chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Blood pressure went incredibly high 208/108; Shaking uncontrollably; Aches; Extremely high anxiety; Emergency said it was probably side effects from the vaccine; Fever; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure went incredibly high 208/108) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced HYPERTENSION (Blood pressure went incredibly high 208/108) (seriousness criterion medically significant), TREMOR (Shaking uncontrollably), PAIN (Aches), ANXIETY (Extremely high anxiety), VACCINATION COMPLICATION (Emergency said it was probably side effects from the vaccine), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, HYPERTENSION (Blood pressure went incredibly high 208/108), TREMOR (Shaking uncontrollably), PAIN (Aches), ANXIETY (Extremely high anxiety), VACCINATION COMPLICATION (Emergency said it was probably side effects from the vaccine), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Blood pressure measurement: 208/108 (High) Blood pressure 208/108 incredibly high.. On 28-Oct-2021, Blood test: normal (normal) blood test normal..         Concomitant product was not provided by the reporter.  Treatment information was not provided.  Company comment: This case concerns a 57-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of hypertension. The event occurred 1 day after the third dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a 57-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of hypertension. The event occurred 1 day after the third dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications detail were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nodule, Pain, Pyrexia, Therapeutic response unexpected
Clinical narrative: Nodule returned, but the size of a pea; Fever went to 102 degrees Fahrenheit; Lump completely disappeard, (Vaccine) targeted that lump; Had "all the side effects"; Achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had "all the side effects"), PAIN (Achy), NODULE (Nodule returned, but the size of a pea), PYREXIA (Fever went to 102 degrees Fahrenheit) and THERAPEUTIC RESPONSE UNEXPECTED (Lump completely disappeard, (Vaccine) targeted that lump) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 047821A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Subcutaneous nodule (A Subcutaneous nodule on the bottom of her butt).   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced VACCINATION COMPLICATION (Had "all the side effects"), PAIN (Achy), PYREXIA (Fever went to 102 degrees Fahrenheit) and THERAPEUTIC RESPONSE UNEXPECTED (Lump completely disappeard, (Vaccine) targeted that lump). On an unknown date, the patient experienced NODULE (Nodule returned, but the size of a pea). At the time of the report, VACCINATION COMPLICATION (Had "all the side effects"), PAIN (Achy) and THERAPEUTIC RESPONSE UNEXPECTED (Lump completely disappeard, (Vaccine) targeted that lump) outcome was unknown, NODULE (Nodule returned, but the size of a pea) had not resolved and PYREXIA (Fever went to 102 degrees Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Body temperature: 102 (High) 102 degrees Fahrenheit.         No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-372399 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Nodule returned, but the size of a pea; Fever went to 102 degrees Fahrenheit; Lump completely disappeard, (Vaccine) targeted that lump; Had "all the side effects"; Achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had "all the side effects"), PAIN (Achy), NODULE (Nodule returned, but the size of a pea), PYREXIA (Fever went to 102 degrees Fahrenheit) and THERAPEUTIC RESPONSE UNEXPECTED (Lump completely disappeard, (Vaccine) targeted that lump) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 047821A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Subcutaneous nodule (A Subcutaneous nodule on the bottom of her butt).   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced VACCINATION COMPLICATION (Had "all the side effects"), PAIN (Achy), PYREXIA (Fever went to 102 degrees Fahrenheit) and THERAPEUTIC RESPONSE UNEXPECTED (Lump completely disappeard, (Vaccine) targeted that lump). On an unknown date, the patient experienced NODULE (Nodule returned, but the size of a pea). At the time of the report, VACCINATION COMPLICATION (Had "all the side effects"), PAIN (Achy) and THERAPEUTIC RESPONSE UNEXPECTED (Lump completely disappeard, (Vaccine) targeted that lump) outcome was unknown, NODULE (Nodule returned, but the size of a pea) had not resolved and PYREXIA (Fever went to 102 degrees Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2021, Body temperature: 102 (High) 102 degrees Fahrenheit.         No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-372399 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm was sore to the touch; Arm puffed (at injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore to the touch) and VACCINATION SITE SWELLING (Arm puffed (at injection site)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore to the touch) and VACCINATION SITE SWELLING (Arm puffed (at injection site)). At the time of the report, VACCINATION SITE PAIN (Arm was sore to the touch) and VACCINATION SITE SWELLING (Arm puffed (at injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details was not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that patient was doing exercise for adverse events.   This case was linked to MOD-2021-372414, MOD-2021-372416 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. The vial was initially stored in the refrigerator on 21-OCT-2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received full third shot past 12 hour post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received full third shot past 12 hour post puncture) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 022M20A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received full third shot past 12 hour post puncture). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received full third shot past 12 hour post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-371847 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Ear pain, Nausea, Pain
