chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Injection arm became swollen; body aches; Injection arm became painful; Injection arm became warm; headache; rash and itch at injection site; rash and itch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection arm became swollen), VACCINATION SITE PRURITUS (rash and itch at injection site), MYALGIA (body aches), VACCINATION SITE PAIN (Injection arm became painful) and VACCINATION SITE RASH (rash and itch at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included RAMIPRIL, PROPRANOLOL and ROSUVASTATIN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (rash and itch at injection site) and VACCINATION SITE RASH (rash and itch at injection site). On 30-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection arm became swollen), MYALGIA (body aches), VACCINATION SITE PAIN (Injection arm became painful), VACCINATION SITE WARMTH (Injection arm became warm) and HEADACHE (headache). At the time of the report, VACCINATION SITE SWELLING (Injection arm became swollen), VACCINATION SITE PRURITUS (rash and itch at injection site), MYALGIA (body aches), VACCINATION SITE PAIN (Injection arm became painful), VACCINATION SITE RASH (rash and itch at injection site), VACCINATION SITE WARMTH (Injection arm became warm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-May-2021 contains non-significant information, Reporter contact information updated On 13-May-2021: no new information was reported
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection arm became swollen; body aches; Injection arm became painful; Injection arm became warm; headache; rash and itch at injection site; rash and itch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection arm became swollen), VACCINATION SITE PRURITUS (rash and itch at injection site), MYALGIA (body aches), VACCINATION SITE PAIN (Injection arm became painful) and VACCINATION SITE RASH (rash and itch at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included RAMIPRIL, PROPRANOLOL and ROSUVASTATIN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (rash and itch at injection site) and VACCINATION SITE RASH (rash and itch at injection site). On 30-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection arm became swollen), MYALGIA (body aches), VACCINATION SITE PAIN (Injection arm became painful), VACCINATION SITE WARMTH (Injection arm became warm) and HEADACHE (headache). At the time of the report, VACCINATION SITE SWELLING (Injection arm became swollen), VACCINATION SITE PRURITUS (rash and itch at injection site), MYALGIA (body aches), VACCINATION SITE PAIN (Injection arm became painful), VACCINATION SITE RASH (rash and itch at injection site), VACCINATION SITE WARMTH (Injection arm became warm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-May-2021 contains non-significant information, Reporter contact information updated On 13-May-2021: no new information was reported
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: pain in arm; muscle pain at the site of injection; My arm still hurts/It hurts when I raise the arm to 90 degrees and if I extend it; Shoulder is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), JOINT SWELLING (Shoulder is swollen), VACCINATION SITE PAIN (muscle pain at the site of injection) and MYALGIA (My arm still hurts/It hurts when I raise the arm to 90 degrees and if I extend it) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-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 01-Apr-2021, the patient experienced JOINT SWELLING (Shoulder is swollen) and MYALGIA (My arm still hurts/It hurts when I raise the arm to 90 degrees and if I extend it). On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (muscle pain at the site of injection). On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm), JOINT SWELLING (Shoulder is swollen) and MYALGIA (My arm still hurts/It hurts when I raise the arm to 90 degrees and if I extend it) outcome was unknown and VACCINATION SITE PAIN (muscle pain at the site of injection) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Ibuprofen and naproxen . Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: treatment medication was updated
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: No adverse event/possible Invalid AE; temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (No adverse event/possible Invalid AE) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event/possible Invalid AE) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion). At the time of the report, NO ADVERSE EVENT (No adverse event/possible Invalid AE) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) 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 were reported.   Treatment information was not provided.  The temperature was between 1.8 and 1.7 celsius and then the temperature went up to 3.3 Celsius.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional Information received on 30-APR-2021 Include No new significant Information On 04-May-2021: Additional Information received on 4-MAY-2021 In which reporter address updated. Patient initial, gender updated. Possible invalid adverse event was updated.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Head discomfort, Oropharyngeal pain
