chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: SEVERE BODY ACHES; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and severe body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: POTENTIALLY ADMINISTRATION OF AN EXPIRED DOSE; DOSE ADMINISTERED ABOUT 15-30 MINUTES AFTER THE RECOMMENDED STORAGE PERIOD FOR PUNCTURED VIAL; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808980, and expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 16:30 for prophylactic vaccination. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced potentially administration of an expired dose. On 18-AUG-2021, the patient experienced dose administered about 15-30 minutes after the recommended storage period for punctured vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potentially administration of an expired dose and dose administered about 15-30 minutes after the recommended storage period for punctured vial was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Chest pain, Dizziness, Pain assessment
Clinical narrative: This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included: donated whole blood, and other pre-existing medical conditions included: Patient was not pregnant at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820075, and expiry: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced burning feeling in chest. On AUG-2021, the patient experienced tight feeling in chest. On AUG-2021, the patient experienced fullness feeling in both calves, more in left leg. On AUG-2021, the patient experienced light headedness, dizziness, woozy feeling. On AUG-2021, the patient experienced anxiety. Laboratory data included: Pain scale (NR: not provided) burning in chest is a 2 out of 10 on a pain scale of 0-10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light headedness, dizziness, woozy feeling, burning feeling in chest, fullness feeling in both calves, more in left leg, anxiety, and tight feeling in chest. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included: donated whole blood, and other pre-existing medical conditions included: Patient was not pregnant at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820075, and expiry: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced burning feeling in chest. On AUG-2021, the patient experienced tight feeling in chest. On AUG-2021, the patient experienced fullness feeling in both calves, more in left leg. On AUG-2021, the patient experienced light headedness, dizziness, woozy feeling. On AUG-2021, the patient experienced anxiety. Laboratory data included: Pain scale (NR: not provided) burning in chest is a 2 out of 10 on a pain scale of 0-10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light headedness, dizziness, woozy feeling, burning feeling in chest, fullness feeling in both calves, more in left leg, anxiety, and tight feeling in chest. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Musculoskeletal discomfort, Pain
Clinical narrative: ACHE AND SORENESS; JOINT DISCOMFORT; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and concurrent conditions included: non- smoker, and alcohol abstain from alcohol, and other pre-existing medical conditions included: Patient had no known drug allergies. Patient do not had illness at time of vaccination. Patient do not had illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-AUG-2021 16:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-AUG-2021, the patient experienced ache and soreness. On 19-AUG-2021, the patient experienced joint discomfort. On 19-AUG-2021, the patient experienced chills. On 19-AUG-2021, the patient experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 19-AUG-2021, was recovering from ache and soreness, and had not recovered from joint discomfort. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Cold sweat, Disorientation, Hot flush
Clinical narrative: HOT FLASHES; SHOOTING PAIN IN DIFFERENT AREAS; BLURRY VISION AND CANNOT READ AT CERTAIN DISTANCE; BLOOD VESSELS BENEATH  BOTH KNEES AND FEET (LEFT LEG APPEARS WORSE THAN RIGHT LEG); PURPLE-LIKE VEINS; TINGLING IN BOTH THE LEGS/ TINGLING IN HANDS; ITCHING OF RIGHT AND LEFT LEGS; COLD SWEATS; DISORIENTED; BURNING OF RIGHT AND LEFT LEGS/ BURNING SENSATION IN BOTH ARMS; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's past medical history included: tick bite, and concurrent conditions included: cigarette smoker, alcohol user, alpha-gal allergy, and sulfa allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy. On 06-AUG-2021, the patient experienced burning of right and left legs/ burning sensation in both arms. On 06-AUG-2021, the patient experienced disoriented. On 06-AUG-2021, the patient experienced itching of right and left legs. On 06-AUG-2021, the patient experienced cold sweats. Treatment medications included: diphenhydramine hydrochloride. On 16-AUG-2021, the patient experienced blood vessels beneath both knees and feet (left leg appears worse than right leg). On 16-AUG-2021, the patient experienced purple-like veins. On 16-AUG-2021, the patient experienced tingling in both the legs/ tingling in hands. Laboratory data included: Blood test (NR: not provided) not reported, and Ultrasound scan (NR: not provided) no clots in legs. On 17-AUG-2021, the patient experienced blurry vision and cannot read at certain distance. On 18-AUG-2021, the patient experienced hot flashes. On 18-AUG-2021, the patient experienced shooting pain in different areas. Laboratory data included: Pain scale (NR: not provided) 7 out of 10. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from disoriented, and cold sweats on 06-AUG-2021, had not recovered from burning of right and left legs/ burning sensation in both arms, blood vessels beneath both knees and feet (left leg appears worse than right leg), blurry vision and cannot read at certain distance, hot flashes, itching of right and left legs, and tingling in both the legs/ tingling in hands, and the outcome of shooting pain in different areas and purple-like veins was not reported. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain assessment, Paraesthesia, Pruritus, Ultrasound scan
