chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment was reported
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Started itching quite a bit; local swelling; little red; little hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (little red), VACCINATION SITE WARMTH (little hot to touch), VACCINATION SITE PRURITUS (Started itching quite a bit) and VACCINATION SITE SWELLING (local swelling) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (little red) and VACCINATION SITE WARMTH (little hot to touch). On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Started itching quite a bit) and VACCINATION SITE SWELLING (local swelling). At the time of the report, INJECTION SITE ERYTHEMA (little red), VACCINATION SITE WARMTH (little hot to touch), VACCINATION SITE PRURITUS (Started itching quite a bit) and VACCINATION SITE SWELLING (local swelling) outcome was unknown. Related      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.    Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Tender; injection site has a Bumpy rash and itchy.; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PRURITUS (injection site has a Bumpy rash and itchy.), VACCINATION SITE RASH (injection site has a Bumpy rash and itc), INJECTION SITE PAIN (Tender) and VACCINATION SITE SWELLING (injection site has a Bumpy rash and itchy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (Tender) and VACCINATION SITE SWELLING (injection site has a Bumpy rash and itchy). On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site has a Bumpy rash and itchy.) and VACCINATION SITE RASH (injection site has a Bumpy rash and itc). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 18-Jan-2021, INJECTION SITE PAIN (Tender) had resolved. At the time of the report, VACCINATION SITE PRURITUS (injection site has a Bumpy rash and itchy.), VACCINATION SITE RASH (injection site has a Bumpy rash and itc) and VACCINATION SITE SWELLING (injection site has a Bumpy rash and itchy) 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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: developed little raised mark at injection site; warm to touch; it's sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (developed little raised mark at injection site), VACCINATION SITE WARMTH (warm to touch) and INJECTION SITE PAIN (it's sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (developed little raised mark at injection site), VACCINATION SITE WARMTH (warm to touch) and INJECTION SITE PAIN (it's sore). At the time of the report, VACCINATION SITE SWELLING (developed little raised mark at injection site), VACCINATION SITE WARMTH (warm to touch) and INJECTION SITE PAIN (it's sore) outcome was unknown. She developed little raised mark at the injection site that went away. But two weeks later, the mark is back.      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 medication were provided No treatment were provided
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Diarrhoea, Faeces soft, Flatulence, Swelling
Clinical narrative: Head swelling; soft stool that's broken up; lots of gas; unusual bowel movements; loose bowels; This spontaneous case was reported by a consumer and describes the occurrence of FAECES SOFT (soft stool that's broken up), FLATULENCE (lots of gas), BOWEL MOVEMENT IRREGULARITY (unusual bowel movements), DIARRHOEA (loose bowels) and SWELLING (Head swelling) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, TAMSULOSIN HYDROCHLORIDE (TAMULOSIN), FINASTERIDE and RIVAROXABAN (XARELTO) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DIARRHOEA (loose bowels). On 22-Jan-2021, the patient experienced FAECES SOFT (soft stool that's broken up), FLATULENCE (lots of gas) and BOWEL MOVEMENT IRREGULARITY (unusual bowel movements). On an unknown date, the patient experienced SWELLING (Head swelling). At the time of the report, FAECES SOFT (soft stool that's broken up), FLATULENCE (lots of gas), BOWEL MOVEMENT IRREGULARITY (unusual bowel movements) and DIARRHOEA (loose bowels) outcome was unknown and SWELLING (Head swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was Reported   This case was linked to MOD-2021-219795 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Concomitant medications were added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Allergic reaction; Warm; Right arm being swollen; Itching; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE WARMTH (Warm), VACCINATION SITE SWELLING (Right arm being swollen) and VACCINATION SITE PRURITUS (Itching) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20a) for COVID-19 vaccination.     The patient's past medical history included Radiation therapy (Left arm).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE WARMTH (Warm), VACCINATION SITE SWELLING (Right arm being swollen) and VACCINATION SITE PRURITUS (Itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form once a day. At the time of the report, HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE WARMTH (Warm), VACCINATION SITE SWELLING (Right arm being swollen) and VACCINATION SITE PRURITUS (Itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. She was advised to take an allergy pill.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received and updated event outcome to recovered/resolved.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Redness in the area; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness in the area) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness in the area). At the time of the report, INJECTION SITE ERYTHEMA (Redness in the area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided No treatment were provided
