chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hypokinesia
Clinical narrative: Tired; Every bone in my body ached; 101.5 F fever; Chills; Headache; I could hardly move; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (I could hardly move), FATIGUE (Tired), MYALGIA (Every bone in my body ached), PYREXIA (101.5 F fever) and CHILLS (Chills) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Hypertension since June 1997, GERD since July 2000 and Osteoporosis since November 2002. Concomitant products included QUINAPRIL, LANSOPRAZOLE (PREVACID) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 28-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced HYPOKINESIA (I could hardly move), MYALGIA (Every bone in my body ached), PYREXIA (101.5 F fever), CHILLS (Chills) and HEADACHE (Headache). On 31-Mar-2021, the patient experienced FATIGUE (Tired). On 30-Mar-2021, MYALGIA (Every bone in my body ached), PYREXIA (101.5 F fever), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, HYPOKINESIA (I could hardly move) outcome was unknown and FATIGUE (Tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 101.5 (Inconclusive) Fever of 101.5 F.         The patient post receiving their second dose of vaccine developed chills, 101.5 F fever and reported that their every bone in the body ached. The patient could hardly move and experienced headache that lasted 24 hours.   On 26-May-2021 the patient reported that ever since the patient received the second dose of vaccine the patient had felt tired and did not have this same feeling before taking the shot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-071262 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up was received on 26 May 2021.  Added reporter's contact and address information. Added patient demographic. Added current conditions and allergic reaction. Added First and second dose start dates. Added  concomitant medications. Added vaccine facility information. Added new event. Updated the event outcome and stop dates of events.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Tired; Every bone in my body ached; 101.5 F fever; Chills; Headache; I could hardly move; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (I could hardly move), FATIGUE (Tired), MYALGIA (Every bone in my body ached), PYREXIA (101.5 F fever) and CHILLS (Chills) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Hypertension since June 1997, GERD since July 2000 and Osteoporosis since November 2002. Concomitant products included QUINAPRIL, LANSOPRAZOLE (PREVACID) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 28-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced HYPOKINESIA (I could hardly move), MYALGIA (Every bone in my body ached), PYREXIA (101.5 F fever), CHILLS (Chills) and HEADACHE (Headache). On 31-Mar-2021, the patient experienced FATIGUE (Tired). On 30-Mar-2021, MYALGIA (Every bone in my body ached), PYREXIA (101.5 F fever), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, HYPOKINESIA (I could hardly move) outcome was unknown and FATIGUE (Tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 101.5 (Inconclusive) Fever of 101.5 F.         The patient post receiving their second dose of vaccine developed chills, 101.5 F fever and reported that their every bone in the body ached. The patient could hardly move and experienced headache that lasted 24 hours.   On 26-May-2021 the patient reported that ever since the patient received the second dose of vaccine the patient had felt tired and did not have this same feeling before taking the shot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-071262 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up was received on 26 May 2021.  Added reporter's contact and address information. Added patient demographic. Added current conditions and allergic reaction. Added First and second dose start dates. Added  concomitant medications. Added vaccine facility information. Added new event. Updated the event outcome and stop dates of events.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: got sick; she missed her appointment because she was sick.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (she missed her appointment because she was sick.) and ILLNESS (got sick) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (she missed her appointment because she was sick.). On an unknown date, the patient experienced ILLNESS (got sick). On 05-Apr-2021, PRODUCT DOSE OMISSION ISSUE (she missed her appointment because she was sick.) had resolved. At the time of the report, ILLNESS (got sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information provided included Medrol dose pack.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Haemangioma
