chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: SLEEPY; ACHY; CHILLS; LIGHT HEADEDNESS; TIRED; DIZZY WHEN STANDING; COLD; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage at the time of reporting. The patient experienced drug allergy when treated with fluconazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:53 on right arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced light headedness. On 12-MAR-2021, the subject experienced tired. On 12-MAR-2021, the subject experienced dizzy when standing. On 12-MAR-2021, the subject experienced cold. On 12-MAR-2021, the subject experienced chills. On an unspecified date, the subject experienced sleepy, and achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy when standing, had not recovered from light headedness, tired, chills, and cold, and the outcome of sleepy and achy was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: PATIENT FELT LIKE HE IS ON DEATH BED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient felt like he is on death bed. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient felt like he is on death bed was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: CHILLS; HORRIBLE HEADACHE; RIGHT ARM IS SORE; FEVER; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, attention deficit disorder, non smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse and illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced horrible headache. On 11-MAR-2021, the subject experienced right arm is sore. On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 12-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from fever, horrible headache, and right arm is sore. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHINESS; VERY SLIGHT 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: 1805031 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced achiness. On MAR-2021, the subject experienced very slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very slight fever on MAR-2021, and the outcome of achiness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Myalgia, Pyrexia
Clinical narrative: AWFUL METALLIC TASTE IN MOUTH; CHILLS; FEVER; MUSCLE ACHES; 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 08-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced awful metallic taste in mouth, chills, fever, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported and has been requested. The patient recovered from fever, and the outcome of chills, muscle aches and awful metallic taste in mouth was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with acetylsalicylic acid for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and headache, and had not recovered from fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: CHILLS; NAUSEA; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included anemia, penicillin allergy, and allergy to sulphates. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 12-MAR-2021, and had not recovered from chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Neck pain, Pain, Pyrexia
Clinical narrative: SORE/ BODY ACHE; NECK ACHE; DIARRHEA; LOW GRADE FEVER; HEADACHE; 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 was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore/ body ache, neck ache, diarrhea, low grade fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore/ body ache, diarrhea, headache, neck ache and low grade fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fall, Gingival pain, Headache
Clinical narrative: GUMS HURT; BACK ACHE; FALL; CHILLS; FEVER; 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced gums hurt, back ache, and fall. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, and fever, and the outcome of gums hurt, back ache and fall was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: GUMS HURT; BACK ACHE; FALL; CHILLS; FEVER; 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced gums hurt, back ache, and fall. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, chills, and fever, and the outcome of gums hurt, back ache and fall was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dermatitis allergic, Headache, Injection site discomfort, Nausea
Clinical narrative: SEVERE HEADACHE; SLIGHT DISCOMFORT AT THE INJECTION SITE; 2-3 RANDOM PATCHES OF SKIN; VIOLENT CHILLS; VERY SLIGHT WAVES OF 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) dose was not reported, administered on 10-MAR-2021 09:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced slight discomfort at the injection site. On 10-MAR-2021, the subject experienced 2-3 random patches of skin. On 10-MAR-2021, the subject experienced violent chills. On 10-MAR-2021, the subject experienced very slight waves of nausea. On 10-MAR-2021 19:00, the subject experienced severe headache. Treatment medications (dates unspecified) included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from violent chills, was recovering from slight discomfort at the injection site, very slight waves of nausea., and 2-3 random patches of skin, and had not recovered from severe headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Tremor
Clinical narrative: FEELING WARM; MAJOR SHAKING; CHILLS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 14-MAR-2021, the subject experienced feeling warm. On 14-MAR-2021, the subject experienced major shaking. On 14-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, major shaking and feeling warm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pruritus
Clinical narrative: ITCHINESS IN MOUTH AND TONGUE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to shellfish. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 09:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced itchiness in mouth and tongue. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 13-MAR-2021, and had not recovered from fatigue, and itchiness in mouth and tongue. The reporter causality and nausea, fatigue and itchiness in mouth and tongue was possible.  This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHILLS; DIARRHEA; FEVER; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018) dose was not reported, once a total administered  on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced diarrhea. On 11-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 12-MAR-2021, was recovering from body ache, and had not recovered from fever, and diarrhea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy on 11-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body ache and headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; TEMPERATURE WAS AT 101.1; This spontaneous report received from a patient via a 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 11-MAR-2021 13:05 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.1 (unit not provided). On 11-MAR-2021 22:45, the subject experienced chills. On 11-MAR-2021 22:45, the subject experienced temperature was at 101.1. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and temperature was at 101.1 was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: CHILLS; PAIN IN HANDS; HEADACHE; VERY TIRED; MUSCLE ACHES; PAIN IN ELBOW; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not have known allergies.  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 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced pain in hands. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced very tired. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021, the subject experienced pain in elbow. Treatment medications included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-MAR-2021, was recovering from pain in hands, and pain in elbow, and had not recovered from very tired, muscle aches, and chills. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: CHILLS; PAIN IN HANDS; HEADACHE; VERY TIRED; MUSCLE ACHES; PAIN IN ELBOW; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not have known allergies.  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 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced pain in hands. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced very tired. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021, the subject experienced pain in elbow. Treatment medications included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-MAR-2021, was recovering from pain in hands, and pain in elbow, and had not recovered from very tired, muscle aches, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nodule, Pain in extremity, Paraesthesia, Pruritus
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: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ibuprofen for drug used for unknown indication. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced pain to touch. On 11-MAR-2021, the subject experienced had a knot. On 11-MAR-2021, the subject experienced redness. On 11-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, pain to touch, redness, itching, and had a knot. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia
Clinical narrative: FEVER; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102, 100.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A VERY, VERY MINIMAL SORE AREA IN ARM; This spontaneous report received from a patient via a company representative concerned a 56 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: Unk expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.No concomitant medications were reported. On MAR-2021, the subject experienced a very, very minimal sore area in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a very, very minimal sore area in arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Decreased appetite, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: DIARRHEA; BAD HANGOVER; BREATHING RAPIDLY; SHORTNESS OF BREATH; NOT HUNGRY; FEELS FULL; TIREDNESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced diarrhea. On 11-MAR-2021, the subject experienced bad hangover. On 11-MAR-2021, the subject experienced breathing rapidly. On 11-MAR-2021, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced not hungry. On 11-MAR-2021, the subject experienced feels full. On 11-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, tiredness, bad hangover, breathing rapidly, shortness of breath, feels full, and not hungry. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hangover, Respiratory rate increased
Clinical narrative: DIARRHEA; BAD HANGOVER; BREATHING RAPIDLY; SHORTNESS OF BREATH; NOT HUNGRY; FEELS FULL; TIREDNESS; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced diarrhea. On 11-MAR-2021, the subject experienced bad hangover. On 11-MAR-2021, the subject experienced breathing rapidly. On 11-MAR-2021, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced not hungry. On 11-MAR-2021, the subject experienced feels full. On 11-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, tiredness, bad hangover, breathing rapidly, shortness of breath, feels full, and not hungry. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: NUMBNESS ON THE FACE; TINGLES ON THE FACE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hbp, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 in the right arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced numbness on the face. On 12-MAR-2021, the subject experienced tingles on the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on the face, and tingles on the face. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Endocrine test, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: LEFT SIDED THROAT PAIN; LEFT EAR PAIN; PAIN UNDER LEFT EYE; LEFT SIDED HEADACHE; TIRED; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteoporosis, seasonal allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: Endocrine function test (NR: not provided) within normal limits. On MAR-2021, treatment medications included: naproxen. On 07-MAR-2021, the subject experienced left sided throat pain. On 07-MAR-2021, the subject experienced left ear pain. On 07-MAR-2021, the subject experienced pain under left eye. On 07-MAR-2021, the subject experienced left sided headache. On 07-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left sided headache, and tired, and the outcome of left sided throat pain, left ear pain and pain under left eye was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Periorbital pain
Clinical narrative: LEFT SIDED THROAT PAIN; LEFT EAR PAIN; PAIN UNDER LEFT EYE; LEFT SIDED HEADACHE; TIRED; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteoporosis, seasonal allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: Endocrine function test (NR: not provided) within normal limits. On MAR-2021, treatment medications included: naproxen. On 07-MAR-2021, the subject experienced left sided throat pain. On 07-MAR-2021, the subject experienced left ear pain. On 07-MAR-2021, the subject experienced pain under left eye. On 07-MAR-2021, the subject experienced left sided headache. On 07-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left sided headache, and tired, and the outcome of left sided throat pain, left ear pain and pain under left eye was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Ear pain, Headache, Influenza like illness, Lethargy
