chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Sinus disorder, Throat clearing
Clinical narrative: HURT; COULDN'T FOCUS; COULDN'T LIFT A STEP; SHUFFLING; THROAT CLEARING; SINUSES; CHILLS; EXHAUSTED; NAUSEA; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) 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 subject experienced hurt, couldn't focus, couldn't lift a step, shuffling, throat clearing, sinuses, chills, exhausted, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, exhausted, nausea, hurt, couldn't focus, shuffling, throat clearing, couldn't lift a step and sinuses was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache
Clinical narrative: STOMACH ACHE; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced stomach ache, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, stomach ache and fatigue was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pruritus
Clinical narrative: RIGHT DELTOID PAIN; HEADACHE; FATIGUE; ITCHING 3 INCHES BELOW  AND 3 INCHES ABOVE THE ELBOW; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 29/JAN/2023) dose was not reported, administered on 06-APR-2021 10:45 on right deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, treatment medications included: paracetamol. On 06-APR-2021 11:45, the subject experienced itching 3 inches below and 3 inches above the elbow. On 06-APR-2021 13:55, the subject experienced headache. On 06-APR-2021 13:55, the subject experienced fatigue. On 07-APR-2021 03:30, the subject experienced right deltoid pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching 3 inches below and 3 inches above the elbow, headache, and fatigue, and had not recovered from right deltoid pain. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: ELBOW PAIN; PAIN IN LEFT ARM FROM SHOULDER TO ELBOW; PAIN IN THE RIGHT ARM; This spontaneous report received from a consumer concerned a 65 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: 29-JAN-2023) dose was not reported, administered on 06-APR-2021 at 10:30 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced elbow pain. On 06-APR-2021, the subject experienced pain in the right arm. On 06-APR-2021 22:00, the subject experienced pain in left arm from shoulder to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in the right arm, and the outcome of elbow pain and pain in left arm from shoulder to elbow was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Axillary pain, Chills, Headache
Clinical narrative: LEFT SIDE STOMACH PAIN/ACHE; SWALLOWING FEELS STRANGE; CHILLS/SHIVERING; SORE LEFT SHOULDER AREA; HEADACHE; NAUSEA; FEVER; DIFFICULTY SLEEPING; THROAT SORE; SORE ARMPIT; SORE LEFT ARM; LEFT SORE NECK; THROAT SWOLLEN; SWEATING; This spontaneous report received from a patient concerned a 65 year old male. The patient's weight was 175 pounds, and height was 68 inches. The patient's concurrent conditions included Crohn's disease, nerve damage, brachial plexus injuries, muscular atrophy, penicillin allergy, recreational marijuana occasionally, non-alcoholic, non-smoker, disabled veteran, and sulfates allergy. The patient experienced drug allergy when treated with methotrexate, and methocarbamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, administered on 06-APR-2021 12:40 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced left sore neck. On 06-APR-2021, the subject experienced throat swollen. On 06-APR-2021, the subject experienced sweating. On 06-APR-2021, the subject experienced difficulty sleeping. On 06-APR-2021, the subject experienced throat sore. On 06-APR-2021, the subject experienced sore armpit. On 06-APR-2021, the subject experienced sore left arm. On 06-APR-2021, the subject experienced sore left shoulder area. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. On 06-APR-2021 21:00, the subject experienced chills/shivering. On 07-APR-2021, the subject experienced left side stomach pain/ache. On 07-APR-2021, the subject experienced swallowing feels strange. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 07-APR-2021, and difficulty sleeping, and nausea, was recovering from left sore neck, throat swollen, headache, and throat sore, had not recovered from left side stomach pain/ache, swallowing feels strange, and chills/shivering, and the outcome of sore left arm, sore armpit, fever and sore left shoulder area was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Nausea, Neck pain, Odynophagia
Clinical narrative: LEFT SIDE STOMACH PAIN/ACHE; SWALLOWING FEELS STRANGE; CHILLS/SHIVERING; SORE LEFT SHOULDER AREA; HEADACHE; NAUSEA; FEVER; DIFFICULTY SLEEPING; THROAT SORE; SORE ARMPIT; SORE LEFT ARM; LEFT SORE NECK; THROAT SWOLLEN; SWEATING; This spontaneous report received from a patient concerned a 65 year old male. The patient's weight was 175 pounds, and height was 68 inches. The patient's concurrent conditions included Crohn's disease, nerve damage, brachial plexus injuries, muscular atrophy, penicillin allergy, recreational marijuana occasionally, non-alcoholic, non-smoker, disabled veteran, and sulfates allergy. The patient experienced drug allergy when treated with methotrexate, and methocarbamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, administered on 06-APR-2021 12:40 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced left sore neck. On 06-APR-2021, the subject experienced throat swollen. On 06-APR-2021, the subject experienced sweating. On 06-APR-2021, the subject experienced difficulty sleeping. On 06-APR-2021, the subject experienced throat sore. On 06-APR-2021, the subject experienced sore armpit. On 06-APR-2021, the subject experienced sore left arm. On 06-APR-2021, the subject experienced sore left shoulder area. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. On 06-APR-2021 21:00, the subject experienced chills/shivering. On 07-APR-2021, the subject experienced left side stomach pain/ache. On 07-APR-2021, the subject experienced swallowing feels strange. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 07-APR-2021, and difficulty sleeping, and nausea, was recovering from left sore neck, throat swollen, headache, and throat sore, had not recovered from left side stomach pain/ache, swallowing feels strange, and chills/shivering, and the outcome of sore left arm, sore armpit, fever and sore left shoulder area was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Pharyngeal swelling, Pyrexia