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of HAEMANGIOMA (40-50 hemangiomas (proven by biopsy) around her body on arms, legs and trunk) in a 32-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMANGIOMA (40-50 hemangiomas (proven by biopsy) around her body on arms, legs and trunk). At the time of the report, HAEMANGIOMA (40-50 hemangiomas (proven by biopsy) around her body on arms, legs and trunk) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: haemangiomas (Positive) Developed Hemangiomas. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HAEMANGIOMA (40-50 hemangiomas (proven by biopsy) around her body on arms, legs and trunk) to be unlikely related. The reporter was a physician and informed that the He patient who received both doses of Moderna Vaccine developed 40- 50 hemangiomas (proven by biopsy) around their body on arms, legs, and trunk. No Concomitant product use was reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested Positive.     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.   On 07-Mar-2021, the patient received their first dose of Moderna vaccine and was diagnosed with COVID on an unspecified date post receiving their first dose of Moderna vaccine.   Reportedly, the patient was scheduled to receive their second dose of Moderna vaccine on 10-Apr-2021.  No Concomitant product use was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspepsia, Pyrexia
Clinical narrative: burning stomach pain; burning stomach pain; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ABDOMINAL PAIN UPPER (burning stomach pain) and DYSPEPSIA (burning stomach pain) 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.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PYREXIA (Fever), ABDOMINAL PAIN UPPER (burning stomach pain) and DYSPEPSIA (burning stomach pain). On 08-Apr-2021, PYREXIA (Fever), ABDOMINAL PAIN UPPER (burning stomach pain) and DYSPEPSIA (burning stomach pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Give second dose of vaccine 10 days before due; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Give second dose of vaccine 10 days before due) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Give second dose of vaccine 10 days before due). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Give second dose of vaccine 10 days before due) had resolved. 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.   The reporter called in to ask if it was okay to give the second dose of vaccine 10 days before the due date (appointment/scheduled day).  No Concomitant product use was reported. No treatment information was provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Gait inability, Nausea, Vertigo
Clinical narrative: Diagnose with vertigo; Not able to walk; Fatigue; Really-really dizzy and dizziness; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Diagnose with vertigo), GAIT INABILITY (Not able to walk), DIZZINESS (Really-really dizzy and dizziness), NAUSEA (Nausea) and VOMITING (Vomiting) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE and AMLODIPINE BESILATE (PROVASC) 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 DIZZINESS (Really-really dizzy and dizziness), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced VERTIGO (Diagnose with vertigo), GAIT INABILITY (Not able to walk) and FATIGUE (Fatigue). At the time of the report, VERTIGO (Diagnose with vertigo), GAIT INABILITY (Not able to walk), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown and DIZZINESS (Really-really dizzy and dizziness) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 17-Mar-2021, the patient received their first dose of vaccine. On day 1, the patient was really-really dizzy, nausea and vomiting. Following the day, the patient felt better, and dizziness. After 5 days the patient again experienced dizziness.  Reportedly, the patient was not able to walk, and it lasted for a week.   The patient was also diagnosed with vertigo and still felt dizziness, fatigue.   Treatment information provided by the reporter included physical therapy and home exercises.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Diagnose with vertigo; Not able to walk; Fatigue; Really-really dizzy and dizziness; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Diagnose with vertigo), GAIT INABILITY (Not able to walk), DIZZINESS (Really-really dizzy and dizziness), NAUSEA (Nausea) and VOMITING (Vomiting) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE and AMLODIPINE BESILATE (PROVASC) 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 DIZZINESS (Really-really dizzy and dizziness), NAUSEA (Nausea) and VOMITING (Vomiting). On an unknown date, the patient experienced VERTIGO (Diagnose with vertigo), GAIT INABILITY (Not able to walk) and FATIGUE (Fatigue). At the time of the report, VERTIGO (Diagnose with vertigo), GAIT INABILITY (Not able to walk), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown and DIZZINESS (Really-really dizzy and dizziness) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 17-Mar-2021, the patient received their first dose of vaccine. On day 1, the patient was really-really dizzy, nausea and vomiting. Following the day, the patient felt better, and dizziness. After 5 days the patient again experienced dizziness.  Reportedly, the patient was not able to walk, and it lasted for a week.   The patient was also diagnosed with vertigo and still felt dizziness, fatigue.   Treatment information provided by the reporter included physical therapy and home exercises.