chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: A VERY MILD HEADACHE SINCE THE FIRST SHOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced a very mild headache since the first shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a very mild headache since the first shot. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Hyperhidrosis, Pain, Pyrexia, Somnolence
Clinical narrative: ACHES; SWEATS; OVERALL GROGGINESS; CHEST FEELS A SMALL HOT TOO; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced aches, sweats, overall grogginess, chest feels a small hot too, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, sweats, overall grogginess, and fever, and was recovering from chest feels a small hot too. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: ALMOST DIED AFTER A VACCINATION; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced partially paralyzed when treated with polio vaccine for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced almost died after a vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost died after a vaccination was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE GIVEN 3-9 MINUTES AFTER THE 6 HOUR OF IT BEING PUNCTURED; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, administered on 13-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-DEC-2021, the patient experienced vaccine given 3-9 minutes after the 6 hour of it being punctured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given 3-9 minutes after the 6 hour of it being punctured was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: JOINT PAIN; ARM HURT FOR A FEW DAYS; MUSCLE ACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced joint pain, arm hurt for a few days, and muscle aches. Treatment medications (dates unspecified) included: fexofenadine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, and muscle aches, and the outcome of arm hurt for a few days was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned 5 patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: 11-DEC-2021) dose was not reported, administered on 13-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-DEC-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 28-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-DEC-2021, the patient experienced sars cov 2 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sars cov 2 test positive was not reported. This report was non-serious. This report was associated with product quality complaint :90000206786
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Diarrhoea, Fall, Nausea, Pain
Clinical narrative: This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: emphysema, shellfish allergy, penicillin allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 23-AUG-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the patient experienced horrific pain in the whole body. On 20-MAR-2021, the patient experienced bedridden. On 20-MAR-2021, the patient experienced knocked me right up my feet. On 20-MAR-2021, the patient experienced sore arm. On 20-MAR-2021, the patient experienced nausea. On 20-MAR-2021, the patient experienced diarrhea.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient recovered from horrific pain in the whole body, bedridden, knocked me right up my feet, sore arm, nausea, and diarrhea on 25-MAR-2021.This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: emphysema, shellfish allergy, penicillin allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: 23-AUG-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the patient experienced horrific pain in the whole body. On 20-MAR-2021, the patient experienced bedridden. On 20-MAR-2021, the patient experienced knocked me right up my feet. On 20-MAR-2021, the patient experienced sore arm. On 20-MAR-2021, the patient experienced nausea. On 20-MAR-2021, the patient experienced diarrhea.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient recovered from horrific pain in the whole body, bedridden, knocked me right up my feet, sore arm, nausea, and diarrhea on 25-MAR-2021.This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: MAJOR HEART PROBLEMS; This spontaneous report received from a consumer  concerned a 6 decade old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient was perfectly healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported,1 total administered for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced major heart problems and was hospitalized (date unspecified). Number of days of hospitalization was not reported. It was unknown if patient was discharged. As per the report, it was stated that "you are lucky, My husbands friend died 2 weeks after getting his second shot. My neighbor had hand tremors with the feeling of electricity going down her arms and my daughter's friend is in the hospital with major heart problems. He is 50 and was perfectly healthy. The docs told him that it is probably from the shot" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of major heart problems was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211229554 and 20211229704.; Sender's Comments: 20211230043- COVID-19 VACCINE AD26.COV2.S-major heart problems. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: GOUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced gout. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of gout was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: FEELING ABNORMAL/KNOCK ME ON MY BUTT FOR TWO DAYS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-DEC-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On DEC-2021, the patient experienced feeling abnormal/knock me on my butt for two days. On DEC-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling abnormal/knock me on my butt for two days, and had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: A SORE ARM FOR ABOUT 3-4 DAYS; GOT THE CHILLS IN THE  MIDDLE OF THE NIGHT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced a sore arm for about 3-4 days, and got the chills in the middle of the night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a sore arm for about 3-4 days, and the outcome of got the chills in the middle of the night was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: red circle around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red circle around the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 021B21A and 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (high blood pressure), Arthritis and Hormone level abnormal.