chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Patient's neck swale up both sides after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Patient's neck swale up both sides after receiving 1st dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL], ATORVASTATIN, LISINOPRIL, DIAZEPAM and CARVEDILOL for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced SWELLING (Patient's neck swale up both sides after receiving 1st dose). At the time of the report, SWELLING (Patient's neck swale up both sides after receiving 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Called and the consumer refused for further follow-up, he is doing fine
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient is way past the 42 day window for the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient is way past the 42 day window for the second dose) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient is way past the 42 day window for the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient is way past the 42 day window for the second dose) had resolved.        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.   No treatment information was provided.  No concomitant medication was provided.; Sender's Comments: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273 (Batch number unknown) where the patient is yet to get the second dose and it is way past the 42 days window period. There are no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: sore arm; swollen glands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and LYMPHADENOPATHY (swollen glands) 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 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 PAIN IN EXTREMITY (sore arm) and LYMPHADENOPATHY (swollen glands). At the time of the report, PAIN IN EXTREMITY (sore arm) and LYMPHADENOPATHY (swollen glands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling of eyelid
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Swelling around both eye lids) and PRURITUS (Itchiness along her upper back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced SWELLING OF EYELID (Swelling around both eye lids) and PRURITUS (Itchiness along her upper back). At the time of the report, SWELLING OF EYELID (Swelling around both eye lids) and PRURITUS (Itchiness along her upper back) had resolved.        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.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-065273 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Additional information received updated outcome of the events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065273:Dose 2
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: Dizziness; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VOMITING (Vomiting) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness) and VOMITING (Vomiting). At the time of the report, DIZZINESS (Dizziness) and VOMITING (Vomiting) had not resolved.        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.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swollen arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE SWELLING (Swollen arm). The patient was treated with NAPROXEN SODIUM (ALEVE) for Swollen arm, at an unspecified dose and frequency. At the time of the report, INJECTION SITE SWELLING (Swollen arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  She used an ice pack to alleviate the pain and the inflammation and felt better afterwards.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information included updated outcome of the event of swollen arm to recovered. declines further follow-up. Treatment information added.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Brain frog; Fever of 101.1 F; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain frog), PYREXIA (Fever of 101.1 F) and HEADACHE (Slight headache) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Brain frog), PYREXIA (Fever of 101.1 F) and HEADACHE (Slight headache). At the time of the report, FEELING ABNORMAL (Brain frog), PYREXIA (Fever of 101.1 F) and HEADACHE (Slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: fever (High) 101.1 F at 3:15 pm 99F at the time of the report.         No relevant concomitant medications were reported.  No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen and red at the site of the injection and it was itchy and warm; Swollen and red at the site of the injection and it was itchy and warm; Swollen and red at the site of the injection and it was itchy and warm; Swollen and red at the site of the injection and it was itchy and warm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Swollen and red at the site of the injection and it was itchy and warm), INJECTION SITE PRURITUS (Swollen and red at the site of the injection and it was itchy and warm), INJECTION SITE SWELLING (Swollen and red at the site of the injection and it was itchy and warm) and INJECTION SITE ERYTHEMA (Swollen and red at the site of the injection and it was itchy and warm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced INJECTION SITE WARMTH (Swollen and red at the site of the injection and it was itchy and warm), INJECTION SITE PRURITUS (Swollen and red at the site of the injection and it was itchy and warm), INJECTION SITE SWELLING (Swollen and red at the site of the injection and it was itchy and warm) and INJECTION SITE ERYTHEMA (Swollen and red at the site of the injection and it was itchy and warm). The patient was treated with PENICILLIN NOS (PENICILLIN [PENICILLIN NOS]) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (Swollen and red at the site of the injection and it was itchy and warm), INJECTION SITE PRURITUS (Swollen and red at the site of the injection and it was itchy and warm), INJECTION SITE SWELLING (Swollen and red at the site of the injection and it was itchy and warm) and INJECTION SITE ERYTHEMA (Swollen and red at the site of the injection and it was itchy and warm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid-19) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14-JUL-2021 contains Non Significant Information.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (On 14 Jul 2021, the patient had a live full term birth with no complications On 21 Aug 2016, the patient had a live full term birth with no complications. On 17 Feb 2019, the patient had a live full term birth with no complications.) on 14-Jul-2014. Concurrent medical conditions included Hypothyroidism since 2013 and No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID) for Hypothyroidism.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Oct-2020 and the estimated date of delivery was 17-Jul-2021. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  On 03-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2020, Pregnancy test: positive (Positive) Positive.         On 2 mar 2021, the 20 week ultrasound was done. The results were unknown. Treatment information was not provided.   The reporter wanted to be added to the Moderna pregnancy registry.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Opiates positive
