chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site hypersensitivity, Vaccination site pruritus, Vaccination site rash
Clinical narrative: The rash is gone now but still can see the red from were it was; Looked at the arm and it had like a 6 inches rash; Just an allergy and that there was nothing to worry about; The area of the injection started to get itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HYPERSENSITIVITY (Just an allergy and that there was nothing to worry about), VACCINATION SITE PRURITUS (The area of the injection started to get itchy), VACCINATION SITE RASH (Looked at the arm and it had like a 6 inches rash) and VACCINATION SITE ERYTHEMA (The rash is gone now but still can see the red from were it was) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2014) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN POTASSIUM 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 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (The area of the injection started to get itchy). On 22-Jan-2021, the patient experienced VACCINATION SITE HYPERSENSITIVITY (Just an allergy and that there was nothing to worry about). On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (Looked at the arm and it had like a 6 inches rash). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (The rash is gone now but still can see the red from were it was). The patient was treated with HYDROCORTISONE for Itchy, at an unspecified dose and frequency and CETIRIZINE HCL at a dose of 10 milligram. At the time of the report, VACCINATION SITE HYPERSENSITIVITY (Just an allergy and that there was nothing to worry about), VACCINATION SITE PRURITUS (The area of the injection started to get itchy) and VACCINATION SITE ERYTHEMA (The rash is gone now but still can see the red from were it was) outcome was unknown and VACCINATION SITE RASH (Looked at the arm and it had like a 6 inches rash) 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 concomitant medication included Hidrochloro Ciaside used for an unknown indication.  The patient consulted a physician on January 22nd who is not it's primary physician. and stated that it thought it was just an allergy and that there was nothing to worry about. The patient was concerned about receiving the second dose and said that the Dr stated that there was no problem receiving it. The patient stated that the rash is gone now but still can see the red from were it was.   This case was linked to MOD-2021-079735 (Patient Link).   Reporter did not allow further contact
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red rash on the chest and abdomen; Itchy rash on the chest and abdomen; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on the chest and abdomen) and RASH PRURITIC (Itchy rash on the chest and abdomen) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on the chest and abdomen) and RASH PRURITIC (Itchy rash on the chest and abdomen). At the time of the report, RASH ERYTHEMATOUS (Red rash on the chest and abdomen) and RASH PRURITIC (Itchy rash on the chest and abdomen) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported. The patient did not take any treatment medication.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Sore arm; Very severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and DIARRHOEA (Very severe diarrhea) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Lymphoma. Concomitant products included IMMUNOGLOBULIN G HUMAN (IGG) for Lymphoma.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and DIARRHOEA (Very severe diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) on 06-Feb-2021 for Diarrhea, at a dose of UNK dosage form. On 06-Feb-2021, DIARRHOEA (Very severe diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Within an hour of the vaccination, the patient  experienced very severe diarrhea. He had to rush home to take a shower. The severe diarrhea lasted within an hour.  The patient takes an IV IgG treatment every 6 weeks; he had one 2 weeks before the vaccine on 27-Jan-2021; he is a lymphoma survivor.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced RASH (rash). The patient was treated with HYDROCORTISONE for Rash, at a dose of UNK dosage form. At the time of the report, RASH (rash) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Approximately a week later to the vaccination, the patient developed a rash, he still has it on his upper chest, it is going away very slowly at the time of report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperglycaemia, Tremor, Vaccination site pain
Clinical narrative: Glucose what 171; Arm is very painful; Chills and was shaking; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Glucose what 171), TREMOR (Chills and was shaking) and VACCINATION SITE PAIN (Arm is very painful) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Cipro allergy), Diabetes mellitus, Hypertension and Ocular myasthenia. Concomitant products included LISINOPRIL, METFORMIN, LINAGLIPTIN (TRADJENTA), INSULIN, ALPRAZOLAM (XANAX), ATORVASTATIN, FLUVOXAMINE and POTASSIUM for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Chills and was shaking). On 09-Feb-2021, the patient experienced HYPERGLYCAEMIA (Glucose what 171) and VACCINATION SITE PAIN (Arm is very painful). At the time of the report, HYPERGLYCAEMIA (Glucose what 171), TREMOR (Chills and was shaking) and VACCINATION SITE PAIN (Arm is very painful) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062T20A) 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 07-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash on injection site). At the time of the report, VACCINATION SITE RASH (Rash on injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Feeling abnormal, Headache, Hypersensitivity
