chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient concerned a 20 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-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, and chills. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Pyrexia
Clinical narrative: HIGH BLOOD PRESSURE; FEVER; 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: 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 high blood pressure, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and high blood pressure was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report received from a health care professional concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included acute respiratory failure, end stage kidney disease, right heart failure, primary hypertension, COPD, atrial fibrillation, and pulmonary hypertension. The patient was previously treated with mRna 1273 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced second dose of Janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of second dose of Janssen covid-19 vaccine was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dysgeusia, Nausea, Vomiting
Clinical narrative: LACK OF SMELL; LACK OF TASTE; NAUSEA; VOMITING; SEVERE METALLIC TASTE; This spontaneous report received from a patient concerned a 35 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, rare form of gout, and immunocompromised due to chemotherapy infusions., and other pre-existing medical conditions included atromyocin allergy. The patient experienced drug allergy when treated with vancomycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced vomiting. On 07-APR-2021, the subject experienced severe metallic taste. On 07-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced lack of smell. On 08-APR-2021, the subject experienced lack of taste. Treatment medications (dates unspecified) included: ondansetron hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea on 07-APR-2021, and severe metallic taste on 08-APR-2021, and had not recovered from lack of smell, and lack of taste. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 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. Non-company suspect drugs included: upadacitinib (oral, batch number: UNKNOWN expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the subject experienced sickness, and fatigue/tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient was recovering from fatigue/tired, and the outcome of sickness was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Injection site reaction, Nausea, Pain
Clinical narrative: RASH ON ABDOMEN THEN SPREADING TO THE BACK FACE THROAT AND ARMS; NAUSEA; ACHY; FLU; LUMP AT INJECTION SITE; HEADACHE; 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 asthma, food allergy, and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced lump at injection site. On 13-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced achy. On 14-MAR-2021, the subject experienced flu. On 17-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced rash on abdomen then spreading to the back face throat and arms. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, and flu on 17-MAR-2021, lump at injection site on 20-MAR-2021, rash on abdomen then spreading to the back face throat and arms on 26-MAR-2021, and headache, and nausea on 18-MAR-2021. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON ABDOMEN THEN SPREADING TO THE BACK FACE THROAT AND ARMS; NAUSEA; ACHY; FLU; LUMP AT INJECTION SITE; HEADACHE; 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 asthma, food allergy, and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced lump at injection site. On 13-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced achy. On 14-MAR-2021, the subject experienced flu. On 17-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced rash on abdomen then spreading to the back face throat and arms. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, and flu on 17-MAR-2021, lump at injection site on 20-MAR-2021, rash on abdomen then spreading to the back face throat and arms on 26-MAR-2021, and headache, and nausea on 18-MAR-2021. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Depo-Provera allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have had any medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced the whole left side arm and leg got numb. On 07-APR-2021, the subject experienced the whole left side arm and leg got tingly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from the whole left side arm and leg got numb, and the whole left side arm and leg got tingly. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report received from a patient concerned a 73 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 on Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced rash on chest/back/neck/stomach. On 07-APR-2021, the subject experienced red rash. On 07-APR-2021, the subject experienced itchy rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on chest/back/neck/stomach, red rash, and itchy rash. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: FEELING TIRED; CHILLS; HEADACHE; MUSCLE PAIN; This spontaneous report received from a patient concerned an adult 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: Unknown) , dose was not reported, administered on 06-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced muscle pain. On 07-APR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-APR-2021, was recovering from headache, and had not recovered from muscle pain, and feeling tired. This report was non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 32 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 07:30 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 to 102 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 headache, body ache, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Nausea, Product quality issue, Pyrexia
