chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SORENESS DOWN TO LEFT ELBOW; BODY ACHES; CHILLS; LOW-GRADE FEVER; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and hayfever, and other pre-existing medical conditions included patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular,  batch number: 1802072 expiry: 25/MAY/2021) .5 ml, administered on 06-MAR-2021 05:00 to Left Deltoid for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 06-MAR-2021, the subject experienced pain at injection site. On 06-MAR-2021 10:00, the subject experienced low-grade fever. On 06-MAR-2021 10:00, the subject experienced chills. On 07-MAR-2021, the subject experienced soreness down to left elbow. On 07-MAR-2021, the subject experienced body aches. Laboratory data included: Body temperature (NR: not provided) 99.6 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-MAR-2021, and had not recovered from pain at injection site, low-grade fever, body aches, and soreness down to left elbow. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscular weakness, Nausea, Pain
Clinical narrative: VOMITING; CHILLS; WEAK LEGS; ACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history and concurrent conditions not reported. Consumer does not have an HCP and usually seen at the health department. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported) dose was not reported, administered on 07-MAR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced vomiting, chills. weak legs, ache, nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, chills, weak legs, ache, and nausea, and the outcome of fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; CHILLS; WEAK LEGS; ACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history and concurrent conditions not reported. Consumer does not have an HCP and usually seen at the health department. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported) dose was not reported, administered on 07-MAR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced vomiting, chills. weak legs, ache, nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, chills, weak legs, ache, and nausea, and the outcome of fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling cold, Hypoaesthesia, Paraesthesia
Clinical narrative: COOL SENSATION IN MOUTH; TINGLING SENSATION; NUMBNESS; HEAVY CHEST; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805022) dose was not reported, administered on 06-MAR-2021 10:30 to the left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021 11:00, the patient experienced cool sensation in mouth to the back of the throat (similar to the feeing after eating a peppermint patty). The patient also experienced tingling sensation, numbness from ear to back of the head "like novocaine wearing off", and heavy chest possibly from anxiety or asthma.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cool sensation in mouth, tingling sensation, numbness, and heavy chest. The reporter assessed the events as related to covid-19 vaccine ad26.cov2.s This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Myalgia, Nausea
Clinical narrative: HEADACHE; MUSCLE  ACHES; NAUSEA; LOW-GRADE FEVER; BODY ACHE; CHILLS; SO SICK AFTER INJECTION; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, non smoker, Addison's disease, hypothyroidism, and osteoporosis, and other pre-existing medical conditions included patient was not pregnant at the time of event. patient have no drug allergies/drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 13:15 to Left Arm for prophylactic vaccination. Concomitant medications included fludrocortisone for Addison's disease, hydrocortisone for Addison's disease, levothyroxine for hypothyroidism, calcium citrate for osteoporosis, amino acids nos, ascorbic acid, ergocalciferol, and tocopherol. On MAR-2021, the subject experienced so sick after injection. On 05-MAR-2021, the subject experienced body ache. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced muscle aches. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced low-grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from muscle aches, chills, nausea, low-grade fever, and body ache, and the outcome of so sick after injection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: HEADACHE; MUSCLE  ACHES; NAUSEA; LOW-GRADE FEVER; BODY ACHE; CHILLS; SO SICK AFTER INJECTION; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, non smoker, Addison's disease, hypothyroidism, and osteoporosis, and other pre-existing medical conditions included patient was not pregnant at the time of event. patient have no drug allergies/drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 13:15 to Left Arm for prophylactic vaccination. Concomitant medications included fludrocortisone for Addison's disease, hydrocortisone for Addison's disease, levothyroxine for hypothyroidism, calcium citrate for osteoporosis, amino acids nos, ascorbic acid, ergocalciferol, and tocopherol. On MAR-2021, the subject experienced so sick after injection. On 05-MAR-2021, the subject experienced body ache. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced muscle aches. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced low-grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, had not recovered from muscle aches, chills, nausea, low-grade fever, and body ache, and the outcome of so sick after injection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysmenorrhoea, Influenza like illness, Nausea, Pain
Clinical narrative: NAUSEA; STARTED MENSTRUAL CYCLE 1 WEEK EARLY; DIARRHEA; PERIOD CRAMPS; FLU LIKE SYMPTOMS; BODY ACHE; This spontaneous report received from a patient concerned a 41 year old white ,Not Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 01:45 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 03:00, the subject experienced flu like symptoms. On 06-MAR-2021 03:00, the subject experienced body ache. Treatment medications included: ibuprofen. On 07-MAR-2021 03:00, the subject experienced period cramps. On 07-MAR-2021 05:00, the subject experienced started menstrual cycle 1 week early. On 07-MAR-2021 05:00, the subject experienced diarrhea. On 07-MAR-2021 07:40, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the period cramps, started menstrual cycle 1 week early, flu like symptoms, body ache, diarrhea and nausea was not reported. This report was non-serious.     .
