chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) and malaise (did not feel great but was not bad/had a really horrible reaction) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011A21A) for COVID-19 immunization. No medical history reported. On Mar 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In March 2021, patient experienced pain in extremity (sore arm) and malaise (did not feel great but was not bad/had a really horrible reaction). At the time of the report, pain in extremity (sore arm) and malaise (did not feel great but was not bad/had a really horrible reaction) outcome: unknown. The patient took medications for other health conditions. No treatment medication provided. This case linked to MOD-2021-363603 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Now suffering from symptoms similar to that of COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Now suffering from symptoms similar to that of COVID-19) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Now suffering from symptoms similar to that of COVID-19). At the time of the report, SUSPECTED COVID-19 (Now suffering from symptoms similar to that of COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Patient has tested COVID-19 negative for multiple times.         No Concomitant medications were reported. No Treatment details were reported.  Company Comment:- This case concerns a female patient  of unknown age with no relevant medical history reported, who experienced the unexpected event of suspected COVID 19. The event occurred on an unknown date after the second dose of Moderna COVID-19 Vaccine. The patient reported that she was suffering at the time from symptoms similar to that of COVID-19. Patient has tested COVID-19 negative for multiple times. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up document contains Non- Significant information; Sender's Comments: This case concerns a female patient  of unknown age with no relevant medical history reported, who experienced the unexpected event of suspected COVID 19. The event occurred on an unknown date after the second dose of Moderna COVID-19 Vaccine. The patient reported that she was suffering at the time from symptoms similar to that of COVID-19. Patient has tested COVID-19 negative for multiple times. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Drug ineffective, SARS-CoV-2 test positive, Somnolence
Clinical narrative: slept a lot; lower back hurt; tested positive for COVID; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID), DRUG INEFFECTIVE (Lack of drug effect), SOMNOLENCE (slept a lot) and BACK PAIN (lower back hurt) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced SOMNOLENCE (slept a lot) and BACK PAIN (lower back hurt). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and SOMNOLENCE (slept a lot) and BACK PAIN (lower back hurt) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, SARS-CoV-2 test positive: positive (Positive) positive.         Concomitant medications include  Ace Inhibitor.  It was reported that patient symptoms lasted for about a week, after which he felt fine. Patient symptoms were very mild as well.  Company Comment: This case concerns a 73-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred approximately 6 months after the second dose of vax. The rechallenge for COVID-19 is not applicable. The benefit-risk relationship of vax is not affected by this report. Drug ineffective was considered as an additional event.; Sender's Comments: This case concerns a 73-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred approximately 6 months after the second dose of vax. The rechallenge for COVID-19 is not applicable. The benefit-risk relationship of vax is not affected by this report. Drug ineffective was considered as an additional event.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Is not immunocompromise and received 0.5 ml instead of 0.25 ml for the booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Is not immunocompromise and received 0.5 ml instead of 0.25 ml for the booster) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 006M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Is not immunocompromise and received 0.5 ml instead of 0.25 ml for the booster). On 22-Oct-2021, ACCIDENTAL OVERDOSE (Is not immunocompromise and received 0.5 ml instead of 0.25 ml for the booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was reported to not take any concomitant medications.  No treatment information was reported.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose,expired on 24-Oct-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose,expired on 24-Oct-2021) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose,expired on 24-Oct-2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna COVID-19 Vaccine as a booster dose,expired on 24-Oct-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received 0.5 ml dose for their booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5 ml dose for their booster) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.   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 ACCIDENTAL OVERDOSE (Received 0.5 ml dose for their booster). At the time of the report, ACCIDENTAL OVERDOSE (Received 0.5 ml dose for their booster) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-363330 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered incorrect dose (received 0.5mL dose instead of a 0.25mL dose for booster) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 071F21A) for COVID-19 immunization. No medical history reported. On Oct 25, 2021, patient received the third (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; .5 milliliter. On Oct 25, 2021, patient experienced administered incorrect dose (received 0.5mL dose instead of a 0.25mL dose for booster). On Oct 25, 2021, administered incorrect dose (received 0.5mL dose instead of a 0.25mL dose for booster) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter stated 5 patients received a 0.5mL dose instead of a 0.25mL dose for the booster shot. This case linked to MOD-2021-363591, MOD-2021-363330 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Cough, Vaccination complication
