chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Rash all over the entire arm,red; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH ERYTHEMATOUS (Rash all over the entire arm,red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Rash all over the entire arm,red). At the time of the report, RASH ERYTHEMATOUS (Rash all over the entire arm,red) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case concerns a male of unknown age who experienced a nonserious expected event of rash erythematous.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment included diphenhydramine. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a male of unknown age who experienced a nonserious expected event of rash erythematous.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment included diphenhydramine. Event ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: cannot move her arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (cannot move her arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced MOBILITY DECREASED (cannot move her arm). At the time of the report, MOBILITY DECREASED (cannot move her arm) 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 concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: TCR; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Injection site hardness; injection site appears like a cellulitis; Injection site feels warm to touch; injection site redness; injection site sore, achy/painful; injection site swollen/severe swelling; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE CELLULITIS (injection site appears like a cellulitis), INJECTION SITE WARMTH (Injection site feels warm to touch), INJECTION SITE INDURATION (Injection site hardness), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE PAIN (injection site sore, achy/painful) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy. Concomitant products included VITAMIN B COMPLEX, VITAMIN D3 and BIOTIN for Supplementation therapy.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site feels warm to touch), INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE PAIN (injection site sore, achy/painful) and INJECTION SITE SWELLING (injection site swollen/severe swelling). On 17-Jan-2021, the patient experienced INJECTION SITE CELLULITIS (injection site appears like a cellulitis). On an unknown date, the patient experienced INJECTION SITE INDURATION (Injection site hardness). At the time of the report, INJECTION SITE CELLULITIS (injection site appears like a cellulitis), INJECTION SITE WARMTH (Injection site feels warm to touch), INJECTION SITE INDURATION (Injection site hardness), INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE PAIN (injection site sore, achy/painful) and INJECTION SITE SWELLING (injection site swollen/severe swelling) 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.   The patient went to urgent care on 17-Jan-2021 and saw a nurse practioner who diagnosed the patient's symptoms as cellulitis of right arm at injection site. The patient was prescribed with Cephalexin 500 mg 4 times a day for 10 days and the symptoms resolved.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: The significant follow up case was received on 07-APR-2021. Concomitant medications are added. Events  are added.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Injection site hardness; injection site appears like a cellulitis; Injection site feels warm to touch; injection site redness; injection site sore, achy/painful; injection site swollen/severe swelling; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE CELLULITIS (injection site appears like a cellulitis), INJECTION SITE WARMTH (Injection site feels warm to touch), INJECTION SITE INDURATION (Injection site hardness), INJECTION SITE ERYTHEMA (injection site redness) and INJECTION SITE PAIN (injection site sore, achy/painful) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy. Concomitant products included VITAMIN B COMPLEX, VITAMIN D3 and BIOTIN for Supplementation therapy.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site feels warm to touch), INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE PAIN (injection site sore, achy/painful) and INJECTION SITE SWELLING (injection site swollen/severe swelling). On 17-Jan-2021, the patient experienced INJECTION SITE CELLULITIS (injection site appears like a cellulitis). On an unknown date, the patient experienced INJECTION SITE INDURATION (Injection site hardness). At the time of the report, INJECTION SITE CELLULITIS (injection site appears like a cellulitis), INJECTION SITE WARMTH (Injection site feels warm to touch), INJECTION SITE INDURATION (Injection site hardness), INJECTION SITE ERYTHEMA (injection site redness), INJECTION SITE PAIN (injection site sore, achy/painful) and INJECTION SITE SWELLING (injection site swollen/severe swelling) 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.   The patient went to urgent care on 17-Jan-2021 and saw a nurse practioner who diagnosed the patient's symptoms as cellulitis of right arm at injection site. The patient was prescribed with Cephalexin 500 mg 4 times a day for 10 days and the symptoms resolved.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: The significant follow up case was received on 07-APR-2021. Concomitant medications are added. Events  are added.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness at injecton at the site of injection; Tender at the site of injection; Swollen at the site of injection; Itchy at the injection; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at injecton at the site of injection), INJECTION SITE PAIN (Tender at the site of injection), INJECTION SITE SWELLING (Swollen at the site of injection) and INJECTION SITE PRURITUS (Itchy at the injection) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at injecton at the site of injection), INJECTION SITE PAIN (Tender at the site of injection), INJECTION SITE SWELLING (Swollen at the site of injection) and INJECTION SITE PRURITUS (Itchy at the injection). At the time of the report, INJECTION SITE ERYTHEMA (Redness at injecton at the site of injection), INJECTION SITE PAIN (Tender at the site of injection), INJECTION SITE SWELLING (Swollen at the site of injection) and INJECTION SITE PRURITUS (Itchy at the injection) was resolving.        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.  Treatment information provided included the use of OTC antihistamines for this reaction.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nausea; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) 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 (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On 05-Jan-2021, NAUSEA (Nausea) and HEADACHE (Headache) 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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, SARS-CoV-2 test, Somnolence