Clinical narrative: HOT FLASHES; SHOOTING PAIN IN DIFFERENT AREAS; BLURRY VISION AND CANNOT READ AT CERTAIN DISTANCE; BLOOD VESSELS BENEATH  BOTH KNEES AND FEET (LEFT LEG APPEARS WORSE THAN RIGHT LEG); PURPLE-LIKE VEINS; TINGLING IN BOTH THE LEGS/ TINGLING IN HANDS; ITCHING OF RIGHT AND LEFT LEGS; COLD SWEATS; DISORIENTED; BURNING OF RIGHT AND LEFT LEGS/ BURNING SENSATION IN BOTH ARMS; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's past medical history included: tick bite, and concurrent conditions included: cigarette smoker, alcohol user, alpha-gal allergy, and sulfa allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy. On 06-AUG-2021, the patient experienced burning of right and left legs/ burning sensation in both arms. On 06-AUG-2021, the patient experienced disoriented. On 06-AUG-2021, the patient experienced itching of right and left legs. On 06-AUG-2021, the patient experienced cold sweats. Treatment medications included: diphenhydramine hydrochloride. On 16-AUG-2021, the patient experienced blood vessels beneath both knees and feet (left leg appears worse than right leg). On 16-AUG-2021, the patient experienced purple-like veins. On 16-AUG-2021, the patient experienced tingling in both the legs/ tingling in hands. Laboratory data included: Blood test (NR: not provided) not reported, and Ultrasound scan (NR: not provided) no clots in legs. On 17-AUG-2021, the patient experienced blurry vision and cannot read at certain distance. On 18-AUG-2021, the patient experienced hot flashes. On 18-AUG-2021, the patient experienced shooting pain in different areas. Laboratory data included: Pain scale (NR: not provided) 7 out of 10. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from disoriented, and cold sweats on 06-AUG-2021, had not recovered from burning of right and left legs/ burning sensation in both arms, blood vessels beneath both knees and feet (left leg appears worse than right leg), blurry vision and cannot read at certain distance, hot flashes, itching of right and left legs, and tingling in both the legs/ tingling in hands, and the outcome of shooting pain in different areas and purple-like veins was not reported. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Varicose vein, Vein discolouration, Vision blurred
Clinical narrative: HOT FLASHES; SHOOTING PAIN IN DIFFERENT AREAS; BLURRY VISION AND CANNOT READ AT CERTAIN DISTANCE; BLOOD VESSELS BENEATH  BOTH KNEES AND FEET (LEFT LEG APPEARS WORSE THAN RIGHT LEG); PURPLE-LIKE VEINS; TINGLING IN BOTH THE LEGS/ TINGLING IN HANDS; ITCHING OF RIGHT AND LEFT LEGS; COLD SWEATS; DISORIENTED; BURNING OF RIGHT AND LEFT LEGS/ BURNING SENSATION IN BOTH ARMS; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's past medical history included: tick bite, and concurrent conditions included: cigarette smoker, alcohol user, alpha-gal allergy, and sulfa allergy, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergy. On 06-AUG-2021, the patient experienced burning of right and left legs/ burning sensation in both arms. On 06-AUG-2021, the patient experienced disoriented. On 06-AUG-2021, the patient experienced itching of right and left legs. On 06-AUG-2021, the patient experienced cold sweats. Treatment medications included: diphenhydramine hydrochloride. On 16-AUG-2021, the patient experienced blood vessels beneath both knees and feet (left leg appears worse than right leg). On 16-AUG-2021, the patient experienced purple-like veins. On 16-AUG-2021, the patient experienced tingling in both the legs/ tingling in hands. Laboratory data included: Blood test (NR: not provided) not reported, and Ultrasound scan (NR: not provided) no clots in legs. On 17-AUG-2021, the patient experienced blurry vision and cannot read at certain distance. On 18-AUG-2021, the patient experienced hot flashes. On 18-AUG-2021, the patient experienced shooting pain in different areas. Laboratory data included: Pain scale (NR: not provided) 7 out of 10. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from disoriented, and cold sweats on 06-AUG-2021, had not recovered from burning of right and left legs/ burning sensation in both arms, blood vessels beneath both knees and feet (left leg appears worse than right leg), blurry vision and cannot read at certain distance, hot flashes, itching of right and left legs, and tingling in both the legs/ tingling in hands, and the outcome of shooting pain in different areas and purple-like veins was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness, Pain
