chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Very confused 2 days after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Very confused 2 days after 2nd dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CONFUSIONAL STATE (Very confused 2 days after 2nd dose). At the time of the report, CONFUSIONAL STATE (Very confused 2 days after 2nd dose) outcome was unknown.            Patient doesn't remember doing certain things like going to bed, getting up, swimming or driving. Patient was still confused.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vomiting
Clinical narrative: Vomiting; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and FATIGUE (extreme fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VOMITING (Vomiting) and FATIGUE (extreme fatigue). At the time of the report, VOMITING (Vomiting) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: itching at the injection site; rash at the injection site; redness at the injection site of a size of a clementine; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE RASH (rash at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site of a size of a clementine) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), FAMOTIDINE (PEPCID [FAMOTIDINE]), VITAMIN D NOS and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE RASH (rash at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site of a size of a clementine). At the time of the report, INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE RASH (rash at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site of a size of a clementine) outcome was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: pain in the muscle; headache; fatigue; nausea; fever; little vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the muscle), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (nausea) and PYREXIA (fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced MYALGIA (pain in the muscle), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (fever) and VOMITING (little vomiting). On 07-Mar-2021, MYALGIA (pain in the muscle), FATIGUE (fatigue), PYREXIA (fever) and VOMITING (little vomiting) had resolved. At the time of the report, HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: pain in the muscle; headache; fatigue; nausea; fever; little vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in the muscle), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (nausea) and PYREXIA (fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced MYALGIA (pain in the muscle), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (nausea), PYREXIA (fever) and VOMITING (little vomiting). On 07-Mar-2021, MYALGIA (pain in the muscle), FATIGUE (fatigue), PYREXIA (fever) and VOMITING (little vomiting) had resolved. At the time of the report, HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: bad chemical taste on their mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (bad chemical taste on their mouth) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DYSGEUSIA (bad chemical taste on their mouth). At the time of the report, DYSGEUSIA (bad chemical taste on their mouth) had resolved. Not Provided      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 medication reported was thyroid medicine
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: feeling nauseous; having diarrhea; running fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAUSEA (feeling nauseous), DIARRHOEA (having diarrhea) and PYREXIA (running fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included PREGABALIN (LYRICA), OMEPRAZOLE, DULOXETINE HYDROCHLORIDE (CYMBALTA) and CELECOXIB (CELEBREX) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced NAUSEA (feeling nauseous), DIARRHOEA (having diarrhea) and PYREXIA (running fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ONDANSETRON at an unspecified dose and frequency and DICYCLOMINE HYDROCHLORIDE at an unspecified dose and frequency. At the time of the report, NAUSEA (feeling nauseous), DIARRHOEA (having diarrhea) and PYREXIA (running fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: morning blood sugar started creeping up; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (morning blood sugar started creeping up) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN, GLYBURIDE and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (morning blood sugar started creeping up). At the time of the report, BLOOD GLUCOSE INCREASED (morning blood sugar started creeping up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was unknown   This case was linked to MOD-2021-035990, MOD-2021-059395 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Fatigue, Myalgia, Urinary tract infection
Clinical narrative: blood sugar dropped; UTI; Sore arm; extreme fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of MYALGIA (Sore arm), the second episode of MYALGIA (Sore arm), BLOOD GLUCOSE DECREASED (blood sugar dropped), FATIGUE (extreme fatigue) and URINARY TRACT INFECTION (UTI) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced the first episode of MYALGIA (Sore arm). On 01-Feb-2021, the patient experienced the second episode of MYALGIA (Sore arm), BLOOD GLUCOSE DECREASED (blood sugar dropped), FATIGUE (extreme fatigue) and URINARY TRACT INFECTION (UTI). At the time of the report, BLOOD GLUCOSE DECREASED (blood sugar dropped), FATIGUE (extreme fatigue) and URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-036316 (Linked Report). This case was linked to MOD-2021-035704 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-036316:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling of body temperature change, Gastrointestinal sounds abnormal, Influenza like illness
