chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: tiny little rash; little soreness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (tiny little rash) and MYALGIA (little soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Jan-2021, the patient experienced RASH (tiny little rash) and MYALGIA (little soreness). On 23-Jan-2021, RASH (tiny little rash) and MYALGIA (little soreness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Unknown. No relevant concomitant medications were reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin break out exacerbated; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Skin break out exacerbated) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Skin break out exacerbated). At the time of the report, RASH (Skin break out exacerbated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information for the event was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Dizziness, Dysstasia, Headache
Clinical narrative: barely can be stand; diarrhea; almost past out; back pain; cramps; lower back hurt; pain all over her body, barely can be stand; headache; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), DIARRHOEA (diarrhea), DIZZINESS (almost past out), BACK PAIN (back pain) and MUSCLE SPASMS (cramps) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced ILLNESS (felt sick), BACK PAIN (lower back hurt), MYALGIA (pain all over her body, barely can be stand) and HEADACHE (headache). On 04-Feb-2021, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (almost past out), BACK PAIN (back pain) and MUSCLE SPASMS (cramps). On an unknown date, the patient experienced DYSSTASIA (barely can be stand). At the time of the report, ILLNESS (felt sick), DIARRHOEA (diarrhea), DIZZINESS (almost past out), BACK PAIN (back pain), MUSCLE SPASMS (cramps), BACK PAIN (lower back hurt), DYSSTASIA (barely can be stand), MYALGIA (pain all over her body, barely can be stand) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment details included ibuprofen.  No relavent concomitant medications were reported.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Muscle spasms, Myalgia
Clinical narrative: barely can be stand; diarrhea; almost past out; back pain; cramps; lower back hurt; pain all over her body, barely can be stand; headache; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), DIARRHOEA (diarrhea), DIZZINESS (almost past out), BACK PAIN (back pain) and MUSCLE SPASMS (cramps) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced ILLNESS (felt sick), BACK PAIN (lower back hurt), MYALGIA (pain all over her body, barely can be stand) and HEADACHE (headache). On 04-Feb-2021, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (almost past out), BACK PAIN (back pain) and MUSCLE SPASMS (cramps). On an unknown date, the patient experienced DYSSTASIA (barely can be stand). At the time of the report, ILLNESS (felt sick), DIARRHOEA (diarrhea), DIZZINESS (almost past out), BACK PAIN (back pain), MUSCLE SPASMS (cramps), BACK PAIN (lower back hurt), DYSSTASIA (barely can be stand), MYALGIA (pain all over her body, barely can be stand) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment details included ibuprofen.  No relavent concomitant medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical conditions 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 COVID-19 (Positive Covid-19). At the time of the report, COVID-19 (Positive Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-023205 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-023205:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Myalgia, Pruritus
Clinical narrative: Mild itching; Redness at the injection site; Slightly mild sore muscle; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Mild itching), INJECTION SITE ERYTHEMA (Redness at the injection site) and MYALGIA (Slightly mild sore muscle) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition provided.). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced MYALGIA (Slightly mild sore muscle). On 03-Feb-2021, the patient experienced PRURITUS (Mild itching) and INJECTION SITE ERYTHEMA (Redness at the injection site). On 04-Feb-2021, INJECTION SITE ERYTHEMA (Redness at the injection site) had resolved. At the time of the report, PRURITUS (Mild itching) had not resolved and MYALGIA (Slightly mild sore muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: the whole area is a big patch that is red and feels hot; The area where I had the shot started to itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (The area where I had the shot started to itch) and VACCINATION SITE ERYTHEMA (the whole area is a big patch that is red and feels hot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (The area where I had the shot started to itch). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (the whole area is a big patch that is red and feels hot). At the time of the report, VACCINATION SITE PRURITUS (The area where I had the shot started to itch) outcome was unknown and VACCINATION SITE ERYTHEMA (the whole area is a big patch that is red and feels hot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Limitation of movement on the left arm; Soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Limitation of movement on the left arm) and VACCINATION SITE PAIN (Soreness on the injection site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Limitation of movement on the left arm) and VACCINATION SITE PAIN (Soreness on the injection site). On 23-Feb-2021, INJECTED LIMB MOBILITY DECREASED (Limitation of movement on the left arm) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: It was Itchy; Lump under the arm; It was red; It was hot; Arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (It was hot), VACCINATION SITE PRURITUS (It was Itchy), VACCINATION SITE PAIN (Arm was sore), VACCINATION SITE SWELLING (Lump under the arm) and VACCINATION SITE ERYTHEMA (It was red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 17-Feb-2021, the patient experienced INJECTION SITE WARMTH (It was hot), VACCINATION SITE SWELLING (Lump under the arm) and VACCINATION SITE ERYTHEMA (It was red). On 20-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (It was Itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 09-Feb-2021, VACCINATION SITE PAIN (Arm was sore) had resolved. On 24-Feb-2021, INJECTION SITE WARMTH (It was hot), VACCINATION SITE PRURITUS (It was Itchy), VACCINATION SITE SWELLING (Lump under the arm) and VACCINATION SITE ERYTHEMA (It was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information for the events included diphenhydramine. No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Erythema, Injection site mass, Myalgia, Pruritus
Clinical narrative: still having side effects after 2 weeks; RASH; warm; red; itcky; got a lump near injection site; Still has lump and doctor said to get an ultrasound; if it was ok to get her second dose of the Moderna vaccine in the opposite arm as her first injection; it is still sore; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (still having side effects after 2 weeks), RASH (RASH), VACCINATION SITE WARMTH (warm), ERYTHEMA (red) and PRURITUS (itcky) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012LD0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (still having side effects after 2 weeks), RASH (RASH), VACCINATION SITE WARMTH (warm), ERYTHEMA (red), PRURITUS (itcky), INJECTION SITE MASS (got a lump near injection site), VACCINATION SITE MASS (Still has lump and doctor said to get an ultrasound), VACCINATION SITE DISCOMFORT (if it was ok to get her second dose of the Moderna vaccine in the opposite arm as her first injection) and MYALGIA (it is still sore). At the time of the report, ADVERSE EVENT (still having side effects after 2 weeks), RASH (RASH), VACCINATION SITE WARMTH (warm), ERYTHEMA (red), PRURITUS (itcky), INJECTION SITE MASS (got a lump near injection site), VACCINATION SITE MASS (Still has lump and doctor said to get an ultrasound) and VACCINATION SITE DISCOMFORT (if it was ok to get her second dose of the Moderna vaccine in the opposite arm as her first injection) 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.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site discomfort, Vaccination site mass, Vaccination site warmth
Clinical narrative: still having side effects after 2 weeks; RASH; warm; red; itcky; got a lump near injection site; Still has lump and doctor said to get an ultrasound; if it was ok to get her second dose of the Moderna vaccine in the opposite arm as her first injection; it is still sore; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (still having side effects after 2 weeks), RASH (RASH), VACCINATION SITE WARMTH (warm), ERYTHEMA (red) and PRURITUS (itcky) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012LD0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (still having side effects after 2 weeks), RASH (RASH), VACCINATION SITE WARMTH (warm), ERYTHEMA (red), PRURITUS (itcky), INJECTION SITE MASS (got a lump near injection site), VACCINATION SITE MASS (Still has lump and doctor said to get an ultrasound), VACCINATION SITE DISCOMFORT (if it was ok to get her second dose of the Moderna vaccine in the opposite arm as her first injection) and MYALGIA (it is still sore). At the time of the report, ADVERSE EVENT (still having side effects after 2 weeks), RASH (RASH), VACCINATION SITE WARMTH (warm), ERYTHEMA (red), PRURITUS (itcky), INJECTION SITE MASS (got a lump near injection site), VACCINATION SITE MASS (Still has lump and doctor said to get an ultrasound) and VACCINATION SITE DISCOMFORT (if it was ok to get her second dose of the Moderna vaccine in the opposite arm as her first injection) 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: Arthralgia
Clinical narrative: pain in the left shoulder; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (pain in the left shoulder) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included TOPIRAMATE (TROKENDI), LEVOTHYROXINE SODIUM (SYNTHROID) and CETIRIZINE HYDROCHLORIDE (ZYRTEC R) for an unknown indication.    On 05-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 ARTHRALGIA (pain in the left shoulder). The patient was treated with IBUPROFEN for Shoulder pain, at a dose of unknown; PARACETAMOL (TYLENOL) for Shoulder pain, at a dose of unknown and CORTISONE on 03-Feb-2021 at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (pain in the left shoulder) 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.   Concomitant medication included lathortin.