chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Feeling abnormal, Vaccine positive rechallenge
Clinical narrative: felt horrible; This case was reported by a consumer via  interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose and experienced felts awful, refer case US2021AMR241338).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feels awful was unknown.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had reported for him/herself. The patient received Shingles vaccine after his/her sister had them. After receiving Shingles vaccine, the patient felt horrible and stated that, it was better than getting shingles. This case had been linked with case US2021AMR241338, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241338:same patient - 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: it hurt after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated, the patient reported that it hurt after she received her first dose of Shingrix. No further details were available from pharmacist regarding patient or product. The reporter consented to follow up. This case has been linked to US2021239194, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021239194:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Confirmed Clinical Vaccination Failure; Confirmed COVID-19 Infection; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity 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: unknown expiry: unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-NOV-2021, the patient went for PCR (Polymerase Chain Reaction) testing and on 19-NOV-2021, he received results that he was positive for COVID (confirmed clinical vaccination failure and confirmed Covid-19 infection). The patient's symptoms were fever, congestion and body aches. Laboratory data included: COVID-19 PCR test (NR: not provided) positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed Covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000203302.; Sender's Comments: V0: 20211149729-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site is extremely hot; is not feeling well; injection site is extremely red; injection site is now about the size of a baseball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is extremely hot), VACCINATION SITE ERYTHEMA (injection site is extremely red), VACCINATION SITE SWELLING (injection site is now about the size of a baseball) and MALAISE (is not feeling well) 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 November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION SITE WARMTH (injection site is extremely hot), VACCINATION SITE ERYTHEMA (injection site is extremely red), VACCINATION SITE SWELLING (injection site is now about the size of a baseball) and MALAISE (is not feeling well). At the time of the report, VACCINATION SITE WARMTH (injection site is extremely hot), VACCINATION SITE ERYTHEMA (injection site is extremely red), VACCINATION SITE SWELLING (injection site is now about the size of a baseball) and MALAISE (is not feeling well) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives) and RASH (Rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives) and RASH (Rash). At the time of the report, URTICARIA (Hives) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant were reported.  No treatment were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow up document received and included NewEvent information.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: severe headache; chills; slight fever 100.8 degrees; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), CHILLS (chills) and PYREXIA (slight fever 100.8 degrees) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced HEADACHE (severe headache), CHILLS (chills) and PYREXIA (slight fever 100.8 degrees). On 14-Nov-2021, HEADACHE (severe headache), CHILLS (chills) and PYREXIA (slight fever 100.8 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, Body temperature: 100.8 (High) slight fever 100.8 degrees.         No concomitant medication was reported. The treatment information was unknown.   This case was linked to MOD-2021-361849 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired booster dose was administered to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was administered to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was administered to a patient). On 13-Nov-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided. Pharmacist reported that a booster dose was administered 10 hours after it expired. Pharmacist wanted  to know about stability of that dose so that they can decide whether to repeat the dose or not. Dose was administered 22 hours post puncture.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine doses administered to unknown # of patients/ Multiple expired doses administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered to unknown # of patients/ Multiple expired doses administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered to unknown # of patients/ Multiple expired doses administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered to unknown # of patients/ Multiple expired doses administered) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  It was reported that it was their 1 and 2 doses.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from expired vial; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided. Date the vial was initially stored in the refrigerator: Unknown   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Significant Follow-up received on 17-Nov-21  includes reporter information, patient information and batch number updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 100°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100°F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048U(Y)21A and 077CZ1B) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (Fever of 100°F). At the time of the report, PYREXIA (Fever of 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 100 (High) Fever of 100°F.         No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-389187 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Jaw hurst when trying to move it and trying to eat.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Jaw hurst when trying to move it and trying to eat.) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN JAW (Jaw hurst when trying to move it and trying to eat.). At the time of the report, PAIN IN JAW (Jaw hurst when trying to move it and trying to eat.) outcome was unknown.            Concomitant medication included high blood pressure medication.  Treatment information was not provided.   