chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: The patient experienced fatigue which has not gone away. The patient has gone to see her Physician about this fatigue. All test results are normal; redness at injection site; swelling at injection site; itching at injection site; body aches; headache; chills; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SPIRONOLACTONE, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ALPRAZOLAM (XANAX), FLUOXETINE HYDROCHLORIDE (PROZAC) and PRAVASTATIN for an unknown indication.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (body aches), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever). 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itching at injection site). On an unknown date, the patient experienced FATIGUE (The patient experienced fatigue which has not gone away. The patient has gone to see her Physician about this fatigue. All test results are normal). On 21-Mar-2021, VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itching at injection site) had resolved. At the time of the report, PAIN (body aches), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown and FATIGUE (The patient experienced fatigue which has not gone away. The patient has gone to see her Physician about this fatigue. All test results are normal) had not resolved.            Treatment details not provided.    This case was linked to MOD-2021-350614 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: The patient experienced fatigue which has not gone away. The patient has gone to see her Physician about this fatigue. All test results are normal; redness at injection site; swelling at injection site; itching at injection site; body aches; headache; chills; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SPIRONOLACTONE, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ALPRAZOLAM (XANAX), FLUOXETINE HYDROCHLORIDE (PROZAC) and PRAVASTATIN for an unknown indication.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (body aches), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever). 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itching at injection site). On an unknown date, the patient experienced FATIGUE (The patient experienced fatigue which has not gone away. The patient has gone to see her Physician about this fatigue. All test results are normal). On 21-Mar-2021, VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PRURITUS (itching at injection site) had resolved. At the time of the report, PAIN (body aches), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown and FATIGUE (The patient experienced fatigue which has not gone away. The patient has gone to see her Physician about this fatigue. All test results are normal) had not resolved.            Treatment details not provided.    This case was linked to MOD-2021-350614 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: diagnosed with Bells Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (diagnosed with Bells Palsy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029120A and 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, the patient experienced BELL'S PALSY (diagnosed with Bells Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (diagnosed with Bells Palsy) outcome was unknown.            No concomitant medications provided. No treatment medications provided.  Patient was taken Eliquis before got the Moderna vaccine.  Company comment -This case concerns a  male patient 9Age not provided) with no relevant medical history, who experienced the unexpected event of Bells palsy. The event occurred approximately 7 months 8 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after the second dose.. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a  male patient 9Age not provided) with no relevant medical history, who experienced the unexpected event of Bells palsy. The event occurred approximately 7 months 8 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after the second dose.. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine is not affected by this report.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave a 3rd dose about 22 hours after the vial had been first punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave a 3rd dose about 22 hours after the vial had been first punctured) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave a 3rd dose about 22 hours after the vial had been first punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave a 3rd dose about 22 hours after the vial had been first punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment information reported
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Fatigue, Hypomenorrhoea, Menstrual disorder, Menstruation irregular
Clinical narrative: Her period came on 7Sept2021 but it was 35 days cycle; missed her periods on July and August; March2021 her period was really light; Planning to get pregnant; issues with her menstrual cycle which is not normal; was tired; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (missed her periods on July and August), HYPOMENORRHOEA (March2021 her period was really light), MENSTRUATION IRREGULAR (Her period came on 7Sept2021 but it was 35 days cycle), PLANNING TO BECOME PREGNANT (Planning to get pregnant) and MENSTRUAL DISORDER (issues with her menstrual cycle which is not normal) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PLANNING TO BECOME PREGNANT (Planning to get pregnant), MENSTRUAL DISORDER (issues with her menstrual cycle which is not normal) and FATIGUE (was tired). In March 2021, the patient experienced HYPOMENORRHOEA (March2021 her period was really light). In July 2021, the patient experienced AMENORRHOEA (missed her periods on July and August). On 07-Sep-2021, the patient experienced MENSTRUATION IRREGULAR (Her period came on 7Sept2021 but it was 35 days cycle). At the time of the report, AMENORRHOEA (missed her periods on July and August), HYPOMENORRHOEA (March2021 her period was really light), MENSTRUATION IRREGULAR (Her period came on 7Sept2021 but it was 35 days cycle), PLANNING TO BECOME PREGNANT (Planning to get pregnant), MENSTRUAL DISORDER (issues with her menstrual cycle which is not normal) and FATIGUE (was tired) outcome was unknown.            