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Dec-2021 at 12:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE ERYTHEMA (red circle around the injection site). The patient was treated with CORTISONE (topical) for Injection site redness, at a dose of Corstisone cream this morning. At the time of the report, INJECTION SITE ERYTHEMA (red circle around the injection site) had not resolved.            Concomitant medication included high blood pressure medication, arthritis medication and hormone medication.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ALOPECIA (Since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time). The patient was treated with FINASTERIDE on 11-Nov-2021 for Hair loss, at an unspecified dose and frequency. At the time of the report, ALOPECIA (Since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time) had not resolved.            No concomitant medications were provided.  Patient's dermatologist gave her a steroid Medication for her scalp.  Reporter stated that the blood work would be performed to see if there were any other reason for the hair loss. She did not get COVID.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Added date of birth and added treatment. On 23-Nov-2021: Updated reporter details and event verbatim On 13-Dec-2021: Follow up received contains significant information, medical history was updated.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 0.5ml is given as a booster dose / What if the dose given for booster is 0.5ml; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (0.5ml is given as a booster dose / What if the dose given for booster is 0.5ml) 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) .5 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (0.5ml is given as a booster dose / What if the dose given for booster is 0.5ml). At the time of the report, INCORRECT DOSE ADMINISTERED (0.5ml is given as a booster dose / What if the dose given for booster is 0.5ml) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.  Patient had no adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Added information on occurrence of no adverse events and Reporter's first name and postal code updated.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid breaththrough case/ she was tested positive with a Covid breakthrough case; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid breaththrough case/ she was tested positive with a Covid breakthrough case) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced COVID-19 (Covid breaththrough case/ she was tested positive with a Covid breakthrough case). At the time of the report, COVID-19 (Covid breaththrough case/ she was tested positive with a Covid breakthrough case) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant products were reported. Patient reported that on 06-Oct-2021 she was treated with one time infusion of monoclonal antibodies. And states she was fine since the infusion.  Company comment: This is a Spontaneous case concerning a female patient of unknown age with unknown medical history,  who experienced the unexpected  non serious (AESI) event of COVID 19. The event occurred approximately 8 months after the second dose of mRNA 1273 vaccine. Exact latency between doses is unknown.  Patient was treated with monoclonal antibodies and has been stable.  The rechallenge is not applicable.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a female patient of unknown age with unknown medical history,  who experienced the unexpected non serious (AESI) event of COVID 19. The event occurred approximately 8 months after the second dose of mRNA 1273 vaccine. Exact latency between doses is unknown.  Patient was treated with monoclonal antibodies and has been stable.  The rechallenge is not applicable.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product dispensing error
Clinical narrative: moderna vial was punctured more than 20 times/doses administered to patients after vial was puncture more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DISPENSING ERROR (moderna vial was punctured more than 20 times/doses administered to patients after vial was puncture more than 20 times) 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 28-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced PRODUCT DISPENSING ERROR (moderna vial was punctured more than 20 times/doses administered to patients after vial was puncture more than 20 times). On 28-Nov-2021, PRODUCT DISPENSING ERROR (moderna vial was punctured more than 20 times/doses administered to patients after vial was puncture more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling like crap after recieving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling like crap after recieving the vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-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 MALAISE (Feeling like crap after recieving the vaccine). At the time of the report, MALAISE (Feeling like crap after recieving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-400115 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm were I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm were I got the shot) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-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 PAIN (sore arm were I got the shot). At the time of the report, VACCINATION SITE PAIN (sore arm were I got the shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not take any regular medications. It was reported that, the reporter was on his 60s, may be the year and the month was march but the date was missing. Treatment information was not provided.   This case was linked to MOD-2021-400033, MOD-2021-400048 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm were I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm were I got the shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-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 an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm were I got the shot). At the time of the report, VACCINATION SITE PAIN (sore arm were I got the shot) had resolved.            Patient did not take any regular medications. It was reported that, the reporter was on his 60s, may be the year and the month was march but the date was missing. The caller mention that after the 1st and 2nd shot of the Moderna COVID-19 vaccine he had a "sore arm were I got the shot" for a few days Treatment information was not provided.   