chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles 24 days after 1st Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles 24 days after 1st Covid-19 vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HERPES ZOSTER (shingles 24 days after 1st Covid-19 vaccine). At the time of the report, HERPES ZOSTER (shingles 24 days after 1st Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient received the first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Nov-2020 and the estimated date of delivery was 17-Aug-2021. On 24-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 24-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Injection site erythema, Injection site pain, Injection site swelling, SARS-CoV-2 test
Clinical narrative: unable to walk; Difficulty with speech; Pain in left arm; Injection site red and swollen; Injection site red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (unable to walk), SPEECH DISORDER (Difficulty with speech), INJECTION SITE PAIN (Pain in left arm), INJECTION SITE ERYTHEMA (Injection site red and swollen) and INJECTION SITE SWELLING (Injection site red and swollen) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain in left arm), INJECTION SITE ERYTHEMA (Injection site red and swollen) and INJECTION SITE SWELLING (Injection site red and swollen). On 26-Feb-2021, the patient experienced GAIT INABILITY (unable to walk) and SPEECH DISORDER (Difficulty with speech). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, GAIT INABILITY (unable to walk), SPEECH DISORDER (Difficulty with speech), INJECTION SITE PAIN (Pain in left arm), INJECTION SITE ERYTHEMA (Injection site red and swollen) and INJECTION SITE SWELLING (Injection site red and swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2020, SARS-CoV-2 test: 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.   Concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2021: Follow up received and events added.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: unable to walk; Difficulty with speech; Pain in left arm; Injection site red and swollen; Injection site red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (unable to walk), SPEECH DISORDER (Difficulty with speech), INJECTION SITE PAIN (Pain in left arm), INJECTION SITE ERYTHEMA (Injection site red and swollen) and INJECTION SITE SWELLING (Injection site red and swollen) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain in left arm), INJECTION SITE ERYTHEMA (Injection site red and swollen) and INJECTION SITE SWELLING (Injection site red and swollen). On 26-Feb-2021, the patient experienced GAIT INABILITY (unable to walk) and SPEECH DISORDER (Difficulty with speech). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, GAIT INABILITY (unable to walk), SPEECH DISORDER (Difficulty with speech), INJECTION SITE PAIN (Pain in left arm), INJECTION SITE ERYTHEMA (Injection site red and swollen) and INJECTION SITE SWELLING (Injection site red and swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2020, SARS-CoV-2 test: 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.   Concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2021: Follow up received and events added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Hair disorder, Headache
Clinical narrative: Tested positive for COVID; Aches; Hair hurt; congestion; runny nose; cough; nausea; headache; hurting all over; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), PAIN IN EXTREMITY (Aches), HAIR DISORDER (Hair hurt), NASAL CONGESTION (congestion) and RHINORRHOEA (runny nose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Aches), HAIR DISORDER (Hair hurt), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), COUGH (cough), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (hurting all over). On 23-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID). The patient was treated with BAMLANIVIMAB (intravenous) on 26-Feb-2021 for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (Tested positive for COVID), PAIN IN EXTREMITY (Aches), HAIR DISORDER (Hair hurt), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), COUGH (cough), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (hurting all over) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were reported Patient said she is scheduled for second dose on 9Mar2021   This case was linked to MOD-2021-033480 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up information received and contains significant information. Outcome of the events were changed from Unknown to Not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, Pain in extremity, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Aches; Hair hurt; congestion; runny nose; cough; nausea; headache; hurting all over; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), PAIN IN EXTREMITY (Aches), HAIR DISORDER (Hair hurt), NASAL CONGESTION (congestion) and RHINORRHOEA (runny nose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Aches), HAIR DISORDER (Hair hurt), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), COUGH (cough), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (hurting all over). On 23-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID). The patient was treated with BAMLANIVIMAB (intravenous) on 26-Feb-2021 for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (Tested positive for COVID), PAIN IN EXTREMITY (Aches), HAIR DISORDER (Hair hurt), NASAL CONGESTION (congestion), RHINORRHOEA (runny nose), COUGH (cough), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (hurting all over) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were reported Patient said she is scheduled for second dose on 9Mar2021   This case was linked to MOD-2021-033480 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up information received and contains significant information. Outcome of the events were changed from Unknown to Not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided . No treatment information provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headache; sore arm; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE PAIN (sore arm), HEADACHE (headache) and the second episode of VACCINATION SITE PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced the first episode of VACCINATION SITE PAIN (sore arm). On 26-Feb-2021, the patient experienced HEADACHE (headache) and the second episode of VACCINATION SITE PAIN (sore arm). At the time of the report, HEADACHE (headache) and the last episode of VACCINATION SITE PAIN (sore arm) outcome was unknown.            No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Sex: F