The patient states that since the second dose, she had issues with her menstrual cycle. She never had issues with her period until this vaccine. She states she had her periods both times when she got the vaccine   No concomitant medications were reported   Treatment included Acupuncture
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Planning to become pregnant
Clinical narrative: Her period came on 7Sept2021 but it was 35 days cycle; missed her periods on July and August; March2021 her period was really light; Planning to get pregnant; issues with her menstrual cycle which is not normal; was tired; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (missed her periods on July and August), HYPOMENORRHOEA (March2021 her period was really light), MENSTRUATION IRREGULAR (Her period came on 7Sept2021 but it was 35 days cycle), PLANNING TO BECOME PREGNANT (Planning to get pregnant) and MENSTRUAL DISORDER (issues with her menstrual cycle which is not normal) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PLANNING TO BECOME PREGNANT (Planning to get pregnant), MENSTRUAL DISORDER (issues with her menstrual cycle which is not normal) and FATIGUE (was tired). In March 2021, the patient experienced HYPOMENORRHOEA (March2021 her period was really light). In July 2021, the patient experienced AMENORRHOEA (missed her periods on July and August). On 07-Sep-2021, the patient experienced MENSTRUATION IRREGULAR (Her period came on 7Sept2021 but it was 35 days cycle). At the time of the report, AMENORRHOEA (missed her periods on July and August), HYPOMENORRHOEA (March2021 her period was really light), MENSTRUATION IRREGULAR (Her period came on 7Sept2021 but it was 35 days cycle), PLANNING TO BECOME PREGNANT (Planning to get pregnant), MENSTRUAL DISORDER (issues with her menstrual cycle which is not normal) and FATIGUE (was tired) outcome was unknown.            The patient states that since the second dose, she had issues with her menstrual cycle. She never had issues with her period until this vaccine. She states she had her periods both times when she got the vaccine   No concomitant medications were reported   Treatment included Acupuncture
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that it was unknown if the doses was first, second or third for the patient. Reporter also reported that vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. Reporter also said that vials did not undergo any temperature excursion.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported  Vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Felt Oozy after the 3rd dose; Could not concentrate after the 3rd dose/Could not concentrate to drive safely after the 3rd dose; Could not drive after the 3rd dose/Could not concentrate to drive safely after the 3rd dose; Body pain after the 3rd dose; Fever on & off after the 3rd dose; Fever 100F for 2 days after the 3rd dose; Extra dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt Oozy after the 3rd dose), DISTURBANCE IN ATTENTION (Could not concentrate after the 3rd dose/Could not concentrate to drive safely after the 3rd dose), IMPAIRED DRIVING ABILITY (Could not drive after the 3rd dose/Could not concentrate to drive safely after the 3rd dose), MYALGIA (Body pain after the 3rd dose) and PYREXIA (Fever on & off after the 3rd dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9339901, 027620A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced PYREXIA (Fever 100F for 2 days after the 3rd dose) and EXTRA DOSE ADMINISTERED (Extra dose). On 07-Oct-2021, the patient experienced PYREXIA (Fever on & off after the 3rd dose). On 12-Oct-2021, the patient experienced DIZZINESS (Felt Oozy after the 3rd dose), DISTURBANCE IN ATTENTION (Could not concentrate after the 3rd dose/Could not concentrate to drive safely after the 3rd dose), IMPAIRED DRIVING ABILITY (Could not drive after the 3rd dose/Could not concentrate to drive safely after the 3rd dose) and MYALGIA (Body pain after the 3rd dose). The patient was treated with IBUPROFEN on 04-Oct-2021 for Fever, at an unspecified dose and frequency. On 04-Oct-2021, EXTRA DOSE ADMINISTERED (Extra dose) had resolved. On 06-Oct-2021, PYREXIA (Fever 100F for 2 days after the 3rd dose) had resolved. At the time of the report, DIZZINESS (Felt Oozy after the 3rd dose), DISTURBANCE IN ATTENTION (Could not concentrate after the 3rd dose/Could not concentrate to drive safely after the 3rd dose), IMPAIRED DRIVING ABILITY (Could not drive after the 3rd dose/Could not concentrate to drive safely after the 3rd dose) and MYALGIA (Body pain after the 3rd dose) outcome was unknown and PYREXIA (Fever on & off after the 3rd dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2021, Body temperature: 100f (High) Fever-100F.   No concomitant medications were provided.  Patient has reported that she has concern regarding administration of booster/third dose by the nurse though she was not a immunocompromised patient.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident
Clinical narrative: "fatal" COVID19 following vaccination with inflammation; Brain stroke; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ("fatal" COVID19 following vaccination with inflammation) and CEREBROVASCULAR ACCIDENT (Brain stroke) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 ("fatal" COVID19 following vaccination with inflammation) (seriousness criteria death and medically significant) and CEREBROVASCULAR ACCIDENT (Brain stroke) (seriousness criteria death and medically significant). The reported cause of death was covid-19. It is unknown if an autopsy was performed.            No concomitant medications were reported.  Patient had 7 brain strokes and he had that knowledge to treat her symptoms. Patient was ruined without a job. Patient received natural medicine to treat event.  Company Comment This case concerns a 60-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of COVID-19 and cerebrovascular accident. The event occurred approximately on an unknown number of days after an unknown number of doses of mRNA-1273 and had a fatal outcome, with death occurring on an unknown date. No autopsy report was disclosed. The rechallenge was not applicable since the patient died.  The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 60-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of COVID-19 and cerebrovascular accident. The event occurred approximately on an unknown number of days after an unknown number of doses of mRNA-1273 and had a fatal outcome, with death occurring on an unknown date. No autopsy report was disclosed. The rechallenge was not applicable since the patient died.  The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Reported Cause(s) of Death: COVID-19
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) 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 case was linked to MOD-2021-313106 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyond 30 days of refrigeration period; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given. Patient anatomical location was deltoid.   This case was linked to MOD-2021-313106 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) to be not related.No concomitant medication were reported. No treatment medication were reported. Patient's anatomical location of vaccine was reported as deltoid. This case was linked to MOD-2021-313106, MOD-2021-356728 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Vision blurred
Clinical narrative: Blurred Vision; Shortness of Breath; Fogged Mind; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred Vision), DYSPNOEA (Shortness of Breath) and FEELING ABNORMAL (Fogged Mind) 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 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced VISION BLURRED (Blurred Vision), DYSPNOEA (Shortness of Breath) and FEELING ABNORMAL (Fogged Mind). At the time of the report, VISION BLURRED (Blurred Vision), DYSPNOEA (Shortness of Breath) and FEELING ABNORMAL (Fogged Mind) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyond 30 days refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Penicillin), Drug allergy (Vicodin.) and Drug allergy (Lexapro).   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period) to be possibly related.    No concomitant medication information was provided. No treatment medication information was provided.  This case was linked to MOD-2021-353124 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received first shot past 30-day use by date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received first shot past 30-day use by date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received first shot past 30-day use by date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received first shot past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants were reported. No Treatment informations were reported.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyond 30 days refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Bacterium allergy).   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine given beyond 30 days refrigeration period) to be not related.    No Concomitant medications were provided No treatment medications were provided.   This case was linked to MOD-2021-353581 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0471321A and 0471321A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 06-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccine was given on Deltoid.  No concomitant medication were provided.  No treatment medication was provided.   This case was linked to MOD-2021-353768 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Nausea, SARS-CoV-2 antibody test, Weight decreased
Clinical narrative: Extremely dizzy; nausea; diahreaa; weight loss; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 50-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Ew0183), dose 2 via an unspecified route of administration, administered in Arm Left on 06Jul2021 at 11:30 AM (Age at Vaccination: 50-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient was not Pregnant at Time of Vaccination. The patient took no other vaccine in four weeks, had no COVID prior vaccination, was COVID tested post vaccination. The patient had no Known allergies. Medical history included HBP from an unknown date and unknown if ongoing, degenerative disc disease from an unknown date and unknown if ongoing. Other concomitant medications taken in two weeks included bupropion hydrochloride (WELLBUTRIN); alprazolam (XANAX); trazodone; chlorthalidone. It was reported that earlier patient took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Ew0183), dose 1 via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On 06Jul2021 at 05:00 PM, the patient experienced Extremely dizzy, nausea, diahrea (as reported) and weight loss. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse event treatment for nausea was taken with Nausea medicine. The patient underwent lab test and procedure which included Covid test: Negative Nasal Swab, on 10Jul2021, covid test type post vaccination. Outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: her arm is sore at the injection site; red near the injection site /The redness showed up today and its a pink color.; has a lump, and is red/ injection site lump; This is a spontaneous report from a contactable consumer or other non-HCP. A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EWO184, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 23Jul2021 as dose 1, 0.3 ml single (at the age of 70-years-old) for COVID-19 immunization. Medical history included Kidney transplant in 1993 (takes rejection medication), COVID-19 from Nov2020, has had Covid in Nov and was in the hospital for a week, heart ablation twice (cardiac disorder), atrial fibrillation as the patient had Covid in Nov and was in the hospital for a week, which put her back into AFIB and she was treated with medicine and then normal again. Patient had earlier received flu vaccine as in 2016 the patient had a reaction to the flu vaccine, she was in the ICU for a week. Concomitant medications included cycloserine (50 mg twice a day; rejection pill) and prednisone (5 mg once a day) both taken on unspecified dates for unspecified indications. On an unspecified date the patient experienced her arm was sore at the injection site. On 24Jul2021 the patient had a lump, and was red and injection site lump. On 27Jul2021 the patient experienced red near the injection site and the redness showed up today and it was pink color, still tender. Vaccine Supplemental Form has been declined. The outcome of event her arm is sore at the injection site was unknown while outcome of rest all event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Myalgia, Vaccination site mass, Vaccination site pain
Clinical narrative: it is very tender; lump up to side of my neck; My collar bone on the side that I have gotten the shot at, my collar bone started to hurt; sore from that lump up to side of my neck; collar bone started to hurt; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EWO185), via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 60-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any prior vaccination. On an unknown date, the patient stated that last night she started to notice that her collar bone on the side that I have gotten the shot at, my collar bone started to hurt and there is small lump there and it is very tender and sore from that lump up to side of my neck. The patient received treatment but was just took some Tylenol. The outcome of the events was unknown.  Follow-up (18Aug2021): Follow-up attempts were completed. No further information was expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Tinnitus began approximately 15May and is persistent mild to moderate in nature, it is not exacerbated or relieved by anything.  The severity of the tinnitus is increasing and is currently not resolved.; severe fatigue; myalgias; headache; fever; occasional rigors; The tender lymphadenopathy of the left clavicular area recurred 01May and resolved by 15May; This is a spontaneous report from a contactable other healthcare professional. A 51 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 (Batch/Lot Number: ER8735) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. The patient experienced severe fatigue on 01May2021 with outcome of not recovered, myalgias on 01May2021 with outcome of not recovered, headache on 01May2021 with outcome of not recovered, fever on 01May2021 with outcome of not recovered, occasional rigors and chills on 01May2021 with outcome of not recovered, the tender lymphadenopathy of the left clavicular area recurred on 01may and resolved by 15may on 01May2021 with outcome of recovered, tinnitus began approximately on 15may and is persistent mild to moderate in nature, it is not exacerbated or relieved by anything.  the severity of the tinnitus is increasing and is currently not resolved on 15May2021 with outcome of not recovered.    Follow-up (23Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Tinnitus began approximately 15May and is persistent mild to moderate in nature, it is not exacerbated or relieved by anything.  The severity of the tinnitus is increasing and is currently not resolved.; severe fatigue; myalgias; headache; fever; occasional rigors; The tender lymphadenopathy of the left clavicular area recurred 01May and resolved by 15May; This is a spontaneous report from a contactable other healthcare professional. A 51 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 (Batch/Lot Number: ER8735) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. The patient experienced severe fatigue on 01May2021 with outcome of not recovered, myalgias on 01May2021 with outcome of not recovered, headache on 01May2021 with outcome of not recovered, fever on 01May2021 with outcome of not recovered, occasional rigors and chills on 01May2021 with outcome of not recovered, the tender lymphadenopathy of the left clavicular area recurred on 01may and resolved by 15may on 01May2021 with outcome of recovered, tinnitus began approximately on 15may and is persistent mild to moderate in nature, it is not exacerbated or relieved by anything.  the severity of the tinnitus is increasing and is currently not resolved on 15May2021 with outcome of not recovered.    Follow-up (23Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Headache