Clinical narrative: LEFT SIDE STOMACH PAIN/ACHE; SWALLOWING FEELS STRANGE; CHILLS/SHIVERING; SORE LEFT SHOULDER AREA; HEADACHE; NAUSEA; FEVER; DIFFICULTY SLEEPING; THROAT SORE; SORE ARMPIT; SORE LEFT ARM; LEFT SORE NECK; THROAT SWOLLEN; SWEATING; This spontaneous report received from a patient concerned a 65 year old male. The patient's weight was 175 pounds, and height was 68 inches. The patient's concurrent conditions included Crohn's disease, nerve damage, brachial plexus injuries, muscular atrophy, penicillin allergy, recreational marijuana occasionally, non-alcoholic, non-smoker, disabled veteran, and sulfates allergy. The patient experienced drug allergy when treated with methotrexate, and methocarbamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, administered on 06-APR-2021 12:40 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced left sore neck. On 06-APR-2021, the subject experienced throat swollen. On 06-APR-2021, the subject experienced sweating. On 06-APR-2021, the subject experienced difficulty sleeping. On 06-APR-2021, the subject experienced throat sore. On 06-APR-2021, the subject experienced sore armpit. On 06-APR-2021, the subject experienced sore left arm. On 06-APR-2021, the subject experienced sore left shoulder area. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. Treatment medications included: paracetamol. On 06-APR-2021 21:00, the subject experienced chills/shivering. On 07-APR-2021, the subject experienced left side stomach pain/ache. On 07-APR-2021, the subject experienced swallowing feels strange. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating on 07-APR-2021, and difficulty sleeping, and nausea, was recovering from left sore neck, throat swollen, headache, and throat sore, had not recovered from left side stomach pain/ache, swallowing feels strange, and chills/shivering, and the outcome of sore left arm, sore armpit, fever and sore left shoulder area was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VIAL ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced expired vial administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vial administered was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature increased, Headache, Nausea, Pain in extremity
Clinical narrative: BACK PAIN; LEG PAIN; HEADACHE; ELEVATED TEMPERATURE; NAUSEA; This spontaneous report received from a consumer concerned a 29 year old female. The patient's weight was 82 kilograms, and height was 159 centimeters. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient has no known allergies. the patient had no drug abuse or illicit drug usage. the patient was not pregnant at the of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered at left arm on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced back pain. On 06-APR-2021, the subject experienced leg pain. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced elevated temperature. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain, leg pain, headache, and elevated temperature, and the outcome of nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: BOTH SHOULDER WAS IN PAIN; HEADACHE; FEVER; EXHAUSTION; BODY ACHE; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042821A, and batch number: 042821A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced exhaustion. On 07-APR-2021, the subject experienced both shoulder was in pain. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and exhaustion on 07-APR-2021, was recovering from body ache, and had not recovered from both shoulder was in pain, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BOTH SHOULDER WAS IN PAIN; HEADACHE; FEVER; EXHAUSTION; BODY ACHE; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042821A, and batch number: 042821A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced exhaustion. On 07-APR-2021, the subject experienced both shoulder was in pain. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and exhaustion on 07-APR-2021, was recovering from body ache, and had not recovered from both shoulder was in pain, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: ARM PAIN; HORRIBLE HEADACHE; NAUSEATED; This spontaneous report received from a vaccine facility concerned a male of unspecified age. The patient's weight, height, and medical history were not 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced horrible headache, nauseated, and arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the horrible headache, nauseated and arm pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: SLEEPINESS; FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. 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 03-APR-2021 08:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-APR-2021, the subject experienced sleepiness. On 04-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and sleepiness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Lip swelling, Middle insomnia, Night sweats, Pruritus