Clinical narrative: very bad sore throat; stuffy head; minoe loose cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (very bad sore throat), HEAD DISCOMFORT (stuffy head) and COUGH (minoe loose cough) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (very bad sore throat), HEAD DISCOMFORT (stuffy head) and COUGH (minoe loose cough). At the time of the report, OROPHARYNGEAL PAIN (very bad sore throat), HEAD DISCOMFORT (stuffy head) and COUGH (minoe loose cough) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported having done self treatment with Dayquil, Chloraseptic spray and rubbing on Vicks at night.  Patient reported doctor's prescribed medicines as 'an antibiotics shot and some other medicines'. No concomitant medicines information provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site irritation
Clinical narrative: left arm hurt; injection site irritated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm hurt) and VACCINATION SITE IRRITATION (injection site irritated) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (left arm hurt) and VACCINATION SITE IRRITATION (injection site irritated). On 20-Mar-2021, VACCINATION SITE IRRITATION (injection site irritated) had resolved. On 21-Mar-2021, PAIN IN EXTREMITY (left arm hurt) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Gait inability, Pain, Vertigo, Vomiting
Clinical narrative: Vomiting; Trouble walking; Chills; Vertigo; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), VERTIGO (Vertigo), VOMITING (Vomiting), GAIT INABILITY (Trouble walking) and CHILLS (Chills) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 29-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 PAIN (Soreness). On 01-May-2021, the patient experienced VERTIGO (Vertigo). On 02-May-2021, the patient experienced VOMITING (Vomiting), GAIT INABILITY (Trouble walking) and CHILLS (Chills). At the time of the report, PAIN (Soreness), VERTIGO (Vertigo), VOMITING (Vomiting), GAIT INABILITY (Trouble walking) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol for the pain Advil for the soreness.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality sleep, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Vaccination site rash; Injection site redness; 15 minutes after injection, arm pain which gradually increased 6 hours later; sleep unwell; Injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (15 minutes after injection, arm pain which gradually increased 6 hours later), POOR QUALITY SLEEP (sleep unwell), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and HR038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy (Crustaceans/Shrimp Burning in mouth and throat for about 8 hours after eating shrimp) since 01-Jun-1990. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (15 minutes after injection, arm pain which gradually increased 6 hours later), POOR QUALITY SLEEP (sleep unwell) and VACCINATION SITE PRURITUS (Injection site itching). On 26-Mar-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash). 26-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness). On 19-Mar-2021, POOR QUALITY SLEEP (sleep unwell) had resolved. On 24-Mar-2021, PAIN IN EXTREMITY (15 minutes after injection, arm pain which gradually increased 6 hours later) had resolved. On 30-Mar-2021, VACCINATION SITE ERYTHEMA (Injection site redness) had resolved. On 31-Mar-2021, VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE RASH (Vaccination site rash) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.    Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up Received: Added Patient Demographics, Medical History, Event Outcome was added.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (batch no. 023C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included BUPROPION and MULTI VIT for an unknown indication.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and SUMATRIPTAN for Headache, at an unspecified dose and frequency. At the time of the report, CHILLS (chills) and HEADACHE (headache) outcome was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Malaise, Myalgia, Pain in extremity
Clinical narrative: pain in shoulder; Chills/Teeth chattering; body aches; fever (states he never took temperature); arm pain, the pain made it tough to sleep; Shaking; Malaise; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain, the pain made it tough to sleep), TREMOR (Shaking), MALAISE (Malaise), ARTHRALGIA (pain in shoulder) and CHILLS (Chills/Teeth chattering) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038b21a and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 19-Apr-2021 at 11:50 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain, the pain made it tough to sleep), TREMOR (Shaking), MALAISE (Malaise), CHILLS (Chills/Teeth chattering), MYALGIA (body aches) and PYREXIA (fever (states he never took temperature)). On 22-Apr-2021, the patient experienced ARTHRALGIA (pain in shoulder). On 20-Apr-2021, MALAISE (Malaise) and CHILLS (Chills/Teeth chattering) had resolved. On 21-Apr-2021, TREMOR (Shaking) and PYREXIA (fever (states he never took temperature)) had resolved. On 26-Apr-2021, MYALGIA (body aches) had resolved. On 04-May-2021, PAIN IN EXTREMITY (arm pain, the pain made it tough to sleep) had resolved. At the time of the report, ARTHRALGIA (pain in shoulder) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-100365 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Outcome of events changed. Second dose details was added.