chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine from expired vial/183 people were vaccinated with these expired vials.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine from expired vial/183 people were vaccinated with these expired vials.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) 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 EXPIRED PRODUCT ADMINISTERED (received vaccine from expired vial/183 people were vaccinated with these expired vials.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received vaccine from expired vial/183 people were vaccinated with these expired vials.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No treatment  was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Dec-2021: Non Significant follow-up appended
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 patients received booster doses from an expired vial (lot #001C21A & a manufacturer expiration date of 13Dec2021) of the Moderna Covid-19 Vaccine today 15Dec2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses from an expired vial (lot #001C21A & a manufacturer expiration date of 13Dec2021) of the Moderna Covid-19 Vaccine today 15Dec2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses from an expired vial (lot #001C21A & a manufacturer expiration date of 13Dec2021) of the Moderna Covid-19 Vaccine today 15Dec2021). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses from an expired vial (lot #001C21A & a manufacturer expiration date of 13Dec2021) of the Moderna Covid-19 Vaccine today 15Dec2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment details were not given.   This case was linked to MOD-2021-414469 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment details were not given.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment details were not given.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment details were not given.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 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 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of the Moderna vaccine/vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine/vaccine given 6 days post expiry) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine/vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine/vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: achiness for half of a day; he felt tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (achiness for half of a day) and FATIGUE (he felt tiredness) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A. and 026L20A.) for COVID-19 vaccination.     Concurrent medical conditions included Joint injury (Joint injuries). Concomitant products included MULTIVITAMINS [VITAMINS NOS] from 01-Jan-2000 to an unknown date for an unknown indication.   On 08-Jan-2021 at 1:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021 at 1:42 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (achiness for half of a day). 03-Feb-2021, the patient experienced FATIGUE (he felt tiredness). On 04-Feb-2021, PAIN (achiness for half of a day) and FATIGUE (he felt tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   In concomitant medications GNC Joint supplement was also reported. No treatment details were reported.  Company Comment - This case concerns a 39 year old male patient with concurrent medical condition of joint injury, who experienced the non-serious unexpected event of pain and the expected event fatigue. The events occurred on the same day after receiving the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. Patient's concurrent condition of joint injury remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-402807 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2021: Concomitant medication, anatomical location, time of suspect and patient details (height, weight and race) were added. On 10-Dec-2021: Follow up received: Outcome of event updated; Sender's Comments: This case concerns a 39 year old male patient with concurrent medical condition of joint injury, who experienced the non-serious unexpected event of pain and the expected event fatigue. The events occurred on the same day after receiving the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. Patient's concurrent condition of joint injury remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of drug effect; Tested positive twice after fully vaccinated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Tested positive twice after fully vaccinated) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028821A and 029921A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Tested positive twice after fully vaccinated). At the time of the report, DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Tested positive twice after fully vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2021, SARS-CoV-2 test: positive (Positive) positive. On 26-Nov-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medications include Monoclonal antibody treatment.  Patient tested positive on 07Oct2021 for the first time and on 26Nov2021 for the second time, patient went to ER and Dr. give Monoclonal antibody treatment.  Company comment:This case concerns a 64-year-old, male patient with no medical history reported, who experienced the unexpected non-serious AESI  of COVID-19. Additionally, Drug ineffective is also reported. The event occurred approximately 186 days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 64-year-old, male patient with no medical history reported, who experienced the unexpected non-serious AESI  of COVID-19. Additionally, Drug ineffective is also reported. The event occurred approximately 186 days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Product dose omission issue
