chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity
Clinical narrative: she got COVID-19; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and COVID-19 (she got COVID-19) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced COVID-19 (she got COVID-19). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 06-Oct-2021, PAIN IN EXTREMITY (Sore arm) outcome was unknown. At the time of the report, COVID-19 (she got COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   This case was linked to MOD-2021-377596.; Sender's Comments: This case concerns a 31 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred at an unknown date after the first dose of Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, POOR QUALITY PRODUCT ADMINISTERED (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided. It was reported that vial at that clinic was punctured 30 times and All doses given were Booster doses. Patient date of birth was reported as --1962.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration, Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times), ACCIDENTAL UNDERDOSE (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times), ACCIDENTAL UNDERDOSE (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times), ACCIDENTAL UNDERDOSE (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-375352.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administering the half dose booster shot of Moderna COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administering the half dose booster shot of Moderna COVID-19 vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066F21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administering the half dose booster shot of Moderna COVID-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administering the half dose booster shot of Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported. nurse assumed that this patient received the second dose in May 2021   This case was linked to MOD-2021-377687 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 12-OCT-2021 at 08 am, the vaccine was removed from the freezer.  No concomitant medications were reported.  No treatment information was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: kind of achy all over the body; Headaches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (kind of achy all over the body), HEADACHE (Headaches) and PYREXIA (low grade fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 002A21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced PAIN (kind of achy all over the body), HEADACHE (Headaches) and PYREXIA (low grade fever). At the time of the report, PAIN (kind of achy all over the body), HEADACHE (Headaches) and PYREXIA (low grade fever) had not resolved.            No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021 at 8:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.  Vaccine Removed from freezer at 8 am on 15-Oct-2021.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  The Nurse is providing information for 35 patients. A vial at their clinic was punctured 30 times
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported. No concomitants drugs were reported.  VIAL REMOVED FROM FREEZER 8 AM, 10/18/21
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The vaccine was removed from freezer on 19-Oct-2021 at 8 am. No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Feeling cold, Headache
Clinical narrative: felt cold; sick to my stomach; felt weak/felt weak in the legs; felt sick; arm hurt up to the shoulder and down to my elbow; could hardly sleep; ached everywhere; felt tiredness; felt like I had a fever; head hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt cold), ABDOMINAL PAIN UPPER (sick to my stomach), ASTHENIA (felt weak/felt weak in the legs), ILLNESS (felt sick) and PAIN IN EXTREMITY (arm hurt up to the shoulder and down to my elbow) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (felt cold), ABDOMINAL PAIN UPPER (sick to my stomach), ASTHENIA (felt weak/felt weak in the legs), ILLNESS (felt sick), PAIN IN EXTREMITY (arm hurt up to the shoulder and down to my elbow), INSOMNIA (could hardly sleep), PAIN (ached everywhere), FATIGUE (felt tiredness), PYREXIA (felt like I had a fever) and HEADACHE (head hurt). At the time of the report, FEELING COLD (felt cold), ABDOMINAL PAIN UPPER (sick to my stomach), ASTHENIA (felt weak/felt weak in the legs), ILLNESS (felt sick), PAIN IN EXTREMITY (arm hurt up to the shoulder and down to my elbow), INSOMNIA (could hardly sleep), PAIN (ached everywhere), FATIGUE (felt tiredness), PYREXIA (felt like I had a fever) and HEADACHE (head hurt) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   not concomitant was recorded. not treatment  was recorded This case concerns a  71-year-old, female patient with no relevant medical history, who experienced the unexpected events of Abdominal pain upper, Feeling cold, Asthenia, Illness, Pain in extremity, Insomnia and Pain; and the expected events of Fatigue, Headache, Pyrexia. The events occurred on an unknown date after the first dose of Moderna CoviD-19 Vaccine. The rechallenge was not applicable as the events that occurred in  this case was referring  to the first dose. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-377968, MOD-2021-377972 (Patient Link).; Sender's Comments: This case concerns a  71-year-old, female patient with no relevant medical history, who experienced the unexpected events of Abdominal pain upper, Feeling cold, Asthenia, Illness, Pain in extremity, Insomnia and Pain; and the expected events of Fatigue, Headache, Pyrexia. The events occurred on an unknown date after the first dose of Moderna CoviD-19 Vaccine. The rechallenge was not applicable as the events that occurred in  this case was referring  to the first dose. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Insomnia, Pain, Pain in extremity, Pyrexia
