chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia, Nausea, Pyrexia
Clinical narrative: after the second shot I was very very sick/symptoms after the second vaccine hung on for a while; Fatigue; high fever; headache; Chills; Body ache; Severe Nausea; Diarrhea; stomach is just not right; heart burn and acid reflux; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (stomach is just not right), GASTROOESOPHAGEAL REFLUX DISEASE (heart burn and acid reflux), ILLNESS (after the second shot I was very very sick/symptoms after the second vaccine hung on for a while) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (stomach is just not right), GASTROOESOPHAGEAL REFLUX DISEASE (heart burn and acid reflux), FATIGUE (Fatigue), PYREXIA (high fever), HEADACHE (headache), CHILLS (Chills), MYALGIA (Body ache) and NAUSEA (Severe Nausea). On an unknown date, the patient experienced ILLNESS (after the second shot I was very very sick/symptoms after the second vaccine hung on for a while). The patient was treated with CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) at an unspecified dose and frequency and CALCIUM CARBONATE, MAGNESIUM HYDROXIDE (ROLAIDS [CALCIUM CARBONATE;MAGNESIUM HYDROXIDE]) at an unspecified dose and frequency. On 11-Mar-2021, PYREXIA (high fever) had resolved. On 12-Mar-2021, DIARRHOEA (Diarrhea), CHILLS (Chills), MYALGIA (Body ache) and NAUSEA (Severe Nausea) had resolved. On 15-Mar-2021, FATIGUE (Fatigue) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (stomach is just not right), GASTROOESOPHAGEAL REFLUX DISEASE (heart burn and acid reflux) and HEADACHE (headache) had not resolved and ILLNESS (after the second shot I was very very sick/symptoms after the second vaccine hung on for a while) outcome was unknown.            No concomitant medications were reported.   Action taken with mRNA-1273 in response to the event was not applicable.          This case was linked to MOD-2021-059889 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-May-2021, contains non-significant information.; Sender's Comments:  MOD-2021-059889:First Dose of Vaccine case for same patient.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Somnolence, Swelling
Clinical narrative: very swollen; very red; felt a lot of sleepiness; a lot of itching; red mark around; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (very swollen), ERYTHEMA (very red), SOMNOLENCE (felt a lot of sleepiness), PRURITUS (a lot of itching) and ERYTHEMA (red mark around) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (NO MEDICAL HSTORY REPORTED).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-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 SWELLING (very swollen), ERYTHEMA (very red), SOMNOLENCE (felt a lot of sleepiness), PRURITUS (a lot of itching) and ERYTHEMA (red mark around). At the time of the report, SWELLING (very swollen), ERYTHEMA (very red), SOMNOLENCE (felt a lot of sleepiness), PRURITUS (a lot of itching) and ERYTHEMA (red mark around) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Constipation, Insomnia, Nightmare, Pyrexia
Clinical narrative: Constipation; Fever 100.6; Chills; Couldn't sleep; Had bad dream; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), NIGHTMARE (Had bad dream), CONSTIPATION (Constipation), PYREXIA (Fever 100.6) and CHILLS (Chills) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for an unknown indication.     The patient's past medical history included No adverse event since an unknown date.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INSOMNIA (Couldn't sleep) and NIGHTMARE (Had bad dream). On an unknown date, the patient experienced CONSTIPATION (Constipation), PYREXIA (Fever 100.6) and CHILLS (Chills). At the time of the report, INSOMNIA (Couldn't sleep), NIGHTMARE (Had bad dream), CONSTIPATION (Constipation), PYREXIA (Fever 100.6) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia (Unknown-100.6): (High) 100.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose more than 42 days ago. Yet to get second dose; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose more than 42 days ago. Yet to get second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 (First dose more than 42 days ago. Yet to get second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose more than 42 days ago. Yet to get second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: No specific follow-up information recorded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: area was hot; Patient had little discomfort on 1st day of receiving vaccine; her arm started itching at injection site 7 days after receiving 1st dose; she felt fatigued; it is still big and red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (area was hot), DISCOMFORT (Patient had little discomfort on 1st day of receiving vaccine), VACCINATION SITE PRURITUS (her arm started itching at injection site 7 days after receiving 1st dose), FATIGUE (she felt fatigued) and VACCINATION SITE ERYTHEMA (it is still big and red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and HYDROCHLOROTHIAZIDE, VALSARTAN (DIOVAN HCT) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE WARMTH (area was hot), DISCOMFORT (Patient had little discomfort on 1st day of receiving vaccine), VACCINATION SITE PRURITUS (her arm started itching at injection site 7 days after receiving 1st dose), FATIGUE (she felt fatigued) and VACCINATION SITE ERYTHEMA (it is still big and red). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (area was hot), DISCOMFORT (Patient had little discomfort on 1st day of receiving vaccine), VACCINATION SITE PRURITUS (her arm started itching at injection site 7 days after receiving 1st dose), FATIGUE (she felt fatigued) and VACCINATION SITE ERYTHEMA (it is still big and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter       Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 contains significant information includes event update, Reporter's details, product information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: neck is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (neck is swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced SWELLING (neck is swollen). On 28-Feb-2021, SWELLING (neck is swollen) had resolved. Not Provided          Treatment details were not provided. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: facial reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (facial reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (facial reactions). At the time of the report, VACCINATION COMPLICATION (facial reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow-up received and contains no new information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Chills, Fatigue, Hyperhidrosis
Clinical narrative: anxious; migraine headache; started getting a little tired; fatigued; all of a sudden she wanted to go back to daily routine but she fell asleep in the couch; got nauseated; had chills; fever; broke a sweat; joint pain; muscle pain; it was a little sore on my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (it was a little sore on my arm), FATIGUE (started getting a little tired), FATIGUE (fatigued), ANXIETY (anxious) and SOMNOLENCE (all of a sudden she wanted to go back to daily routine but she fell asleep in the couch) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Benadryl for nausea, Tramadol for pain, Tylenol ocassionally for pain, Ativan for panic disorder severe anxiety and PTSD, Risperidone small dose and Andriol for cardiac for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (it was a little sore on my arm). On 18-Mar-2021, the patient experienced FATIGUE (started getting a little tired), FATIGUE (fatigued), SOMNOLENCE (all of a sudden she wanted to go back to daily routine but she fell asleep in the couch), NAUSEA (got nauseated), CHILLS (had chills), PYREXIA (fever), HYPERHIDROSIS (broke a sweat), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On an unknown date, the patient experienced ANXIETY (anxious) and MIGRAINE (migraine headache). At the time of the report, PAIN IN EXTREMITY (it was a little sore on my arm), FATIGUE (started getting a little tired), FATIGUE (fatigued), NAUSEA (got nauseated), CHILLS (had chills), PYREXIA (fever), HYPERHIDROSIS (broke a sweat), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: anxious; migraine headache; started getting a little tired; fatigued; all of a sudden she wanted to go back to daily routine but she fell asleep in the couch; got nauseated; had chills; fever; broke a sweat; joint pain; muscle pain; it was a little sore on my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (it was a little sore on my arm), FATIGUE (started getting a little tired), FATIGUE (fatigued), ANXIETY (anxious) and SOMNOLENCE (all of a sudden she wanted to go back to daily routine but she fell asleep in the couch) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Benadryl for nausea, Tramadol for pain, Tylenol ocassionally for pain, Ativan for panic disorder severe anxiety and PTSD, Risperidone small dose and Andriol for cardiac for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (it was a little sore on my arm). On 18-Mar-2021, the patient experienced FATIGUE (started getting a little tired), FATIGUE (fatigued), SOMNOLENCE (all of a sudden she wanted to go back to daily routine but she fell asleep in the couch), NAUSEA (got nauseated), CHILLS (had chills), PYREXIA (fever), HYPERHIDROSIS (broke a sweat), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On an unknown date, the patient experienced ANXIETY (anxious) and MIGRAINE (migraine headache). At the time of the report, PAIN IN EXTREMITY (it was a little sore on my arm), FATIGUE (started getting a little tired), FATIGUE (fatigued), NAUSEA (got nauseated), CHILLS (had chills), PYREXIA (fever), HYPERHIDROSIS (broke a sweat), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: anxious; migraine headache; started getting a little tired; fatigued; all of a sudden she wanted to go back to daily routine but she fell asleep in the couch; got nauseated; had chills; fever; broke a sweat; joint pain; muscle pain; it was a little sore on my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (it was a little sore on my arm), FATIGUE (started getting a little tired), FATIGUE (fatigued), ANXIETY (anxious) and SOMNOLENCE (all of a sudden she wanted to go back to daily routine but she fell asleep in the couch) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Benadryl for nausea, Tramadol for pain, Tylenol ocassionally for pain, Ativan for panic disorder severe anxiety and PTSD, Risperidone small dose and Andriol for cardiac for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (it was a little sore on my arm). On 18-Mar-2021, the patient experienced FATIGUE (started getting a little tired), FATIGUE (fatigued), SOMNOLENCE (all of a sudden she wanted to go back to daily routine but she fell asleep in the couch), NAUSEA (got nauseated), CHILLS (had chills), PYREXIA (fever), HYPERHIDROSIS (broke a sweat), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On an unknown date, the patient experienced ANXIETY (anxious) and MIGRAINE (migraine headache). At the time of the report, PAIN IN EXTREMITY (it was a little sore on my arm), FATIGUE (started getting a little tired), FATIGUE (fatigued), NAUSEA (got nauseated), CHILLS (had chills), PYREXIA (fever), HYPERHIDROSIS (broke a sweat), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Pyrexia, Tremor