Clinical narrative: LEFT SIDED THROAT PAIN; LEFT EAR PAIN; PAIN UNDER LEFT EYE; LEFT SIDED HEADACHE; TIRED; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteoporosis, seasonal allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: Endocrine function test (NR: not provided) within normal limits. On MAR-2021, treatment medications included: naproxen. On 07-MAR-2021, the subject experienced left sided throat pain. On 07-MAR-2021, the subject experienced left ear pain. On 07-MAR-2021, the subject experienced pain under left eye. On 07-MAR-2021, the subject experienced left sided headache. On 07-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left sided headache, and tired, and the outcome of left sided throat pain, left ear pain and pain under left eye was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Oropharyngeal pain
Clinical narrative: LEFT SIDED THROAT PAIN; LEFT EAR PAIN; PAIN UNDER LEFT EYE; LEFT SIDED HEADACHE; TIRED; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included osteoporosis, seasonal allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: Endocrine function test (NR: not provided) within normal limits. On MAR-2021, treatment medications included: naproxen. On 07-MAR-2021, the subject experienced left sided throat pain. On 07-MAR-2021, the subject experienced left ear pain. On 07-MAR-2021, the subject experienced pain under left eye. On 07-MAR-2021, the subject experienced left sided headache. On 07-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left sided headache, and tired, and the outcome of left sided throat pain, left ear pain and pain under left eye was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Endocrine test, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: FLU-LIKE SYMPTOMS; UNWELL; LEFT SIDE HEADACHE; LETHARGY; LEFT EAR PAIN; OVERALL WEAKNESS; SORE THROAT; This spontaneous report received from a patient via a company representative concerned a 59 year old female. The patient's weight was 125 pounds, and height was 65 inches. The patient's concurrent conditions included osteoporosis.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 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On MAR-2021, the subject experienced lethargy. On MAR-2021, the subject experienced left ear pain. On MAR-2021, the subject experienced overall weakness. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced unwell. On MAR-2021, the subject experienced left side headache. On 07-MAR-2021, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, unwell, left side headache, sore throat, lethargy, overall weakness, and left ear pain. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Periorbital pain
Clinical narrative: FLU-LIKE SYMPTOMS; UNWELL; LEFT SIDE HEADACHE; LETHARGY; LEFT EAR PAIN; OVERALL WEAKNESS; SORE THROAT; This spontaneous report received from a patient via a company representative concerned a 59 year old female. The patient's weight was 125 pounds, and height was 65 inches. The patient's concurrent conditions included osteoporosis.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 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On MAR-2021, the subject experienced lethargy. On MAR-2021, the subject experienced left ear pain. On MAR-2021, the subject experienced overall weakness. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced unwell. On MAR-2021, the subject experienced left side headache. On 07-MAR-2021, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, unwell, left side headache, sore throat, lethargy, overall weakness, and left ear pain. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Ear pain, Headache, Influenza like illness, Lethargy
Clinical narrative: FLU-LIKE SYMPTOMS; UNWELL; LEFT SIDE HEADACHE; LETHARGY; LEFT EAR PAIN; OVERALL WEAKNESS; SORE THROAT; This spontaneous report received from a patient via a company representative concerned a 59 year old female. The patient's weight was 125 pounds, and height was 65 inches. The patient's concurrent conditions included osteoporosis.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 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On MAR-2021, the subject experienced lethargy. On MAR-2021, the subject experienced left ear pain. On MAR-2021, the subject experienced overall weakness. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced unwell. On MAR-2021, the subject experienced left side headache. On 07-MAR-2021, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, unwell, left side headache, sore throat, lethargy, overall weakness, and left ear pain. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Oropharyngeal pain
Clinical narrative: FLU-LIKE SYMPTOMS; UNWELL; LEFT SIDE HEADACHE; LETHARGY; LEFT EAR PAIN; OVERALL WEAKNESS; SORE THROAT; This spontaneous report received from a patient via a company representative concerned a 59 year old female. The patient's weight was 125 pounds, and height was 65 inches. The patient's concurrent conditions included osteoporosis.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 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On MAR-2021, the subject experienced lethargy. On MAR-2021, the subject experienced left ear pain. On MAR-2021, the subject experienced overall weakness. On MAR-2021, the subject experienced sore throat. On MAR-2021, the subject experienced unwell. On MAR-2021, the subject experienced left side headache. On 07-MAR-2021, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, unwell, left side headache, sore throat, lethargy, overall weakness, and left ear pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: RED BUMP; BRUISED; INJECTION SITE SWELLING; PAIN; 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on the left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced red bump. On MAR-2021, the subject experienced bruised. On MAR-2021, the subject experienced injection site swelling. On MAR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site swelling, red bump, pain and bruised was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; 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 06-MAR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced suspected covid-19 infection. On 06-MAR-2021 20:30, Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 12-MAR-2021 13:20, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This case is associated with PQC number: The suspected product quality complaint has been confirmed to be voided: does not meet PQC criteria based on the PQC evaluation/investigation performed.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious..