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: large Red Injection Site; Warm to the touch Injection Site; Tender to the touch Injection Site; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE ERYTHEMA (large Red Injection Site), VACCINATION SITE WARMTH (Warm to the touch Injection Site) and VACCINATION SITE PAIN (Tender to the touch Injection Site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (large Red Injection Site), VACCINATION SITE WARMTH (Warm to the touch Injection Site) and VACCINATION SITE PAIN (Tender to the touch Injection Site). On 29-Jan-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (large Red Injection Site), VACCINATION SITE WARMTH (Warm to the touch Injection Site) and VACCINATION SITE PAIN (Tender to the touch Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: Dizziness; fever; Shaking Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PYREXIA (fever), CHILLS (Shaking Chills) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), PYREXIA (fever), CHILLS (Shaking Chills) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), PYREXIA (fever), CHILLS (Shaking Chills) and NAUSEA (Nausea) outcome was unknown.        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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Felt sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Felt sore arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Felt sore arm). On 04-Feb-2021, PAIN IN EXTREMITY (Felt sore arm) had resolved. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Amniocentesis normal, Culture urine, Exposure during pregnancy, Pregnancy test, Prenatal screening test
Clinical narrative: Vaccine exposure during pregnancy; A spontaneous report was received from a consumer concerning a 34-years old pregnant female patient who experienced exposure to vaccine during pregnancy.   The patient's medical history was not reported. Concomitant medication reported mentions prenatal vitamins and baby aspirin.   The patient received their first of the two planned doses of mRNA-1273 (Batch number: 004M20A) intramuscularly in the right arm on 21 Jan 2021 for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of events the patient received their second of the two planned doses of mRNA-1273 (Batch number: 022M20A) intramuscularly in the right arm for the prophylaxis of COVID-19 infection.  Patient had a positive pregnancy test on 09 Oct 2021. Her last menstrual period was on 09 Sep 2020 and estimated date of conception was 24 Sep 2020. The patients estimated due date is 16 Jun 2021. On 21 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. She would like to be enrolled to the pregnancy registry. Treatment information was not provided. Action taken with mRNA-1273 in response to the event is not applicable as both doses have been taken.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound foetal
Clinical narrative: Vaccine exposure during pregnancy; A spontaneous report was received from a consumer concerning a 34-years old pregnant female patient who experienced exposure to vaccine during pregnancy.   The patient's medical history was not reported. Concomitant medication reported mentions prenatal vitamins and baby aspirin.   The patient received their first of the two planned doses of mRNA-1273 (Batch number: 004M20A) intramuscularly in the right arm on 21 Jan 2021 for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of events the patient received their second of the two planned doses of mRNA-1273 (Batch number: 022M20A) intramuscularly in the right arm for the prophylaxis of COVID-19 infection.  Patient had a positive pregnancy test on 09 Oct 2021. Her last menstrual period was on 09 Sep 2020 and estimated date of conception was 24 Sep 2020. The patients estimated due date is 16 Jun 2021. On 21 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. She would like to be enrolled to the pregnancy registry. Treatment information was not provided. Action taken with mRNA-1273 in response to the event is not applicable as both doses have been taken.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: It's gotten really red and itchy; It's gotten really red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (It's gotten really red and itchy) and PRURITUS (It's gotten really red and itchy) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (It's gotten really red and itchy) and PRURITUS (It's gotten really red and itchy). At the time of the report, ERYTHEMA (It's gotten really red and itchy) and PRURITUS (It's gotten really red and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash). At the time of the report, VACCINATION SITE RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: caught a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (caught a cold) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced NASOPHARYNGITIS (caught a cold). At the time of the report, NASOPHARYNGITIS (caught a cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. However, cold weather may have been contributory.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. However, cold weather may have been contributory.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: rash injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (rash injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (rash injection site). At the time of the report, VACCINATION SITE ERYTHEMA (rash injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Injection site seems worse this morning; Injection site itchy; Injection site started hurting; Injection site got red; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Injection site seems worse this morning), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Injection site started hurting), VACCINATION SITE ERYTHEMA (Injection site got red) and VACCINATION SITE SWELLING (Swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Injection site started hurting), VACCINATION SITE ERYTHEMA (Injection site got red) and VACCINATION SITE SWELLING (Swollen). On 03-Feb-2021, the patient experienced VACCINATION SITE REACTION (Injection site seems worse this morning). At the time of the report, VACCINATION SITE REACTION (Injection site seems worse this morning), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Injection site started hurting), VACCINATION SITE ERYTHEMA (Injection site got red) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Vaccination site lymphadenopathy
