chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (On the injection arm he experienced itchiness), VACCINATION SITE RASH (injection arm rash), VACCINATION SITE ERYTHEMA (injection arm red spot), PRURITUS (Itchiness) and RASH (RASH) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Z01A21A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (On the injection arm he experienced itchiness), VACCINATION SITE RASH (injection arm rash), VACCINATION SITE ERYTHEMA (injection arm red spot), PRURITUS (Itchiness), RASH (RASH) and ERYTHEMA (Red spot). At the time of the report, VACCINATION SITE PRURITUS (On the injection arm he experienced itchiness), VACCINATION SITE RASH (injection arm rash), VACCINATION SITE ERYTHEMA (injection arm red spot), PRURITUS (Itchiness), RASH (RASH) and ERYTHEMA (Red spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported no side effects with first dose of Moderna vaccine. Patient reported that he experienced similar reactions on his opposite arm under elbow on which he had injection  No concomitant medications were reported.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (On the injection arm he experienced itchiness), VACCINATION SITE RASH (injection arm rash), VACCINATION SITE ERYTHEMA (injection arm red spot), PRURITUS (Itchiness) and RASH (RASH) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Z01A21A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (On the injection arm he experienced itchiness), VACCINATION SITE RASH (injection arm rash), VACCINATION SITE ERYTHEMA (injection arm red spot), PRURITUS (Itchiness), RASH (RASH) and ERYTHEMA (Red spot). At the time of the report, VACCINATION SITE PRURITUS (On the injection arm he experienced itchiness), VACCINATION SITE RASH (injection arm rash), VACCINATION SITE ERYTHEMA (injection arm red spot), PRURITUS (Itchiness), RASH (RASH) and ERYTHEMA (Red spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported no side effects with first dose of Moderna vaccine. Patient reported that he experienced similar reactions on his opposite arm under elbow on which he had injection  No concomitant medications were reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Fatigue, Injection site bruising, Pyrexia
Clinical narrative: fever; bad diarrhea; confused/"in and out of it"; in and out of it"; bruise at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (bruise at injection site), PYREXIA (fever), DIARRHOEA (bad diarrhea), CONFUSIONAL STATE (confused/"in and out of it") and FATIGUE (in and out of it") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Radiation therapy since an unknown date.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INJECTION SITE BRUISING (bruise at injection site). On 04-Mar-2021, the patient experienced PYREXIA (fever), DIARRHOEA (bad diarrhea), CONFUSIONAL STATE (confused/"in and out of it") and FATIGUE (in and out of it"). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE BRUISING (bruise at injection site), PYREXIA (fever), DIARRHOEA (bad diarrhea), CONFUSIONAL STATE (confused/"in and out of it") and FATIGUE (in and out of it") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, HEADACHE and MYALGIA in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021 at 10:00 PM, the patient experienced CHILLS, HEADACHE and MYALGIA. At the time of the report, CHILLS + HEADACHE and MYALGIA had not resolved.            No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis
Clinical narrative: Sweating; Flushing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating) and FLUSHING (Flushing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating) and FLUSHING (Flushing). At the time of the report, HYPERHIDROSIS (Sweating) and FLUSHING (Flushing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. No treatment was reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Discomfort, Eating disorder, Erythema
Clinical narrative: Allergic reaction; More dense Saliva; Headaches; Nauseous; Cold; Discomfort in the body; Not able to eat; Vomit 2 times; Blood pressure high; Pain in the joints; Pain in the neck; Red face; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), SALIVA ALTERED (More dense Saliva), HEADACHE (Headaches), NAUSEA (Nauseous) and NASOPHARYNGITIS (Cold) in a 52-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.     Concurrent medical conditions included Hypertension, Pre-diabetes and Hyperlipidemia (high cholesterol.). Concomitant products included ATORVASTATIN for High cholesterol, METOPROLOL and AMLODIPINE for Hypertension, VITAMIN D2, UBIDECARENONE (Q10) and IRBESARTAN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), SALIVA ALTERED (More dense Saliva), HEADACHE (Headaches), NAUSEA (Nauseous), NASOPHARYNGITIS (Cold), DISCOMFORT (Discomfort in the body), EATING DISORDER (Not able to eat), VOMITING (Vomit 2 times), HYPERTENSION (Blood pressure high), ARTHRALGIA (Pain in the joints), NECK PAIN (Pain in the neck) and ERYTHEMA (Red face). The patient was treated with DICLOFENAC for Adverse event, at an unspecified dose and frequency. On 03-Mar-2021, HYPERSENSITIVITY (Allergic reaction), SALIVA ALTERED (More dense Saliva), HEADACHE (Headaches), NAUSEA (Nauseous), NASOPHARYNGITIS (Cold), DISCOMFORT (Discomfort in the body), EATING DISORDER (Not able to eat), VOMITING (Vomit 2 times), HYPERTENSION (Blood pressure high) and ERYTHEMA (Red face) had resolved. At the time of the report, ARTHRALGIA (Pain in the joints) and NECK PAIN (Pain in the neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: high (High) 180-107-93.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Hypertension, Nasopharyngitis, Nausea