Clinical narrative: Mild left side pain in her back/now is just like the whole area/it's like it started from the mid back under her rib cage; Ear would hurt/strong ear pain for a couple of minutes; Then it went to her whole entire left part, no in her heart but in the soft tissue/sharp pains throughout her body; Nauseous/nausea; Felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt dizzy), BACK PAIN (Mild left side pain in her back/now is just like the whole area/it's like it started from the mid back under her rib cage), EAR PAIN (Ear would hurt/strong ear pain for a couple of minutes), PAIN (Then it went to her whole entire left part, no in her heart but in the soft tissue/sharp pains throughout her body) and NAUSEA (Nauseous/nausea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced DIZZINESS (Felt dizzy), EAR PAIN (Ear would hurt/strong ear pain for a couple of minutes), PAIN (Then it went to her whole entire left part, no in her heart but in the soft tissue/sharp pains throughout her body) and NAUSEA (Nauseous/nausea). On 30-Oct-2021, the patient experienced BACK PAIN (Mild left side pain in her back/now is just like the whole area/it's like it started from the mid back under her rib cage). In October 2021, DIZZINESS (Felt dizzy), EAR PAIN (Ear would hurt/strong ear pain for a couple of minutes), PAIN (Then it went to her whole entire left part, no in her heart but in the soft tissue/sharp pains throughout her body) and NAUSEA (Nauseous/nausea) had resolved. At the time of the report, BACK PAIN (Mild left side pain in her back/now is just like the whole area/it's like it started from the mid back under her rib cage) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided.   It was reported that patient experienced strong ear pain in both sides for a couple of minutes.  Treatment information was not provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired for about one day after his second vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired for about one day after his second vaccination.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (felt tired for about one day after his second vaccination.). In April 2021, FATIGUE (felt tired for about one day after his second vaccination.) had resolved.            Concomitant medication was unknown Treatment information was unknown   This case was linked to MOD-2021-372062 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 3rd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-370951 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We gave the vaccine 2 days after the expiration date / Patient received an expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave the vaccine 2 days after the expiration date / Patient received an expired dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave the vaccine 2 days after the expiration date / Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (We gave the vaccine 2 days after the expiration date / Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No Treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant follow-up appended contains Patient details and Reporter information added
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Malaise, Myalgia, Vaccination complication
Clinical narrative: Adverse effects; Greater difficulty physically performing things that he also did last year; Feels degraded from how I felt before the vaccine; Muscle pain that has been getting worse/ muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse effects), IMPAIRED WORK ABILITY (Greater difficulty physically performing things that he also did last year), MALAISE (Feels degraded from how I felt before the vaccine) and MYALGIA (Muscle pain that has been getting worse/ muscle soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced MYALGIA (Muscle pain that has been getting worse/ muscle soreness). On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse effects), IMPAIRED WORK ABILITY (Greater difficulty physically performing things that he also did last year) and MALAISE (Feels degraded from how I felt before the vaccine). At the time of the report, VACCINATION COMPLICATION (Adverse effects), IMPAIRED WORK ABILITY (Greater difficulty physically performing things that he also did last year) and MALAISE (Feels degraded from how I felt before the vaccine) outcome was unknown and MYALGIA (Muscle pain that has been getting worse/ muscle soreness) had not resolved.            No concomitant medications were reported. No treatment information was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site nodule
Clinical narrative: Big hard bump ( 1.1" ) nodule on the vaccination site on the left arm.; Hard Bump on vaccination site on the left arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Big hard bump ( 1.1" ) nodule on the vaccination site on the left arm.) and VACCINATION SITE INDURATION (Hard Bump on vaccination site on the left arm.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 002B21A and 700M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-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 experienced VACCINATION SITE NODULE (Big hard bump ( 1.1" ) nodule on the vaccination site on the left arm.) and VACCINATION SITE INDURATION (Hard Bump on vaccination site on the left arm.). At the time of the report, VACCINATION SITE NODULE (Big hard bump ( 1.1" ) nodule on the vaccination site on the left arm.) and VACCINATION SITE INDURATION (Hard Bump on vaccination site on the left arm.) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  On an unknown date in November patient experienrd adverse events.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 3rd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-370951 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered dose past the manufacture expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  9 doses were administered from two different vials. On 15-Oct-2021, 3 doses administered. On 22-Oct-2021, 6 doses administered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039c21a) 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  Vial was removed from freezer on 14-Oct-2021 into refrigerator and never opened until the date of administration and temperature was never compromised.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 14-Oct-21 into refrigerator and never opened before today; expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) and PRODUCT STORAGE ERROR (14-Oct-21 into refrigerator and never opened before today) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (14-Oct-21 into refrigerator and never opened before today). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved. At the time of the report, PRODUCT STORAGE ERROR (14-Oct-21 into refrigerator and never opened before today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Inappropriate schedule of product administration
