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL, VARENICLINE and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of the vaccine for the booster). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 17-Apr-2022, stored in refrigerator on 18-Apr-2022 and administered on 19-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of the vaccine for the booster) and PRODUCT STORAGE ERROR (Vial expired on 17-Apr-2022, stored in refrigerator on 18-Apr-2022 and administered on 19-Apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient received 1st booster dose. Treatment medications were not provided.  It was reported that the vial was stored in refrigerator after expiry on 18-Apr-2022. The vial did not undergo any temperature excursion.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (expired vaccine given to patient) and product storage error (vial initially stored in the refrigerator on April 1, 2022; administered April 20, 2022) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 016J212A) for COVID-19 immunization. No medical history reported. On Apr 20, 2022, patient received the fourth dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 20, 2022, patient administered expired product (expired vaccine given to patient). On an unknown date, patient experienced product storage error (vial initially stored in the refrigerator on April 1, 2022; administered April 20, 2022). At the time of the report, administered expired product (expired vaccine given to patient) and product storage error (vial initially stored in the refrigerator on April 1, 2022; administered April 20, 2022) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. On April 1, 2022, vial was initially stored in the refrigerator. Vial did not undergo any temperature excursions.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (vaccine expired on April 17, 2022; given to patient) and product storage error (vaccine stored in refrigerator on Apr 1, 2022, expired on Apr 17, 2022 and administered on Apr 20, 2022) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 016J212A) for COVID-19 immunization. No medical history reported. On Apr 20, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 20, 2022, patient administered expired product (vaccine expired on April 17, 2022; given to patient). On an unknown date, patient experienced product storage error (vaccine stored in refrigerator on Apr 1, 2022, expired on Apr 17, 2022 and administered on Apr 20, 2022). At the time of the report, administered expired product (vaccine expired on April 17, 2022; given to patient) and product storage error (vaccine stored in refrigerator on Apr 1, 2022, expired on Apr 17, 2022 and administered on Apr 20, 2022) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The patient received 2nd booster. The vial initially stored in the refrigerator on April 1, 2022. Vial did not undergo with any temperature excursions. This case linked to MOD-2022-545248 (patient link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (vaccine expired April 17, 2022, believed to be administered to 6 people) and product storage error (vaccine stored past expiry date) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 016J212A) for COVID-19 immunization. No medical history reported. On Apr 20, 2022, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 20, 2022, patient administered expired product (vaccine expired April 17, 2022, believed to be administered to 6 people). On an unknown date, patient experienced product storage error (vaccine stored past expiry date). At the time of the report, administered expired product (vaccine expired April 17, 2022, believed to be administered to 6 people) and product storage error (vaccine stored past expiry date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vial did not undergo any temperature excursions. Vial initially stored in the refrigerator on April 1, 2022. This case linked to MOD-2022-545248 (patient link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hunger, Vaccination site pain
Clinical narrative: Extremely hungry; Headache; Pain and soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Extremely hungry), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain and soreness at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient never had COVID-19 test or diagnosis.  The patient's past medical history included Kidney stones, Intestinal inflammation and Surgery (Small Intestinal Inflammatory issues that needed surgery). Concurrent medical conditions included Sulfonamide allergy, Cancer (Cancer 3 times) and Muscle wasting.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HUNGER (Extremely hungry), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain and soreness at the injection site). On 26-Feb-2021, HUNGER (Extremely hungry), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain and soreness at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the patient had allergies to something but she does not remember. No concomitant medications were reported. No treatment  medications were reported.   This case was linked to MOD-2022-552309 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022; Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that thought that the vaccine expired in Jun-2022, however it was expired in 01-Apr-2022.  