Clinical narrative: He feels like he has flu, chills then not and cold in bed; hot and cold in bed; stomach is gurglin; he feels off; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (He feels like he has flu, chills then not and cold in bed), CHILLS (chills), FEELING OF BODY TEMPERATURE CHANGE (hot and cold in bed), GASTROINTESTINAL SOUNDS ABNORMAL (stomach is gurglin) and FEELING ABNORMAL (he feels off) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (He feels like he has flu, chills then not and cold in bed), CHILLS (chills), FEELING OF BODY TEMPERATURE CHANGE (hot and cold in bed), GASTROINTESTINAL SOUNDS ABNORMAL (stomach is gurglin) and FEELING ABNORMAL (he feels off). At the time of the report, INFLUENZA LIKE ILLNESS (He feels like he has flu, chills then not and cold in bed) outcome was unknown.            This case was linked to MOD-2021-036261 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Pruritus, Pyrexia
Clinical narrative: lump red; warm, hot; itchy; fever; big red mark at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (big red mark at the injection site), INJECTION SITE MASS (lump red), FEELING HOT (warm, hot), PRURITUS (itchy) and PYREXIA (fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, IBUPROFEN, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), LURASIDONE HYDROCHLORIDE (LATUDA), OMEPRAZOLE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA 24 HOUR) and BUPROPION for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (big red mark at the injection site). On an unknown date, the patient experienced INJECTION SITE MASS (lump red), FEELING HOT (warm, hot), PRURITUS (itchy) and PYREXIA (fever). At the time of the report, INJECTION SITE ERYTHEMA (big red mark at the injection site) had not resolved and INJECTION SITE MASS (lump red), FEELING HOT (warm, hot), PRURITUS (itchy) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medication was Ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Coronavirus test, Fatigue, Pain
Clinical narrative: a little tired; Tested positive for COVID-19; Both legs started hurting; Her whole body was hurting; Felt pain in middle and lower back; Aches and pains, both arms hurt bad; Arm was a little sore; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, legs started hurting(pain in extremity), middle and lower back pain, whole body was hurting, a little tired(fatigue) COVID-19 infection.  The patient's medical history was not provided. No relevant concomitant medications were reported. The lab data information included test for COVID-19 with result positive. On 24 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced the event arm was a little sore . On 27 Feb 2021, the patient experienced the event(s) aches and pains in both arms and felt like arms were going to fall off because they hurt so bad. On 1 Mar 2021, the patient experienced the event legs started hurting, middle and lower back pain, whole body was hurting. The patient reported to have tested positive for COVID-19 on 1 Mar 2021. On 5 Mar 2021, the patient reported that she was a little tired.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events arm little sore, aches and pains in both arms, legs started hurting, middle and lower back pain, whole body was hurting, a little tired was unknown on 5 Mar 2021.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little tired; Tested positive for COVID-19; Both legs started hurting; Her whole body was hurting; Felt pain in middle and lower back; Aches and pains, both arms hurt bad; Arm was a little sore; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, legs started hurting(pain in extremity), middle and lower back pain, whole body was hurting, a little tired(fatigue) COVID-19 infection.  The patient's medical history was not provided. No relevant concomitant medications were reported. The lab data information included test for COVID-19 with result positive. On 24 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced the event arm was a little sore . On 27 Feb 2021, the patient experienced the event(s) aches and pains in both arms and felt like arms were going to fall off because they hurt so bad. On 1 Mar 2021, the patient experienced the event legs started hurting, middle and lower back pain, whole body was hurting. The patient reported to have tested positive for COVID-19 on 1 Mar 2021. On 5 Mar 2021, the patient reported that she was a little tired.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events arm little sore, aches and pains in both arms, legs started hurting, middle and lower back pain, whole body was hurting, a little tired was unknown on 5 Mar 2021.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Cheeks were red; Cheeks were itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Cheeks were red) and PRURITUS (Cheeks were itchy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-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 05-Mar-2021, the patient experienced ERYTHEMA (Cheeks were red) and PRURITUS (Cheeks were itchy). At the time of the report, ERYTHEMA (Cheeks were red) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Hypokinesia, Myalgia
Clinical narrative: severe bone pain; cannot move; muscle pain; This spontaneous case was reported by a health care professional and describes the occurrence of BONE PAIN (severe bone pain), HYPOKINESIA (cannot move) and MYALGIA (muscle pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, METOPROLOL TARTRATE, APIXABAN (ELIQUIS), ROSUVASTATIN and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced BONE PAIN (severe bone pain), HYPOKINESIA (cannot move) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and tramadol for Pain, at an unspecified dose and frequency. At the time of the report, BONE PAIN (severe bone pain), HYPOKINESIA (cannot move) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropod bite, Erythema, Pruritus, Swelling