Clinical narrative: Sweats; Had about a week of Sleeping; Muscle aches; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Sweats), SOMNOLENCE (Had about a week of Sleeping) and MYALGIA (Muscle aches) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced HYPERHIDROSIS (Sweats), SOMNOLENCE (Had about a week of Sleeping) and MYALGIA (Muscle aches). At the time of the report, HYPERHIDROSIS (Sweats), SOMNOLENCE (Had about a week of Sleeping) and MYALGIA (Muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site movement impairment
Clinical narrative: more than moderate pain in my arm, it is not the injection site itself, but in the upper arm, it does not radiate and is concentrated in upper arm; I couldn't use or lift my arm hurting; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (more than moderate pain in my arm, it is not the injection site itself, but in the upper arm, it does not radiate and is concentrated in upper arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use or lift my arm hurting) in a 51-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 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced PAIN IN EXTREMITY (more than moderate pain in my arm, it is not the injection site itself, but in the upper arm, it does not radiate and is concentrated in upper arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use or lift my arm hurting). The patient was treated with IBUPROFEN for Pain, at a dose of 800 milligram every four hours. At the time of the report, PAIN IN EXTREMITY (more than moderate pain in my arm, it is not the injection site itself, but in the upper arm, it does not radiate and is concentrated in upper arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't use or lift my arm hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Pain in extremity, Rash
Clinical narrative: Pain in injection site; rash; Redness in injection site; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH (rash), INJECTION SITE ERYTHEMA (Redness in injection site) and INJECTION SITE PAIN (Pain in injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and INJECTION SITE ERYTHEMA (Redness in injection site). On 07-Jan-2021, the patient experienced RASH (rash). On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain in injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH (rash), INJECTION SITE ERYTHEMA (Redness in injection site) and INJECTION SITE PAIN (Pain in injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case concerns a 30-year-old female who experienced nonserious events of unexpected pain in extremity and expected injection site pain, injection site erythema and rash.  Event onset occurred 3 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 30-year-old female who experienced nonserious events of unexpected pain in extremity and expected injection site pain, injection site erythema and rash.  Event onset occurred 3 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia, Vaccination site pain
Clinical narrative: Numbness in both arms; Weakness in both arms; Tingling same arm of injection; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in both arms), MUSCULAR WEAKNESS (Weakness in both arms), PARAESTHESIA (Tingling same arm of injection) and VACCINATION SITE PAIN (Soreness at the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for an unknown indication.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness in both arms), MUSCULAR WEAKNESS (Weakness in both arms), PARAESTHESIA (Tingling same arm of injection) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, HYPOAESTHESIA (Numbness in both arms), MUSCULAR WEAKNESS (Weakness in both arms), PARAESTHESIA (Tingling same arm of injection) and VACCINATION SITE PAIN (Soreness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram change, Myocarditis, Troponin increased
Clinical narrative: CHEST PAIN, ELEVATED TROPONIN WITH EKG CHANGES, SUSPECTED MYOCARDITIS
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Gait inability, Haemorrhage, Pain
Clinical narrative: Lost power in legs feet couldn?t t walk lost control of blaster urine released no control broke out in psoriasis very severe ALL over body some bleeding  major severe pain all over body   Was like body exploading inside out  felt like seriously gonna die for first 20 days went to 2 different hospitals 2 days in first one 4 days in second one ,,,, neither hospital knew what was wrong. With me after ct scans and blood urine tests d,,,, NO Answers. Been here 5 weeks getting better no treatment s
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, Urinary incontinence
Clinical narrative: Lost power in legs feet couldn?t t walk lost control of blaster urine released no control broke out in psoriasis very severe ALL over body some bleeding  major severe pain all over body   Was like body exploading inside out  felt like seriously gonna die for first 20 days went to 2 different hospitals 2 days in first one 4 days in second one ,,,, neither hospital knew what was wrong. With me after ct scans and blood urine tests d,,,, NO Answers. Been here 5 weeks getting better no treatment s