Clinical narrative: Metallic taste; head ache; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration, administered in arm right on 26Aug2021 17:00 (At the age of 58-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not received any other vaccine in four weeks. On 26Aug2021 17:15 the patient experienced metallic taste, head ache. It was unknown if the patient received treatment for the events. The outcome of the events was unknown.   Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Joint stiffness, Myalgia, Pain in extremity
Clinical narrative: Left arm sore at injection site, woke up at 4 am arm, elbow and wrist all very sore like burning. Slowly faded away as I woke up and used my arm. Now mainly sore just at injection site.; elbow and wrist all very sore like burning. Slowly faded away as I woke up and used my arm; woke up at 4 am arm, elbow and wrist all very sore like burning. Slowly faded away as I woke up and used my arm; elbow and wrist all very sore like burning; But deep muscle soreness; joint tight ness after period of no movement (while sleeping); This is a spontaneous report from a contactable consumer (patient). A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration, administered in left arm on 26Aug2021 12:00 (at the age of 32 years) as dose 1, single for COVID-19 immunization. The patient medical history included COVID-19 from an unknown date. Patient had no known allergies and no other medical history. The patient's concomitant medications included unspecified vitamins. The patient was not pregnant at the time of vaccination. Patient not COVID tested post vaccination. On 27Aug2021 04:00, the patient experienced left arm sore at injection site, woke up at 4 am arm, elbow and wrist all very sore like burning. Slowly faded away as she woke up and used her arm. Now mainly sore just at injection site. But deep muscle soreness and joint tightness after period of no movement (while sleeping) on 27Aug2021 04:00. Patient did not receive any treatment for events. The outcome if all the events was recovering.  Follow-up attempts completed. The lot/batch number is not available despite the follow-up attempts made. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm sore at injection site, woke up at 4 am arm, elbow and wrist all very sore like burning. Slowly faded away as I woke up and used my arm. Now mainly sore just at injection site.; elbow and wrist all very sore like burning. Slowly faded away as I woke up and used my arm; woke up at 4 am arm, elbow and wrist all very sore like burning. Slowly faded away as I woke up and used my arm; elbow and wrist all very sore like burning; But deep muscle soreness; joint tight ness after period of no movement (while sleeping); This is a spontaneous report from a contactable consumer (patient). A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration, administered in left arm on 26Aug2021 12:00 (at the age of 32 years) as dose 1, single for COVID-19 immunization. The patient medical history included COVID-19 from an unknown date. Patient had no known allergies and no other medical history. The patient's concomitant medications included unspecified vitamins. The patient was not pregnant at the time of vaccination. Patient not COVID tested post vaccination. On 27Aug2021 04:00, the patient experienced left arm sore at injection site, woke up at 4 am arm, elbow and wrist all very sore like burning. Slowly faded away as she woke up and used her arm. Now mainly sore just at injection site. But deep muscle soreness and joint tightness after period of no movement (while sleeping) on 27Aug2021 04:00. Patient did not receive any treatment for events. The outcome if all the events was recovering.  Follow-up attempts completed. The lot/batch number is not available despite the follow-up attempts made. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Muscle contracture, Pyrexia
Clinical narrative: Full body tremors; bones/body contracturing; felt like a parasites was moving from injection site; headache; fever; fatigue; This is a spontaneous report from a contactable Nurse (Patient), who reported for herself.  A 54-years-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EL9262) via an intramuscular route of administration on 20Janl2021 (at 20:45), administered in right arm (age at the time of vaccination was 54-years-old) as a DOSE 2, SINGLE dose for COVID-19 immunization. The patient's medical history included Hashimotos Thyroiditis, vit D deficiency, Attention deficit hyperactivity disorder, pet dander allergy, HLD, acne, hormone replacements and Medals, no, but so food intolerance from an unspecified date. The patient's concomitant medications included LEVOTHYROXINE SODIUM, Ambien (ZOLPIDEM TARTRATE), Adderall (AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE), Vitamin B2 (RIBOFLAVIN), Vitamin B3 (NICOTINAMIDE) and Vitamin B12 (CYANOCOBALAMIN) taken for an unspecified indication. The patient had no other vaccine in 4 weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post the vaccination. Previously, the patient also received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EL1685) via an unspecified route of administration on 29Dec2020 (at 18:30), administered in right arm (age at the time of vaccination was 54-years-old) as a DOSE 1, SINGLE dose for COVID-19 immunization. On 20Jan2021 (at 22:15), the patient experienced Full body tremors, bones/body contracturing, felt like a parasites was moving from injection site, headache, fever and fatigue. The clinical outcome of all the events was recovered with sequel.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. .