chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Headache, Myalgia, Nausea, Pain
Clinical narrative: PAIN IN LUNGS; BODY PAIN; BONE PAIN; FEVER; HEADACHE; NAUSEA; MUSCLE 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, and batch number were not reported) 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 an unspecified date, the subject experienced pain in lungs, body pain, bone pain, fever, headache, nausea, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in lungs, and body pain, and the outcome of fever, headache, nausea, muscle pain and bone pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210432269.; Sender's Comments: v0-Medical assessment comment not required as per standard operating procedures.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary pain, Pyrexia
Clinical narrative: PAIN IN LUNGS; BODY PAIN; BONE PAIN; FEVER; HEADACHE; NAUSEA; MUSCLE 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, and batch number were not reported) 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 an unspecified date, the subject experienced pain in lungs, body pain, bone pain, fever, headache, nausea, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in lungs, and body pain, and the outcome of fever, headache, nausea, muscle pain and bone pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210432269.; Sender's Comments: v0-Medical assessment comment not required as per standard operating procedures.
Sex: U
Vaccine: COVID19
Symptoms: Muscle twitching, Pinguecula, Skin mass
Clinical narrative: YELLOW SPOT IN EYES; 2 KNOTS ON HEAD THAT ARE SORE TO TOUCH; VACCINE WITH TWITCHING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 2021, the subject experienced vaccine with twitching. On an unspecified date, the subject experienced yellow spot in eyes, and 2 knots on head that are sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine with twitching on 2021, and the outcome of yellow spot in eyes and 2 knots on head that are sore to touch was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Chills, Fatigue, Feeling abnormal, Pain
Clinical narrative: BLOOD IN URINE; FEELING BAD; BODY ACHES; CHILLS; EXHAUSTED; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included iga nephropathy, non-smoker, and non alcoholic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced blood in urine. On 11-APR-2021, the subject experienced feeling bad. On 11-APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood in urine on 13-APR-2021, and chills, was recovering from feeling bad, and had not recovered from body aches, and exhausted. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry eye, Headache, Laziness, Somnolence
Clinical narrative: DIZZY; HEADACHE; DRY EYES; FEELS LAZY; SLEEPY; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included anemic, and hysterectomy, and concurrent conditions included stones in gallbladder, high cholesterol, borderline diabetic, overweight, alcohol user, and non-smoker, and other pre-existing medical conditions included no known drug allergies. The patient experienced stomach upset when treated with paracetamol for pain. 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-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced dry eyes. On 12-APR-2021, the subject experienced feels lazy. On 12-APR-2021, the subject experienced sleepy. On 13-APR-2021, the subject experienced dizzy. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dry eyes, feels lazy, sleepy, headache, and dizzy. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia, Throat irritation
Clinical narrative: BURNING THROAT PAIN; DIFFICULTY IN SWALLOWING; 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: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced burning throat pain. On APR-2021, the subject experienced difficulty in swallowing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning throat pain and difficulty in swallowing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Pyrexia
Clinical narrative: DIZZINESS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache and dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: ITCHING; REGULAR HIVES; 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 hives.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, treatment medications included: cetirizine hydrochloride, diphenhydramine hydrochloride, omalizumab, and prednisone. On 12-APR-2021, the subject experienced itching. On 12-APR-2021, the subject experienced regular hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching, and regular hives. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypotension
Clinical narrative: LOW BLOOD PRESSURE; TIREDNESS; SLIGHTLY LIGHT HEADEDNESS; This spontaneous report received from a patient concerned a 60 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) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested.  No concomitant medications were reported. On 10-APR-2021, the subject experienced slightly light headedness. On 10-APR-2021, the subject experienced tiredness. On an unspecified date, the subject experienced low blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, and slightly light headedness, and the outcome of low blood pressure was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Chills, Hypertension, Memory impairment, Pain in extremity
Clinical narrative: SPEECH PROBLEM/SLUTTER; LACK OF MEMORY (FORGET THINGS); WEIGHT LOSS; HIGH BLOOD PRESSURE 172/95 SOMETIMES 180; RASH ON  HER FACE; CHILLS; PAIN IN  RIGHT ARM AND RIGHT LEG; This spontaneous report received from a patient concerned a 62 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, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced speech problem/slutter, lack of memory (forget things), weight loss, high blood pressure 172/95 sometimes 180, rash on her face, chills, and pain in right arm and right leg. Laboratory data (dates unspecified) included: Blood pressure high (NR: not provided) BLOOD PRESSURE 172/95 SOMETIMES 180. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right arm and right leg, weight loss, chills, lack of memory (forget things), speech problem/slutter, rash on her face, and high blood pressure 172/95 sometimes 180. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Speech disorder, Weight decreased