Clinical narrative: Stroke; did not get second dose when she was supposed to; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and PRODUCT DOSE OMISSION ISSUE (did not get second dose when she was supposed to) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) and PRODUCT DOSE OMISSION ISSUE (did not get second dose when she was supposed to). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not get second dose when she was supposed to) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were reported.  Patient had a stroke. Patient was given her first dose of the vaccine (they went to give it to her) and the second dose was supposed to be on 14 Nov 2021 but they did not go to give it to her.   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Non Significant follow up information received Contact information updated; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with medical history of stroke and vaccine history of receiving first dose of unspecified vaccine, who experienced product dose omission. The patient received her first dose of unspecified vaccine and was supposed to received the second dose of unspecified vaccine but was not able to because the vaccinator did not come. The patient was inquiring why the vaccinator didn't come which resulted to patient missed her appointed schedule. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A, 002C21A and 0034C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tylenol), Hypothyroidism since 15-Jan-2020, Type 2 diabetes mellitus since 04-Aug-2020, Seizures since 15-Jan-2020 and Chronic obstructive pulmonary disease since 15-Jan-2020. Concomitant products included LEVOTHYROXINE from 25-May-2021 to an unknown date for Hypothyroidism, METFORMIN from 16-Sep-2021 to an unknown date for Type 2 diabetes mellitus, IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter. It was reported to the clinic on 15-Dec-2021, that patient didn't experienced any adverse reactions.   Most recent FOLLOW-UP information incorporated above includes: On 15-Dec-2021: Added the patient demographics (height, weight, medical history and allergy information), vaccine information, concomitant medication (Levothyroxine) and indication for Metformin
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Patient felt tired after his second dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Patient felt tired after his second dose of Moderna Covid-19 vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Patient felt tired after his second dose of Moderna Covid-19 vaccine). At the time of the report, FATIGUE (Patient felt tired after his second dose of Moderna Covid-19 vaccine) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  The patient had no adverse reactions after his first Moderna covid-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Follow-up information included no new information. On 14-Dec-2021: Follow-up information included no new information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Formication, Illness, Nausea
Clinical narrative: bad stomach ache; too sick; back ache; nauseated; fever; felt as something was crawling underneath her skin; This spontaneous case was reported by a consumer and describes the occurrence of FORMICATION (felt as something was crawling underneath her skin), ABDOMINAL PAIN UPPER (bad stomach ache), ILLNESS (too sick), BACK PAIN (back ache) and NAUSEA (nauseated) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced FORMICATION (felt as something was crawling underneath her skin) and PYREXIA (fever). On 15-Dec-2021, the patient experienced ABDOMINAL PAIN UPPER (bad stomach ache), ILLNESS (too sick), BACK PAIN (back ache) and NAUSEA (nauseated). At the time of the report, FORMICATION (felt as something was crawling underneath her skin), ABDOMINAL PAIN UPPER (bad stomach ache), ILLNESS (too sick), BACK PAIN (back ache), NAUSEA (nauseated) and PYREXIA (fever) outcome was unknown.            No concomitant medications or treatment details were reported.  The patient was reported to have received 2 doses (dose 1 and dose 2) of Moderna vaccine already.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: bad stomach ache; too sick; back ache; nauseated; fever; felt as something was crawling underneath her skin; This spontaneous case was reported by a consumer and describes the occurrence of FORMICATION (felt as something was crawling underneath her skin), ABDOMINAL PAIN UPPER (bad stomach ache), ILLNESS (too sick), BACK PAIN (back ache) and NAUSEA (nauseated) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced FORMICATION (felt as something was crawling underneath her skin) and PYREXIA (fever). On 15-Dec-2021, the patient experienced ABDOMINAL PAIN UPPER (bad stomach ache), ILLNESS (too sick), BACK PAIN (back ache) and NAUSEA (nauseated). At the time of the report, FORMICATION (felt as something was crawling underneath her skin), ABDOMINAL PAIN UPPER (bad stomach ache), ILLNESS (too sick), BACK PAIN (back ache), NAUSEA (nauseated) and PYREXIA (fever) outcome was unknown.            No concomitant medications or treatment details were reported.  The patient was reported to have received 2 doses (dose 1 and dose 2) of Moderna vaccine already.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: .25mg Moderna for a 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (.25mg Moderna for a 1st dose) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (.25mg Moderna for a 1st dose). At the time of the report, INCORRECT DOSE ADMINISTERED (.25mg Moderna for a 1st dose) 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 medications or treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: moderna vial left out of fridge for approx. 26 hours and some vaccine was delivered.; moderna vial left out of fridge for approx. 26 hours and some vaccine was delivered.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (moderna vial left out of fridge for approx. 26 hours and some vaccine was delivered.) and PRODUCT STORAGE ERROR (moderna vial left out of fridge for approx. 26 hours and some vaccine was delivered.) in a  patient of an unknown age and gender 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 EXPIRED PRODUCT ADMINISTERED (moderna vial left out of fridge for approx. 