Clinical narrative: INCREDIBLE PAIN; MUSCLE ARE WEAK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on JUN-2021 for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced incredible pain, and muscle are weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle are weak and incredible pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: POST NASAL DRIP; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced post nasal drip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from post nasal drip. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included: surgery for ovarian cancer, and concurrent conditions included: non-alcoholic, non-smoker, and ovarian cancer, and other pre-existing medical conditions included: No known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, treatment medications included: paracetamol.  On 15-MAR-2021, the patient experienced injection site soreness. The action taken with covid-19 vaccine  was not applicable. The patient recovered from injection site soreness on 17-MAR-2021. This report was non-serious.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: ARM SORENESS; HEADACHE; This spontaneous report received from a consumer concerned an 86 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 31-MAR-2021, the patient experienced arm soreness. On 31-MAR-2021, the patient experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from headache on 03-APR-2021, and was recovering from arm soreness. This report was non-serious. This case, from the same reporter is linked to 20210840400.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH WAS COVERING WHOLE FOREARM ON LEFT AND RIGHT ARMS FROM ELBOW TO WRIST; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, alcohol use, and non-smoker, and other pre-existing medical conditions included: Patient had no known allergies. Patient did not have drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included amlodipine, ezetimibe, furosemide, hydrochlorothiazide/lisinopril, metoprolol tartrate, potassium, rosuvastatin, and zolpidem.  On MAY-2021, the patient experienced rash was covering whole forearm on left and right arms from elbow to wrist. On 19-AUG-2021, treatment medications included: betamethasone dipropionate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash was covering whole forearm on left and right arms from elbow to wrist. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Feeling hot, Headache, Insomnia
Clinical narrative: HAD A ROUGH NIGHT; BURNING UP; GASTRO UPSET; CHILLS; VOMITING; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced had a rough night, burning up, gastro upset, chills, vomiting, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had a rough night, chills, burning up, nausea, vomiting, gastro upset and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: HAD A ROUGH NIGHT; BURNING UP; GASTRO UPSET; CHILLS; VOMITING; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced had a rough night, burning up, gastro upset, chills, vomiting, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had a rough night, chills, burning up, nausea, vomiting, gastro upset and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature fluctuation, Influenza like illness, Paranasal sinus hypersecretion
Clinical narrative: SEVERE STOMACH CRAMPING/SEVERE LIKE MENSTRUAL CRAMPING OR STOMACH VIRUS; HAD NO FEVER BUT WAS WARM THAN WAS COLD; CONSTANT SINUS DRAINAGE; FLU LIKE SYMPTOMS/SORE THROAT/CHILLS/TIREDNESS/MUSCLE PAIN/HEADACHE; KNEES WERE HURTING; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included: thyroid gland removed, and concurrent conditions included: immunocompromised. The patient experienced drug allergy when treated with prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced severe stomach cramping/severe like menstrual cramping or stomach virus. On MAR-2021, the patient experienced had no fever but was warm than was cold. On MAR-2021, the patient experienced constant sinus drainage. On MAR-2021, the patient experienced flu like symptoms/sore throat/chills/tiredness/muscle pain/headache. On MAR-2021, the patient experienced knees were hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach cramping/severe like menstrual cramping or stomach virus, had no fever but was warm than was cold, constant sinus drainage, flu like symptoms/sore throat/chills/tiredness/muscle pain/headache, and knees were hurting. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Vaccination site pain
Clinical narrative: chills; Body aches - mainly on left side - arm and leg - muscle and joint; Body aches - mainly on left side - arm and leg - muscle and joint; Arm sore at injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MYALGIA (Body aches - mainly on left side - arm and leg - muscle and joint), ARTHRALGIA (Body aches - mainly on left side - arm and leg - muscle and joint), VACCINATION SITE PAIN (Arm sore at injection site) and CHILLS (chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020 at 12:27 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2020 at 5:30 PM, the patient experienced MYALGIA (Body aches - mainly on left side - arm and leg - muscle and joint), ARTHRALGIA (Body aches - mainly on left side - arm and leg - muscle and joint) and VACCINATION SITE PAIN (Arm sore at injection site). On 20-Jan-2021, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Jan-2021, CHILLS (chills) had resolved. At the time of the report, MYALGIA (Body aches - mainly on left side - arm and leg - muscle and joint), ARTHRALGIA (Body aches - mainly on left side - arm and leg - muscle and joint) and VACCINATION SITE PAIN (Arm sore at injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-061872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: No specific follow-up information recorded. On 31-Mar-2021: No new information On 12-May-2021: NNI
