chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Neck pain, Vaccination site pain
Clinical narrative: eyes do seem dry; allergic reaction all over the inside and outside of her eyes; slightly warm and a little chilly; eyes also became itchy; feels like a mix of a sunburn and poison ivy in that area; shooting pain up her arm, neck and head; shooting pain up her arm, neck and head; shooting pain up her arm, neck and head; slightly warm and a little chilly; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (eyes do seem dry), ALLERGY TO VACCINE (allergic reaction all over the inside and outside of her eyes), FEELING HOT (slightly warm and a little chilly), EYE PRURITUS (eyes also became itchy; feels like a mix of a sunburn and poison ivy in that area) and VACCINATION SITE PAIN (shooting pain up her arm, neck and head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY EYE (eyes do seem dry), ALLERGY TO VACCINE (allergic reaction all over the inside and outside of her eyes), FEELING HOT (slightly warm and a little chilly), EYE PRURITUS (eyes also became itchy; feels like a mix of a sunburn and poison ivy in that area), VACCINATION SITE PAIN (shooting pain up her arm, neck and head), NECK PAIN (shooting pain up her arm, neck and head), HEADACHE (shooting pain up her arm, neck and head) and CHILLS (slightly warm and a little chilly). At the time of the report, DRY EYE (eyes do seem dry), ALLERGY TO VACCINE (allergic reaction all over the inside and outside of her eyes), FEELING HOT (slightly warm and a little chilly), EYE PRURITUS (eyes also became itchy; feels like a mix of a sunburn and poison ivy in that area), VACCINATION SITE PAIN (shooting pain up her arm, neck and head), NECK PAIN (shooting pain up her arm, neck and head), HEADACHE (shooting pain up her arm, neck and head) and CHILLS (slightly warm and a little chilly) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 100.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events given as some eye drops.   This case was linked to MOD-2021-251046 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eye pruritus, Headache, Heart rate, Neck pain
Clinical narrative: Shooting pain up her arm, neck and head; Shooting pain up her arm, neck and head; Her eye area was still very itchy, both inside her eye and around it; Sometimes her forehead and head with itch; Shooting pain up her arm, neck and head; Fever of 100.8; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Shooting pain up her arm, neck and head), NECK PAIN (Shooting pain up her arm, neck and head), EYE PRURITUS (Her eye area was still very itchy, both inside her eye and around it), PRURITUS (Sometimes her forehead and head with itch) and HEADACHE (Shooting pain up her arm, neck and head) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021 at 2:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever of 100.8). On an unknown date, the patient experienced PAIN IN EXTREMITY (Shooting pain up her arm, neck and head), NECK PAIN (Shooting pain up her arm, neck and head), EYE PRURITUS (Her eye area was still very itchy, both inside her eye and around it), PRURITUS (Sometimes her forehead and head with itch) and HEADACHE (Shooting pain up her arm, neck and head). At the time of the report, PAIN IN EXTREMITY (Shooting pain up her arm, neck and head), NECK PAIN (Shooting pain up her arm, neck and head), EYE PRURITUS (Her eye area was still very itchy, both inside her eye and around it), PRURITUS (Sometimes her forehead and head with itch), HEADACHE (Shooting pain up her arm, neck and head) and PYREXIA (Fever of 100.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Body temperature: 100.8 (High) A fever of 100.8 was reported.. On 26-May-2021, Heart rate: 110 (High) A rapid heart beat of 110 beats/min was reported..         No concomitant medications were reported. Treatment information was not provided.   This case was linked to MOD-2021-250985 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Shooting pain up her arm, neck and head; Shooting pain up her arm, neck and head; Her eye area was still very itchy, both inside her eye and around it; Sometimes her forehead and head with itch; Shooting pain up her arm, neck and head; Fever of 100.8; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Shooting pain up her arm, neck and head), NECK PAIN (Shooting pain up her arm, neck and head), EYE PRURITUS (Her eye area was still very itchy, both inside her eye and around it), PRURITUS (Sometimes her forehead and head with itch) and HEADACHE (Shooting pain up her arm, neck and head) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021 at 2:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever of 100.8). On an unknown date, the patient experienced PAIN IN EXTREMITY (Shooting pain up her arm, neck and head), NECK PAIN (Shooting pain up her arm, neck and head), EYE PRURITUS (Her eye area was still very itchy, both inside her eye and around it), PRURITUS (Sometimes her forehead and head with itch) and HEADACHE (Shooting pain up her arm, neck and head). At the time of the report, PAIN IN EXTREMITY (Shooting pain up her arm, neck and head), NECK PAIN (Shooting pain up her arm, neck and head), EYE PRURITUS (Her eye area was still very itchy, both inside her eye and around it), PRURITUS (Sometimes her forehead and head with itch), HEADACHE (Shooting pain up her arm, neck and head) and PYREXIA (Fever of 100.