This case was linked to MOD-2021-389209, MOD-2021-389210 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: pain in the arm, a tingling, but no big deal; pain in the arm, a tingling, but no big deal; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm, a tingling, but no big deal) and PARAESTHESIA (pain in the arm, a tingling, but no big deal) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   In April 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. In April 2021, the patient experienced PAIN IN EXTREMITY (pain in the arm, a tingling, but no big deal) and PARAESTHESIA (pain in the arm, a tingling, but no big deal). At the time of the report, PAIN IN EXTREMITY (pain in the arm, a tingling, but no big deal) and PARAESTHESIA (pain in the arm, a tingling, but no big deal) outcome was unknown.            Concomitant medication include High BP medication No treatment information were provided.   This case was linked to MOD-2021-389183, MOD-2021-389210 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: "pain in the arm, a tingling, but no big deal"; "pain in the arm, a tingling, but no big deal"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("pain in the arm, a tingling, but no big deal") and PARAESTHESIA ("pain in the arm, a tingling, but no big deal") in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY ("pain in the arm, a tingling, but no big deal") and PARAESTHESIA ("pain in the arm, a tingling, but no big deal"). At the time of the report, PAIN IN EXTREMITY ("pain in the arm, a tingling, but no big deal") and PARAESTHESIA ("pain in the arm, a tingling, but no big deal") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications High BP Medication was  provided. Treatment information was not provided.    This case was linked to MOD-2021-389209, MOD-2021-389183 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: received a Pfizer vaccine 12/2020, never received the 2nd dose/today we gave her Moderna; Interchange of vaccine products; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a Pfizer vaccine 12/2020, never received the 2nd dose/today we gave her Moderna) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine on 23-Dec-2020. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 17-Nov-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a Pfizer vaccine 12/2020, never received the 2nd dose/today we gave her Moderna) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 17-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a Pfizer vaccine 12/2020, never received the 2nd dose/today we gave her Moderna) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. There was no adverse event with this patient, the patient received her first Pfizer vaccine, patient never received a second vaccine, came into office requesting another vaccine our health center explained we only have Moderna, patient asked to receive Moderna. Health center did not question the request since it has been close to a year since receiving the first vaccine. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Nov-2021: Follow up information includes reporters details, patient demographics information, ethnicity, vaccine information and narrative was updated.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Terrific headache; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Terrific headache) and PYREXIA (low grade fever) 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 HEADACHE (Terrific headache) and PYREXIA (low grade fever). At the time of the report, HEADACHE (Terrific headache) and PYREXIA (low grade fever) outcome was unknown.            No concomitant medication were reported  No treatment medication were reported   This case was linked to MOD-2021-389429 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Balance disorder, Malaise
Clinical narrative: Autoimmune disease relapse; Balance issues; Other issues/Physically wasn't able to go get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune disease relapse) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder (Autoimmune disorder before receiving the Moderna vaccine.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune disease relapse) (seriousness criterion hospitalization), BALANCE DISORDER (Balance issues) and MALAISE (Other issues/Physically wasn't able to go get the second dose). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE DISORDER (Autoimmune disease relapse), BALANCE DISORDER (Balance issues) and MALAISE (Other issues/Physically wasn't able to go get the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. The patient was out of work with some balance issues and some other issues. It happened like three weeks after the vaccination. The patient said he has MSNRA, but that the doctors are not sure what it was. The patient received first dose on 24-Dec-2021 and then could have been 5th. The patient never received the second dose because it was hospitalized. Treatment information was not provided. Company's comment: This is a spontaneous case concerning a 44 years old, male patient with clinical history of Autoimmune disease who experienced the unexpected events of AUTOIMMUNE DISORDER, BALANCE DISORDER and MALAISE. The events occurred unknown days after the first dose of mRNA-1273 vaccine The rechallenge is not applicable as the events occurred after the first dose and no more doses were received by the patient  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow up received included no new information.; Sender's Comments: This is a spontaneous case concerning a 44 years old, male patient with clinical history of Autoimmune disease who experienced the unexpected events of AUTOIMMUNE DISORDER, BALANCE DISORDER and MALAISE. The events occurred unknown days after the first dose of mRNA-1273 vaccine The rechallenge is not applicable as the events occurred after the first dose and no more doses were received by the patient  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: He had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (He had a sore arm) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (He's diabetic). Concomitant products included GLIPIZIDE and SEMAGLUTIDE (OZEMPIC) for Diabetic.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced PAIN IN EXTREMITY (He had a sore arm). At the time of the report, PAIN IN EXTREMITY (He had a sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment details were reported.  Company comment- This case concerns a 48-year-old male patient with no relevant medical history, who experienced the unexpected event of Pain in Extremity. The event occurred 1 day after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-389689 (Patient Link).; Sender's Comments: This case concerns a 48-year-old male patient with no relevant medical history, who experienced the unexpected event of Pain in Extremity. The event occurred 1 day after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Swollen Injection Site  8cm X 1/2 cm; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE SWELLING (Swollen Injection Site  8cm X 1/2 cm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 032L20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced INJECTION SITE SWELLING (Swollen Injection Site  8cm X 1/2 cm). At the time of the report, INJECTION SITE SWELLING (Swollen Injection Site  8cm X 1/2 cm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness, Fatigue, Feeling abnormal, Impaired work ability