26 hours and some vaccine was delivered.) and PRODUCT STORAGE ERROR (moderna vial left out of fridge for approx. 26 hours and some vaccine was delivered.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (moderna vial left out of fridge for approx. 26 hours and some vaccine was delivered.) and PRODUCT STORAGE ERROR (moderna vial left out of fridge for approx. 26 hours and some vaccine was delivered.) 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 medications or treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: muscle twitching at night; This spontaneous case was reported by a pharmacist and describes the occurrence of MUSCLE TWITCHING (muscle twitching at night) 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 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 MUSCLE TWITCHING (muscle twitching at night). At the time of the report, MUSCLE TWITCHING (muscle twitching at night) 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 medications or treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: delayed second dose; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed second dose) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  Patient got first dose like 4 months ago and that's when patient got second one and was just wondering about the booster. Patient was good no side effects. Patient had covid vaccination report card that has the dates and stuff. The patient had no complaints, was just wondering if there's going to be a booster as the patient had the first two moderna.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 patients received booster doses from an expired vial (lot #001C21A & a manufacturer expiration date of 13Dec2021) of the Moderna Covid-19 Vaccine today 15Dec2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses from an expired vial (lot #001C21A & a manufacturer expiration date of 13Dec2021) of the Moderna Covid-19 Vaccine today 15Dec2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses from an expired vial (lot #001C21A & a manufacturer expiration date of 13Dec2021) of the Moderna Covid-19 Vaccine today 15Dec2021). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses from an expired vial (lot #001C21A & a manufacturer expiration date of 13Dec2021) of the Moderna Covid-19 Vaccine today 15Dec2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported. Expiry date of vaccine was 13 Dec 2021.   This case was linked to MOD-2021-414451, MOD-2021-414474 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Booster dose side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Booster dose side effects) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Booster dose side effects). At the time of the report, VACCINATION COMPLICATION (Booster dose side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle changes post vaccination; This spontaneous case was reported by a nurse and describes the occurrence of MENSTRUAL DISORDER (Menstrual cycle changes post vaccination) 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 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 MENSTRUAL DISORDER (Menstrual cycle changes post vaccination). At the time of the report, MENSTRUAL DISORDER (Menstrual cycle changes post vaccination) 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 medications were reported.  No treatment medications were reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy, Myalgia, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: General lethargy; Joint pain; Achy muscles; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (General lethargy), ARTHRALGIA (Joint pain), MYALGIA (Achy muscles) and PYREXIA (Low grade fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A, 037L20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Atrial fibrillation and Allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, SOTALOL HYDROCHLORIDE (BETAPACE) and ACETYLSALICYLIC ACID (ASPIRIN LOW) for Atrial fibrillation, ENALAPRILAT (VASOTEC [ENALAPRILAT]) for Blood pressure high.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-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 LETHARGY (General lethargy), ARTHRALGIA (Joint pain), MYALGIA (Achy muscles) and PYREXIA (Low grade fever). At the time of the report, LETHARGY (General lethargy), ARTHRALGIA (Joint pain), MYALGIA (Achy muscles) and PYREXIA (Low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, SARS-CoV-2 antibody test: 155 (abnormal) 155 for SARS COV2 total antibodies, test type: ECLIA. On 13-Dec-2021, SARS-CoV-2 antibody test: 148 (abnormal) 148 for SARS COV2 total antibodies, test type: ECLIA.         Patient was a part in the COVID care study, where antibodies are monitored every 3 months or 12 weeks. When patient first entered the program, the antibody level was 620 for SARS COV2 total antibody. However, ever since patient received the booster dose of the Moderna COVID-19 vaccine,  antibody levels had dropped 500%. As of test conducted on 07 Sep 2021 antibody level was 620 and test type was ECLIA.  No treatment information were provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Asthma; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthmatic attack (2 Asthma attacks Occurred During at High school Graduation 1962/1963.) from 1962 to 1963. Concurrent medical conditions included Asthma.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-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 ASTHMA (Asthma). At the time of the report, ASTHMA (Asthma) had not resolved. Not Provided          No concomitant treatment was provided. No treatment medication was provided.  Patient had experienced Difficulties with Asthma but those difficulties substantially lessened and he was not experienced in his school age that 1957-1961 after that he had 2 attacks in his high school graduation that is in 1962-1963. From 1963 onwards patient had no difficulties with Asthma and until recently Seldom gave it a thought but Asthma has no become a daily and continuing problem. Patient was curious about is there any linkage between Moderna covid vaccine  and Asthma.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Impaired work ability, Myalgia, Pain
