chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had some side effects from the vaccine and went to hospital. The hospitalization days was unspecified The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211124761-COVID-19 VACCINE AD26.COV2.S-Side effects. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Really stiff; Hurts a lot/it's been like a week and a half; Really swollen; 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 VACCINATION SITE INDURATION (Really stiff), VACCINATION SITE PAIN (Hurts a lot/it's been like a week and a half) and VACCINATION SITE SWELLING (Really swollen) 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 VACCINATION SITE INDURATION (Really stiff), VACCINATION SITE PAIN (Hurts a lot/it's been like a week and a half) and VACCINATION SITE SWELLING (Really swollen). At the time of the report, VACCINATION SITE INDURATION (Really stiff), VACCINATION SITE PAIN (Hurts a lot/it's been like a week and a half) and VACCINATION SITE SWELLING (Really swollen) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medications were reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received and AE information updated, event outcome updated as recovering/resolving.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 01-Jan-2000 and GERD since 01-Jan-2000. Concomitant products included OMEPRAZOLE from 01-Jul-2020 to an unknown date for GERD, LEVOTHYROXINE SODIUM (SYNTHROID) from 07-May-2020 to an unknown date for Hypothyroidism.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up received. Patient demographics were updated. Patient medical history was added. Patient route of administration, anatomical location, and concomitant medications were added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) 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 EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a re frozen dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported. No adverse event reported.  It was reported that there were two different lot numbers involved in the incident: 047C21A and 23C21A   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Non-significant follow up appended On 05-Nov-2021: Follow-up received on 08-Nov-2021 contains Non-significant information.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose of the Moderna COVID19 vaccine lot number 033C21A, dose administered past the expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID19 vaccine lot number 033C21A, dose administered past the expiry date) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-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 30-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID19 vaccine lot number 033C21A, dose administered past the expiry date). On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID19 vaccine lot number 033C21A, dose administered past the expiry 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 was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant follow up was received and included patient identifiers (Initials, gender, DOB), dose number information.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in the shoulder (vaccinated arm)), NAUSEA (Nausea) and PYREXIA (Temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 ARTHRALGIA (Pain in the shoulder (vaccinated arm)), NAUSEA (Nausea) and PYREXIA (Temperature). At the time of the report, ARTHRALGIA (Pain in the shoulder (vaccinated arm)) and NAUSEA (Nausea) outcome was unknown and PYREXIA (Temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.  It took a day and a half for temperature to go away.
Sex: U
Vaccine: COVID19
Symptoms: Vasculitis
Clinical narrative: Vasculitis; 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 VASCULITIS (Vasculitis) 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 VASCULITIS (Vasculitis). At the time of the report, VASCULITIS (Vasculitis) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Doctor shared an article with her about COVID-19 vaccines (in general) and vasculitis. According to the article there have been only 3 reported cases as of September and the three received the vaccine but does not say which one  No concomitant medications were reported  No treatment information was provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: After the second dose it was a little bit itchy around the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (After the second dose it was a little bit itchy around the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (After the second dose it was a little bit itchy around the injection site). At the time of the report, VACCINATION SITE PRURITUS (After the second dose it was a little bit itchy around the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  All 3 were injections on her right arm, she is left handed.  Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-375229 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site reaction, Vaccination site warmth
Clinical narrative: After the booster shot she had a skin reaction to the shot around the injection site/skin reaction to booster is about 2-3 inches; Skin reaction to booster is hot; Skin reaction to booster is red; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (After the booster shot she had a skin reaction to the shot around the injection site/skin reaction to booster is about 2-3 inches), VACCINATION SITE WARMTH (Skin reaction to booster is hot) and VACCINATION SITE ERYTHEMA (Skin reaction to booster is red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 039K20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 02-Nov-2021, the patient experienced VACCINATION SITE REACTION (After the booster shot she had a skin reaction to the shot around the injection site/skin reaction to booster is about 2-3 inches), VACCINATION SITE WARMTH (Skin reaction to booster is hot) and VACCINATION SITE ERYTHEMA (Skin reaction to booster is red). At the time of the report, VACCINATION SITE REACTION (After the booster shot she had a skin reaction to the shot around the injection site/skin reaction to booster is about 2-3 inches), VACCINATION SITE WARMTH (Skin reaction to booster is hot) and VACCINATION SITE ERYTHEMA (Skin reaction to booster is red) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Feeling abnormal, Headache, Malaise
