chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test negative, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Loss smell; Loss of taste; Swelling on the injection site; Purple red circle on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss smell), AGEUSIA (Loss of taste), VACCINATION SITE SWELLING (Swelling on the injection site) and VACCINATION SITE ERYTHEMA (Purple red circle on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was reported. No relevant concomitant medications reported.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Loss smell), AGEUSIA (Loss of taste), VACCINATION SITE SWELLING (Swelling on the injection site) and VACCINATION SITE ERYTHEMA (Purple red circle on the injection site). At the time of the report, ANOSMIA (Loss smell) and AGEUSIA (Loss of taste) had not resolved and VACCINATION SITE SWELLING (Swelling on the injection site) and VACCINATION SITE ERYTHEMA (Purple red circle on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Follow up received on 01-MAY-2021 included events outcome not resolved On 25-May-2021: Follow up received on 01-MAY-2021 contain significant information that outcome of events not resolved still after 3 month. On 02-Jun-2021: Email from reporter, still waiting on answer. On 02-Jun-2021: Email On 02-Jun-2021: Follow-up case booked in ,routed for triage
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: arm is swollen like a lump; arm  is red; Sore arm, arm have a lot less pain; chills; muscle pain; fatigue; headache; fever; dizziness; couldn't sleep at all; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (dizziness), SLEEP DISORDER (couldn't sleep at all), VACCINATION SITE SWELLING (arm is swollen like a lump), VACCINATION SITE ERYTHEMA (arm  is red) and VACCINATION SITE PAIN (Sore arm, arm have a lot less pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL, AMLODIPINE, METFORMIN and ATORVASTATIN for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (dizziness), SLEEP DISORDER (couldn't sleep at all), CHILLS (chills), MYALGIA (muscle pain), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever). On 05-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm is swollen like a lump), VACCINATION SITE ERYTHEMA (arm  is red) and VACCINATION SITE PAIN (Sore arm, arm have a lot less pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), SLEEP DISORDER (couldn't sleep at all), CHILLS (chills), MYALGIA (muscle pain), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever) had resolved and VACCINATION SITE SWELLING (arm is swollen like a lump), VACCINATION SITE ERYTHEMA (arm  is red) and VACCINATION SITE PAIN (Sore arm, arm have a lot less pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: arm is swollen like a lump; arm  is red; Sore arm, arm have a lot less pain; chills; muscle pain; fatigue; headache; fever; dizziness; couldn't sleep at all; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (dizziness), SLEEP DISORDER (couldn't sleep at all), VACCINATION SITE SWELLING (arm is swollen like a lump), VACCINATION SITE ERYTHEMA (arm  is red) and VACCINATION SITE PAIN (Sore arm, arm have a lot less pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL, AMLODIPINE, METFORMIN and ATORVASTATIN for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (dizziness), SLEEP DISORDER (couldn't sleep at all), CHILLS (chills), MYALGIA (muscle pain), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever). On 05-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm is swollen like a lump), VACCINATION SITE ERYTHEMA (arm  is red) and VACCINATION SITE PAIN (Sore arm, arm have a lot less pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), SLEEP DISORDER (couldn't sleep at all), CHILLS (chills), MYALGIA (muscle pain), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever) had resolved and VACCINATION SITE SWELLING (arm is swollen like a lump), VACCINATION SITE ERYTHEMA (arm  is red) and VACCINATION SITE PAIN (Sore arm, arm have a lot less pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Hypertension