Clinical narrative: Allergic reaction; More dense Saliva; Headaches; Nauseous; Cold; Discomfort in the body; Not able to eat; Vomit 2 times; Blood pressure high; Pain in the joints; Pain in the neck; Red face; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), SALIVA ALTERED (More dense Saliva), HEADACHE (Headaches), NAUSEA (Nauseous) and NASOPHARYNGITIS (Cold) in a 52-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.     Concurrent medical conditions included Hypertension, Pre-diabetes and Hyperlipidemia (high cholesterol.). Concomitant products included ATORVASTATIN for High cholesterol, METOPROLOL and AMLODIPINE for Hypertension, VITAMIN D2, UBIDECARENONE (Q10) and IRBESARTAN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), SALIVA ALTERED (More dense Saliva), HEADACHE (Headaches), NAUSEA (Nauseous), NASOPHARYNGITIS (Cold), DISCOMFORT (Discomfort in the body), EATING DISORDER (Not able to eat), VOMITING (Vomit 2 times), HYPERTENSION (Blood pressure high), ARTHRALGIA (Pain in the joints), NECK PAIN (Pain in the neck) and ERYTHEMA (Red face). The patient was treated with DICLOFENAC for Adverse event, at an unspecified dose and frequency. On 03-Mar-2021, HYPERSENSITIVITY (Allergic reaction), SALIVA ALTERED (More dense Saliva), HEADACHE (Headaches), NAUSEA (Nauseous), NASOPHARYNGITIS (Cold), DISCOMFORT (Discomfort in the body), EATING DISORDER (Not able to eat), VOMITING (Vomit 2 times), HYPERTENSION (Blood pressure high) and ERYTHEMA (Red face) had resolved. At the time of the report, ARTHRALGIA (Pain in the joints) and NECK PAIN (Pain in the neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: high (High) 180-107-93.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Saliva altered, Vomiting
Clinical narrative: Allergic reaction; More dense Saliva; Headaches; Nauseous; Cold; Discomfort in the body; Not able to eat; Vomit 2 times; Blood pressure high; Pain in the joints; Pain in the neck; Red face; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), SALIVA ALTERED (More dense Saliva), HEADACHE (Headaches), NAUSEA (Nauseous) and NASOPHARYNGITIS (Cold) in a 52-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.     Concurrent medical conditions included Hypertension, Pre-diabetes and Hyperlipidemia (high cholesterol.). Concomitant products included ATORVASTATIN for High cholesterol, METOPROLOL and AMLODIPINE for Hypertension, VITAMIN D2, UBIDECARENONE (Q10) and IRBESARTAN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), SALIVA ALTERED (More dense Saliva), HEADACHE (Headaches), NAUSEA (Nauseous), NASOPHARYNGITIS (Cold), DISCOMFORT (Discomfort in the body), EATING DISORDER (Not able to eat), VOMITING (Vomit 2 times), HYPERTENSION (Blood pressure high), ARTHRALGIA (Pain in the joints), NECK PAIN (Pain in the neck) and ERYTHEMA (Red face). The patient was treated with DICLOFENAC for Adverse event, at an unspecified dose and frequency. On 03-Mar-2021, HYPERSENSITIVITY (Allergic reaction), SALIVA ALTERED (More dense Saliva), HEADACHE (Headaches), NAUSEA (Nauseous), NASOPHARYNGITIS (Cold), DISCOMFORT (Discomfort in the body), EATING DISORDER (Not able to eat), VOMITING (Vomit 2 times), HYPERTENSION (Blood pressure high) and ERYTHEMA (Red face) had resolved. At the time of the report, ARTHRALGIA (Pain in the joints) and NECK PAIN (Pain in the neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: high (High) 180-107-93.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: high fever; headache; chills; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever), HEADACHE (headache), CHILLS (chills), PAIN (body aches) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever), HEADACHE (headache), CHILLS (chills), PAIN (body aches) and NAUSEA (nausea). At the time of the report, PYREXIA (high fever), HEADACHE (headache), CHILLS (chills), PAIN (body aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Papule, Peau d'orange, Swelling
Clinical narrative: itching big nod; hot; swollen; cellulite; This spontaneous case was reported by a consumer and describes the occurrence of PAPULE (itching big nod), FEELING HOT (hot), SWELLING (swollen) and PEAU D'ORANGE (cellulite) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE MAGNESIUM, SERTRALINE, MIRTAZAPINE and ETHINYLESTRADIOL, NORGESTREL (CONTRACEPTIVE HD) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PAPULE (itching big nod), FEELING HOT (hot), SWELLING (swollen) and PEAU D'ORANGE (cellulite). The patient was treated with AZITHROMYCIN for Adverse event, at an unspecified dose and frequency. On 02-Mar-2021, PAPULE (itching big nod), FEELING HOT (hot), SWELLING (swollen) and PEAU D'ORANGE (cellulite) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, SARS-CoV-2 test positive, Vomiting