Clinical narrative: Achy; extremely dizzy; hands from his fingers to his knuckles are white as snow & ice cold; didn't feel well; came back home from work this morning; hands from his fingers to his knuckles are white as snow & ice cold; acting like he's high; Exhaustion/tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), DIZZINESS (extremely dizzy), SKIN DISCOLOURATION (hands from his fingers to his knuckles are white as snow & ice cold), MALAISE (didn't feel well) and IMPAIRED WORK ABILITY (came back home from work this morning) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included GLIPIZIDE and SEMAGLUTIDE (OZEMPIC) for Diabetic.   On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced FATIGUE (Exhaustion/tired). On 17-Nov-2021, the patient experienced PAIN (Achy), DIZZINESS (extremely dizzy), SKIN DISCOLOURATION (hands from his fingers to his knuckles are white as snow & ice cold), MALAISE (didn't feel well), IMPAIRED WORK ABILITY (came back home from work this morning), PERIPHERAL COLDNESS (hands from his fingers to his knuckles are white as snow & ice cold) and FEELING ABNORMAL (acting like he's high). At the time of the report, PAIN (Achy), DIZZINESS (extremely dizzy), SKIN DISCOLOURATION (hands from his fingers to his knuckles are white as snow & ice cold), MALAISE (didn't feel well), IMPAIRED WORK ABILITY (came back home from work this morning), PERIPHERAL COLDNESS (hands from his fingers to his knuckles are white as snow & ice cold), FEELING ABNORMAL (acting like he's high) and FATIGUE (Exhaustion/tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, Blood glucose: 100 (normal) blood sugar is low at 100.         No Treatment medication was reported.  Patient blood sugar was at 100 and it was normally 140-150.   This case was linked to MOD-2021-389612 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Peripheral coldness, Skin discolouration
Clinical narrative: Achy; extremely dizzy; hands from his fingers to his knuckles are white as snow & ice cold; didn't feel well; came back home from work this morning; hands from his fingers to his knuckles are white as snow & ice cold; acting like he's high; Exhaustion/tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), DIZZINESS (extremely dizzy), SKIN DISCOLOURATION (hands from his fingers to his knuckles are white as snow & ice cold), MALAISE (didn't feel well) and IMPAIRED WORK ABILITY (came back home from work this morning) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic. Concomitant products included GLIPIZIDE and SEMAGLUTIDE (OZEMPIC) for Diabetic.   On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced FATIGUE (Exhaustion/tired). On 17-Nov-2021, the patient experienced PAIN (Achy), DIZZINESS (extremely dizzy), SKIN DISCOLOURATION (hands from his fingers to his knuckles are white as snow & ice cold), MALAISE (didn't feel well), IMPAIRED WORK ABILITY (came back home from work this morning), PERIPHERAL COLDNESS (hands from his fingers to his knuckles are white as snow & ice cold) and FEELING ABNORMAL (acting like he's high). At the time of the report, PAIN (Achy), DIZZINESS (extremely dizzy), SKIN DISCOLOURATION (hands from his fingers to his knuckles are white as snow & ice cold), MALAISE (didn't feel well), IMPAIRED WORK ABILITY (came back home from work this morning), PERIPHERAL COLDNESS (hands from his fingers to his knuckles are white as snow & ice cold), FEELING ABNORMAL (acting like he's high) and FATIGUE (Exhaustion/tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, Blood glucose: 100 (normal) blood sugar is low at 100.         No Treatment medication was reported.  Patient blood sugar was at 100 and it was normally 140-150.   This case was linked to MOD-2021-389612 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Occupational exposure to product
Clinical narrative: Occupational exposure to product via eye; 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 OCCUPATIONAL EXPOSURE TO PRODUCT (Occupational exposure to product via eye) 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 OCCUPATIONAL EXPOSURE TO PRODUCT (Occupational exposure to product via eye). At the time of the report, OCCUPATIONAL EXPOSURE TO PRODUCT (Occupational exposure to product via eye) outcome was unknown. Not Provided     No relevant concomitant medications was reported. Treatment information was not provided. Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the non serious event of occupational exposure to product via eye. The event occupational exposure to product via eye occurred while the patient was vaccinating. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the non serious event of occupational exposure to product via eye. The event occupational exposure to product via eye occurred while the patient was vaccinating. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination complication
Clinical narrative: Felt a little unwell the next day following the booster; like hives; broken out like a rash all over the body, face, hands, legs; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt a little unwell the next day following the booster), URTICARIA (like hives) and RASH (broken out like a rash all over the body, face, hands, legs) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Felt a little unwell the next day following the booster), URTICARIA (like hives) and RASH (broken out like a rash all over the body, face, hands, legs). At the time of the report, VACCINATION COMPLICATION (Felt a little unwell the next day following the booster) outcome was unknown and URTICARIA (like hives) and RASH (broken out like a rash all over the body, face, hands, legs) had not resolved.            No concomitant medication were reported. Treatment reports were Benadryl and steroids Reporter states that patient Ended up on ER on Sunday night because it was moving to the throat.