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chills, Head discomfort, Headache, Hypoaesthesia
Clinical narrative: Immediately started having numbness on nose and spread to the rest of face; Pressure on head and eyes; Didn't feel good that night; Very bad arm  aches; Pain on the left side of breast; Headache; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Immediately started having numbness on nose and spread to the rest of face), HEAD DISCOMFORT (Pressure on head and eyes), VACCINATION COMPLICATION (Didn't feel good that night), PAIN IN EXTREMITY (Very bad arm  aches) and BREAST PAIN (Pain on the left side of breast) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast pain (she had pain before in the past and still experiencing pain).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced HYPOAESTHESIA (Immediately started having numbness on nose and spread to the rest of face), HEAD DISCOMFORT (Pressure on head and eyes), VACCINATION COMPLICATION (Didn't feel good that night), PAIN IN EXTREMITY (Very bad arm  aches), BREAST PAIN (Pain on the left side of breast), HEADACHE (Headache) and CHILLS (Shivers). On 20-Jan-2021, HYPOAESTHESIA (Immediately started having numbness on nose and spread to the rest of face) had resolved. On 22-Jan-2021, HEAD DISCOMFORT (Pressure on head and eyes) had resolved. At the time of the report, VACCINATION COMPLICATION (Didn't feel good that night), PAIN IN EXTREMITY (Very bad arm  aches) and CHILLS (Shivers) outcome was unknown and BREAST PAIN (Pain on the left side of breast) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient took 4 Tylenol which didn't work so she took some 4-6 Advil. She wasn't sure if she felt better due to Advil or due to time. The patient was going to see her health care professional.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: Immediately started having numbness on nose and spread to the rest of face; Pressure on head and eyes; Didn't feel good that night; Very bad arm  aches; Pain on the left side of breast; Headache; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Immediately started having numbness on nose and spread to the rest of face), HEAD DISCOMFORT (Pressure on head and eyes), VACCINATION COMPLICATION (Didn't feel good that night), PAIN IN EXTREMITY (Very bad arm  aches) and BREAST PAIN (Pain on the left side of breast) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast pain (she had pain before in the past and still experiencing pain).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced HYPOAESTHESIA (Immediately started having numbness on nose and spread to the rest of face), HEAD DISCOMFORT (Pressure on head and eyes), VACCINATION COMPLICATION (Didn't feel good that night), PAIN IN EXTREMITY (Very bad arm  aches), BREAST PAIN (Pain on the left side of breast), HEADACHE (Headache) and CHILLS (Shivers). On 20-Jan-2021, HYPOAESTHESIA (Immediately started having numbness on nose and spread to the rest of face) had resolved. On 22-Jan-2021, HEAD DISCOMFORT (Pressure on head and eyes) had resolved. At the time of the report, VACCINATION COMPLICATION (Didn't feel good that night), PAIN IN EXTREMITY (Very bad arm  aches) and CHILLS (Shivers) outcome was unknown and BREAST PAIN (Pain on the left side of breast) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient took 4 Tylenol which didn't work so she took some 4-6 Advil. She wasn't sure if she felt better due to Advil or due to time. The patient was going to see her health care professional.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test
Clinical narrative: positive for COVID-19; could not taste; could not smell; This spontaneous case was reported by a nurse and describes the occurrence of AGEUSIA (could not taste), ANOSMIA (could not smell) and COVID-19 (positive for COVID-19) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Arm fracture.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced AGEUSIA (could not taste) and ANOSMIA (could not smell). On 17-Jan-2021, the patient experienced COVID-19 (positive for COVID-19). On 19-Jan-2021, AGEUSIA (could not taste) and ANOSMIA (could not smell) had resolved. At the time of the report, COVID-19 (positive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test: positive positive.     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 medication were provided Treatment included Meloxicam for her broken arm.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, SARS-CoV-2 test