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Body temperature: 100.8 (High) A fever of 100.8 was reported.. On 26-May-2021, Heart rate: 110 (High) A rapid heart beat of 110 beats/min was reported..         No concomitant medications were reported. Treatment information was not provided.   This case was linked to MOD-2021-250985 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and HEADACHE (Slight headache) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and HEADACHE (Slight headache). The patient was treated with PARACETAMOL for Headache, at a dose of 1 dosage form. On 05-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. At the time of the report, HEADACHE (Slight headache) 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 provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspepsia, Eructation, Weight decreased
Clinical narrative: Burping; stomach upset; indigestion; he is losing a lot of weight; This spontaneous case was reported by a consumer and describes the occurrence of ERUCTATION (Burping), ABDOMINAL DISCOMFORT (stomach upset), DYSPEPSIA (indigestion) and WEIGHT DECREASED (he is losing a lot of weight) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERUCTATION (Burping), ABDOMINAL DISCOMFORT (stomach upset), DYSPEPSIA (indigestion) and WEIGHT DECREASED (he is losing a lot of weight). The patient was treated with OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) at an unspecified dose and frequency. At the time of the report, ERUCTATION (Burping), ABDOMINAL DISCOMFORT (stomach upset), DYSPEPSIA (indigestion) and WEIGHT DECREASED (he is losing a lot of weight) outcome was unknown.            Concomitant medications were not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, COVID-19, Chills, Fatigue, Feeling cold
Clinical narrative: I feel cold; have chills & body aches; body aches; felt really tired, like I've been playing football; temperature was 99.5°F,My temperature was 105°F; I was sweating a lot; I couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (temperature was 99.5°F,My temperature was 105°F), HYPERHIDROSIS (I was sweating a lot), INSOMNIA (I couldn't sleep), FEELING COLD (I feel cold) and CHILLS (have chills & body aches) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 17-Mar-2021. Previously administered products included for an unreported indication: SHINGRIX (Vaccine given for left arm). Concurrent medical conditions included Pneumonia.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced BODY TEMPERATURE INCREASED (temperature was 99.5°F,My temperature was 105°F), HYPERHIDROSIS (I was sweating a lot), INSOMNIA (I couldn't sleep) and FATIGUE (felt really tired, like I've been playing football). On 08-Jul-2021, the patient experienced FEELING COLD (I feel cold), CHILLS (have chills & body aches) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE INCREASED (temperature was 99.5°F,My temperature was 105°F), HYPERHIDROSIS (I was sweating a lot), INSOMNIA (I couldn't sleep), FEELING COLD (I feel cold), CHILLS (have chills & body aches), FATIGUE (felt really tired, like I've been playing football) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, COVID-19: positive (Positive) Positive. On 07-Jul-2021, Pyrexia: 99.5 High. On 08-Jul-2021, Pyrexia: 105 (High) high.     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 medication were Provided. Med Info Agent: 118722 and MOD21-118748. Caller received a phone call from Moderna and was asked to provide an email address. Patient stated that he got both shots and he's "all good now." Patient didn't clarify which shots he got.  He said, "Don't worry about it" and then disconnected the call.  He declined providing his email address.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Event outcome updated
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Myalgia, Pyrexia