Clinical narrative: Blood pressure high; Hot Face; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure high) and HOT FLUSH (Hot Face) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 immunisation.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPERTENSION (Blood pressure high) and HOT FLUSH (Hot Face). At the time of the report, HYPERTENSION (Blood pressure high) and HOT FLUSH (Hot Face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza immunisation, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: just like getting a flu shot; sore arm; Pain underneath the pectoral muscle; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA IMMUNISATION (just like getting a flu shot), PAIN IN EXTREMITY (sore arm), MYALGIA (Pain underneath the pectoral muscle) and VACCINATION SITE PAIN (Injection site pain) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced MYALGIA (Pain underneath the pectoral muscle) and VACCINATION SITE PAIN (Injection site pain). On an unknown date, the patient experienced INFLUENZA IMMUNISATION (just like getting a flu shot) and PAIN IN EXTREMITY (sore arm). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, INFLUENZA IMMUNISATION (just like getting a flu shot), PAIN IN EXTREMITY (sore arm), MYALGIA (Pain underneath the pectoral muscle) and VACCINATION SITE PAIN (Injection site pain) had resolved.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: TCR received on 29-06-2021.Dose 2 information was added.Events were added
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: Headache; Injection site soreness; generalised body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), INJECTION SITE PAIN (Injection site soreness) and MYALGIA (generalised body ache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (Headache), INJECTION SITE PAIN (Injection site soreness) and MYALGIA (generalised body ache). The patient was treated with OXYCODONE at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) was resolving and INJECTION SITE PAIN (Injection site soreness) and MYALGIA (generalised body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site rash
Clinical narrative: Flamed where patient got the shot; Red where patient got the shot; rush where patient got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Flamed where patient got the shot), VACCINATION SITE ERYTHEMA (Red where patient got the shot) and VACCINATION SITE RASH (rush where patient got the shot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included ROSUVASTATIN, LEVOTHYROXINE, LOSARTAN, CITALOPRAM, OMEPRAZOLE and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE INFLAMMATION (Flamed where patient got the shot), VACCINATION SITE ERYTHEMA (Red where patient got the shot) and VACCINATION SITE RASH (rush where patient got the shot). At the time of the report, VACCINATION SITE INFLAMMATION (Flamed where patient got the shot), VACCINATION SITE ERYTHEMA (Red where patient got the shot) and VACCINATION SITE RASH (rush where patient got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly, patient was taking sirotto, mecorlol, aifil, ceramal, and cametaiane. No treatment related information has been reported.    Reporter did not allow further contact
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: severe itching on the site administration; pain on the site administration; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (severe itching on the site administration) and VACCINATION SITE PAIN (pain on the site administration) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (severe itching on the site administration) and VACCINATION SITE PAIN (pain on the site administration). At the time of the report, VACCINATION SITE PRURITUS (severe itching on the site administration) and VACCINATION SITE PAIN (pain on the site administration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly, patient was taking arthritis medications. Patient was not taking any treatment for symptoms.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus
Clinical narrative: A lot of itching - her ankles, the bottom of her feet and her neck area are the worse; Aching all over her body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A lot of itching - her ankles, the bottom of her feet and her neck area are the worse) and MYALGIA (Aching all over her body) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PRURITUS (A lot of itching - her ankles, the bottom of her feet and her neck area are the worse) and MYALGIA (Aching all over her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency; CETIRIZINE at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (A lot of itching - her ankles, the bottom of her feet and her neck area are the worse) and MYALGIA (Aching all over her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gingival swelling, Lip swelling, Vaccination site pain
