chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: MEDICATION ERROR (ADMINISTERED 1 CC); OFF LABEL USE; This spontaneous report received from a health care professional 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, route of admin not reported, batch number: 1805031 expiry: 30/DEC/2069) dose was not reported, administered on 22-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject had medication error (administered 1 cc) and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the medication error (administered 1 cc) and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHES; DIARRHEA; FEVER; HEADACHES; NAUSEA; This spontaneous report received from a physician concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The patient was vaccinated at left deltoid. No concomitant medications were reported. On 19-MAR-2021, the subject experienced body aches. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced headaches. On 19-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, diarrhea, fever, headaches, and nausea on 20-MAR-2021.  No Follow up required as reporter declined. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain, Peripheral swelling
Clinical narrative: DIZZINESS AND LIGHT HEADEDNESS; PAIN BEHIND THE EARS; LEFT ARM SWOLLEN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included no known drug allergies. 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 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced dizziness and light headedness. On 17-MAR-2021, the subject experienced pain behind the ears. On 17-MAR-2021, the subject experienced left arm swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain behind the ears, and left arm swollen on 17-MAR-2021, and had not recovered from dizziness and light headedness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: ITCHY ARM; SWOLLEN ARM; REDNESS IN ARM; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination on arm. No concomitant medications were reported. On an unspecified date, the subject experienced itchy arm, swollen arm, and redness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy arm, swollen arm and redness in arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON CHEST NECK AND FACE; 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: 1805031, and  expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On MAR-2021, the subject experienced rash on chest neck and face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash on chest neck and face was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain, Retching
Clinical narrative: SHARP PAINS; DRY HEAVING; DIZZINESS/DIZZY WHEN WALKING; NAUSEA; LIGHTNING FLASHES AT CROWN OF HEAD AND RIGHT SIDE; 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: 18055081 expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 07:30 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced sharp pains. On 17-MAR-2021, the subject experienced dry heaving. On 17-MAR-2021, the subject experienced dizziness/dizzy when walking. On 17-MAR-2021, the subject experienced nausea. On 17-MAR-2021, the subject experienced lightning flashes at crown of head and right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness/dizzy when walking, nausea, sharp pains, dry heaving, and lightning flashes at crown of head and right side. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hyperaesthesia, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use 1 drink per month, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-MAR-2021 on right deltoid for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 20-MAR-2021, the subject experienced injection site pain described as arm pain. On 21-MAR-2021, the subject experienced arm sensitivity. On 21-MAR-2021, the subject experienced pain in right leg. On 21-MAR-2021 10:00, the subject experienced pain in the right hip, groin and ankle. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain described as arm pain, and pain in the right hip ,groin and ankle, and the outcome of arm sensitivity and pain in right leg was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: LOW PLATELET COUNT; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, and cigarette smoker, and other pre-existing medical conditions included the patient has no known drug allergies.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 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced low platelet count. Laboratory data included: Platelet count (NR: 150 - 450) Platelets 138. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low platelet count was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: DRAMATIC IMPROVEMENT OF MULTIPLE SCLEROSIS SYMPTOMS; 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 squamous cancer removal on forehead, and concurrent conditions included multiple sclerosis. The patient was previously treated with fingolimod hydrochloride for multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-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 dramatic improvement of multiple sclerosis symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dramatic improvement of multiple sclerosis symptoms was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: JOHNSON & JOHNSON MILD SIDE EFFECTS; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced johnson & johnson mild side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of johnson & johnson mild side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MINIMAL SIDE EFFECTS; 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 minimal side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of minimal side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: RINGING ON LEFT EAR; 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 was not pregnant at the time of reporting. 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 09-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 10-MAR-2021 around 10 AM, the subject experienced ringing on left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing on left ear. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia, Tremor
Clinical narrative: BODY ACHES; SHAKING; SWEATS; CHILLS; FEVER; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, shaking, sweats, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, chills, shaking, fever, and sweats. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 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) dose was not reported, once a total administered, start therapy date was 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 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.8 to 100.2 (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: ARM SORE; FATIGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included depression, and concurrent conditions included anxiety, and non-smoker, and other pre-existing medical conditions included no known drug allergies. The patient was previously treated with buspirone for anxiety, and clonazepam for anxiety. 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 10-MAR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fatigue. On 11-MAR-2021, the subject experienced arm sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm sore on 18-MAR-2021, and had not recovered from fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: BACK HURTS; FEELING FATIGUED, TIRED; BODY CHILLS; HIGH FEVER; HEADACHE; 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: Unk) dose was not reported, administered on 19-MAR-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 19-MAR-2021, the subject experienced body chills. On 19-MAR-2021, the subject experienced high fever. On 19-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced back hurts. On 20-MAR-2021, the subject experienced feeling fatigued, tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, body chills, headache, feeling fatigued, tired and back hurts was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 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: Unk) 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 temperature, and pain my body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature and pain my body was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: ARM WAS A LITTLE BIT SORE AT THE INJECTION SITE; 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, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced arm was a little bit sore at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm was a little bit sore at the injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injury, Nausea
