chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested for covid and came back positive; feels kinda weak; started feeling sick; coughing; feel bad; not very good appetite,; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested for covid and came back positive), ASTHENIA (feels kinda weak), MALAISE (started feeling sick), COUGH (coughing) and FEELING ABNORMAL (feel bad) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included GABAPENTIN, METFORMIN HYDROCHLORIDE, AMLODIPINE, METOPROLOL and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ASTHENIA (feels kinda weak), MALAISE (started feeling sick), COUGH (coughing), FEELING ABNORMAL (feel bad), DECREASED APPETITE (not very good appetite,) and PYREXIA (fever). On 19-Feb-2021, the patient experienced COVID-19 (tested for covid and came back positive). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) ongoing since an unknown date at a dose of UNK, bid; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and GUAIFENESIN at an unspecified dose and frequency. At the time of the report, COVID-19 (tested for covid and came back positive), ASTHENIA (feels kinda weak), MALAISE (started feeling sick), COUGH (coughing), FEELING ABNORMAL (feel bad), DECREASED APPETITE (not very good appetite,) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 102 °F (High) fluctuated to 100°F. On 19-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: Chills; Nausea; Had a fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Had a fever of 101) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Blood pressure abnormal, Cholesterol total abnormal NOS, Thyroid disorder NOS and Heartburn. Concomitant products included CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D) for an unknown indication.    On 15-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 CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Had a fever of 101). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Feb-2021, CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, PYREXIA (Had a fever of 101) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was concomitantly taking blood pressure med, cholesterol med, Thyroid med, and heartburn med.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Pyrexia, Weight
Clinical narrative: Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCODONE and IBUPROFEN for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: unknown High. On 13-Jan-2021, Weight: unknown High.         Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information  received on 14 Jun 2021 contains patient denied for further follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Nausea, Pain
Clinical narrative: Mouth and tongue numb; bitter taste; soreness; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Mouth and tongue numb), DYSGEUSIA (bitter taste), PAIN (soreness) and NAUSEA (nauseated) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included EZETIMIBE, AMLODIPINE, LISINOPRIL, GLIMEPIRIDE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    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 PAIN (soreness) and NAUSEA (nauseated). On 12-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (Mouth and tongue numb) and DYSGEUSIA (bitter taste). On 11-Feb-2021, PAIN (soreness) had resolved. At the time of the report, HYPOAESTHESIA ORAL (Mouth and tongue numb), DYSGEUSIA (bitter taste) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took no treatment for symptoms.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feels like got run over by a truck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels like got run over by a truck) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced FEELING ABNORMAL (feels like got run over by a truck). At the time of the report, FEELING ABNORMAL (feels like got run over by a truck) had resolved.            No concomitant medications were reported. No treatment related information has been reported.   This case was linked to MOD-2021-255982, MOD-2021-255983 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Regulatory Authority report received on 14-JUL-2021 : updated patient demographics , AE outcome updated- recovered/resolved
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: On 27JAN injection area started to itch and kept itching throughout the night; little rash broke out around area; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (little rash broke out around area) and VACCINATION SITE PRURITUS (On 27JAN injection area started to itch and kept itching throughout the night) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included THYROID for Thyroiditis NOS, APIXABAN (ELIQUIS) for an unknown indication.   On 26-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 RASH (little rash broke out around area).   On 31-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (On 27JAN injection area started to itch and kept itching throughout the night). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE RASH (little rash broke out around area) and VACCINATION SITE PRURITUS (On 27JAN injection area started to itch and kept itching throughout the night) 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 treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: 102 F Fever; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 F Fever) and FATIGUE (Exhausted) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant (multiple ). Concomitant products included TACROLIMUS (PROGRAF) for Immunosuppressant drug therapy.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (102 F Fever) and FATIGUE (Exhausted). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (102 F Fever) and FATIGUE (Exhausted) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 °F (High) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly patient is taking antibiotics and a nasal rinse.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue
Clinical narrative: Dizziness; tiredness; pain in her hips and knees; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (tiredness) and ARTHRALGIA (pain in her hips and knees) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination.     Concurrent medical conditions included Shaking of hands.    On 08-Feb-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 DIZZINESS (Dizziness), FATIGUE (tiredness) and ARTHRALGIA (pain in her hips and knees). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), FATIGUE (tiredness) and ARTHRALGIA (pain in her hips and knees) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitantly patient was taking medication for shaking hand along with supplements.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Lymphadenopathy
Clinical narrative: Inch and a half of erythema spreading on the deltoid area; Some adenopathy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE ERYTHEMA (Inch and a half of erythema spreading on the deltoid area) and LYMPHADENOPATHY (Some adenopathy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 17-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 INJECTION SITE ERYTHEMA (Inch and a half of erythema spreading on the deltoid area) and LYMPHADENOPATHY (Some adenopathy).   At the time of the report, INJECTION SITE ERYTHEMA (Inch and a half of erythema spreading on the deltoid area) and LYMPHADENOPATHY (Some adenopathy) 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.   No treatment information was provided. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI - Reporter denied further contact.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Muscular weakness, Oropharyngeal discomfort, Pain in extremity
Clinical narrative: felt like sinus symptoms and congested; respiratory symptoms; puffy nose; left wrist feels like broken and can't even lift things; area beneath pinky is very sore; Itching; Vaccination site erythema; headache; left wrist feels like broken and can't even lift things; felt a scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (felt a scratchy throat), SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose) and MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history information was reported.  Concomitant products included AMLODIPINE BESILATE (LODOPIN [AMLODIPINE BESILATE]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (felt a scratchy throat). On an unknown date, the patient experienced SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose), MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things), PAIN IN EXTREMITY (area beneath pinky is very sore), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Vaccination site erythema), HEADACHE (headache) and ARTHRALGIA (left wrist feels like broken and can't even lift things). The patient was treated with GUAIFENESIN (MUCINEX) for Cough, at a dose of UNK dosage form. At the time of the report, OROPHARYNGEAL DISCOMFORT (felt a scratchy throat), SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose), MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things), PAIN IN EXTREMITY (area beneath pinky is very sore), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Vaccination site erythema), HEADACHE (headache) and ARTHRALGIA (left wrist feels like broken and can't even lift things) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Dose 2 details added, event added-itching, vaccination site erythema for 1st dose.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Respiratory symptom, SARS-CoV-2 test, Sinus congestion, Swelling
Clinical narrative: felt like sinus symptoms and congested; respiratory symptoms; puffy nose; left wrist feels like broken and can't even lift things; area beneath pinky is very sore; Itching; Vaccination site erythema; headache; left wrist feels like broken and can't even lift things; felt a scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (felt a scratchy throat), SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose) and MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history information was reported.  Concomitant products included AMLODIPINE BESILATE (LODOPIN [AMLODIPINE BESILATE]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (felt a scratchy throat). On an unknown date, the patient experienced SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose), MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things), PAIN IN EXTREMITY (area beneath pinky is very sore), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Vaccination site erythema), HEADACHE (headache) and ARTHRALGIA (left wrist feels like broken and can't even lift things). The patient was treated with GUAIFENESIN (MUCINEX) for Cough, at a dose of UNK dosage form. At the time of the report, OROPHARYNGEAL DISCOMFORT (felt a scratchy throat), SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose), MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things), PAIN IN EXTREMITY (area beneath pinky is very sore), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Vaccination site erythema), HEADACHE (headache) and ARTHRALGIA (left wrist feels like broken and can't even lift things) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Dose 2 details added, event added-itching, vaccination site erythema for 1st dose.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: felt like sinus symptoms and congested; respiratory symptoms; puffy nose; left wrist feels like broken and can't even lift things; area beneath pinky is very sore; Itching; Vaccination site erythema; headache; left wrist feels like broken and can't even lift things; felt a scratchy throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (felt a scratchy throat), SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose) and MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history information was reported.  