Clinical narrative: weak, "in bed all day"; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and ASTHENIA (weak, "in bed all day") in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A71A) for COVID-19 vaccination.     Concomitant products included METOPROLOL and AMLODIPINE for an unknown indication.    On 02-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). On an unknown date, the patient experienced ASTHENIA (weak, "in bed all day"). At the time of the report, VOMITING (vomiting) and ASTHENIA (weak, "in bed all day") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test positive: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Headache, Pyrexia
Clinical narrative: fever of greater than 102; headache; fatigue; chest heaviness; A spontaneous  report  as received from a health care professional concerning,a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever of greater than 102, headache, fatigue and chest heaviness.   The patient's medical history included,SARS-CoV-2 infection.   Products known to have been used by the patient, within two weeks prior to the event, were not reported.  On 20 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On unknow date, the patient developed fever of greater than 102, headache, fatigue and chest heaviness .   Treatment for the event ,was not reported.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, fever of greater than 102, headache, fatigue and chest heaviness, was considered unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Nausea, Paraesthesia, Vertigo
Clinical narrative: Numbness; Tingling in her hands and legs; Legs are achy; Vertigo; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of VERTIGO (Vertigo), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling in her hands and legs), NAUSEA (Nausea) and MYALGIA (Legs are achy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VERTIGO (Vertigo) and NAUSEA (Nausea). On 04-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling in her hands and legs) and MYALGIA (Legs are achy). The patient was treated with DIPHENHYDRAMINE for Adverse event, at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo), HYPOAESTHESIA (Numbness), PARAESTHESIA (Tingling in her hands and legs), NAUSEA (Nausea) and MYALGIA (Legs are achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Non significant follow up received. Email address updated.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-035051 (E2B Linked Report).; Sender's Comments:  MOD-2021-035051:Crosslinked case
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.            No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site has a knot underneath it; Injection site swollen; injection site super itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Injection site has a knot underneath it), INJECTION SITE SWELLING (Injection site swollen) and INJECTION SITE PRURITUS (injection site super itching) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 24-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 INJECTION SITE MASS (Injection site has a knot underneath it), INJECTION SITE SWELLING (Injection site swollen) and INJECTION SITE PRURITUS (injection site super itching). At the time of the report, INJECTION SITE MASS (Injection site has a knot underneath it), INJECTION SITE SWELLING (Injection site swollen) and INJECTION SITE PRURITUS (injection site super itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included applying unknown cream.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Chills, Decreased appetite, Fatigue, Pain
Clinical narrative: Frequent urination; lower back pain; body aches; loss of appetite; Chills; Fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination), BACK PAIN (lower back pain), PAIN (body aches), DECREASED APPETITE (loss of appetite) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for Adverse event.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 04-Mar-2021, the patient experienced POLLAKIURIA (Frequent urination), BACK PAIN (lower back pain), PAIN (body aches), DECREASED APPETITE (loss of appetite), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (fatigue). At the time of the report, POLLAKIURIA (Frequent urination), BACK PAIN (lower back pain), PAIN (body aches), DECREASED APPETITE (loss of appetite), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (fatigue) 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 reported that she recorded her fever 100F which went down to 99 F next morning and rose again to 101.2 F at 3:20 pm. Patient reported that she was drinking enough fluids.  No concomitant medications were reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pollakiuria, Pyrexia