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got first dose on 16Mar2021 and second on 05Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got first dose on 16Mar2021 and second on 05Apr2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got first dose on 16Mar2021 and second on 05Apr2021). On 05-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got first dose on 16Mar2021 and second on 05Apr2021) had resolved.            The reporter was a Spanish speaker and was calling on behalf of their husband and brother-in law who received their first dose of the Moderna vaccine on 16-Mar-2021. Both of them received their first dose on the same day. The patient (brother-in-law) received the second dose on 05-Apr-2021 but the reporter's husband didn't receive the vaccine, even though the reporter insisted. The provider said that they only had orders for one.   No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: "eight to nine rashes now"; rash starting on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash starting on arm of injection) and RASH ("eight to nine rashes now") in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for an unknown indication.     The patient's past medical history included No adverse event. Concomitant products included ENALAPRIL MALEATE, HYDROCHLOROTHIAZIDE (ENALAPRIL HCT) and ATORVASTATIN for an unknown indication.    On 26-Feb-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 INJECTION SITE RASH (rash starting on arm of injection) and RASH ("eight to nine rashes now"). At the time of the report, INJECTION SITE RASH (rash starting on arm of injection) and RASH ("eight to nine rashes now") had not resolved. Not Provided          This case was linked to MOD-2021-071311 (Patient Link).   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Mouth swelling, Oral discomfort, Oral pain, Vaccination site rash
Clinical narrative: Lips burn; Mucus membrane in mouth was burn; Mucus membrane in their mouth was burning, swollen and sore; Mucus membrane in mouth was burn, swollen; Bad chest pains; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Lips burn), ORAL DISCOMFORT (Mucus membrane in mouth was burn), ORAL PAIN (Mucus membrane in their mouth was burning, swollen and sore), MOUTH SWELLING (Mucus membrane in mouth was burn, swollen) and CHEST PAIN (Bad chest pains) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced ORAL DISCOMFORT (Lips burn), ORAL DISCOMFORT (Mucus membrane in mouth was burn), ORAL PAIN (Mucus membrane in their mouth was burning, swollen and sore), MOUTH SWELLING (Mucus membrane in mouth was burn, swollen), CHEST PAIN (Bad chest pains) and VACCINATION SITE RASH (COVID arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, ORAL DISCOMFORT (Lips burn), ORAL DISCOMFORT (Mucus membrane in mouth was burn), ORAL PAIN (Mucus membrane in their mouth was burning, swollen and sore), MOUTH SWELLING (Mucus membrane in mouth was burn, swollen), CHEST PAIN (Bad chest pains) and VACCINATION SITE RASH (COVID arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       On 18-Mar-2021, the patient received their first dose of Moderna Covid-19 vaccine. Seven days later the patient developed COVID arm, lips burn and bad chest pains. The patient also mentioned that the mucus membrane in their mouth was burning, swollen and sore. The patient took Benadryl to treat symptoms. The only symptom that was still going on was the chest pain.   On 08-May-2021, the patient reported that all the symptoms resolved, and the patient took the second dose and was doing good.   No Concomitant product use was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: TCR received. Updated the outcome of all the events. Updated the action taken as per the TCR received.; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Little arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little arm pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Little arm pain). At the time of the report, PAIN IN EXTREMITY (Little arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site nodule, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site hard bump, then solid lesion about the diameter of a softball; Injection site hard bump, then solid lesion about the diameter of a softball; Injection site itchy; Injection site soreness, described as being a little tender; Injection site swollen; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE NODULE (Injection site hard bump, then solid lesion about the diameter of a softball), VACCINATION SITE MASS (Injection site hard bump, then solid lesion about the diameter of a softball), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Injection site soreness, described as being a little tender) and VACCINATION SITE SWELLING (Injection site swollen) 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 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (Injection site hard bump, then solid lesion about the diameter of a softball), VACCINATION SITE MASS (Injection site hard bump, then solid lesion about the diameter of a softball), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Injection site soreness, described as being a little tender) and VACCINATION SITE SWELLING (Injection site swollen). At the time of the report, VACCINATION SITE NODULE (Injection site hard bump, then solid lesion about the diameter of a softball), VACCINATION SITE MASS (Injection site hard bump, then solid lesion about the diameter of a softball), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Injection site soreness, described as being a little tender) and VACCINATION SITE SWELLING (Injection site swollen) 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 medication list was not provided. Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH, RASH, VACCINATION SITE PRURITUS, VACCINATION SITE RASH, and VACCINATION SITE ERYTHEMA in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE WARMTH, RASH, VACCINATION SITE PRURITUS, VACCINATION SITE RASH, and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE WARMTH, RASH, VACCINATION SITE PRURITUS, VACCINATION SITE RASH, and VACCINATION SITE ERYTHEMA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 31-Mar-2021, the patient received their first dose of Moderna vaccine. Since 07-Apr-2021, the patient noticed a rash at injection site which started as itching and later felt very hot and red in color. The patient reported that the rash was moving rapidly and getting bigger and bigger.   The patient received prescription for Prednisone medication to take for 4 days for the symptom but didn't start yet.  No Concomitant product use was reported.  Treatment medication prescribed to the patient was Prednisone, but the patient didn't start yet.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: rapid heartbeat; fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (rapid heartbeat) and PYREXIA (fever) 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 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PYREXIA (fever). On 07-Feb-2021 at 3:00 AM, the patient experienced PALPITATIONS (rapid heartbeat). At the time of the report, PALPITATIONS (rapid heartbeat) and PYREXIA (fever) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site inflammation, Vaccination site pruritus, Vaccination site rash
Clinical narrative: she started to feel inflamed around the injection site; she started to feel itchy around the injection site; she started to feel a rash around the injection site; A bit of a sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A bit of a sore arm), VACCINATION SITE INFLAMMATION (she started to feel inflamed around the injection site), VACCINATION SITE PRURITUS (she started to feel itchy around the injection site) and VACCINATION SITE RASH (she started to feel a rash around the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (A bit of a sore arm). On 08-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (she started to feel inflamed around the injection site), VACCINATION SITE PRURITUS (she started to feel itchy around the injection site) and VACCINATION SITE RASH (she started to feel a rash around the injection site). At the time of the report, PAIN IN EXTREMITY (A bit of a sore arm), VACCINATION SITE INFLAMMATION (she started to feel inflamed around the injection site), VACCINATION SITE PRURITUS (she started to feel itchy around the injection site) and VACCINATION SITE RASH (she started to feel a rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Dyspnoea, Electric shock sensation
Clinical narrative: Sore arm; My brain is shaking; lumps under my left arm; Lumps under my neck by the column bone; Hard to take a deep breath; Chest hurts; I can't work anymore; Covid arm (Red itchy rash); rash; Vomiting; Headache; chills; Swollen lymph nodes; I couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ELECTRIC SHOCK SENSATION (My brain is shaking), PERIPHERAL SWELLING (lumps under my left arm), SWELLING (Lumps under my neck by the column bone) and DYSPNOEA (Hard to take a deep breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced INSOMNIA (I couldn't sleep). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ELECTRIC SHOCK SENSATION (My brain is shaking), PERIPHERAL SWELLING (lumps under my left arm), SWELLING (Lumps under my neck by the column bone), DYSPNOEA (Hard to take a deep breath), CHEST PAIN (Chest hurts), ASTHENIA (I can't work anymore), RASH PRURITIC (Covid arm (Red itchy rash)), RASH (rash), VOMITING (Vomiting), HEADACHE (Headache), CHILLS (chills) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (lumps under my left arm), SWELLING (Lumps under my neck by the column bone), DYSPNOEA (Hard to take a deep breath), CHEST PAIN (Chest hurts), INSOMNIA (I couldn't sleep), ASTHENIA (I can't work anymore), RASH PRURITIC (Covid arm (Red itchy rash)), RASH (rash), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (chills) had resolved and ELECTRIC SHOCK SENSATION (My brain is shaking) and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment product information was provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received on 08-Jul-2021. Events added and event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm; My brain is shaking; lumps under my left arm; Lumps under my neck by the column bone; Hard to take a deep breath; Chest hurts; I can't work anymore; Covid arm (Red itchy rash); rash; Vomiting; Headache; chills; Swollen lymph nodes; I couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ELECTRIC SHOCK SENSATION (My brain is shaking), PERIPHERAL SWELLING (lumps under my left arm), SWELLING (Lumps under my neck by the column bone) and DYSPNOEA (Hard to take a deep breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced INSOMNIA (I couldn't sleep). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ELECTRIC SHOCK SENSATION (My brain is shaking), PERIPHERAL SWELLING (lumps under my left arm), SWELLING (Lumps under my neck by the column bone), DYSPNOEA (Hard to take a deep breath), CHEST PAIN (Chest hurts), ASTHENIA (I can't work anymore), RASH PRURITIC (Covid arm (Red itchy rash)), RASH (rash), VOMITING (Vomiting), HEADACHE (Headache), CHILLS (chills) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (lumps under my left arm), SWELLING (Lumps under my neck by the column bone), DYSPNOEA (Hard to take a deep breath), CHEST PAIN (Chest hurts), INSOMNIA (I couldn't sleep), ASTHENIA (I can't work anymore), RASH PRURITIC (Covid arm (Red itchy rash)), RASH (rash), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (chills) had resolved and ELECTRIC SHOCK SENSATION (My brain is shaking) and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment product information was provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received on 08-Jul-2021. Events added and event outcome updated.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Swelling, Vomiting
Clinical narrative: Sore arm; My brain is shaking; lumps under my left arm; Lumps under my neck by the column bone; Hard to take a deep breath; Chest hurts; I can't work anymore; Covid arm (Red itchy rash); rash; Vomiting; Headache; chills; Swollen lymph nodes; I couldn't sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ELECTRIC SHOCK SENSATION (My brain is shaking), PERIPHERAL SWELLING (lumps under my left arm), SWELLING (Lumps under my neck by the column bone) and DYSPNOEA (Hard to take a deep breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced INSOMNIA (I couldn't sleep). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ELECTRIC SHOCK SENSATION (My brain is shaking), PERIPHERAL SWELLING (lumps under my left arm), SWELLING (Lumps under my neck by the column bone), DYSPNOEA (Hard to take a deep breath), CHEST PAIN (Chest hurts), ASTHENIA (I can't work anymore), RASH PRURITIC (Covid arm (Red itchy rash)), RASH (rash), VOMITING (Vomiting), HEADACHE (Headache), CHILLS (chills) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (lumps under my left arm), SWELLING (Lumps under my neck by the column bone), DYSPNOEA (Hard to take a deep breath), CHEST PAIN (Chest hurts), INSOMNIA (I couldn't sleep), ASTHENIA (I can't work anymore), RASH PRURITIC (Covid arm (Red itchy rash)), RASH (rash), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (chills) had resolved and ELECTRIC SHOCK SENSATION (My brain is shaking) and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment product information was provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received on 08-Jul-2021. Events added and event outcome updated.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Discomfort, Feeling abnormal, Feeling drunk
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Body was heavy (After the Second Shot)), FEELING ABNORMAL (Felt out of it (After the Second Shot)), FEELING DRUNK (Felt like Drunk (After the Second Shot)), ASTHENIA (Felt Weakness Coming (After the Second Shot)) and GAIT DISTURBANCE (Trouble Walking (After the Second Shot)) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DISCOMFORT (Body was heavy (After the Second Shot)), FEELING ABNORMAL (Felt out of it (After the Second Shot)), FEELING DRUNK (Felt like Drunk (After the Second Shot)), ASTHENIA (Felt Weakness Coming (After the Second Shot)), GAIT DISTURBANCE (Trouble Walking (After the Second Shot)), HYPOAESTHESIA ORAL (Numbness in the Mouth and Lip (After the Second Shot)), HEART RATE INCREASED (Elevated Heart Rate (After the Second Shot)) and ANXIETY (Anxiety Attack per MD). At the time of the report, DISCOMFORT (Body was heavy (After the Second Shot)), FEELING ABNORMAL (Felt out of it (After the Second Shot)), FEELING DRUNK (Felt like Drunk (After the Second Shot)), ASTHENIA (Felt Weakness Coming (After the Second Shot)), GAIT DISTURBANCE (Trouble Walking (After the Second Shot)), HYPOAESTHESIA ORAL (Numbness in the Mouth and Lip (After the Second Shot)), HEART RATE INCREASED (Elevated Heart Rate (After the Second Shot)) and ANXIETY (Anxiety Attack per MD) outcome was unknown.            This case was linked to MOD-2021-071289 (E2B Linked Report).; Sender's Comments:  MOD-2021-071289:First Dose
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Heart rate increased, Hypoaesthesia oral