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and PAIN (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced PYREXIA (Fever), CHILLS (Chills) and PAIN (Body aches). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and PAIN (Body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment for reported events included acetaminophen (Tylenol) and Ibuprofen.        Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: No new information was provided.; Reporter's Comments: This case concerns a male subject of unknown age, who experienced a non-serious expected events of fever and chills and non-serious unexpected event of body pain. All events occurred one day after after first dose of mRNA-1273 vaccine. Treatment for reported events included Tylenol and Ibuprofen, however outcome was reported as unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Constant diarrhea; A spontaneous report was received from a healthcare professional concerning a 33 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced constant diarrhea.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Dec 2020 the patient had constant diarrhea. It is unknown if patient has had any reaction to vaccines in the past.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, constant diarrhea, was not reported.; Reporter's Comments: This case concerns a 33 year-old, female patient, who experienced events of constant diarrhea. The event occurred the next day after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding
Clinical narrative: Lactating women; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Lactating women) 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 Pregnancy (patient currently lactating).    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Lactating women). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Lactating women) 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: NNI
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Myalgia, Pyrexia, Vaccination site swelling
Clinical narrative: Arm  is swollen; Fever; Fatigue; Body ache; Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy), PERIPHERAL SWELLING (Arm  is swollen), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body ache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Apr-2020 and the estimated date of delivery was 13-Jan-2021. On 27-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). On 28-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (Arm  is swollen), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body ache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-seventh week of the pregnancy.  On 27-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm  is swollen), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Body ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment for the event included acetaminophen (Tylenol) 500 mg once.; Sender's Comments: This is a case of vaccine exposure during pregnancy and AEs of vaccination site swelling, pyrexia, fatigue, and myalgia for this 34-year-old female. Patient will continue to be contacted for further monitoring of the adverse events during pregnancy. 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: Chills, Hyperhidrosis, Myalgia, Pain, Pain in extremity
Clinical narrative: Fever; Body ache; Muscle ache; Sweating; Chills; Arm hurt; Felt sluggish; A spontaneous report was received from a consumer concerning a 49 year-old male patient who experienced arm hurt, felt sluggish, fever, body ache, muscle ache, sweating, and chills.  The patient's medical history was reported as COVID in March 2020 and concomitant product use was not provided by the reporter.  On 28-Dec-2020, about four hours prior to onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 28-Dec-2020 the patient developed arm pain and felt sluggish.  On an unknown date the patient developed a fever, body ache, muscle ache, sweating and chills.  The events were treated with Tylenol.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events were unknown/not reported.   The reporter did not provide causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness
Clinical narrative: Fever; Body ache; Muscle ache; Sweating; Chills; Arm hurt; Felt sluggish; A spontaneous report was received from a consumer concerning a 49 year-old male patient who experienced arm hurt, felt sluggish, fever, body ache, muscle ache, sweating, and chills.  The patient's medical history was reported as COVID in March 2020 and concomitant product use was not provided by the reporter.  On 28-Dec-2020, about four hours prior to onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 28-Dec-2020 the patient developed arm pain and felt sluggish.  On an unknown date the patient developed a fever, body ache, muscle ache, sweating and chills.  The events were treated with Tylenol.    Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events were unknown/not reported.   The reporter did not provide causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, SARS-CoV-2 test
Clinical narrative: Got vaccinated and tested positive for Covid next day; Loss of taste; A spontaneous report was received from a male patient of unknown age who received the mRNA-1273 vaccine and tested positive for Covid the next day.     There was no relevant medical history or concomitant medications provided.  On 29 Dec 2020 the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection. The patient described the event saying he felt fine on the day of vaccination.  On 30 Dec 2020, one day after receiving the mRNA-1273, the patient experienced loss of taste and  tested positive for Covid19.    There was no treatment information provided.  Relevant laboratory test on 30 Dec 2020 included a positive SARS-CoV-2 by RT-PCR nasopharyngeal swab.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event "Covid-19 positive" was not recovered/not resolved, and loss of taste was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Developed a cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Developed a cough) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced COUGH (Developed a cough). At the time of the report, COUGH (Developed a cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was prescribed steroids for his cough. Patient enquired if he can take steroids as treatment for cough post Moderna vaccine shot. Concomitant medications were not provided.  