chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received first shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received first shot) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received first shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received first shot) 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.   Concomitant medication information not provided.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Arm redness within 48 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (Arm redness within 48 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced ERYTHEMA (Arm redness within 48 hours). At the time of the report, ERYTHEMA (Arm redness within 48 hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to MOD21-078675 (E2B Linked Report).; Sender's Comments:  MOD21-078675:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm soreness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm soreness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Vaccination site pain, at an unspecified dose and frequency. On 30-Mar-2021, VACCINATION SITE PAIN (Left arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications provided included Contraceptive pills.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Slight headache; general fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) and FATIGUE (general fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Slight headache) and FATIGUE (general fatigue). At the time of the report, HEADACHE (Slight headache) and FATIGUE (general fatigue) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-081490 (E2B Linked Report).; Sender's Comments:  MOD-2021-081490:dose 2
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Myalgia, Polymerase chain reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), DIZZINESS (Dizzy when walking), RHINORRHEA (Runny Nose), CHILLS (Chills) and MYALGIA (Aches all over the body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DIARRHEA (Diarrhea), DIZZINESS (Dizzy when walking), RHINORRHEA (Runny Nose), CHILLS (Chills) and MYALGIA (Aches all over the body). At the time of the report, DIARRHEA (Diarrhea), DIZZINESS (Dizzy when walking), RHINORRHEA (Runny Nose), CHILLS (Chills) and MYALGIA (Aches all over the body) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient visited the hospital emergency response (ER). It was reported that all tests were normal. Concomitant medications and treatment information were not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), DIZZINESS (Dizzy when walking), RHINORRHEA (Runny Nose), CHILLS (Chills) and MYALGIA (Aches all over the body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DIARRHEA (Diarrhea), DIZZINESS (Dizzy when walking), RHINORRHEA (Runny Nose), CHILLS (Chills) and MYALGIA (Aches all over the body). At the time of the report, DIARRHEA (Diarrhea), DIZZINESS (Dizzy when walking), RHINORRHEA (Runny Nose), CHILLS (Chills) and MYALGIA (Aches all over the body) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient visited the hospital emergency response (ER). It was reported that all tests were normal. Concomitant medications and treatment information were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Dose calculation error
Clinical narrative: First dose leaked due to poor technique from a new HCP; syringe connection; This spontaneous case was reported by a consumer and describes the occurrence of DOSE CALCULATION ERROR (First dose leaked due to poor technique from a new HCP) and DEVICE CONNECTION ISSUE (syringe connection) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DOSE CALCULATION ERROR (First dose leaked due to poor technique from a new HCP) and DEVICE CONNECTION ISSUE (syringe connection). At the time of the report, DOSE CALCULATION ERROR (First dose leaked due to poor technique from a new HCP) and DEVICE CONNECTION ISSUE (syringe connection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.    This case was linked to MOD-2021-061094 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Exposed to COVID-19 after first dose and tested positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Exposed to COVID-19 after first dose and tested positive) 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Exposed to COVID-19 after first dose and tested positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Exposed to COVID-19 after first dose and tested positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information were not provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered vaccine to patient which vial was unpunctured 2 weeks ago; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccine to patient which vial was unpunctured 2 weeks ago) 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 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 EXPIRED PRODUCT ADMINISTERED (administered vaccine to patient which vial was unpunctured 2 weeks ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccine to patient which vial was unpunctured 2 weeks ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MOD21-079129, US-MODERNATX, INC.-MOD-2021-081595 (E2B Linked Report).; Sender's Comments: This report refers to a case of Expired product administered (administered vaccine to patient which vial was unpunctured 2 weeks ago) for mRNA-1273, lot # unknown is assessed as not applicable. MOD21-079129:Crosslinked US-MODERNATX, INC.-MOD-2021-081595:Crosslinked
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, SARS-CoV-2 test, SARS-CoV-2 test positive, X-ray