Clinical narrative: I feel cold; have chills & body aches; body aches; felt really tired, like I've been playing football; temperature was 99.5°F,My temperature was 105°F; I was sweating a lot; I couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (temperature was 99.5°F,My temperature was 105°F), HYPERHIDROSIS (I was sweating a lot), INSOMNIA (I couldn't sleep), FEELING COLD (I feel cold) and CHILLS (have chills & body aches) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 17-Mar-2021. Previously administered products included for an unreported indication: SHINGRIX (Vaccine given for left arm). Concurrent medical conditions included Pneumonia.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced BODY TEMPERATURE INCREASED (temperature was 99.5°F,My temperature was 105°F), HYPERHIDROSIS (I was sweating a lot), INSOMNIA (I couldn't sleep) and FATIGUE (felt really tired, like I've been playing football). On 08-Jul-2021, the patient experienced FEELING COLD (I feel cold), CHILLS (have chills & body aches) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE INCREASED (temperature was 99.5°F,My temperature was 105°F), HYPERHIDROSIS (I was sweating a lot), INSOMNIA (I couldn't sleep), FEELING COLD (I feel cold), CHILLS (have chills & body aches), FATIGUE (felt really tired, like I've been playing football) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, COVID-19: positive (Positive) Positive. On 07-Jul-2021, Pyrexia: 99.5 High. On 08-Jul-2021, Pyrexia: 105 (High) high.     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 medication were Provided. Med Info Agent: 118722 and MOD21-118748. Caller received a phone call from Moderna and was asked to provide an email address. Patient stated that he got both shots and he's "all good now." Patient didn't clarify which shots he got.  He said, "Don't worry about it" and then disconnected the call.  He declined providing his email address.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Event outcome updated
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pain in extremity, Walking aid user
Clinical narrative: extremely weak; dizzy; Prior to the vaccine she didn't use it constantly, now she uses it all the time.she could not have walked without her walker; extremely sharp pain in her legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extremely sharp pain in her legs), ASTHENIA (extremely weak), DIZZINESS (dizzy) and WALKING AID USER (Prior to the vaccine she didn't use it constantly, now she uses it all the time.she could not have walked without her walker) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D12L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROPINIROLE, PROPRANOLOL, PROCHLORPERAZINE EDISYLATE (COMPAZINE [PROCHLORPERAZINE EDISYLATE]), PRAVASTATIN, PHENAZOPYRIDINE, MULTIVITAMIN [VITAMINS NOS], METFORMIN, MAGNESIUM OXIDE, LINAGLIPTIN (TRADJENTA), HYDROXYZINE, GABAPENTIN, DOCUSATE SODIUM (DOK), COLECALCIFEROL (CHOLECALCIFEROL), ASPIRIN [ACETYLSALICYLIC ACID], AMLODIPINE BESILATE (NORVASC) and TECHNETIUM TC 99M APCITIDE (ACUTECT) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (extremely sharp pain in her legs). On an unknown date, the patient experienced ASTHENIA (extremely weak), DIZZINESS (dizzy) and WALKING AID USER (Prior to the vaccine she didn't use it constantly, now she uses it all the time.she could not have walked without her walker). At the time of the report, PAIN IN EXTREMITY (extremely sharp pain in her legs), ASTHENIA (extremely weak), DIZZINESS (dizzy) and WALKING AID USER (Prior to the vaccine she didn't use it constantly, now she uses it all the time.she could not have walked without her walker) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was vitamin D12. The treatment information was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache,"crazy headache"/ headache on the right side of my head/ headaches began; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache,"crazy headache"/ headache on the right side of my head/ headaches began) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Headache (in patient's young age in 30s and 40s). Concurrent medical conditions included Milk allergy. Concomitant products included AMLODIPINE for Blood pressure high, XANTOFYL, ZEAXANTHIN (EYE HEALTH EXTRA STRENGTH LUTEIN) for Eye disorder NOS, VITAMINS NOS and CALCIUM CITRATE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (slight headache,"crazy headache"/ headache on the right side of my head/ headaches began). The patient was treated with MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (slight headache,"crazy headache"/ headache on the right side of my head/ headaches began) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient sawher doctor and had MRI done, but they did not find anything. Flonase was prescribed to treat her Symptoms. Patient has never been tested positive for COVID -19. Patient had no acute illness at the time of vaccination and up to one month before. Regarding headache patient mentioned sometimes it's intense and sometimes not so intense but it's always there.   This case was linked to MOD-2021-251769 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information received contains Significant information Patient information, relevant history, dosage details, concomitant medication details, facility name, event onset date, event outcome and reporter causality updated.