Clinical narrative: swelling of gums and lips; swelling of gums and lips; felt fatigue; pain at the injection site (on and off for the next couple of weeks); This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL SWELLING (swelling of gums and lips), LIP SWELLING (swelling of gums and lips), FATIGUE (felt fatigue) and VACCINATION SITE PAIN (pain at the injection site (on and off for the next couple of weeks)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Seasonal allergy.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced GINGIVAL SWELLING (swelling of gums and lips), LIP SWELLING (swelling of gums and lips), FATIGUE (felt fatigue) and VACCINATION SITE PAIN (pain at the injection site (on and off for the next couple of weeks)). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, GINGIVAL SWELLING (swelling of gums and lips), LIP SWELLING (swelling of gums and lips) and FATIGUE (felt fatigue) had resolved and VACCINATION SITE PAIN (pain at the injection site (on and off for the next couple of weeks)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Headache
Clinical narrative: it's more uncomfortable than usual; been having pains, joint pain, and several head aches; head aches; left knee was really a mess; This spontaneous case was reported by a  and describes the occurrence of DYSPNOEA (it's more uncomfortable than usual), ARTHRALGIA (been having pains, joint pain, and several head aches), HEADACHE (head aches) and ARTHRALGIA (left knee was really a mess) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for an unknown indication.     no medical history was reported.  Concomitant products included COLECALCIFEROL (VITAMIN D 3), DOCUSATE SODIUM (COLACE), PSYLLIUM FIBRE and IBUPROFEN for an unknown indication.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (it's more uncomfortable than usual), ARTHRALGIA (been having pains, joint pain, and several head aches), HEADACHE (head aches) and ARTHRALGIA (left knee was really a mess). At the time of the report, ARTHRALGIA (been having pains, joint pain, and several head aches), HEADACHE (head aches) and ARTHRALGIA (left knee was really a mess) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: No specific follow-up information recorded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Limb discomfort, Malaise, Muscular weakness
Clinical narrative: slept almost all day; feeling very weak in their arms and legs; not feeling well; arm was heavy; This spontaneous case was reported by a physician and describes the occurrence of HYPERSOMNIA (slept almost all day), MUSCULAR WEAKNESS (feeling very weak in their arms and legs), MALAISE (not feeling well) and LIMB DISCOMFORT (arm was heavy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included MERCAPTOPURINE, VITAMIN C [ASCORBIC ACID] and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced LIMB DISCOMFORT (arm was heavy). On 09-Feb-2021, the patient experienced HYPERSOMNIA (slept almost all day), MUSCULAR WEAKNESS (feeling very weak in their arms and legs) and MALAISE (not feeling well). At the time of the report, HYPERSOMNIA (slept almost all day), MUSCULAR WEAKNESS (feeling very weak in their arms and legs), MALAISE (not feeling well) and LIMB DISCOMFORT (arm was heavy) 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Head discomfort, Limb discomfort, Neck pain, Oropharyngeal pain
Clinical narrative: Sensations to muscle in leg started to bother her; right side of neck started to hurt her; Sensations to head; Sensations to right side of throat; Sensations to face; Sensations to scalp; Gastric Reflux; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Sensations to muscle in leg started to bother her), NECK PAIN (right side of neck started to hurt her), HEAD DISCOMFORT (Sensations to head), OROPHARYNGEAL PAIN (Sensations to right side of throat) and FACIAL DISCOMFORT (Sensations to face) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (years ago) and Reflux gastritis (she took antacids for Gastric reflux). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), SIMETICONE (GAS X) and CALCIUM CARBONATE (TUMS 500 CALCIUM) for an unknown indication, FISH OIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced LIMB DISCOMFORT (Sensations to muscle in leg started to bother her), NECK PAIN (right side of neck started to hurt her), HEAD DISCOMFORT (Sensations to head), OROPHARYNGEAL PAIN (Sensations to right side of throat), FACIAL DISCOMFORT (Sensations to face), SKIN IRRITATION (Sensations to scalp) and REFLUX GASTRITIS (Gastric Reflux). At the time of the report, LIMB DISCOMFORT (Sensations to muscle in leg started to bother her), NECK PAIN (right side of neck started to hurt her), HEAD DISCOMFORT (Sensations to head), OROPHARYNGEAL PAIN (Sensations to right side of throat), FACIAL DISCOMFORT (Sensations to face), SKIN IRRITATION (Sensations to scalp) and REFLUX GASTRITIS (Gastric Reflux) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       8 hours later after 1st dose she had "sensations" of the muscles in leg started to bother her, right side of neck started to hurt, her head, right side of throat, face and scalp experienced "sensations" and Gastric Reflux. Patient states she took antacids for Gastric reflux