Clinical narrative: Allergic reaction; Tingling and numb tongue; blood pressure went up; Heavy arms and legs; unsteady; whole body felt off; Joint pain; Muscle pain; Mild headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), PARAESTHESIA ORAL (Tingling and numb tongue), BLOOD PRESSURE INCREASED (blood pressure went up), LIMB DISCOMFORT (Heavy arms and legs) and UNEVALUABLE EVENT (unsteady) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037V20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), PARAESTHESIA ORAL (Tingling and numb tongue), BLOOD PRESSURE INCREASED (blood pressure went up), LIMB DISCOMFORT (Heavy arms and legs), UNEVALUABLE EVENT (unsteady), FEELING ABNORMAL (whole body felt off), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), HEADACHE (Mild headache) and INJECTION SITE PAIN (Pain at the injection site). On 16-Jan-2021, HYPERSENSITIVITY (Allergic reaction), PARAESTHESIA ORAL (Tingling and numb tongue), BLOOD PRESSURE INCREASED (blood pressure went up), LIMB DISCOMFORT (Heavy arms and legs), UNEVALUABLE EVENT (unsteady) and FEELING ABNORMAL (whole body felt off) had resolved. On 18-Jan-2021, INJECTION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   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 start dates of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Limb discomfort, Myalgia, Paraesthesia oral, Unevaluable event
Clinical narrative: Allergic reaction; Tingling and numb tongue; blood pressure went up; Heavy arms and legs; unsteady; whole body felt off; Joint pain; Muscle pain; Mild headache; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), PARAESTHESIA ORAL (Tingling and numb tongue), BLOOD PRESSURE INCREASED (blood pressure went up), LIMB DISCOMFORT (Heavy arms and legs) and UNEVALUABLE EVENT (unsteady) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037V20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), PARAESTHESIA ORAL (Tingling and numb tongue), BLOOD PRESSURE INCREASED (blood pressure went up), LIMB DISCOMFORT (Heavy arms and legs), UNEVALUABLE EVENT (unsteady), FEELING ABNORMAL (whole body felt off), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), HEADACHE (Mild headache) and INJECTION SITE PAIN (Pain at the injection site). On 16-Jan-2021, HYPERSENSITIVITY (Allergic reaction), PARAESTHESIA ORAL (Tingling and numb tongue), BLOOD PRESSURE INCREASED (blood pressure went up), LIMB DISCOMFORT (Heavy arms and legs), UNEVALUABLE EVENT (unsteady) and FEELING ABNORMAL (whole body felt off) had resolved. On 18-Jan-2021, INJECTION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   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 start dates of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy; There was a bump; Arm was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (There was a bump) and VACCINATION SITE ERYTHEMA (Arm was red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), PARACETAMOL (TYLENOL), POTASSIUM CHLORIDE (KLOR-CON), TRAMADOL, CITALOPRAM, FUROSEMIDE, GABAPENTIN, LISINOPRIL and LORAZEPAM for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (There was a bump) and VACCINATION SITE ERYTHEMA (Arm was red). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE SWELLING (There was a bump) and VACCINATION SITE ERYTHEMA (Arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included cream for pain and reported that it helped in itching.   The patient reported that even though she had some side effects it was feeling fantastic and had not consulted any physician.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Follow up document received on 26-Mar-2021 and information related to medical confirmation was added. On 28-Jun-2021: Follow-up document received on 28-Jun-2021 and contains no newinformation.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: red arm; swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE SWELLING (swollen arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE SWELLING (swollen arm). At the time of the report, VACCINATION SITE ERYTHEMA (red arm) and VACCINATION SITE SWELLING (swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Experienced an adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experienced an adverse reaction) 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 adverse event 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 VACCINATION COMPLICATION (Experienced an adverse reaction). At the time of the report, VACCINATION COMPLICATION (Experienced an adverse reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       During follow-up patient told she had side effect but feeling fantastic. She did not see any doctor.  Concomitant medication information not provided. Treatment given not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: No specific follow-up information recorded.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Warm and hot; It is completely swollen; Itchy; So painful; A tiny bit red at the injection site; General soreness; Every bone and muscle hurt; Stabbing sharp headache; Feeling exhausted; Every bone and muscle hurt; Chills; Fever at 103.7F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General soreness), VACCINATION SITE WARMTH (Warm and hot), ARTHRALGIA (Every bone and muscle hurt), CHILLS (Chills) and PYREXIA (Fever at 103.7F) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive (She tested positive of COVID at the end of April in 2020) in April 2020 and Viral pneumonia (She also had community viral pneumonia back in January) in January 2020. Concurrent medical conditions included Allergy (iodine contrast dye, surgical adhesive).