chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chills, Computerised tomogram, Fatigue, Haematuria
Clinical narrative: malaise; weaker than usual; lymph node swollen in abdomen; hematuria; aches; chills; fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HAEMATURIA (hematuria), MALAISE (malaise), PAIN (aches), CHILLS (chills) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) 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 ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    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 HAEMATURIA (hematuria), PAIN (aches), CHILLS (chills) and PYREXIA (fever). On 07-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph node swollen in abdomen). On 08-Mar-2021, the patient experienced MALAISE (malaise) and FATIGUE (weaker than usual). On 07-Mar-2021, HAEMATURIA (hematuria), PAIN (aches), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, MALAISE (malaise), FATIGUE (weaker than usual) and LYMPHADENOPATHY (lymph node swollen in abdomen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood test normal: normal (normal) normal. On 06-Mar-2021, Computerised tomogram: abnormal (abnormal) lymph node swollen in abdomen.     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.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pain, Pyrexia
Clinical narrative: malaise; weaker than usual; lymph node swollen in abdomen; hematuria; aches; chills; fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HAEMATURIA (hematuria), MALAISE (malaise), PAIN (aches), CHILLS (chills) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) 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 ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    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 HAEMATURIA (hematuria), PAIN (aches), CHILLS (chills) and PYREXIA (fever). On 07-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph node swollen in abdomen). On 08-Mar-2021, the patient experienced MALAISE (malaise) and FATIGUE (weaker than usual). On 07-Mar-2021, HAEMATURIA (hematuria), PAIN (aches), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, MALAISE (malaise), FATIGUE (weaker than usual) and LYMPHADENOPATHY (lymph node swollen in abdomen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood test normal: normal (normal) normal. On 06-Mar-2021, Computerised tomogram: abnormal (abnormal) lymph node swollen in abdomen.     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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: nausea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Feb-2021, the patient experienced NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-037329 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Injection site mass, Migraine, Pyrexia
Clinical narrative: painful burning; low grade fever; Migraines; Headache; small raised bump/ large raised lump; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines), BURNING SENSATION (painful burning), INJECTION SITE MASS (small raised bump/ large raised lump), HEADACHE (Headache) and PYREXIA (low grade fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A2IA) for COVID-19 vaccination.     Concurrent medical conditions included Insomnia, Arthritis and Anxiety. Concomitant products included CLONAZEPAM (KLONOPIN) and NAPROXEN (MOTRIN [NAPROXEN]) for an unknown indication.    On 26-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 INJECTION SITE MASS (small raised bump/ large raised lump). On 27-Feb-2021, the patient experienced MIGRAINE (Migraines) and HEADACHE (Headache). On 07-Mar-2021, the patient experienced BURNING SENSATION (painful burning) and PYREXIA (low grade fever). At the time of the report, MIGRAINE (Migraines), BURNING SENSATION (painful burning), INJECTION SITE MASS (small raised bump/ large raised lump), HEADACHE (Headache) and PYREXIA (low grade 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.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (body aches) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced PYREXIA (fever) and MYALGIA (body aches). On 09-Jan-2021, PYREXIA (fever) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Severe dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Severe dizziness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A021A) for COVID-19 vaccination.     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 07-Mar-2021, the patient experienced DIZZINESS (Severe dizziness). At the time of the report, DIZZINESS (Severe dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal
Clinical narrative: lot of allergies like if coughing; very bad; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (lot of allergies like if coughing) and FEELING ABNORMAL (very bad) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (lot of allergies like if coughing) and FEELING ABNORMAL (very bad). At the time of the report, COUGH (lot of allergies like if coughing) and FEELING ABNORMAL (very bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Nausea, Vomiting
Clinical narrative: very weak; Joint aches; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), ARTHRALGIA (Joint aches), NAUSEA (Nausea) and VOMITING (Vomiting) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Mar-2021, the patient experienced ASTHENIA (very weak), ARTHRALGIA (Joint aches), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) at an unspecified dose and frequency. On 07-Mar-2021, ASTHENIA (very weak), ARTHRALGIA (Joint aches) and NAUSEA (Nausea) had resolved and VOMITING (Vomiting) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site rash, Pruritus, Rash papular, Vaccination site warmth
Clinical narrative: Hypersensitivity reaction; raised; hot to touch; Itchy "like poison ivy"; rash at injection site 4 x 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), RASH PAPULAR (raised), VACCINATION SITE WARMTH (hot to touch), PRURITUS (Itchy "like poison ivy") and INJECTION SITE RASH (rash at injection site 4 x 3 inches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy and Drug allergy (zosyn).   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced RASH PAPULAR (raised), VACCINATION SITE WARMTH (hot to touch), PRURITUS (Itchy "like poison ivy") and INJECTION SITE RASH (rash at injection site 4 x 3 inches). On 27-Mar-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved and RASH PAPULAR (raised), VACCINATION SITE WARMTH (hot to touch), PRURITUS (Itchy "like poison ivy") and INJECTION SITE RASH (rash at injection site 4 x 3 inches) outcome was unknown.            No concomitant medications was provided. Treatment information include Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: final AE diagnosis with start date, and event outcome, Product information was updated, event was updated, medical history was updated
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of chest pain (chest started hurting/chest felt like it was on fire) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. Concurrent medical conditions included hypertension. On Mar 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 6, 2021, patient experienced chest pain (chest started hurting/chest felt like it was on fire). The patient treated with Advil (ibuprofen), at an unspecified dose and frequency; and clonidine for hypertension, at an unspecified dose and frequency. At the time of the report, chest pain (chest started hurting/chest felt like it was on fire) outcome: unknown. Diagnostic results: On Mar 1, 2021, blood pressure measurement: 200/105 (high). The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant product use not provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza, Pain, Pyrexia, Rash
Clinical narrative: FEELING SORE; ACHY JUST LIKE GETTING THE FLUE; RASH COVERNING BODY; LOW GRADE FEVER; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (FEELING SORE), INFLUENZA (ACHY JUST LIKE GETTING THE FLUE), PYREXIA (LOW GRADE FEVER), RASH (RASH COVERNING BODY) and HEADACHE (HEADACHE) in a 57-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 Surgery (Foot surgery in january). Concomitant products included Torvistatin, LEVOTHYROXINE, ALLOPURINOL and sulfamethoxazole TMP BS 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 PAIN (FEELING SORE), INFLUENZA (ACHY JUST LIKE GETTING THE FLUE), PYREXIA (LOW GRADE FEVER), RASH (RASH COVERNING BODY) and HEADACHE (HEADACHE). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 08-Mar-2021, PAIN (FEELING SORE), INFLUENZA (ACHY JUST LIKE GETTING THE FLUE), PYREXIA (LOW GRADE FEVER) and HEADACHE (HEADACHE) had resolved. At the time of the report, RASH (RASH COVERNING BODY) 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.   Treatment details included Patient took Benadryl and ibuprofen to help relieve symptoms..