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered the Moderna Covid-19 vaccine from a vial which is past its 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine from a vial which is past its 30 day use by date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine from a vial which is past its 30 day use by date). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine from a vial which is past its 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given. Reportedly, Vaccines were removed from freezer on 15-Oct-2021 BUD and then determined to be 14-Nov-2021.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow up was received, contains patient demographics (initials, age, date of birth and gender), suspect dose, anatomical location and updated expiration date from 19-Jan-2021 to 19-Jan-2022.; Sender's Comments: This is a spontaneous case concerning a 27-year-old, male patient with no relevant medical history, who experienced the non serious event of expired product administered. The event expired product administered occurred right after the first dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 3 days past its 30 day use by date (initially placed in the refrigerator on 15 October 2021 and administered at 17 Nov2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: 28 doses(booster) were given to patients out of 20 dose vials/Vaccine underdose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (28 doses(booster) were given to patients out of 20 dose vials/Vaccine underdose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (28 doses(booster) were given to patients out of 20 dose vials/Vaccine underdose). At the time of the report, ACCIDENTAL UNDERDOSE (28 doses(booster) were given to patients out of 20 dose vials/Vaccine underdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medication was provided.  No treatment  was provided.  No adverse event experienced by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received on 19-NOV-2021.Contains event information added in I narrative.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Hard where they poked me/real hard; Tenderness in my arm; Swelling up real big/steadily swelling up; Red/it was his right arm. It's real hard, red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard where they poked me/real hard), VACCINATION SITE PAIN (Tenderness in my arm), VACCINATION SITE SWELLING (Swelling up real big/steadily swelling up) and VACCINATION SITE ERYTHEMA (Red/it was his right arm. It's real hard, red) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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. On 15-Nov-2021, the patient experienced VACCINATION SITE INDURATION (Hard where they poked me/real hard), VACCINATION SITE PAIN (Tenderness in my arm), VACCINATION SITE SWELLING (Swelling up real big/steadily swelling up) and VACCINATION SITE ERYTHEMA (Red/it was his right arm. It's real hard, red). At the time of the report, VACCINATION SITE INDURATION (Hard where they poked me/real hard), VACCINATION SITE PAIN (Tenderness in my arm), VACCINATION SITE SWELLING (Swelling up real big/steadily swelling up) and VACCINATION SITE ERYTHEMA (Red/it was his right arm. It's real hard, red) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Around 50 booster doses were administered past the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Around 50 booster doses were administered past the expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Around 50 booster doses were administered past the expiration date). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Around 50 booster doses were administered past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 21-OCT-2021 vial was initially stored in the refrigerator. Vial  did not undergone any temperature excursions. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm after second Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm after second Moderna Covid-19 vaccine) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore left arm after second Moderna Covid-19 vaccine). At the time of the report, PAIN IN EXTREMITY (Sore left arm after second Moderna Covid-19 vaccine) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 11 doses were administered from 1 vial was that past the 30 day use by date in refrigerated storage; however was in refrigerated storage longer then 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 doses were administered from 1 vial was that past the 30 day use by date in refrigerated storage) and PRODUCT STORAGE ERROR (however was in refrigerated storage longer then 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 doses were administered from 1 vial was that past the 30 day use by date in refrigerated storage) and PRODUCT STORAGE ERROR (however was in refrigerated storage longer then 30 days). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (11 doses were administered from 1 vial was that past the 30 day use by date in refrigerated storage) and PRODUCT STORAGE ERROR (however was in refrigerated storage longer then 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. Number of doses/vials are 11 doses administered from 1 vial. Nurse states 8 doses were 0.25mL booster doses and 3 doses were 1st primary series Moderna dose.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of dose more that 12 hours post puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of dose more that 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of dose more that 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of dose more that 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Felt a little achy; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt a little achy) and FATIGUE (Extremely tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (Felt a little achy) and FATIGUE (Extremely tired). On 15-Feb-2021, PAIN (Felt a little achy) and FATIGUE (Extremely tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-390033, MOD-2021-390040 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: my son got the 1st & 2nd doses of the Moderna Covid-19 vaccine. He's only 17 years old.; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my son got the 1st & 2nd doses of the Moderna Covid-19 vaccine. He's only 17 years old.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my son got the 1st & 2nd doses of the Moderna Covid-19 vaccine. He's only 17 years old.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 12-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (my son got the 1st & 2nd doses of the Moderna Covid-19 vaccine. He's only 17 years old.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No concomitant medications are provided. No treatment medications are provided.   This case was linked to MOD-2021-390055 (Patient Link).