This case was linked to MOD-2021-400033, MOD-2021-400044 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from vial punctured more than 12 hours before; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured more than 12 hours before) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     Concurrent medical conditions included GERD and Pain. Concomitant products included FAMOTIDINE from 02-Sep-2021 to an unknown date for GERD, IBUPROFEN and HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) from 15-Mar-2021 to an unknown date for Pain.    On 29-Nov-2021 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Nov-2021 at 9:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured more than 12 hours before). On 29-Nov-2021 at 9:30 AM, EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured more than 12 hours before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received .25mL of Moderna on 11/29/21. The vial used was opened/punctured on 11/26/21 at 3:40pm and put the vial back in the fridge. Vials did not undergo any temperature excursion and was punctured only three times. Patient has not had any adverse reaction.    This case was linked to MOD-2021-400131 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow up received: Patient demographics, dosage detail updated,  Medical history and con-med details added
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from vial punctured more than 12 hours before; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator on 26-NOV-2021. The vial was initially punctured on 26-Nov-2021. The vial had no temperature excursions. Patient did not have any adverse reactions.   This case was linked to MOD-2021-400110 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow-up received contains Significant information-Updated Patient demographics-Height, Weight, Race, Ethnicity. Updated Product information-Patient route of administration, Anatomical location.  Contains Updated Reporter's comment-Patient did not have any adverse reactions.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021 at 11:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine). On 16-Mar-2021 at 11:45 AM, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) to be not related.    No concomitant medication were reported.  No adverse event was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021 at 11:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021 at 11:50 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine). On 16-Mar-2021 at 11:50 AM, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) to be not related.    No concomitant medication information was provided. It was reported that patient has no known allergies. It was reported that patient was contacted to received a second full dose as soon as possible.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus since 28-Jul-2020, Congestive heart failure since 23-Mar-2020, COPD (COPD with Asthma) since 23-Mar-2020, Asthma (COPD with Asthma) since 23-Mar-2020, Chronic back pain (Chronic Lower Back Pain) since 20-Jun-2013 and BPH since 27-Aug-2013. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) from 28-Mar-2021 to an unknown date for BPH, FUROSEMIDE (LASIX [FUROSEMIDE]) from 26-Oct-2020 to an unknown date, SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) from 26-Jun-2020 to an unknown date and APIXABAN (ELIQUIS) from 26-Mar-2020 to an unknown date for Congestive heart failure.    On 16-Mar-2021 at 10:54 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021 at 10:54 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine). On 16-Mar-2021 at 10:54 AM, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) to be not related.    No treatment medication were reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021 at 11:55 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021 at 11:55 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine). On 16-Mar-2021 at 11:55 AM, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient was administered expired vaccine) to be not related.    No concomitant medications were reported  The patient has no known allergies.  No treatment medications were reported   This case was linked to MOD-2021-396123 (Patient Link).; Sender's Comments: This is a case of expired product administered for this 37-year-old male patient with no medical history reported. No adverse events were reported in association with expired product administered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dehydration, Dyskinesia, Feeding disorder, Headache
Clinical narrative: Right leg has involuntary movements; 104 temperature; Proning headache on the right side of the head,"Headache and vomiting were horrible"; Vomiting,"Headache and vomiting were horrible"; Seemed like patient was having a seizure; "I had nothing on stomach but kept vomiting",Couldn't drink water or eat anything nor take any medication; "I was deathly ill, never felt so ill"; Dehydrated; This spontaneous case was reported by a nurse and describes the occurrence of SEIZURE (Seemed like patient was having a seizure), FEEDING DISORDER ("I had nothing on stomach but kept vomiting",Couldn't drink water or eat anything nor take any medication), ILLNESS ("I was deathly ill, never felt so ill"), DEHYDRATION (Dehydrated) and DYSKINESIA (Right leg has involuntary movements) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced SEIZURE (Seemed like patient was having a seizure), FEEDING DISORDER ("I had nothing on stomach but kept vomiting",Couldn't drink water or eat anything nor take any medication), ILLNESS ("I was deathly ill, never felt so ill"), DEHYDRATION (Dehydrated), PYREXIA (104 temperature), HEADACHE (Proning headache on the right side of the head,"Headache and vomiting were horrible") and VOMITING (Vomiting,"Headache and vomiting were horrible"). In April 2021, the patient experienced DYSKINESIA (Right leg has involuntary movements). On 31-Mar-2021, SEIZURE (Seemed like patient was having a seizure), FEEDING DISORDER ("I had nothing on stomach but kept vomiting",Couldn't drink water or eat anything nor take any medication), ILLNESS ("I was deathly ill, never felt so ill"), DEHYDRATION (Dehydrated), PYREXIA (104 temperature), HEADACHE (Proning headache on the right side of the head,"Headache and vomiting were horrible") and VOMITING (Vomiting,"Headache and vomiting were horrible") had resolved. At the time of the report, DYSKINESIA (Right leg has involuntary movements) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 29-Mar-2021, Body temperature: 104 temperature (abnormal) 104 temperature.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported.No treatment medication were provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Seizure, Vomiting