Clinical narrative: QUITE ANXIOUS ABOUT THE SYMPTOMS; HIVES; HALF OF LIP SWOLLEN; ITCHY ABOVE THE HIPS; NIGHT SWEATS; WOKE UP A FEW TIMES DURING THE NIGHT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0418Z1A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced night sweats. On 06-APR-2021, the subject experienced woke up a few times during the night. On 07-APR-2021 07:00, the subject experienced half of lip swollen. On 07-APR-2021 07:00, the subject experienced itchy above the hips. On 07-APR-2021 07:00, the subject experienced hives. On an unspecified date, the subject experienced quite anxious about the symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from woke up a few times during the night on 07-APR-2021, was recovering from night sweats, had not recovered from half of lip swollen, hives, and itchy above the hips, and the outcome of quite anxious about the symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: QUITE ANXIOUS ABOUT THE SYMPTOMS; HIVES; HALF OF LIP SWOLLEN; ITCHY ABOVE THE HIPS; NIGHT SWEATS; WOKE UP A FEW TIMES DURING THE NIGHT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0418Z1A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced night sweats. On 06-APR-2021, the subject experienced woke up a few times during the night. On 07-APR-2021 07:00, the subject experienced half of lip swollen. On 07-APR-2021 07:00, the subject experienced itchy above the hips. On 07-APR-2021 07:00, the subject experienced hives. On an unspecified date, the subject experienced quite anxious about the symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from woke up a few times during the night on 07-APR-2021, was recovering from night sweats, had not recovered from half of lip swollen, hives, and itchy above the hips, and the outcome of quite anxious about the symptoms was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Feeling cold, Hyperhidrosis, Injection site pain
Clinical narrative: FREEZING COLD FEELING; NO APPETITE; SHAKING; SWEATING; CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 11:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced freezing cold feeling. On 06-APR-2021, the subject experienced no appetite. On 06-APR-2021, the subject experienced shaking. On 06-APR-2021, the subject experienced sweating. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from freezing cold feeling, no appetite, and shaking on APR-2021, and had not recovered from chills, injection site pain, and sweating. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: FREEZING COLD FEELING; NO APPETITE; SHAKING; SWEATING; CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 11:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced freezing cold feeling. On 06-APR-2021, the subject experienced no appetite. On 06-APR-2021, the subject experienced shaking. On 06-APR-2021, the subject experienced sweating. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from freezing cold feeling, no appetite, and shaking on APR-2021, and had not recovered from chills, injection site pain, and sweating. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pain in extremity
Clinical narrative: SICK AS A DOG FOR 2 DAYS; ARM HURT BAD; LEFT PECTORAL MUSCLE HURT BAD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.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 02-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced sick as a dog for 2 days. On APR-2021, the subject experienced arm hurt bad. On APR-2021, the subject experienced left pectoral muscle hurt bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick as a dog for 2 days on APR-2021, and the outcome of arm hurt bad and left pectoral muscle hurt bad was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: SORENESS; PAIN AT INJECTION SITE; FEELS VERY TIRED; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 04-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 04-APR-2021, the subject experienced soreness. On 04-APR-2021, the subject experienced pain at injection site. On 04-APR-2021, the subject experienced feels very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness, pain at injection site, and feels very tired. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 72 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04ZA21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 04-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, and nausea on 05-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pruritus, Rash, Sluggishness
Clinical narrative: RASH ON MID TO LOWER BACK; TIRED; SLUGGISH; ITCHING  AT THE SHOT SITE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and sulfa allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-MAR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced itching at the shot site. On 31-MAR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced sluggish. On 02-APR-2021, the subject experienced tired. Treatment medications included: ibuprofen. On 03-APR-2021, the subject experienced rash on mid to lower back. Treatment medications included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on mid to lower back on 05-APR-2021, and headache on 03-APR-2021, was recovering from itching at the shot site, and tired, and the outcome of sluggish was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Nausea, Pyrexia