Clinical narrative: Insect Bite Type Reaction; red; itchy; Swollen; This spontaneous case was reported by a physician and describes the occurrence of ARTHROPOD BITE (Insect Bite Type Reaction), ERYTHEMA (red), PRURITUS (itchy) and SWELLING (Swollen) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included PREDNISONE for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHROPOD BITE (Insect Bite Type Reaction), ERYTHEMA (red), PRURITUS (itchy) and SWELLING (Swollen). At the time of the report, ARTHROPOD BITE (Insect Bite Type Reaction), ERYTHEMA (red), PRURITUS (itchy) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient used unspecified vitamins as concomitant medications.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: dizzy; headache; nausea; vomiting; diarrhea; tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), DIZZINESS (dizzy), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) mRNA-1273. On 23-Feb-2021, the patient experienced FATIGUE (tired). On 01-Mar-2021, the patient experienced DIZZINESS (dizzy), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea). On 28-Feb-2021, FATIGUE (tired) outcome was unknown. On 01-Mar-2021, HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea) outcome was unknown. On 03-Mar-2021, DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes Tylenol
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: dizzy; headache; nausea; vomiting; diarrhea; tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), DIZZINESS (dizzy), HEADACHE (headache), NAUSEA (nausea) and VOMITING (vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) mRNA-1273. On 23-Feb-2021, the patient experienced FATIGUE (tired). On 01-Mar-2021, the patient experienced DIZZINESS (dizzy), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea). On 28-Feb-2021, FATIGUE (tired) outcome was unknown. On 01-Mar-2021, HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and DIARRHOEA (diarrhea) outcome was unknown. On 03-Mar-2021, DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes Tylenol
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: shingles; itchy rash at the injection site; blotchy red rash; itchy rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), VACCINATION SITE PRURITUS (itchy rash at the injection site), VACCINATION SITE ERYTHEMA (blotchy red rash) and VACCINATION SITE RASH (itchy rash at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PRURITUS (itchy rash at the injection site), VACCINATION SITE ERYTHEMA (blotchy red rash) and VACCINATION SITE RASH (itchy rash at the injection site). On 23-Feb-2021, the patient experienced HERPES ZOSTER (shingles). The patient was treated with FAMCICLOVIR at an unspecified dose and frequency. In February 2021, VACCINATION SITE ERYTHEMA (blotchy red rash) and VACCINATION SITE RASH (itchy rash at the injection site) outcome was unknown. On 03-Mar-2021, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The relevant concomitant medications use were not reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: incredibly sick for almost a week; had COVID all over again; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (incredibly sick for almost a week) and COVID-19 (had COVID all over again) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (incredibly sick for almost a week) and COVID-19 (had COVID all over again). At the time of the report, ILLNESS (incredibly sick for almost a week) and COVID-19 (had COVID all over again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not reported.  Treatment medication not reported.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Dysphagia, Dyspnoea, Eating disorder symptom, Oropharyngeal pain
Clinical narrative: Difficulty breathing; Difficult time swallow; Difficult time talking; Difficulty eating; Sore; Sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Difficulty breathing), EATING DISORDER SYMPTOM (Difficulty eating), DYSPHAGIA (Difficult time swallow) and APHASIA (Difficult time talking) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney disorder (Kidney disease requiring dialysis) and Dialysis.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). 26-Feb-2021, the patient experienced PAIN (Sore). On 27-Feb-2021, the patient experienced EATING DISORDER SYMPTOM (Difficulty eating). On 28-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), DYSPHAGIA (Difficult time swallow) and APHASIA (Difficult time talking). The patient was treated with CEFUROXIME AXETIL for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Difficulty breathing), EATING DISORDER SYMPTOM (Difficulty eating), DYSPHAGIA (Difficult time swallow), APHASIA (Difficult time talking) and PAIN (Sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Difficulty breathing; Difficult time swallow; Difficult time talking; Difficulty eating; Sore; Sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Difficulty breathing), EATING DISORDER SYMPTOM (Difficulty eating), DYSPHAGIA (Difficult time swallow) and APHASIA (Difficult time talking) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney disorder (Kidney disease requiring dialysis) and Dialysis.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). 26-Feb-2021, the patient experienced PAIN (Sore). On 27-Feb-2021, the patient experienced EATING DISORDER SYMPTOM (Difficulty eating). On 28-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), DYSPHAGIA (Difficult time swallow) and APHASIA (Difficult time talking). The patient was treated with CEFUROXIME AXETIL for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Difficulty breathing), EATING DISORDER SYMPTOM (Difficulty eating), DYSPHAGIA (Difficult time swallow), APHASIA (Difficult time talking) and PAIN (Sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Injection site swelling