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Body was heavy (After the Second Shot)), FEELING ABNORMAL (Felt out of it (After the Second Shot)), FEELING DRUNK (Felt like Drunk (After the Second Shot)), ASTHENIA (Felt Weakness Coming (After the Second Shot)) and GAIT DISTURBANCE (Trouble Walking (After the Second Shot)) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DISCOMFORT (Body was heavy (After the Second Shot)), FEELING ABNORMAL (Felt out of it (After the Second Shot)), FEELING DRUNK (Felt like Drunk (After the Second Shot)), ASTHENIA (Felt Weakness Coming (After the Second Shot)), GAIT DISTURBANCE (Trouble Walking (After the Second Shot)), HYPOAESTHESIA ORAL (Numbness in the Mouth and Lip (After the Second Shot)), HEART RATE INCREASED (Elevated Heart Rate (After the Second Shot)) and ANXIETY (Anxiety Attack per MD). At the time of the report, DISCOMFORT (Body was heavy (After the Second Shot)), FEELING ABNORMAL (Felt out of it (After the Second Shot)), FEELING DRUNK (Felt like Drunk (After the Second Shot)), ASTHENIA (Felt Weakness Coming (After the Second Shot)), GAIT DISTURBANCE (Trouble Walking (After the Second Shot)), HYPOAESTHESIA ORAL (Numbness in the Mouth and Lip (After the Second Shot)), HEART RATE INCREASED (Elevated Heart Rate (After the Second Shot)) and ANXIETY (Anxiety Attack per MD) outcome was unknown.            This case was linked to MOD-2021-071289 (E2B Linked Report).; Sender's Comments:  MOD-2021-071289:First Dose
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: soreness; injection site is itchy, red, and hot; injection site is itchy, red, and hot; injection site is itchy, red, and hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is itchy, red, and hot), VACCINATION SITE PRURITUS (injection site is itchy, red, and hot), VACCINATION SITE ERYTHEMA (injection site is itchy, red, and hot) and VACCINATION SITE PAIN (soreness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site is itchy, red, and hot), VACCINATION SITE PRURITUS (injection site is itchy, red, and hot) and VACCINATION SITE ERYTHEMA (injection site is itchy, red, and hot). On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness). At the time of the report, VACCINATION SITE WARMTH (injection site is itchy, red, and hot), VACCINATION SITE PRURITUS (injection site is itchy, red, and hot), VACCINATION SITE ERYTHEMA (injection site is itchy, red, and hot) and VACCINATION SITE PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.   This case was linked to US-MODERNATX, INC.-MOD-2021-071274 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071274:crosslinked
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: arm became itchy; arm had smooth red area; arm had hard area; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE PRURITUS (arm became itchy), VACCINATION SITE ERYTHEMA (arm had smooth red area) and VACCINATION SITE INDURATION (arm had hard area) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 07-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (arm became itchy), VACCINATION SITE ERYTHEMA (arm had smooth red area) and VACCINATION SITE INDURATION (arm had hard area). On 01-Apr-2021, VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (arm became itchy), VACCINATION SITE ERYTHEMA (arm had smooth red area) and VACCINATION SITE INDURATION (arm had hard area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Gait disturbance, Limb immobilisation, Pain in extremity
Clinical narrative: sharp eletric burning in the right side; Temporary immobilization in lower legs; Tendinitis in right arm; Couldn't even walk; Pain on lower back right side; Pain on thigh on the right side. it was like needles shooting into my body on that side.; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Couldn't even walk), BACK PAIN (Pain on lower back right side), PAIN IN EXTREMITY (Pain on thigh on the right side. it was like needles shooting into my body on that side.), BURNING SENSATION (sharp eletric burning in the right side) and LIMB IMMOBILISATION (Temporary immobilization in lower legs) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery (Patient stated that she had back surgery Nov 2019 and now has 9 screws in her back.) in November 2019 and Acupuncture (Patient usually has an acupuncture treatment done on her back and she got the acupuncture for her back.) on 16-Feb-2021. Concurrent medical conditions included Allergy NOS (Numerous) and Celiac disease. Concomitant products included CALCIUM, MULTIVITAMINS [VITAMINS NOS], VITAMIN K NOS and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 17-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced GAIT DISTURBANCE (Couldn't even walk), BACK PAIN (Pain on lower back right side) and PAIN IN EXTREMITY (Pain on thigh on the right side. it was like needles shooting into my body on that side.). On 20-Feb-2021 at 3:00 AM, the patient experienced BURNING SENSATION (sharp eletric burning in the right side), LIMB IMMOBILISATION (Temporary immobilization in lower legs) and TENDONITIS (Tendinitis in right arm). On 22-Feb-2021, GAIT DISTURBANCE (Couldn't even walk), BACK PAIN (Pain on lower back right side), PAIN IN EXTREMITY (Pain on thigh on the right side. it was like needles shooting into my body on that side.), BURNING SENSATION (sharp eletric burning in the right side), LIMB IMMOBILISATION (Temporary immobilization in lower legs) and TENDONITIS (Tendinitis in right arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-071338 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Reporter's contact details, patient demographics, new adverse events, concomitant medications, medical history, suspect drug dosage information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071338:2nd dose vaccine