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: 5 blood blisters on her right stomach; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (5 blood blisters on her right stomach) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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 05-Mar-2021, the patient experienced BLISTER (5 blood blisters on her right stomach). At the time of the report, BLISTER (5 blood blisters on her right stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Prostatic specific antigen
Clinical narrative: PSA detectable; mild sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mild sore arm) and PROSTATIC SPECIFIC ANTIGEN (PSA detectable) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Prostatectomy (3 years ago).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (mild sore arm). On 01-Mar-2021, the patient experienced PROSTATIC SPECIFIC ANTIGEN (PSA detectable). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Feb-2021, PAIN IN EXTREMITY (mild sore arm) had resolved. At the time of the report, PROSTATIC SPECIFIC ANTIGEN (PSA detectable) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Prostatic specific antigen: detectable (Positive) detectable.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Shortly after the second shot the patient went to hospital and got blood drawn for PSA, it was detectable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Myalgia
Clinical narrative: good size lump at injectin site; quarter size red patch at injection site,  red patch at injection site reappeared; can't lift her left arm past halfway bc it hurts too bad; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (good size lump at injectin site), INJECTION SITE ERYTHEMA (quarter size red patch at injection site,  red patch at injection site reappeared) and MYALGIA (can't lift her left arm past halfway bc it hurts too bad) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INJECTION SITE MASS (good size lump at injectin site), INJECTION SITE ERYTHEMA (quarter size red patch at injection site,  red patch at injection site reappeared) and MYALGIA (can't lift her left arm past halfway bc it hurts too bad). At the time of the report, INJECTION SITE MASS (good size lump at injectin site), INJECTION SITE ERYTHEMA (quarter size red patch at injection site,  red patch at injection site reappeared) and MYALGIA (can't lift her left arm past halfway bc it hurts too bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site pruritus, Injection site reaction
Clinical narrative: Tingling at site of injection; Feels tight at site of injection; Itchy kind of feeling at site of injection; Pain at site of injection; Red at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PARAESTHESIA (Tingling at site of injection), INJECTION SITE REACTION (Feels tight at site of injection), INJECTION SITE PRURITUS (Itchy kind of feeling at site of injection), INJECTION SITE PAIN (Pain at site of injection) and INJECTION SITE ERYTHEMA (Red at site of injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) 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 INJECTION SITE PARAESTHESIA (Tingling at site of injection), INJECTION SITE REACTION (Feels tight at site of injection), INJECTION SITE PRURITUS (Itchy kind of feeling at site of injection), INJECTION SITE PAIN (Pain at site of injection) and INJECTION SITE ERYTHEMA (Red at site of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PARAESTHESIA (Tingling at site of injection), INJECTION SITE REACTION (Feels tight at site of injection), INJECTION SITE PRURITUS (Itchy kind of feeling at site of injection), INJECTION SITE PAIN (Pain at site of injection) and INJECTION SITE ERYTHEMA (Red at site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included Tylenol.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: dizzy; nausea; threw up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), NAUSEA (nausea) and VOMITING (threw up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included CLONAZEPAM, HYOSCYAMINE and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) 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 DIZZINESS (dizzy), NAUSEA (nausea) and VOMITING (threw up). On 04-Mar-2021, DIZZINESS (dizzy), NAUSEA (nausea) and VOMITING (threw up) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Contact Information Updated
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Headache, Myalgia
Clinical narrative: Achy bones and muscles; Really tired; Achy bones and muscles; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Achy bones and muscles), FATIGUE (Really tired), MYALGIA (Achy bones and muscles) and HEADACHE (Headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 BONE PAIN (Achy bones and muscles), FATIGUE (Really tired), MYALGIA (Achy bones and muscles) and HEADACHE (Headache). At the time of the report, BONE PAIN (Achy bones and muscles), FATIGUE (Really tired), MYALGIA (Achy bones and muscles) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-037105 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Fatigue, Gait disturbance