Clinical narrative: DID NOT FEEL WELL RIGHT AFTER THE VACCINATION; FEVER; CHILLS; NAUSEA; FACT SHEET MISLEADING; This spontaneous report received from a consumer concerned a 44 year old female. The patient's height, and weight were not reported.  The patient's relevant medical history included no known allergies, no alcohol consumption, non smoker. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1808980) dose was not reported, administered on 06-APR-2021 at 02:45 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient didn't feel well right after getting the vaccine and at 17:30 she started experiencing fever, chills and nausea, which lasted throughout the day and continued until next day.  The reporter also complained that the fact sheet had misleading information as it stated that "The Janssen COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19, then "The FDA has authorized the emergency use of the Janssen COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization." So does the Janssen COVID 19 Vaccine prevent people from getting COVID 19 or may not?" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and nausea, and the outcome of fact sheet misleading and did not feel well right after the vaccination was not reported. This report was non-serious. This case, from the same reporter is linked to report.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis
Clinical narrative: SWEATING; HEADACHE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 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 07-APR-2021, the subject experienced sweating. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 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, 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 07-APR-2021, 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.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: VACCINE GIVEN TO 17 YEAR OLD PATIENT; This spontaneous report received from a pharmacist concerned an adolescent of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, the vaccine given to 17 year old subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given to 17 year old patient was not reported. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Insomnia, Pain in extremity
Clinical narrative: COULDN'T SLEEP LAST NIGHT; TINY HEADACHE; LEFT ARM HURTING; LEFT SHOULDER HURTING; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 at 14.30 to left deltoid at 14:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced couldn't sleep last night. On 07-APR-2021, the patient experienced tiny headache. On 07-APR-2021, the patient experienced left arm hurting. On 07-APR-2021, the patient experienced left shoulder hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiny headache, left arm hurting, and left shoulder hurting, and the outcome of couldn't sleep last night was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: KNOCKED DOWN A BIT, IT FELT ROUGH; 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: Unknown) dose was not reported, administered in left arm on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced knocked down a bit, it felt rough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of knocked down a bit, it felt rough was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Feeling hot, Myalgia, Pain in extremity
Clinical narrative: WOKE UP GROGGY; SORE ARM; UNCONTROLLABLE SHIVERS; MUSCLE ACHINESS; UNCONTROLLABLE SHAKING; FEELING VERY HOT; FEELING VERY COLD; 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, and batch number were not reported) dose was not reported, administered on 06-APR-2021 13:00 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 06-APR-2021 22:00, the subject experienced uncontrollable shaking. On 06-APR-2021 22:00, the subject experienced feeling very hot. On 06-APR-2021 22:00, the subject experienced feeling very cold. On 06-APR-2021 22:00, the subject experienced uncontrollable shivers. On 06-APR-2021 22:00, the subject experienced muscle achiness. Treatment medications included: paracetamol. On 07-APR-2021 04:00, treatment medications included: paracetamol. On 07-APR-2021 10:00, the subject experienced woke up groggy. On 07-APR-2021 10:00, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle achiness, and the outcome of uncontrollable shaking, uncontrollable shivers, feeling very hot, feeling very cold, woke up groggy and sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence, Tremor
Clinical narrative: WOKE UP GROGGY; SORE ARM; UNCONTROLLABLE SHIVERS; MUSCLE ACHINESS; UNCONTROLLABLE SHAKING; FEELING VERY HOT; FEELING VERY COLD; 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, and batch number were not reported) dose was not reported, administered on 06-APR-2021 13:00 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 06-APR-2021 22:00, the subject experienced uncontrollable shaking. On 06-APR-2021 22:00, the subject experienced feeling very hot. On 06-APR-2021 22:00, the subject experienced feeling very cold. On 06-APR-2021 22:00, the subject experienced uncontrollable shivers. On 06-APR-2021 22:00, the subject experienced muscle achiness. Treatment medications included: paracetamol. On 07-APR-2021 04:00, treatment medications included: paracetamol. On 07-APR-2021 10:00, the subject experienced woke up groggy. On 07-APR-2021 10:00, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle achiness, and the outcome of uncontrollable shaking, uncontrollable shivers, feeling very hot, feeling very cold, woke up groggy and sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Oropharyngeal pain, Pain
Clinical narrative: 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: 042a2a2, and  expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced sore throat. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, headache, body aches, sore throat, fever, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 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: 042a2a2, and  expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced sore throat. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, headache, body aches, sore throat, fever, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS; 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) dose was not reported, administered on 10-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 2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Hypersomnia, Nausea
Clinical narrative: SLEEP EXCESSIVE; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported and had been requested expiry: unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced sleep excessive. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and nausea, and the outcome of chills and sleep excessive was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hypersomnia, Lethargy, Musculoskeletal stiffness
Clinical narrative: SORE NECK; STIFF NECK; LETHARGIC; DROWSY; SLEEP MOST OF THE DAY/ DIFFICULT TO STAY AWAKE; INTENSE HEADACHE; FEVER; This spontaneous report received from a vaccine facility via a company representative concerned a 37 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: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore neck. On 06-APR-2021, the subject experienced stiff neck. On 06-APR-2021, the subject experienced lethargic. On 06-APR-2021, the subject experienced drowsy. On 06-APR-2021, the subject experienced sleep most of the day/ difficult to stay awake. On 06-APR-2021, the subject experienced intense headache. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103.3 F, 104.4 F, ABOVE 101 F. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9-102.5 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, intense headache, sore neck, lethargic, drowsy, stiff neck, and sleep most of the day/ difficult to stay awake. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, Somnolence
Clinical narrative: SORE NECK; STIFF NECK; LETHARGIC; DROWSY; SLEEP MOST OF THE DAY/ DIFFICULT TO STAY AWAKE; INTENSE HEADACHE; FEVER; This spontaneous report received from a vaccine facility via a company representative concerned a 37 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: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sore neck. On 06-APR-2021, the subject experienced stiff neck. On 06-APR-2021, the subject experienced lethargic. On 06-APR-2021, the subject experienced drowsy. On 06-APR-2021, the subject experienced sleep most of the day/ difficult to stay awake. On 06-APR-2021, the subject experienced intense headache. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103.3 F, 104.4 F, ABOVE 101 F. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9-102.5 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, intense headache, sore neck, lethargic, drowsy, stiff neck, and sleep most of the day/ difficult to stay awake. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: EVERYTHING TASTE LIKE METAL; 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) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be required for this case. No concomitant medications were reported. On an unspecified date, the subject experienced everything taste like metal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of everything taste like metal was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: BODY ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 13:30 vaccinated at left deltoid  for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, headache, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Decreased appetite, Fatigue
Clinical narrative: APPETITE LOST; JOINT PAIN; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 35 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 was not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. 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 14-MAR-2021, the subject experienced appetite lost. On 14-MAR-2021, the subject experienced joint pain. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from appetite lost, joint pain, and fatigue on 15-MAR-2021. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle spasms, Pain, Pyrexia
Clinical narrative: FEVER; MUSCLE SPASMS AT BACK OF NECK TO HEAD; BODY HURTS; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 38 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 at 12:00 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021 01:30, the subject experienced muscle spasms at back of neck to head. On 07-APR-2021 01:30, the subject experienced body hurts. On 07-APR-2021 01:30, the subject experienced headache. On 07-APR-2021 01:30, the subject experienced fatigue. On 07-APR-2021 13:30, the subject experienced fever. 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 muscle spasms at back of neck to head, headache, fatigue, fever, and body hurts. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: MYALGIA THROUGHOUT BODY; FEVER; POUNDING HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies zero co-morbidities. 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-APR-2021 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 myalgia, fever, pounding headache, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myalgia, fever, pounding headache and nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: LIGHT HEADED; NAUSEOUS ABOUT 90 MIN AFTER SHOT; TIRED A BIT EARLIER THAN NORMAL; 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) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced light headed, nauseous about 90 min after shot, and tired a bit earlier than normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, and nauseous about 90 min after shot, and the outcome of tired a bit earlier than normal was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: GENERAL BODY PAIN; This spontaneous report received from a patient concerned an adult male. 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: not reported) 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. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the subject experienced general body pain. The action taken with covid-19 vaccine ad26.cov2.s, and upadacitinib was not applicable. The outcome of general body pain was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Injection site mass, Peripheral swelling
Clinical narrative: SWELLING ARM; HARD LUMP UNDER THE SHOT; CHILLS; FEVER 102.2; EXCRUCIATING HEADACHES; This spontaneous report received from a patient. 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: 180503, expiry: UNKNOWN) dose was not reported, administered in left Arm on 06-APR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102.2 (units unspecified). On 07-APR-2021, treatment medications included: paracetamol. On 07-APR-2021 01:30, the subject experienced chills. On 07-APR-2021 01:30, the subject experienced shivering. On 07-APR-2021 01:30, the subject experienced fever 102.2. On 07-APR-2021 01:30, the subject experienced excruciating headaches. On an unspecified date, the subject experienced swelling arm, and hard lump under the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and excruciating headaches, and the outcome of shivering, fever 102.2, swelling arm and hard lump under the shot was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SWELLING ARM; HARD LUMP UNDER THE SHOT; CHILLS; FEVER 102.2; EXCRUCIATING HEADACHES; This spontaneous report received from a patient. 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: 180503, expiry: UNKNOWN) dose was not reported, administered in left Arm on 06-APR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102.2 (units unspecified). On 07-APR-2021, treatment medications included: paracetamol. On 07-APR-2021 01:30, the subject experienced chills. On 07-APR-2021 01:30, the subject experienced shivering. On 07-APR-2021 01:30, the subject experienced fever 102.2. On 07-APR-2021 01:30, the subject experienced excruciating headaches. On an unspecified date, the subject experienced swelling arm, and hard lump under the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and excruciating headaches, and the outcome of shivering, fever 102.2, swelling arm and hard lump under the shot was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot
Clinical narrative: FEELING HOT/FEVER 104.8; This spontaneous report received from a parent concerned a 25 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) dose was not reported, administered on 07-APR-2021 around 8:00 or 9:00 vaccinated on left deltoid 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 07-APR-2021, the subject experienced feeling hot/fever 104.8. Treatment medications included: ibuprofen. On 07-APR-2021 21:00, Laboratory data included: Body temperature (NR: not provided) 104.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling hot/fever 104.8 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: CRAZY ITCH WITHOUT ANY RASH; 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 and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 11:45 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced crazy itch without any rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of crazy itch without any rash was not reported. This report was non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling of body temperature change, Incorrect route of product administration, Myalgia