Patient responded follow-up denying the relation between the event cough and Moderna vaccine. He also denied to fill the adverse report form due to his age.   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Bad rash; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Modern'a Covid-19 vaccine (mRNA-1273) and developed a bad rash.  The patient's medical history was not provided. No concomitant medications were provided.   On an unspecified date, prior to onset of the event bad rash, the patient received their dose of mRNA-1273 (Lot/batch number: unknown) for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced a bad rash. Not treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event bad rash was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Chills; Bright red rash; Entire area is swollen and is about the size of a hamburger; Injection site itching; Injection is a little sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), INJECTION SITE PAIN (Injection is a little sore), INJECTION SITE RASH (Bright red rash), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE SWELLING (Entire area is swollen and is about the size of a hamburger) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced INJECTION SITE PAIN (Injection is a little sore) and INJECTION SITE PRURITUS (Injection site itching). On 30-Dec-2020, the patient experienced CHILLS (Chills), INJECTION SITE RASH (Bright red rash) and INJECTION SITE SWELLING (Entire area is swollen and is about the size of a hamburger). At the time of the report, CHILLS (Chills), INJECTION SITE PAIN (Injection is a little sore), INJECTION SITE RASH (Bright red rash), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE SWELLING (Entire area is swollen and is about the size of a hamburger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Arm pain; Fatigue; A spontaneous report was received from a consumer concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccination (mRNA-1273) and experienced arm pain and fatigue after vaccination.  The patient's medical history included heart arrhythmia PVC and he took a beer on the same of vaccination. No concomitant medications were reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced arm pain from the vaccination and fatigue. No treatment information was provided.  Action taken with mRNA-1273 vaccine was not provided.  The outcome of the events, pain in the arm and fatigue was reported as not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding, Chills, Dizziness, Nausea, Pain
Clinical narrative: Breast feeding; rash on left ankle; Nausea; Light headedness; Arm soreness; Chills; Body aches and soreness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of NAUSEA (Nausea), DIZZINESS (Light headedness), PAIN IN EXTREMITY (Arm soreness), CHILLS (Chills) and PAIN (Body aches and soreness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced NAUSEA (Nausea), DIZZINESS (Light headedness), PAIN IN EXTREMITY (Arm soreness), CHILLS (Chills) and PAIN (Body aches and soreness). On 04-Jan-2021, the patient experienced RASH (rash on left ankle). On an unknown date, the patient experienced BREAST FEEDING (Breast feeding). On 30-Dec-2020, NAUSEA (Nausea) and DIZZINESS (Light headedness) had resolved. On 31-Dec-2020, PAIN IN EXTREMITY (Arm soreness) had resolved. At the time of the report, CHILLS (Chills), PAIN (Body aches and soreness) and RASH (rash on left ankle) outcome was unknown and BREAST FEEDING (Breast feeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Action taken with mRNA-1273 in response to the event is not applicable.  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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: Additional event received; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Breast feeding; rash on left ankle; Nausea; Light headedness; Arm soreness; Chills; Body aches and soreness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of NAUSEA (Nausea), DIZZINESS (Light headedness), PAIN IN EXTREMITY (Arm soreness), CHILLS (Chills) and PAIN (Body aches and soreness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced NAUSEA (Nausea), DIZZINESS (Light headedness), PAIN IN EXTREMITY (Arm soreness), CHILLS (Chills) and PAIN (Body aches and soreness). On 04-Jan-2021, the patient experienced RASH (rash on left ankle). On an unknown date, the patient experienced BREAST FEEDING (Breast feeding). On 30-Dec-2020, NAUSEA (Nausea) and DIZZINESS (Light headedness) had resolved. On 31-Dec-2020, PAIN IN EXTREMITY (Arm soreness) had resolved. At the time of the report, CHILLS (Chills), PAIN (Body aches and soreness) and RASH (rash on left ankle) outcome was unknown and BREAST FEEDING (Breast feeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Action taken with mRNA-1273 in response to the event is not applicable.  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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: Additional event received; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Fever; Muscle pain; Joint pain; Chills; A spontaneous report was received from a 58 year old female consumer who was participating in the mRNA-1273  Program and experienced headache, chills, fever, muscle pain and joint pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Jan 2020 (pending clarification), the patient received their first of two planned doses of mRNA-1273 (Lot# 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 02 Jan 2020 (pending clarification), at 18:00, the patient experienced a headache, chills, fever, muscle pain and joint pain.   Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, headache, chills, fever, muscle pain and joint pain were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.