Clinical narrative: bad reaction; cough; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction) and COUGH (cough) 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 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction) and COUGH (cough). At the time of the report, VACCINATION COMPLICATION (bad reaction) and COUGH (cough) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-363559 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity
Clinical narrative: The sore arm was the same as the first two/arms were sore for a couple days; got a full dose (100 mcg shot) as opposed to a half dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The sore arm was the same as the first two/arms were sore for a couple days) and OVERDOSE (got a full dose (100 mcg shot) as opposed to a half dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 022M20H and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 15-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (got a full dose (100 mcg shot) as opposed to a half dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (The sore arm was the same as the first two/arms were sore for a couple days). On 15-Oct-2021, OVERDOSE (got a full dose (100 mcg shot) as opposed to a half dose) had resolved. At the time of the report, PAIN IN EXTREMITY (The sore arm was the same as the first two/arms were sore for a couple days) had resolved.            Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-363645, MOD-2021-363625 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) 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 VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Customer mentioned that he has friends who after getting the Moderna Covid-19 vaccine had similar adverse event like his vertigo. No concomitant medications were mentioned. No treatment details were reported.    This case was linked to MOD-2021-064301 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: very huge reaction in that injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (very huge reaction in that injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20H, 028L20A and 017F21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergy injections for almost 35 years).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-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 VACCINATION SITE REACTION (very huge reaction in that injection site). At the time of the report, VACCINATION SITE REACTION (very huge reaction in that injection site) outcome was unknown.            She got the flu shot about 2 weeks prior to the booster, she takes the higher dose for that because of her age.  No concomitant medication was reported. No treatment medication use was reported.   This case was linked to MOD-2021-009697, MOD-2021-363249 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Face injury, Influenza, Lip swelling, Pruritus, Rash
Clinical narrative: whole body skin welting situation/hives; serious, serious itching/scratching my bearded area on my face/he was scratching his bearded area on his face. He realized it was on his arm, stomach, and shouldersarm, stomach and shoulders; Flu symptoms; Red welts that were shallow; Face broke out; lips are swollen; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (whole body skin welting situation/hives), PRURITUS (serious, serious itching/scratching my bearded area on my face/he was scratching his bearded area on his face. He realized it was on his arm, stomach, and shouldersarm, stomach and shoulders), INFLUENZA (Flu symptoms), URTICARIA (Red welts that were shallow) and FACE INJURY (Face broke out) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced URTICARIA (whole body skin welting situation/hives), PRURITUS (serious, serious itching/scratching my bearded area on my face/he was scratching his bearded area on his face. He realized it was on his arm, stomach, and shouldersarm, stomach and shoulders), INFLUENZA (Flu symptoms), URTICARIA (Red welts that were shallow), FACE INJURY (Face broke out) and LIP SWELLING (lips are swollen). 25-Oct-2021, the patient experienced RASH (Rash). The patient was treated with METHYLPREDNISOLONE on 25-Oct-2021 for Adverse event, at a dose of 4 milligram for 6 days and HYDROXYZINE HYDROCHLORIDE on 25-Oct-2021 for Adverse event, at a dose of 25 milligram three times a day. At the time of the report, URTICARIA (whole body skin welting situation/hives), PRURITUS (serious, serious itching/scratching my bearded area on my face/he was scratching his bearded area on his face. He realized it was on his arm, stomach, and shouldersarm, stomach and shoulders), INFLUENZA (Flu symptoms), URTICARIA (Red welts that were shallow), FACE INJURY (Face broke out), LIP SWELLING (lips are swollen) and RASH (Rash) outcome was unknown.            