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (miss dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (miss dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (miss dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jul-2021 and was forwarded to Moderna on 08-Jul-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st dose of at the age of 17 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st dose of at the age of 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st dose of at the age of 17 years old) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 17 year old patient has taken the first dose of the Moderna Covid 19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient has taken the first dose of the Moderna Covid 19 Vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient has taken the first dose of the Moderna Covid 19 Vaccine). On 08-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient has taken the first dose of the Moderna Covid 19 Vaccine) 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 concomitant medication reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed her 2nd dose of Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose of Moderna COVID 19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose of Moderna COVID 19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose of Moderna COVID 19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Nausea
Clinical narrative: severe headache; feel nauseated; Decreased appetite; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), NAUSEA (feel nauseated) and DECREASED APPETITE (Decreased appetite) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03AB21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced HEADACHE (severe headache), NAUSEA (feel nauseated) and DECREASED APPETITE (Decreased appetite). At the time of the report, HEADACHE (severe headache), NAUSEA (feel nauseated) and DECREASED APPETITE (Decreased appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No medical information were reported
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: head felt like it would explode; sinuses were stuffy; 103 degree F temperature; tired; whole body hurt; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head felt like it would explode), NASAL CONGESTION (sinuses were stuffy), PYREXIA (103 degree F temperature), FATIGUE (tired) and MYALGIA (whole body hurt) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced HEAD DISCOMFORT (head felt like it would explode), NASAL CONGESTION (sinuses were stuffy), PYREXIA (103 degree F temperature), FATIGUE (tired) and MYALGIA (whole body hurt). At the time of the report, HEAD DISCOMFORT (head felt like it would explode), NASAL CONGESTION (sinuses were stuffy), PYREXIA (103 degree F temperature), FATIGUE (tired) and MYALGIA (whole body hurt) outcome was unknown.            No Concomitant medication was reported. No treatment medication was reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in right leg in joint area; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in right leg in joint area) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced ARTHRALGIA (Pain in right leg in joint area). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in joint involving lower leg, at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (Pain in right leg in joint area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medication used was Allergy medication (Unknown).  Patient also experienced pain radiating to the left leg that he doesn't knowif it is coming from vaccine or not.   This case was linked to MOD-2021-251377 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose of Moderna COVID-19 vaccine outside of 6 week window (51 days after 1st dose); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna COVID-19 vaccine outside of 6 week window (51 days after 1st dose)) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna COVID-19 vaccine outside of 6 week window (51 days after 1st dose)). On 08-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna COVID-19 vaccine outside of 6 week window (51 days after 1st dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: One week after receiving 1st dose, patient started getting pain in right leg in joint area,Pain started radiating to the left leg; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (One week after receiving 1st dose, patient started getting pain in right leg in joint area,Pain started radiating to the left leg) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 041C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced VACCINATION SITE PAIN (One week after receiving 1st dose, patient started getting pain in right leg in joint area,Pain started radiating to the left leg). At the time of the report, VACCINATION SITE PAIN (One week after receiving 1st dose, patient started getting pain in right leg in joint area,Pain started radiating to the left leg) outcome was unknown.            Concomitant medications include Allergy medication Treatment medications include Advil.   This case was linked to MOD-2021-251334 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac murmur, Headache, Nasal congestion
