chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: slight itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (slight itchiness) 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 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 07-May-2021, the patient experienced PRURITUS (slight itchiness). At the time of the report, PRURITUS (slight itchiness) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  No relevant concomitant medications were reported. Treatment information was unknown.    Reporter did not allow further contact
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Unexpected beneficial therapeutic response; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Unexpected beneficial therapeutic response) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Obesity, Autism since an unknown date, Psoriasis and Stomach ulcer. Concomitant products included SECUKINUMAB (COSENTYX) for Psoriasis, TRAZODONE for Sleep disorder, SUCRALFATE for Stomach ulcer, Flintstones vitamin for Vitamin supplementation, NALTREXONE for Weight loss, PANTOPRAZOLE for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Unexpected beneficial therapeutic response). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Unexpected beneficial therapeutic response) outcome was unknown. Not Provided          The patient 'is kind of coming out from autism and psoriasis and stomach ulcers have calmed down to nothing.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant and received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received vaccine) 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 10-May-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. Last menstrual period and estimated date of delivery were not provided. In April 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received vaccine). On 10-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received vaccine) had resolved. Not Provided          On april-2021 patient had received first dose and on 10-MAY-2021 received second dose and denied for further follow up. No concomitant and treatment information is provided. Pregnancy information also not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Headache, Miliaria, Posture abnormal
Clinical narrative: Severe Headache; Dehyrdration; Really dizzy; Could not sit upright; Heat Rush; This spontaneous case was reported by a consumer and describes the occurrence of MILIARIA (Heat Rush), DEHYDRATION (Dehyrdration), DIZZINESS (Really dizzy), POSTURE ABNORMAL (Could not sit upright) and HEADACHE (Severe Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MILIARIA (Heat Rush). On 07-May-2021, the patient experienced DEHYDRATION (Dehyrdration), DIZZINESS (Really dizzy) and POSTURE ABNORMAL (Could not sit upright). On an unknown date, the patient experienced HEADACHE (Severe Headache). On 06-May-2021, MILIARIA (Heat Rush) had resolved. At the time of the report, DEHYDRATION (Dehyrdration), DIZZINESS (Really dizzy) and POSTURE ABNORMAL (Could not sit upright) outcome was unknown and HEADACHE (Severe Headache) had not resolved. Not Provided          Concomitant product use was not provided. Treatment information included Tylenol for headache. Action taken with mRNA-1273 in response to the events was  not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Rash, Vaccination site reaction
Clinical narrative: Local reaction; Rash; Chills; Headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Local reaction), RASH (Rash), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE REACTION (Local reaction), RASH (Rash), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (sore arm). On 11-Jan-2021, CHILLS (Chills) and HEADACHE (Headache) had resolved. On 17-Jan-2021, VACCINATION SITE REACTION (Local reaction), RASH (Rash) and MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-116965 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: Cold/Felt frozen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-May-2021 and was forwarded to Moderna on 10-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold/Felt frozen) 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) (Intramuscular) 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 FEELING COLD (Cold/Felt frozen). At the time of the report, FEELING COLD (Cold/Felt frozen) had resolved.            Treatment medication not provided.  Concomitant medication not provided. Action taken with mRNA-1273 in response to the drug was not applicable.   This case was linked to MOD-2021-051499 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination site reaction
Clinical narrative: Injection site skin marks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Injection site skin marks) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis, Hypertension and Alcohol use. Concomitant products included LOSARTAN and HYDRALAZINE for Blood pressure high.   In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE REACTION (Injection site skin marks). At the time of the report, VACCINATION SITE REACTION (Injection site skin marks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 19 Feb 2021, patient received, second dose of mRNA1273. Treatment information was not provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Child is coming out of autism and calmed down of stomach problems and stomach ulcers; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Child is coming out of autism and calmed down of stomach problems and stomach ulcers) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autism (severely autistic), Overweight (300 pounds weight), Psoriasis and Stomach ulcer (and stomach problems). Concomitant products included SECUKINUMAB (COSENTYX) for Psoriasis, TRAZODONE for Sleep disorder NOS, SUCRALFATE for Stomach ulcer, VITAMINS NOS (FLINTSTONES MULTIPLE VITAMINS [VITAMINS NOS]) for Vitamin supplementation, NALTREXONE for Weight loss, PANTOPRAZOLE for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Child is coming out of autism and calmed down of stomach problems and stomach ulcers). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Child is coming out of autism and calmed down of stomach problems and stomach ulcers) outcome was unknown. Not Provided          Reporter mentioned that her son after 3 weeks of receiving first dose of Moderna covid-19 vaccine, good things happening with his autism. She mentioned that her son is coming out of severely autistic signs after receiving the first dose of covid-19 Moderna vaccine. She added that her son is focusing more and making more progress and has had hardly any speech and just started speaking, able to use bathroom independently and can now wipe self.  Reporter mentioned that her son had history of stomach problems and stomach ulcers, which have calmed down to nothing.  Action taken with mRNA-1273 with respect to events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pneumococcal immunisation
Clinical narrative: pneumococcal vaccine given 18 days after getting the 2nd dose of the Moderna covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMOCOCCAL IMMUNISATION (pneumococcal vaccine given 18 days after getting the 2nd dose of the Moderna covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 22-Apr-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 10-May-2021, the patient experienced PNEUMOCOCCAL IMMUNISATION (pneumococcal vaccine given 18 days after getting the 2nd dose of the Moderna covid-19 vaccine). At the time of the report, PNEUMOCOCCAL IMMUNISATION (pneumococcal vaccine given 18 days after getting the 2nd dose of the Moderna covid-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided Action taken with mRNA-1273 in response to the events were Not Applicable
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Therapeutic response unexpected
Clinical narrative: left ankle is only a little stiff; unexpected therapeutic benefit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (unexpected therapeutic benefit) and JOINT STIFFNESS (left ankle is only a little stiff) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included Psoriatic arthritis. Concurrent medical conditions included Penicillin allergy (penicillin and all derivatives) and Drug allergy (Bactrim, Zovirax).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (unexpected therapeutic benefit). On an unknown date, the patient experienced JOINT STIFFNESS (left ankle is only a little stiff). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (unexpected therapeutic benefit) and JOINT STIFFNESS (left ankle is only a little stiff) outcome was unknown. Not Provided.          Patient stated that it was after the second dose that symptoms seemed to have gotten better. Prior to, patient reports feeling like going crazy with the psoriatic burns, itching, and pain. Patient states that knees would swell up and it would hurt in eyes. Patient reports the symptoms were intolerable and could not help. Patient wants to report that skin was clearing up and left ankle which used to hurt to bend now was only a little stiff.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Illness
Clinical narrative: second dose side effects were worse; Mild symptoms after the first dose; 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 ADVERSE EVENT (second dose side effects were worse) and ILLNESS (Mild symptoms after the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (second dose side effects were worse) and ILLNESS (Mild symptoms after the first dose). At the time of the report, ADVERSE EVENT (second dose side effects were worse) and ILLNESS (Mild symptoms after the first dose) outcome was unknown. Not Provided          No Concomitant medication No treatment medication  The action taken with the product was not applicable   This case was linked to MOD-2021-116461 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling hot, Nausea, Pruritus, Rash erythematous
Clinical narrative: It is became itchy; Mild Nausea; Strange painful stomach ache; Slightly raised rash; Long red rash; Hot to touch rash; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Strange painful stomach ache), RASH PAPULAR (Slightly raised rash), RASH ERYTHEMATOUS (Long red rash), FEELING HOT (Hot to touch rash) and PRURITUS (It is became itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Strange painful stomach ache), RASH PAPULAR (Slightly raised rash), RASH ERYTHEMATOUS (Long red rash), FEELING HOT (Hot to touch rash) and NAUSEA (Mild Nausea). On 28-Apr-2021, the patient experienced PRURITUS (It is became itchy). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at a dose of 400 milligram; LIDOCAINE for Itch, at a dose of 12 %; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Stomach pain, at a dose of 400 milligram. At the time of the report, ABDOMINAL PAIN UPPER (Strange painful stomach ache), RASH PAPULAR (Slightly raised rash), RASH ERYTHEMATOUS (Long red rash), FEELING HOT (Hot to touch rash) and NAUSEA (Mild Nausea) outcome was unknown and PRURITUS (It is became itchy) had not resolved.            Concomitant product information was not provided by the reporter. Treatment information includes Diphenhydramine.