Clinical narrative: SPEECH PROBLEM/SLUTTER; LACK OF MEMORY (FORGET THINGS); WEIGHT LOSS; HIGH BLOOD PRESSURE 172/95 SOMETIMES 180; RASH ON  HER FACE; CHILLS; PAIN IN  RIGHT ARM AND RIGHT LEG; This spontaneous report received from a patient concerned a 62 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, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced speech problem/slutter, lack of memory (forget things), weight loss, high blood pressure 172/95 sometimes 180, rash on her face, chills, and pain in right arm and right leg. Laboratory data (dates unspecified) included: Blood pressure high (NR: not provided) BLOOD PRESSURE 172/95 SOMETIMES 180. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right arm and right leg, weight loss, chills, lack of memory (forget things), speech problem/slutter, rash on her face, and high blood pressure 172/95 sometimes 180. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pain in extremity, Pruritus, Rash
Clinical narrative: ITCHING; WARM AT INJECTION SITE; RASH; RIGHT LEG IS ACHING FROM KNEE TO HIP AREA; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced itching. On APR-2021, the subject experienced warm at injection site. On APR-2021, the subject experienced rash. On APR-2021, the subject experienced right leg is aching from knee to hip area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash, right leg is aching from knee to hip area, itching and warm at injection site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: strong headache; 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, and batch number were not reported) dose was not reported, administered on 08-APR-2021 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 09-APR-2021, the subject experienced strong headache. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the strong headache and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Polymenorrhoea
Clinical narrative: CRAMPS ON MY PELVIS/CRAMPS ON LOWER BACK; INDUCED PERIODS; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) dose, start therapy date were not reported for prophylactic vaccination The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced cramps on my pelvis/cramps on lower back, and induced periods. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps on my pelvis/cramps on lower back, and induced periods. This report was non-serious. This case is a duplicate of 20210424112. This case, from the same reporter is linked to 20210412152.  It was determined that this case is a duplicate of Manufacture Case number (20210428669). This case, Manufacturer Report Number (20210424112), will be nullified and deleted. All relevant information will be submitted under a Manufacturer Case Number (20210428669).
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: ADMINISTER TO 16 YEAR OLD PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced administer to 16 year old subject. On 13-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administer to 16 year old patient and off label use was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bronchitis, Chills, Feeling cold, Malaise
Clinical narrative: LEG PAIN; KNEE JOINT PAIN; CHILLS; FEELING UNWELL; FEVERISH; MUSCLE PAIN; BODY ACHE; COUGH WITH PHLEGM; IRRITATION IN BRONCHIOLES; FEELING COLD WITH GOOSEBUMPS; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced cough with phlegm. On 06-APR-2021, the subject experienced irritation in bronchioles. On 06-APR-2021, the subject experienced feeling cold with goosebumps. On 06-APR-2021, the subject experienced knee joint pain. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced feeling unwell. On 06-APR-2021, the subject experienced feverish. On 06-APR-2021, the subject experienced muscle pain. On 12-APR-2021, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feverish, chills, body ache, muscle pain, cough with phlegm, irritation in bronchioles, feeling cold with goosebumps, leg pain, knee joint pain and feeling unwell was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Productive cough, Pyrexia
Clinical narrative: LEG PAIN; KNEE JOINT PAIN; CHILLS; FEELING UNWELL; FEVERISH; MUSCLE PAIN; BODY ACHE; COUGH WITH PHLEGM; IRRITATION IN BRONCHIOLES; FEELING COLD WITH GOOSEBUMPS; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced cough with phlegm. On 06-APR-2021, the subject experienced irritation in bronchioles. On 06-APR-2021, the subject experienced feeling cold with goosebumps. On 06-APR-2021, the subject experienced knee joint pain. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced feeling unwell. On 06-APR-2021, the subject experienced feverish. On 06-APR-2021, the subject experienced muscle pain. On 12-APR-2021, the subject experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feverish, chills, body ache, muscle pain, cough with phlegm, irritation in bronchioles, feeling cold with goosebumps, leg pain, knee joint pain and feeling unwell was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: CHILLS; MUSCLE ACHES; This spontaneous report received from a consumer concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches and chills was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: LUMP ON LEFT SIDE OF NECK; CHILLS; FATIGUE; HEADACHE; FEVER; SHAKING; FLU-LIKE SYMPTOMS; ACHYING JOINTS; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto's disease, seasonal allergies, and certain metal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced shaking. On 10-APR-2021, the subject experienced flu-like symptoms. On 10-APR-2021, the subject experienced achying joints. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced lump on left side of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, flu-like symptoms, achying joints, chills, fatigue, headache, and fever on 13-APR-2021, and had not recovered from lump on left side of neck. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass, Pyrexia, Tremor