He states he had nothing after the first two shots of Moderna; his arm was a little sore. The patient received his first dose (lot number DIZAZIA) of Moderna COVID19 Vaccine on 01Mar2021 and second dose (lot number 025B21A) on 29Mar2021. Consent given for safety to contact the patient and his HCP.  No concomitant medications were reported.   This case was linked to MOD-2021-363693, MOD-2021-363695 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: whole body skin welting situation/hives; serious, serious itching/scratching my bearded area on my face/he was scratching his bearded area on his face. He realized it was on his arm, stomach, and shouldersarm, stomach and shoulders; Flu symptoms; Red welts that were shallow; Face broke out; lips are swollen; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (whole body skin welting situation/hives), PRURITUS (serious, serious itching/scratching my bearded area on my face/he was scratching his bearded area on his face. He realized it was on his arm, stomach, and shouldersarm, stomach and shoulders), INFLUENZA (Flu symptoms), URTICARIA (Red welts that were shallow) and FACE INJURY (Face broke out) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced URTICARIA (whole body skin welting situation/hives), PRURITUS (serious, serious itching/scratching my bearded area on my face/he was scratching his bearded area on his face. He realized it was on his arm, stomach, and shouldersarm, stomach and shoulders), INFLUENZA (Flu symptoms), URTICARIA (Red welts that were shallow), FACE INJURY (Face broke out) and LIP SWELLING (lips are swollen). 25-Oct-2021, the patient experienced RASH (Rash). The patient was treated with METHYLPREDNISOLONE on 25-Oct-2021 for Adverse event, at a dose of 4 milligram for 6 days and HYDROXYZINE HYDROCHLORIDE on 25-Oct-2021 for Adverse event, at a dose of 25 milligram three times a day. At the time of the report, URTICARIA (whole body skin welting situation/hives), PRURITUS (serious, serious itching/scratching my bearded area on my face/he was scratching his bearded area on his face. He realized it was on his arm, stomach, and shouldersarm, stomach and shoulders), INFLUENZA (Flu symptoms), URTICARIA (Red welts that were shallow), FACE INJURY (Face broke out), LIP SWELLING (lips are swollen) and RASH (Rash) outcome was unknown.            He states he had nothing after the first two shots of Moderna; his arm was a little sore. The patient received his first dose (lot number DIZAZIA) of Moderna COVID19 Vaccine on 01Mar2021 and second dose (lot number 025B21A) on 29Mar2021. Consent given for safety to contact the patient and his HCP.  No concomitant medications were reported.   This case was linked to MOD-2021-363693, MOD-2021-363695 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was a little sore). At the time of the report, PAIN IN EXTREMITY (Arm was a little sore) outcome was unknown.            No concomitant medications were provided.  The patient had nothing after the first two shots of Moderna; his arm was a little sore.  No treatment medication were provided.   This case was linked to MOD-2021-363693, MOD-2021-363679 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna booster which seems to be from an expired vial it expired 11Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna booster which seems to be from an expired vial it expired 11Oct2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1808609) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna booster which seems to be from an expired vial it expired 11Oct2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna booster which seems to be from an expired vial it expired 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment medications was not specified The patient received a first dose of Johnson & Johnson COVID19 Vaccine (lot number 1808609) on 30Mar2021
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Extra dose administered, Fatigue, Headache
Clinical narrative: diarrhea; arm pain; chills; headaches; muscle aches; fatigues; received third dose instead of booster; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received third dose instead of booster), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (arm pain), CHILLS (chills) and HEADACHE (headaches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Emphysema and Kidney disorder.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (received third dose instead of booster). On an unknown date, the patient experienced DIARRHOEA (diarrhea), PAIN IN EXTREMITY (arm pain), CHILLS (chills), HEADACHE (headaches), MYALGIA (muscle aches) and FATIGUE (fatigues). On 22-Oct-2021, EXTRA DOSE ADMINISTERED (received third dose instead of booster) had resolved. At the time of the report, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (arm pain), CHILLS (chills), HEADACHE (headaches), MYALGIA (muscle aches) and FATIGUE (fatigues) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.  Patient was not immunocompromised.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: diarrhea; arm pain; chills; headaches; muscle aches; fatigues; received third dose instead of booster; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received third dose instead of booster), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (arm pain), CHILLS (chills) and HEADACHE (headaches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Emphysema and Kidney disorder.