Clinical narrative: Arm hurts; When she woke up she doesn't feel good; She just feels terrible; Had diarrhea last night; A headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, MALAISE, FEELING ABNORMAL, DIARRHOEA, and HEADACHE in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 024M20A, and 0011321A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY, MALAISE, FEELING ABNORMAL, DIARRHOEA, and HEADACHE. The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL for Headache, at an unspecified dose and frequency and MELATONIN for Adverse event, at a dose of 10 milligram. At the time of the report, PAIN IN EXTREMITY, MALAISE, and FEELING ABNORMAL outcome was unknown and DIARRHOEA and HEADACHE had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, Body temperature: 100 (High) little over a hundred degrees temperature.         No relevant concomitant medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurts; When she woke up she doesn't feel good; She just feels terrible; Had diarrhea last night; A headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, MALAISE, FEELING ABNORMAL, DIARRHOEA, and HEADACHE in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 024M20A, and 0011321A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY, MALAISE, FEELING ABNORMAL, DIARRHOEA, and HEADACHE. The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL for Headache, at an unspecified dose and frequency and MELATONIN for Adverse event, at a dose of 10 milligram. At the time of the report, PAIN IN EXTREMITY, MALAISE, and FEELING ABNORMAL outcome was unknown and DIARRHOEA and HEADACHE had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, Body temperature: 100 (High) little over a hundred degrees temperature.         No relevant concomitant medications were reported.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired booster dose administered to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered to a patient) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 027A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered to a patient). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported. No Concomitant medication reported. Patient taken other medications, names were not specified. Initial date of refrigeration of third dose of vaccine  was 02-OCT-2021 and  it was packed appropriately.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up received contain significant information contain   Batch number, Route of administration, Anatomical location of first and second dose, Start of drug of first dose, Event verbatim updated, new reporter added. On 08-Nov-2021: Follow-up received contain significant information: Reporter  added, initial date of refrigeration received added in  I narrative.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest pain, Headache, Insomnia, Movement disorder
Clinical narrative: injection site hard; nausea; vomiting; injection site red; injection site swollen; severe headache; stiff neck; trouble moving around, her body would hardly move; didn't sleep; chest pain right in the middle of her chest; did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), MOVEMENT DISORDER (trouble moving around, her body would hardly move), INSOMNIA (didn't sleep), CHEST PAIN (chest pain right in the middle of her chest) and VACCINATION COMPLICATION (did not feel well) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), MOVEMENT DISORDER (trouble moving around, her body would hardly move), INSOMNIA (didn't sleep), CHEST PAIN (chest pain right in the middle of her chest), VACCINATION COMPLICATION (did not feel well) and HEADACHE (severe headache). On an unknown date, the patient experienced VACCINATION SITE INDURATION (injection site hard), NAUSEA (nausea), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site swollen). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and NITROGLYCERIN for Adverse event, at an unspecified dose and frequency. On 03-Nov-2021, VACCINATION COMPLICATION (did not feel well) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck), MOVEMENT DISORDER (trouble moving around, her body would hardly move), INSOMNIA (didn't sleep), VACCINATION SITE INDURATION (injection site hard), NAUSEA (nausea), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE SWELLING (injection site swollen) and HEADACHE (severe headache) outcome was unknown and CHEST PAIN (chest pain right in the middle of her chest) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal (normal) There was nothing wrong with her heart. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, she did not have COVID before either.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-375291 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, SARS-CoV-2 test, Vaccination complication, Vaccination site erythema
Clinical narrative: injection site hard; nausea; vomiting; injection site red; injection site swollen; severe headache; stiff neck; trouble moving around, her body would hardly move; didn't sleep; chest pain right in the middle of her chest; did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), MOVEMENT DISORDER (trouble moving around, her body would hardly move), INSOMNIA (didn't sleep), CHEST PAIN (chest pain right in the middle of her chest) and VACCINATION COMPLICATION (did not feel well) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), MOVEMENT DISORDER (trouble moving around, her body would hardly move), INSOMNIA (didn't sleep), CHEST PAIN (chest pain right in the middle of her chest), VACCINATION COMPLICATION (did not feel well) and HEADACHE (severe headache). On an unknown date, the patient experienced VACCINATION SITE INDURATION (injection site hard), NAUSEA (nausea), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site swollen). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and NITROGLYCERIN for Adverse event, at an unspecified dose and frequency. On 03-Nov-2021, VACCINATION COMPLICATION (did not feel well) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck), MOVEMENT DISORDER (trouble moving around, her body would hardly move), INSOMNIA (didn't sleep), VACCINATION SITE INDURATION (injection site hard), NAUSEA (nausea), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE SWELLING (injection site swollen) and HEADACHE (severe headache) outcome was unknown and CHEST PAIN (chest pain right in the middle of her chest) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal (normal) There was nothing wrong with her heart. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, she did not have COVID before either.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-375291 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling, Vomiting