Sex: M
Vaccine: COVID19
Symptoms: Injection site haematoma, Injection site haemorrhage, Injection site nodule, Injection site swelling
Clinical narrative: BLEEDING; HEMATOMA; BUMP AT INJECTION SITE; SWELLING; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The patient vaccinated on left arm. No concomitant medications were reported. On 13-MAR-2021, the subject experienced bleeding. On 13-MAR-2021, the subject experienced hematoma. On 13-MAR-2021, the subject experienced bump at injection site. On 13-MAR-2021, the subject experienced swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding on MAR-2021, was recovering from swelling, had not recovered from bump at injection site, and the outcome of hematoma was not reported. This report was non-serious.   Additional information was received on 23-Mar-2021. The following information was updated and incorporated into the case narrative: Patient's sex .; 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: Chills, Headache, Insomnia, Malaise, Night sweats
Clinical narrative: HEADACHE; UNWELL WITH CHILLS; SHAKING/TREMORS OF HANDS/ARMS; OVERALL ACHES; FELT UNWELL; NIGHT SWEATS (FEVER); TROUBLE SLEEPING AT NIGHT DUE TO THESE SYMPTOMS; 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 not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 12-MAR-2021, the subject experienced trouble sleeping at night due to these symptoms. On 12-MAR-2021, the subject experienced night sweats (fever). On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021 22:30, the subject experienced shaking/tremors of hands/arms. On 12-MAR-2021 22:30, the subject experienced overall aches. On 12-MAR-2021 22:30, the subject experienced felt unwell. On 12-MAR-2021 22:30, the subject experienced unwell with chills. On 14-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking/tremors of hands/arms, trouble sleeping at night due to these symptoms, overall aches, felt unwell, night sweats (fever), unwell with chills, fever, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: HEADACHE; UNWELL WITH CHILLS; SHAKING/TREMORS OF HANDS/ARMS; OVERALL ACHES; FELT UNWELL; NIGHT SWEATS (FEVER); TROUBLE SLEEPING AT NIGHT DUE TO THESE SYMPTOMS; 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 not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: paracetamol. On 12-MAR-2021, the subject experienced trouble sleeping at night due to these symptoms. On 12-MAR-2021, the subject experienced night sweats (fever). On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021 22:30, the subject experienced shaking/tremors of hands/arms. On 12-MAR-2021 22:30, the subject experienced overall aches. On 12-MAR-2021 22:30, the subject experienced felt unwell. On 12-MAR-2021 22:30, the subject experienced unwell with chills. On 14-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking/tremors of hands/arms, trouble sleeping at night due to these symptoms, overall aches, felt unwell, night sweats (fever), unwell with chills, fever, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dry mouth, Dyspnoea, Headache
Clinical narrative: ROUGH NIGHTS SLEEP; DRY MOUTH; HEADCOLD; BREATHING ISSUES; SWEATING; FEVER; CHILLS; MILD HEADACHE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had drug abuse/illicit drug use. not necessarily takes cholesterol pill.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 08-MAR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced rough nights sleep. On MAR-2021, the subject experienced dry mouth. On MAR-2021, the subject experienced headcold. On MAR-2021, the subject experienced breathing issues. On MAR-2021, the subject experienced sweating. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced mild headache. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and chills on 12-MAR-2021, had not recovered from dry mouth, headcold, and breathing issues, and the outcome of rough nights sleep, mild headache and sweating was not reported. This report was non-serious.