Clinical narrative: bronchitis; SARS-CoV-2 test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive ) and BRONCHITIS (bronchitis) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (chronic).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive ). On an unknown date, the patient experienced BRONCHITIS (bronchitis). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of 1 dosage form. At the time of the report, SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive ) and BRONCHITIS (bronchitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, X-ray: normal (normal) no signs of COVID damage.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included inhaler forasthma   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information included new event, treatment medication, medical history and lab data.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (No Adverse event) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001r214) for COVID-19 vaccination.     Concomitant products included CYNARA CARDUNCULUS LEAF, GANODERMA LUCIDUM, MONASCUS PURPUREUS, SILYBUM MARIANUM SEED, UBIDECARENONE (CHOLESTEROL CARE) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, NO ADVERSE EVENT (No Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Other concomitant drugs include Blood pressure medications and cholesterol medications.   This case was linked to MOD-2021-081498 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diplopia, Fatigue, Headache
Clinical narrative: mild fatigue; Double vision; headache all the way to the jaw line; weak; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (mild fatigue), HEADACHE (headache all the way to the jaw line), ASTHENIA (weak) and DIPLOPIA (Double vision) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced ASTHENIA (weak). On 19-Apr-2021, the patient experienced HEADACHE (headache all the way to the jaw line). On 20-Apr-2021, the patient experienced FATIGUE (mild fatigue) and DIPLOPIA (Double vision). At the time of the report, FATIGUE (mild fatigue), HEADACHE (headache all the way to the jaw line), ASTHENIA (weak) and DIPLOPIA (Double vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were reported. No concomitant mediations were reported.   This case was linked to MOD-2021-081479 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-081479:1st dose
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Lip pain, Rash
Clinical narrative: started to blister; seems that classic shingles attacked; classic shingles skinny eruption; staving pain in her hips; suspected was shingles; This spontaneous case was reported by a consumer and describes the occurrence of LIP PAIN (staving pain in her hips), HERPES ZOSTER (suspected was shingles), BLISTER (started to blister), HERPES ZOSTER (seems that classic shingles attacked) and RASH (classic shingles skinny eruption) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046421A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced LIP PAIN (staving pain in her hips), HERPES ZOSTER (suspected was shingles) and RASH (classic shingles skinny eruption). On 19-Apr-2021, the patient experienced BLISTER (started to blister) and HERPES ZOSTER (seems that classic shingles attacked). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIP PAIN (staving pain in her hips) and BLISTER (started to blister) outcome was unknown and HERPES ZOSTER (suspected was shingles), HERPES ZOSTER (seems that classic shingles attacked) and RASH (classic shingles skinny eruption) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-May-2021: event shingles outcome was updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Nausea, Product dose omission issue, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: diagnosed with COVID-19 three weeks after first dose; had sinuses like situations; Second dose greater than day 36; nausea; stopped up ears; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (diagnosed with COVID-19 three weeks after first dose), SINUSITIS (had sinuses like situations), PRODUCT DOSE OMISSION ISSUE (Second dose greater than day 36), EAR DISCOMFORT (stopped up ears) and NAUSEA (nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthmatic.    On 19-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 SARS-COV-2 TEST POSITIVE (diagnosed with COVID-19 three weeks after first dose), SINUSITIS (had sinuses like situations), PRODUCT DOSE OMISSION ISSUE (Second dose greater than day 36), EAR DISCOMFORT (stopped up ears) and NAUSEA (nausea). At the time of the report, SARS-COV-2 TEST POSITIVE (diagnosed with COVID-19 three weeks after first dose), SINUSITIS (had sinuses like situations) and NAUSEA (nausea) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Second dose greater than day 36) and EAR DISCOMFORT (stopped up ears) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was provided by the reporter as Asthma Medications. Treatment information was provided Steroid and Antibiotic.   This case was linked to MOD-2021-265840 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow-up received and contains significant information updated new events (stopped up ears and nausea). On 25-Jul-2021: Follow-up received and contains no new information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: diagnosed with COVID-19 three weeks after first dose; had sinuses like situations; Second dose greater than day 36; nausea; stopped up ears; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (diagnosed with COVID-19 three weeks after first dose), SINUSITIS (had sinuses like situations), PRODUCT DOSE OMISSION ISSUE (Second dose greater than day 36), EAR DISCOMFORT (stopped up ears) and NAUSEA (nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthmatic.    On 19-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 SARS-COV-2 TEST POSITIVE (diagnosed with COVID-19 three weeks after first dose), SINUSITIS (had sinuses like situations), PRODUCT DOSE OMISSION ISSUE (Second dose greater than day 36), EAR DISCOMFORT (stopped up ears) and NAUSEA (nausea). At the time of the report, SARS-COV-2 TEST POSITIVE (diagnosed with COVID-19 three weeks after first dose), SINUSITIS (had sinuses like situations) and NAUSEA (nausea) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Second dose greater than day 36) and EAR DISCOMFORT (stopped up ears) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was provided by the reporter as Asthma Medications. Treatment information was provided Steroid and Antibiotic.   