Clinical narrative: headache; COVID-19; chills; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), HEADACHE (headache) and COVID-19 (COVID-19) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced CHILLS (chills) and COVID-19 (COVID-19). On 14-Jan-2021, the patient experienced HEADACHE (headache). At the time of the report, CHILLS (chills), HEADACHE (headache) and COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (COVID-19) to be not related. No further causality assessments were provided for CHILLS (chills) and HEADACHE (headache).    No relevant concomitant medications were provided. He received a monoclonal antibody treatment on 14 Jan 2021 at his physician's recommendation. No treatment information was provided for headache.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Insomnia, Oropharyngeal pain, Pain
Clinical narrative: sore throat; intense body pain; back pain is sharp, from the back of shoulder blades, mid back; back is burning; pain in legs, arms; haven't slept since Friday even with the medications; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PAIN (intense body pain), BACK PAIN (back pain is sharp, from the back of shoulder blades, mid back), BURNING SENSATION (back is burning) and PAIN IN EXTREMITY (pain in legs, arms) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Herniated disc since an unknown date. Concomitant products included HYDROCODONE HCL and HYDROCODONE BITARTRATE (HYSINGLA) for Back pain.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PAIN (intense body pain), BACK PAIN (back pain is sharp, from the back of shoulder blades, mid back), BURNING SENSATION (back is burning), PAIN IN EXTREMITY (pain in legs, arms) and INSOMNIA (haven't slept since Friday even with the medications). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and PAIN (intense body pain) outcome was unknown and BACK PAIN (back pain is sharp, from the back of shoulder blades, mid back), BURNING SENSATION (back is burning), PAIN IN EXTREMITY (pain in legs, arms) and INSOMNIA (haven't slept since Friday even with the medications) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided Treatment of the event included using the conmeds of Hydrocodone and Hysingla that the patient was using for herniated disc pain.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received on 15APR2021 date included no new information.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore throat; intense body pain; back pain is sharp, from the back of shoulder blades, mid back; back is burning; pain in legs, arms; haven't slept since Friday even with the medications; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), PAIN (intense body pain), BACK PAIN (back pain is sharp, from the back of shoulder blades, mid back), BURNING SENSATION (back is burning) and PAIN IN EXTREMITY (pain in legs, arms) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Herniated disc since an unknown date. Concomitant products included HYDROCODONE HCL and HYDROCODONE BITARTRATE (HYSINGLA) for Back pain.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), PAIN (intense body pain), BACK PAIN (back pain is sharp, from the back of shoulder blades, mid back), BURNING SENSATION (back is burning), PAIN IN EXTREMITY (pain in legs, arms) and INSOMNIA (haven't slept since Friday even with the medications). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and PAIN (intense body pain) outcome was unknown and BACK PAIN (back pain is sharp, from the back of shoulder blades, mid back), BURNING SENSATION (back is burning), PAIN IN EXTREMITY (pain in legs, arms) and INSOMNIA (haven't slept since Friday even with the medications) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided Treatment of the event included using the conmeds of Hydrocodone and Hysingla that the patient was using for herniated disc pain.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received on 15APR2021 date included no new information.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Tremor
Clinical narrative: Shakes; Low grade Fever 100.3 Fahrenheit/fever an and off; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), PYREXIA (Low grade Fever 100.3 Fahrenheit/fever an and off), HEADACHE (Headache) and FATIGUE (Tired) in an 83-year-old male 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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced TREMOR (Shakes), PYREXIA (Low grade Fever 100.3 Fahrenheit/fever an and off), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, TREMOR (Shakes) and HEADACHE (Headache) outcome was unknown and PYREXIA (Low grade Fever 100.3 Fahrenheit/fever an and off) and FATIGUE (Tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature: 100.3 °F (High) 100.3 and 100.1 °F (High) 100.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. The patient took acetaminophen for fever and the fever came down to 100.1 Fahrenheit. Treatment included Tylenol