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Arm red; Extremely sore; Itching; This spontaneous case was reported by a consumer and describes the occurrence of   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 (No reported medical history.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided  This case concerns a female of unknown age who experienced nonserious unexpected events of erythema, pruritus, and pain in extremity.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected events of erythema, pruritus, and pain in extremity.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: Itching really bad; Swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching really bad) and SWELLING (Swelled up) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PRURITUS (Itching really bad) and SWELLING (Swelled up). At the time of the report, PRURITUS (Itching really bad) and SWELLING (Swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Paracetamol and ice.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Injection site pain; Muscle pain; Joint pain; Chills; Fatigue; I think I had a fever; This spontaneous case was reported by an occupational therapist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Dec-2020 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021 at 3:00 AM, the patient experienced VACCINATION SITE PAIN (Injection site pain) and ARTHRALGIA (Joint pain). 01-Jan-2021 at 3:00 AM, the patient experienced MYALGIA (Muscle pain), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (I think I had a fever). On 02-Jan-2021, VACCINATION SITE PAIN (Injection site pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (I think I had a fever) 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.   Concomitant and treatment information not provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; Muscle pain; Joint pain; Chills; Fatigue; I think I had a fever; This spontaneous case was reported by an occupational therapist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Dec-2020 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021 at 3:00 AM, the patient experienced VACCINATION SITE PAIN (Injection site pain) and ARTHRALGIA (Joint pain). 01-Jan-2021 at 3:00 AM, the patient experienced MYALGIA (Muscle pain), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (I think I had a fever). On 02-Jan-2021, VACCINATION SITE PAIN (Injection site pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (I think I had a fever) 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.   Concomitant and treatment information not provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eyelids pruritus, Pain in extremity
Clinical narrative: Diarrhea; eyelid itch; mild arm sore; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), EYELIDS PRURITUS (eyelid itch) and PAIN IN EXTREMITY (mild arm sore) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), EYELIDS PRURITUS (eyelid itch) and PAIN IN EXTREMITY (mild arm sore). On 10-Jan-2021, EYELIDS PRURITUS (eyelid itch) had resolved. At the time of the report, DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (mild arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever 100 F; Muscle Aches; A spontaneous report was received from a consumer concerning a 48-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever 100 F (Fahrenheit) and muscle aches.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 08 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 09 Jan 2021, the patient developed a fever 100 F and muscle aches and the symptoms were still going on. Treatment for the events included paracetamol.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, fever and muscle aches, was considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Injection site is warm; Injection site is welted; Injection site is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE URTICARIA (Injection site is welted) and VACCINATION SITE ERYTHEMA (Injection site is red) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE URTICARIA (Injection site is welted) and VACCINATION SITE ERYTHEMA (Injection site is red). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm), VACCINATION SITE URTICARIA (Injection site is welted) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 08-Jan-2021, The patient experience arm pain. Outcome of the event was unknown  The consumer's health care professional recommended Tylenol and Ice.  This case concerns a 52-year-old male who experienced a nonserious unexpected event of Pain in extremity.  Event onset occurred 2 days after the first dose of mRNA-1273. Treatment unknown. Event outcome not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 52-year-old male who experienced a nonserious unexpected event of Pain in extremity.  Event onset occurred 2 days after the first dose of mRNA-1273. Treatment unknown. Event outcome not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache in the forefront; Muscle pain; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache in the forefront) and MYALGIA (Muscle pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included AMLODIPINE and METFORMIN for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (Headache in the forefront) and MYALGIA (Muscle pain). On 08-Jan-2021, HEADACHE (Headache in the forefront) had resolved. At the time of the report, MYALGIA (Muscle pain) 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 for the event included paracetamol.   This case concerns a 66-year-old female who experienced nonserious expected events of headache and myalgia.  Event onset occurred 2 days after the first dose of mRNA-1273. Treatment with paracetamol. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 66-year-old female who experienced nonserious expected events of headache and myalgia.  Event onset occurred 2 days after the first dose of mRNA-1273. Treatment with paracetamol. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: injection site knot; exhausted; chills; Joint aches and pain; body aches and pain; Headache; Nausea; injection site swelling; injection site redness; fever not over 100° F; unable to eat for days; injection site black and blue and hard; injection site was black and blue and hard; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (unable to eat for days), INJECTION SITE MASS (injection site knot), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DECREASED APPETITE (unable to eat for days), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (injection site redness) and PYREXIA (fever not over 100° F). On 07-Jan-2021 at 3:00 AM, the patient experienced CHILLS (chills), ARTHRALGIA (Joint aches and pain), MYALGIA (body aches and pain), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced INJECTION SITE MASS (injection site knot) and FATIGUE (exhausted). At the time of the report, DECREASED APPETITE (unable to eat for days), INJECTION SITE MASS (injection site knot), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard), CHILLS (chills), ARTHRALGIA (Joint aches and pain), MYALGIA (body aches and pain), HEADACHE (Headache), NAUSEA (Nausea), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (injection site redness), PYREXIA (fever not over 100° F) and FATIGUE (exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: (Negative) Negative results 09 Jan 2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: injection site knot; exhausted; chills; Joint aches and pain; body aches and pain; Headache; Nausea; injection site swelling; injection site redness; fever not over 100° F; unable to eat for days; injection site black and blue and hard; injection site was black and blue and hard; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (unable to eat for days), INJECTION SITE MASS (injection site knot), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DECREASED APPETITE (unable to eat for days), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (injection site redness) and PYREXIA (fever not over 100° F). On 07-Jan-2021 at 3:00 AM, the patient experienced CHILLS (chills), ARTHRALGIA (Joint aches and pain), MYALGIA (body aches and pain), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced INJECTION SITE MASS (injection site knot) and FATIGUE (exhausted). At the time of the report, DECREASED APPETITE (unable to eat for days), INJECTION SITE MASS (injection site knot), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard), CHILLS (chills), ARTHRALGIA (Joint aches and pain), MYALGIA (body aches and pain), HEADACHE (Headache), NAUSEA (Nausea), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (injection site redness), PYREXIA (fever not over 100° F) and FATIGUE (exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: (Negative) Negative results 09 Jan 2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: injection site knot; exhausted; chills; Joint aches and pain; body aches and pain; Headache; Nausea; injection site swelling; injection site redness; fever not over 100° F; unable to eat for days; injection site black and blue and hard; injection site was black and blue and hard; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (unable to eat for days), INJECTION SITE MASS (injection site knot), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DECREASED APPETITE (unable to eat for days), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (injection site redness) and PYREXIA (fever not over 100° F). On 07-Jan-2021 at 3:00 AM, the patient experienced CHILLS (chills), ARTHRALGIA (Joint aches and pain), MYALGIA (body aches and pain), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced INJECTION SITE MASS (injection site knot) and FATIGUE (exhausted). At the time of the report, DECREASED APPETITE (unable to eat for days), INJECTION SITE MASS (injection site knot), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard), CHILLS (chills), ARTHRALGIA (Joint aches and pain), MYALGIA (body aches and pain), HEADACHE (Headache), NAUSEA (Nausea), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (injection site redness), PYREXIA (fever not over 100° F) and FATIGUE (exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: (Negative) Negative results 09 Jan 2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches 5 days after getting the Moderna COVID-19 Vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (Headaches 5 days after getting the Moderna COVID-19 Vaccine) 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 (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced HEADACHE (Headaches 5 days after getting the Moderna COVID-19 Vaccine). At the time of the report, HEADACHE (Headaches 5 days after getting the Moderna COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case concerns a female of unknown age a nonserious expected event of headache. Event onset 6 days after first dose mRNA-1273.  Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: This case concerns a female of unknown age a nonserious expected event of headache. Event onset 6 days after first dose mRNA-1273.  Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Headache, Immune system disorder
Clinical narrative: The patient's past medical history included No adverse effect (no adverse event reported). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 05-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations). At the time of the report, PALPITATIONS (Heart palpitations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, SARS-CoV-2 antibody test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: Healthcare professional (HCP) called in to report multiple adverse events and asked if she should receive the second dose. Adverse events included headache, fever, chills, chest pain, heart palpitations.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Palpitations, Pyrexia, SARS-CoV-2 antibody test positive
Clinical narrative: The patient's past medical history included No adverse effect (no adverse event reported). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 05-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations). At the time of the report, PALPITATIONS (Heart palpitations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, SARS-CoV-2 antibody test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: Healthcare professional (HCP) called in to report multiple adverse events and asked if she should receive the second dose. Adverse events included headache, fever, chills, chest pain, heart palpitations.