Clinical narrative: My drug test came back positive for codeine; This spontaneous case was reported by a consumer and describes the occurrence of OPIATES POSITIVE (My drug test came back positive for codeine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE. Concomitant products included HYDROCHLOROTHIAZIDE and OMEPRAZOLE for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced OPIATES POSITIVE (My drug test came back positive for codeine). At the time of the report, OPIATES POSITIVE (My drug test came back positive for codeine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided   This case was linked to MOD-2021-122587 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: e-mail address added.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (migraine) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced MIGRAINE (migraine). At the time of the report, MIGRAINE (migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Events treated with Tylenol and "migraine meds". Name and dosing information of migraine medication not provided.  No concomitant medications reported.   This case was linked to MOD-2021-034199 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: followup received  with NNI; Sender's Comments:  MOD-2021-034199:same reporter, different patient and events
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: sore arm; Chills at night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and CHILLS (Chills at night) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and CHILLS (Chills at night). On 04-Mar-2021, PAIN IN EXTREMITY (sore arm) and CHILLS (Chills at night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information were not provided by the reporter. Treatment information were not provided by the reporter.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Raised heartrate / 77-80 beats per minute; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Raised heartrate / 77-80 beats per minute) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced HEART RATE INCREASED (Raised heartrate / 77-80 beats per minute). At the time of the report, HEART RATE INCREASED (Raised heartrate / 77-80 beats per minute) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: Swollen lymph node under breast and arm pit; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and LYMPHADENOPATHY (Swollen lymph node under breast and arm pit) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). On 28-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node under breast and arm pit). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Pain, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swollen arm) had resolved and LYMPHADENOPATHY (Swollen lymph node under breast and arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Restlessness
Clinical narrative: Not able to sleep; Restless; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Not able to sleep) and RESTLESSNESS (Restless) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 INSOMNIA (Not able to sleep) and RESTLESSNESS (Restless). At the time of the report, INSOMNIA (Not able to sleep) and RESTLESSNESS (Restless) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Exposure via skin contact
Clinical narrative: Bunch of the liquid ran down his arm; Bunch of the liquid ran down his arm; A spontaneous report  was received from a consumer who was a male patient of unknown age, who received moderna's covid-19 vaccine (mrna-1273) and experienced a bunch of vaccine ran down his arm (accidental underdose).  The patient's medical history was not provided. Concomitant medications were not reported.  On 30-JAN-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007M20A)intramuscularly for prophylaxis of COVID-19 infection. On 01-MAR-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 014M20A) intramuscularly for prophylaxis of COVID-19 infection  On 0- MAR-2021, the patient reported that when the vaccine was administered to him, a bunch of the liquid ran down his arm and he did not feel pain from the injection. The patient reported that, after the first dose, he experienced fever and headache.   Treatment information for the event was not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken response to the events was not applicable.  The outcome of the event, while vaccine administration a bunch of the liquid ran down the arm, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of accidental underdose of mRNA-1273, lot # 014M20A with no adverse events
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: adverse reaction that was not noted on your site; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction that was not noted on your site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   Concomitant product used was not provided by the reporter. No treatment information was reported. On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction that was not noted on your site).   At the time of the report, ADVERSE REACTION (adverse reaction that was not noted on your site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache
Clinical narrative: Eye pain; Headache came back; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Eye pain), HEADACHE (Headache) and HEADACHE (Headache came back) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Eye pain.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HEADACHE (Headache). On 31-Jan-2021, the patient experienced EYE PAIN (Eye pain) and HEADACHE (Headache came back). On 29-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, EYE PAIN (Eye pain) outcome was unknown and HEADACHE (Headache came back) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported by the reporter. Treatment was not provided. Patient suffers from Migraine and eye pain but has never been diagnosed with Migraine. The patient visited eye doctor and the eyes are fine.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Significant Follow up received in mail and outcome of Event (headache) was resolved
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101.4; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.4) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Fever of 101.4). At the time of the report, PYREXIA (Fever of 101.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.4 degree.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included None.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            No Concomitant medications were provided No Treatment information provided    This case was linked to MOD-2021-034308 (Patient Link).