Clinical narrative: injection site hard; nausea; vomiting; injection site red; injection site swollen; severe headache; stiff neck; trouble moving around, her body would hardly move; didn't sleep; chest pain right in the middle of her chest; did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), MOVEMENT DISORDER (trouble moving around, her body would hardly move), INSOMNIA (didn't sleep), CHEST PAIN (chest pain right in the middle of her chest) and VACCINATION COMPLICATION (did not feel well) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), MOVEMENT DISORDER (trouble moving around, her body would hardly move), INSOMNIA (didn't sleep), CHEST PAIN (chest pain right in the middle of her chest), VACCINATION COMPLICATION (did not feel well) and HEADACHE (severe headache). On an unknown date, the patient experienced VACCINATION SITE INDURATION (injection site hard), NAUSEA (nausea), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE SWELLING (injection site swollen). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and NITROGLYCERIN for Adverse event, at an unspecified dose and frequency. On 03-Nov-2021, VACCINATION COMPLICATION (did not feel well) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck), MOVEMENT DISORDER (trouble moving around, her body would hardly move), INSOMNIA (didn't sleep), VACCINATION SITE INDURATION (injection site hard), NAUSEA (nausea), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE SWELLING (injection site swollen) and HEADACHE (severe headache) outcome was unknown and CHEST PAIN (chest pain right in the middle of her chest) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal (normal) There was nothing wrong with her heart. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative, she did not have COVID before either.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-375291 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: felt nauseous after my second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (felt nauseous after my second dose of the vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced NAUSEA (felt nauseous after my second dose of the vaccine). At the time of the report, NAUSEA (felt nauseous after my second dose of the vaccine) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Pregnant/4-weeks in/Wife is pregnant/Found out that wife is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY 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 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Oct-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY. On 09-Oct-2021, MATERNAL EXPOSURE BEFORE PREGNANCY had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was reported. Patient was not pregnant before the 1st dose was administered.  This case concerns a female with unknown age, who experienced non-serious event of maternal exposure before pregnancy which occurred with the 1st dose of mRNA -1273 vaccine (Moderna Covid 19 Vaccine. The re-challenge for this case is not applicable. The benefit -risk relationship of mRNA-1273 vaccine (Moderna Covid 19 Vaccine) is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck she had had before with the other doses; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck she had had before with the other doses) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck she had had before with the other doses). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck she had had before with the other doses) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.    This case was linked to MOD-2021-375282 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swollen injection site arm after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen injection site arm after the booster dose) 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 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 SITE SWELLING (Swollen injection site arm after the booster dose). At the time of the report, VACCINATION SITE SWELLING (Swollen injection site arm after the booster dose) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-375323, MOD-2021-375331 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: leg hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (leg hurt). At the time of the report, PAIN IN EXTREMITY (leg hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided by the reporter.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feeling weird; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling weird) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and HYDROXYZINE for an unknown indication.    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 FEELING ABNORMAL (Feeling weird). At the time of the report, FEELING ABNORMAL (Feeling weird) had resolved. Not Provided          No concomitant medication was given by reporter. No treatment medication was given by reporter Patient felt weird after the second dose for 10 hours.   This case was linked to MOD-2021-375333, MOD-2021-375339, MOD-2021-375342 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up received on 09-Nov-2021 contains information about concomitant medication.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Sore arm; upset stomach; Aches; Very high fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (Aches), PYREXIA (Very high fever) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399105, 011M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (Aches), PYREXIA (Very high fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Sore arm), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (Aches), PYREXIA (Very high fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-375328, MOD-2021-375313 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; upset stomach; Aches; Very high fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (Aches), PYREXIA (Very high fever) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399105, 011M20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (Aches), PYREXIA (Very high fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Sore arm), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (Aches), PYREXIA (Very high fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-375328, MOD-2021-375313 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Optic ischaemic neuropathy