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19
Clinical narrative: positive covid test after receiving 1st dose; lost her sense smell; lost her sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive covid test after receiving 1st dose), ANOSMIA (lost her sense smell) and AGEUSIA (lost her sense of taste) in a 50-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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced ANOSMIA (lost her sense smell) and AGEUSIA (lost her sense of taste). On 17-Jan-2021, the patient experienced COVID-19 (positive covid test after receiving 1st dose). At the time of the report, COVID-19 (positive covid test after receiving 1st dose), ANOSMIA (lost her sense smell) and AGEUSIA (lost her sense of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. Treatment medications included Sudafed and Zyrtec
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter.  No treatment information provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Reporter's informations were added.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling very well; A spontaneous report was received from a consumer, concerning herself, a female patient of unspecified age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and was not feeling very well.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Jan 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unspecified date in 2021, after the administration of vaccine, the patient was not feeling very well.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of event, not feeling very well was considered unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: Sore breasts and nipples; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Sore breasts and nipples) in a 66-year-old female patient 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.    On 14-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 BREAST PAIN (Sore breasts and nipples). At the time of the report, BREAST PAIN (Sore breasts and nipples) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided No treatment were provided
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal chest pain, Vaccination site erythema, Vaccination site induration, Vaccination site mass
Clinical narrative: there is a bump; Red mark getting redder; arm still hard on that area; chills; felt horrible; mango size swelling at site; bizarre pain on right side by ribs; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (bizarre pain on right side by ribs), VACCINATION SITE MASS (there is a bump), VACCINATION SITE SWELLING (mango size swelling at site), CHILLS (chills) and VACCINATION SITE PAIN (felt horrible) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN and LANSOPRAZOLE (PREVACID) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (bizarre pain on right side by ribs) and VACCINATION SITE SWELLING (mango size swelling at site). On 13-Jan-2021, the patient experienced CHILLS (chills), VACCINATION SITE PAIN (felt horrible) and VACCINATION SITE INDURATION (arm still hard on that area). On 22-Jan-2021, the patient experienced VACCINATION SITE MASS (there is a bump) and VACCINATION SITE ERYTHEMA (Red mark getting redder). At the time of the report, MUSCULOSKELETAL CHEST PAIN (bizarre pain on right side by ribs), VACCINATION SITE MASS (there is a bump), CHILLS (chills), VACCINATION SITE PAIN (felt horrible), VACCINATION SITE ERYTHEMA (Red mark getting redder) and VACCINATION SITE INDURATION (arm still hard on that area) outcome was unknown and VACCINATION SITE SWELLING (mango size swelling at site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient did not mention any treatment medications
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: there is a bump; Red mark getting redder; arm still hard on that area; chills; felt horrible; mango size swelling at site; bizarre pain on right side by ribs; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (bizarre pain on right side by ribs), VACCINATION SITE MASS (there is a bump), VACCINATION SITE SWELLING (mango size swelling at site), CHILLS (chills) and VACCINATION SITE PAIN (felt horrible) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN and LANSOPRAZOLE (PREVACID) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (bizarre pain on right side by ribs) and VACCINATION SITE SWELLING (mango size swelling at site). On 13-Jan-2021, the patient experienced CHILLS (chills), VACCINATION SITE PAIN (felt horrible) and VACCINATION SITE INDURATION (arm still hard on that area). On 22-Jan-2021, the patient experienced VACCINATION SITE MASS (there is a bump) and VACCINATION SITE ERYTHEMA (Red mark getting redder). At the time of the report, MUSCULOSKELETAL CHEST PAIN (bizarre pain on right side by ribs), VACCINATION SITE MASS (there is a bump), CHILLS (chills), VACCINATION SITE PAIN (felt horrible), VACCINATION SITE ERYTHEMA (Red mark getting redder) and VACCINATION SITE INDURATION (arm still hard on that area) outcome was unknown and VACCINATION SITE SWELLING (mango size swelling at site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient did not mention any treatment medications
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Nasopharyngitis, Pain
Clinical narrative: Cold; Some aches and pain; Cough; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), PAIN (Some aches and pain), COUGH (Cough) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced NASOPHARYNGITIS (Cold), PAIN (Some aches and pain), COUGH (Cough) and CHILLS (Chills). At the time of the report, NASOPHARYNGITIS (Cold), PAIN (Some aches and pain), COUGH (Cough) and CHILLS (Chills) 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 reported. No treatment information provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Tachycardic; stomach pain; severe headcahe; Dizziness; Low blood pressure; Muscle Aches; Chills; Muscle twitches at the injection site left arm; Sore arm; had a skin reaction right away; extreme fatigue; nausea; This spontaneous case was reported by a health care professional and describes the occurrence of SKIN REACTION (had a skin reaction right away), FATIGUE (extreme fatigue), NAUSEA (nausea), ABDOMINAL PAIN UPPER (stomach pain) and HEADACHE (severe headcahe) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Jan-2021, the patient experienced SKIN REACTION (had a skin reaction right away), FATIGUE (extreme fatigue) and NAUSEA (nausea). On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Jan-2021, the patient experienced INJECTION SITE REACTION (Muscle twitches at the injection site left arm). On 23-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), HEADACHE (severe headcahe), DIZZINESS (Dizziness), HYPOTENSION (Low blood pressure), MYALGIA (Muscle Aches) and CHILLS (Chills). On an unknown date, the patient experienced TACHYCARDIA (Tachycardic). On 13-Jan-2021, FATIGUE (extreme fatigue) and NAUSEA (nausea) had resolved. On 14-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 17-Jan-2021, INJECTION SITE REACTION (Muscle twitches at the injection site left arm) had resolved. On 23-Jan-2021, HEADACHE (severe headcahe), DIZZINESS (Dizziness), HYPOTENSION (Low blood pressure), MYALGIA (Muscle Aches) and CHILLS (Chills) had resolved. At the time of the report, SKIN REACTION (had a skin reaction right away), ABDOMINAL PAIN UPPER (stomach pain) and TACHYCARDIA (Tachycardic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: No specific follow-up information recorded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Injection site reaction, Myalgia, Nausea, Pain in extremity
Clinical narrative: Tachycardic; stomach pain; severe headcahe; Dizziness; Low blood pressure; Muscle Aches; Chills; Muscle twitches at the injection site left arm; Sore arm; had a skin reaction right away; extreme fatigue; nausea; This spontaneous case was reported by a health care professional and describes the occurrence of SKIN REACTION (had a skin reaction right away), FATIGUE (extreme fatigue), NAUSEA (nausea), ABDOMINAL PAIN UPPER (stomach pain) and HEADACHE (severe headcahe) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Jan-2021, the patient experienced SKIN REACTION (had a skin reaction right away), FATIGUE (extreme fatigue) and NAUSEA (nausea). On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Jan-2021, the patient experienced INJECTION SITE REACTION (Muscle twitches at the injection site left arm). On 23-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), HEADACHE (severe headcahe), DIZZINESS (Dizziness), HYPOTENSION (Low blood pressure), MYALGIA (Muscle Aches) and CHILLS (Chills). On an unknown date, the patient experienced TACHYCARDIA (Tachycardic). On 13-Jan-2021, FATIGUE (extreme fatigue) and NAUSEA (nausea) had resolved. On 14-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 17-Jan-2021, INJECTION SITE REACTION (Muscle twitches at the injection site left arm) had resolved. On 23-Jan-2021, HEADACHE (severe headcahe), DIZZINESS (Dizziness), HYPOTENSION (Low blood pressure), MYALGIA (Muscle Aches) and CHILLS (Chills) had resolved. At the time of the report, SKIN REACTION (had a skin reaction right away), ABDOMINAL PAIN UPPER (stomach pain) and TACHYCARDIA (Tachycardic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: No specific follow-up information recorded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction, Tachycardia