No treatment information was reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (expired vaccine administered to 155 patients) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 026L21B) for COVID-19 immunization. No medical history reported. On Apr 4, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; .25 milliliter. On Apr 4, 2022, patient administered expired product (expired vaccine administered to 155 patients). At the time of the report, administered expired product (expired vaccine administered to 155 patients) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The pharmacist called to verify an expiration date for batch/lot# 026L21B. The pharmacist said he thought the vaccine expired in June 2022, however the vaccine expired on Apr 1, 2022. 80 patients received the expired vaccine. Vial initially stored in refrigerator on Apr 4, 2022. No temperature excursions.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patients vaccinated with expired doses) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 026L21B) for COVID-19 immunization. No medical history reported. On Apr 4, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; .25 milliliter. On Apr 4, 2022, patient administered expired product (patients vaccinated with expired doses). At the time of the report, administered expired product (patients vaccinated with expired doses) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. It was reported the pharmacist thought the expiry date of the vaccine was June 2022, however the vaccine expired on Apr 1, 2022. The vial didn't undergo temperature excursion issue. Vaccine placed in refrigerator on Apr 4, 2022.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes virus infection, Poor quality product administered, Product administration error
Clinical narrative: Herpes infection; given a dose of the Pfizer Covid 19 Vaccine gray cap formulation which was already 72hours out of the refrigerator and after first puncture; given a dose of the Pfizer Covid 19 Vaccine gray cap formulation which was already 72hours out of the refrigerator and after first puncture.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2022 at 10:45 as dose 3 (booster), single (Lot number: FM0698, Expiration Date: 11May2022) at the age of 51 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR] oral taken for herpes virus infection, start date: 30Mar2022. Vaccination history included: BNT162b2 (First dose, single), administration date: 24Apr2021, when the patient was 50-year-old, for COVID-19 Immunization; BNT162b2 (Second dose, single), administration date: 13May2021, when the patient was 50-year-old, for COVID-19 Immunization.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 28Mar2022, outcome "unknown", described as "given a dose of the Pfizer Covid 19 Vaccine gray cap formulation which was already 72hours out of the refrigerator and after first puncture"; PRODUCT ADMINISTRATION ERROR (non-serious) with onset 28Mar2022, outcome "unknown", described as "given a dose of the Pfizer Covid 19 Vaccine gray cap formulation which was already 72hours out of the refrigerator and after first puncture."; HERPES VIRUS INFECTION (non-serious) with onset 30Mar2022, outcome "unknown", described as "Herpes infection". Therapeutic measures were taken as a result of herpes virus infection.  Additional information: On Monday, 28Mar2022 at 10:45am, a vial of Pfizer Covid 19 vaccine was punctured. It had been left out from Friday 25Mar2022, 61 hours and 15 minutes, longer than Manufacturer's instructions. The original open date of the vial was 25Mar2022 at 9:30 am and expired 9:30pm that day. A second dose was taken from the vial on 28Mar2022 at approximately 10:40 am and administer to a patient at 10:45am. After error realized, the Provider was informed, and patient was contacted.   Follow up(27Apr2022):  New information received from a contactable Other HCP. This other HCP reported for male patient in response to HCP letter sent via follow-up letter which included that: Primary reporter institution name, fax no, and Email address added, RMH added, In historical vaccines dates added for 1st and 2nd dose and same added in notes as first dose and second dose, For suspect product dose no, anatomical site, route added, Vaccination facility name, address, city, state, type, postal code, phone no added, Concomitant coded, New event "Herpes infection" added, event onset date and treatment added.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown), in right arm, on 03Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 28Feb2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Heart disease Asthma" (unspecified if ongoing), notes: Heart disease Asthma; "Heart disease Asthma" (unspecified if ongoing), notes: Heart disease Asthma; "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: PAXLOVID taken for Covid-19, start date: 12Apr2022, stop date: 17Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Apr2022, outcome "not recovered" and all described as "Treatment of COVID-19". It was unknown if therapeutic measures were taken as a result of drug ineffective, Covid-19. Adverse event: After taking full dosage she tested negative for four days. On the fifth day she had cold like symptoms again and tested positive. Patient had no known allergies. No other medication in 2 weeks. Lot numbers were misplaced/discarded. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: she experienced fainting the next morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "she experienced fainting the next morning". Clinical course: As per agent (Name Withheld), caller was asked has anyone experienced fainting after the booster vaccine. after providing response, caller stated that she experienced fainting the next morning. Caller mentioned that she received her vaccine 2 PM and fainted the next morning at 6 AM when she got out of bed. Caller stated that she wondered if that was from the vaccine and she had called the pharmacy and they told here that they have no records of patients fainting after the vaccine administration.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: Unknown. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He received his last shot on Nov2021 and he was diagnosed with Covid infection on Friday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The caller stated that, he received his last shot on Nov2021 and he was diagnosed with Covid infection on Friday and he believed that this could had been prevented. It was ridiculous that second dose was not given to front liners. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Pain, Pyrexia
Clinical narrative: Ag positive 23Apr; Ag positive 23Apr; Sx chills 22Apr; Fevers; Cough; Body aches; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247) and on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years 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), VACCINATION FAILURE (medically significant) all with onset 23Apr2022, outcome "unknown" and all described as "Ag positive 23Apr''; PAIN (non-serious) with onset 22Apr2022, outcome "unknown", described as "Body aches"; COUGH (non-serious) with onset 22Apr2022, outcome "unknown"; PYREXIA (non-serious) with onset 22Apr2022, outcome "unknown", described as "Fevers"; CHILLS (non-serious) with onset 22Apr2022, outcome "unknown", described as "Sx chills 22Apr"; The events "ag positive 23apr", "sx chills 22apr", "fevers", "cough" and "body aches" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Apr2022) Positive, notes: COVID test name post vaccination: Home Ag. It was unknown if therapeutic measures were taken as a result of covid-19, vaccination failure, chills, pyrexia, cough, pain.  Clinical Course: It was unknown if the patient had COVID Prior Vaccination. The patient had COVID Tested Post Vaccination. The COVID Test Type Post Vaccination was unknown. The COVID test name post vaccination was Home Ag.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information in the case the plausible casual relation between the reported events and suspect drug BNT162b2 cannot be excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: Ag positive 23Apr; Ag positive 23Apr; Sx chills 22Apr; Fevers; Cough; Body aches; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 22Mar2021 as dose 2, single (Lot number: EL3247) and on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 42 years 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), VACCINATION FAILURE (medically significant) all with onset 23Apr2022, outcome "unknown" and all described as "Ag positive 23Apr''; PAIN (non-serious) with onset 22Apr2022, outcome "unknown", described as "Body aches"; COUGH (non-serious) with onset 22Apr2022, outcome "unknown"; PYREXIA (non-serious) with onset 22Apr2022, outcome "unknown", described as "Fevers"; CHILLS (non-serious) with onset 22Apr2022, outcome "unknown", described as "Sx chills 22Apr"; The events "ag positive 23apr", "sx chills 22apr", "fevers", "cough" and "body aches" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Apr2022) Positive, notes: COVID test name post vaccination: Home Ag. It was unknown if therapeutic measures were taken as a result of covid-19, vaccination failure, chills, pyrexia, cough, pain.  Clinical Course: It was unknown if the patient had COVID Prior Vaccination. The patient had COVID Tested Post Vaccination. The COVID Test Type Post Vaccination was unknown. The COVID test name post vaccination was Home Ag.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information in the case the plausible casual relation between the reported events and suspect drug BNT162b2 cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Ag positive 24Apr22; Ag positive 24Apr22; cough; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset 22Apr2022, outcome "unknown"; FATIGUE (non-serious) with onset 22Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 24Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 24Apr2022, outcome "unknown" and all described as "Ag positive 24Apr22". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Apr2022) Positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, cough, fatigue.