This case was linked to MOD-2021-265840 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow-up received and contains significant information updated new events (stopped up ears and nausea). On 25-Jul-2021: Follow-up received and contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Patient who already received their first dose was exposed to someone who tested positive for COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPOSURE TO SARS-COV-2 (Patient who already received their first dose was exposed to someone who tested positive for COVID-19) 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 EXPOSURE TO SARS-COV-2 (Patient who already received their first dose was exposed to someone who tested positive for COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Patient who already received their first dose was exposed to someone who tested positive for COVID-19) outcome was unknown. Not Provided      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 concomitant medications were reported. No treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Vomiting
Clinical narrative: bad diarrhea; upset stomach; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (bad diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and VOMITING (vomiting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DIARRHOEA (bad diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and VOMITING (vomiting). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. On 03-Apr-2021, DIARRHOEA (bad diarrhea), ABDOMINAL DISCOMFORT (upset stomach) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Pain in extremity, Skin irritation
Clinical narrative: When the vaccinator injected the vaccine they told the patient that there was some blood; she felt a weird irritation of the skin; she felt a weird irritation of the skin and a little bite of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (When the vaccinator injected the vaccine they told the patient that there was some blood), SKIN IRRITATION (she felt a weird irritation of the skin) and PAIN IN EXTREMITY (she felt a weird irritation of the skin and a little bite of sore arm) 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 COVID-19 vaccination (First dose of Covid-19 vaccination.).   On 16-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HAEMORRHAGE (When the vaccinator injected the vaccine they told the patient that there was some blood), SKIN IRRITATION (she felt a weird irritation of the skin) and PAIN IN EXTREMITY (she felt a weird irritation of the skin and a little bite of sore arm). The patient was treated with Wound care (vaccinator cleansed the injection site then rubbed it alcohol) for Injection site haemorrhage. At the time of the report, INJECTION SITE HAEMORRHAGE (When the vaccinator injected the vaccine they told the patient that there was some blood), SKIN IRRITATION (she felt a weird irritation of the skin) and PAIN IN EXTREMITY (she felt a weird irritation of the skin and a little bite of sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she had less symptoms with the second dose of the covid-19 vaccination compared to the first dose.   This case was linked to US-MODERNATX, INC.-MOD-2021-081491 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081491:Original Case : MOD-2021-081491 Case for Dose 2
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: right arm was aching; lymph node maybe swollen; left arm really hurting after getting vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm really hurting after getting vaccine), PAIN IN EXTREMITY (right arm was aching) and LYMPHADENOPATHY (lymph node maybe swollen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), IBUPROFEN, AMLODIPINE BESILATE (NORVASC), OMEPRAZOLE, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ), POTASSIUM, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), TOPIRAMATE (TOPAMAX), SIMVASTATIN and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm really hurting after getting vaccine). On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (right arm was aching) and LYMPHADENOPATHY (lymph node maybe swollen). At the time of the report, PAIN IN EXTREMITY (left arm really hurting after getting vaccine), PAIN IN EXTREMITY (right arm was aching) and LYMPHADENOPATHY (lymph node maybe swollen) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No treatment medications were reported.  Patient stated she does not want to get her second dose of vaccine which is scheduled for 20-APR-2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Cluster headache, Dyspepsia, Feeling abnormal, Vaccination complication
Clinical narrative: cluster headaches' intensity is through the roof/cluster migraines have kicked up in frequency; felt off a few days after the vaccine; bowel movements are different.; digestive system has felt off; he hasn't felt up to par in the last 2 weeks/he doesn't feel like himself; This spontaneous case was reported by a consumer and describes the occurrence of CLUSTER HEADACHE (cluster headaches' intensity is through the roof/cluster migraines have kicked up in frequency), VACCINATION COMPLICATION (felt off a few days after the vaccine), BOWEL MOVEMENT IRREGULARITY (bowel movements are different.), FEELING ABNORMAL (he hasn't felt up to par in the last 2 weeks/he doesn't feel like himself) and DYSPEPSIA (digestive system has felt off) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included Diverticulosis. Concurrent medical conditions included Headaches cluster and Liver cirrhosis.