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: NAUSEA; STARTED MENSTRUAL CYCLE 1 WEEK EARLY; DIARRHEA; PERIOD CRAMPS; FLU LIKE SYMPTOMS; BODY ACHE; This spontaneous report received from a patient concerned a 41 year old white ,Not Hispanic or Latino female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 01:45 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021 03:00, the subject experienced flu like symptoms. On 06-MAR-2021 03:00, the subject experienced body ache. Treatment medications included: ibuprofen. On 07-MAR-2021 03:00, the subject experienced period cramps. On 07-MAR-2021 05:00, the subject experienced started menstrual cycle 1 week early. On 07-MAR-2021 05:00, the subject experienced diarrhea. On 07-MAR-2021 07:40, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the period cramps, started menstrual cycle 1 week early, flu like symptoms, body ache, diarrhea and nausea was not reported. This report was non-serious.     .
Sex: U
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: RED BLOTCHES ON LEFT ARM AND RIGHT TEMPLE; HIVES ON LEFT ARM AND RIGHT TEMPLE; 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, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 11:51 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021 17:30, the subject experienced red blotches on left arm and right temple. On 07-MAR-2021 17:30, the subject experienced hives on left arm and right temple. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red blotches on left arm and right temple, and hives on left arm and right temple on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal pain, Pain in extremity
Clinical narrative: HEADACHE (WAXING / WANNING); ACHING IN LEGS; ACHING IN BUTTOCKS; 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, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 08:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced headache (waxing / wanning). On 06-MAR-2021, the subject experienced aching in legs. On 06-MAR-2021, the subject experienced aching in buttocks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache (waxing / wanning), aching in legs and aching in buttocks was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: MUSCLE PAIN; SORE AT SITE OF INJECTION; 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 pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced muscle pain. On 06-MAR-2021, the subject experienced sore at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle pain, and sore at site of injection on 07-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: NOT FEELING WELL; HAD FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: 25-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced not feeling well. On 06-MAR-2021, the subject experienced fever. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.5 F, 100.5 F. Treatment medications included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of not feeling well was not reported. This report was non-serious.  Additional information was received from patient on 17-MAR-2021 following information was updated and incorporated into case narrative: Reporter details (name of the reporter), additional event (not feeling well) was added.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Pyrexia
Clinical narrative: FEELING OF SWELLING IN THE HEAD; HEADACHE; LITTLE BIT OF FEVER; 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, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 11:30 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021 01:00, the subject experienced feeling of swelling in the head. On 07-MAR-2021 01:00, the subject experienced headache. On 07-MAR-2021 01:00, the subject experienced little bit of fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little bit of fever on MAR-2021, and had not recovered from headache, and feeling of swelling in the head. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; 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, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 04:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included auto-immune issue.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) .5 ml, once a total administered  on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced chills. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and chills on 07-MAR-2021, was recovering from body aches, and had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood glucose abnormal, Feeling hot, Hyperhidrosis
Clinical narrative: GETTING HOT; WEAKNESS; SWEATY; BLOOD SUGAR WAS IN THE 300'S; 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, intramuscular, batch number: Unknown, expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced blood sugar was in the 300's. On 05-MAR-2021, the subject experienced getting hot. On 05-MAR-2021, the subject experienced weakness. On 05-MAR-2021, the subject experienced sweaty. Laboratory data included: Blood glucose (NR: not provided) 300. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from getting hot, and sweaty, had not recovered from weakness, and the outcome of blood sugar was in the 300's was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Liquid product physical issue
Clinical narrative: MILKY PRESENCE IN THE VACCINE; FATIGUE; This spontaneous report received from a patient concerned an 83 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, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced fatigue. On an unspecified date, the subject experienced milky presence in the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 07-MAR-2021, and the outcome of milky presence in the vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Product quality issue
