chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first vaccine on 12March2021 and missed the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first vaccine on 12March2021 and missed the second dose) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first vaccine on 12March2021 and missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first vaccine on 12March2021 and missed the second dose) 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.   No relevant concomitant medications reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up appended
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Malaise, Pain, Pain in extremity
Clinical narrative: feels sick; achy; presented 101F fever; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feels sick), PAIN IN EXTREMITY (sore arm), PAIN (achy), PYREXIA (presented 101F fever) and HEADACHE (headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced MALAISE (feels sick), PAIN (achy), PYREXIA (presented 101F fever) and HEADACHE (headache). At the time of the report, MALAISE (feels sick), PAIN IN EXTREMITY (sore arm), PAIN (achy), PYREXIA (presented 101F fever) and HEADACHE (headache) outcome was unknown. Not provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101 Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported   This case was linked to US-irms-MOD21-169009 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received and contains no new information On 04-Aug-2021: Non significant FU: email ID updated; Sender's Comments:  US-irms-MOD21-169009:irms
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feels sick; achy; presented 101F fever; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feels sick), PAIN IN EXTREMITY (sore arm), PAIN (achy), PYREXIA (presented 101F fever) and HEADACHE (headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced MALAISE (feels sick), PAIN (achy), PYREXIA (presented 101F fever) and HEADACHE (headache). At the time of the report, MALAISE (feels sick), PAIN IN EXTREMITY (sore arm), PAIN (achy), PYREXIA (presented 101F fever) and HEADACHE (headache) outcome was unknown. Not provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101 Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported   This case was linked to US-irms-MOD21-169009 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received and contains no new information On 04-Aug-2021: Non significant FU: email ID updated; Sender's Comments:  US-irms-MOD21-169009:irms
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: area began to itch; pooled under my skin just below the injection site; area is red, raised; 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 VACCINATION SITE PRURITUS (area began to itch), VACCINATION SITE SWELLING (pooled under my skin just below the injection site) and VACCINATION SITE ERYTHEMA (area is red, raised) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (area began to itch), VACCINATION SITE SWELLING (pooled under my skin just below the injection site) and VACCINATION SITE ERYTHEMA (area is red, raised). At the time of the report, VACCINATION SITE PRURITUS (area began to itch), VACCINATION SITE SWELLING (pooled under my skin just below the injection site) and VACCINATION SITE ERYTHEMA (area is red, raised) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant F/U
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: shot site is hard; shot site about 2 inches long; shot site hurts; 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 VACCINATION SITE INDURATION (shot site is hard), VACCINATION SITE SWELLING (shot site about 2 inches long) and VACCINATION SITE PAIN (shot site hurts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (shot site is hard), VACCINATION SITE SWELLING (shot site about 2 inches long) and VACCINATION SITE PAIN (shot site hurts). At the time of the report, VACCINATION SITE INDURATION (shot site is hard), VACCINATION SITE SWELLING (shot site about 2 inches long) and VACCINATION SITE PAIN (shot site hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported Treatment medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: follow up received on 26-May-2021 No new information.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: Rash with in round circles; Sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (Rash with in round circles) and MYALGIA (Sore arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced RASH (Rash with in round circles) and MYALGIA (Sore arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, RASH (Rash with in round circles) and MYALGIA (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up received on25-may-2021 No significant information was reported .
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Little Shivers After Second Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Little Shivers After Second Vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Obesity. Concurrent medical conditions included Blood pressure high since 2004, Arthritis in 2000 and Seasonal allergy. Concomitant products included NAPROXEN for Arthritis, LOSARTAN for Blood pressure, OMEPRAZOLE for Heartburn, LEVOTHYROXINE for Hyperthyroidism, CLARITHROMYCIN for Seasonal allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Little Shivers After Second Vaccine). On 06-Mar-2021, CHILLS (Little Shivers After Second Vaccine) had resolved.            No treatment details were provided by the reporter.   This case was linked to MOD-2021-026217 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Nonsiginificant Follow up included no new significant information. On 27-Jul-2021: Additional information included current conditions like blood pressure, obesity, arthritis and also included concomitant medications such as losartan , levothyroxine, naproxen, omeprazole, clarithromycin and reporter information.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm is very painful/hurts to lift it) and PYREXIA (Running temp 100.1) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm is very painful/hurts to lift it) and PYREXIA (Running temp 100.1). At the time of the report, PAIN IN EXTREMITY (my arm is very painful/hurts to lift it) and PYREXIA (Running temp 100.1) outcome was unknown. Not Provided          Treatment : PII(32):ASqMhfjN9H5a1F2TMEGn2iJiPn6UAmEu No concomitant medication was reported .   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up received on 26-may-2021 Non significant information was reported .