Clinical narrative: lose vision in her right eye; ischemic optic neuropathy; This spontaneous case was reported by a nurse and describes the occurrence of OPTIC ISCHAEMIC NEUROPATHY (ischemic optic neuropathy) and BLINDNESS (lose vision in her right eye) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced OPTIC ISCHAEMIC NEUROPATHY (ischemic optic neuropathy) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced BLINDNESS (lose vision in her right eye) (seriousness criteria disability and medically significant). At the time of the report, OPTIC ISCHAEMIC NEUROPATHY (ischemic optic neuropathy) and BLINDNESS (lose vision in her right eye) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. patient had a small bump in the back of her right eye.; Sender's Comments: This case concerns a 66 year old female with no reported medical history who experienced Seirous , Unexpedted event of Optic Ischemic Neuropathy .which occurred 7 months  6 days after the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine)  and Blindness ( lost of viison of the right eye) which occurred on an unknown date , after vaccination with the 2nd dose . The re-challenge for this case is not applicable since the events occurred after the 2nd dose and no additional doses  will be given. The age of the patient is a confounder for this case because age is a factor that can to possible optic ischemic neuropathy ( age above 50 ) . The benefit-risk relationship of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had COVID in September 2021; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (had COVID in September 2021) 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 February 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 September 2021, the patient experienced COVID-19 (had COVID in September 2021). At the time of the report, COVID-19 (had COVID in September 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received antibody treatment around  09Sep2021 .  No concomitant treatment was reported This case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of COVID-19. The event occurred approximately 7 months after the second dose of Moderna COVID-19 vaccine (exact date unknown). The rechallenge was not applicable since the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of COVID-19. The event occurred approximately 7 months after the second dose of Moderna COVID-19 vaccine (exact date unknown). The rechallenge was not applicable since the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient only got half dose as the second dose instead of full dose; 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 (Patient only got half dose as the second dose instead of full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient only got half dose as the second dose instead of full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient only got half dose as the second dose instead of full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: left injection site arm sore for 72 hours; left injection site arm swollen for 72 hours; left injection site arm red for 72 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left injection site arm sore for 72 hours), VACCINATION SITE SWELLING (left injection site arm swollen for 72 hours) and VACCINATION SITE ERYTHEMA (left injection site arm red for 72 hours) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (left injection site arm sore for 72 hours), VACCINATION SITE SWELLING (left injection site arm swollen for 72 hours) and VACCINATION SITE ERYTHEMA (left injection site arm red for 72 hours). On 17-Apr-2021, VACCINATION SITE PAIN (left injection site arm sore for 72 hours), VACCINATION SITE SWELLING (left injection site arm swollen for 72 hours) and VACCINATION SITE ERYTHEMA (left injection site arm red for 72 hours) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had their second dose probably two months later; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had their second dose probably two months later) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had their second dose probably two months later). In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had their second dose probably two months later) had resolved.            Concomitant medications were not reported.  Treatment medications were not reported.   This case was linked to MOD-2021-375343 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little soreness where he had the shot the 3 times he received the shots; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little soreness where he had the shot the 3 times he received the shots) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 VACCINATION SITE PAIN (little soreness where he had the shot the 3 times he received the shots). At the time of the report, VACCINATION SITE PAIN (little soreness where he had the shot the 3 times he received the shots) outcome was unknown.            No concomitant medications or treatment details were reported.   This case was linked to MOD-2021-375356, MOD-2021-375381 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered to 2 patients from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.  The patient received the first dose but the dose was drawn from an expired vial. No side effects were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruise/hit a blood vessel.; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise/hit a blood vessel.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 007MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, VITAMIN C [ASCORBIC ACID] and MULTIVITAMINS;MINERALS for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced CONTUSION (Bruise/hit a blood vessel.). At the time of the report, CONTUSION (Bruise/hit a blood vessel.) outcome was unknown.            Lab data details and Treatment information were not provided.   This case was linked to MOD-2021-375383, MOD-2021-375417 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow-up received on 09-Nov-2021: contains No New Information.