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Reflux gastritis, Skin irritation
Clinical narrative: Sensations to muscle in leg started to bother her; right side of neck started to hurt her; Sensations to head; Sensations to right side of throat; Sensations to face; Sensations to scalp; Gastric Reflux; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Sensations to muscle in leg started to bother her), NECK PAIN (right side of neck started to hurt her), HEAD DISCOMFORT (Sensations to head), OROPHARYNGEAL PAIN (Sensations to right side of throat) and FACIAL DISCOMFORT (Sensations to face) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke (years ago) and Reflux gastritis (she took antacids for Gastric reflux). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), SIMETICONE (GAS X) and CALCIUM CARBONATE (TUMS 500 CALCIUM) for an unknown indication, FISH OIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced LIMB DISCOMFORT (Sensations to muscle in leg started to bother her), NECK PAIN (right side of neck started to hurt her), HEAD DISCOMFORT (Sensations to head), OROPHARYNGEAL PAIN (Sensations to right side of throat), FACIAL DISCOMFORT (Sensations to face), SKIN IRRITATION (Sensations to scalp) and REFLUX GASTRITIS (Gastric Reflux). At the time of the report, LIMB DISCOMFORT (Sensations to muscle in leg started to bother her), NECK PAIN (right side of neck started to hurt her), HEAD DISCOMFORT (Sensations to head), OROPHARYNGEAL PAIN (Sensations to right side of throat), FACIAL DISCOMFORT (Sensations to face), SKIN IRRITATION (Sensations to scalp) and REFLUX GASTRITIS (Gastric Reflux) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       8 hours later after 1st dose she had "sensations" of the muscles in leg started to bother her, right side of neck started to hurt, her head, right side of throat, face and scalp experienced "sensations" and Gastric Reflux. Patient states she took antacids for Gastric reflux
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: injection site was also itchy; she noticed a red rash at the injection site; she noticed a red rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site was also itchy), VACCINATION SITE RASH (she noticed a red rash at the injection site) and VACCINATION SITE ERYTHEMA (she noticed a red rash at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was also itchy), VACCINATION SITE RASH (she noticed a red rash at the injection site) and VACCINATION SITE ERYTHEMA (she noticed a red rash at the injection site). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (injection site was also itchy), VACCINATION SITE RASH (she noticed a red rash at the injection site) and VACCINATION SITE ERYTHEMA (she noticed a red rash at the injection site) outcome was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain and soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain and soreness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain and soreness). At the time of the report, PAIN (pain and soreness) 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.   Treatment details included None. Concomitant medications reported were Vitamins, Insulin, diabetic medication  The reporters comments in follo-up were that "she is doing fine and declined further follow-up". There was no other additional information provided in follow-up.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: event outcome updated and declined for a follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 29-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]), PROBIOTICS NOS, VITAMIN B6 and DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 12-Dec-2020 and the estimated date of delivery was 18-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pregnancy test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Action taken with mRNA-1273 in response to the event is not applicable.
Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Urticaria, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: warm to the touch rump at the site of injection; Wales at the wrist; wales at the stomach; itchy rump at the injection site; itchy rump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch rump at the site of injection), URTICARIA (Wales at the wrist), URTICARIA (wales at the stomach), VACCINATION SITE MASS (itchy rump at the injection site) and VACCINATION SITE PRURITUS (itchy rump at the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.    Co-suspect product included non-company product LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL ) for an unknown indication.    The patient's past medical history included No adverse event.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL ) (unknown route) at an unspecified dose. On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch rump at the site of injection), URTICARIA (Wales at the wrist), URTICARIA (wales at the stomach), VACCINATION SITE MASS (itchy rump at the injection site) and VACCINATION SITE PRURITUS (itchy rump at the injection site). At the time of the report, VACCINATION SITE WARMTH (warm to the touch rump at the site of injection), URTICARIA (Wales at the wrist), URTICARIA (wales at the stomach), VACCINATION SITE MASS (itchy rump at the injection site) and VACCINATION SITE PRURITUS (itchy rump at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included benadryl
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Wrong technique in product usage process
Clinical narrative: 1 dose from 2 separate vials; Sore injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 dose from 2 separate vials), INJECTION SITE PAIN (Sore injection site) and FATIGUE (Fatigue) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 dose from 2 separate vials), INJECTION SITE PAIN (Sore injection site) and FATIGUE (Fatigue). On 25-Jan-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1 dose from 2 separate vials) had resolved. At the time of the report, INJECTION SITE PAIN (Sore injection site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypersensitivity, Pruritus, Swelling, Swelling face
Clinical narrative: allergic reaction; swelling of face; itchiness of face and neck; dizziness; swelling of neck; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (allergic reaction), SWELLING FACE (swelling of face), PRURITUS (itchiness of face and neck), DIZZINESS (dizziness) and SWELLING (swelling of neck) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A or T) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Environmental allergy. Concomitant products included CALCIUM for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), SWELLING FACE (swelling of face), PRURITUS (itchiness of face and neck), DIZZINESS (dizziness) and SWELLING (swelling of neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergic reaction), SWELLING FACE (swelling of face), PRURITUS (itchiness of face and neck), DIZZINESS (dizziness) and SWELLING (swelling of neck) 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.   Concomitant medications included hidroclorotizia, calcium, slow nides, salastin. Patient had chosen to not receive the second shot.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph node above her collar bone swollen; Lymph node above collar bone tender; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node above her collar bone swollen) and LYMPH NODE PAIN (Lymph node above collar bone tender) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph node above her collar bone swollen) and LYMPH NODE PAIN (Lymph node above collar bone tender). On 06-Feb-2021, LYMPH NODE PAIN (Lymph node above collar bone tender) had resolved. At the time of the report, LYMPHADENOPATHY (Lymph node above her collar bone swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant product use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to touch; Feverish; Slight swelling; Feeling painful; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch), PYREXIA (Feverish), VACCINATION SITE SWELLING (Slight swelling) and VACCINATION SITE PAIN (Feeling painful) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical Adverse event 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 SITE WARMTH (Hot to touch), PYREXIA (Feverish), VACCINATION SITE SWELLING (Slight swelling) and VACCINATION SITE PAIN (Feeling painful). At the time of the report, VACCINATION SITE WARMTH (Hot to touch), PYREXIA (Feverish), VACCINATION SITE SWELLING (Slight swelling) and VACCINATION SITE PAIN (Feeling painful) 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 relevant concomitant medications were reported.  No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Injection site bruising, Pain, Product administered at inappropriate site
Clinical narrative: constant back pain; suffering; vaccination was given "too high" on her arm; it doesn't look right; left arm was bruised at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (left arm was bruised at the injection site), BACK PAIN (constant back pain), PAIN (suffering), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given "too high" on her arm) and FEELING ABNORMAL (it doesn't look right) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hernia in 2003, Back pain (Patient had ongoing back trouble (long history).), Heart valve replacement (heart valve replacement (pig valve) in 2015) in 2015 and Bladder disorder NOS (Patient had bladder problem (stent placed)). Concomitant products included TRAMADOL for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Feb-2021, the patient experienced INJECTION SITE BRUISING (left arm was bruised at the injection site), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given "too high" on her arm) and FEELING ABNORMAL (it doesn't look right). On 19-Feb-2021, the patient experienced BACK PAIN (constant back pain) and PAIN (suffering). At the time of the report, INJECTION SITE BRUISING (left arm was bruised at the injection site), BACK PAIN (constant back pain), PAIN (suffering), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given "too high" on her arm) and FEELING ABNORMAL (it doesn't look right) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR form appended