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills) and FATIGUE (Tiredness) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event and Diabetes since an unknown date. Concomitant products included LINAGLIPTIN (TRADJENTA) for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Tiredness). At the time of the report, CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Tylenol   This case was linked to MOD-2021-016540 (Patient Link).   Reporter did not allow further contact
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: It's been itching; huge rash in the injection site, in their junk, in the middle of their back; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRURITUS (It's been itching) and RASH (huge rash in the injection site, in their junk, in the middle of their back) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Hypothyroidism and Diabetes.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (It's been itching) and RASH (huge rash in the injection site, in their junk, in the middle of their back). At the time of the report, PRURITUS (It's been itching) and RASH (huge rash in the injection site, in their junk, in the middle of their back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included Cortisone cream.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Nausea
Clinical narrative: nauseated; Redness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseated) and ERYTHEMA (Redness) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (nauseated) and ERYTHEMA (Redness). At the time of the report, NAUSEA (nauseated) and ERYTHEMA (Redness) outcome was unknown.            Concomitant medication was not provided by the reporter.  The treatment medication was unknown.   This case was linked to MOD-2021-034270 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Sligth temperature; Achy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Sligth temperature) and PAIN (Achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Sligth temperature) and PAIN (Achy). At the time of the report, PYREXIA (Sligth temperature) and PAIN (Achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cystitis, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills), HYPERHIDROSIS (sweating) and TREMOR (uncontrollable shaking) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 0081321-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN & MINERAL, AMLODIPINE and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE, METFORMIN HYDROCHLORIDE (XIGDUO XR).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever). On 03-Mar-2021, the patient experienced CHILLS (chills), HYPERHIDROSIS (sweating) and TREMOR (uncontrollable shaking). On an unknown date, the patient experienced CYSTITIS (Bladder infection). At the time of the report, FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills), HYPERHIDROSIS (sweating), TREMOR (uncontrollable shaking) and CYSTITIS (Bladder infection) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Treatment medication included Alot of water and two tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: New event: Bladder infection added,2nd dose information added.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills), HYPERHIDROSIS (sweating) and TREMOR (uncontrollable shaking) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 0081321-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN & MINERAL, AMLODIPINE and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE, METFORMIN HYDROCHLORIDE (XIGDUO XR).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever). On 03-Mar-2021, the patient experienced CHILLS (chills), HYPERHIDROSIS (sweating) and TREMOR (uncontrollable shaking). On an unknown date, the patient experienced CYSTITIS (Bladder infection). At the time of the report, FATIGUE (fatigue), PYREXIA (fever), CHILLS (chills), HYPERHIDROSIS (sweating), TREMOR (uncontrollable shaking) and CYSTITIS (Bladder infection) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Treatment medication included Alot of water and two tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: New event: Bladder infection added,2nd dose information added.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tenderness to left arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness to left arm/vaccination site pain.  The patient's medical history was not provided. Concomitant medications reported were Hydrochlorothiazide, Atorvastatin, Bisoprolol Fumarate, Baby Aspirin for drug use for unknown indication.  On 28 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: O25A214) via unknown route for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced the event, tenderness to left arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 1 Mar 2021 the outcome of event, tenderness to left arm was resolved.