Clinical narrative: felt cold; sick to my stomach; felt weak/felt weak in the legs; felt sick; arm hurt up to the shoulder and down to my elbow; could hardly sleep; ached everywhere; felt tiredness; felt like I had a fever; head hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt cold), ABDOMINAL PAIN UPPER (sick to my stomach), ASTHENIA (felt weak/felt weak in the legs), ILLNESS (felt sick) and PAIN IN EXTREMITY (arm hurt up to the shoulder and down to my elbow) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (felt cold), ABDOMINAL PAIN UPPER (sick to my stomach), ASTHENIA (felt weak/felt weak in the legs), ILLNESS (felt sick), PAIN IN EXTREMITY (arm hurt up to the shoulder and down to my elbow), INSOMNIA (could hardly sleep), PAIN (ached everywhere), FATIGUE (felt tiredness), PYREXIA (felt like I had a fever) and HEADACHE (head hurt). At the time of the report, FEELING COLD (felt cold), ABDOMINAL PAIN UPPER (sick to my stomach), ASTHENIA (felt weak/felt weak in the legs), ILLNESS (felt sick), PAIN IN EXTREMITY (arm hurt up to the shoulder and down to my elbow), INSOMNIA (could hardly sleep), PAIN (ached everywhere), FATIGUE (felt tiredness), PYREXIA (felt like I had a fever) and HEADACHE (head hurt) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   not concomitant was recorded. not treatment  was recorded This case concerns a  71-year-old, female patient with no relevant medical history, who experienced the unexpected events of Abdominal pain upper, Feeling cold, Asthenia, Illness, Pain in extremity, Insomnia and Pain; and the expected events of Fatigue, Headache, Pyrexia. The events occurred on an unknown date after the first dose of Moderna CoviD-19 Vaccine. The rechallenge was not applicable as the events that occurred in  this case was referring  to the first dose. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-377968, MOD-2021-377972 (Patient Link).; Sender's Comments: This case concerns a  71-year-old, female patient with no relevant medical history, who experienced the unexpected events of Abdominal pain upper, Feeling cold, Asthenia, Illness, Pain in extremity, Insomnia and Pain; and the expected events of Fatigue, Headache, Pyrexia. The events occurred on an unknown date after the first dose of Moderna CoviD-19 Vaccine. The rechallenge was not applicable as the events that occurred in  this case was referring  to the first dose. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed.; patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed.) and PRODUCT STORAGE ERROR (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed.) and PRODUCT STORAGE ERROR (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed.) and PRODUCT STORAGE ERROR (patients that received Moderna vaccine doses after the vaccine had been refrozen and rethawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. This case concerns a 73-year-old patient, unknown gender, with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  on unknown date after third dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-381132.; Sender's Comments: This case concerns a 73-year-old patient, unknown gender, with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  on unknown date after third dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the patient received Moderna vaccine after the vaccine had been refrozen and rethawed; the patient received Moderna vaccine after the vaccine had been refrozen and rethawed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the patient received Moderna vaccine after the vaccine had been refrozen and rethawed) and PRODUCT STORAGE ERROR (the patient received Moderna vaccine after the vaccine had been refrozen and rethawed) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (the patient received Moderna vaccine after the vaccine had been refrozen and rethawed) and PRODUCT STORAGE ERROR (the patient received Moderna vaccine after the vaccine had been refrozen and rethawed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the patient received Moderna vaccine after the vaccine had been refrozen and rethawed) and PRODUCT STORAGE ERROR (the patient received Moderna vaccine after the vaccine had been refrozen and rethawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Company comment- This is a case of Expired product administered and Product storage error for this 77-year-old patient of of an unknown gender with no medical history provided. Reportedly, the patient received the dose of the Moderna COVID-19 Vaccine (batch no. 047C21A) which had been refrozen and again rethawed. No adverse events were reported at the time of this report. The company causality for the events of Expired product administered and Product storage error is not applicable.   This case was linked to MOD-2021-381132 (Patient Link).; Sender's Comments: This is a case of Expired product administered and Product storage error for this 77-year-old patient of of an unknown gender with no medical history provided. Reportedly, the patient received the dose of the Moderna COVID-19 Vaccine (batch no. 047C21A) which had been refrozen and again rethawed. No adverse events were reported at the time of this report. The company causality for the events of Expired product administered and Product storage error is not applicable.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received A re frozen of the vaccine; Patient received A re frozen of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received A re frozen of the vaccine) and PRODUCT STORAGE ERROR (Patient received A re frozen of the vaccine) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received A re frozen of the vaccine) and PRODUCT STORAGE ERROR (Patient received A re frozen of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received A re frozen of the vaccine) and PRODUCT STORAGE ERROR (Patient received A re frozen of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. This is a case of Expired Product Administered concerning 79-year-old patient of an unknown gender with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-381132 (Patient Link).; Sender's Comments: This is a case of Expired Product Administered concerning 79-year-old patient of an unknown gender with no relevant medical history, who experienced no other associated adverse events. The event occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown since no information on other doses were disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a re frozen dose of the vaccine; Patient received a re frozen dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re frozen dose of the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 23C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re frozen dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) and PRODUCT STORAGE ERROR (Patient received a re frozen dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  unknown date after the third dose of Moderna vaccine.  The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious events of expired product administered and product storage error. The events occurred  unknown date after the third dose of Moderna vaccine.  The benefit-risk relationship of Moderna vaccine is not affected by this report.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain in extremity, Pyrexia, Vaccination site rash