Clinical narrative: Tachycardic; stomach pain; severe headcahe; Dizziness; Low blood pressure; Muscle Aches; Chills; Muscle twitches at the injection site left arm; Sore arm; had a skin reaction right away; extreme fatigue; nausea; This spontaneous case was reported by a health care professional and describes the occurrence of SKIN REACTION (had a skin reaction right away), FATIGUE (extreme fatigue), NAUSEA (nausea), ABDOMINAL PAIN UPPER (stomach pain) and HEADACHE (severe headcahe) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Jan-2021, the patient experienced SKIN REACTION (had a skin reaction right away), FATIGUE (extreme fatigue) and NAUSEA (nausea). On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Jan-2021, the patient experienced INJECTION SITE REACTION (Muscle twitches at the injection site left arm). On 23-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), HEADACHE (severe headcahe), DIZZINESS (Dizziness), HYPOTENSION (Low blood pressure), MYALGIA (Muscle Aches) and CHILLS (Chills). On an unknown date, the patient experienced TACHYCARDIA (Tachycardic). On 13-Jan-2021, FATIGUE (extreme fatigue) and NAUSEA (nausea) had resolved. On 14-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 17-Jan-2021, INJECTION SITE REACTION (Muscle twitches at the injection site left arm) had resolved. On 23-Jan-2021, HEADACHE (severe headcahe), DIZZINESS (Dizziness), HYPOTENSION (Low blood pressure), MYALGIA (Muscle Aches) and CHILLS (Chills) had resolved. At the time of the report, SKIN REACTION (had a skin reaction right away), ABDOMINAL PAIN UPPER (stomach pain) and TACHYCARDIA (Tachycardic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Jan-2021, 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 ERYTHEMA (Red spot at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: injection site red; injection site burning; injection site swelling; injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site burning), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE PRURITUS (injection site itching) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included MELATONIN for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site burning), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE PRURITUS (injection site itching). At the time of the report, INJECTION SITE PAIN (injection site burning), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE PRURITUS (injection site itching) 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.   patient was taken treatment DIPHENHYDRAMINE HYDROCHLORIDE IN NIGHT Treatment included Benadryl
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Got vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Got vaccine while pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 013L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from January 2021 to an unknown date for an unknown indication.   On 06-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 08-Oct-2021. On 03-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Got vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Got vaccine while pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Non-Significant Follow-up received: Consumer calling back in to update pregnancy registry form. She wanted to add pregnancy doctor and most recent tests received.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: viral rash on my trunk, chest, on my back and at my wrist; Much more red; This spontaneous case was reported by a consumer and describes the occurrence of RASH (viral rash on my trunk, chest, on my back and at my wrist) and RASH ERYTHEMATOUS (Much more red) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism since an unknown date and Colitis since an unknown date. Concomitant products included LEVOTHYROXINE and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced RASH (viral rash on my trunk, chest, on my back and at my wrist) and RASH ERYTHEMATOUS (Much more red). On 23-Jan-2021, RASH (viral rash on my trunk, chest, on my back and at my wrist) and RASH ERYTHEMATOUS (Much more red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 25-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (viral rash on my trunk, chest, on my back and at my wrist) and RASH ERYTHEMATOUS (Much more red) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism since an unknown date and Colitis since an unknown date. Concomitant products included LEVOTHYROXINE and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced RASH (viral rash on my trunk, chest, on my back and at my wrist) and RASH ERYTHEMATOUS (Much more red). On 23-Jan-2021, RASH (viral rash on my trunk, chest, on my back and at my wrist) and RASH ERYTHEMATOUS (Much more red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Treatment information for the event was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the left arm; A spontaneous report was received from a consumer who was also a 69-years-old male patient who received Moderna's COVID-19 vaccine experienced pain from injection site.  Patient's medical history and concomitant medicines were not provided.  On 22 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced pain in the left arm where the vaccine was administered.   Treatment included two Advils to treat the pain.  Action taken with mRNA-1273 was not reported.  The outcome of the events of pain in the left arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.