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: It is became itchy; Mild Nausea; Strange painful stomach ache; Slightly raised rash; Long red rash; Hot to touch rash; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Strange painful stomach ache), RASH PAPULAR (Slightly raised rash), RASH ERYTHEMATOUS (Long red rash), FEELING HOT (Hot to touch rash) and PRURITUS (It is became itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Strange painful stomach ache), RASH PAPULAR (Slightly raised rash), RASH ERYTHEMATOUS (Long red rash), FEELING HOT (Hot to touch rash) and NAUSEA (Mild Nausea). On 28-Apr-2021, the patient experienced PRURITUS (It is became itchy). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at a dose of 400 milligram; LIDOCAINE for Itch, at a dose of 12 %; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Stomach pain, at a dose of 400 milligram. At the time of the report, ABDOMINAL PAIN UPPER (Strange painful stomach ache), RASH PAPULAR (Slightly raised rash), RASH ERYTHEMATOUS (Long red rash), FEELING HOT (Hot to touch rash) and NAUSEA (Mild Nausea) outcome was unknown and PRURITUS (It is became itchy) had not resolved.            Concomitant product information was not provided by the reporter. Treatment information includes Diphenhydramine.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 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. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Fatigue, Headache, Influenza like illness
Clinical narrative: nausea; cold sweats; fatigue; flu like symptoms; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). On 13-Feb-2021, the patient experienced FATIGUE (fatigue), INFLUENZA LIKE ILLNESS (flu like symptoms) and COLD SWEAT (cold sweats). On an unknown date, the patient experienced NAUSEA (nausea). On 11-Jan-2021, CHILLS (chills) and HEADACHE (headache) had resolved. On 18-Feb-2021, FATIGUE (fatigue), INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (nausea) and COLD SWEAT (cold sweats) had resolved. Not Provided          No concomitant medications were reported.  No treatment medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; cold sweats; fatigue; flu like symptoms; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), FATIGUE (fatigue), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). On 13-Feb-2021, the patient experienced FATIGUE (fatigue), INFLUENZA LIKE ILLNESS (flu like symptoms) and COLD SWEAT (cold sweats). On an unknown date, the patient experienced NAUSEA (nausea). On 11-Jan-2021, CHILLS (chills) and HEADACHE (headache) had resolved. On 18-Feb-2021, FATIGUE (fatigue), INFLUENZA LIKE ILLNESS (flu like symptoms), NAUSEA (nausea) and COLD SWEAT (cold sweats) had resolved. Not Provided          No concomitant medications were reported.  No treatment medications were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Electric shock sensation, Headache, Influenza like illness, Injection site pain
Clinical narrative: Sharp electric shooting pains (left side/brain); Flue like symptoms; Feelings of blockage that sends semi-sharp pain to left shoulder; Brain surges/headache; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ELECTRIC SHOCK SENSATION (Sharp electric shooting pains (left side/brain)), INFLUENZA LIKE ILLNESS (Flue like symptoms), ARTHRALGIA (Feelings of blockage that sends semi-sharp pain to left shoulder), HEADACHE (Brain surges/headache) and INJECTION SITE PAIN (Soreness at the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A21A) for an unknown indication.     The patient's past medical history included Osteoarthritis in 1990. Previously administered products included for an unreported indication: METHYLPREDNISOLONE (methylprednisolone 40mg right knee joint.) on 26-Mar-2021.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-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 ELECTRIC SHOCK SENSATION (Sharp electric shooting pains (left side/brain)), INFLUENZA LIKE ILLNESS (Flue like symptoms), ARTHRALGIA (Feelings of blockage that sends semi-sharp pain to left shoulder), HEADACHE (Brain surges/headache) and INJECTION SITE PAIN (Soreness at the injection site). On 29-Apr-2021, ELECTRIC SHOCK SENSATION (Sharp electric shooting pains (left side/brain)) had resolved, INFLUENZA LIKE ILLNESS (Flue like symptoms) and ARTHRALGIA (Feelings of blockage that sends semi-sharp pain to left shoulder) outcome was unknown. At the time of the report, HEADACHE (Brain surges/headache) and INJECTION SITE PAIN (Soreness at the injection site) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable Hospital cardiology testing results showed: __ LBBB (left branch bundle blockage). __ Blunted systolic BP response to exercise (treadmill & nuclear-drug induced).