Clinical narrative: Gone 2 Days without Sleeping; Arms are in a lot of pain; Pain in his legs; has a big rash at the site of injection; suffering from a high fever; headaches; This is a spontaneous report from a contactable consumer (patient daughter). A48 year old male patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, lot number:  EW0191) at 9-9:30 into arm left via an unspecified route of administration on 20Jul2021as dose 2, single for covid-19 immunization (age at vaccination: 48-year-old) at clinic. The patient medical history and concomitant medication was not reported. The patient had previously taken bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, lot number: EW0191) via an unspecified route of administration on 24Jun2021at 11:00 into arm left as DOSE 1, SINGLE for covid-19 immunization. The patient took Tylenol as a past drug event. It was reported that patient did not receive any vaccination within 4 weeks prior to vaccination.  On 20Jul2021at 20:00 the patient had experienced a lot of pain in arms, big rash at the site of injection, fever, headaches, pain in his legs and he has gone 2 days without sleeping. The clinical outcome of the events arms were in a lot of pain, headaches, big rash at the site of injection and Gone 2 Days without Sleeping were not recovered and outcome of events high fever are recovered and outcome of event pain in legs was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pyrexia
Clinical narrative: localized pain on the 3rd day, in the armpits on the side that received the vaccine; 2 days of fever; This is a spontaneous report from a contactable consumer (patient).  A 13-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: RX#6123158) via an unspecified route of administration in right arm on 18Jul2021 14:00 (at the age of 13-year-old) as dose 2, single for covid-19 immunization. Patient was not pregnant at the time of vaccination. Patient was known allergic to penicillins. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: RX6121432) via an unspecified route of administration in right arm on 27Jun2021 14:00 (at the age of 12-year-old) as dose 1, single for covid-19 immunization. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccine in four weeks. On an unspecified date in Jul2021, the patient experienced 2 days of fever and localized pain on the 3rd day (20Jul2021) in the armpits on the side where the vaccine was received. Therapeutic measures were taken as a result of the event 2 days of fever. Patient was not received other medications in two weeks. The clinical outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: it swelled in to my right lung so bad; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0198) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not know but had pretty involved situation due to, patient had got one of 2 shots and had been on the phone for 2 hours speaking with doctors and everything and it was on 23Jun2021 and it swelled in to right lung so bad, it last 3 days now, the patient had nothing the problems ever since got that shot and did not know that language barriers may affect what was understanding you are trying to tell because of your accent. The patient had gotten over the world and had got nothing against anybody. Anyhow patient spoke to family doctor. The patient having a bad side effect it went through body. The outcome of event was unknown.  No follow-up attempts are possible. No further information was expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pain, Urticaria
Clinical narrative: Severe migraine, body aches and Hives two days after second dose. Currently still experiencing hives.; body aches and Hives two days after second dose. Currently still experiencing hives.; Hives two days after second dose.; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route, administered in right arm on 23Jul2021 at 10:00 (at the age of 36-years-old, Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was none and had no known allergies. The concomitant medications were not reported. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 02Jul2021 at 17:30 (at the age of 36-years-old, Lot Number: EW0198) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. On 26Jul2021, at 06:00, the patient experienced severe migraine, body aches and hives two days after second dose. Currently still experiencing hives. The patient was prescribed Singular 10mg, as a treatment to events. AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast swelling, Discomfort, Lymphadenopathy, Pain in extremity