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: pain in shoulder; Chills/Teeth chattering; body aches; fever (states he never took temperature); arm pain, the pain made it tough to sleep; Shaking; Malaise; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain, the pain made it tough to sleep), TREMOR (Shaking), MALAISE (Malaise), ARTHRALGIA (pain in shoulder) and CHILLS (Chills/Teeth chattering) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038b21a and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 19-Apr-2021 at 11:50 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain, the pain made it tough to sleep), TREMOR (Shaking), MALAISE (Malaise), CHILLS (Chills/Teeth chattering), MYALGIA (body aches) and PYREXIA (fever (states he never took temperature)). On 22-Apr-2021, the patient experienced ARTHRALGIA (pain in shoulder). On 20-Apr-2021, MALAISE (Malaise) and CHILLS (Chills/Teeth chattering) had resolved. On 21-Apr-2021, TREMOR (Shaking) and PYREXIA (fever (states he never took temperature)) had resolved. On 26-Apr-2021, MYALGIA (body aches) had resolved. On 04-May-2021, PAIN IN EXTREMITY (arm pain, the pain made it tough to sleep) had resolved. At the time of the report, ARTHRALGIA (pain in shoulder) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-100365 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Outcome of events changed. Second dose details was added.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16-year-old received both doses of vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received both doses of vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-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) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received both doses of vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16-year-old received both doses of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Impaired driving ability, Pyrexia
Clinical narrative: his driving was affected too; some memory loss; mild fevers; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (his driving was affected too), AMNESIA (some memory loss) and PYREXIA (mild fevers) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced IMPAIRED DRIVING ABILITY (his driving was affected too), AMNESIA (some memory loss) and PYREXIA (mild fevers). At the time of the report, IMPAIRED DRIVING ABILITY (his driving was affected too) and PYREXIA (mild fevers) outcome was unknown and AMNESIA (some memory loss) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Patient reported that his driving was affected too, after vaccination, due to which he ran into a ditch as an accident. He did not get second dose out of fear. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Non Sig Follow-Up received- reporter phone number added.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced COVID-19 (Diagnosed with COVID-19). At the time of the report, COVID-19 (Diagnosed with COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment information was not provided
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Influenza like illness
Clinical narrative: Flue like symptoms; Profuse bleeding from nose; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Profuse bleeding from nose) and INFLUENZA LIKE ILLNESS (Flue like symptoms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINOXIDIL for an unknown indication.    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 EPISTAXIS (Profuse bleeding from nose) and INFLUENZA LIKE ILLNESS (Flue like symptoms). At the time of the report, EPISTAXIS (Profuse bleeding from nose) had resolved and INFLUENZA LIKE ILLNESS (Flue like symptoms) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site swelling
Clinical narrative: swelling at the site of injection; Red spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the site of injection) and ERYTHEMA (Red spot) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 038C71A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 30-Aug-1987.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the site of injection) and ERYTHEMA (Red spot). At the time of the report, VACCINATION SITE SWELLING (swelling at the site of injection) and ERYTHEMA (Red spot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-100383 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Initial Additional-1 : VAERS, AE details, outcome, Dose 2 details, past med history
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling; Soreness of left arm; injection site erythema; Redness at shot site for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at shot site for 2 days), INJECTION SITE SWELLING (Swelling), INJECTION SITE PAIN (Soreness of left arm) and INJECTION SITE ERYTHEMA (injection site erythema) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History was Provided by Reporter.  Concomitant products included ORAL CONTRACEPTIVE NOS and PARACETAMOL (TYLENOL) for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at shot site for 2 days). On 30-Apr-2021, the patient experienced INJECTION SITE SWELLING (Swelling), INJECTION SITE PAIN (Soreness of left arm) and INJECTION SITE ERYTHEMA (injection site erythema). On 23-Apr-2021, INJECTION SITE ERYTHEMA (Redness at shot site for 2 days) had resolved. At the time of the report, INJECTION SITE SWELLING (Swelling), INJECTION SITE PAIN (Soreness of left arm) and INJECTION SITE ERYTHEMA (injection site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she took Paracetamol for treatment.   This case was linked to MOD-2021-100379 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Initial Additional-1 : VAERS, AE details and outcome, Past med history
