chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm is hard and stiff.; Arm stiff; fever; chills; muscle aches; sore arm ated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.; Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to her face; Arm is swollen and when pushed, it is hard and stiff.; has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch her; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), VACCINATION SITE PAIN (sore arm ated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.) and PAIN IN EXTREMITY (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to her face) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Glycopyrrolate and Vyvant.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), VACCINATION SITE PAIN (sore arm ated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.), PAIN IN EXTREMITY (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to her face), VACCINATION SITE SWELLING (Arm is swollen and when pushed, it is hard and stiff.) and VACCINATION SITE BRUISING (has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch her). On an unknown date, the patient experienced VACCINATION SITE INDURATION (Arm is hard and stiff.) and MUSCULOSKELETAL STIFFNESS (Arm stiff). At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), VACCINATION SITE PAIN (sore arm ated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.), PAIN IN EXTREMITY (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to her face), VACCINATION SITE SWELLING (Arm is swollen and when pushed, it is hard and stiff.), VACCINATION SITE BRUISING (has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch her), VACCINATION SITE INDURATION (Arm is hard and stiff.) and MUSCULOSKELETAL STIFFNESS (Arm stiff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: felt lethargic; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lethargic), PYREXIA (fever) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy to antibiotic (Antibiotic which the patient cannot recall) and Allergy (Allergy to Voltaren gel). Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced LETHARGY (felt lethargic), PYREXIA (fever) and CHILLS (chills). At the time of the report, LETHARGY (felt lethargic), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided. Action taken with respect to mRNA-1273 was not applicable. Additional information was provided that patient had not took OTC medication for cough drop.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient outside of 42 days to receive 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient outside of 42 days to receive 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient outside of 42 days to receive 2nd dose). On 29-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient outside of 42 days to receive 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. Treatment information not provided.  "As per client, MO error in DOB capture".
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: explosive diarrhea; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (explosive diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sjogren's syndrome and Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (explosive diarrhea). At the time of the report, DIARRHOEA (explosive diarrhea) had not resolved.            concomitant medication was not reported treatment information was  not provided.   This case was linked to MOD-2021-099514 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: Arm warm to the touch; Left ear pain; Arm red; tired; Fever101.8; headache/aches in the  left side of the head; body aches; strong flu like symptoms; big sweats that night; mucus on nose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (strong flu like symptoms), NIGHT SWEATS (big sweats that night), SECRETION DISCHARGE (mucus on nose), FEELING HOT (Arm warm to the touch) and EAR PAIN (Left ear pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (strong flu like symptoms), NIGHT SWEATS (big sweats that night), SECRETION DISCHARGE (mucus on nose), PAIN (body aches), PYREXIA (Fever101.8) and HEADACHE (headache/aches in the  left side of the head). On 28-Apr-2021, the patient experienced FATIGUE (tired). On 29-Apr-2021, the patient experienced FEELING HOT (Arm warm to the touch), EAR PAIN (Left ear pain) and ERYTHEMA (Arm red). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (strong flu like symptoms), NIGHT SWEATS (big sweats that night), SECRETION DISCHARGE (mucus on nose), FEELING HOT (Arm warm to the touch), EAR PAIN (Left ear pain), ERYTHEMA (Arm red), PYREXIA (Fever101.8), HEADACHE (headache/aches in the  left side of the head) and FATIGUE (tired) outcome was unknown and PAIN (body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Pyrexia: 101.8 (High) 101.8.         Concomitant product use was not provided by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Night sweats, Pain, Pyrexia, Secretion discharge