Clinical narrative: diarrhea every other day; fever; fatigue; had shakes all over her body but not from cold; Felt like palsy; strange; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea every other day), TREMOR (had shakes all over her body but not from cold; Felt like palsy), FEELING ABNORMAL (strange), FATIGUE (fatigue) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FEELING ABNORMAL (strange). On 13-Mar-2021, the patient experienced TREMOR (had shakes all over her body but not from cold; Felt like palsy). On 14-Mar-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced DIARRHOEA (diarrhea every other day) and PYREXIA (fever). At the time of the report, DIARRHOEA (diarrhea every other day), TREMOR (had shakes all over her body but not from cold; Felt like palsy), FEELING ABNORMAL (strange) and PYREXIA (fever) outcome was unknown and FATIGUE (fatigue) had resolved.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Formication, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Extremely mild reaction; Skin crawling feeling; Injection site swollen up to size of an egg, cleared up day after; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Extremely mild reaction), FORMICATION (Skin crawling feeling) and VACCINATION SITE SWELLING (Injection site swollen up to size of an egg, cleared up day after) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE REACTION (Extremely mild reaction), FORMICATION (Skin crawling feeling) and VACCINATION SITE SWELLING (Injection site swollen up to size of an egg, cleared up day after). On 20-Mar-2021, VACCINATION SITE REACTION (Extremely mild reaction), FORMICATION (Skin crawling feeling) and VACCINATION SITE SWELLING (Injection site swollen up to size of an egg, cleared up day after) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information  received on 11-May-2021 contains non-significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dizziness and severe headache in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 023M20A and 006B21A) for an unknown indication. The patient's past medical history included no adverse event. On Feb 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 22, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 23, 2021, patient experienced dizziness and severe headache. At the time of the report, dizziness and severe headache outcome: unknown/not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Swollen lymph nodes; Chills; Fever; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.    Co-suspect product included non-company product BUSPIRONE for an unknown indication.    The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included ENALAPRIL, FAMOTIDINE, COLECALCIFEROL, FISH OIL (OMEGA 3D), MULTIVITAMIN [VITAMINS NOS], METHOCARBAMOL, LOSARTAN POTASSIUM (COZARIL), GARLIC [ALLIUM SATIVUM], TRAMADOL, ATORVASTATIN and GABAPENTIN (GABAPEN) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started BUSPIRONE (unknown route) at an unspecified dose. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (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.   Treatment medications included paracetamol.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Grip strength decreased, Muscle tightness, Tremor
Clinical narrative: Tightness in arm; Shaking of right arm; Couldn't grip anything; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Tightness in arm), TREMOR (Shaking of right arm) and GRIP STRENGTH DECREASED (Couldn't grip anything) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 25-Mar-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in arm), TREMOR (Shaking of right arm) and GRIP STRENGTH DECREASED (Couldn't grip anything). At the time of the report, MUSCLE TIGHTNESS (Tightness in arm), TREMOR (Shaking of right arm) and GRIP STRENGTH DECREASED (Couldn't grip anything) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain to leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain to leg) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain to leg). At the time of the report, PAIN IN EXTREMITY (pain to leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle twitching
Clinical narrative: L arm twitching inside the elbow and bruised yellow; twitching; Lymph nodes of L arm swelling; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (L arm twitching inside the elbow and bruised yellow), MUSCLE TWITCHING (twitching) and LYMPHADENOPATHY (Lymph nodes of L arm swelling) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 030B21A) for COVID-19 vaccination.     patient medical history was not reported.  Concomitant products included MINOCYCLINE and CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (L arm twitching inside the elbow and bruised yellow), MUSCLE TWITCHING (twitching) and LYMPHADENOPATHY (Lymph nodes of L arm swelling). At the time of the report, MUSCLE TWITCHING (L arm twitching inside the elbow and bruised yellow), MUSCLE TWITCHING (twitching) and LYMPHADENOPATHY (Lymph nodes of L arm swelling) outcome was unknown.            patient medical history was not reported.  Concomitant products included MINOCYCLINE and CURCUMA LONGA  no treatment medications were reported   This case was linked to MOD-2021-273942 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant follow-up received. Patient date of birth was updated. 2nd dose Batch no was updated. Event verbatim was updated to twitching.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Vaccination site pain