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site pain
Clinical narrative: Could not get the second dose before 42 days, do I need to get the 2nd dose or do I repeat the; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Could not get the second dose before 42 days, do I need to get the 2nd dose or do I repeat the) and VACCINATION SITE PAIN (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) and PARACETAMOL (TYLENOL) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 11-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Could not get the second dose before 42 days, do I need to get the 2nd dose or do I repeat the) and VACCINATION SITE PAIN (sore arm). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Could not get the second dose before 42 days, do I need to get the 2nd dose or do I repeat the) and VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   patient did not want to call the vaccinating facility to reschedule as she is frustrated that the 2nd dose scheduling got messed up. And mentioned that her healthcare provider asked her to call the Moderna for recommendation. No treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up contain no new information
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a dose of the Moderna Covid-19 vaccine administered to a pediatric patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a dose of the Moderna Covid-19 vaccine administered to a pediatric patient) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a dose of the Moderna Covid-19 vaccine administered to a pediatric patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a dose of the Moderna Covid-19 vaccine administered to a pediatric patient) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  Caller who is a Pharmacy Director wants recommendation for a dose of the Moderna Covid-19 vaccine administered to pediatric patients aged 17-year-old and 14 year old. Caller does not have any patient specific information on either of the patients; he just wants recommendation on what to do.  No concomitant medication details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up
Sex: U
Vaccine: COVID19
Symptoms: Nervousness, Panic attack
Clinical narrative: I had bad panic attack; I was very nervous about getting it; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (I had bad panic attack) and NERVOUSNESS (I was very nervous about getting it) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (I had bad panic attack) and NERVOUSNESS (I was very nervous about getting it). At the time of the report, PANIC ATTACK (I had bad panic attack) and NERVOUSNESS (I was very nervous about getting it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021, contains no newinformation.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications  was reported . No treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow up appended
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy, Fatigue, Mass, Renal function test, Sigmoidoscopy
Clinical narrative: vaccination site pain; lump arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), MASS (lump arm) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A. and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant and Urinary tract infection from 20-May-2021 to 21-May-2021. Concomitant products included RABEPRAZOLE for Acid reflux (oesophageal), CEVIMELINE for Dry mouth, VITAMIN B3, CRANBERRY [VACCINIUM MACROCARPON], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), TACROLIMUS, MYCOPHENOLIC ACID, PREDNISONE, PRIMIDONE, ROSUVASTATIN CALCIUM, FLUOXETINE HYDROCHLORIDE (PROZAC), LORAZEPAM (ATIVAN), HYDROCODONE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain), MASS (lump arm) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; FLUCONAZOLE (DIFLUCAN) at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency; PROMETHAZINE (PHENERGAN [PROMETHAZINE]) at an unspecified dose and frequency; PHOSPHORUS at an unspecified dose and frequency and DOXYCYCLINE at an unspecified dose and frequency. On 16-Feb-2021, VACCINATION SITE PAIN (vaccination site pain) and MASS (lump arm) had resolved. At the time of the report, FATIGUE (Fatigue) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Endoscopy: candida candida in her throat. On an unknown date, Renal function test: normal normal (normal) normal. On an unknown date, Sigmoidoscopy: normal normal (normal) normal.         Treatment information also included fluids.   This case was linked to MOD-2021-169159 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up received on 25-may-2021 contains Non significant follow up
