chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oral herpes, Somnolence, Vaccination site pain
Clinical narrative: cold sore (small and then big as a nickel); Drowsy; Feel tired; Arm was sore at the injection site; This spontaneous case was reported by a physician and describes the occurrence of ORAL HERPES (cold sore (small and then big as a nickel)), SOMNOLENCE (Drowsy), VACCINATION SITE PAIN (Arm was sore at the injection site) and FATIGUE (Feel tired) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore at the injection site). On 28-Apr-2021, the patient experienced ORAL HERPES (cold sore (small and then big as a nickel)), SOMNOLENCE (Drowsy) and FATIGUE (Feel tired). At the time of the report, ORAL HERPES (cold sore (small and then big as a nickel)), SOMNOLENCE (Drowsy), VACCINATION SITE PAIN (Arm was sore at the injection site) and FATIGUE (Feel tired) outcome was unknown.        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.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Sex: F
Vaccine: COVID19
Symptoms: Hyperglycaemia
Clinical narrative: Spiking blood sugar levels; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Spiking blood sugar levels) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERGLYCAEMIA (Spiking blood sugar levels). At the time of the report, HYPERGLYCAEMIA (Spiking blood sugar levels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-095403, US-MODERNATX, INC.-MOD-2021-095337 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095403: US-MODERNATX, INC.-MOD-2021-095337:
Sex: F
Vaccine: COVID19
Symptoms: Gingival bleeding
Clinical narrative: experiencing bleeding from gums; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL BLEEDING (experiencing bleeding from gums) 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.  Concomitant products included APIXABAN (ELIQUIS) and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 08-Mar-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 GINGIVAL BLEEDING (experiencing bleeding from gums). At the time of the report, GINGIVAL BLEEDING (experiencing bleeding from gums) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye swelling, Headache, Pharyngeal swelling, Swelling face
Clinical narrative: Swelling throat; Tightening of throat; Shortness of breath, difficulty breathing; Swelling of eyes; Swelling face, cheeks; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (Swelling throat), THROAT TIGHTNESS (Tightening of throat), DYSPNOEA (Shortness of breath, difficulty breathing), EYE SWELLING (Swelling of eyes) and SWELLING FACE (Swelling face, cheeks) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (esophageal), Constipation and Stress. Concurrent medical conditions included Food allergy (Allergy to string beans), Dust allergy and Penicillin allergy. Concomitant products included FAMOTIDINE for Acid reflux (esophageal), LINACLOTIDE (LINZESS) for Constipation, POTASSIUM CITRATE and CHLORTHALIDONE for Kidney stone prevention, BUPROPION and DULOXETINE for Stress, VITAMIN D3, FISH OIL, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) and MAGNESIUM for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Swelling throat), THROAT TIGHTNESS (Tightening of throat), DYSPNOEA (Shortness of breath, difficulty breathing), EYE SWELLING (Swelling of eyes), SWELLING FACE (Swelling face, cheeks) and HEADACHE (Headache). On 03-Mar-2021, PHARYNGEAL SWELLING (Swelling throat), THROAT TIGHTNESS (Tightening of throat), DYSPNOEA (Shortness of breath, difficulty breathing), EYE SWELLING (Swelling of eyes), SWELLING FACE (Swelling face, cheeks) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer reported cellulitis began in late Mar-2021. Treatment for cellulitis included oral and intravenous antibiotics.  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.   This case was linked to MOD-2021-060919 (Patient Link).; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Swelling throat; Tightening of throat; Shortness of breath, difficulty breathing; Swelling of eyes; Swelling face, cheeks; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (Swelling throat), THROAT TIGHTNESS (Tightening of throat), DYSPNOEA (Shortness of breath, difficulty breathing), EYE SWELLING (Swelling of eyes) and SWELLING FACE (Swelling face, cheeks) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (esophageal), Constipation and Stress. Concurrent medical conditions included Food allergy (Allergy to string beans), Dust allergy and Penicillin allergy. Concomitant products included FAMOTIDINE for Acid reflux (esophageal), LINACLOTIDE (LINZESS) for Constipation, POTASSIUM CITRATE and CHLORTHALIDONE for Kidney stone prevention, BUPROPION and DULOXETINE for Stress, VITAMIN D3, FISH OIL, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) and MAGNESIUM for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Swelling throat), THROAT TIGHTNESS (Tightening of throat), DYSPNOEA (Shortness of breath, difficulty breathing), EYE SWELLING (Swelling of eyes), SWELLING FACE (Swelling face, cheeks) and HEADACHE (Headache). On 03-Mar-2021, PHARYNGEAL SWELLING (Swelling throat), THROAT TIGHTNESS (Tightening of throat), DYSPNOEA (Shortness of breath, difficulty breathing), EYE SWELLING (Swelling of eyes), SWELLING FACE (Swelling face, cheeks) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer reported cellulitis began in late Mar-2021. Treatment for cellulitis included oral and intravenous antibiotics.  