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (General soreness), ARTHRALGIA (Every bone and muscle hurt), CHILLS (Chills), PYREXIA (Fever at 103.7F), VACCINATION SITE ERYTHEMA (A tiny bit red at the injection site), MYALGIA (Every bone and muscle hurt), HEADACHE (Stabbing sharp headache) and FATIGUE (Feeling exhausted). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm and hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (So painful) and VACCINATION SITE SWELLING (It is completely swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (General soreness), ARTHRALGIA (Every bone and muscle hurt), CHILLS (Chills), PYREXIA (Fever at 103.7F), MYALGIA (Every bone and muscle hurt), HEADACHE (Stabbing sharp headache) and FATIGUE (Feeling exhausted) had resolved and VACCINATION SITE WARMTH (Warm and hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (So painful), VACCINATION SITE ERYTHEMA (A tiny bit red at the injection site) and VACCINATION SITE SWELLING (It is completely swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 103.7f (High) 103.7F. On 06-Feb-2021, Body temperature: 98.6f (Low) 98.6F. On an unknown date, Body temperature: 101f (High) Temperature decreased after taking Tylenol and ibuprofen.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Warm and hot; It is completely swollen; Itchy; So painful; A tiny bit red at the injection site; General soreness; Every bone and muscle hurt; Stabbing sharp headache; Feeling exhausted; Every bone and muscle hurt; Chills; Fever at 103.7F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General soreness), VACCINATION SITE WARMTH (Warm and hot), ARTHRALGIA (Every bone and muscle hurt), CHILLS (Chills) and PYREXIA (Fever at 103.7F) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive (She tested positive of COVID at the end of April in 2020) in April 2020 and Viral pneumonia (She also had community viral pneumonia back in January) in January 2020. Concurrent medical conditions included Allergy (iodine contrast dye, surgical adhesive).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (General soreness), ARTHRALGIA (Every bone and muscle hurt), CHILLS (Chills), PYREXIA (Fever at 103.7F), VACCINATION SITE ERYTHEMA (A tiny bit red at the injection site), MYALGIA (Every bone and muscle hurt), HEADACHE (Stabbing sharp headache) and FATIGUE (Feeling exhausted). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm and hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (So painful) and VACCINATION SITE SWELLING (It is completely swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (General soreness), ARTHRALGIA (Every bone and muscle hurt), CHILLS (Chills), PYREXIA (Fever at 103.7F), MYALGIA (Every bone and muscle hurt), HEADACHE (Stabbing sharp headache) and FATIGUE (Feeling exhausted) had resolved and VACCINATION SITE WARMTH (Warm and hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (So painful), VACCINATION SITE ERYTHEMA (A tiny bit red at the injection site) and VACCINATION SITE SWELLING (It is completely swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 103.7f (High) 103.7F. On 06-Feb-2021, Body temperature: 98.6f (Low) 98.6F. On an unknown date, Body temperature: 101f (High) Temperature decreased after taking Tylenol and ibuprofen.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm and hot; It is completely swollen; Itchy; So painful; A tiny bit red at the injection site; General soreness; Every bone and muscle hurt; Stabbing sharp headache; Feeling exhausted; Every bone and muscle hurt; Chills; Fever at 103.7F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General soreness), VACCINATION SITE WARMTH (Warm and hot), ARTHRALGIA (Every bone and muscle hurt), CHILLS (Chills) and PYREXIA (Fever at 103.7F) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive (She tested positive of COVID at the end of April in 2020) in April 2020 and Viral pneumonia (She also had community viral pneumonia back in January) in January 2020. Concurrent medical conditions included Allergy (iodine contrast dye, surgical adhesive).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (General soreness), ARTHRALGIA (Every bone and muscle hurt), CHILLS (Chills), PYREXIA (Fever at 103.7F), VACCINATION SITE ERYTHEMA (A tiny bit red at the injection site), MYALGIA (Every bone and muscle hurt), HEADACHE (Stabbing sharp headache) and FATIGUE (Feeling exhausted). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm and hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (So painful) and VACCINATION SITE SWELLING (It is completely swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (General soreness), ARTHRALGIA (Every bone and muscle hurt), CHILLS (Chills), PYREXIA (Fever at 103.7F), MYALGIA (Every bone and muscle hurt), HEADACHE (Stabbing sharp headache) and FATIGUE (Feeling exhausted) had resolved and VACCINATION SITE WARMTH (Warm and hot), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (So painful), VACCINATION SITE ERYTHEMA (A tiny bit red at the injection site) and VACCINATION SITE SWELLING (It is completely swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 103.7f (High) 103.7F. On 06-Feb-2021, Body temperature: 98.6f (Low) 98.6F. On an unknown date, Body temperature: 101f (High) Temperature decreased after taking Tylenol and ibuprofen.