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FEELING ABNORMAL (he hasn't felt up to par in the last 2 weeks/he doesn't feel like himself). On an unknown date, the patient experienced CLUSTER HEADACHE (cluster headaches' intensity is through the roof/cluster migraines have kicked up in frequency), VACCINATION COMPLICATION (felt off a few days after the vaccine), BOWEL MOVEMENT IRREGULARITY (bowel movements are different.) and DYSPEPSIA (digestive system has felt off). At the time of the report, CLUSTER HEADACHE (cluster headaches' intensity is through the roof/cluster migraines have kicked up in frequency), VACCINATION COMPLICATION (felt off a few days after the vaccine), BOWEL MOVEMENT IRREGULARITY (bowel movements are different.), FEELING ABNORMAL (he hasn't felt up to par in the last 2 weeks/he doesn't feel like himself) and DYSPEPSIA (digestive system has felt off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that he was due for his second dose of Covid-19 vaccination 20-APR-2021. Patient also reports having a history of cluster migraines that had been regressing in frequency. Those cluster migraines had kicked up in frequency in the last two weeks. He also reported increased intensity of the cluster headaches. To treat the cluster migraines the patient had to hyperventilate with oxygen when they start. He had to do it 4 times yesterday.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a physician assistant and describes the occurrence of PERIPHERAL SWELLING (left arm swelling), FEELING HOT (warmth to the area) and ERYTHEMA (redness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PERIPHERAL SWELLING (left arm swelling), FEELING HOT (warmth to the area) and ERYTHEMA (redness). At the time of the report, PERIPHERAL SWELLING (left arm swelling), FEELING HOT (warmth to the area) and ERYTHEMA (redness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment drugs included cold compress. This case was linked to US-MODERNATX, INC.-MOD-2021-081439, US-MODERNATX, INC.-MOD-2021-081427 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-081439: US-MODERNATX, INC.-MOD-2021-081427:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Feeling hot, Rash, Rash pruritic
Clinical narrative: COPD; a rash developed all over her body where the itching is unbearable; Her legs are hot to touch; rash on lower ankle legs it was itchy and resembled bites; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash on lower ankle legs it was itchy and resembled bites), FEELING HOT (Her legs are hot to touch), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and RASH (a rash developed all over her body where the itching is unbearable) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and #018B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 21-Mar-2021, the patient experienced RASH PRURITIC (rash on lower ankle legs it was itchy and resembled bites). On 17-Apr-2021, the patient experienced FEELING HOT (Her legs are hot to touch) and RASH (a rash developed all over her body where the itching is unbearable). On an unknown date, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). The patient was treated with MUPIROCIN at a dose of 2 % and TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash on lower ankle legs it was itchy and resembled bites), FEELING HOT (Her legs are hot to touch), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and RASH (a rash developed all over her body where the itching is unbearable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided. Treatment with Mucpirocin 2%cream and Triamcinolone cream were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-081605 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non-Significant follow up appended to AER On 26-May-2021: TCR FORM; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081605:second dose case
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: Scared to receive the 2nd vaccine; Shortness of breath; Projectile vomiting; Uncontrollable chills; Headache; Fever of 101.5; Nauseas; Tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Scared to receive the 2nd vaccine), DYSPNOEA (Shortness of breath), VOMITING PROJECTILE (Projectile vomiting) and CHILLS (Uncontrollable chills) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      Medical history was not provided.     On 19-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Apr-2021, the patient experienced FEELING ABNORMAL (Scared to receive the 2nd vaccine), DYSPNOEA (Shortness of breath), VOMITING PROJECTILE (Projectile vomiting), CHILLS (Uncontrollable chills), HEADACHE (Headache), PYREXIA (Fever of 101.5), NAUSEA (Nauseas) and FATIGUE (Tired). The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Scared to receive the 2nd vaccine), DYSPNOEA (Shortness of breath), VOMITING PROJECTILE (Projectile vomiting), CHILLS (Uncontrollable chills), HEADACHE (Headache), PYREXIA (Fever of 101.5), NAUSEA (Nauseas) and FATIGUE (Tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Patient stated he is "all good now". AEs have resolved and patient denied any lingering effect, nor does he have anything else to report.   This case was linked to MOD-2021-276204 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: TCR doc: Significant info updated
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Vomiting projectile