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.   This case was linked to MOD-2021-060919 (Patient Link).; 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No medical history was provided.     On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 26-Nov-2020 and the estimated date of delivery was 02-Sep-2021. On 28-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 28-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      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.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Runny nose; Sore throat; Loss of smell; Concerned she might have covid; This spontaneous case was reported by a health care professional and describes the occurrence of RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), ANOSMIA (Loss of smell) and COVID-19 (Concerned she might have covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), ANOSMIA (Loss of smell) and COVID-19 (Concerned she might have covid). At the time of the report, RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), ANOSMIA (Loss of smell) and COVID-19 (Concerned she might have covid) outcome was unknown.        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 Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy, Fatigue, Headache, Insomnia, Menstrual disorder
Clinical narrative: disruption in my monthly cycle with moderate complications; clotting; migraines; insomnia; tinnitus; fatigue; Irregular Menstration; had a very sore arm; Arm was stiff; Moderna Knot which was large; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm was stiff), VACCINATION SITE MASS (Moderna Knot which was large), MENSTRUAL DISORDER (disruption in my monthly cycle with moderate complications), COAGULOPATHY (clotting) and MIGRAINE (migraines) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (latex powder). Concomitant products included MYDAYIS from 02-Mar-2020 to an unknown date for ADD and Obsessive-compulsive disorder.    On 03-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm was stiff), VACCINATION SITE MASS (Moderna Knot which was large) and HEADACHE (Headache). On 09-Mar-2021 at 11:30 AM, the patient experienced MYALGIA (had a very sore arm). On 11-Mar-2021, the patient experienced MENSTRUATION IRREGULAR (Irregular Menstration). On an unknown date, the patient experienced MENSTRUAL DISORDER (disruption in my monthly cycle with moderate complications), COAGULOPATHY (clotting), MIGRAINE (migraines), INSOMNIA (insomnia), TINNITUS (tinnitus) and FATIGUE (fatigue). On 06-Mar-2021, MUSCULOSKELETAL STIFFNESS (Arm was stiff) had resolved. At the time of the report, VACCINATION SITE MASS (Moderna Knot which was large), MENSTRUAL DISORDER (disruption in my monthly cycle with moderate complications), COAGULOPATHY (clotting), MIGRAINE (migraines), INSOMNIA (insomnia), TINNITUS (tinnitus), HEADACHE (Headache), MYALGIA (had a very sore arm) and FATIGUE (fatigue) outcome was unknown and MENSTRUATION IRREGULAR (Irregular Menstration) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported. Treatment information was not provided.   This case was linked to MOD-2021-095551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information form received on 01-JUN-2021. Updated initials, race, ethnicity, height, weight. Added vaccination time, concomitant medication. Added event myalgia, menstrual disorder, coagulopathy, migraine, fatigue, insomnia, tinnitus, Irregular Menstruation.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Migraine, Musculoskeletal stiffness, Myalgia, Tinnitus
Clinical narrative: disruption in my monthly cycle with moderate complications; clotting; migraines; insomnia; tinnitus; fatigue; Irregular Menstration; had a very sore arm; Arm was stiff; Moderna Knot which was large; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm was stiff), VACCINATION SITE MASS (Moderna Knot which was large), MENSTRUAL DISORDER (disruption in my monthly cycle with moderate complications), COAGULOPATHY (clotting) and MIGRAINE (migraines) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (latex powder). Concomitant products included MYDAYIS from 02-Mar-2020 to an unknown date for ADD and Obsessive-compulsive disorder.    On 03-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm was stiff), VACCINATION SITE MASS (Moderna Knot which was large) and HEADACHE (Headache). On 09-Mar-2021 at 11:30 AM, the patient experienced MYALGIA (had a very sore arm). On 11-Mar-2021, the patient experienced MENSTRUATION IRREGULAR (Irregular Menstration). On an unknown date, the patient experienced MENSTRUAL DISORDER (disruption in my monthly cycle with moderate complications), COAGULOPATHY (clotting), MIGRAINE (migraines), INSOMNIA (insomnia), TINNITUS (tinnitus) and FATIGUE (fatigue). On 06-Mar-2021, MUSCULOSKELETAL STIFFNESS (Arm was stiff) had resolved. At the time of the report, VACCINATION SITE MASS (Moderna Knot which was large), MENSTRUAL DISORDER (disruption in my monthly cycle with moderate complications), COAGULOPATHY (clotting), MIGRAINE (migraines), INSOMNIA (insomnia), TINNITUS (tinnitus), HEADACHE (Headache), MYALGIA (had a very sore arm) and FATIGUE (fatigue) outcome was unknown and MENSTRUATION IRREGULAR (Irregular Menstration) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported. Treatment information was not provided.   