Clinical narrative: SEVERE BODY SHAKES; VOMITING; CHILLS; NAUSEA; FEVER; FEELING HOT; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included ibuprofen. On 06-APR-2021, the subject experienced feeling hot. On 06-APR-2021, the subject experienced fever. On 06-APR-2021 23:00, the subject experienced severe body shakes. On 06-APR-2021 23:00, the subject experienced vomiting. On 06-APR-2021 23:00, the subject experienced chills. On 06-APR-2021 23:00, the subject experienced nausea. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body shakes, and chills on 07-APR-2021 02:00, and had not recovered from fever, nausea, feeling hot, and vomiting. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: SEVERE BODY SHAKES; VOMITING; CHILLS; NAUSEA; FEVER; FEELING HOT; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included ibuprofen. On 06-APR-2021, the subject experienced feeling hot. On 06-APR-2021, the subject experienced fever. On 06-APR-2021 23:00, the subject experienced severe body shakes. On 06-APR-2021 23:00, the subject experienced vomiting. On 06-APR-2021 23:00, the subject experienced chills. On 06-APR-2021 23:00, the subject experienced nausea. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body shakes, and chills on 07-APR-2021 02:00, and had not recovered from fever, nausea, feeling hot, and vomiting. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: ADMINISTRATION ERROR; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number was not reported and has been requested.) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 07-APR-2021, the subject experienced administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration error was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: HEADACHE; FEVER; This spontaneous report received from a vaccine facility concerned a 50 year old male. The patient's weight, height, and medical history were not reported. 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 05-APR-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 07-APR-2021, the subject experienced fever. On 07-APR-2021 07:00, Laboratory data included: Body temperature (NR: not provided) 99.4 F. On an unspecified date, the subject experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and headache was not reported. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Neck pain, Pain in extremity, Vomiting
Clinical narrative: VOMITING; NECK PAIN; MALAISE; ARM SORENESS/PAIN WAS ACROSS SHOULDER; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced neck pain. On 03-APR-2021, the subject experienced malaise. On 03-APR-2021, the subject experienced arm soreness/pain was across shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 04-APR-2021, and malaise on 06-APR-2021, was recovering from arm soreness/pain was across shoulder, and had not recovered from neck pain. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: FEVER; SEVERE HEADACHE; VERY ACHY; CHILLS; PAIN IN ARM; This spontaneous report received from a patient concerned a 34 year old female. The patient's weight was 117 pounds, and height was 62 inches. 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: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 12:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain in arm. On 06-APR-2021 19:00, the subject experienced very achy. On 06-APR-2021 19:00, the subject experienced chills. On 06-APR-2021 23:45, the subject experienced fever. On 06-APR-2021 23:45, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, and pain in arm, and the outcome of fever, chills and very achy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: FLU LIKE SYMPTOMS; ACHEY; CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a parent concerned a 26 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced achey. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu like symptoms, headache, chills, and nausea, and the outcome of achey was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: SORE ARM; JOINT MUSCLE ACHE; HEADACHE; NAUSEA; DIARRHEA; DIZZINESS; This spontaneous report received from a patient concerned a 63-year-old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at 10:10 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021 10:25, the subject experienced dizziness. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced joint muscle ache. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced nausea.  Treatment medications (dates unspecified) included: bismuth subsalicylate/calcium carbonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 07-APR-2021, and had not recovered from headache, joint muscle ache, nausea, dizziness, and sore arm. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; JOINT MUSCLE ACHE; HEADACHE; NAUSEA; DIARRHEA; DIZZINESS; This spontaneous report received from a patient concerned a 63-year-old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at 10:10 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021 10:25, the subject experienced dizziness. On 07-APR-2021, the subject experienced diarrhea. On 07-APR-2021, the subject experienced sore arm. On 07-APR-2021, the subject experienced joint muscle ache. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced nausea.  Treatment medications (dates unspecified) included: bismuth subsalicylate/calcium carbonate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 07-APR-2021, and had not recovered from headache, joint muscle ache, nausea, dizziness, and sore arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: LITTLE HEADACHE; This spontaneous report received from a patient concerned an 82 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 12:05 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced little headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little headache on 06-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Nausea