Clinical narrative: Arm warm to the touch; Left ear pain; Arm red; tired; Fever101.8; headache/aches in the  left side of the head; body aches; strong flu like symptoms; big sweats that night; mucus on nose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (strong flu like symptoms), NIGHT SWEATS (big sweats that night), SECRETION DISCHARGE (mucus on nose), FEELING HOT (Arm warm to the touch) and EAR PAIN (Left ear pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (strong flu like symptoms), NIGHT SWEATS (big sweats that night), SECRETION DISCHARGE (mucus on nose), PAIN (body aches), PYREXIA (Fever101.8) and HEADACHE (headache/aches in the  left side of the head). On 28-Apr-2021, the patient experienced FATIGUE (tired). On 29-Apr-2021, the patient experienced FEELING HOT (Arm warm to the touch), EAR PAIN (Left ear pain) and ERYTHEMA (Arm red). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (strong flu like symptoms), NIGHT SWEATS (big sweats that night), SECRETION DISCHARGE (mucus on nose), FEELING HOT (Arm warm to the touch), EAR PAIN (Left ear pain), ERYTHEMA (Arm red), PYREXIA (Fever101.8), HEADACHE (headache/aches in the  left side of the head) and FATIGUE (tired) outcome was unknown and PAIN (body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Pyrexia: 101.8 (High) 101.8.         Concomitant product use was not provided by the reporter.   Reporter did not allow further contact
Age: 86.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cat scratch disease, Confusional state, Pain in extremity, Peripheral swelling, Rib fracture
Clinical narrative: fracture rib; skin disorder; confusion; cat scratch disease; pain in arm; peripheral swelling; This spontaneous case was reported by a physician and describes the occurrence of RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease) and PAIN IN EXTREMITY (pain in arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Macular degeneration (No Medical History was provided) and Arrhythmia.   On 14-May-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease), PAIN IN EXTREMITY (pain in arm) and PERIPHERAL SWELLING (peripheral swelling). At the time of the report, RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), PAIN IN EXTREMITY (pain in arm) and PERIPHERAL SWELLING (peripheral swelling) had not resolved and CAT SCRATCH DISEASE (cat scratch disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (pain in arm) to be possibly related. No further causality assessments were provided for RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease) and PERIPHERAL SWELLING (peripheral swelling).    On an unknown date, post vaccination, the patient reported that he experienced symptoms of macular degeneration, oxygen saturation low, white blood cells low and fractured rib. The patient also reported that he experienced symptoms of skin disorder, confusion, cat scratch disease and peripheral swelling.   No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: No new information was received.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except Cat Scratch disease which is unlikely.
Age: 86.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Skin disorder
Clinical narrative: fracture rib; skin disorder; confusion; cat scratch disease; pain in arm; peripheral swelling; This spontaneous case was reported by a physician and describes the occurrence of RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease) and PAIN IN EXTREMITY (pain in arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Macular degeneration (No Medical History was provided) and Arrhythmia.   On 14-May-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease), PAIN IN EXTREMITY (pain in arm) and PERIPHERAL SWELLING (peripheral swelling). At the time of the report, RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), PAIN IN EXTREMITY (pain in arm) and PERIPHERAL SWELLING (peripheral swelling) had not resolved and CAT SCRATCH DISEASE (cat scratch disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (pain in arm) to be possibly related. No further causality assessments were provided for RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease) and PERIPHERAL SWELLING (peripheral swelling).    On an unknown date, post vaccination, the patient reported that he experienced symptoms of macular degeneration, oxygen saturation low, white blood cells low and fractured rib. The patient also reported that he experienced symptoms of skin disorder, confusion, cat scratch disease and peripheral swelling.   No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: No new information was received.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except Cat Scratch disease which is unlikely.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: sweating for 4 days; fever of 103; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating for 4 days), PYREXIA (fever of 103) and MYALGIA (body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (fever of 103) and MYALGIA (body aches). On an unknown date, the patient experienced HYPERHIDROSIS (sweating for 4 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Mar-2021, PYREXIA (fever of 103) and MYALGIA (body aches) had resolved. At the time of the report, HYPERHIDROSIS (sweating for 4 days) 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 were provided.   This case was linked to MOD-2021-099496 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Ear pain, Hyperhidrosis