Clinical narrative: Swollen Lymph Nodes at the Injection Site; Bad Sore Throat; Chills; Very Bad Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph Nodes at the Injection Site), OROPHARYNGEAL PAIN (Bad Sore Throat), CHILLS (Chills) and HEADACHE (Very Bad Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph Nodes at the Injection Site), OROPHARYNGEAL PAIN (Bad Sore Throat), CHILLS (Chills) and HEADACHE (Very Bad Headache). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph Nodes at the Injection Site), OROPHARYNGEAL PAIN (Bad Sore Throat), CHILLS (Chills) and HEADACHE (Very Bad Headache) 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.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Myalgia
Clinical narrative: Individuals with severe muscle pain; Individuals with sever side effects that was not considered allergic response; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of ADVERSE EVENT (Individuals with sever side effects that was not considered allergic response) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL), NEFOPAM HYDROCHLORIDE (ACUPAN) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Individuals with sever side effects that was not considered allergic response). At the time of the report, ADVERSE EVENT (Individuals with sever side effects that was not considered allergic response) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Nausea, Vomiting
Clinical narrative: became violently sick with vomiting; diarrhea; nausea; still sick from it; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (became violently sick with vomiting), DIARRHOEA (diarrhea), NAUSEA (nausea) and ASTHENIA (still sick from it) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2021, the patient experienced VOMITING (became violently sick with vomiting), DIARRHOEA (diarrhea), NAUSEA (nausea) and ASTHENIA (still sick from it). The patient was treated with ONDANSETRON on 03-Feb-2021 for Nausea, at an unspecified dose and frequency. At the time of the report, VOMITING (became violently sick with vomiting), DIARRHOEA (diarrhea), NAUSEA (nausea) and ASTHENIA (still sick from it) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Blood pressure measurement, Dizziness, Impaired driving ability, Pain
Clinical narrative: dizzy spell; driving; dizziness; dizziness; sore; blood pressure; light headedness; bedridden; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of DIZZINESS (dizziness), PAIN (sore), BLOOD PRESSURE MEASUREMENT (blood pressure), DIZZINESS (light headedness) and BEDRIDDEN (bedridden) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced BEDRIDDEN (bedridden). On 27-Jan-2021, the patient experienced the first episode of DIZZINESS (dizziness), PAIN (sore), BLOOD PRESSURE MEASUREMENT (blood pressure) and DIZZINESS (light headedness). On 28-Jan-2021, the patient experienced DIZZINESS (dizzy spell), IMPAIRED DRIVING ABILITY (driving) and the second episode of DIZZINESS (dizziness). At the time of the report, PAIN (sore), BLOOD PRESSURE MEASUREMENT (blood pressure), DIZZINESS (light headedness), BEDRIDDEN (bedridden), DIZZINESS (dizzy spell), IMPAIRED DRIVING ABILITY (driving) and the last episode of DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Illness, Influenza like illness
Clinical narrative: sore arm; felt extremely sick.; stayed in bed for 24 hours.; extreme aches; flu-like symptoms; Even food did not taste right; extreme fatigue; hot and cold chills; nauseated a bit.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ILLNESS (felt extremely sick.), ASTHENIA (stayed in bed for 24 hours.), PAIN (extreme aches) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ILLNESS (felt extremely sick.), ASTHENIA (stayed in bed for 24 hours.), PAIN (extreme aches), INFLUENZA LIKE ILLNESS (flu-like symptoms), TASTE DISORDER (Even food did not taste right), FATIGUE (extreme fatigue), CHILLS (hot and cold chills) and NAUSEA (nauseated a bit.). On 04-Feb-2021, PAIN IN EXTREMITY (sore arm), ILLNESS (felt extremely sick.), ASTHENIA (stayed in bed for 24 hours.), PAIN (extreme aches), INFLUENZA LIKE ILLNESS (flu-like symptoms), TASTE DISORDER (Even food did not taste right), FATIGUE (extreme fatigue), CHILLS (hot and cold chills) and NAUSEA (nauseated a bit.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Taste disorder