Clinical narrative: ACHY HIPS/ACHY KNEES; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 subject experienced achy hips/achy knees, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and achy hips/achy knees was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Death, Echocardiogram, Myocardial infarction, Vomiting
Clinical narrative: Massive heart attack; Death; vomiting; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Massive heart attack), CEREBROVASCULAR ACCIDENT (Stroke) and DEATH (Death) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011m20a and 013a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN POTASSIUM (COZAAR) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DEATH (Death) (seriousness criterion death) and VOMITING (vomiting). In March 2021, the patient experienced MYOCARDIAL INFARCTION (Massive heart attack) (seriousness criteria hospitalization and life threatening) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). On 11-Mar-2021, MYOCARDIAL INFARCTION (Massive heart attack), CEREBROVASCULAR ACCIDENT (Stroke) and VOMITING (vomiting) had resolved. The patient died on 11-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Echocardiogram: unknown (Inconclusive) unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information also included inhalers, non specified and eye drops non specified. No treatment information was reported.   Based on the current available information and temporal association between the use of the product and the start dates of the events,  a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events,  a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Fatigue, Syncope
Clinical narrative: Collapsed; Lost her vision; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Collapsed), BLINDNESS (Lost her vision) and FATIGUE (Exhausted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.    On 26-Feb-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 SYNCOPE (Collapsed) (seriousness criterion hospitalization), BLINDNESS (Lost her vision) (seriousness criterion hospitalization) and FATIGUE (Exhausted) (seriousness criterion hospitalization). At the time of the report, SYNCOPE (Collapsed) and FATIGUE (Exhausted) outcome was unknown and BLINDNESS (Lost her vision) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the events though start date was not provided- reporter indicated event occurred after the first dose), a causal relationship with the events cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events though start date was not provided- reporter indicated event occurred after the first dose), a causal relationship with the events cannot be excluded
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Basal cell carcinoma, Body temperature abnormal, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Positive diagnosis of Covid-19; Surgery to remove basal cell cancer; Fever of 99.5° F; Felt exhausted; Got tired & sleepy after I ate; Am was sore; This spontaneous case was reported by a consumer and describes the occurrence of BASAL CELL CARCINOMA (Surgery to remove basal cell cancer) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) 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 recorded medical history).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Am was sore). On 06-Mar-2021, the patient experienced PYREXIA (Fever of 99.5° F), SOMNOLENCE (Got tired & sleepy after I ate) and FATIGUE (Felt exhausted). On 15-Mar-2021, the patient experienced BASAL CELL CARCINOMA (Surgery to remove basal cell cancer) (seriousness criterion medically significant). On 20-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive diagnosis of Covid-19). At the time of the report, BASAL CELL CARCINOMA (Surgery to remove basal cell cancer), PYREXIA (Fever of 99.5° F), PAIN IN EXTREMITY (Am was sore), SOMNOLENCE (Got tired & sleepy after I ate), SARS-COV-2 TEST POSITIVE (Positive diagnosis of Covid-19) and FATIGUE (Felt exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature abnormal: 99.5 °F (Inconclusive) 99.5 ° F. On 20-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Somnolence
Clinical narrative: Positive diagnosis of Covid-19; Surgery to remove basal cell cancer; Fever of 99.5° F; Felt exhausted; Got tired & sleepy after I ate; Am was sore; This spontaneous case was reported by a consumer and describes the occurrence of BASAL CELL CARCINOMA (Surgery to remove basal cell cancer) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) 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 recorded medical history).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Am was sore). On 06-Mar-2021, the patient experienced PYREXIA (Fever of 99.5° F), SOMNOLENCE (Got tired & sleepy after I ate) and FATIGUE (Felt exhausted). On 15-Mar-2021, the patient experienced BASAL CELL CARCINOMA (Surgery to remove basal cell cancer) (seriousness criterion medically significant). On 20-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive diagnosis of Covid-19). At the time of the report, BASAL CELL CARCINOMA (Surgery to remove basal cell cancer), PYREXIA (Fever of 99.5° F), PAIN IN EXTREMITY (Am was sore), SOMNOLENCE (Got tired & sleepy after I ate), SARS-COV-2 TEST POSITIVE (Positive diagnosis of Covid-19) and FATIGUE (Felt exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature abnormal: 99.5 °F (Inconclusive) 99.5 ° F. On 20-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.