Clinical narrative: Right leg has involuntary movements; 104 temperature; Proning headache on the right side of the head,"Headache and vomiting were horrible"; Vomiting,"Headache and vomiting were horrible"; Seemed like patient was having a seizure; "I had nothing on stomach but kept vomiting",Couldn't drink water or eat anything nor take any medication; "I was deathly ill, never felt so ill"; Dehydrated; This spontaneous case was reported by a nurse and describes the occurrence of SEIZURE (Seemed like patient was having a seizure), FEEDING DISORDER ("I had nothing on stomach but kept vomiting",Couldn't drink water or eat anything nor take any medication), ILLNESS ("I was deathly ill, never felt so ill"), DEHYDRATION (Dehydrated) and DYSKINESIA (Right leg has involuntary movements) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced SEIZURE (Seemed like patient was having a seizure), FEEDING DISORDER ("I had nothing on stomach but kept vomiting",Couldn't drink water or eat anything nor take any medication), ILLNESS ("I was deathly ill, never felt so ill"), DEHYDRATION (Dehydrated), PYREXIA (104 temperature), HEADACHE (Proning headache on the right side of the head,"Headache and vomiting were horrible") and VOMITING (Vomiting,"Headache and vomiting were horrible"). In April 2021, the patient experienced DYSKINESIA (Right leg has involuntary movements). On 31-Mar-2021, SEIZURE (Seemed like patient was having a seizure), FEEDING DISORDER ("I had nothing on stomach but kept vomiting",Couldn't drink water or eat anything nor take any medication), ILLNESS ("I was deathly ill, never felt so ill"), DEHYDRATION (Dehydrated), PYREXIA (104 temperature), HEADACHE (Proning headache on the right side of the head,"Headache and vomiting were horrible") and VOMITING (Vomiting,"Headache and vomiting were horrible") had resolved. At the time of the report, DYSKINESIA (Right leg has involuntary movements) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 29-Mar-2021, Body temperature: 104 temperature (abnormal) 104 temperature.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported.No treatment medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspepsia, Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: Heart was fluttering after booster; Arm hurt after booster; Felt awful after booster; Stomach was burning after booster; Fever at 100.6 deg F after booster; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart was fluttering after booster), PAIN IN EXTREMITY (Arm hurt after booster), VACCINATION COMPLICATION (Felt awful after booster), DYSPEPSIA (Stomach was burning after booster) and PYREXIA (Fever at 100.6 deg F after booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced CARDIAC FLUTTER (Heart was fluttering after booster), PAIN IN EXTREMITY (Arm hurt after booster), VACCINATION COMPLICATION (Felt awful after booster), DYSPEPSIA (Stomach was burning after booster) and PYREXIA (Fever at 100.6 deg F after booster). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at a dose of 1 dosage form. At the time of the report, CARDIAC FLUTTER (Heart was fluttering after booster), PAIN IN EXTREMITY (Arm hurt after booster), VACCINATION COMPLICATION (Felt awful after booster), DYSPEPSIA (Stomach was burning after booster) and PYREXIA (Fever at 100.6 deg F after booster) outcome was unknown.            Company comment: This is a spontaneous case concerning a female patient of an unknown age with Breast cancer, who experienced the non-serious events cardiac flutter, fever and malaise. The events occurred after the third   dose of mRNA-1273. Patient describe "her heart felt funny" and "the heart is fluttering a little" that resolved spontaneously and not seek for medical care.   Concurrent  event pyrexia could be a potentially confounder for the heart flutter. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant medications provided.   This case was linked to MOD-2021-402738, MOD-2021-402739 (Patient Link). Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with Breast cancer, who experienced the non-serious events cardiac flutter, fever and malaise. The events occurred after the third   dose of mRNA-1273. Patient describe "her heart felt funny" and "the heart is fluttering a little" that resolved spontaneously and not seek for medical care.   Concurrent  event pyrexia could be a potentially confounder for the heart flutter. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Colon injury, Volvulus
Clinical narrative: intestine had twisted; experienced stomach pain; it is unclear if some of the colon had to be removed; This spontaneous case was reported by an other health care professional and describes the occurrence of VOLVULUS (intestine had twisted) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VOLVULUS (intestine had twisted) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (experienced stomach pain) and COLON INJURY (it is unclear if some of the colon had to be removed). The patient was treated with Surgery (Exploratory surgery) for Volvulus. At the time of the report, VOLVULUS (intestine had twisted), ABDOMINAL PAIN UPPER (experienced stomach pain) and COLON INJURY (it is unclear if some of the colon had to be removed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter No treatment medication details was provided.  Company comment include This is a spontaneous case concerning a male of unknown gender patient with no reported medical history, who experienced the serious (medically significant) unexpected event intestinal volvulus, on an unknown date after receiving  the third  dose of mRNA-1273. Patient experienced abdominal pain, went to ER, and was told "their intestine had twisted". Surgery was performed and it is unknown if a piece of colon had to be removed. The benefit-risk relationship of mRNA-1273 is not affected by this report. No concomitant medication details was provided.  It was reported that sometime following receiving the booster dose, the patient experienced stomach pain and went to the ER where he was told that his intestine had twisted. Exploratory surgery and it is unclear if some of the colon had to be removed. The contents of the stomach were aspirated on 26-Nov-2021.; Sender's Comments: This is a spontaneous case concerning a male of unknown gender patient with no reported medical history, who experienced the serious (medically significant) unexpected event intestinal volvulus, on an unknown date after receiving  the third  dose of mRNA-1273. Patient experienced abdominal pain, went to ER, and was told "their intestine had twisted". Surgery was performed and it is unknown if a piece of colon had to be removed. The benefit-risk relationship of mRNA-1273 is not affected by this report.