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Achiness over body; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Achiness over body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient experienced MYALGIA (Achiness over body). At the time of the report, MYALGIA (Achiness over body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Frustration tolerance decreased, Impaired work ability, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping day and night ,I have been sleeping more , have been sleeping both afternoon and night), FEELING COLD (Feeling cold), PAIN IN EXTREMITY (Arm hurt / sore arm), FRUSTRATION TOLERANCE DECREASED (Frustrated) and IMPAIRED WORK ABILITY (can't function) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003CZ1A or 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for Blood pressure, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN), SERTRALINE and CLONAZEPAM (KLONOPIN) for Depression, METFORMIN for Diabetes, SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced SOMNOLENCE (Sleeping day and night ,I have been sleeping more , have been sleeping both afternoon and night), FEELING COLD (Feeling cold), PAIN IN EXTREMITY (Arm hurt / sore arm), FRUSTRATION TOLERANCE DECREASED (Frustrated) and IMPAIRED WORK ABILITY (can't function). On 28-May-2021, the patient experienced FATIGUE (I have extreme fatigue for 3 weeks). At the time of the report, SOMNOLENCE (Sleeping day and night ,I have been sleeping more , have been sleeping both afternoon and night), FEELING COLD (Feeling cold) and FRUSTRATION TOLERANCE DECREASED (Frustrated) outcome was unknown and PAIN IN EXTREMITY (Arm hurt / sore arm), IMPAIRED WORK ABILITY (can't function) and FATIGUE (I have extreme fatigue for 3 weeks) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-201744 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Concomitant medication added. Event extreme fatigued added
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping day and night ,I have been sleeping more , have been sleeping both afternoon and night), FEELING COLD (Feeling cold), PAIN IN EXTREMITY (Arm hurt / sore arm), FRUSTRATION TOLERANCE DECREASED (Frustrated) and IMPAIRED WORK ABILITY (can't function) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003CZ1A or 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for Blood pressure, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN), SERTRALINE and CLONAZEPAM (KLONOPIN) for Depression, METFORMIN for Diabetes, SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced SOMNOLENCE (Sleeping day and night ,I have been sleeping more , have been sleeping both afternoon and night), FEELING COLD (Feeling cold), PAIN IN EXTREMITY (Arm hurt / sore arm), FRUSTRATION TOLERANCE DECREASED (Frustrated) and IMPAIRED WORK ABILITY (can't function). On 28-May-2021, the patient experienced FATIGUE (I have extreme fatigue for 3 weeks). At the time of the report, SOMNOLENCE (Sleeping day and night ,I have been sleeping more , have been sleeping both afternoon and night), FEELING COLD (Feeling cold) and FRUSTRATION TOLERANCE DECREASED (Frustrated) outcome was unknown and PAIN IN EXTREMITY (Arm hurt / sore arm), IMPAIRED WORK ABILITY (can't function) and FATIGUE (I have extreme fatigue for 3 weeks) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-201744 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Concomitant medication added. Event extreme fatigued added
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria