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; lump arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain), MASS (lump arm) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A. and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant and Urinary tract infection from 20-May-2021 to 21-May-2021. Concomitant products included RABEPRAZOLE for Acid reflux (oesophageal), CEVIMELINE for Dry mouth, VITAMIN B3, CRANBERRY [VACCINIUM MACROCARPON], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), TACROLIMUS, MYCOPHENOLIC ACID, PREDNISONE, PRIMIDONE, ROSUVASTATIN CALCIUM, FLUOXETINE HYDROCHLORIDE (PROZAC), LORAZEPAM (ATIVAN), HYDROCODONE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain), MASS (lump arm) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; FLUCONAZOLE (DIFLUCAN) at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency; PROMETHAZINE (PHENERGAN [PROMETHAZINE]) at an unspecified dose and frequency; PHOSPHORUS at an unspecified dose and frequency and DOXYCYCLINE at an unspecified dose and frequency. On 16-Feb-2021, VACCINATION SITE PAIN (vaccination site pain) and MASS (lump arm) had resolved. At the time of the report, FATIGUE (Fatigue) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Endoscopy: candida candida in her throat. On an unknown date, Renal function test: normal normal (normal) normal. On an unknown date, Sigmoidoscopy: normal normal (normal) normal.         Treatment information also included fluids.   This case was linked to MOD-2021-169159 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow up received on 25-may-2021 contains Non significant follow up
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Branchial cyst, Fatigue, Swelling
Clinical narrative: Brachial Clest cyst; Feeling tired the next day; Swelling in neck; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in neck), BRANCHIAL CYST (Brachial Clest cyst) and FATIGUE (Feeling tired the next day) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 14-Apr-2021, the patient experienced SWELLING (Swelling in neck). On 15-Apr-2021, the patient experienced FATIGUE (Feeling tired the next day). On an unknown date, the patient experienced BRANCHIAL CYST (Brachial Clest cyst). At the time of the report, SWELLING (Swelling in neck) and BRANCHIAL CYST (Brachial Clest cyst) outcome was unknown and FATIGUE (Feeling tired the next day) had resolved. Not Provided          Concomitant product include trilostrintec. No treatment was reported. Action taken in response to mRNA-1273 was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: lump under her chin; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (lump under her chin) 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 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (lump under her chin). At the time of the report, SKIN MASS (lump under her chin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: followup received on 25-may-2021 No new information was reported .
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Cough, Fatigue
Clinical narrative: sick at home with cough and COVID; sick at home with cough and COVID; feels likes crap; feels weak; not feeling good; sore left arm; nauseous; feels tired; Fever (She reported a fever of 101F using an oral thermometer),she repeated her temperature with a contact-less forehead thermometer and it read 99.7F/feverish; having chills; This spontaneous case was reported by a patient and describes the occurrence of COUGH (sick at home with cough and COVID), COVID-19 (sick at home with cough and COVID), FEELING ABNORMAL (feels likes crap), ASTHENIA (feels weak) and MALAISE (not feeling good) in a 64-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.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (sick at home with cough and COVID), COVID-19 (sick at home with cough and COVID), FEELING ABNORMAL (feels likes crap), ASTHENIA (feels weak), MALAISE (not feeling good), VACCINATION SITE PAIN (sore left arm), NAUSEA (nauseous), FATIGUE (feels tired), PYREXIA (Fever (She reported a fever of 101F using an oral thermometer),she repeated her temperature with a contact-less forehead thermometer and it read 99.7F/feverish) and CHILLS (having chills). At the time of the report, FEELING ABNORMAL (feels likes crap), ASTHENIA (feels weak), MALAISE (not feeling good), VACCINATION SITE PAIN (sore left arm), NAUSEA (nauseous), FATIGUE (feels tired), PYREXIA (Fever (She reported a fever of 101F using an oral thermometer),she repeated her temperature with a contact-less forehead thermometer and it read 99.7F/feverish) and CHILLS (having chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported . No treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant follow up appended :AE added. Patient DOB ,age and  Reporter address added. On 25-May-2021: Non-significant follow-up On 25-May-2021: AE updated
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: sick at home with cough and COVID; sick at home with cough and COVID; feels likes crap; feels weak; not feeling good; sore left arm; nauseous; feels tired; Fever (She reported a fever of 101F using an oral thermometer),she repeated her temperature with a contact-less forehead thermometer and it read 99.7F/feverish; having chills; This spontaneous case was reported by a patient and describes the occurrence of COUGH (sick at home with cough and COVID), COVID-19 (sick at home with cough and COVID), FEELING ABNORMAL (feels likes crap), ASTHENIA (feels weak) and MALAISE (not feeling good) in a 64-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.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (sick at home with cough and COVID), COVID-19 (sick at home with cough and COVID), FEELING ABNORMAL (feels likes crap), ASTHENIA (feels weak), MALAISE (not feeling good), VACCINATION SITE PAIN (sore left arm), NAUSEA (nauseous), FATIGUE (feels tired), PYREXIA (Fever (She reported a fever of 101F using an oral thermometer),she repeated her temperature with a contact-less forehead thermometer and it read 99.7F/feverish) and CHILLS (having chills). At the time of the report, FEELING ABNORMAL (feels likes crap), ASTHENIA (feels weak), MALAISE (not feeling good), VACCINATION SITE PAIN (sore left arm), NAUSEA (nauseous), FATIGUE (feels tired), PYREXIA (Fever (She reported a fever of 101F using an oral thermometer),she repeated her temperature with a contact-less forehead thermometer and it read 99.7F/feverish) and CHILLS (having chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported . No treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant follow up appended :AE added. Patient DOB ,age and  Reporter address added. On 25-May-2021: Non-significant follow-up On 25-May-2021: AE updated