Clinical narrative: MILKY PRESENCE IN THE VACCINE; FATIGUE; This spontaneous report received from a patient concerned an 83 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, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced fatigue. On an unspecified date, the subject experienced milky presence in the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 07-MAR-2021, and the outcome of milky presence in the vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Fatigue, Influenza like illness, Pain
Clinical narrative: FATIGUE; LOSS OF TASTE; GENERAL FLU LIKE ACHES; BODY ACHES; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 02:45 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced loss of taste. On 06-MAR-2021, the subject experienced general flu like aches. On 06-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general flu like aches, and body aches on 07-MAR-2021, and had not recovered from fatigue, and loss of taste. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; HEADACHE; FEVER; 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, intramuscular) 0.5 ml, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.5 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with Covid-19 vaccine AD26.cov2.s was not applicable. The patient had not recovered from fever, and the outcome of body ache and headache was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Taste disorder
Clinical narrative: HEADACHE; BODY ACHES; CHILLS; TIREDNESS; STRANGE TASTE IN MOUTH; This spontaneous report received from a patient concerned a 66 year old. The patient's height, and weight were not reported. The patient's past medical history included family history of cholesterol, and concurrent conditions included chemical allergies, and petroleum byproducts allergy. The patient experienced drug allergy when treated with cefotetan.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced body aches. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced tiredness. On 05-MAR-2021, the subject experienced strange taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, body aches, chills, and tiredness on 07-MAR-2021, and was recovering from strange taste in mouth. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain
Clinical narrative: CHILLS; BODY ACHE; HEADACHE; 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, intramuscular, batch number: 1805022, and batch number: 1805022) .5 ml, once a total administered on 05-MAR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) no fever. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021 14:45, the subject experienced body ache. On 05-MAR-2021 15:30, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache on MAR-2021, chills on 05-MAR-2021 16:30, and headache on 06-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a parent 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, intramuscular, batch number: Unknown) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Incorrect route of product administration
Clinical narrative: INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; CHILLS; SWEATS; RUNNY NOSE; MUSCLE ACHES; FEVER; HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 51 year old white not Hispanic or Latino female. The patient's weight was 158 (unit not reported) and height was 160 centimeters. The patient's concurrent conditions included non-smoker, one drink per week, and seasonal allergies, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s by intravenous route (inappropriate route of vaccine administration and off label use) (batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, administered on 06-Mar-2021. Concomitant medications included vitamins and supplements for good health. On 06-MAR-2021, the patient had experienced chills, sweats, fever, headache, nausea, fatigue, runny nose and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sweats, fever, headache, and nausea on 08-MAR-2021, was recovering from fatigue, and runny nose, had not recovered from muscle aches, and the outcome of inappropriate route of vaccine administration and off label use was not reported. This report was non-serious.  Additional follow up information received on 16-Mar-2021.The following information was updated and incorporated into the case: medical history, demographics, concomitant medication, route of administration for suspect product, lot number expiry date, events (inappropriate route of vaccine administration and off label use) and outcome (recovering from fatigue, and runny nose, had not recovered from muscle ache) was updated; Sender's Comments: V1:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Off label use, Pyrexia, Rhinorrhoea