Clinical narrative: Died; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient died on 30-Oct-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No concomitant medication provided.  1st dose was given on 20Sep2021 with lot number 046C21A.  Reporter states that she was fine with no illnesses prior to getting the vaccine.  Company Comment: This case concerns a 58-year-old, female patient with no relevant medical history, who experienced the unexpected serious fatal adverse event of death. Inappropriate schedule of product administration was considered an additional event. The event death occurred approximately 1 month and 10 days after the second dose of Moderna COVID-19 vaccine with fatal outcome. Death occurred on 30-Oct-2021 and no autopsy results were available at the time of the report. Cause of death was reported as unknown. The rechallenge was not applicable due to the fatal outcome. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 58-year-old, female patient with no relevant medical history, who experienced the unexpected serious fatal adverse event of death. Inappropriate schedule of product administration was considered an additional event. The event death occurred approximately 1 month and 10 days after the second dose of Moderna COVID-19 vaccine with fatal outcome. Death occurred on 30-Oct-2021 and no autopsy results were available at the time of the report. Cause of death was reported as unknown. The rechallenge was not applicable due to the fatal outcome. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Warm spot at the injection site; Sore spot at the injection site; Itchy spot at the injection site; looked like a rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm spot at the injection site), VACCINATION SITE PAIN (Sore spot at the injection site), VACCINATION SITE PRURITUS (Itchy spot at the injection site) and VACCINATION SITE RASH (looked like a rash at the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.  On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm spot at the injection site), VACCINATION SITE PAIN (Sore spot at the injection site), VACCINATION SITE PRURITUS (Itchy spot at the injection site) and VACCINATION SITE RASH (looked like a rash at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm spot at the injection site), VACCINATION SITE PAIN (Sore spot at the injection site), VACCINATION SITE PRURITUS (Itchy spot at the injection site) and VACCINATION SITE RASH (looked like a rash at the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications was reported. Treatment information was not provided.    This case was linked to MOD-2021-372658 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Aches and pains; Slight fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and pains), PYREXIA (Slight fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A, 036A21A and 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Subcutaneous nodule (Subcutaneous nodule on bottom of butt for years).   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced PAIN (Aches and pains), PYREXIA (Slight fever), HEADACHE (Headache) and NAUSEA (Nausea). On 19-Apr-2021, PAIN (Aches and pains), PYREXIA (Slight fever), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.            No concomitant medications were reported  No treatment medications were reported.   This case was linked to MOD-2021-372093, MOD-2021-372399 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: F/U received on 05-NOV-2021: correct dose 2 date and lot no. added.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) 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.  Caller does not know which dosage it was, if it was 0.5/0.25ML or 50/100mcg, stated it was the one from the booster dose.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm hurt and was sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm hurt and was sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Arm hurt and was sore). At the time of the report, MYALGIA (Arm hurt and was sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment medication provided.  Reporter stated that Dring market research, the respondent mentioned that she had both shots of the Moderna Covid-10 vaccine and her arm hurt and was sore after both doses.  This was a minor issue and resolved within a couple of days each time   This case was linked to MOD-2021-372569 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: follow up received on 03 nov 2021, reporter details updated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm  hurt and was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  hurt and was sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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 an unknown date, the patient experienced PAIN IN EXTREMITY (Arm  hurt and was sore). At the time of the report, PAIN IN EXTREMITY (Arm  hurt and was sore) had resolved. Not Provided          No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-372522 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow-up received and Reporter information updated.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Effects reported/all symptoms have stopped; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ADVERSE EVENT (Effects reported/all symptoms have stopped) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Effects reported/all symptoms have stopped). At the time of the report, ADVERSE EVENT (Effects reported/all symptoms have stopped) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2021-372607 (Parent-Child Link).   See case MOD-2021-372607 for details regarding the child case.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Pyrexia