Clinical narrative: Frequent urination; lower back pain; body aches; loss of appetite; Chills; Fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination), BACK PAIN (lower back pain), PAIN (body aches), DECREASED APPETITE (loss of appetite) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for Adverse event.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 04-Mar-2021, the patient experienced POLLAKIURIA (Frequent urination), BACK PAIN (lower back pain), PAIN (body aches), DECREASED APPETITE (loss of appetite), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (fatigue). At the time of the report, POLLAKIURIA (Frequent urination), BACK PAIN (lower back pain), PAIN (body aches), DECREASED APPETITE (loss of appetite), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (fatigue) 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 reported that she recorded her fever 100F which went down to 99 F next morning and rose again to 101.2 F at 3:20 pm. Patient reported that she was drinking enough fluids.  No concomitant medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle aches). At the time of the report, MYALGIA (Muscle aches) had not resolved. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: red spots/patches all over body with itching; red spots/patches all over body with itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red spots/patches all over body with itching) and PRURITUS (red spots/patches all over body with itching) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (red spots/patches all over body with itching). On an unknown date, the patient experienced PRURITUS (red spots/patches all over body with itching). At the time of the report, ERYTHEMA (red spots/patches all over body with itching) and PRURITUS (red spots/patches all over body with itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Dizziness, Feeling abnormal, Head discomfort
Clinical narrative: hot to touch; Dizziness; Weakness; Sinuses are closed up; feels like she has a hangover; Head is very full; she has soreness in her waist, hips and back; she has soreness in her waist, hips and back; sinus issues; itching; palm-sized swelling at injection site; body soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch), DIZZINESS (Dizziness), ASTHENIA (Weakness), PARANASAL SINUS DISCOMFORT (Sinuses are closed up) and FEELING ABNORMAL (feels like she has a hangover) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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 APIXABAN (ELIQUIS), METOPROLOL SUCCINATE (TOPROL), METOPROLOL, TORSEMIDE, POTASSIUM CHLORIDE, BUPROPION, LEVOCETIRIZINE, FLUTICASONE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ALBUTEROL [SALBUTAMOL] and L-ARGININE [ARGININE] for an unknown indication.   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 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), DIZZINESS (Dizziness), ASTHENIA (Weakness), PARANASAL SINUS DISCOMFORT (Sinuses are closed up), FEELING ABNORMAL (feels like she has a hangover), HEAD DISCOMFORT (Head is very full), MUSCULOSKELETAL DISCOMFORT (she has soreness in her waist, hips and back), BACK PAIN (she has soreness in her waist, hips and back), SINUS DISORDER (sinus issues), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (palm-sized swelling at injection site) and MYALGIA (body soreness). At the time of the report, VACCINATION SITE WARMTH (hot to touch), DIZZINESS (Dizziness), ASTHENIA (Weakness), PARANASAL SINUS DISCOMFORT (Sinuses are closed up), FEELING ABNORMAL (feels like she has a hangover), HEAD DISCOMFORT (Head is very full), MUSCULOSKELETAL DISCOMFORT (she has soreness in her waist, hips and back), BACK PAIN (she has soreness in her waist, hips and back), SINUS DISORDER (sinus issues), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (palm-sized swelling at injection site) and MYALGIA (body soreness) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Other relevant medication history included l-glulisine,multivitamin,eye vitamins for for macular degeneration. No treatment information was provided.   This case was linked to MOD-2021-035083 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Myalgia, Paranasal sinus discomfort, Sinus disorder, Vaccination site pruritus
Clinical narrative: hot to touch; Dizziness; Weakness; Sinuses are closed up; feels like she has a hangover; Head is very full; she has soreness in her waist, hips and back; she has soreness in her waist, hips and back; sinus issues; itching; palm-sized swelling at injection site; body soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch), DIZZINESS (Dizziness), ASTHENIA (Weakness), PARANASAL SINUS DISCOMFORT (Sinuses are closed up) and FEELING ABNORMAL (feels like she has a hangover) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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 APIXABAN (ELIQUIS), METOPROLOL SUCCINATE (TOPROL), METOPROLOL, TORSEMIDE, POTASSIUM CHLORIDE, BUPROPION, LEVOCETIRIZINE, FLUTICASONE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ALBUTEROL [SALBUTAMOL] and L-ARGININE [ARGININE] for an unknown indication.   