This case was linked to MOD-2021-095551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information form received on 01-JUN-2021. Updated initials, race, ethnicity, height, weight. Added vaccination time, concomitant medication. Added event myalgia, menstrual disorder, coagulopathy, migraine, fatigue, insomnia, tinnitus, Irregular Menstruation.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: disruption in my monthly cycle with moderate complications; clotting; migraines; insomnia; tinnitus; fatigue; Irregular Menstration; had a very sore arm; Arm was stiff; Moderna Knot which was large; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm was stiff), VACCINATION SITE MASS (Moderna Knot which was large), MENSTRUAL DISORDER (disruption in my monthly cycle with moderate complications), COAGULOPATHY (clotting) and MIGRAINE (migraines) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy (latex powder). Concomitant products included MYDAYIS from 02-Mar-2020 to an unknown date for ADD and Obsessive-compulsive disorder.    On 03-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm was stiff), VACCINATION SITE MASS (Moderna Knot which was large) and HEADACHE (Headache). On 09-Mar-2021 at 11:30 AM, the patient experienced MYALGIA (had a very sore arm). On 11-Mar-2021, the patient experienced MENSTRUATION IRREGULAR (Irregular Menstration). On an unknown date, the patient experienced MENSTRUAL DISORDER (disruption in my monthly cycle with moderate complications), COAGULOPATHY (clotting), MIGRAINE (migraines), INSOMNIA (insomnia), TINNITUS (tinnitus) and FATIGUE (fatigue). On 06-Mar-2021, MUSCULOSKELETAL STIFFNESS (Arm was stiff) had resolved. At the time of the report, VACCINATION SITE MASS (Moderna Knot which was large), MENSTRUAL DISORDER (disruption in my monthly cycle with moderate complications), COAGULOPATHY (clotting), MIGRAINE (migraines), INSOMNIA (insomnia), TINNITUS (tinnitus), HEADACHE (Headache), MYALGIA (had a very sore arm) and FATIGUE (fatigue) outcome was unknown and MENSTRUATION IRREGULAR (Irregular Menstration) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported. Treatment information was not provided.   This case was linked to MOD-2021-095551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information form received on 01-JUN-2021. Updated initials, race, ethnicity, height, weight. Added vaccination time, concomitant medication. Added event myalgia, menstrual disorder, coagulopathy, migraine, fatigue, insomnia, tinnitus, Irregular Menstruation.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Paraesthesia
Clinical narrative: Legs tingling; back of legs all red; muscles aching going into her feet; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Legs tingling), ERYTHEMA (back of legs all red), and MYALGIA (muscles aching going into her feet) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALLEVESS for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PARAESTHESIA (Legs tingling), ERYTHEMA (back of legs all red), and MYALGIA (muscles aching going into her feet). At the time of the report, PARAESTHESIA (Legs tingling) outcome was unknown and ERYTHEMA (back of legs all red), and MYALGIA (muscles aching going into her feet) 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.   Concomitant medicine include Alleve  Treatment drugs were not included  Action taken with mRNA-1273 in response to the event was unknown       Reporter did not allow further contact.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass, Swelling, Vaccination site pain
Clinical narrative: Hardness in the neck area; swelling in the shoulder; General soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (Hardness in the neck area), SWELLING (swelling in the shoulder) and VACCINATION SITE PAIN (General soreness at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced NECK MASS (Hardness in the neck area), SWELLING (swelling in the shoulder) and VACCINATION SITE PAIN (General soreness at the injection site). At the time of the report, NECK MASS (Hardness in the neck area), SWELLING (swelling in the shoulder) and VACCINATION SITE PAIN (General soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose of vaccine administered more than 12 hours after vial was 1st punctured; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose of vaccine administered more than 12 hours after vial was 1st punctured) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose of vaccine administered more than 12 hours after vial was 1st punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose of vaccine administered more than 12 hours after vial was 1st punctured) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant and  treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received and does not contains any significant information.
Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Flu like symptoms; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Pressure in chest after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Pressure in chest after 1st dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN.    On 28-Apr-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 CHEST DISCOMFORT (Pressure in chest after 1st dose). At the time of the report, CHEST DISCOMFORT (Pressure in chest after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash
Clinical narrative: Rash on legs and arms; This spontaneous case was reported by a physician and describes the occurrence of RASH (Rash on legs and arms) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    The patient's past medical history included No adverse event. Patient's concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. No treatment information was provided.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form; likewise, on an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and patient also received ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose.   On an unknown date, the patient experienced RASH (Rash on legs and arms).   At the time of the report, RASH (Rash on legs and arms) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) administered intramuscularly in response to events was unknown.  For mRNA-1273 (COVID 19 Vaccine Moderna) administered intramuscularly, the reporter did not provide any causality assessments.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Skin discolouration, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: slightly raise; discoloration; looks like muscle tissue; pain at the site; red; itches; slightly swollen; 3.5 inches wide and 7 inches long; This spontaneous case was reported by a consumer and describes the occurrence of MASS (slightly raise), SKIN DISCOLORATION (discoloration), MASS (looks like muscle tissue), VACCINATION SITE PAIN (pain at the site) and VACCINATION SITE ERYTHEMA (red) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 18-Apr-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 MASS (slightly raise), SKIN DISCOLORATION (discoloration), MASS (looks like muscle tissue), VACCINATION SITE PAIN (pain at the site), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itches), VACCINATION SITE SWELLING (slightly swollen) and VACCINATION SITE RASH (3.5 inches wide and 7 inches long). At the time of the report, MASS (slightly raise), SKIN DISCOLORATION (discoloration), MASS (looks like muscle tissue), VACCINATION SITE PAIN (pain at the site), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itches), VACCINATION SITE SWELLING (slightly swollen) and VACCINATION SITE RASH (3.5 inches wide and 7 inches long) 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 medications were not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: slightly raise; discoloration; looks like muscle tissue; pain at the site; red; itches; slightly swollen; 3.5 inches wide and 7 inches long; This spontaneous case was reported by a consumer and describes the occurrence of MASS (slightly raise), SKIN DISCOLORATION (discoloration), MASS (looks like muscle tissue), VACCINATION SITE PAIN (pain at the site) and VACCINATION SITE ERYTHEMA (red) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 18-Apr-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 MASS (slightly raise), SKIN DISCOLORATION (discoloration), MASS (looks like muscle tissue), VACCINATION SITE PAIN (pain at the site), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itches), VACCINATION SITE SWELLING (slightly swollen) and VACCINATION SITE RASH (3.5 inches wide and 7 inches long). At the time of the report, MASS (slightly raise), SKIN DISCOLORATION (discoloration), MASS (looks like muscle tissue), VACCINATION SITE PAIN (pain at the site), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itches), VACCINATION SITE SWELLING (slightly swollen) and VACCINATION SITE RASH (3.5 inches wide and 7 inches long) 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 medications were not provided.
Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Chills, Headache, Inappropriate schedule of product administration, Neuropathy peripheral
Clinical narrative: Neuropathy in both legs; Premature start of scheduled drug administration; Body aches/Aching; Chills; Fever; Headache; This spontaneous case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy in both legs), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Premature start of scheduled drug administration), PAIN (Body aches/Aching), CHILLS (Chills) and PYREXIA (Fever) in a 75-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy in both legs), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Premature start of scheduled drug administration), PAIN (Body aches/Aching), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy in both legs) had not resolved, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Premature start of scheduled drug administration) had resolved and PAIN (Body aches/Aching), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: fever (High) Fever. In 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN (Body aches/Aching), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) to be probably related. No further causality assessments were provided for NEUROPATHY PERIPHERAL (Neuropathy in both legs) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Premature start of scheduled drug administration).    Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was no change.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for fever, chills, pain and headache. The events of Peripheral neuropathy is assessed by an HCP as reasonably related to Humira.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for fever, chills, pain and headache. The events of Peripheral neuropathy is assessed by an HCP as reasonably related to Humira.
Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Neuropathy in both legs; Premature start of scheduled drug administration; Body aches/Aching; Chills; Fever; Headache; This spontaneous case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy in both legs), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Premature start of scheduled drug administration), PAIN (Body aches/Aching), CHILLS (Chills) and PYREXIA (Fever) in a 75-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy in both legs), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Premature start of scheduled drug administration), PAIN (Body aches/Aching), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy in both legs) had not resolved, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Premature start of scheduled drug administration) had resolved and PAIN (Body aches/Aching), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: fever (High) Fever. In 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN (Body aches/Aching), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) to be probably related. No further causality assessments were provided for NEUROPATHY PERIPHERAL (Neuropathy in both legs) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Premature start of scheduled drug administration).    Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was no change.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for fever, chills, pain and headache. The events of Peripheral neuropathy is assessed by an HCP as reasonably related to Humira.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for fever, chills, pain and headache. The events of Peripheral neuropathy is assessed by an HCP as reasonably related to Humira.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo) and DIZZINESS (Dizziness). At the time of the report, VERTIGO (Vertigo) and DIZZINESS (Dizziness) had not resolved.            Concomitant medications were not provided. Treatment information include the patient has visited her doctor and has been receiving physical therapy for the side effects.   This case was linked to US-MODERNATX, INC.-MOD-2021-029178 (E2B Linked Report).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Low-grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low-grade fever) and CHILLS (chills) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PYREXIA (Low-grade fever) and CHILLS (chills). At the time of the report, PYREXIA (Low-grade fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received Moderna vaccine from vials that had passed 30 days of thawed state in the; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Moderna vaccine from vials that had passed 30 days of thawed state in the) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received Moderna vaccine from vials that had passed 30 days of thawed state in the). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received Moderna vaccine from vials that had passed 30 days of thawed state in the) outcome was unknown. 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.   Concomitant product use was unknown by the reporter. Treatment information was not provided. 10 vials were administered to 100 patient at their pharmacy on 22Apr2021, 23Apr2021 and 27Apr2021.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: had a high fever 103 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (had a high fever 103 degrees F) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (had a high fever 103 degrees F). At the time of the report, PYREXIA (had a high fever 103 degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.         Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-023079 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Insomnia, Myalgia, Pyrexia
Clinical narrative: had trouble sleeping at night due to chills-up and down the bed; still a little bit weak; soreness on the arm; fever about a 100; chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (had trouble sleeping at night due to chills-up and down the bed), ASTHENIA (still a little bit weak), MYALGIA (soreness on the arm), PYREXIA (fever about a 100) and CHILLS (chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure, SIMVASTATIN for Cholesterol.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced INSOMNIA (had trouble sleeping at night due to chills-up and down the bed), ASTHENIA (still a little bit weak), MYALGIA (soreness on the arm), PYREXIA (fever about a 100) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of for first 12 hours. On 25-Apr-2021, INSOMNIA (had trouble sleeping at night due to chills-up and down the bed), MYALGIA (soreness on the arm), PYREXIA (fever about a 100) and CHILLS (chills) had resolved. At the time of the report, ASTHENIA (still a little bit weak) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Tylenol is used as treatment medication.  Patient has schedules second dose on 26-MAY-2021   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: The follow up received on 28-APR-2021.It does not contain any new information.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site urticaria
Clinical narrative: Hives at injection site; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE URTICARIA (Hives at injection site) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE URTICARIA (Hives at injection site) and HEADACHE (Headache). At the time of the report, INJECTION SITE URTICARIA (Hives at injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No concomitant medication or treatment for the events was reported.   This case was linked to MOD-2021-027687 (E2B Linked Report).; Sender's Comments:  MOD-2021-027687:Same Reporter
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: soreness in the arm where it was injected; last a couple of days; mild headache; lasted about 8 hours or so; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm where it was injected; last a couple of days) and HEADACHE (mild headache; lasted about 8 hours or so) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SALBUTAMOL (VENTOLIN ES) for COPD, COLECALCIFEROL (VITAMIIN D PAIKESE) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm where it was injected; last a couple of days) and HEADACHE (mild headache; lasted about 8 hours or so). On 30-Mar-2021, HEADACHE (mild headache; lasted about 8 hours or so) had resolved. On 31-Mar-2021, PAIN IN EXTREMITY (soreness in the arm where it was injected; last a couple of days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient took Tylenol to relieve the symptoms.   This case was linked to MOD-2021-096269 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Severe Allergic reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.     This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Severe Allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced HYPERSENSITIVITY (Severe Allergic reaction). At the time of the report, HYPERSENSITIVITY (Severe Allergic reaction) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.