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site swelling, Neck pain, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingles in the whole arm), NECK PAIN (Neck pain in same side she took vaccine), ERYTHEMA (Big red area in the whole upper arm), PAIN (Soreness, she could not lay on it or touch it) and INJECTION SITE SWELLING (Swelling around injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PARAESTHESIA (Tingles in the whole arm), NECK PAIN (Neck pain in same side she took vaccine) and PAIN (Soreness, she could not lay on it or touch it). On 22-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swelling around injection site), VACCINATION SITE WARMTH (Warm around injection site about 3 inches by 3 inches) and INJECTION SITE ERYTHEMA (Big red area in the whole upper arm). On 28-Jan-2021, the patient experienced ERYTHEMA (Big red area in the whole upper arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingles in the whole arm), NECK PAIN (Neck pain in same side she took vaccine), ERYTHEMA (Big red area in the whole upper arm), PAIN (Soreness, she could not lay on it or touch it), INJECTION SITE SWELLING (Swelling around injection site), VACCINATION SITE WARMTH (Warm around injection site about 3 inches by 3 inches) and INJECTION SITE ERYTHEMA (Big red area in the whole upper arm) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingles in the whole arm), NECK PAIN (Neck pain in same side she took vaccine), ERYTHEMA (Big red area in the whole upper arm), PAIN (Soreness, she could not lay on it or touch it) and INJECTION SITE SWELLING (Swelling around injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PARAESTHESIA (Tingles in the whole arm), NECK PAIN (Neck pain in same side she took vaccine) and PAIN (Soreness, she could not lay on it or touch it). On 22-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swelling around injection site), VACCINATION SITE WARMTH (Warm around injection site about 3 inches by 3 inches) and INJECTION SITE ERYTHEMA (Big red area in the whole upper arm). On 28-Jan-2021, the patient experienced ERYTHEMA (Big red area in the whole upper arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingles in the whole arm), NECK PAIN (Neck pain in same side she took vaccine), ERYTHEMA (Big red area in the whole upper arm), PAIN (Soreness, she could not lay on it or touch it), INJECTION SITE SWELLING (Swelling around injection site), VACCINATION SITE WARMTH (Warm around injection site about 3 inches by 3 inches) and INJECTION SITE ERYTHEMA (Big red area in the whole upper arm) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction) 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 medical history 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 ADVERSE REACTION (Adverse reaction). At the time of the report, ADVERSE REACTION (Adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Very limited information regarding this event/s has been provided at this time.  Further information has been requested, however causal relationship of the adverse reaction after the vaccination, even with unknown date,  cannot be excluded .; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested, however causal relationship of the adverse reaction after the vaccination, even with unknown date,  cannot be excluded .
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: Stomach ache; Dizzy; Feels super sick; Headache; feeling like he has to vomit; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), DIZZINESS (Dizzy), MALAISE (Feels super sick), HEADACHE (Headache) and NAUSEA (feeling like he has to vomit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), DIZZINESS (Dizzy), MALAISE (Feels super sick), HEADACHE (Headache), NAUSEA (feeling like he has to vomit) and FATIGUE (Tired). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache), DIZZINESS (Dizzy), MALAISE (Feels super sick), HEADACHE (Headache), NAUSEA (feeling like he has to vomit) and FATIGUE (Tired) 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: followup information received on 24-JUN-2021 contains no significant information. TCR form attached patient did not have any symptoms after the second shot of vaccine; 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: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Stomach ache; Dizzy; Feels super sick; Headache; feeling like he has to vomit; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), DIZZINESS (Dizzy), MALAISE (Feels super sick), HEADACHE (Headache) and NAUSEA (feeling like he has to vomit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), DIZZINESS (Dizzy), MALAISE (Feels super sick), HEADACHE (Headache), NAUSEA (feeling like he has to vomit) and FATIGUE (Tired). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache), DIZZINESS (Dizzy), MALAISE (Feels super sick), HEADACHE (Headache), NAUSEA (feeling like he has to vomit) and FATIGUE (Tired) 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: followup information received on 24-JUN-2021 contains no significant information. TCR form attached patient did not have any symptoms after the second shot of vaccine; 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin laxity, Vaccination site erythema, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: aches and pain; skin is sagging on her arm; Soreness at injection site; Redness at injection site; Swelling at injection site; Swelling under her arm/ swollen lymph node; Rash at injection site; Warmness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness at the site of injection), PAIN (aches and pain), SKIN LAXITY (skin is sagging on her arm), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the site of injection), VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE LYMPHADENOPATHY (Swelling under her arm/ swollen lymph node) and VACCINATION SITE RASH (Rash at injection site). On an unknown date, the patient experienced PAIN (aches and pain). an unknown date, the patient experienced SKIN LAXITY (skin is sagging on her arm). The patient was treated with IBUPROFEN for Adverse event, at a dose of 600 and 400mg. At the time of the report, VACCINATION SITE WARMTH (Warmness at the site of injection), VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE RASH (Rash at injection site) was resolving and PAIN (aches and pain), SKIN LAXITY (skin is sagging on her arm) and VACCINATION SITE LYMPHADENOPATHY (Swelling under her arm/ swollen lymph node) outcome was unknown.            