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Second shot rescheduled for March 13th, and there will be a difference of more than 36 days; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Second shot rescheduled for March 13th, and there will be a difference of more than 36 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced OFF LABEL USE (Second shot rescheduled for March 13th, and there will be a difference of more than 36 days). At the time of the report, OFF LABEL USE (Second shot rescheduled for March 13th, and there will be a difference of more than 36 days) outcome was unknown.         No treatment information was reported.   Reporter did not allow further contact
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: muscle pain; low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) and PYREXIA (low-grade fever) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition were reported.).  No concomitant medication 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 MYALGIA (muscle pain) and PYREXIA (low-grade fever). At the time of the report, MYALGIA (muscle pain) and PYREXIA (low-grade fever) outcome was unknown.      No treatment medication was reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is very sore and sensitive off and on; 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 PAIN IN EXTREMITY (arm is very sore and sensitive off and on) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is very sore and sensitive off and on). At the time of the report, PAIN IN EXTREMITY (arm is very sore and sensitive off and on) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were taken. No treatment drugs were taken.   Reporter did not allow further contact
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Muscular weakness, Pyrexia
Clinical narrative: chills; fever (his temperature was 104-105°F); muscle weakness in legs and shoulders; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever (his temperature was 104-105°F)) and MUSCULAR WEAKNESS (muscle weakness in legs and shoulders) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Thyroid disorder NOS.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever (his temperature was 104-105°F)) and MUSCULAR WEAKNESS (muscle weakness in legs and shoulders). On 03-Feb-2021, CHILLS (chills) had resolved. At the time of the report, PYREXIA (fever (his temperature was 104-105°F)) and MUSCULAR WEAKNESS (muscle weakness in legs and shoulders) had not resolved.             Treatment information was not provided.    This case was linked to MOD-2021-033733 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Event outcome was updated to recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Inflammation, Prenatal screening test, Rash erythematous
Clinical narrative: Vaccine exposure during pregnancy; Rash that was red on opposite arm from the arm she had received the vaccination; Rash inflamed and on the opposite arm from the arm she had received the vaccination; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), RASH ERYTHEMATOUS (Rash that was red on opposite arm from the arm she had received the vaccination) and INFLAMMATION (Rash inflamed and on the opposite arm from the arm she had received the vaccination) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergies to Ceclor, Amoxil, Bactrim). Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) from 23-Nov-2020 to an unknown date for Nausea, PRENATAL MULTIVITAMIN + DHA for Pregnancy.   On 20-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 04-Oct-2020 and the estimated date of delivery was 11-Jul-2021. In February 2021, the patient experienced RASH ERYTHEMATOUS (Rash that was red on opposite arm from the arm she had received the vaccination) and INFLAMMATION (Rash inflamed and on the opposite arm from the arm she had received the vaccination). On 20-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 20-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, RASH ERYTHEMATOUS (Rash that was red on opposite arm from the arm she had received the vaccination) and INFLAMMATION (Rash inflamed and on the opposite arm from the arm she had received the vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2020, Ultrasound abdomen: normal (normal) normal. On 14-Dec-2020, Prenatal screening test: normal (normal) normal. On 02-Feb-2021, Ultrasound abdomen: normal (normal) normal. On 25-Feb-2021, Alpha 1 foetoprotein normal: normal (normal) normal.         Treatment information for rash was not provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Second vaccination information.  Reporting of an AE not previously reported after first injection.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound abdomen
Clinical narrative: Vaccine exposure during pregnancy; Rash that was red on opposite arm from the arm she had received the vaccination; Rash inflamed and on the opposite arm from the arm she had received the vaccination; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), RASH ERYTHEMATOUS (Rash that was red on opposite arm from the arm she had received the vaccination) and INFLAMMATION (Rash inflamed and on the opposite arm from the arm she had received the vaccination) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergies to Ceclor, Amoxil, Bactrim). Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) from 23-Nov-2020 to an unknown date for Nausea, PRENATAL MULTIVITAMIN + DHA for Pregnancy.   On 20-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 04-Oct-2020 and the estimated date of delivery was 11-Jul-2021. In February 2021, the patient experienced RASH ERYTHEMATOUS (Rash that was red on opposite arm from the arm she had received the vaccination) and INFLAMMATION (Rash inflamed and on the opposite arm from the arm she had received the vaccination). On 20-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 20-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, RASH ERYTHEMATOUS (Rash that was red on opposite arm from the arm she had received the vaccination) and INFLAMMATION (Rash inflamed and on the opposite arm from the arm she had received the vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2020, Ultrasound abdomen: normal (normal) normal. On 14-Dec-2020, Prenatal screening test: normal (normal) normal. On 02-Feb-2021, Ultrasound abdomen: normal (normal) normal. On 25-Feb-2021, Alpha 1 foetoprotein normal: normal (normal) normal.         Treatment information for rash was not provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Second vaccination information.  Reporting of an AE not previously reported after first injection.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm is sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is sore at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is sore at the injection site). At the time of the report, VACCINATION SITE PAIN (arm is sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.