Clinical narrative: Diarrhea; Injection site throbbing; Injection site aching/Injection site hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Injection site throbbing) and VACCINATION SITE PAIN (Injection site aching/Injection site hurt so bad) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included No adverse event (no medical history provided).   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced PAIN (Injection site throbbing) and VACCINATION SITE PAIN (Injection site aching/Injection site hurt so bad). On 21-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Diarrhea, at an unspecified dose and frequency; Manual therapy (Patient used her homemade cream that she uses for aches and pains) for Pain and Manual therapy (Patient used her homemade cream that she uses for aches and pains) for Vaccination site pain. On 23-Mar-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, PAIN (Injection site throbbing) and VACCINATION SITE PAIN (Injection site aching/Injection site hurt so bad) outcome was unknown. Not Provided   Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information received from the initial reporter: The reporter declined to provided email address or any other information.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Inappropriate schedule of product administration, Pain in extremity, Peripheral swelling
Clinical narrative: 2nd vaccine is scheduled on 4th may 2021; sinus infection from allergies; coughing up flehm; soreness in arm; severe fatigue; numbness to hand; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection from allergies), PRODUCTIVE COUGH (coughing up flehm), HYPOAESTHESIA (numbness to hand), PERIPHERAL SWELLING (Swollen arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd vaccine is scheduled on 4th may 2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified, Emphysema and COPD.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPOAESTHESIA (numbness to hand) and PERIPHERAL SWELLING (Swollen arm). On 28-Feb-2021, the patient experienced PRODUCTIVE COUGH (coughing up flehm), PAIN IN EXTREMITY (soreness in arm) and FATIGUE (severe fatigue). On 26-Mar-2021, the patient experienced SINUSITIS (sinus infection from allergies). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd vaccine is scheduled on 4th may 2021). At the time of the report, SINUSITIS (sinus infection from allergies), PRODUCTIVE COUGH (coughing up flehm), HYPOAESTHESIA (numbness to hand), PERIPHERAL SWELLING (Swollen arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd vaccine is scheduled on 4th may 2021), PAIN IN EXTREMITY (soreness in arm) and FATIGUE (severe fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was scheduled to receive his 2nd vaccine but he had a tick bite so he had to cancel. From the tick bite he had a swelling and irritation on the back of his knee and redness. HCP gave him an antibiotic for the tick bite. His new 2nd vaccine appointment has been scheduled for 04MAY2021.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Sinusitis
Clinical narrative: 2nd vaccine is scheduled on 4th may 2021; sinus infection from allergies; coughing up flehm; soreness in arm; severe fatigue; numbness to hand; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection from allergies), PRODUCTIVE COUGH (coughing up flehm), HYPOAESTHESIA (numbness to hand), PERIPHERAL SWELLING (Swollen arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd vaccine is scheduled on 4th may 2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified, Emphysema and COPD.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPOAESTHESIA (numbness to hand) and PERIPHERAL SWELLING (Swollen arm). On 28-Feb-2021, the patient experienced PRODUCTIVE COUGH (coughing up flehm), PAIN IN EXTREMITY (soreness in arm) and FATIGUE (severe fatigue). On 26-Mar-2021, the patient experienced SINUSITIS (sinus infection from allergies). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd vaccine is scheduled on 4th may 2021). At the time of the report, SINUSITIS (sinus infection from allergies), PRODUCTIVE COUGH (coughing up flehm), HYPOAESTHESIA (numbness to hand), PERIPHERAL SWELLING (Swollen arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd vaccine is scheduled on 4th may 2021), PAIN IN EXTREMITY (soreness in arm) and FATIGUE (severe fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was scheduled to receive his 2nd vaccine but he had a tick bite so he had to cancel. From the tick bite he had a swelling and irritation on the back of his knee and redness. HCP gave him an antibiotic for the tick bite. His new 2nd vaccine appointment has been scheduled for 04MAY2021.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Rash
Clinical narrative: Severe body Rash; Dizziness; Lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), RASH (Severe body Rash) and DIZZINESS (Dizziness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (Lightheaded) and DIZZINESS (Dizziness). On 10-Mar-2021, the patient experienced RASH (Severe body Rash). At the time of the report, DIZZINESS (Lightheaded), RASH (Severe body Rash) and DIZZINESS (Dizziness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included Allegra, Benadryl.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient had a sore arm next day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient had a sore arm next day after receiving 1st dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Patient had a sore arm next day after receiving 1st dose). On 20-Mar-2021, PAIN IN EXTREMITY (Patient had a sore arm next day after receiving 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.   Patient reported in TCR that sore arm cleared up the next day. No medical care was needed. No further follow up required.   This case was linked to US-MODERNATX, INC.-MOD-2021-059984 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-May-2021. Outcome of event was updated to recovered/resolved. It contains significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059984:Case for wife
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Blood glucose abnormal, Body temperature, Pyrexia