Clinical narrative: Flu like symptoms as after 1st vaccination; Having trouble walking; Fatigue; Stomach symptoms; Diarrhea; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like symptoms as after 1st vaccination) and GAIT DISTURBANCE (Having trouble walking) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ADALIMUMAB (HUMIRA), OXYCODONE, BACLOFEN, LEVOTHYROXINE and IBUPROFEN for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weakness) and FATIGUE (Fatigue). On 06-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms as after 1st vaccination) and GAIT DISTURBANCE (Having trouble walking). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like symptoms as after 1st vaccination), GAIT DISTURBANCE (Having trouble walking) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms as after 1st vaccination; Having trouble walking; Fatigue; Stomach symptoms; Diarrhea; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like symptoms as after 1st vaccination) and GAIT DISTURBANCE (Having trouble walking) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ADALIMUMAB (HUMIRA), OXYCODONE, BACLOFEN, LEVOTHYROXINE and IBUPROFEN for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weakness) and FATIGUE (Fatigue). On 06-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms as after 1st vaccination) and GAIT DISTURBANCE (Having trouble walking). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach symptoms), DIARRHOEA (Diarrhea), ASTHENIA (Weakness), INFLUENZA LIKE ILLNESS (Flu like symptoms as after 1st vaccination), GAIT DISTURBANCE (Having trouble walking) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: slight dizziness; no appetite; Fever; chills; sever head ache; feels real tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (slight dizziness), DECREASED APPETITE (no appetite), PYREXIA (Fever), CHILLS (chills) and HEADACHE (sever head ache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not available) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Diabetes.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (slight dizziness), DECREASED APPETITE (no appetite), PYREXIA (Fever), CHILLS (chills), HEADACHE (sever head ache) and FATIGUE (feels real tired). At the time of the report, DIZZINESS (slight dizziness), DECREASED APPETITE (no appetite), PYREXIA (Fever), CHILLS (chills), HEADACHE (sever head ache) and FATIGUE (feels real tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: slight dizziness; no appetite; Fever; chills; sever head ache; feels real tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (slight dizziness), DECREASED APPETITE (no appetite), PYREXIA (Fever), CHILLS (chills) and HEADACHE (sever head ache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not available) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Diabetes.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (slight dizziness), DECREASED APPETITE (no appetite), PYREXIA (Fever), CHILLS (chills), HEADACHE (sever head ache) and FATIGUE (feels real tired). At the time of the report, DIZZINESS (slight dizziness), DECREASED APPETITE (no appetite), PYREXIA (Fever), CHILLS (chills), HEADACHE (sever head ache) and FATIGUE (feels real tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Itchy arm; Spot size of a baseball on left upper arm which is red; She is reporting this as a COVID arm; Spot is swollen; Spot is painful; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy arm), RASH MACULAR (Spot size of a baseball on left upper arm which is red), VACCINATION SITE REACTION (She is reporting this as a COVID arm), VACCINATION SITE SWELLING (Spot is swollen) and VACCINATION SITE PAIN (Spot is painful) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A2JA) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (Itchy arm), RASH MACULAR (Spot size of a baseball on left upper arm which is red), VACCINATION SITE REACTION (She is reporting this as a COVID arm), VACCINATION SITE SWELLING (Spot is swollen) and VACCINATION SITE PAIN (Spot is painful). At the time of the report, PRURITUS (Itchy arm), RASH MACULAR (Spot size of a baseball on left upper arm which is red), VACCINATION SITE REACTION (She is reporting this as a COVID arm), VACCINATION SITE SWELLING (Spot is swollen) and VACCINATION SITE PAIN (Spot is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included Osteoporosis tablets, Cholesterol Medication, Multivitamins.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: pink at the injection site; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (pink at the injection site) and PYREXIA (slight fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included Duodenal ulcer and Thyroidectomy (4 years ago). Concomitant products included LEVOTHYROXINE for an unknown indication.   On 06-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 06-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (pink at the injection site) and PYREXIA (slight fever). The patient was treated with Manual therapy (using heating pan) for Injection site erythema. At the time of the report, INJECTION SITE ERYTHEMA (pink at the injection site) and PYREXIA (slight fever) outcome was unknown.            Treatment medication included using heating pan to help with the pink at injection site, Tylenol. Some medication used for duodenal ulcer.  Patient reported that Symptoms resumed after 2 days.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received on 3-MAY-2021 : Non pharmacological treatment updated for the event pink at the injection site.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Limb discomfort, Pain in extremity
Clinical narrative: Very cold; hand hurt so bad; cant shower, sleep or dress bc cant move hands; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Very cold), PAIN IN EXTREMITY (hand hurt so bad) and LIMB DISCOMFORT (cant shower, sleep or dress bc cant move hands) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FEELING COLD (Very cold), PAIN IN EXTREMITY (hand hurt so bad) and LIMB DISCOMFORT (cant shower, sleep or dress bc cant move hands). The patient was treated with DIPHENHYDRAMINE CITRATE, IBUPROFEN (MOTRIN PM) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING COLD (Very cold), PAIN IN EXTREMITY (hand hurt so bad) and LIMB DISCOMFORT (cant shower, sleep or dress bc cant move hands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: inflamed; her arm that she received the injection in is red, inflamed, itchy, and hot; itchy; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE WARMTH (her arm that she received the injection in is red, inflamed, itchy, and hot), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE WARMTH (her arm that she received the injection in is red, inflamed, itchy, and hot), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red). On 27-Feb-2021, VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE WARMTH (her arm that she received the injection in is red, inflamed, itchy, and hot), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Influenza like illness, Nausea