Clinical narrative: red welt left arm; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red welt left arm) and PAIN IN EXTREMITY (sore left arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia since 1977, Drug allergy (sulfa drugs), Bee sting, Drug allergy (dilaudid), Allergic reaction to antibiotics (erythromycin), Allergic reaction to antibiotics (tobramycin), Prehypertension since 2001, High cholesterol and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), LISINOPRIL for Blood pressure management, CEFIXIME (FLEXERIL [CEFIXIME]) for Fibromyalgia, LOVASTATIN for High cholesterol, CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE WITH VITAMIN D3) for Osteoporosis, UBIDECARENONE (COQ 10) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced URTICARIA (red welt left arm) and PAIN IN EXTREMITY (sore left arm). The patient was treated with Manual therapy (Iced left arm) for Urticaria and Manual therapy (Iced left arm) for Pain in extremity. On 16-Feb-2021, URTICARIA (red welt left arm) and PAIN IN EXTREMITY (sore left arm) 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.   No treatment medications were reported.   This case was linked to MOD-2021-046218 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow information included Medical history.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Lethargy, Myalgia
Clinical narrative: Lethargic; Mild flu like symptoms; Chills; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), INFLUENZA LIKE ILLNESS (Mild flu like symptoms), CHILLS (Chills) and MYALGIA (Muscle aches) 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 LETHARGY (Lethargic), INFLUENZA LIKE ILLNESS (Mild flu like symptoms), CHILLS (Chills) and MYALGIA (Muscle aches). At the time of the report, LETHARGY (Lethargic), CHILLS (Chills) and MYALGIA (Muscle aches) had resolved and INFLUENZA LIKE ILLNESS (Mild flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The treatment information was unknown.   This case was linked to MOD-2021-079689 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional information received from Pfizer for this first dose. On 28-May-2021: Follow up received on 28-MAY-2021 and added AE.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Heart rate, Lymphadenopathy
Clinical narrative: could not move her arm; Back ache; Bad chill; Fever; Headache; Nausea; lymph node is swollen and painful/could not move her arm; Bad body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her arm), BACK PAIN (Back ache), MYALGIA (Bad body ache), CHILLS (Bad chill) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concomitant products included LORATADINE (CLARITIN [LORATADINE]), GABAPENTIN and PRAVASTATIN for an unknown indication.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced MYALGIA (Bad body ache). On 09-May-2021, the patient experienced BACK PAIN (Back ache), CHILLS (Bad chill), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and LYMPHADENOPATHY (lymph node is swollen and painful/could not move her arm). On 10-May-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her arm), BACK PAIN (Back ache), MYALGIA (Bad body ache), CHILLS (Bad chill), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and LYMPHADENOPATHY (lymph node is swollen and painful/could not move her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 110 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Advil as treatment medication for the reported events and feels better.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site movement impairment
Clinical narrative: could not move her arm; Back ache; Bad chill; Fever; Headache; Nausea; lymph node is swollen and painful/could not move her arm; Bad body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her arm), BACK PAIN (Back ache), MYALGIA (Bad body ache), CHILLS (Bad chill) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concomitant products included LORATADINE (CLARITIN [LORATADINE]), GABAPENTIN and PRAVASTATIN for an unknown indication.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced MYALGIA (Bad body ache). On 09-May-2021, the patient experienced BACK PAIN (Back ache), CHILLS (Bad chill), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and LYMPHADENOPATHY (lymph node is swollen and painful/could not move her arm). On 10-May-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (could not move her arm), BACK PAIN (Back ache), MYALGIA (Bad body ache), CHILLS (Bad chill), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and LYMPHADENOPATHY (lymph node is swollen and painful/could not move her arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 110 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Advil as treatment medication for the reported events and feels better.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue
Clinical narrative: was supposed to get the second dose on Apr272021/missed on it; wasn't feeling well; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (was supposed to get the second dose on Apr272021/missed on it) and MALAISE (wasn't feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (was supposed to get the second dose on Apr272021/missed on it) and MALAISE (wasn't feeling well). At the time of the report, PRODUCT DOSE OMISSION ISSUE (was supposed to get the second dose on Apr272021/missed on it) had resolved and MALAISE (wasn't feeling well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: felt hot for a day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt hot for a day) in an adult male 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 FEELING HOT (felt hot for a day). At the time of the report, FEELING HOT (felt hot for a day) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-054593 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Myalgia, Pain in extremity
Clinical narrative: don't feel good; legs hurting very bad; Headache; wrists sores and hurts; whole body hurting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (don't feel good), PAIN IN EXTREMITY (legs hurting very bad), HEADACHE (Headache), ARTHRALGIA (wrists sores and hurts) and MYALGIA (whole body hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 03-May-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 03-May-2021, the patient experienced FEELING ABNORMAL (don't feel good), PAIN IN EXTREMITY (legs hurting very bad), HEADACHE (Headache), ARTHRALGIA (wrists sores and hurts) and MYALGIA (whole body hurting). At the time of the report, FEELING ABNORMAL (don't feel good), PAIN IN EXTREMITY (legs hurting very bad), HEADACHE (Headache), ARTHRALGIA (wrists sores and hurts) and MYALGIA (whole body hurting) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Urine analysis: abnormal (abnormal) Pee-pee is not good.         Concomitant medications included blood pressure medications  Action taken with mRNA-1273 in response to the events was not applicable.  No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD-2021-074896.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Bump on top of the butt; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Bump on top of the butt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Bump on top of the butt). At the time of the report, SWELLING (Bump on top of the butt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Vaccination site pain, Vertigo
Clinical narrative: Vertigo (now resolved); Vomiting (now resolved); Vaccine Arm" site of injection very painful; Dizziness; Nausea (still persists); Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo (now resolved)), DIZZINESS (Dizziness), NAUSEA (Nausea (still persists)), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccine Arm" site of injection very painful) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nausea (still persists)) and FATIGUE (Tiredness). On 05-May-2021, the patient experienced VACCINATION SITE PAIN (Vaccine Arm" site of injection very painful). On 10-May-2021, the patient experienced VERTIGO (Vertigo (now resolved)) and VOMITING (Vomiting (now resolved)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 02-May-2021, DIZZINESS (Dizziness) and FATIGUE (Tiredness) had resolved. On 10-May-2021, VERTIGO (Vertigo (now resolved)) and VOMITING (Vomiting (now resolved)) had resolved. At the time of the report, NAUSEA (Nausea (still persists)) had not resolved and VACCINATION SITE PAIN (Vaccine Arm" site of injection very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vertigo (now resolved); Vomiting (now resolved); Vaccine Arm" site of injection very painful; Dizziness; Nausea (still persists); Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo (now resolved)), DIZZINESS (Dizziness), NAUSEA (Nausea (still persists)), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccine Arm" site of injection very painful) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nausea (still persists)) and FATIGUE (Tiredness). On 05-May-2021, the patient experienced VACCINATION SITE PAIN (Vaccine Arm" site of injection very painful). On 10-May-2021, the patient experienced VERTIGO (Vertigo (now resolved)) and VOMITING (Vomiting (now resolved)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 02-May-2021, DIZZINESS (Dizziness) and FATIGUE (Tiredness) had resolved. On 10-May-2021, VERTIGO (Vertigo (now resolved)) and VOMITING (Vomiting (now resolved)) had resolved. At the time of the report, NAUSEA (Nausea (still persists)) had not resolved and VACCINATION SITE PAIN (Vaccine Arm" site of injection very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.