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia, Vaccination site erythema, Vaccination site rash
Clinical narrative: very sore arm; Rash on injection arm; Headache; swelling at vaccination site; swelling and redness in the vaccine site; fever until today; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (very sore arm), VACCINATION SITE RASH (Rash on injection arm), VACCINATION SITE SWELLING (swelling at vaccination site), VACCINATION SITE ERYTHEMA (swelling and redness in the vaccine site) and PYREXIA (fever until today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced VACCINATION SITE SWELLING (swelling at vaccination site), VACCINATION SITE ERYTHEMA (swelling and redness in the vaccine site) and PYREXIA (fever until today). On an unknown date, the patient experienced PAIN IN EXTREMITY (very sore arm), VACCINATION SITE RASH (Rash on injection arm) and HEADACHE (Headache). On 25-May-2021, PYREXIA (fever until today) had resolved. At the time of the report, PAIN IN EXTREMITY (very sore arm), VACCINATION SITE RASH (Rash on injection arm), VACCINATION SITE SWELLING (swelling at vaccination site), VACCINATION SITE ERYTHEMA (swelling and redness in the vaccine site) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Symptoms: It was reported that patient had experienced Snippier, snaps and was lacking Patience more than usual. Patient had a rash of size of fist around her injection site.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-169421 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 07-JUN-2021 contains significant information: Added new event terms.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-169421:Crosslinked with the reporter- MOD21-097338 (Son's case)
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: very sore arm; Rash on injection arm; Headache; swelling at vaccination site; swelling and redness in the vaccine site; fever until today; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (very sore arm), VACCINATION SITE RASH (Rash on injection arm), VACCINATION SITE SWELLING (swelling at vaccination site), VACCINATION SITE ERYTHEMA (swelling and redness in the vaccine site) and PYREXIA (fever until today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced VACCINATION SITE SWELLING (swelling at vaccination site), VACCINATION SITE ERYTHEMA (swelling and redness in the vaccine site) and PYREXIA (fever until today). On an unknown date, the patient experienced PAIN IN EXTREMITY (very sore arm), VACCINATION SITE RASH (Rash on injection arm) and HEADACHE (Headache). On 25-May-2021, PYREXIA (fever until today) had resolved. At the time of the report, PAIN IN EXTREMITY (very sore arm), VACCINATION SITE RASH (Rash on injection arm), VACCINATION SITE SWELLING (swelling at vaccination site), VACCINATION SITE ERYTHEMA (swelling and redness in the vaccine site) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Symptoms: It was reported that patient had experienced Snippier, snaps and was lacking Patience more than usual. Patient had a rash of size of fist around her injection site.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-169421 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 07-JUN-2021 contains significant information: Added new event terms.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-169421:Crosslinked with the reporter- MOD21-097338 (Son's case)
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Injection site pain; Extreme fatigue; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PAIN (Injection site pain) and FATIGUE (Extreme fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain) and FATIGUE (Extreme fatigue). At the time of the report, INJECTION SITE PAIN (Injection site pain) and FATIGUE (Extreme fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant information was provided by the reporter   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up document is received on 25-MAY-2021 and it doesn't have any new information.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pyrexia
Clinical narrative: cough; fever; fatigue; 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 COUGH (cough), PYREXIA (fever) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced COUGH (cough), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, COUGH (cough) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication included.  No treatment medication included.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up received. No new information