Clinical narrative: Delayed dizziness after 3 days; Felt weak; heart was racing; hardly breathe; flu like symptoms; Delayed nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Delayed dizziness after 3 days), ASTHENIA (Felt weak), PALPITATIONS (heart was racing), DYSPNOEA (hardly breathe) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 74-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.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (Delayed dizziness after 3 days), ASTHENIA (Felt weak), PALPITATIONS (heart was racing), DYSPNOEA (hardly breathe), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (Delayed nausea). At the time of the report, DIZZINESS (Delayed dizziness after 3 days), ASTHENIA (Felt weak), PALPITATIONS (heart was racing), DYSPNOEA (hardly breathe), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (Delayed nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Delayed dizziness after 3 days; Felt weak; heart was racing; hardly breathe; flu like symptoms; Delayed nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Delayed dizziness after 3 days), ASTHENIA (Felt weak), PALPITATIONS (heart was racing), DYSPNOEA (hardly breathe) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 74-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.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (Delayed dizziness after 3 days), ASTHENIA (Felt weak), PALPITATIONS (heart was racing), DYSPNOEA (hardly breathe), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (Delayed nausea). At the time of the report, DIZZINESS (Delayed dizziness after 3 days), ASTHENIA (Felt weak), PALPITATIONS (heart was racing), DYSPNOEA (hardly breathe), INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (Delayed nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: really bad rash on her right arm (dominant); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (really bad rash on her right arm (dominant)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 VACCINATION SITE RASH (really bad rash on her right arm (dominant)). At the time of the report, VACCINATION SITE RASH (really bad rash on her right arm (dominant)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Cortizone cream twice daily for 4 days.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal chest pain
Clinical narrative: Pain in upper back; Pain in ribs; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Pain in upper back) and MUSCULOSKELETAL CHEST PAIN (Pain in ribs) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced BACK PAIN (Pain in upper back) and MUSCULOSKELETAL CHEST PAIN (Pain in ribs). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Pain in upper back) and MUSCULOSKELETAL CHEST PAIN (Pain in ribs) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  No relevant concomitant medications reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Hypertension
Clinical narrative: dizzy; blood pressure; foggy headed; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), HYPERTENSION (blood pressure), FEELING ABNORMAL (foggy headed), HEADACHE (headache) and CHILLS (chills) 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 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 DIZZINESS (dizzy), HYPERTENSION (blood pressure), FEELING ABNORMAL (foggy headed), HEADACHE (headache) and CHILLS (chills). At the time of the report, DIZZINESS (dizzy), HYPERTENSION (blood pressure), FEELING ABNORMAL (foggy headed), HEADACHE (headache) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleed) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced EPISTAXIS (nose bleed). At the time of the report, EPISTAXIS (nose bleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: slight fever 98.4 degrees F; tired; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever 98.4 degrees F), FATIGUE (tired) and FATIGUE (fatigue) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M2EA and 012AQ1A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Sinusitis.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (slight fever 98.4 degrees F), FATIGUE (tired) and FATIGUE (fatigue). At the time of the report, PYREXIA (slight fever 98.4 degrees F), FATIGUE (tired) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.4 98.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-224949 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: outbreak of shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (outbreak of shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concomitant products included VALACYCLOVIR [VALACICLOVIR] for Shingles.    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 HERPES ZOSTER (outbreak of shingles). At the time of the report, HERPES ZOSTER (outbreak of shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: weakness; dizziness; nausea; fatigue; headache; chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE 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 ASTHENIA (weakness), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and CHILLS (chills). On 08-Mar-2021, ASTHENIA (weakness), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: weakness; dizziness; nausea; fatigue; headache; chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and HEADACHE (headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE 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 ASTHENIA (weakness), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and CHILLS (chills). On 08-Mar-2021, ASTHENIA (weakness), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (headache) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.