Clinical narrative: She feels like she is having migraine right now; She feels nauseous; She has stomach upset.; She is having stomach cramps; At midnight, she woke up with sweats; Chills; Her temperature was 99.3; Her head was hurting so bad at midnight so she used ice packs.; Her ear drums were hurting; On same day at night, she had a really sore left arm(injected arm); it went up to shoulder/ now pain is radiating to neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (On same day at night, she had a really sore left arm(injected arm)), PAIN (it went up to shoulder/ now pain is radiating to neck), MIGRAINE (She feels like she is having migraine right now), NAUSEA (She feels nauseous) and ABDOMINAL DISCOMFORT (She has stomach upset.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Levothyroxine 50mcg.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE PAIN (On same day at night, she had a really sore left arm(injected arm)) and PAIN (it went up to shoulder/ now pain is radiating to neck). On 30-Apr-2021, the patient experienced MIGRAINE (She feels like she is having migraine right now), NAUSEA (She feels nauseous), ABDOMINAL DISCOMFORT (She has stomach upset.), ABDOMINAL PAIN UPPER (She is having stomach cramps), HYPERHIDROSIS (At midnight, she woke up with sweats), CHILLS (Chills), PYREXIA (Her temperature was 99.3), PAIN (Her head was hurting so bad at midnight so she used ice packs.) and EAR PAIN (Her ear drums were hurting). At the time of the report, VACCINATION SITE PAIN (On same day at night, she had a really sore left arm(injected arm)), PAIN (it went up to shoulder/ now pain is radiating to neck), MIGRAINE (She feels like she is having migraine right now), NAUSEA (She feels nauseous), ABDOMINAL DISCOMFORT (She has stomach upset.), ABDOMINAL PAIN UPPER (She is having stomach cramps), HYPERHIDROSIS (At midnight, she woke up with sweats), CHILLS (Chills), PYREXIA (Her temperature was 99.3), PAIN (Her head was hurting so bad at midnight so she used ice packs.) and EAR PAIN (Her ear drums were hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment: Tylenol   This case was linked to US-MODERNATX, INC.-MOD-2021-099513 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-099513:case for wife
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: She feels like she is having migraine right now; She feels nauseous; She has stomach upset.; She is having stomach cramps; At midnight, she woke up with sweats; Chills; Her temperature was 99.3; Her head was hurting so bad at midnight so she used ice packs.; Her ear drums were hurting; On same day at night, she had a really sore left arm(injected arm); it went up to shoulder/ now pain is radiating to neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (On same day at night, she had a really sore left arm(injected arm)), PAIN (it went up to shoulder/ now pain is radiating to neck), MIGRAINE (She feels like she is having migraine right now), NAUSEA (She feels nauseous) and ABDOMINAL DISCOMFORT (She has stomach upset.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Levothyroxine 50mcg.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE PAIN (On same day at night, she had a really sore left arm(injected arm)) and PAIN (it went up to shoulder/ now pain is radiating to neck). On 30-Apr-2021, the patient experienced MIGRAINE (She feels like she is having migraine right now), NAUSEA (She feels nauseous), ABDOMINAL DISCOMFORT (She has stomach upset.), ABDOMINAL PAIN UPPER (She is having stomach cramps), HYPERHIDROSIS (At midnight, she woke up with sweats), CHILLS (Chills), PYREXIA (Her temperature was 99.3), PAIN (Her head was hurting so bad at midnight so she used ice packs.) and EAR PAIN (Her ear drums were hurting). At the time of the report, VACCINATION SITE PAIN (On same day at night, she had a really sore left arm(injected arm)), PAIN (it went up to shoulder/ now pain is radiating to neck), MIGRAINE (She feels like she is having migraine right now), NAUSEA (She feels nauseous), ABDOMINAL DISCOMFORT (She has stomach upset.), ABDOMINAL PAIN UPPER (She is having stomach cramps), HYPERHIDROSIS (At midnight, she woke up with sweats), CHILLS (Chills), PYREXIA (Her temperature was 99.3), PAIN (Her head was hurting so bad at midnight so she used ice packs.) and EAR PAIN (Her ear drums were hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment: Tylenol   This case was linked to US-MODERNATX, INC.-MOD-2021-099513 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-099513:case for wife
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Vaccination site pain