Clinical narrative: pain; I couldn't work; pain and soreness at the injection site/arm is still sore and painful; Body ache and pain/I can still feel it with slight movements; chills; slight pain in my joints to the point were I couldn't work; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), IMPAIRED WORK ABILITY (I couldn't work), VACCINATION SITE PAIN (pain and soreness at the injection site/arm is still sore and painful), MYALGIA (Body ache and pain/I can still feel it with slight movements) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 007C21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Allergy NOS.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient experienced PAIN (pain), VACCINATION SITE PAIN (pain and soreness at the injection site/arm is still sore and painful), MYALGIA (Body ache and pain/I can still feel it with slight movements), CHILLS (chills) and ARTHRALGIA (slight pain in my joints to the point were I couldn't work). 14-Dec-2021, the patient experienced IMPAIRED WORK ABILITY (I couldn't work). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Adverse event, at an unspecified dose and frequency. On 14-Dec-2021, CHILLS (chills) had resolved. At the time of the report, PAIN (pain), VACCINATION SITE PAIN (pain and soreness at the injection site/arm is still sore and painful), MYALGIA (Body ache and pain/I can still feel it with slight movements) and ARTHRALGIA (slight pain in my joints to the point were I couldn't work) had not resolved and IMPAIRED WORK ABILITY (I couldn't work) outcome was unknown.            The patient was on blood pressure medication and allergy medications concomitantly.   This case was linked to MOD-2021-415972 (Patient Link).   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain; I couldn't work; pain and soreness at the injection site/arm is still sore and painful; Body ache and pain/I can still feel it with slight movements; chills; slight pain in my joints to the point were I couldn't work; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), IMPAIRED WORK ABILITY (I couldn't work), VACCINATION SITE PAIN (pain and soreness at the injection site/arm is still sore and painful), MYALGIA (Body ache and pain/I can still feel it with slight movements) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 007C21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Allergy NOS.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient experienced PAIN (pain), VACCINATION SITE PAIN (pain and soreness at the injection site/arm is still sore and painful), MYALGIA (Body ache and pain/I can still feel it with slight movements), CHILLS (chills) and ARTHRALGIA (slight pain in my joints to the point were I couldn't work). 14-Dec-2021, the patient experienced IMPAIRED WORK ABILITY (I couldn't work). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Adverse event, at an unspecified dose and frequency. On 14-Dec-2021, CHILLS (chills) had resolved. At the time of the report, PAIN (pain), VACCINATION SITE PAIN (pain and soreness at the injection site/arm is still sore and painful), MYALGIA (Body ache and pain/I can still feel it with slight movements) and ARTHRALGIA (slight pain in my joints to the point were I couldn't work) had not resolved and IMPAIRED WORK ABILITY (I couldn't work) outcome was unknown.            The patient was on blood pressure medication and allergy medications concomitantly.   This case was linked to MOD-2021-415972 (Patient Link).   Reporter did not allow further contact
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose was given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was given to patient) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Janssen on 08-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose was given to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose was given to patient) 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 information was provided.  The caller states that on 13-Dec-2021, a vial of the Moderna vaccine was opened and was not disposed of properly. And on 14-Dec-2021, 3 doses were accidently administered to patients from the punctured vial. She reported that the vial was refrigerated the entire time and it was administered approximately 18 hours post puncture. It was reported that none of the patients have reported adverse reactions to this expired dose.   This case was linked to MOD-2021-414582 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine administered >12/ hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine administered >12/ hours post puncture) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Dec-2021 at 8:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine administered >12/ hours post puncture). On 14-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine administered >12/ hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-414692 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Tinnitus; Sore arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and PAIN IN EXTREMITY (Sore arm for a few days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     The patient's past medical history included Epstein-Barr virus infection (Got infected in her early 20's.).   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 TINNITUS (Tinnitus) and PAIN IN EXTREMITY (Sore arm for a few days). At the time of the report, TINNITUS (Tinnitus) outcome was unknown and PAIN IN EXTREMITY (Sore arm for a few days) had resolved.            Concomitant products were not provided. Treatment medication were not reported. Patient had experienced tinnitus ever since the second dose of the Moderna vaccine, she has visited multiple doctors and has no reason for the tinnitus.