Vaccine: COVID19
Symptoms: Amniocentesis, Maternal exposure during pregnancy, Ultrasound foetal
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D10A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 17-Oct-2020 and the estimated date of delivery was 24-Jul-2021. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound foetal: normal (normal) Normal. On an unknown date, Amniocentesis: normal (normal) Normal.     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.   past pregnancy details: Live birth, full term pregnancy on Aug-2018.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dyspnoea, Fatigue
Clinical narrative: Difficulty breathing; Weak; Cough; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), ASTHENIA (Weak), COUGH (Cough) and FATIGUE (Fatigue) 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 DYSPNOEA (Difficulty breathing), ASTHENIA (Weak), COUGH (Cough) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Difficulty breathing), ASTHENIA (Weak), COUGH (Cough) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash under both arms, back, neck , groin and waste area.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash under both arms, back, neck , groin and waste area.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced RASH (Rash under both arms, back, neck , groin and waste area.). At the time of the report, RASH (Rash under both arms, back, neck , groin and waste area.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE RASH (rash).         No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Couple hours with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Couple hours with fatigue) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FATIGUE (Couple hours with fatigue). At the time of the report, FATIGUE (Couple hours with fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-041006 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Pain, Pain in extremity, Pruritus
Clinical narrative: bumps have tiny blisters in the center; bumps are itchy; bumps are very bright red; Bumps on neck, torso, legs and back; Little body ache; left arm was a little sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was a little sore), BLISTER (bumps have tiny blisters in the center), PAIN (Little body ache), PRURITUS (bumps are itchy) and ERYTHEMA (bumps are very bright red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vitamin D deficiency, Drug allergy and Digestion impaired (trouble digesting pills in stomach). Concomitant products included COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm was a little sore) and PAIN (Little body ache). On 23-Feb-2021, the patient experienced BLISTER (bumps have tiny blisters in the center), PRURITUS (bumps are itchy), ERYTHEMA (bumps are very bright red) and RASH (Bumps on neck, torso, legs and back). At the time of the report, PAIN IN EXTREMITY (left arm was a little sore), BLISTER (bumps have tiny blisters in the center), PAIN (Little body ache), PRURITUS (bumps are itchy), ERYTHEMA (bumps are very bright red) and RASH (Bumps on neck, torso, legs and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported. patient took Neuro-Immune Stabilizer topical cream as concomitant medication.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: bumps have tiny blisters in the center; bumps are itchy; bumps are very bright red; Bumps on neck, torso, legs and back; Little body ache; left arm was a little sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was a little sore), BLISTER (bumps have tiny blisters in the center), PAIN (Little body ache), PRURITUS (bumps are itchy) and ERYTHEMA (bumps are very bright red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vitamin D deficiency, Drug allergy and Digestion impaired (trouble digesting pills in stomach). Concomitant products included COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (left arm was a little sore) and PAIN (Little body ache). On 23-Feb-2021, the patient experienced BLISTER (bumps have tiny blisters in the center), PRURITUS (bumps are itchy), ERYTHEMA (bumps are very bright red) and RASH (Bumps on neck, torso, legs and back). At the time of the report, PAIN IN EXTREMITY (left arm was a little sore), BLISTER (bumps have tiny blisters in the center), PAIN (Little body ache), PRURITUS (bumps are itchy), ERYTHEMA (bumps are very bright red) and RASH (Bumps on neck, torso, legs and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported. patient took Neuro-Immune Stabilizer topical cream as concomitant medication.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Feeling abnormal, Pain
Clinical narrative: impressive level of sore; deep tissue bruise; extremely uncomfortable; a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (impressive level of sore), CONTUSION (deep tissue bruise), FEELING ABNORMAL (extremely uncomfortable) and PAIN (a little sore) in a 36-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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (impressive level of sore), CONTUSION (deep tissue bruise), FEELING ABNORMAL (extremely uncomfortable) and PAIN (a little sore). At the time of the report, PAIN (impressive level of sore), CONTUSION (deep tissue bruise), FEELING ABNORMAL (extremely uncomfortable) and PAIN (a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Patient have large pink area around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Patient have large pink area around the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Patient have large pink area around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Patient have large pink area around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: She also had hives and itching all over; She