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: severe stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach pain) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029120A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for Blood pressure, SIMVASTATIN for Cholesterol.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (severe stomach pain). On 24-Jan-2021, ABDOMINAL PAIN UPPER (severe stomach pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient took second dose on 03Mar2021 (Lot no :013A21A) left arm. treatment information not provided   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Patient demographic was added or updated, vaccine information was added, concomitant medications was added
Sex: U
Vaccine: COVID19
Symptoms: Product packaging quantity issue
Clinical narrative: 3 vials only have 8 doses; A spontaneous report was received from a pharmacist concerning 24 patients who received Moderna's COVID-19 (mRNA-1273) vaccine from 3 vials that only had 8 doses in them.   The patients' medical history was not provided. Concomitant product use was not provided/unknown by the reporter.   On an unknown date, the patient received a dose of mRNA-1273 (Batch number: 015M20A)intramuscularly for prophylaxis of COVID-19 infection.   The reporter stated that she thought there were 3 vials that only had 8 doses in them. She thought it was Lot number: 015M20A, but she could not be sure. She stated that all 8 doses from 3 vials were administered to patients. She did not have information on which patients those were. Upon further questioning, caller stated it was a possibility that the vials had all 10 doses and because multiple were drawn up out of a single vial they may have lost count. Caller stated the vials were disposed of.  Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was unknown/not reported.; Reporter's Comments: This report refers to a case of Product packaging quantity issue for mRNA-1273 with lot # 015M20A with no associated AEs.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: FEVER; CHILLS; ACHINESS; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER), CHILLS (CHILLS) and PAIN (ACHINESS) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PYREXIA (FEVER), CHILLS (CHILLS) and PAIN (ACHINESS). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (FEVER), CHILLS (CHILLS) and PAIN (ACHINESS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Lab details were not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bursitis, Chills, Fatigue, Somnolence
Clinical narrative: sleepiness; bursitis in the arm and shoulder blade; quite a bit of chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepiness), BURSITIS (bursitis in the arm and shoulder blade), CHILLS (quite a bit of chills) and FATIGUE (tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.   On 03-Feb-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 03-Feb-2021, the patient experienced SOMNOLENCE (sleepiness), BURSITIS (bursitis in the arm and shoulder blade), CHILLS (quite a bit of chills) and FATIGUE (tired). At the time of the report, SOMNOLENCE (sleepiness), BURSITIS (bursitis in the arm and shoulder blade), CHILLS (quite a bit of chills) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9-102.1 (High) Result-99.9-102.1.         Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant information not provided bursitis in the arm and shoulder blade, so takes the pain medication
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). At the time of the report, HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No treatment information was provided.  No relevant concomitant medications were reported.    Reporter did not allow further contact
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: AST/ALT ratio, Asthenia, Body temperature, C-reactive protein increased, Pyrexia
Clinical narrative: Weakness; Fever; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weakness) and PYREXIA (Fever) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Coronary artery disease since 01-Apr-2004, Sulfonamide allergy (Sulfa) and Allergy to antibiotic (Levaquin). Concomitant products included CLOPIDOGREL and ACETYLSALICYLIC ACID (ECOTRIN) for Coronary artery disease, LISINOPRIL and AMLODIPINE for Hypertension, ROSUVASTATIN for an unknown indication.   On 30-Dec-2020 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced ASTHENIA (Weakness) and PYREXIA (Fever). On 05-Feb-2021, PYREXIA (Fever) had resolved. On 28-Feb-2021, ASTHENIA (Weakness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, AST/ALT ratio: (High) Mild elevation. On an unknown date, Body temperature: 100 and 100.2. On an unknown date, C-reactive protein increased: (High) elevated. On an unknown date, Red blood cell sedimentation rate increased: (High) Elevated. On an unknown date, White blood cell count: 12000 (High) Elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information include Tylenol. Action taken with mRNA-1273 in response to the events was  not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Updated patient demographics and medical history. New concomitant medication added. The outcome of the event changed from unknown to recovered.