Clinical narrative: had flu like reaction but not strong ones; soreness on injection site; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu like reaction but not strong ones), VACCINATION SITE PAIN (soreness on injection site) and FATIGUE (feeling tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (had flu like reaction but not strong ones), VACCINATION SITE PAIN (soreness on injection site) and FATIGUE (feeling tired). On 12-Feb-2021, INFLUENZA LIKE ILLNESS (had flu like reaction but not strong ones), VACCINATION SITE PAIN (soreness on injection site) and FATIGUE (feeling tired) had resolved.        Concomitant medications was not reported. Treatment history was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-032269, US-MODERNATX, INC.-MOD-2021-065557 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-032269:Wife case US-MODERNATX, INC.-MOD-2021-065557:wife case
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site bruise, Chills, Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: fever; chills; muscle ache; sore arm rated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.; Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to; it is swollen and when pushed it is hard and stiff.; it is hard and stiff.; has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (muscle ache), PAIN IN EXTREMITY (sore arm rated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.) and SENSORY DISTURBANCE (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information reported.  Concomitant products included GLYCOPYRROLATE and LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (muscle ache), PAIN IN EXTREMITY (sore arm rated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.), SENSORY DISTURBANCE (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to), PERIPHERAL SWELLING (it is swollen and when pushed it is hard and stiff.), MUSCULOSKELETAL STIFFNESS ( it is hard and stiff.) and ADMINISTRATION SITE BRUISE (has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch). At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (muscle ache), PAIN IN EXTREMITY (sore arm rated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.), SENSORY DISTURBANCE (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to), PERIPHERAL SWELLING (it is swollen and when pushed it is hard and stiff.), MUSCULOSKELETAL STIFFNESS ( it is hard and stiff.) and ADMINISTRATION SITE BRUISE (has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient treated events with Tylenol and an ice pack per HCP.    This case was linked to MOD-2021-099429 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Sensory disturbance
Clinical narrative: fever; chills; muscle ache; sore arm rated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.; Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to; it is swollen and when pushed it is hard and stiff.; it is hard and stiff.; has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (muscle ache), PAIN IN EXTREMITY (sore arm rated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.) and SENSORY DISTURBANCE (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information reported.  Concomitant products included GLYCOPYRROLATE and LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (muscle ache), PAIN IN EXTREMITY (sore arm rated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.), SENSORY DISTURBANCE (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to), PERIPHERAL SWELLING (it is swollen and when pushed it is hard and stiff.), MUSCULOSKELETAL STIFFNESS ( it is hard and stiff.) and ADMINISTRATION SITE BRUISE (has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch). At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (muscle ache), PAIN IN EXTREMITY (sore arm rated pain as 6 to 7 out of 10, kinda like inhibits doing stuff.), SENSORY DISTURBANCE (Feels like arm is broken, hurts whenever she holds a drink, can barely lift her mobile phone up to), PERIPHERAL SWELLING (it is swollen and when pushed it is hard and stiff.), MUSCULOSKELETAL STIFFNESS ( it is hard and stiff.) and ADMINISTRATION SITE BRUISE (has a bruise on the injection site, became bigger, size of a fist and looks like somebody punch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient treated events with Tylenol and an ice pack per HCP.    This case was linked to MOD-2021-099429 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip swelling, Oral herpes, Pyrexia, Vaccination site erythema
Clinical narrative: my arm was red at the injection site; Cold sore; bottom right lip is swollen; fever of 102.5°F 12 hrs later; sore at the injection site; The skin on my arm, not near the injection site, was red with little tiny red discolorations; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (The skin on my arm, not near the injection site, was red with little tiny red discolorations), ORAL HERPES (Cold sore), LIP SWELLING (bottom right lip is swollen), VACCINATION SITE ERYTHEMA (my arm was red at the injection site) and PYREXIA (fever of 102.5°F 12 hrs later) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 26-Apr-2021, the patient experienced ERYTHEMA (The skin on my arm, not near the injection site, was red with little tiny red discolorations), PYREXIA (fever of 102.5°F 12 hrs later) and VACCINATION SITE PAIN (sore at the injection site). On 29-Apr-2021, the patient experienced ORAL HERPES (Cold sore) and LIP SWELLING (bottom right lip is swollen). On 