Clinical narrative: good side effect.; Mild fever of 99 the night after; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever of 99 the night after) and ADVERSE EVENT (good side effect.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included LEVOTHYROXINE, GLIPIZIDE, DULOXETINE HYDROCHLORIDE (CYMBALTA), CITRIC ACID, SODIUM CITRATE ACID (SODIUM CITRATE/CITRIC ACID), INSULIN ASPART (NOVOLOG), DOLUTEGRAVIR SODIUM, RILPIVIRINE HYDROCHLORIDE (JULUCA), GEMFIBROZIL, ROSUVASTATIN, FINASTERIDE, FOLIC ACID, LOSARTAN, ALLOPURINOL and INSULIN DEGLUDEC (TRESIBA) for an unknown indication.   On 20-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (Mild fever of 99 the night after). On an unknown date, the patient experienced ADVERSE EVENT (good side effect.). At the time of the report, PYREXIA (Mild fever of 99 the night after) and ADVERSE EVENT (good side effect.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 99 (Inconclusive) 99. On an unknown date, Blood glucose abnormal: blood sugar has gone down (Low) blood sugar has gone down.         No relevant concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-059870 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up information was received and event was added.; Sender's Comments:  MOD-2021-059870:First Dose of Vaccine case for same patient.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pruritus (itchiness in the injection site), vaccination site erythema (redness in the injection site) and vaccination site swelling (swelling in the vaccination area) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030A21A) for COVID-19 immunization. No medical history reported. On Mar 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 17, 2021, patient experienced vaccination site pruritus (itchiness in the injection site), vaccination site erythema (redness in the injection site) and vaccination site swelling (swelling in the vaccination area). On Mar 24, 2021, vaccination site pruritus (itchiness in the injection site), vaccination site erythema (redness in the injection site) and vaccination site swelling (swelling in the vaccination area) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain tender at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain tender at injection site) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia and Lupus syndrome (lupus). Concomitant products included TOPIRAMATE (TOPAMAX), GABAPENTIN and NORTRIPTYLINE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm pain tender at injection site). At the time of the report, VACCINATION SITE PAIN (Arm pain tender at injection site) 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 Treatment information was  provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: I had itching at the injection site; I had pain at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (I had itching at the injection site) and VACCINATION SITE PAIN (I had pain at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-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 VACCINATION SITE PRURITUS (I had itching at the injection site) and VACCINATION SITE PAIN (I had pain at the injection site). At the time of the report, VACCINATION SITE PRURITUS (I had itching at the injection site) and VACCINATION SITE PAIN (I had pain at the injection site) 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 medications provided.  No treatment information provided.   This case was linked to MOD-2021-035705 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Vaccination site pain
Clinical narrative: she has been having insomnia; "it's like deadweight; Her left arm is still achy; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (she has been having insomnia), LIMB DISCOMFORT ("it's like deadweight) and VACCINATION SITE PAIN (Her left arm is still achy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was reported.     On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced INSOMNIA (she has been having insomnia), LIMB DISCOMFORT ("it's like deadweight) and VACCINATION SITE PAIN (Her left arm is still achy). At the time of the report, INSOMNIA (she has been having insomnia), LIMB DISCOMFORT ("it's like deadweight) and VACCINATION SITE PAIN (Her left arm is still achy) 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  information was  provided. No Treatment information was  provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: It is very itchy; She started with a red circle about 2 inches big at injection site on her left arm; Patient had a sore left arm on next day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient had a sore left arm on next day after receiving 1st dose), VACCINATION SITE PRURITUS (It is very itchy) and VACCINATION SITE ERYTHEMA (She started with a red circle about 2 inches big at injection site on her left arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PANTOPRAZOLE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Patient had a sore left arm on next day after receiving 1st dose). On 26-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (It is very itchy) and VACCINATION SITE ERYTHEMA (She started with a red circle about 2 inches big at injection site on her left arm). At the time of the report, PAIN IN EXTREMITY (Patient had a sore left arm on next day after receiving 1st dose), VACCINATION SITE PRURITUS (It is very itchy) and VACCINATION SITE ERYTHEMA (She started with a red circle about 2 inches big at injection site on her left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-059974 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Non significant On 11-May-2021: Event outcome updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059974:Case for husband