Concomitant medications were not reported.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received 03-Jun-21: Significant information received included adverse events (pain and skin laxity), second dose details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: aches and pain; skin is sagging on her arm; Soreness at injection site; Redness at injection site; Swelling at injection site; Swelling under her arm/ swollen lymph node; Rash at injection site; Warmness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness at the site of injection), PAIN (aches and pain), SKIN LAXITY (skin is sagging on her arm), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the site of injection), VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE LYMPHADENOPATHY (Swelling under her arm/ swollen lymph node) and VACCINATION SITE RASH (Rash at injection site). On an unknown date, the patient experienced PAIN (aches and pain). an unknown date, the patient experienced SKIN LAXITY (skin is sagging on her arm). The patient was treated with IBUPROFEN for Adverse event, at a dose of 600 and 400mg. At the time of the report, VACCINATION SITE WARMTH (Warmness at the site of injection), VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE RASH (Rash at injection site) was resolving and PAIN (aches and pain), SKIN LAXITY (skin is sagging on her arm) and VACCINATION SITE LYMPHADENOPATHY (Swelling under her arm/ swollen lymph node) outcome was unknown.            Concomitant medications were not reported.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received 03-Jun-21: Significant information received included adverse events (pain and skin laxity), second dose details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine headache; A spontaneous report was received from a consumer concerning a 29-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced migraine headache.  The patient's medical history included migraine since she was a teenager. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) for prophylaxis of COVID-19 infection.  On 28 Jan 20213-4 hours after the shot, the patient experienced headaches. It was worse the second day despite taking paracetamol and ibuprofen. She was eventually sent home from work because she couldn't function. The patient sought for medical intervention from her neurologist. Doctor prescribed her a migraine headache medicine but her prescription medication was not helping her headaches.  Treatment details included paracetamol and ibuprofen initially and then later her doctor prescribed her a migraine headache medicine.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event migraine headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of migraine, a causal relationship cannot be excluded.  However, patient's medical history of migraine is considered a significant confounder.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site reaction, Injection site swelling, Pain in extremity
Clinical narrative: Arm hurt; Red; delayed reaction; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), ERYTHEMA (Red), INJECTION SITE REACTION (delayed reaction) and INJECTION SITE SWELLING (swollen at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ERYTHEMA (Red), INJECTION SITE REACTION (delayed reaction) and INJECTION SITE SWELLING (swollen at injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), ERYTHEMA (Red), INJECTION SITE REACTION (delayed reaction) and INJECTION SITE SWELLING (swollen at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired for a couple of days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TESTOSTERONE for an unknown indication.    On 05-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 FATIGUE (Tired for a couple of days). At the time of the report, FATIGUE (Tired for a couple of days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in jaw, Vaccination site pain
Clinical narrative: Jawhas pain on the right side; Has a headache; Arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Jawhas pain on the right side), HEADACHE (Has a headache) and VACCINATION SITE PAIN (Arm is still sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (Jawhas pain on the right side), HEADACHE (Has a headache) and VACCINATION SITE PAIN (Arm is still sore). At the time of the report, PAIN IN JAW (Jawhas pain on the right side), HEADACHE (Has a headache) and VACCINATION SITE PAIN (Arm is still sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Headache, Nausea, Pain
Clinical narrative: Bone pain; Sore; Dizziness; Nausea; Developed bad headache; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headache, sore, nausea, dizziness and bone pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, Tuesday, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced the headache, sore, nausea, dizziness and bone pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, headache, sore, nausea, dizziness and bone pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.