30-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (my arm was red at the injection site). At the time of the report, ERYTHEMA (The skin on my arm, not near the injection site, was red with little tiny red discolorations), ORAL HERPES (Cold sore), LIP SWELLING (bottom right lip is swollen), VACCINATION SITE ERYTHEMA (my arm was red at the injection site), PYREXIA (fever of 102.5°F 12 hrs later) and VACCINATION SITE PAIN (sore at the injection site) outcome was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my arm was red at the injection site; Cold sore; bottom right lip is swollen; fever of 102.5°F 12 hrs later; sore at the injection site; The skin on my arm, not near the injection site, was red with little tiny red discolorations; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (The skin on my arm, not near the injection site, was red with little tiny red discolorations), ORAL HERPES (Cold sore), LIP SWELLING (bottom right lip is swollen), VACCINATION SITE ERYTHEMA (my arm was red at the injection site) and PYREXIA (fever of 102.5°F 12 hrs later) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 26-Apr-2021, the patient experienced ERYTHEMA (The skin on my arm, not near the injection site, was red with little tiny red discolorations), PYREXIA (fever of 102.5°F 12 hrs later) and VACCINATION SITE PAIN (sore at the injection site). On 29-Apr-2021, the patient experienced ORAL HERPES (Cold sore) and LIP SWELLING (bottom right lip is swollen). On 30-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (my arm was red at the injection site). At the time of the report, ERYTHEMA (The skin on my arm, not near the injection site, was red with little tiny red discolorations), ORAL HERPES (Cold sore), LIP SWELLING (bottom right lip is swollen), VACCINATION SITE ERYTHEMA (my arm was red at the injection site), PYREXIA (fever of 102.5°F 12 hrs later) and VACCINATION SITE PAIN (sore at the injection site) outcome was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mild muscle pain; Mild joint pain; Mild headache; Bodyaches; Fevorish at and around the injection site; Swelling at and around the injection site; Redness at and around the injection site; Soreness at and around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bodyaches), INJECTION SITE WARMTH (Fevorish at and around the injection site), MYALGIA (Mild muscle pain), ARTHRALGIA (Mild joint pain) and INJECTION SITE SWELLING (Swelling at and around the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Drug allergy (Nyquil/Dayquil allergy), Drug allergy (Aspartame allergy), Fibromyalgia since 1995, Osteoarthritis, Irritable bowel syndrome since 1991, Overactive bladder since 1981, Mitral valve prolapse since 1991 and Acid reflux (esophageal) since 1996. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, COLECALCIFEROL (VITAMIN D 3) for Deficiency vitamin, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for Fibromyalgia, FISH OIL and GARLIC [ALLIUM SATIVUM] for Heart disease, unspecified, CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) for Osteopenia, OXYBUTYNIN for Overactive bladder.   On 13-Feb-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE WARMTH (Fevorish at and around the injection site), INJECTION SITE SWELLING (Swelling at and around the injection site), INJECTION SITE ERYTHEMA (Redness at and around the injection site) and INJECTION SITE PAIN (Soreness at and around the injection site). On 14-Mar-2021, the patient experienced PAIN (Bodyaches). On 14-Mar-2021 at 10:00 AM, the patient experienced MYALGIA (Mild muscle pain). 14-Mar-2021 at 10:00 AM, the patient experienced ARTHRALGIA (Mild joint pain) and HEADACHE (Mild headache). The patient was treated with PARACETAMOL (TYLENOL) 14-Mar-2021 for Headache and Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Bodyaches), INJECTION SITE WARMTH (Fevorish at and around the injection site), MYALGIA (Mild muscle pain), ARTHRALGIA (Mild joint pain), INJECTION SITE SWELLING (Swelling at and around the injection site), INJECTION SITE ERYTHEMA (Redness at and around the injection site), INJECTION SITE PAIN (Soreness at and around the injection site) and HEADACHE (Mild headache) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Pain
Clinical narrative: Mild muscle pain; Mild joint pain; Mild headache; Bodyaches; Fevorish at and around the injection site; Swelling at and around the injection site; Redness at and around the injection site; Soreness at and around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bodyaches), INJECTION SITE WARMTH (Fevorish at and around the injection site), MYALGIA (Mild muscle pain), ARTHRALGIA (Mild joint pain) and INJECTION SITE SWELLING (Swelling at and around the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Drug allergy (Nyquil/Dayquil allergy), Drug allergy (Aspartame allergy), Fibromyalgia since 1995, Osteoarthritis, Irritable bowel syndrome since 1991, Overactive bladder since 1981, Mitral valve prolapse since 1991 and Acid reflux (esophageal) since 1996. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, COLECALCIFEROL (VITAMIN D 3) for Deficiency vitamin, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for Fibromyalgia, FISH OIL and GARLIC [ALLIUM SATIVUM] for Heart disease, unspecified, CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]) for Osteopenia, OXYBUTYNIN for Overactive bladder.   On 13-Feb-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE WARMTH (Fevorish at and around the injection site), INJECTION SITE SWELLING (Swelling at and around the injection site), INJECTION SITE ERYTHEMA (Redness at and around the injection site) and INJECTION SITE PAIN (Soreness at and around the injection site). On 14-Mar-2021, the patient experienced PAIN (Bodyaches). On 14-Mar-2021 at 10:00 AM, the patient experienced MYALGIA (Mild muscle pain). 14-Mar-2021 at 10:00 AM, the patient experienced ARTHRALGIA (Mild joint pain) and HEADACHE (Mild headache). The patient was treated with PARACETAMOL (TYLENOL) 14-Mar-2021 for Headache and Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Bodyaches), INJECTION SITE WARMTH (Fevorish at and around the injection site), MYALGIA (Mild muscle pain), ARTHRALGIA (Mild joint pain), INJECTION SITE SWELLING (Swelling at and around the injection site), INJECTION SITE ERYTHEMA (Redness at and around the injection site), INJECTION SITE PAIN (Soreness at and around the injection site) and HEADACHE (Mild headache) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-038254 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Rash pruritic, Sleep disorder
Clinical narrative: Cannot sleep; Itchy rash that is uncomfortable on arms and legs; High fever; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Cannot sleep), RASH PRURITIC (Itchy rash that is uncomfortable on arms and legs) and PYREXIA (High fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.  Concurrent medical conditions included Diabetes. Concomitant products included EMPAGLIFLOZIN (JARDIANCE) for Diabetes.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced PYREXIA (High fever). On 29-Apr-2021, the patient experienced RASH PRURITIC (Itchy rash that is uncomfortable on arms and legs). On an unknown date, the patient experienced SLEEP DISORDER (Cannot sleep). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Fever, at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Rash, at an unspecified dose and frequency. On 26-Apr-2021, PYREXIA (High fever) had resolved. At the time of the report, SLEEP DISORDER (Cannot sleep) and RASH PRURITIC (Itchy rash that is uncomfortable on arms and legs) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Body temperature: 103 (High) 103 Fahrenheit.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Low grade fever; minor nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) and NAUSEA (minor nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 02BL2OA) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included MELOXICAM, CITALOPRAM, TAMSULOSIN, ATORVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Low grade fever) and NAUSEA (minor nausea). On 12-Feb-2021, PYREXIA (Low grade fever) and NAUSEA (minor nausea) had resolved.            This case was linked to MOD-2021-008303, MOD-2021-099943 (Patient Link).   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness where she shot me; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness where she shot me) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness where she shot me). On 30-Mar-2021, VACCINATION SITE PAIN (soreness where she shot me) had resolved.            This case was linked to MOD-2021-033469 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right arm painful for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm painful for 2 days) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Blood pressure management, GERD and Cholesterol. Concomitant products included LISINOPRIL from an unknown date to 21-Apr-2021 for Blood pressure, MAGNESIUM for Bone disorder NOS and Muscle disorder NOS, ATORVASTATIN for Cholesterol, PANTOPRAZOLE for GERD, BIOTIN for Hair disorder NOS, Nail disorder NOS and Skin disorder NOS, ACETYLSALICYLIC ACID (ASPIRIN LOW) for Heart disease, unspecified.   On 04-Feb-2021 at 8:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021 at 3:11 AM, the patient experienced PAIN IN EXTREMITY (Right arm painful for 2 days). On 11-Mar-2021, PAIN IN EXTREMITY (Right arm painful for 2 days) had resolved.            It was reported that the patient experiences a similar reaction from the yearly flu vaccinations.  Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-034711, MOD-2021-034040 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Fluid ran half way down the arm; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Fluid ran half way down the arm) 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 27-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 27-Apr-2021, the patient experienced UNDERDOSE (Fluid ran half way down the arm). On 27-Apr-2021, UNDERDOSE (Fluid ran half way down the arm) had resolved.            Concomitant medication was not reported.  Treatment information was not provided.