Clinical narrative: had a temperature of almost 102F which is similar to what happened after the other doses; breastfeeding when she got her 1st dose & stopped 2 or 3 weeks later; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (had a temperature of almost 102F which is similar to what happened after the other doses) and MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding when she got her 1st dose & stopped 2 or 3 weeks later) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding when she got her 1st dose & stopped 2 or 3 weeks later). On an unknown date, the patient experienced PYREXIA (had a temperature of almost 102F which is similar to what happened after the other doses). At the time of the report, PYREXIA (had a temperature of almost 102F which is similar to what happened after the other doses) and MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding when she got her 1st dose & stopped 2 or 3 weeks later) outcome was unknown.        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 medication were provided Company Comment : This case concerns a 34 year old female with no reported medical history , who experienced Non-serious event of Maternal exposure during breastfeeding when vaccination with the 1st dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the events is unknown  The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 vaccine ) is not affected by this report.   This case was linked to MOD-2021-373021, MOD-2021-373022 (Patient Link).; Sender's Comments: This case concerns a 34 year old female with no reported medical history , who experienced Non-serious event of Maternal exposure during breastfeeding when vaccination with the 1st dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the outcome of the events is unknown  The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 vaccine ) is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature decreased, Chest pain, Electrocardiogram, Feeling cold
Clinical narrative: muscle spasms in the chest; chest pain that was severe, dull, in the middle of the chest; experienced the pain at the back as well; body temperature dropping; coldness; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (body temperature dropping), FEELING COLD (coldness), CHEST PAIN (chest pain that was severe, dull, in the middle of the chest), BACK PAIN (experienced the pain at the back as well) and MUSCLE SPASMS (muscle spasms in the chest) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Herpes virus infection.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced BODY TEMPERATURE DECREASED (body temperature dropping) and FEELING COLD (coldness). On 01-Apr-2021, the patient experienced CHEST PAIN (chest pain that was severe, dull, in the middle of the chest) and BACK PAIN (experienced the pain at the back as well). On 02-Apr-2021, the patient experienced MUSCLE SPASMS (muscle spasms in the chest). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 31-Mar-2021 for Chest pain, at an unspecified dose and frequency. On 02-Apr-2021, CHEST PAIN (chest pain that was severe, dull, in the middle of the chest) had resolved. On 06-Apr-2021, MUSCLE SPASMS (muscle spasms in the chest) had resolved. At the time of the report, BODY TEMPERATURE DECREASED (body temperature dropping), FEELING COLD (coldness) and BACK PAIN (experienced the pain at the back as well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) EKG of the chest was normal.         No concomitant medications was reported. The patient  sought medical attention from primary care physician who referred her to a physical therapist. She had an EKG done, and the primary physician said everything was fine. through the discussion with the primary care physician, the cause was possibly due to the Moderna Vaccine.   This case was linked to MOD-2021-372919 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: muscle spasms in the chest; chest pain that was severe, dull, in the middle of the chest; experienced the pain at the back as well; body temperature dropping; coldness; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (body temperature dropping), FEELING COLD (coldness), CHEST PAIN (chest pain that was severe, dull, in the middle of the chest), BACK PAIN (experienced the pain at the back as well) and MUSCLE SPASMS (muscle spasms in the chest) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Herpes virus infection.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced BODY TEMPERATURE DECREASED (body temperature dropping) and FEELING COLD (coldness). On 01-Apr-2021, the patient experienced CHEST PAIN (chest pain that was severe, dull, in the middle of the chest) and BACK PAIN (experienced the pain at the back as well). On 02-Apr-2021, the patient experienced MUSCLE SPASMS (muscle spasms in the chest). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 31-Mar-2021 for Chest pain, at an unspecified dose and frequency. On 02-Apr-2021, CHEST PAIN (chest pain that was severe, dull, in the middle of the chest) had resolved. On 06-Apr-2021, MUSCLE SPASMS (muscle spasms in the chest) had resolved. At the time of the report, BODY TEMPERATURE DECREASED (body temperature dropping), FEELING COLD (coldness) and BACK PAIN (experienced the pain at the back as well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) EKG of the chest was normal.         No concomitant medications was reported. The patient  sought medical attention from primary care physician who referred her to a physical therapist. She had an EKG done, and the primary physician said everything was fine. through the discussion with the primary care physician, the cause was possibly due to the Moderna Vaccine.   This case was linked to MOD-2021-372919 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.