Clinical narrative: HURT; MILD HEADACHE; NAUSEA; 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, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced hurt. On MAR-2021, the subject experienced mild headache. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild headache, and nausea on MAR-2021, and the outcome of hurt was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Malaise, Pain in extremity
Clinical narrative: SICK; NOT FEEL UP/NOT FEELING WELL; SORE ARM; BAD CHILLS OVERNIGHT; HEADACHE; FEVER; This spontaneous report received from a patient 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, route of admin not reported) 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 sick. On MAR-2021, the subject experienced not feel up/not feeling well. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced bad chills overnight. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick, not feel up/not feeling well, headache, sore arm, bad chills overnight and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SICK; NOT FEEL UP/NOT FEELING WELL; SORE ARM; BAD CHILLS OVERNIGHT; HEADACHE; FEVER; This spontaneous report received from a patient 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, route of admin not reported) 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 sick. On MAR-2021, the subject experienced not feel up/not feeling well. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced bad chills overnight. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick, not feel up/not feeling well, headache, sore arm, bad chills overnight and fever was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance
Clinical narrative: COULD NOT WALK FAR WITHOUT FEELING TIRED; HAD BEEN TIRED; This spontaneous report received from a patient concerned a 71 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 administration, and batch number were not reported) 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 MAR-2021, the subject experienced could not walk far without feeling tired. On MAR-2021, the subject experienced had been tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not walk far without feeling tired, and had been tired on MAR-2021. This report was non-serious. This case, involving the same patient.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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, 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Headache, Pain
Clinical narrative: BODY ACHES; FEELING LOW; HEADACHE; 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 past medical history included covid. 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 body aches, feeling low, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, body aches, and feeling low. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: VOMITING; ACHES; NAUSEA; 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, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced vomiting. On 17-MAR-2021, the subject experienced aches. On 17-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting and aches 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: Dyspnoea, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: WINDED; SORE THROAT; SPLITTING HEADACHE; VERY TIRED; 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 MAR-2021 for prophylactic vaccination. The batch was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced winded. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced splitting headache. On MAR-2021, the subject experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the splitting headache, very tired, winded and sore throat was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: DOUBLE DOSE RECIEVED; 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) 1 ml, administered on 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAR-2021, the subject experienced double dose received. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of double dose was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decubitus ulcer, Pyrexia
Clinical narrative: BED RIDDEN; CHILLS; HIGH FEVER; This spontaneous report received from a consumer via a company representative 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-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 an unspecified date, the subject experienced bed ridden, chills, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bed ridden, high fever and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: LUMP ON NECK; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and heart arrhythmia. 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 20-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021 16:00, the subject experienced lump on neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lump on neck. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; SORE ARM; LOW GRADE FEVER; EXTREMELY TIRED; 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 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. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, sore arm, low grade fever, and extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, body aches, sore arm, low grade fever and extremely tired was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: A FEW ACHES AND PAINS; LOW GRADE FEVER; This spontaneous report received from a patient via an unspecified 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 unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced a few aches and pains, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and the outcome of a few aches and pains was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: SMALL RED BUMPS/ HIVES ON BOTH ARMS; ITCHY RASH ON BOTH ARMS AND ITCHY RASH ON ANKLE; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies and has not been exposed to new chemicals or foods prior to the occurrence. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced itchy rash on both arms and itchy rash on ankle. On 21-MAR-2021, the subject experienced small red bumps/ hives on both arms. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy rash on both arms and itchy rash on ankle and small red bumps/ hives on both arms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Nausea
Clinical narrative: STRUGGLING WITH SLEEPING DUE TO THE NAUSEA; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-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 15-MAR-2021, the subject experienced struggling with sleeping due to the nausea. On 15-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and struggling with sleeping due to the nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Gait disturbance, Heart rate, Heart rate increased, Muscular weakness