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 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), DIZZINESS (Dizziness), ASTHENIA (Weakness), PARANASAL SINUS DISCOMFORT (Sinuses are closed up), FEELING ABNORMAL (feels like she has a hangover), HEAD DISCOMFORT (Head is very full), MUSCULOSKELETAL DISCOMFORT (she has soreness in her waist, hips and back), BACK PAIN (she has soreness in her waist, hips and back), SINUS DISORDER (sinus issues), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (palm-sized swelling at injection site) and MYALGIA (body soreness). At the time of the report, VACCINATION SITE WARMTH (hot to touch), DIZZINESS (Dizziness), ASTHENIA (Weakness), PARANASAL SINUS DISCOMFORT (Sinuses are closed up), FEELING ABNORMAL (feels like she has a hangover), HEAD DISCOMFORT (Head is very full), MUSCULOSKELETAL DISCOMFORT (she has soreness in her waist, hips and back), BACK PAIN (she has soreness in her waist, hips and back), SINUS DISORDER (sinus issues), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (palm-sized swelling at injection site) and MYALGIA (body soreness) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Other relevant medication history included l-glulisine,multivitamin,eye vitamins for for macular degeneration. No treatment information was provided.   This case was linked to MOD-2021-035083 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot to touch; Dizziness; Weakness; Sinuses are closed up; feels like she has a hangover; Head is very full; she has soreness in her waist, hips and back; she has soreness in her waist, hips and back; sinus issues; itching; palm-sized swelling at injection site; body soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch), DIZZINESS (Dizziness), ASTHENIA (Weakness), PARANASAL SINUS DISCOMFORT (Sinuses are closed up) and FEELING ABNORMAL (feels like she has a hangover) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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 APIXABAN (ELIQUIS), METOPROLOL SUCCINATE (TOPROL), METOPROLOL, TORSEMIDE, POTASSIUM CHLORIDE, BUPROPION, LEVOCETIRIZINE, FLUTICASONE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ALBUTEROL [SALBUTAMOL] and L-ARGININE [ARGININE] for an unknown indication.   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 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), DIZZINESS (Dizziness), ASTHENIA (Weakness), PARANASAL SINUS DISCOMFORT (Sinuses are closed up), FEELING ABNORMAL (feels like she has a hangover), HEAD DISCOMFORT (Head is very full), MUSCULOSKELETAL DISCOMFORT (she has soreness in her waist, hips and back), BACK PAIN (she has soreness in her waist, hips and back), SINUS DISORDER (sinus issues), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (palm-sized swelling at injection site) and MYALGIA (body soreness). At the time of the report, VACCINATION SITE WARMTH (hot to touch), DIZZINESS (Dizziness), ASTHENIA (Weakness), PARANASAL SINUS DISCOMFORT (Sinuses are closed up), FEELING ABNORMAL (feels like she has a hangover), HEAD DISCOMFORT (Head is very full), MUSCULOSKELETAL DISCOMFORT (she has soreness in her waist, hips and back), BACK PAIN (she has soreness in her waist, hips and back), SINUS DISORDER (sinus issues), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (palm-sized swelling at injection site) and MYALGIA (body soreness) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Other relevant medication history included l-glulisine,multivitamin,eye vitamins for for macular degeneration. No treatment information was provided.   This case was linked to MOD-2021-035083 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Covid on; allergic reaction; itching at injection site; burning at injection site; swelling at injection site; tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid on), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (burning at injection site) and VACCINATION SITE SWELLING (swelling at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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 CLONIDINE, ALISKIREN, LEVOTHYROXINE SODIUM (SYNTHROID) and LIFITEGRAST (XIIDRA) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid on), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (burning at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PAIN (tenderness at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Covid on), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (burning at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PAIN (tenderness at injection site) 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 took Benadryl oral Benadryl topical. Other relevant medication history included OTC supplements.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Tachycardia, Vaccination site rash
Clinical narrative: she then got a rash on the injection arm that was about 2-2.5in big; fatigue; heart beat went up a little bit; Fever; 5in long 3in across rash on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (she then got a rash on the injection arm that was about 2-2.5in big), FATIGUE (fatigue), TACHYCARDIA (heart beat went up a little bit), PYREXIA (Fever) and VACCINATION SITE RASH (5in long 3in across rash on the injection arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (she then got a rash on the injection arm that was about 2-2.5in big), FATIGUE (fatigue), TACHYCARDIA (heart beat went up a little bit), PYREXIA (Fever) and VACCINATION SITE RASH (5in long 3in across rash on the injection arm). At the time of the report, VACCINATION SITE RASH (she then got a rash on the injection arm that was about 2-2.5in big), FATIGUE (fatigue), TACHYCARDIA (heart beat went up a little bit), PYREXIA (Fever) and VACCINATION SITE RASH (5in long 3in across rash on the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.   This case was linked to MOD-2021-059389 (Patient Link).   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain
Clinical narrative: Injection site is extremely sore; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site is extremely sore), CHILLS (Chills) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M014) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 04-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 INJECTION SITE PAIN (Injection site is extremely sore), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, INJECTION SITE PAIN (Injection site is extremely sore), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Decreased appetite, Fatigue, Feeling abnormal, Injection site pain
Clinical narrative: left arm become weaker; shoulder started to hurt down to his elbow and then down to his; injection site pain; injection site tenderness; tongue felt funny; felt weird; he went into a rage (he was crazy angry; he was nuts angry) He was yelling all kinds of stuff and; food appetite is off, he does not feel like eating; tired, "pooped out"; A spontaneous report was received from a consumer concerning a 67-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm become weaker and his shoulder started to hurt down to his elbow and then down to his, at the injection site, he felt pain and tenderness, tongue felt funny, felt weird, he went into a rage (he was crazy angry he was nuts angry) he was yelling all kinds of stuff and, food appetite is off, he does not feel like eating, he is tired.  The patient's medical history was not provided. Concomitant medications reported were oxcarbazepine 450mg twice a day Epilepsy for drug use for unknown indication.  No relevant lab data was reported by the reporter.  On 4 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 036A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient experienced the event(s) left arm become weaker and his shoulder started to hurt down to his elbow and then down to his. at the injection site, he felt pain and tenderness, tongue felt funny, felt weird, he went into a rage (he was crazy angry he was nuts angry) he was yelling all kinds of stuff and, food appetite is off, he does not feel like eating, he is tired.  Treatment details included Orange juice, Water.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event(s) tongue felt funny was considered resolved on 4 Mar 2021.The outcome of event(s) felt weird was considered resolved on 4 Mar 2021. The outcome of event(s), left arm become weaker and his shoulder started to hurt down to his elbow and then down to his, at the injection site,he felt pain and tenderness,he went into a rage (he was crazy angry he was nuts angry) he was yelling all kinds of stuff and,food appetite is off,he does not feel like eating,he is tired.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia oral
Clinical narrative: left arm become weaker; shoulder started to hurt down to his elbow and then down to his; injection site pain; injection site tenderness; tongue felt funny; felt weird; he went into a rage (he was crazy angry; he was nuts angry) He was yelling all kinds of stuff and; food appetite is off, he does not feel like eating; tired, "pooped out"; A spontaneous report was received from a consumer concerning a 67-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm become weaker and his shoulder started to hurt down to his elbow and then down to his, at the injection site, he felt pain and tenderness, tongue felt funny, felt weird, he went into a rage (he was crazy angry he was nuts angry) he was yelling all kinds of stuff and, food appetite is off, he does not feel like eating, he is tired.  The patient's medical history was not provided. Concomitant medications reported were oxcarbazepine 450mg twice a day Epilepsy for drug use for unknown indication.  No relevant lab data was reported by the reporter.  On 4 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 036A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient experienced the event(s) left arm become weaker and his shoulder started to hurt down to his elbow and then down to his. at the injection site, he felt pain and tenderness, tongue felt funny, felt weird, he went into a rage (he was crazy angry he was nuts angry) he was yelling all kinds of stuff and, food appetite is off, he does not feel like eating, he is tired.  Treatment details included Orange juice, Water.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event(s) tongue felt funny was considered resolved on 4 Mar 2021.The outcome of event(s) felt weird was considered resolved on 4 Mar 2021. The outcome of event(s), left arm become weaker and his shoulder started to hurt down to his elbow and then down to his, at the injection site,he felt pain and tenderness,he went into a rage (he was crazy angry he was nuts angry) he was yelling all kinds of stuff and,food appetite is off,he does not feel like eating,he is tired.