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (received third dose instead of booster). On an unknown date, the patient experienced DIARRHOEA (diarrhea), PAIN IN EXTREMITY (arm pain), CHILLS (chills), HEADACHE (headaches), MYALGIA (muscle aches) and FATIGUE (fatigues). On 22-Oct-2021, EXTRA DOSE ADMINISTERED (received third dose instead of booster) had resolved. At the time of the report, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (arm pain), CHILLS (chills), HEADACHE (headaches), MYALGIA (muscle aches) and FATIGUE (fatigues) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.  Patient was not immunocompromised.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: 3rd dose administered to non-immunocompromised patient; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (3rd dose administered to non-immunocompromised patient) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (3rd dose administered to non-immunocompromised patient). On 13-Jun-2021, OFF LABEL USE (3rd dose administered to non-immunocompromised patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Per reporter, patient was not immunocompromised and received a full dose of the vaccine.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  Reporter stated that patient had no side effects.   This case was linked to MOD-2021-351064, MOD-2021-363707, MOD-2021-363709, MOD-2021-363708, MOD-2021-355809 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Contains no new information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 to 5 patients received shot past 30-day use by date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported.  No concomitant medication reported.  Reporter stated that patient had no side effects.   This case was linked to MOD-2021-351064, MOD-2021-363703, MOD-2021-363708, MOD-2021-363709, MOD-2021-355809, MOD-2021-351064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Contains no new information.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 to 5 patients received shot past 30-day use by date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported . No treatment medication was reported . Date the vial was initially stored in the refrigerator: 08Sep2021 Reporter stated that patient had no side effects.   This case was linked to MOD-2021-351064, MOD-2021-363707, MOD-2021-363709, MOD-2021-363709, MOD-2021-355809, MOD-2021-363703, MOD-2021-351064 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Contains no new information.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was provided.  818 patients received dose from vials beyond 30-day use by date and refrigeration date is 07May2021   This case was linked to MOD-2021-363032, MOD-2021-363781, MOD-2021-363753 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received on 25-oct-2021 contain no new information .
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jul 20, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Jul 20, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date). On Jul 20, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration of vaccine: May 7, 2021.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Date of refrigeration of vaccine was reported as 07-May-2021.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication reported date of refrigeration 8/6/2021   This case was linked to MOD-2021-363737 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 21-Jan-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-363731, MOD-2021-364488, MOD-2021-365189 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jul 21, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 21, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date). On Jul 21, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration of vial: May 7, 2021. This case linked to MOD-2021-363730 (patient link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was 07-May-2021  No concomitant medications information was not reported No treatment medications were provided    This case was linked to MOD-2021-363735 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 20-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration 07-MAY-2021. No concomitant medications were reported. No treatment medications were provided.   This case was linked to MOD-2021-363733 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) and product storage error (318 patients received dose from vials beyond 30-day use by date) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jun 30, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 30, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date) and product storage error (318 patients received dose from vials beyond 30-day use by date). On Jun 30, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) and product storage error (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration: May 7, 2021.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 002F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information were reported No treatment medications were provided  Date of refrigeration was 19-Aug-2021   This case was linked to MOD-2021-363729, MOD-2021-363032 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date). On 17-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date) 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 reported.  The date of vaccine refrigeration was reported as 07-May-2021
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. Date of Refrigeration was given as 07-May-2021.   This case was linked to MOD-2021-363032 (Patient Link).