also had hives and itching all over; Full body rash with itching including the soles of her feet, palms of her hands, and in her ears; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of RASH (Full body rash with itching including the soles of her feet, palms of her hands, and in her ears), URTICARIA (She also had hives and itching all over) and PRURITUS (She also had hives and itching all over) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced RASH (Full body rash with itching including the soles of her feet, palms of her hands, and in her ears). On an unknown date, the patient experienced URTICARIA (She also had hives and itching all over) and PRURITUS (She also had hives and itching all over). At the time of the report, RASH (Full body rash with itching including the soles of her feet, palms of her hands, and in her ears), URTICARIA (She also had hives and itching all over) and PRURITUS (She also had hives and itching all over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was reported as Antihistamines. Concomitant product use was not provided by the reporter.   This case was linked to MOD21-039588 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Nausea, Swelling face, Vomiting
Clinical narrative: Nausea; Vomiting; Looks flush; Face slightly swollen; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting), FLUSHING (Looks flush) and SWELLING FACE (Face slightly swollen) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced SWELLING FACE (Face slightly swollen). On 26-Feb-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and FLUSHING (Looks flush). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting), FLUSHING (Looks flush) and SWELLING FACE (Face slightly swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported Treatment information were not provided
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: large red circular welt that is 2 inches wide and 2.5 inches long,; Welt is warm to touch; Welt is a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (large red circular welt that is 2 inches wide and 2.5 inches long,), SKIN WARM (Welt is warm to touch) and SWELLING (Welt is a little swollen) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced URTICARIA (large red circular welt that is 2 inches wide and 2.5 inches long,), SKIN WARM (Welt is warm to touch) and SWELLING (Welt is a little swollen). At the time of the report, URTICARIA (large red circular welt that is 2 inches wide and 2.5 inches long,), SKIN WARM (Welt is warm to touch) and SWELLING (Welt is a little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Poor quality sleep
Clinical narrative: anxiety was exaggerated; feels anxiety day and night and wakes up in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety was exaggerated) and POOR QUALITY SLEEP (feels anxiety day and night and wakes up in the middle of the night) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Mental disorder NOS.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced ANXIETY (anxiety was exaggerated) and POOR QUALITY SLEEP (feels anxiety day and night and wakes up in the middle of the night). At the time of the report, ANXIETY (anxiety was exaggerated) and POOR QUALITY SLEEP (feels anxiety day and night and wakes up in the middle of the night) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vaccination complication
Clinical narrative: Reaction; Rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction) and RASH (Rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction) and RASH (Rash). At the time of the report, VACCINATION COMPLICATION (Reaction) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Information about concomitant medication was not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Bladder pain, Limb discomfort, Myalgia, Night sweats
Clinical narrative: Eye heaviness; Sore arm; Fever; Heavy arm; Night sweats; Bladder Pressure; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), BLADDER PAIN (Bladder Pressure), ASTHENOPIA (Eye heaviness), MYALGIA (Sore arm) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to macrobid), Drug allergy (Allergy to pepcid), Sulfonamide allergy (Allergy to sulfa), Drug allergy (Allergy to minocycline), Drug allergy (Allergy to foxin) and Drug allergy (Allergy to amitiza). Concomitant products included DENOSUMAB (PROLIA) for Bone density abnormal, MULTIVITAMIN [VITAMINS NOS], BIOTIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and CALCIUM for an unknown indication.   On 15-Feb-2021, 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced NIGHT SWEATS (Night sweats), BLADDER PAIN (Bladder Pressure) and LIMB DISCOMFORT (Heavy arm). On an unknown date, the patient experienced ASTHENOPIA (Eye heaviness), MYALGIA (Sore arm) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, NIGHT SWEATS (Night sweats), BLADDER PAIN (Bladder Pressure), ASTHENOPIA (Eye heaviness), MYALGIA (Sore arm), PYREXIA (Fever) and LIMB DISCOMFORT (Heavy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked. This case was linked. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Second dose information was added On 21-Jul-2021: Follow up information received on 21-Jul-2021 and included Updated patient demographics, medical history , vaccine facility. Updated  events and concomitant medications.; Sender's Comments:  MOD21-083869:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Eye heaviness; Sore arm; Fever; Heavy arm; Night sweats; Bladder Pressure; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), BLADDER PAIN (Bladder Pressure), ASTHENOPIA (Eye heaviness), MYALGIA (Sore arm) and PYREXIA (Fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to macrobid), Drug allergy (Allergy to pepcid), Sulfonamide allergy (Allergy to sulfa), Drug allergy (Allergy to minocycline), Drug allergy (Allergy to foxin) and Drug allergy (Allergy to amitiza). Concomitant products included DENOSUMAB (PROLIA) for Bone density abnormal, MULTIVITAMIN [VITAMINS NOS], BIOTIN, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and CALCIUM for an unknown indication.   On 15-Feb-2021, 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced NIGHT SWEATS (Night sweats), BLADDER PAIN (Bladder Pressure) and LIMB DISCOMFORT (Heavy arm). On an unknown date, the patient experienced ASTHENOPIA (Eye heaviness), MYALGIA (Sore arm) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, NIGHT SWEATS (Night sweats), BLADDER PAIN (Bladder Pressure), ASTHENOPIA (Eye heaviness), MYALGIA (Sore arm), PYREXIA (Fever) and LIMB DISCOMFORT (Heavy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked. This case was linked. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Second dose information was added On 21-Jul-2021: Follow up information received on 21-Jul-2021 and included Updated patient demographics, medical history , vaccine facility. Updated  events and concomitant medications.; Sender's Comments:  MOD21-083869:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Paraesthesia, Swelling face