Clinical narrative: left breast is bigger than the right; Stated on the left backside there is pressure like someone pushing towards inside is not painful but one feels pressure; armpit over to chest side is swollen; swollen under left armpit; left arm soreness; left side pain toward her back feeling like someone is pushing toward the inside; This is a spontaneous report from a contactable consumer (patient) reported that:   A 37-year-old female consumer (patient) received bnt162b2 (COMIRNATY, Solution for injection, (Batch/Lot Number: EW0179) via an unspecified route of administration, administered in left arm on 23Jul2021 (at the age of 37 years old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On23Jul2021, the patient had experienced left arm soreness. On25Jul2021, the patient had experienced swollen under left armpit. On 26Jul2021, the patient had experienced armpit over to chest side is swollen and Stated on the left backside there is pressure like someone pushing towards inside is not painful but one feels pressure. On27Jul2021, the patient had experienced left breast is bigger than the right. Treatment Patient Stated that she drank Tylenol for the left arm soreness. At the time of reporting, the events swollen under left armpit, left breast is bigger than the right and stated on the left backside there is pressure like someone pushing towards inside is not painful but one feels pressure were not recovered. The events armpit over to chest side is swollen and left arm soreness were recovering.   Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: left breast is bigger than the right; Stated on the left backside there is pressure like someone pushing towards inside is not painful but one feels pressure; armpit over to chest side is swollen; swollen under left armpit; left arm soreness; left side pain toward her back feeling like someone is pushing toward the inside; This is a spontaneous report from a contactable consumer (patient) reported that:   A 37-year-old female consumer (patient) received bnt162b2 (COMIRNATY, Solution for injection, (Batch/Lot Number: EW0179) via an unspecified route of administration, administered in left arm on 23Jul2021 (at the age of 37 years old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On23Jul2021, the patient had experienced left arm soreness. On25Jul2021, the patient had experienced swollen under left armpit. On 26Jul2021, the patient had experienced armpit over to chest side is swollen and Stated on the left backside there is pressure like someone pushing towards inside is not painful but one feels pressure. On27Jul2021, the patient had experienced left breast is bigger than the right. Treatment Patient Stated that she drank Tylenol for the left arm soreness. At the time of reporting, the events swollen under left armpit, left breast is bigger than the right and stated on the left backside there is pressure like someone pushing towards inside is not painful but one feels pressure were not recovered. The events armpit over to chest side is swollen and left arm soreness were recovering.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Prolapse
Clinical narrative: had a prolapse; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a prolapse. Therapeutic measures were taken as a result of had a prolapse which was reported as the patient had a surgery and doctor said patient should use the estrogens conjugated like twice a week, 0.05 mg or grams. The outcome of the event was unknown.   Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Tinnitus
Clinical narrative: A severe headache with in 5 hours; ringing in my ears to a point I could not function; Starting running a fever of 101 after 24 hours; This is a spontaneous report from a contactable consumer (patient) reported that.  A 59-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA7485), intramuscularly administered in Arm Left on 26Jul2021 (at the age of 59-year-old) as dose 1, single for covid-19 immunization, facility in Pharmacy or Drug Store. Known allergies included yes, Keflex, sulfa, wheat, eggs, corn, milk. The patient medical history was reported. Thyroid disease, the patient took Keflex (CEFALEXIN MONOHYDRATE) before vaccination for Keflex allergy. Concomitant medication included only hormones progesterone, estridiol and thyroid. On 26Jul2021, the patient experienced a severe headache within 5 hours, ringing in my ears to a point she could not function. The headaches after 24 hours are worse than yesterday, she cannot felt parts of my head and the ringing in the ears was at best excruciating. Starting running a fever of 101 after 24 hours. The patient underwent lab tests and procedures which included body temperature at 101. No treatment received for the events. As resulted, the patient was visited in professional office/clinic visit. The patient was not Covid prior vaccination and not Covid tested post vaccination. The outcome of all events was not resolved.  Follow-Up (11Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Productive cough, Pyrexia, Vomiting
Clinical narrative: Fever; Throwing up a lot of phlegm; throwing up; This is a spontaneous report from a contactable consumer (patient's wife) reported for a 67-Year-old male patient (husband). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0198, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 21Jul2021 at 10:30 (at the age of 67-year-old) as a single dose for covid-19 immunisation at pharmacy. Medical history included ongoing asthma, blood pressure high and sinuses. Patient's family history included high blood pressure of dad (family history). Concomitant medications included ongoing fluticasone propionate, salmeterol xinafoate (ADVAIR) 250/50, 1 puff once a day for lung function; ongoing montelukast 10mg once daily taken for sinuses; ongoing hydrochlorothiazide, losartan potassium 50/12.5mg, once a day taken for blood pressure high and low dose acetylsalicylic acid (ASPIRIN) 81mg once daily, heart doctor told him to take it, may be a blood thinner. No additional vaccine was administered on same date of the Pfizer Suspect. No adverse events prior vaccination. No prior vaccination within 4 weeks of Pfizer vaccine. Patient's wife reported, her husband has been throwing up a lot of phlegm and has also had a fever since the 22Jul2021. Patient had a mild fever the evening of 22Jul2021, but the fever didn't really get bad until Friday. The fever has been going up and down, from 102.9 to 99. Stated that the fever was persisting and throwing up is about the same. Patient went to the doctor yesterday, and the doctor said that everything was okay. Events leads to physician office visits. The patient underwent lab tests and procedures which included body temperature resulting mild on 22Jul2021, going up and down and ranging in 102.9 to 99 on 23Jul2021. Tylenol was taken as a treatment for the events. Patient's wife's Oncologist does want him to have a covid test. The clinical outcome of the events was not recovered at the time of reporting.  Follow-up attempts are completed. No further information is expected.