Concomitant products included AMLODIPINE BESILATE (LODOPIN [AMLODIPINE BESILATE]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (felt a scratchy throat). On an unknown date, the patient experienced SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose), MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things), PAIN IN EXTREMITY (area beneath pinky is very sore), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Vaccination site erythema), HEADACHE (headache) and ARTHRALGIA (left wrist feels like broken and can't even lift things). The patient was treated with GUAIFENESIN (MUCINEX) for Cough, at a dose of UNK dosage form. At the time of the report, OROPHARYNGEAL DISCOMFORT (felt a scratchy throat), SINUS CONGESTION (felt like sinus symptoms and congested), RESPIRATORY SYMPTOM (respiratory symptoms), SWELLING (puffy nose), MUSCULAR WEAKNESS (left wrist feels like broken and can't even lift things), PAIN IN EXTREMITY (area beneath pinky is very sore), PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Vaccination site erythema), HEADACHE (headache) and ARTHRALGIA (left wrist feels like broken and can't even lift things) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Dose 2 details added, event added-itching, vaccination site erythema for 1st dose.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair was falling and thinning, have bald spots; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair was falling and thinning, have bald spots) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21 and 42L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics (augmentin caused lips swollen.) and Allergic reaction to antibiotics (Levaquin caused lips swollen). Concomitant products included LOSARTAN, METOPROLOL, BUPROPION, ALENDRONATE SODIUM (ALENDRONATE) and OXYBUTYNIN for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair was falling and thinning, have bald spots). At the time of the report, ALOPECIA (Hair was falling and thinning, have bald spots) outcome was unknown.            Treatment medications included antihistamines.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-023307 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Updated patient demographics, medical history ,concomitant medications Events information is updated.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Discomfort, Neck pain
Clinical narrative: pain has gone up back, into neck; Back Pain; Little Bug; pain has gone up back, into shoulders; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain has gone up back, into neck), BACK PAIN (Back Pain), DISCOMFORT (Little Bug) and ARTHRALGIA (pain has gone up back, into shoulders) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced NECK PAIN (pain has gone up back, into neck), BACK PAIN (Back Pain), DISCOMFORT (Little Bug) and ARTHRALGIA (pain has gone up back, into shoulders). At the time of the report, NECK PAIN (pain has gone up back, into neck), BACK PAIN (Back Pain), DISCOMFORT (Little Bug) and ARTHRALGIA (pain has gone up back, into shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Insomnia, Nervousness, Vaccination site pain
Clinical narrative: Really jittery; Really nervous; Didn't sleep well Saturday night due to pain; Pain in her shoulder at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Didn't sleep well Saturday night due to pain), FEELING JITTERY (Really jittery), NERVOUSNESS (Really nervous) and VACCINATION SITE PAIN (Pain in her shoulder at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05m20a) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety and Blood pressure high.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in her shoulder at the injection site). On 21-Feb-2021, the patient experienced INSOMNIA (Didn't sleep well Saturday night due to pain). On 22-Feb-2021, the patient experienced FEELING JITTERY (Really jittery) and NERVOUSNESS (Really nervous). At the time of the report, INSOMNIA (Didn't sleep well Saturday night due to pain), FEELING JITTERY (Really jittery), NERVOUSNESS (Really nervous) and VACCINATION SITE PAIN (Pain in her shoulder at the injection site) outcome was unknown.            Concomitant medications reported were anxiety, blood pressure and stomach medications. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling cold, Headache, Influenza like illness
Clinical narrative: started feeling sick; Coughing; Flu like symptoms; aching; Fever; Headache; Freezing; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started feeling sick), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (aching) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HCL, OMEPRAZOLE, CLOPIDOGREL, METOPROLOL and SIMVASTATIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MALAISE (started feeling sick), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (aching), PYREXIA (Fever), HEADACHE (Headache), FEELING COLD (Freezing) and CHILLS (chills). At the time of the report, MALAISE (started feeling sick), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (aching), HEADACHE (Headache), FEELING COLD (Freezing) and CHILLS (chills) outcome was unknown and PYREXIA (Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 23-Feb-2021, the patient tested negative for covid-19. Treatment information included dextromethorphan (16 mg), guaifenesin 1200 mg 2/day, and at the time of the report she was still taking ibuprofen and paracetamol.