Clinical narrative: headache; tingling in hand; swelling of face; feeling of shortness of breath; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), PARAESTHESIA (tingling in hand), SWELLING FACE (swelling of face) and DYSPNOEA (feeling of shortness of breath) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0237L20A) for COVID-19 vaccination.     Concurrent medical conditions included IgG decreased.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (headache), PARAESTHESIA (tingling in hand), SWELLING FACE (swelling of face) and DYSPNOEA (feeling of shortness of breath). At the time of the report, HEADACHE (headache), PARAESTHESIA (tingling in hand), SWELLING FACE (swelling of face) and DYSPNOEA (feeling of shortness of breath) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included, benadryl and injection epi pen. No concomitant medications were provided by reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Site of injection is itching; Site of injection has red mark; pain on the site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (pain on the site of injection), VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain on the site of injection). On 25-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark). On 21-Feb-2021, VACCINATION SITE PAIN (pain on the site of injection) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) 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 concomitant medication details was reported. No treatment medication details was reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: stiffness of the neck; Weakness in the body; Headaches; a little achiness/feel achy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness of the neck), ASTHENIA (Weakness in the body), PAIN (a little achiness/feel achy) and HEADACHE (Headaches) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (a little achiness/feel achy). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness of the neck), ASTHENIA (Weakness in the body) and HEADACHE (Headaches). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness of the neck), ASTHENIA (Weakness in the body), PAIN (a little achiness/feel achy) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Migraine, Pyrexia
Clinical narrative: Arthralgia; fever; fatigue; Severe headache; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (Arthralgia), PYREXIA (fever), FATIGUE (fatigue) and MIGRAINE (Severe headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced ARTHRALGIA (Arthralgia), PYREXIA (fever), FATIGUE (fatigue) and MIGRAINE (Severe headache). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 29-Jan-2021, ARTHRALGIA (Arthralgia), PYREXIA (fever), FATIGUE (fatigue) and MIGRAINE (Severe headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) over 100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ARTHRALGIA (Arthralgia), PYREXIA (fever), FATIGUE (fatigue) and MIGRAINE (Severe headache) to be possibly related.    No concomitant medications were reported.     This case was linked to MOD-2021-028515 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-May-2021 and added Event stop date.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Headache
Clinical narrative: Pregnant; Fatigue; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), FATIGUE (Fatigue) and HEADACHE (Headache) in a 31-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 09-Feb-2021, the patient received first 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 10-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not take any treatment. No concomitant medication were reported
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: itching; Pain at injection site; Heat (left); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat (left)), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (Pain at injection site) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011MZ0A) for COVID-19 vaccination.     The patient's past medical history included Heart valve operation (Heart valve repaired.). Concomitant products included WARFARIN SODIUM (WARFIN) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Heat (left)) and VACCINATION SITE PAIN (Pain at injection site). On 21-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching). The patient was treated with CORTISONE (topical) at an unspecified dose and frequency. On 23-Feb-2021, VACCINATION SITE WARMTH (Heat (left)) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received  included outcome of the event updated to recovered. Corrections made on the initial, treatment medication  were added.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vomiting
Clinical narrative: Temperature of up to 102; violently puking; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of up to 102) and VOMITING (violently puking) in a 39-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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Temperature of up to 102) and VOMITING (violently puking). At the time of the report, PYREXIA (Temperature of up to 102) and VOMITING (violently puking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 001A21A) for COVID-19 vaccination.     Concomitant products included ESTROGEN NOS;PROGESTERONE and LEVODOPA for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 28-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable