chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Muscle spasms, Pain, Pyrexia
Clinical narrative: SEVERE MUSCLE CRAMPS ALL OVER BODY; BODY ACHE; DIARRHEA; RED HIVES ON FACE; CHILLS; FEVER; 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 expiry: 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 severe muscle cramps all over body, body ache, diarrhea, red hives on face, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, body ache, diarrhea, severe muscle cramps all over body and red hives on face was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: SEVERE MUSCLE CRAMPS ALL OVER BODY; BODY ACHE; DIARRHEA; RED HIVES ON FACE; CHILLS; FEVER; 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 expiry: 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 severe muscle cramps all over body, body ache, diarrhea, red hives on face, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, body ache, diarrhea, severe muscle cramps all over body and red hives on face was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash, Swelling face
Clinical narrative: SWELLING OF FACE; FATIGUE; HEADACHE; RASH; 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 patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen. On 13-MAR-2021, the subject experienced swelling of face. On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of face, rash, fatigue, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; 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, 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 sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pain, Palpitations, Pyrexia
Clinical narrative: MIGRAINE ALL DAY; HEART RACING; ACHY; FEVER; This spontaneous report received from a consumer via a company representative 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 number. No concomitant medications were reported.  On an unspecified date, the subject experienced migraine all day, heart racing, achy, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine all day, heart racing, fever and achy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer concerned multiple patients. 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, 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 headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.; Reporter's Comments: This case contains multiple patients.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: SORE ARM; A LITTLE FATIGUE; 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, route of admin not reported, batch number: Unknown) dose was not reported, once a total administered on 11-MAR-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 11-MAR-2021, the subject experienced sore arm. On 11-MAR-2021, the subject experienced a little fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and a little fatigue on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache
Clinical narrative: BACK HURT; HEADACHE; FATIGUED; 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: Unk) 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 back hurt, headache, and fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, back hurt and fatigued was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Rash
Clinical narrative: RASH ON SHOULDER/ARM; 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced rash on shoulder/arm. On 14-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 14-MAR-2021, and had not recovered from rash on shoulder/arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Malaise
Clinical narrative: LIGHT-HEADED; NOT FEELING WELL; HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included unknown.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 21:00 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced light-headed. On 15-MAR-2021, the subject experienced not feeling well. On 15-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, light-headed, not feeling well and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: vomiting; sweats; Joint pain; chills; Severe Muscle Aches; nausea; lingering fatigue; 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, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 12-MAR-2021 18:45 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021 04:00, the subject experienced vomiting. On 13-MAR-2021 04:00, the subject experienced sweats. On 13-MAR-2021 04:00, the subject experienced joint pain. On 13-MAR-2021 04:00, the subject experienced chills. On 13-MAR-2021 04:00, the subject experienced severe muscle aches. On 13-MAR-2021 04:00, the subject experienced nausea. On 13-MAR-2021 04:00, the subject experienced lingering fatigue. On 13-MAR-2021 04:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, sweats, joint pain, chills, severe muscle aches, and nausea on MAR-2021, and was recovering from lingering fatigue, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: vomiting; sweats; Joint pain; chills; Severe Muscle Aches; nausea; lingering fatigue; 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, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 12-MAR-2021 18:45 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021 04:00, the subject experienced vomiting. On 13-MAR-2021 04:00, the subject experienced sweats. On 13-MAR-2021 04:00, the subject experienced joint pain. On 13-MAR-2021 04:00, the subject experienced chills. On 13-MAR-2021 04:00, the subject experienced severe muscle aches. On 13-MAR-2021 04:00, the subject experienced nausea. On 13-MAR-2021 04:00, the subject experienced lingering fatigue. On 13-MAR-2021 04:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, sweats, joint pain, chills, severe muscle aches, and nausea on MAR-2021, and was recovering from lingering fatigue, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Head discomfort, Headache
Clinical narrative: FEEL A LITTLE PRESSURE IN THE CHEST LEFT SIDE; WHOLE HEAD FEELS HEAVY; TERRIBLE 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 at 14:22 (PST) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced feel a little pressure in the chest left side. On MAR-2021, the subject experienced whole head feels heavy. On MAR-2021, the subject experienced terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible headache, feel a little pressure in the chest left side and whole head feels heavy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Pyrexia, Rash
Clinical narrative: REDNESS; RASH / RASH WAS SPREADING FROM NECK TO THE UPPER PART OF CHEST; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a White Not Hispanic/Latino female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic skin condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced redness. On 13-MAR-2021, the subject experienced rash / rash was spreading from neck to the upper part of chest. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-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 headache on 15-MAR-2021, and had not recovered from rash / rash was spreading from neck to the upper part of chest, and redness. This report was non-serious..; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Injection site pain
Clinical narrative: FLUE LIKE SYMPTOMS; INJECTION SITE ARM PAIN; TIRED; This spontaneous report received from a consumer concerned a 66 year old female. 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, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced flue like symptoms. On 05-MAR-2021, the subject experienced injection site arm pain. On 05-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flue like symptoms on 08-MAR-2021, and tired on 09-MAR-2021, and had not recovered from injection site arm pain. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: FEELING FOGGY; JOINT ACHES; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 123 pounds, and height was 65 inches. The patient's concurrent conditions included immunoglobulin type a deficiency, endometriosis, ibs, dust allergy, cat allergy, grass allergy, fragrance allergy, alcoholic, non smoker, gluten allergy, dairy allergy, and soy sensitivity, and other pre-existing medical conditions included allergic to dust, grass, cats, certain medical adhesives, fragrance. patient had no drug abuse illicit allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 18:30 for prophylactic vaccination. Concomitant medications included folic acid, loratadine, magnesium, montelukast sodium, senna alexandrina, vitamin c, and vitamin d.  On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 13-MAR-2021, the subject experienced feeling foggy. On 13-MAR-2021, the subject experienced joint aches. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced fatigue. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling foggy on 16-MAR-2021, joint aches, and fatigue on 15-MAR-2021, and fever on 14-MAR-2021. This report was non-serious.  Additional information was received from patient on 19-Mar-2021. The following information was updated and incorporated into case narrative. Patient's demographics added (height, weight), patient's concurrent conditions (immunoglobulin type a deficiency, endometriosis, ibs, dust allergy, cat allergy, grass allergy, fragrance allergy, alcoholic, non smoker, gluten allergy, dairy allergy, and soy sensitivity),  Concomitant medications were added from additional information which included folic acid, loratadine, magnesium, montelukast sodium, senna alexandrina, vitamin c, and vitamin d.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Palpitations, Pyrexia
Clinical narrative: HEART RACING; ACHY ALL OVER; HEADACHE; FEVER; This spontaneous report received from a consumer via a company representative 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: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced heart racing. On 2021, the subject experienced achy all over. On 2021, the subject experienced headache. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, heart racing, fever and achy all over was not reported. This report was non-serious. This case, involving the same patient is linked to 20210328948.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: DIARRHEA; CHILLS; FEVER; SEVERE HEADACHE; FATIGUE; INDIVIDUAL 16 YEARS OF AGE  RECEIVED VACCINE; OFF LABEL USE; This spontaneous report received from a consumer concerned a 16 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced severe headache. On 14-MAR-2021, the subject experienced diarrhea. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced individual 16 years of age received vaccine. On 14-MAR-2021, the subject experienced off label use. Laboratory data included: Body temperature (NR: not provided) 102 F. On 15-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, severe headache, diarrhea, chills, and fatigue, and the outcome of individual 16 years of age received vaccine and off label use was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: DIARRHEA; CHILLS; FEVER; SEVERE HEADACHE; FATIGUE; INDIVIDUAL 16 YEARS OF AGE  RECEIVED VACCINE; OFF LABEL USE; This spontaneous report received from a consumer concerned a 16 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced severe headache. On 14-MAR-2021, the subject experienced diarrhea. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced individual 16 years of age received vaccine. On 14-MAR-2021, the subject experienced off label use. Laboratory data included: Body temperature (NR: not provided) 102 F. On 15-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.8 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, severe headache, diarrhea, chills, and fatigue, and the outcome of individual 16 years of age received vaccine and off label use was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Increased viscosity of upper respiratory secretion, Injection site pain
Clinical narrative: NASAL CONGESTION; MUCUS; CHILLS; PAIN AT THE INJECTION SITE; FEVER; 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, batch number: Unk) dose was not reported, administered on 13-MAR-2021 15:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced nasal congestion. On 13-MAR-2021, the subject experienced mucus. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced pain at the injection site. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache, fatigue, nasal congestion, mucus and pain at the injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: NASAL CONGESTION; MUCUS; CHILLS; PAIN AT THE INJECTION SITE; FEVER; 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, batch number: Unk) dose was not reported, administered on 13-MAR-2021 15:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced nasal congestion. On 13-MAR-2021, the subject experienced mucus. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced pain at the injection site. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache, fatigue, nasal congestion, mucus and pain at the injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: RIGHT BREAST PAIN; 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 sudden onset of pain.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: 26-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced right breast pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right breast pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Choking sensation, Dizziness, Dysphagia, Injection site pain, Pharyngeal erythema
Clinical narrative: ITCHY THROAT; CHOCKING SENSATION; RED TO PINK COLOR OF THROAT; DIFFICULTY IN SWALLOWING; INJECTION SITE PAIN; DIZZINESS; 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 included nose surgery- reconstruction., and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies. no drug use or illicit drug use. no smoking. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced injection site pain. On 10-MAR-2021, the subject experienced itchy throat. On 10-MAR-2021, the subject experienced chocking sensation. On 10-MAR-2021, the subject experienced red to pink color of throat. On 10-MAR-2021, the subject experienced difficulty in swallowing. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and injection site pain on MAR-2021, and was recovering from itchy throat, chocking sensation, red to pink color of throat, and difficulty in swallowing. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: ITCHY THROAT; CHOCKING SENSATION; RED TO PINK COLOR OF THROAT; DIFFICULTY IN SWALLOWING; INJECTION SITE PAIN; DIZZINESS; 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 included nose surgery- reconstruction., and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies. no drug use or illicit drug use. no smoking. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced injection site pain. On 10-MAR-2021, the subject experienced itchy throat. On 10-MAR-2021, the subject experienced chocking sensation. On 10-MAR-2021, the subject experienced red to pink color of throat. On 10-MAR-2021, the subject experienced difficulty in swallowing. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and injection site pain on MAR-2021, and was recovering from itchy throat, chocking sensation, red to pink color of throat, and difficulty in swallowing. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: FEVER; HEADACHE; BODYACHE; This spontaneous report received from a consumer 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: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced bodyache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and bodyache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness postural, Headache, Hypoaesthesia, Peripheral swelling
Clinical narrative: ARM NUMBNESS; ARM BURNING; SWELLING DOWN ARM TO FINGER TIPS; DIZZINESS UPON STANDING; HEADACHE; This spontaneous report received from a physician 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported, the company was not able to follow up. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced arm numbness. On 15-MAR-2021, the subject experienced arm burning. On 15-MAR-2021, the subject experienced swelling down arm to finger tips. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced dizziness upon standing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm numbness, arm burning, swelling down arm to finger tips, and dizziness upon standing, and the outcome of headache was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: LEFT ARM MUSCLE TENDERNESS STARTING FROM THE LEFT WRIST EXTENDING TO THE LEFT SHOULDER; SORE LEFT ARM AND FEELS OVERUSED STARTING FROM THE LEFT WRIST EXTENDING TO THE LEFT SHOULDER; This spontaneous report received from a patient concerned a 41 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in left upper arm for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced sore left arm and feels overused starting from the left wrist extending to the left shoulder. On 14-MAR-2021, the subject experienced left arm muscle tenderness starting from the left wrist extending to the left shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore left arm and feels overused starting from the left wrist extending to the left shoulder, and left arm muscle tenderness starting from the left wrist extending to the left shoulder. This report was non-serious. This case, from the same reporter is linked to 20210353764.  Version(1) created to amend previously reported information on 15/Mar/2021. Upon review the following information was amended: Labeling of event (sore left arm and feels overused starting from the left wrist extending to the left shoulder) updated to unlabeled from labeled in USPI.  Additional information was received from patient on 15-Mar-2021 following information was updated and incorporated into case narrative: Link case added.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: body aches; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer via a company representative 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 was not reported, administered on MAR-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 MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, chills, and low grade fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE SORENESS; 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 left arm on 11-MAR-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 12-MAR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness on MAR-2021. This report was non-serious. This case, from the Others is linked to 20200903207.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Dysphonia, Fatigue, Headache
Clinical narrative: LOSS OF APPETITE; HOARSENESS OF VOICE; COUGH; HEADACHE; SLEEPINESS; TIREDNESS, FATIGUE; 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sleepiness. On 12-MAR-2021, the subject experienced tiredness, fatigue. On 14-MAR-2021, the subject experienced loss of appetite. On 14-MAR-2021, the subject experienced hoarseness of voice. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepiness, loss of appetite, cough, and headache on 15-MAR-2021, and was recovering from tiredness, fatigue, and hoarseness of voice. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: LOSS OF APPETITE; HOARSENESS OF VOICE; COUGH; HEADACHE; SLEEPINESS; TIREDNESS, FATIGUE; 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced sleepiness. On 12-MAR-2021, the subject experienced tiredness, fatigue. On 14-MAR-2021, the subject experienced loss of appetite. On 14-MAR-2021, the subject experienced hoarseness of voice. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepiness, loss of appetite, cough, and headache on 15-MAR-2021, and was recovering from tiredness, fatigue, and hoarseness of voice. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: SICK; PAIN; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: 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 sick, and pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick and pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: NORMAL SORENESS TO GETTING A SHOT; This spontaneous report received from a patient via a company representative 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: Unk) dose was not reported, administered on 13-MAR-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 MAR-2021, the subject experienced normal soreness to getting a shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from normal soreness to getting a shot on MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Feeling cold
Clinical narrative: FREEZING; BACKACHE; This spontaneous report received from a consumer via a company representative 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: Unk) dose was not reported, administered on MAR-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 MAR-2021, the subject experienced backache. On 12-MAR-2021, the subject experienced freezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from freezing, and the outcome of backache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Myalgia, Pyrexia
Clinical narrative: CHILLS; FEVER; MUSCLE ACHE; PAIN AT INJECTION SITE; 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced muscle ache. On 14-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, muscle ache, chills, and pain at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: WEAKNESS; 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: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not provided and has been requested. Concomitant medications included apixaban. On MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weakness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORENESS IN ARM; 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, and batch number were not reported) dose was not reported, administered on 06-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 soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness in arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Eye swelling, Insomnia, Intraocular pressure increased, Pain
Clinical narrative: ACHING AROUND 5-6 PM; AROUND 5-6 PM EYE BALLS WERE SWELLING; COULDNT FALL ASLEEP; EYE PRESSURE VERY HIGH; GENERAL WEAKNESS AROUND 5-6 PM; FEVER AROUND 100; This spontaneous report received from a patient 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 09:15 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced could not fall asleep. On MAR-2021, the subject experienced eye pressure very high. On 11-MAR-2021, the subject experienced aching around 5-6 pm. On 11-MAR-2021, the subject experienced around 5-6 pm eye balls were swelling. On 11-MAR-2021, the subject experienced general weakness around 5-6 pm. On 11-MAR-2021, the subject experienced fever around 100. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aching around 5-6 pm, fever around 100, around 5-6 pm eye balls were swelling, general weakness around 5-6 pm, could not fall asleep and eye pressure very high was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHING AROUND 5-6 PM; AROUND 5-6 PM EYE BALLS WERE SWELLING; COULDNT FALL ASLEEP; EYE PRESSURE VERY HIGH; GENERAL WEAKNESS AROUND 5-6 PM; FEVER AROUND 100; This spontaneous report received from a patient 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 09:15 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced could not fall asleep. On MAR-2021, the subject experienced eye pressure very high. On 11-MAR-2021, the subject experienced aching around 5-6 pm. On 11-MAR-2021, the subject experienced around 5-6 pm eye balls were swelling. On 11-MAR-2021, the subject experienced general weakness around 5-6 pm. On 11-MAR-2021, the subject experienced fever around 100. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the aching around 5-6 pm, fever around 100, around 5-6 pm eye balls were swelling, general weakness around 5-6 pm, could not fall asleep and eye pressure very high was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hot flush, Hyperhidrosis, Migraine, Myalgia
Clinical narrative: BLURRED VISION; MIGRAINE; HOT FLASHES; PALE; SWEATING; FEVER; MUSCLE ACHES; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mitral valve prolapse, drug allergies: compazine, and non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 10:30 for prophylactic vaccination. Concomitant medications included metoprolol tartrate for mitral valve prolapse. On 12-MAR-2021 07:00, the subject experienced blurred vision. On 12-MAR-2021 07:00, the subject experienced migraine. On 12-MAR-2021 07:00, the subject experienced hot flashes. On 12-MAR-2021 07:00, the subject experienced pale. On 12-MAR-2021 07:00, the subject experienced sweating. On 12-MAR-2021 07:00, the subject experienced fever. On 12-MAR-2021 07:00, the subject experienced muscle aches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.9 F, and COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision on 14-MAR-2021, and migraine, and muscle aches on 13-MAR-2021, and had not recovered from fever, hot flashes, pale, and sweating. This report was non-serious.