Clinical narrative: INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; OFF LABEL USE; CHILLS; SWEATS; RUNNY NOSE; MUSCLE ACHES; FEVER; HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 51 year old white not Hispanic or Latino female. The patient's weight was 158 (unit not reported) and height was 160 centimeters. The patient's concurrent conditions included non-smoker, one drink per week, and seasonal allergies, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s by intravenous route (inappropriate route of vaccine administration and off label use) (batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, administered on 06-Mar-2021. Concomitant medications included vitamins and supplements for good health. On 06-MAR-2021, the patient had experienced chills, sweats, fever, headache, nausea, fatigue, runny nose and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sweats, fever, headache, and nausea on 08-MAR-2021, was recovering from fatigue, and runny nose, had not recovered from muscle aches, and the outcome of inappropriate route of vaccine administration and off label use was not reported. This report was non-serious.  Additional follow up information received on 16-Mar-2021.The following information was updated and incorporated into the case: medical history, demographics, concomitant medication, route of administration for suspect product, lot number expiry date, events (inappropriate route of vaccine administration and off label use) and outcome (recovering from fatigue, and runny nose, had not recovered from muscle ache) was updated; Sender's Comments: V1:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a 48 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, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 03:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Nausea, Productive cough
Clinical narrative: NAUSEA; HEADACHE; MUSCLE PAIN; COUGH MUCUS; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included seasonal allergies, and other pre-existing medical conditions included the patient had a allergy of pain medicines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.3 F. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced muscle pain. On 07-MAR-2021, the subject experienced cough mucus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and cough mucus on 07-MAR-2021, and had not recovered from fever, headache, and muscle pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: NAUSEA; HEADACHE; MUSCLE PAIN; COUGH MUCUS; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included seasonal allergies, and other pre-existing medical conditions included the patient had a allergy of pain medicines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.3 F. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced muscle pain. On 07-MAR-2021, the subject experienced cough mucus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and cough mucus on 07-MAR-2021, and had not recovered from fever, headache, and muscle pain. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Myalgia
Clinical narrative: BODYCHILLS; MUSCLE ACHES; This spontaneous report received from a patient concerned a 54 year old. The patient's weight was 160 pounds, and height was 68 inches. The patient's concurrent conditions included non smoker, alcohol user, and treenut allergy, and other pre-existing medical conditions included the patient was not doing any drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: 05/MAY/2021) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced bodychills. On 06-MAR-2021, the patient experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bodychills, and muscle aches. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Myalgia, Pain
Clinical narrative: BODYCHILLS; MUSCLE ACHES; This spontaneous report received from a patient concerned a 54 year old. The patient's weight was 160 pounds, and height was 68 inches. The patient's concurrent conditions included non smoker, alcohol user, and treenut allergy, and other pre-existing medical conditions included the patient was not doing any drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: 05/MAY/2021) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced bodychills. On 06-MAR-2021, the patient experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bodychills, and muscle aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: HEADACHE; ARM SORENESS; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN) .5 ml, administered on 06-MAR-2021 13:00 to Right Arm 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 headache, and arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and arm soreness was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Malaise, Myalgia
Clinical narrative: NOT FEELING GOOD; BACK HURTS; JOINT ACHES/SHOULDER PAIN; MUSCLE PAIN; HEADACHE; ALL OVER BODY ACHES; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced all over body aches. On 07-MAR-2021, the subject experienced back hurts. On 07-MAR-2021, the subject experienced joint aches/shoulder pain. On 07-MAR-2021, the subject experienced muscle pain. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021 09:00, the subject experienced not feeling good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from all over body aches, muscle pain, joint aches/shoulder pain, headache, not feeling good, and back hurts. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: NOT FEELING GOOD; BACK HURTS; JOINT ACHES/SHOULDER PAIN; MUSCLE PAIN; HEADACHE; ALL OVER BODY ACHES; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced all over body aches. On 07-MAR-2021, the subject experienced back hurts. On 07-MAR-2021, the subject experienced joint aches/shoulder pain. On 07-MAR-2021, the subject experienced muscle pain. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021 09:00, the subject experienced not feeling good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from all over body aches, muscle pain, joint aches/shoulder pain, headache, not feeling good, and back hurts. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: FATIGUE; NAUSEA; 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, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced fatigue. On 06-MAR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and nausea. This report was non-serious. This case, from the same reporter is linked to 20210314997.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Crying, Disorientation