Clinical narrative: SORE ARM; TIREDNESS; SHIVERING; MUSCLE ACHINESS; SHAKING; CYCLING BETWEEN FEELING VERY HOT AND VERY COLD; TINGLING; INAPPROPRIATE ROUTE OF VACCINATION; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 138 pounds, and height was 167 centimeters. The patient's concurrent conditions included non-alcoholic, non-smoker, asthma, and tmj, and other pre-existing medical conditions included patient have no known allergies and had no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 13:00 for prophylactic vaccination. Concomitant medications included cyclobenzaprine for tmj, fish oil for tmj, lactobacillus reuteri for tmj, and vitamins nos for tmj.  On 06-APR-2021, the subject experienced inappropriate route of vaccination. On 06-APR-2021 22:00, the subject experienced shaking. On 06-APR-2021 22:00, the subject experienced cycling between feeling very hot and very cold. On 06-APR-2021 22:00, the subject experienced tingling. On 06-APR-2021 22:00, the subject experienced shivering. On 06-APR-2021 22:00, the subject experienced muscle achiness. Treatment medications included: paracetamol. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021 04:00, treatment medications included: paracetamol. On 07-APR-2021 10:00, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, cycling between feeling very hot and very cold, tingling, sore arm, shivering, muscle achiness, and tiredness on 08-APR-2021, and the outcome of inappropriate route of vaccination was not reported. This report was non-serious. This case, from the same reporter is linked to 20210413992.   Additional information was received agency Follow Up on 09/Apr/2021.The following information was updated and incorporated into case narrative: Reporter details, Patient demographics, medical history, events (tingling and tiredness added),Event stop date added for all events, Event Outcome updated for all events, Concomitant products Cyclobenzaprine, multivitamin, fish oil,  probiotic. added, Product Lot number added.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Tremor
Clinical narrative: SORE ARM; TIREDNESS; SHIVERING; MUSCLE ACHINESS; SHAKING; CYCLING BETWEEN FEELING VERY HOT AND VERY COLD; TINGLING; INAPPROPRIATE ROUTE OF VACCINATION; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 138 pounds, and height was 167 centimeters. The patient's concurrent conditions included non-alcoholic, non-smoker, asthma, and tmj, and other pre-existing medical conditions included patient have no known allergies and had no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 13:00 for prophylactic vaccination. Concomitant medications included cyclobenzaprine for tmj, fish oil for tmj, lactobacillus reuteri for tmj, and vitamins nos for tmj.  On 06-APR-2021, the subject experienced inappropriate route of vaccination. On 06-APR-2021 22:00, the subject experienced shaking. On 06-APR-2021 22:00, the subject experienced cycling between feeling very hot and very cold. On 06-APR-2021 22:00, the subject experienced tingling. On 06-APR-2021 22:00, the subject experienced shivering. On 06-APR-2021 22:00, the subject experienced muscle achiness. Treatment medications included: paracetamol. On 07-APR-2021, the subject experienced tiredness. On 07-APR-2021 04:00, treatment medications included: paracetamol. On 07-APR-2021 10:00, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, cycling between feeling very hot and very cold, tingling, sore arm, shivering, muscle achiness, and tiredness on 08-APR-2021, and the outcome of inappropriate route of vaccination was not reported. This report was non-serious. This case, from the same reporter is linked to 20210413992.   Additional information was received agency Follow Up on 09/Apr/2021.The following information was updated and incorporated into case narrative: Reporter details, Patient demographics, medical history, events (tingling and tiredness added),Event stop date added for all events, Event Outcome updated for all events, Concomitant products Cyclobenzaprine, multivitamin, fish oil,  probiotic. added, Product Lot number added.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Chills, Eye pain, Feeling abnormal
Clinical narrative: IMMENSE PAIN; ABDOMINAL PAIN; UNCOMFORTABLE  TO TOUCH BODY; PAIN IN EYEBALLS; FEELS HOT AND COLD ON AND OFF; CHATTERING OF THE TEETH AND JAW; PAIN IN BACK MUSCLES; FEVER; This spontaneous report received from a consumer concerned an 18 year old female. The patient's weight was 155 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-202111:50 in left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On an unspecified date, the subject experienced immense pain, abdominal pain, uncomfortable to touch body, pain in eyeballs, feels hot and cold on and off, chattering of the teeth and jaw, and pain in back muscles. Treatment medications (dates unspecified) included: metoclopramide hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, immense pain, abdominal pain, uncomfortable to touch body, pain in eyeballs, pain in back muscles, chattering of the teeth and jaw, and feels hot and cold on and off. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Myalgia, Pain, Pyrexia
Clinical narrative: IMMENSE PAIN; ABDOMINAL PAIN; UNCOMFORTABLE  TO TOUCH BODY; PAIN IN EYEBALLS; FEELS HOT AND COLD ON AND OFF; CHATTERING OF THE TEETH AND JAW; PAIN IN BACK MUSCLES; FEVER; This spontaneous report received from a consumer concerned an 18 year old female. The patient's weight was 155 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-202111:50 in left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On an unspecified date, the subject experienced immense pain, abdominal pain, uncomfortable to touch body, pain in eyeballs, feels hot and cold on and off, chattering of the teeth and jaw, and pain in back muscles. Treatment medications (dates unspecified) included: metoclopramide hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, immense pain, abdominal pain, uncomfortable to touch body, pain in eyeballs, pain in back muscles, chattering of the teeth and jaw, and feels hot and cold on and off. This report was non-serious.