Clinical narrative: BREATHING DIFFICULTIES; DIFFICULTY WALKING; FATIGUE IN LEGS; MUSCLE PAIN; INCREASE IN HEART RATE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. 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 left arm on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced increase in heart rate. Laboratory data included: Heart rate (NR: not provided) Increased heart rate. On 06-MAR-2021, the subject experienced muscle pain. On 07-MAR-2021, the subject experienced breathing difficulties. On 07-MAR-2021, the subject experienced difficulty walking. On 07-MAR-2021, the subject experienced fatigue in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle pain on MAR-2021, and had not recovered from fatigue in legs, breathing difficulties, difficulty walking, and increase in heart rate. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: BREATHING DIFFICULTIES; DIFFICULTY WALKING; FATIGUE IN LEGS; MUSCLE PAIN; INCREASE IN HEART RATE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. 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 left arm on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced increase in heart rate. Laboratory data included: Heart rate (NR: not provided) Increased heart rate. On 06-MAR-2021, the subject experienced muscle pain. On 07-MAR-2021, the subject experienced breathing difficulties. On 07-MAR-2021, the subject experienced difficulty walking. On 07-MAR-2021, the subject experienced fatigue in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle pain on MAR-2021, and had not recovered from fatigue in legs, breathing difficulties, difficulty walking, and increase in heart rate. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Migraine, Pain
Clinical narrative: FELT LIKE HIT BY A TRUCK; BODY HURT ALL OVER; FEVER; CHILLS; MIGRAINE; DON'T HAVE ENERGY; 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, expiry: UNKNOWN) dose was not reported, administered on 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 felt like hit by a truck. On MAR-2021, the subject experienced body hurt all over. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced migraine. On MAR-2021, the subject experienced don't have energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body hurt all over, chills, migraine, felt like hit by a truck and don't have energy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FELT LIKE HIT BY A TRUCK; BODY HURT ALL OVER; FEVER; CHILLS; MIGRAINE; DON'T HAVE ENERGY; 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, expiry: UNKNOWN) dose was not reported, administered on 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 felt like hit by a truck. On MAR-2021, the subject experienced body hurt all over. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced migraine. On MAR-2021, the subject experienced don't have energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body hurt all over, chills, migraine, felt like hit by a truck and don't have energy was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: DIZZINESS; SORE ARM; 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 on 18-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 sore arm. On 21-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on MAR-2021, and the outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: LOSS OF SENSATION IN 3 FINGERS IN ONE HAND; This spontaneous report received from a physician concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis. 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 loss of sensation in 3 fingers in one hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of loss of sensation in 3 fingers in one hand was not reported. This report was non-serious.  Additional information was received from patient on 24-Mar-2020 following information was updated and incorporated into case narrative:  Reporter updated; Patient's details updated; Reporter details updated.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER GREATER THAN 102F; This spontaneous report received from a patient via a company representative 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, 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 reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) greater than 102 F. On 12-MAR-2021, the subject experienced fever greater than 102f. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever greater than 102f was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: PATIENT HAD A VACCINE AND FALL; 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 (form of admin and route of admin were 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 subject had a vaccine and fall. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient had a vaccine and fall was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient have unknown medical history.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. No concomitant medications were reported. On an unspecified date, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Chills, Dry mouth, Feeling abnormal
Clinical narrative: FELT LIKE CRAP; TIGHTNESS IN CHEST; COLD HANDS; BURNING SENSATION IN BODY; INSOMNIA; DRY MOUTH; FREQUENT URINATION; CHILLS; 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, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced burning sensation in body. On 21-MAR-2021, the subject experienced insomnia. On 21-MAR-2021, the subject experienced dry mouth. On 21-MAR-2021, the subject experienced frequent urination. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced headache. On 22-MAR-2021, the subject experienced tightness in chest. On 22-MAR-2021, the subject experienced cold hands. On an unspecified date, the subject experienced felt like crap. 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 cold hands, and the outcome of burning sensation in body, tightness in chest, insomnia, chills, headache, dry mouth, frequent urination and felt like crap was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Peripheral coldness, Pollakiuria
Clinical narrative: FELT LIKE CRAP; TIGHTNESS IN CHEST; COLD HANDS; BURNING SENSATION IN BODY; INSOMNIA; DRY MOUTH; FREQUENT URINATION; CHILLS; 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, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced burning sensation in body. On 21-MAR-2021, the subject experienced insomnia. On 21-MAR-2021, the subject experienced dry mouth. On 21-MAR-2021, the subject experienced frequent urination. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced headache. On 22-MAR-2021, the subject experienced tightness in chest. On 22-MAR-2021, the subject experienced cold hands. On an unspecified date, the subject experienced felt like crap. 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 cold hands, and the outcome of burning sensation in body, tightness in chest, insomnia, chills, headache, dry mouth, frequent urination and felt like crap was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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 sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, the batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers) dose was not reported, administered on 18-MAR-2021 10:30 in right deltoid  for prophylactic vaccination. Non-company suspect drugs included: paracetamol (tablet, oral, batch number was not reported) 500 mg, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 18-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 18-MAR-2021 22:30. This report was non-serious.