Clinical narrative: FEVER; NAUSEA; Dizziness; WEAKNESS; Disoriented; FEEL LIKE HIGH; COULD NOT FOUCS ON TASK; VERY EMOTIONAL; FEEL LIKE CRYING; HEART PALPITATION; 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, intramuscular, and batch number: 1805022 expiry: UNKNOWN) 0.5 ml, administered on 07-MAR-2021 02:45 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021 11:35, the patient experienced chills. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.1 F, and EKG (NR: not provided) Normal. On 08-MAR-2021 02:30, the patientt experienced heart palpitation. On an unspecified date, the patientt experienced fever, nausea, dizziness, weakness, disoriented, feel like high, could not foucs on task, very emotional, and feel like crying. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitation, and the outcome of chills, fever, nausea, dizziness, weakness, disoriented, feel like high, could not foucs on task, very emotional and feel like crying was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Electrocardiogram, Emotional disorder, Euphoric mood
Clinical narrative: FEVER; NAUSEA; Dizziness; WEAKNESS; Disoriented; FEEL LIKE HIGH; COULD NOT FOUCS ON TASK; VERY EMOTIONAL; FEEL LIKE CRYING; HEART PALPITATION; 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, intramuscular, and batch number: 1805022 expiry: UNKNOWN) 0.5 ml, administered on 07-MAR-2021 02:45 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021 11:35, the patient experienced chills. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.1 F, and EKG (NR: not provided) Normal. On 08-MAR-2021 02:30, the patientt experienced heart palpitation. On an unspecified date, the patientt experienced fever, nausea, dizziness, weakness, disoriented, feel like high, could not foucs on task, very emotional, and feel like crying. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitation, and the outcome of chills, fever, nausea, dizziness, weakness, disoriented, feel like high, could not foucs on task, very emotional and feel like crying was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Pyrexia
Clinical narrative: FEVER; NAUSEA; Dizziness; WEAKNESS; Disoriented; FEEL LIKE HIGH; COULD NOT FOUCS ON TASK; VERY EMOTIONAL; FEEL LIKE CRYING; HEART PALPITATION; 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, intramuscular, and batch number: 1805022 expiry: UNKNOWN) 0.5 ml, administered on 07-MAR-2021 02:45 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021 11:35, the patient experienced chills. On 08-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.1 F, and EKG (NR: not provided) Normal. On 08-MAR-2021 02:30, the patientt experienced heart palpitation. On an unspecified date, the patientt experienced fever, nausea, dizziness, weakness, disoriented, feel like high, could not foucs on task, very emotional, and feel like crying. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitation, and the outcome of chills, fever, nausea, dizziness, weakness, disoriented, feel like high, could not foucs on task, very emotional and feel like crying was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Tachycardia
Clinical narrative: TACHYCARDIA; FEVER; CHILLS; BODY ACHES; This spontaneous report received from a patient via a company representative 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, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced fever. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced tachycardia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, chills, and body aches on 06-MAR-2021, and the outcome of tachycardia was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza, Nausea, Pain, Pyrexia
Clinical narrative: FLU; NAUSEA; FEVER 102; GENERALIZE ACHES AND PAIN; This spontaneous report received from a consumer concerned a 50 year old. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included ethnicity background. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced flu. On 08-MAR-2021, the subject experienced nausea. On 08-MAR-2021, the subject experienced fever 102. On 08-MAR-2021, the subject experienced generalize aches and pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu, nausea, fever 102, and generalize aches and pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: ACHY ALL OVER; FELT TERRIBLE; This spontaneous report received from a female patient 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, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 08-MAR-2021, the patient experienced achy all over and felt terrible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy all over, and felt terrible. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Dry mouth, Influenza like illness
Clinical narrative: CHILLS; FLU LIKE SYMPTOMS; JOINT PAIN; PASTY DRY MOUTH; TEMPERATURE 99.8; This spontaneous report received from a patient concerned a patient 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 09:40 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced flu like symptoms. On MAR-2021, the subject experienced joint pain. On MAR-2021, the subject experienced pasty dry mouth. On MAR-2021, the subject experienced temperature 99.8. Laboratory data included: Body temperature increased (NR: not provided) 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, flu like symptoms, joint pain, pasty dry mouth and temperature 99.8 was not reported. This report was non-serious.