Clinical narrative: Scared to receive the 2nd vaccine; Shortness of breath; Projectile vomiting; Uncontrollable chills; Headache; Fever of 101.5; Nauseas; Tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Scared to receive the 2nd vaccine), DYSPNOEA (Shortness of breath), VOMITING PROJECTILE (Projectile vomiting) and CHILLS (Uncontrollable chills) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      Medical history was not provided.     On 19-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Apr-2021, the patient experienced FEELING ABNORMAL (Scared to receive the 2nd vaccine), DYSPNOEA (Shortness of breath), VOMITING PROJECTILE (Projectile vomiting), CHILLS (Uncontrollable chills), HEADACHE (Headache), PYREXIA (Fever of 101.5), NAUSEA (Nauseas) and FATIGUE (Tired). The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Scared to receive the 2nd vaccine), DYSPNOEA (Shortness of breath), VOMITING PROJECTILE (Projectile vomiting), CHILLS (Uncontrollable chills), HEADACHE (Headache), PYREXIA (Fever of 101.5), NAUSEA (Nauseas) and FATIGUE (Tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Patient stated he is "all good now". AEs have resolved and patient denied any lingering effect, nor does he have anything else to report.   This case was linked to MOD-2021-276204 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: TCR doc: Significant info updated
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: thumb keeps twitching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (thumb keeps twitching) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced MUSCLE TWITCHING (thumb keeps twitching). At the time of the report, MUSCLE TWITCHING (thumb keeps twitching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lethargy, Pyrexia, Vaccination site rash
Clinical narrative: very lethargic; high fever of 103; rash on arm at injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (very lethargic), PYREXIA (high fever of 103), VACCINATION SITE RASH (rash on arm at injection site) and CHILLS (chills) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) 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) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced LETHARGY (very lethargic), PYREXIA (high fever of 103), VACCINATION SITE RASH (rash on arm at injection site) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, LETHARGY (very lethargic), VACCINATION SITE RASH (rash on arm at injection site) and CHILLS (chills) had not resolved and PYREXIA (high fever of 103) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 (abnormal) fever has gone down slightly, 101. On 18-Apr-2021, Body temperature: 103 (High) High fever.         No concomitant medication were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: patient thinks second dose on 01may2021 (previous noted first dose 22mar2021 in crosslink case); shingles outbreak appeared on neck and chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles outbreak appeared on neck and chest) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient thinks second dose on 01may2021 (previous noted first dose 22mar2021 in crosslink case)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for COPD.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced HERPES ZOSTER (shingles outbreak appeared on neck and chest). On 01-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient thinks second dose on 01may2021 (previous noted first dose 22mar2021 in crosslink case)). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at a dose of 3 times daily for seven days. On 01-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient thinks second dose on 01may2021 (previous noted first dose 22mar2021 in crosslink case)) had resolved. At the time of the report, HERPES ZOSTER (shingles outbreak appeared on neck and chest) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Added second dose of the drug and updated the Action taken from unknown to not applicable in product tab. Added the event Inappropriate schedule of product administration.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed hives 15 minutes after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives 15 minutes after vaccination) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Developed hives 15 minutes after vaccination). In April 2021, URTICARIA (Developed hives 15 minutes after vaccination) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The reporter stated that hives started 15 minutes after vaccination and hives lasted for one hour. No treatment information reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Foggy; Very tired; Body Aches; Severe Chills; Severe Thirst; Shivers; Fever 101 F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), THIRST (Severe Thirst), CHILLS (Shivers), PYREXIA (Fever 101 F) and FATIGUE (Very tired) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (Fever 101 F). On 15-Apr-2021, the patient experienced THIRST (Severe Thirst), CHILLS (Shivers) and CHILLS (Severe Chills). On 16-Apr-2021, the patient experienced MYALGIA (Body Aches). On 17-Apr-2021, the patient experienced FEELING ABNORMAL (Foggy) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Apr-2021, THIRST (Severe Thirst), CHILLS (Shivers) and PYREXIA (Fever 101 F) outcome was unknown, CHILLS (Severe Chills) had resolved. On 16-Apr-2021, MYALGIA (Body Aches) had resolved. At the time of the report, FEELING ABNORMAL (Foggy) and FATIGUE (Very tired) outcome was unknown.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Foggy; Very tired; Body Aches; Severe Chills; Severe Thirst; Shivers; Fever 101 F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), THIRST (Severe Thirst), CHILLS (Shivers), PYREXIA (Fever 101 F) and FATIGUE (Very tired) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (Fever 101 F). On 15-Apr-2021, the patient experienced THIRST (Severe Thirst), CHILLS (Shivers) and CHILLS (Severe Chills). On 16-Apr-2021, the patient experienced MYALGIA (Body Aches). On 17-Apr-2021, the patient experienced FEELING ABNORMAL (Foggy) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Apr-2021, THIRST (Severe Thirst), CHILLS (Shivers) and PYREXIA (Fever 101 F) outcome was unknown, CHILLS (Severe Chills) had resolved. On 16-Apr-2021, MYALGIA (Body Aches) had resolved. At the time of the report, FEELING ABNORMAL (Foggy) and FATIGUE (Very tired) outcome was unknown.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.