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination Failure and COVID - 19which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: Left eye cataract; Right eye cataract; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 at 09:00 as dose 1, single (Lot number: EL3248), in left arm and on 26Feb2021 at 13:00 as dose 2, single (Lot number: EL9262), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: CATARACT (medically significant) with onset 15Apr2021, outcome "unknown", described as "Right eye cataract"; CATARACT (medically significant) with onset 13May2021, outcome "unknown", described as "Left eye cataract". Therapeutic measures were taken as a result of cataract, cataract. (cataract surgery).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 today; tested positive for Covid-19 today; running a fever of 102 F; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Apr2022, outcome "unknown", described as "running a fever of 102 F"; COVID-19 (medically significant) with onset 25Apr2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive for Covid-19 today". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) fever of 102 F, notes: fever of 102 F; SARS-CoV-2 test: (25Apr2022) positive, notes: tested positive for Covid-19 today. Therapeutic measures were taken as a result of covid-19, pyrexia. Clinical course: Reporter stated she received two primary series doses of the Pfizer BioNTech COVID-19 Vaccine and a booster dose. Reporter states she went on vacation with her family and when she got back her niece tested positive for COVID-19. Reporter states she, herself, also tested positive for COVID-19 on 25Apr2022. Reporter states her doctor prescribed her Paxlovid and she just started her treatment a few moments ago with her first dose. Reporter was running a fever of 102 F. Reporter asking if it was okay that she started her Paxlovid at night instead of in the morning. Reporter asking if Tylenol can be taken with Paxlovid.  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: Drug ineffective, Suspected COVID-19
Clinical narrative: she got the last dose of the COVID vaccine on the 5th, then diagnosed with COVID on the 9th; she got the last dose of the COVID vaccine on the 5th, then diagnosed with COVID on the 9th; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EN6201), on 02Mar2021 as dose 2, single (Lot number: EN6198), on 30Aug2021 as dose 3 (booster), single (Lot number: EW0185) and on 05Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 09Apr2022, outcome "unknown" and all described as "she got the last dose of the COVID vaccine on the 5th, then diagnosed with COVID on the 9th". Therapeutic measures were taken as a result of suspected covid-19.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 at 13:00 as dose 2 (booster), single (Lot number: FH3020) at the age of 64 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 14Mar2021 at 14:00 as dose 1, single (Lot number: 1805018), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "elevated cholesterol" (unspecified if ongoing), notes: elevated cholesterol; "HIV positive" (unspecified if ongoing); "interchange of vaccine products", start date: 25Oct2021, stop date: 25Oct2021, notes: Dose 1 JNJ, Dose 2 (booster) Pfizer. Concomitant medication(s) included: ENALAPRIL; ENALAPRIL+HCTZ; DELSTRIGO; VALACYCLOVIR [VALACICLOVIR]; ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21Apr2022 at 08:00, outcome "unknown", COVID-19 (medically significant) with onset 21Apr2022 at 08:00, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) positive; (Apr2022) Negative, notes: Had tested negative at day 4 and day 5 on drug with RAT; (Apr2022) Negative, notes: Had tested negative at day 4 and day 5 on drug with RAT. Therapeutic measures were taken as a result of covid-19. Clinical course: Return of symptoms after last dose of Paxlovid along with positive RAT. Had tested negative at day 4 and day 5 on drug with RAT. Antiviral details included COVID 19 treatment, Treatment start date 13Apr2022, Treatment stop date=18Apr2022, indication was treatment of COVID-19.; Sender's Comments: Based on available information in the case the plausible casual relation between the reported events and suspect drug BNT162b2 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Drug ineffective, Sleep disorder, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2020, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Jan2020, outcome "recovered" (2020) and all described as "I have been fully vaccinated, I got Covid"; SLEEP DISORDER (non-serious), outcome "unknown", described as "I'm also having trouble sleeping"; ASTHENIA (non-serious), outcome "unknown", described as "I just don't have the kind of "energy" I had before/debilitating". It was reported that, a potential AE has been reported to the Pfizer Clinical Trials Contact Center. Stated that, the patient was over 60-years-old. Stated that, although the patient had been fully vaccinated, the patient got Covid before anyone knew what it was. Stated that, the patient had experienced a very bad case of Covid on an unspecified date in Jan2020. It was debilitating. Stated that, the patient had recovered but the patient just didn't had the kind of energy that the patient had before. Stated that, the patient was very active for the patient age. Stated that, the patient work out 3-4 times a week but it's been a struggle lately. Stated that, the patient also having trouble sleeping. Withheld. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.