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm). On 30-Apr-2021, PAIN IN EXTREMITY (Soreness in the arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Event outcome were reported and had  second dose.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: arm was hot, red, itchy, bumpy, and swollen.; arm was hot, red, itchy, bumpy, and swollen.; arm was hot, red, itchy, bumpy, and swollen/symptoms have lasted for over a week now since he received his vaccine.; His arm of injection became red and hot. symptoms diminished a bit after a few days/they came back a little bit more intense.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (arm was hot, red, itchy, bumpy, and swollen.), INJECTION SITE PRURITUS (arm was hot, red, itchy, bumpy, and swollen.), INJECTION SITE ERYTHEMA (His arm of injection became red and hot. symptoms diminished a bit after a few days/they came back a little bit more intense.) and INJECTION SITE SWELLING (arm was hot, red, itchy, bumpy, and swollen/symptoms have lasted for over a week now since he received his vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Back pain (Takes Tylenol (Acetaminophen) occasionally.).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced INJECTION SITE ERYTHEMA (His arm of injection became red and hot. symptoms diminished a bit after a few days/they came back a little bit more intense.). On 26-Apr-2021, the patient experienced FEELING HOT (arm was hot, red, itchy, bumpy, and swollen.), INJECTION SITE PRURITUS (arm was hot, red, itchy, bumpy, and swollen.) and INJECTION SITE SWELLING (arm was hot, red, itchy, bumpy, and swollen/symptoms have lasted for over a week now since he received his vaccine.). At the time of the report, FEELING HOT (arm was hot, red, itchy, bumpy, and swollen.), INJECTION SITE PRURITUS (arm was hot, red, itchy, bumpy, and swollen.), INJECTION SITE ERYTHEMA (His arm of injection became red and hot. symptoms diminished a bit after a few days/they came back a little bit more intense.) and INJECTION SITE SWELLING (arm was hot, red, itchy, bumpy, and swollen/symptoms have lasted for over a week now since he received his vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included acetaminophen. Concomitant medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Pyrexia, Testicular pain
Clinical narrative: short of breath; testicular pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA, TESTICULAR PAIN, PYREXIA, and CHILLS in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) 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 28-Apr-2021, the patient experienced DYSPNOEA, TESTICULAR PAIN, PYREXIA, and CHILLS. On 30-Apr-2021, PYREXIA and CHILLS had resolved. At the time of the report, DYSPNOEA and TESTICULAR PAIN had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: heart rate racing; feeling faint; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate racing) and DIZZINESS (feeling faint) in a 65-year-old female patient who received mRNA-1273 (batch no. 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and ELDERBERRY [SAMBUCUS NIGRA] for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HEART RATE INCREASED (heart rate racing) and DIZZINESS (feeling faint). On 29-Apr-2021, HEART RATE INCREASED (heart rate racing) and DIZZINESS (feeling faint) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included black elderberry,arthritis topical cream. Treatment included Patient used a cold compress on her face and neck.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with Covid 19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Diagnosed with Covid 19) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-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 (Diagnosed with Covid 19). At the time of the report, COVID-19 (Diagnosed with Covid 19) 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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: No specific follow-up information recorded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: felt weak; light headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) and HEADACHE (light headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced ASTHENIA (felt weak) and HEADACHE (light headache). At the time of the report, ASTHENIA (felt weak) and HEADACHE (light headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.  No concomitant medication was provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired ever since second dose of vaccine/it's in a way that patient's never been tired before; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired ever since second dose of vaccine/it's in a way that patient's never been tired before) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced FATIGUE (tired ever since second dose of vaccine/it's in a way that patient's never been tired before). At the time of the report, FATIGUE (tired ever since second dose of vaccine/it's in a way that patient's never been tired before) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 123 days post first Shot scheduling for second shot now; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (123 days post first Shot scheduling for second shot now) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (123 days post first Shot scheduling for second shot now). At the time of the report, PRODUCT DOSE OMISSION ISSUE (123 days post first Shot scheduling for second shot now) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Vaccination site discolouration