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: started feeling sick; Coughing; Flu like symptoms; aching; Fever; Headache; Freezing; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started feeling sick), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (aching) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HCL, OMEPRAZOLE, CLOPIDOGREL, METOPROLOL and SIMVASTATIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MALAISE (started feeling sick), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (aching), PYREXIA (Fever), HEADACHE (Headache), FEELING COLD (Freezing) and CHILLS (chills). At the time of the report, MALAISE (started feeling sick), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (aching), HEADACHE (Headache), FEELING COLD (Freezing) and CHILLS (chills) outcome was unknown and PYREXIA (Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 23-Feb-2021, the patient tested negative for covid-19. Treatment information included dextromethorphan (16 mg), guaifenesin 1200 mg 2/day, and at the time of the report she was still taking ibuprofen and paracetamol.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Exposure to SARS-CoV-2
Clinical narrative: Exposed to someone with Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to someone with Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to someone with Covid-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to someone with Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) Antibody IgG test-positive.         Lab data included Rapid antigen test-negative, antibody IgG test-positive, swab test-awaiting results.  Concomitant product use was not provided by the reporter.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Pain
Clinical narrative: Really bad body aches; Shivering from cold chills; Fatigue and less energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Really bad body aches), NASOPHARYNGITIS (Shivering from cold chills) and FATIGUE (Fatigue and less energy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Really bad body aches), NASOPHARYNGITIS (Shivering from cold chills) and FATIGUE (Fatigue and less energy). At the time of the report, PAIN (Really bad body aches), NASOPHARYNGITIS (Shivering from cold chills) and FATIGUE (Fatigue and less energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Myalgia, Pyrexia
Clinical narrative: Dry mouth; Body aches; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache) 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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (Dry mouth), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, DRY MOUTH (Dry mouth), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Malaise, Myalgia, Pain in extremity
Clinical narrative: She could not walk; feet were hurting; Extremelly ill; fever (unknown); chills; Severe body pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (She could not walk), PAIN IN EXTREMITY (feet were hurting), MALAISE (Extremelly ill), PYREXIA (fever (unknown)) and CHILLS (chills) in a 34-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 COVID-19.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced GAIT DISTURBANCE (She could not walk), PAIN IN EXTREMITY (feet were hurting), MALAISE (Extremelly ill), PYREXIA (fever (unknown)), CHILLS (chills) and MYALGIA (Severe body pain). At the time of the report, GAIT DISTURBANCE (She could not walk), PAIN IN EXTREMITY (feet were hurting), MALAISE (Extremelly ill), PYREXIA (fever (unknown)), CHILLS (chills) and MYALGIA (Severe body pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that he side effects of the vaccine were worst than the Covid-19 disease. Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She could not walk; feet were hurting; Extremelly ill; fever (unknown); chills; Severe body pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (She could not walk), PAIN IN EXTREMITY (feet were hurting), MALAISE (Extremelly ill), PYREXIA (fever (unknown)) and CHILLS (chills) in a 34-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 COVID-19.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced GAIT DISTURBANCE (She could not walk), PAIN IN EXTREMITY (feet were hurting), MALAISE (Extremelly ill), PYREXIA (fever (unknown)), CHILLS (chills) and MYALGIA (Severe body pain). At the time of the report, GAIT DISTURBANCE (She could not walk), PAIN IN EXTREMITY (feet were hurting), MALAISE (Extremelly ill), PYREXIA (fever (unknown)), CHILLS (chills) and MYALGIA (Severe body pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that he side effects of the vaccine were worst than the Covid-19 disease. Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vomiting
Clinical narrative: Fatigue for a week; Vomiting for 24 hours; Nausea for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea for 24 hours), FATIGUE (Fatigue for a week) and VOMITING (Vomiting for 24 hours) 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 NAUSEA (Nausea for 24 hours), FATIGUE (Fatigue for a week) and VOMITING (Vomiting for 24 hours). At the time of the report, NAUSEA (Nausea for 24 hours) and VOMITING (Vomiting for 24 hours) had resolved and FATIGUE (Fatigue for a week) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Paraesthesia, Presyncope, Urticaria
Clinical narrative: started breathing really hard; got dizzy; body was tingling; side of face was itchy; almost passed out; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (started breathing really hard), DIZZINESS (got dizzy), PARAESTHESIA (body was tingling), URTICARIA (side of face was itchy) and PRESYNCOPE (almost passed out) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DYSPNOEA (started breathing really hard), DIZZINESS (got dizzy), PARAESTHESIA (body was tingling), URTICARIA (side of face was itchy) and PRESYNCOPE (almost passed out). At the time of the report, DYSPNOEA (started breathing really hard), DIZZINESS (got dizzy), PARAESTHESIA (body was tingling), URTICARIA (side of face was itchy) and PRESYNCOPE (almost passed out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient received antihistamines as face was getting itchy.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia, Pharyngeal hypoaesthesia
Clinical narrative: weird sensation which started in her throat, then tongue and came to her lips, it was like numb and tingling sensation. Felt like it was swelling but there was no swelling; weird sensation which started in her throat, then tongue and came to her lips, it was like numb; weird sensation which started in her throat, then tongue and came to her lips, it was like numb; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb and tingling sensation. Felt like it was swelling but there was no swelling), PHARYNGEAL HYPOAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) and HYPOAESTHESIA ORAL (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IRBESARTAN, DOXYCYCLINE HYCLATE, ESTRADIOL, PROGESTERONE and GABAPENTIN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PARAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb and tingling sensation. Felt like it was swelling but there was no swelling), PHARYNGEAL HYPOAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) and HYPOAESTHESIA ORAL (weird sensation which started in her throat, then tongue and came to her lips, it was like numb). On 12-Feb-2021, PARAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb and tingling sensation. Felt like it was swelling but there was no swelling), PHARYNGEAL HYPOAESTHESIA (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) and HYPOAESTHESIA ORAL (weird sensation which started in her throat, then tongue and came to her lips, it was like numb) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information was received on 13 Jul 2021 and contains no significant information
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: lower back pain; right shoulder pain; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lower back pain/back pain, right shoulder pain/arthralgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) lower back pain, right shoulder pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), lower back pain, right shoulder pain was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms for 36 hours; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event flu-like symptoms for 36 hours.  The patient's medical history was not provided. Concomitant medications reported were unknown for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.   On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event flu-like symptoms for 36 hours.  No treatment information provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, flu-like symptoms for 36 hours was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Irritability, Myalgia, Pyrexia
Clinical narrative: Body chills; Fever; Soreness; Felt out of sorts; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Body chills), PYREXIA (Fever), MYALGIA (Soreness) and IRRITABILITY (Felt out of sorts) in a 68-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Body chills), PYREXIA (Fever), MYALGIA (Soreness) and IRRITABILITY (Felt out of sorts). At the time of the report, CHILLS (Body chills), PYREXIA (Fever), MYALGIA (Soreness) and IRRITABILITY (Felt out of sorts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported. no treatment details reported.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Spike in her blood sugars; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Spike in her blood sugars) 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 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 BLOOD GLUCOSE INCREASED (Spike in her blood sugars).   At the time of the report, BLOOD GLUCOSE INCREASED (Spike in her blood sugars) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication information was provided.  No treatment product information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site urticaria, Injection site warmth, Pain in extremity
Clinical narrative: felt so hot at the injection site; sore arm - left arm; Moderna arm - hives at the injection site; arm hurt so bad - left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (felt so hot at the injection site), PAIN IN EXTREMITY (sore arm - left arm), INJECTION SITE URTICARIA (Moderna arm - hives at the injection site) and INJECTION SITE PAIN (arm hurt so bad - left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L70A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Levaquin caused swollen lips), Allergy to antibiotic (Augmentin Levaquin caused swollen lips) and Hay fever. Concomitant products included LOSARTAN, METOPROLOL, ALENDRONATE SODIUM (ALENDRONATE), OXYBUTYNIN and BUPROPION for an unknown indication.   On 01-Feb-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Feb-2021, the patient experienced INJECTION SITE WARMTH (felt so hot at the injection site), PAIN IN EXTREMITY (sore arm - left arm), INJECTION SITE URTICARIA (Moderna arm - hives at the injection site) and INJECTION SITE PAIN (arm hurt so bad - left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 17-Feb-2021, INJECTION SITE WARMTH (felt so hot at the injection site), PAIN IN EXTREMITY (sore arm - left arm), INJECTION SITE URTICARIA (Moderna arm - hives at the injection site) and INJECTION SITE PAIN (arm hurt so bad - left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Treatment medications included ice pack, itch cream on the hives when itched.   This case was linked to MOD-2021-023271 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Added relevant medical history, concomitant  and treatment medications and the events outcome changed from unknown to recovered with  added stop date.