Clinical narrative: Very sick from it; arm soreness; headache; fever; rash; chills; tired; swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick from it), PAIN IN EXTREMITY (arm soreness), HEADACHE (headache), PYREXIA (fever) and RASH (rash) in a 68-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 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ILLNESS (Very sick from it), PAIN IN EXTREMITY (arm soreness), HEADACHE (headache), PYREXIA (fever), RASH (rash), CHILLS (chills), FATIGUE (tired) and INJECTION SITE SWELLING (swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, PYREXIA (fever) and RASH (rash) had resolved. At the time of the report, ILLNESS (Very sick from it), PAIN IN EXTREMITY (arm soreness), HEADACHE (headache), CHILLS (chills), FATIGUE (tired) and INJECTION SITE SWELLING (swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter  treatment information was not provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: Very sick from it; arm soreness; headache; fever; rash; chills; tired; swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick from it), PAIN IN EXTREMITY (arm soreness), HEADACHE (headache), PYREXIA (fever) and RASH (rash) in a 68-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 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ILLNESS (Very sick from it), PAIN IN EXTREMITY (arm soreness), HEADACHE (headache), PYREXIA (fever), RASH (rash), CHILLS (chills), FATIGUE (tired) and INJECTION SITE SWELLING (swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, PYREXIA (fever) and RASH (rash) had resolved. At the time of the report, ILLNESS (Very sick from it), PAIN IN EXTREMITY (arm soreness), HEADACHE (headache), CHILLS (chills), FATIGUE (tired) and INJECTION SITE SWELLING (swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter  treatment information was not provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Chest pain, Discomfort, Feeling abnormal
Clinical narrative: crappy feeling; The middle of their body hurts; everything hurt; pain in their chest; pain in their lower abdomen; pain in their chest lower back; middle of their body hurts; had a lot of gas; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (everything hurt), CHEST PAIN (pain in their chest), ABDOMINAL PAIN (pain in their lower abdomen), BACK PAIN (pain in their chest lower back) and DISCOMFORT (middle of their body hurts) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DISCOMFORT (everything hurt), CHEST PAIN (pain in their chest), ABDOMINAL PAIN (pain in their lower abdomen), BACK PAIN (pain in their chest lower back), DISCOMFORT (middle of their body hurts), FLATULENCE (had a lot of gas) and PAIN (The middle of their body hurts). On an unknown date, the patient experienced FEELING ABNORMAL (crappy feeling). The patient was treated with PARACETAMOL (TYLENOL) for Prophylaxis, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Prophylaxis, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (everything hurt), CHEST PAIN (pain in their chest), ABDOMINAL PAIN (pain in their lower abdomen), BACK PAIN (pain in their chest lower back), DISCOMFORT (middle of their body hurts), FLATULENCE (had a lot of gas), FEELING ABNORMAL (crappy feeling) and PAIN (The middle of their body hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported were levothyroxine Treatment details included Tylenol and Advil   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Pain
Clinical narrative: crappy feeling; The middle of their body hurts; everything hurt; pain in their chest; pain in their lower abdomen; pain in their chest lower back; middle of their body hurts; had a lot of gas; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (everything hurt), CHEST PAIN (pain in their chest), ABDOMINAL PAIN (pain in their lower abdomen), BACK PAIN (pain in their chest lower back) and DISCOMFORT (middle of their body hurts) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DISCOMFORT (everything hurt), CHEST PAIN (pain in their chest), ABDOMINAL PAIN (pain in their lower abdomen), BACK PAIN (pain in their chest lower back), DISCOMFORT (middle of their body hurts), FLATULENCE (had a lot of gas) and PAIN (The middle of their body hurts). On an unknown date, the patient experienced FEELING ABNORMAL (crappy feeling). The patient was treated with PARACETAMOL (TYLENOL) for Prophylaxis, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Prophylaxis, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (everything hurt), CHEST PAIN (pain in their chest), ABDOMINAL PAIN (pain in their lower abdomen), BACK PAIN (pain in their chest lower back), DISCOMFORT (middle of their body hurts), FLATULENCE (had a lot of gas), FEELING ABNORMAL (crappy feeling) and PAIN (The middle of their body hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported were levothyroxine Treatment details included Tylenol and Advil   Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: body aches; fatigue; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02NA21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, CEFUROXIME (MAXIM [CEFUROXIME]) for Indigestion.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever). At the time of the report, MYALGIA (body aches), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 101 degree f (abnormal) 101 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information regarding corrective treatment was reported by the patient.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Scar, Vaccination site pruritus