Clinical narrative: Heart Murmur; Nose congestion; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC MURMUR (Heart Murmur), NASAL CONGESTION (Nose congestion) and HEADACHE (Slight Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC MURMUR (Heart Murmur), NASAL CONGESTION (Nose congestion) and HEADACHE (Slight Headache). At the time of the report, CARDIAC MURMUR (Heart Murmur), NASAL CONGESTION (Nose congestion) and HEADACHE (Slight Headache) 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: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient missed her 2nd dose which was scheduled on 11-May-2021.  Concomitant medication not provided.  Treatment information not provided.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Photophobia, Pyrexia
Clinical narrative: Photophobia; Blurred vision; Fever ranging from 101.6/101.7 degrees Fahrenheit; Body aches; Headaches; This spontaneous case was reported by an other caregiver and describes the occurrence of PHOTOPHOBIA (Photophobia), VISION BLURRED (Blurred vision), PYREXIA (Fever ranging from 101.6/101.7 degrees Fahrenheit), MYALGIA (Body aches) and HEADACHE (Headaches) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced PHOTOPHOBIA (Photophobia), VISION BLURRED (Blurred vision), PYREXIA (Fever ranging from 101.6/101.7 degrees Fahrenheit), MYALGIA (Body aches) and HEADACHE (Headaches). The patient was treated with ZINC for Adverse event, at a dose of 1 dosage form; VITAMIN D [VITAMIN D NOS] for Adverse event, at a dose of 1 dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, PHOTOPHOBIA (Photophobia), VISION BLURRED (Blurred vision), PYREXIA (Fever ranging from 101.6/101.7 degrees Fahrenheit), MYALGIA (Body aches) and HEADACHE (Headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2021, Body temperature: 101.6/101.7 (High) Fever ranging from 101.6/101.7 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was provided.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Photophobia; Blurred vision; Fever ranging from 101.6/101.7 degrees Fahrenheit; Body aches; Headaches; This spontaneous case was reported by an other caregiver and describes the occurrence of PHOTOPHOBIA (Photophobia), VISION BLURRED (Blurred vision), PYREXIA (Fever ranging from 101.6/101.7 degrees Fahrenheit), MYALGIA (Body aches) and HEADACHE (Headaches) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced PHOTOPHOBIA (Photophobia), VISION BLURRED (Blurred vision), PYREXIA (Fever ranging from 101.6/101.7 degrees Fahrenheit), MYALGIA (Body aches) and HEADACHE (Headaches). The patient was treated with ZINC for Adverse event, at a dose of 1 dosage form; VITAMIN D [VITAMIN D NOS] for Adverse event, at a dose of 1 dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, PHOTOPHOBIA (Photophobia), VISION BLURRED (Blurred vision), PYREXIA (Fever ranging from 101.6/101.7 degrees Fahrenheit), MYALGIA (Body aches) and HEADACHE (Headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2021, Body temperature: 101.6/101.7 (High) Fever ranging from 101.6/101.7 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was provided.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Pharmacist misread a communication from the Agency and administered a Moderna COVID  vaccination to a 15 year old male.  Concomitant medications were not provided. Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Interchange of vaccine products, Myalgia, Nausea
Clinical narrative: Chills; Fever; Body Aches; Nausea; Loose stools/diarrhea; Mixed vaccination of COVID-19 vaccines-Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed vaccination of COVID-19 vaccines-Pfizer), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body Aches) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) 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 Nexlatol, GABAPENTIN, ALPRAZOLAM (XANAX), VITAMINS NOS (DAILY VITAMINS) and CALCIUM for an unknown indication.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed vaccination of COVID-19 vaccines-Pfizer). On 07-Jul-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body Aches), NAUSEA (Nausea) and DIARRHOEA (Loose stools/diarrhea). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Mixed vaccination of COVID-19 vaccines-Pfizer), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body Aches), NAUSEA (Nausea) and DIARRHOEA (Loose stools/diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Fever; Body Aches; Nausea; Loose stools/diarrhea; Mixed vaccination of COVID-19 vaccines-Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed vaccination of COVID-19 vaccines-Pfizer), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body Aches) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) 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 Nexlatol, GABAPENTIN, ALPRAZOLAM (XANAX), VITAMINS NOS (DAILY VITAMINS) and CALCIUM for an unknown indication.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Mixed vaccination of COVID-19 vaccines-Pfizer). On 07-Jul-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body Aches), NAUSEA (Nausea) and DIARRHOEA (Loose stools/diarrhea). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Mixed vaccination of COVID-19 vaccines-Pfizer), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body Aches), NAUSEA (Nausea) and DIARRHOEA (Loose stools/diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Rash, Urticaria, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: she is feeling in the left side of her back the same reaction she felt in the arm before having a; Injection site started itching a lot; Injection site started getting red; like if she had hives; rash; a little worried; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site started itching a lot), VACCINATION SITE ERYTHEMA (Injection site started getting red), URTICARIA (like if she had hives), RASH (rash) and ANXIETY (a little worried) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site started itching a lot), VACCINATION SITE ERYTHEMA (Injection site started getting red), URTICARIA (like if she had hives), RASH (rash) and ANXIETY (a little worried). On an unknown date, the patient experienced RASH (she is feeling in the left side of her back the same reaction she felt in the arm before having a). At the time of the report, VACCINATION SITE PRURITUS (Injection site started itching a lot), VACCINATION SITE ERYTHEMA (Injection site started getting red), URTICARIA (like if she had hives), RASH (rash) and RASH (she is feeling in the left side of her back the same reaction she felt in the arm before having a) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Lichenoid keratosis
Clinical narrative: Lichenoid dermatitis; This spontaneous case was reported by a consumer and describes the occurrence of LICHENOID KERATOSIS (Lichenoid dermatitis) in a 78-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. In January 2021, the patient experienced LICHENOID KERATOSIS (Lichenoid dermatitis). At the time of the report, LICHENOID KERATOSIS (Lichenoid dermatitis) 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.   Relevant concomitant medications were not reported.  Patient received second dose of Moderna COVID-19 vaccine on 03 -Feb-2021. Patient reported today his Lichenoid dermatitis was not too bad but other times it got very intense. Patient's doctor reported that "the process was not consistent with urticaria". Patient also reported that his dermatologist had another patient (female) who received the Moderna COVID-19 vaccine and early on had the same conditions that he had (itchy and scratching) and she had lichenoid dermatitis.  Patient reported he received various treatments from his dermatologist, not specified.   This case was linked to MOD-2021-251557 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Oral herpes, Peripheral swelling, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Fever blister in her mouth), PERIPHERAL SWELLING (Left hand became Swollen and both feet became Swollen), RASH (She started Rash on both legs), MYALGIA (Left Arm was hurting) and NAUSEA (Nauseous) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced MYALGIA (Left Arm was hurting) and NAUSEA (Nauseous). On 24-Jun-2021, the patient experienced ORAL HERPES (Fever blister in her mouth) and PERIPHERAL SWELLING (Left hand became Swollen and both feet became Swollen). On 28-Jun-2021, the patient experienced RASH (She started Rash on both legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash on leg, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Fever blister in her mouth), PERIPHERAL SWELLING (Left hand became Swollen and both feet became Swollen), MYALGIA (Left Arm was hurting) and NAUSEA (Nauseous) outcome was unknown and RASH (She started Rash on both legs) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 8-Jul-2021, the rash faded a little but still visible. No relevant concomitant medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Groin pain, Myalgia, Pain in extremity
Clinical narrative: muscle pain in her legs, back; muscle pain in her legs, back and groin.; bad muscle pain in her legs; bad muscle pain in her legs; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (bad muscle pain in her legs), BACK PAIN (muscle pain in her legs, back), GROIN PAIN (muscle pain in her legs, back and groin.) and PAIN IN EXTREMITY (bad muscle pain in her legs) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 21ac09021a) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced MYALGIA (bad muscle pain in her legs). On an unknown date, the patient experienced BACK PAIN (muscle pain in her legs, back), GROIN PAIN (muscle pain in her legs, back and groin.) and PAIN IN EXTREMITY (bad muscle pain in her legs). At the time of the report, MYALGIA (bad muscle pain in her legs), BACK PAIN (muscle pain in her legs, back), GROIN PAIN (muscle pain in her legs, back and groin.) and PAIN IN EXTREMITY (bad muscle pain in her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not reported.