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very tired; 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 FATIGUE (very tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (very tired). At the time of the report, FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant Follow up appended
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a dose of the Moderna Covid-19 vaccine administered to a pediatric patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a dose of the Moderna Covid-19 vaccine administered to a pediatric patient) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a dose of the Moderna Covid-19 vaccine administered to a pediatric patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a dose of the Moderna Covid-19 vaccine administered to a pediatric patient) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 26-MAY-2021 and does not contain any new information
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, Rash
Clinical narrative: More than 36 days have passed since first dose; I developed COVID-19 after my 1st dose with no symptoms; rash in the hole body; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose), COVID-19 (I developed COVID-19 after my 1st dose with no symptoms) and RASH (rash in the hole body) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced RASH (rash in the hole body). On 28-Mar-2021, the patient experienced COVID-19 (I developed COVID-19 after my 1st dose with no symptoms). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose). On 04-Mar-2021, RASH (rash in the hole body) outcome was unknown. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose) and COVID-19 (I developed COVID-19 after my 1st dose with no symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included many steroids.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021, contains no newinformation.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: itchy; intermittent pain; bumps and rash on right arm; rash on left cheek; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on left cheek), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (intermittent pain) and VACCINATION SITE RASH (bumps and rash on right arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001c21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced RASH (rash on left cheek) and VACCINATION SITE RASH (bumps and rash on right arm). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE PAIN (intermittent pain). At the time of the report, RASH (rash on left cheek), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (intermittent pain) and VACCINATION SITE RASH (bumps and rash on right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 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) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.    On an unknown date, the patient received 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 24-May-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided          No concomitant medication was reported . No treatment medication was reported .
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Vitreous floaters
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EYE SWELLING (eye swelling) and VITREOUS FLOATERS (seeing "eye floaters"/seeing "squiggly things") in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced EYE SWELLING (eye swelling) and VITREOUS FLOATERS (seeing "eye floaters"/seeing "squiggly things"). At the time of the report, EYE SWELLING (eye swelling) and VITREOUS FLOATERS (seeing "eye floaters"/seeing "squiggly things") outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: outside 42 day window for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (outside 42 day window for second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PRODUCT DOSE OMISSION ISSUE (outside 42 day window for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (outside 42 day window for second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-May-2021 contain no new information
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Broken in hives; intense itching; 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 URTICARIA (Broken in hives) and PRURITUS (intense itching) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Broken in hives) and PRURITUS (intense itching). At the time of the report, URTICARIA (Broken in hives) and PRURITUS (intense itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information was provided
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine dose given from expired vaccine vial/Vaccine given after refrigerated beyond best use date.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose given from expired vaccine vial/Vaccine given after refrigerated beyond best use date.) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     The patient's past medical history included Asthma in 2004.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose given from expired vaccine vial/Vaccine given after refrigerated beyond best use date.). On 24-May-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine dose given from expired vaccine vial/Vaccine given after refrigerated beyond best use date.) had resolved. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow up appended On 30-Jun-2021: Additional information received