Clinical narrative: sore arm; felt extremely sick.; stayed in bed for 24 hours.; extreme aches; flu-like symptoms; Even food did not taste right; extreme fatigue; hot and cold chills; nauseated a bit.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ILLNESS (felt extremely sick.), ASTHENIA (stayed in bed for 24 hours.), PAIN (extreme aches) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), ILLNESS (felt extremely sick.), ASTHENIA (stayed in bed for 24 hours.), PAIN (extreme aches), INFLUENZA LIKE ILLNESS (flu-like symptoms), TASTE DISORDER (Even food did not taste right), FATIGUE (extreme fatigue), CHILLS (hot and cold chills) and NAUSEA (nauseated a bit.). On 04-Feb-2021, PAIN IN EXTREMITY (sore arm), ILLNESS (felt extremely sick.), ASTHENIA (stayed in bed for 24 hours.), PAIN (extreme aches), INFLUENZA LIKE ILLNESS (flu-like symptoms), TASTE DISORDER (Even food did not taste right), FATIGUE (extreme fatigue), CHILLS (hot and cold chills) and NAUSEA (nauseated a bit.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Rash at site of injection; Itching; Really chilly; Swelled up; Tender; Red spot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Red spot), CHILLS (Really chilly), VACCINATION SITE SWELLING (Swelled up) and VACCINATION SITE PAIN (Tender) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 VACCINATION SITE ERYTHEMA (Red spot). On 28-Jan-2021, the patient experienced PRURITUS (Itching), CHILLS (Really chilly), VACCINATION SITE SWELLING (Swelled up) and VACCINATION SITE PAIN (Tender). On 03-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at site of injection). On 02-Feb-2021, PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Red spot), CHILLS (Really chilly), VACCINATION SITE SWELLING (Swelled up) and VACCINATION SITE PAIN (Tender) had resolved. At the time of the report, VACCINATION SITE RASH (Rash at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Rash at site of injection; Itching; Really chilly; Swelled up; Tender; Red spot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Red spot), CHILLS (Really chilly), VACCINATION SITE SWELLING (Swelled up) and VACCINATION SITE PAIN (Tender) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 VACCINATION SITE ERYTHEMA (Red spot). On 28-Jan-2021, the patient experienced PRURITUS (Itching), CHILLS (Really chilly), VACCINATION SITE SWELLING (Swelled up) and VACCINATION SITE PAIN (Tender). On 03-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at site of injection). On 02-Feb-2021, PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Red spot), CHILLS (Really chilly), VACCINATION SITE SWELLING (Swelled up) and VACCINATION SITE PAIN (Tender) had resolved. At the time of the report, VACCINATION SITE RASH (Rash at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Headache, Pyrexia
Clinical narrative: fever of greater than 102; headache; fatigue; chest heaviness; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (fever of greater than 102), HEADACHE (headache), FATIGUE (fatigue) and CHEST DISCOMFORT (chest heaviness) 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 20-Jan-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 PYREXIA (fever of greater than 102), HEADACHE (headache), FATIGUE (fatigue) and CHEST DISCOMFORT (chest heaviness). At the time of the report, PYREXIA (fever of greater than 102), HEADACHE (headache) and CHEST DISCOMFORT (chest heaviness) outcome was unknown and FATIGUE (fatigue) 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.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dermatitis allergic, Injection site reaction, Urine analysis, Urticaria
Clinical narrative: round of 2 inches in the site of injection and dots around it; covid arm; hives that spreaded; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (covid arm), URTICARIA (hives that spreaded) and INJECTION SITE REACTION (round of 2 inches in the site of injection and dots around it) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced DERMATITIS ALLERGIC (covid arm) and URTICARIA (hives that spreaded). On 30-Jan-2021, the patient experienced INJECTION SITE REACTION (round of 2 inches in the site of injection and dots around it). At the time of the report, DERMATITIS ALLERGIC (covid arm), URTICARIA (hives that spreaded) and INJECTION SITE REACTION (round of 2 inches in the site of injection and dots around it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Urine analysis: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Headache, Palpitations
Clinical narrative: Pressure on the chest/Throbbing pressure on the chest; Raised blood pressure in the middle of the night; Heart racing; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Pressure on the chest/Throbbing pressure on the chest), BLOOD PRESSURE INCREASED (Raised blood pressure in the middle of the night), PALPITATIONS (Heart racing) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-1900, the patient experienced HEADACHE (Headache). On 02-Feb-2021, the patient experienced CHEST DISCOMFORT (Pressure on the chest/Throbbing pressure on the chest), BLOOD PRESSURE INCREASED (Raised blood pressure in the middle of the night) and PALPITATIONS (Heart racing). At the time of the report, CHEST DISCOMFORT (Pressure on the chest/Throbbing pressure on the chest), BLOOD PRESSURE INCREASED (Raised blood pressure in the middle of the night), PALPITATIONS (Heart racing) and HEADACHE (Headache) outcome was unknown. Not Provided      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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: heat and pain at the injection side; heat and pain at the injection side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat and pain at the injection side) and VACCINATION SITE PAIN (heat and pain at the injection side) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (heat and pain at the injection side) and VACCINATION SITE PAIN (heat and pain at the injection side). The patient was treated with PHENIRAMINE MALEATE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (heat and pain at the injection side) and VACCINATION SITE PAIN (heat and pain at the injection side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. treatment information  provided includes Pheniramine maleate(avil)   Reporter did not allow further contact