Clinical narrative: Pinking at injection site; redness in left arm; soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pinking at injection site), ERYTHEMA (redness in left arm) and MYALGIA (soreness in left arm) in a 74-year-old male patient who received mRNA-1273 (batch no. 042B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 31-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Pinking at injection site), ERYTHEMA (redness in left arm) and MYALGIA (soreness in left arm). At the time of the report, VACCINATION SITE DISCOLOURATION (Pinking at injection site), ERYTHEMA (redness in left arm) and MYALGIA (soreness in left arm) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Infectious mononucleosis, Lymphadenopathy
Clinical narrative: active mononucleosis; Swollen lymph nodes all over the place, lymph nodes in his throat, lymph nodes at his clavicle, and lymph nodes up his neck; This spontaneous case was reported by a consumer and describes the occurrence of INFECTIOUS MONONUCLEOSIS (active mononucleosis) and LYMPHADENOPATHY (Swollen lymph nodes all over the place, lymph nodes in his throat, lymph nodes at his clavicle, and lymph nodes up his neck) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Mononucleosis.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTIOUS MONONUCLEOSIS (active mononucleosis) and LYMPHADENOPATHY (Swollen lymph nodes all over the place, lymph nodes in his throat, lymph nodes at his clavicle, and lymph nodes up his neck). At the time of the report, INFECTIOUS MONONUCLEOSIS (active mononucleosis) and LYMPHADENOPATHY (Swollen lymph nodes all over the place, lymph nodes in his throat, lymph nodes at his clavicle, and lymph nodes up his neck) outcome was unknown.            The patient did not know until after vaccination that he had active mononucleosis. No relevant concomitant medications reported. Treatment information not provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: tired; sleep all day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and SOMNOLENCE (sleep all day) in a female patient of an unknown age who received mRNA-1273 (batch nos. 014M42A and 028A21A) for COVID-19 vaccine.     Concurrent medical conditions included High cholesterol and Heart disorder.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired) and SOMNOLENCE (sleep all day). At the time of the report, FATIGUE (tired) and SOMNOLENCE (sleep all day) had resolved.            No treatment information was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-101495 (Patient Link).
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the first dose earlier this year. And she gave a dose today(1stMay2021); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose earlier this year. And she gave a dose today(1stMay2021)) in a 31-year-old patient of an unknown gender who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.   On 01-May-2021, the patient received second dose of mRNA-1273 (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 01-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose earlier this year. And she gave a dose today(1stMay2021)). On 01-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first dose earlier this year. And she gave a dose today(1stMay2021)) had resolved.        For mRNA-1273 (Unknown Route), the reporter did not provide any causality assessments.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site discolouration, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Slight skin discoloring at site of injenction; itchy skins / had itchiness on her arm; rash; slight mark at the injection site; itching at the injection site; swelling at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCOLOURATION (Slight skin discoloring at site of injenction), PRURITUS (itchy skins / had itchiness on her arm), RASH (rash), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Slight skin discoloring at site of injenction), PRURITUS (itchy skins / had itchiness on her arm), RASH (rash) and VACCINATION SITE ERYTHEMA (slight mark at the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Slight skin discoloring at site of injenction), PRURITUS (itchy skins / had itchiness on her arm), RASH (rash) and VACCINATION SITE ERYTHEMA (slight mark at the injection site) outcome was unknown and VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment medications include Topical cream.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Added second dose. Added new events.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Slight skin discoloring at site of injenction; itchy skins / had itchiness on her arm; rash; slight mark at the injection site; itching at the injection site; swelling at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCOLOURATION (Slight skin discoloring at site of injenction), PRURITUS (itchy skins / had itchiness on her arm), RASH (rash), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Slight skin discoloring at site of injenction), PRURITUS (itchy skins / had itchiness on her arm), RASH (rash) and VACCINATION SITE ERYTHEMA (slight mark at the injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Slight skin discoloring at site of injenction), PRURITUS (itchy skins / had itchiness on her arm), RASH (rash) and VACCINATION SITE ERYTHEMA (slight mark at the injection site) outcome was unknown and VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment medications include Topical cream.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Added second dose. Added new events.