Clinical narrative: starting to get scarring from scratching; itching on my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching on my arm) and SCAR (starting to get scarring from scratching) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included METOPROLOL for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching on my arm). On an unknown date, the patient experienced SCAR (starting to get scarring from scratching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching on my arm) and SCAR (starting to get scarring from scratching) was resolving.        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.   Patient has an appointment with her doctor on Friday.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: bout of gout; This spontaneous case was reported by a health care professional and describes the occurrence of GOUT (bout of gout) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included NYSTATIN (STATIN [NYSTATIN]) for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced GOUT (bout of gout). The patient was treated with PREDNISONE at a dose of UNK dosage form. At the time of the report, GOUT (bout of gout) outcome was unknown.        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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Injection site rash, Myalgia
Clinical narrative: fatigue; muscle ache; rash on all of their face and neck; rash looked like the points of a needle; flu like symptoms; chills; fever 101.5; soreness in their arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (soreness in their arm), INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), PYREXIA (fever 101.5) and RASH (rash on all of their face and neck) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUPROPION and PROPRANOLOL for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in their arm). On 23-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills) and PYREXIA (fever 101.5). On 27-Feb-2021, the patient experienced RASH (rash on all of their face and neck) and INJECTION SITE RASH (rash looked like the points of a needle). On an unknown date, the patient experienced FATIGUE (fatigue) and MYALGIA (muscle ache). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency; SERTRALINE HYDROCHLORIDE (SERTAC) for Rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 25-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills) and PYREXIA (fever 101.5) had resolved. On 02-Mar-2021, RASH (rash on all of their face and neck) and INJECTION SITE RASH (rash looked like the points of a needle) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in their arm), FATIGUE (fatigue) and MYALGIA (muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Pyrexia (high-high): 101.5 (High) 101.5.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No specific follow-up information recorded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: fatigue; muscle ache; rash on all of their face and neck; rash looked like the points of a needle; flu like symptoms; chills; fever 101.5; soreness in their arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (soreness in their arm), INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), PYREXIA (fever 101.5) and RASH (rash on all of their face and neck) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUPROPION and PROPRANOLOL for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in their arm). On 23-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills) and PYREXIA (fever 101.5). On 27-Feb-2021, the patient experienced RASH (rash on all of their face and neck) and INJECTION SITE RASH (rash looked like the points of a needle). On an unknown date, the patient experienced FATIGUE (fatigue) and MYALGIA (muscle ache). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency; SERTRALINE HYDROCHLORIDE (SERTAC) for Rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 25-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills) and PYREXIA (fever 101.5) had resolved. On 02-Mar-2021, RASH (rash on all of their face and neck) and INJECTION SITE RASH (rash looked like the points of a needle) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in their arm), FATIGUE (fatigue) and MYALGIA (muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Pyrexia (high-high): 101.5 (High) 101.5.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No specific follow-up information recorded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Injection site pain, Pyrexia
Clinical narrative: soreness at the injection site; chills; Temperature went up to 101.1; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness at the injection site), CHILLS (chills) and PYREXIA (Temperature went up to 101.1) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PROBIOTIC 10, METFORMIN, LISINOPRIL, ALFUZOSIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ATORVASTATIN CALCIUM (LIPITOR) and FINASTERIDE (PROSCAR) for an unknown indication.    On 07-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 INJECTION SITE PAIN (soreness at the injection site), CHILLS (chills) and PYREXIA (Temperature went up to 101.1). At the time of the report, INJECTION SITE PAIN (soreness at the injection site), CHILLS (chills) and PYREXIA (Temperature went up to 101.1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 101.1 (High) 101.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.