Clinical narrative: LUMP ON LEFT SIDE OF NECK; CHILLS; FATIGUE; HEADACHE; FEVER; SHAKING; FLU-LIKE SYMPTOMS; ACHYING JOINTS; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto's disease, seasonal allergies, and certain metal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced shaking. On 10-APR-2021, the subject experienced flu-like symptoms. On 10-APR-2021, the subject experienced achying joints. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced lump on left side of neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, flu-like symptoms, achying joints, chills, fatigue, headache, and fever on 13-APR-2021, and had not recovered from lump on left side of neck. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Headache, Injection site pain, Pain
Clinical narrative: DIARRHEA; BODY ACHES; LEG PAIN; HEADACHE; INJECTION SITE PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 58 year old. 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced back pain. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced injection site pain. On 12-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain, and headache on 11-APR-2021, was recovering from injection site pain, and leg pain, and had not recovered from diarrhea, and body aches. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: DIARRHEA; BODY ACHES; LEG PAIN; HEADACHE; INJECTION SITE PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 58 year old. 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: 205A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced back pain. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced injection site pain. On 12-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain, and headache on 11-APR-2021, was recovering from injection site pain, and leg pain, and had not recovered from diarrhea, and body aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: BAD 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: 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 bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chills
Clinical narrative: SIDE EFFECTS; CHILLS; 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced side effects. On APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effects, and chills on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: NUMB LEFT CHEEK; This spontaneous report received from a patient concerned a 49 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: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. No concomitant medications were reported. On 14-APR-2021, the subject experienced numb left cheek. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numb left cheek. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Application site erythema, Dizziness, Fatigue, Gastrooesophageal reflux disease, Headache
Clinical narrative: MIGRAINE; FATIGUE/EXHAUSTED; HEADACHE; DIZZY, EQUILIBRIUM OFF, ROOM SPINNING; REDNESS TWO X  TWO AREA; ACID REFLUX IN STOMACH; NAUSEA; ARM SWELLING, REDNESS TWO X TWO AREA, HARDNESS AT SITE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included cholecystectomy, and birth control pill, and concurrent conditions included arthritis, herniated discs C5 & C6, knees pain, neck pain, major depressive disorder, hashimoto's disease, hypothyroid, asthma, latex allergy, non-smoker, non-alcoholic, and autoimmune disorder, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:00 for prophylactic vaccination. Concomitant medications included montelukast sodium for asthma, salbutamol for asthma, levothyroxine sodium for hashimoto's disease, hypothyroid, and auto-immune, ibuprofen for herniated discs C5 and C6, cortisone for knees and neck pain, bupropion hydrochloride for major depressive disorder, and sertraline hydrochloride for major depressive disorder. On 10-APR-2021, the subject experienced redness two x two area. On 10-APR-2021, the subject experienced acid reflux in stomach. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced arm swelling, redness two x two area, hardness at site. On 10-APR-2021 12:30, the subject experienced dizzy, equilibrium off, room spinning. On 11-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced fatigue/exhausted. On an unspecified date, the subject experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, equilibrium off, room spinning, acid reflux in stomach, and nausea on 11-APR-2021, and headache on 12-APR-2021, had not recovered from redness two x two area, arm swelling, redness two x two area, hardness at site, and fatigue/exhausted, and the outcome of migraine was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site swelling, Migraine, Nausea
Clinical narrative: MIGRAINE; FATIGUE/EXHAUSTED; HEADACHE; DIZZY, EQUILIBRIUM OFF, ROOM SPINNING; REDNESS TWO X  TWO AREA; ACID REFLUX IN STOMACH; NAUSEA; ARM SWELLING, REDNESS TWO X TWO AREA, HARDNESS AT SITE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included cholecystectomy, and birth control pill, and concurrent conditions included arthritis, herniated discs C5 & C6, knees pain, neck pain, major depressive disorder, hashimoto's disease, hypothyroid, asthma, latex allergy, non-smoker, non-alcoholic, and autoimmune disorder, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 11:00 for prophylactic vaccination. Concomitant medications included montelukast sodium for asthma, salbutamol for asthma, levothyroxine sodium for hashimoto's disease, hypothyroid, and auto-immune, ibuprofen for herniated discs C5 and C6, cortisone for knees and neck pain, bupropion hydrochloride for major depressive disorder, and sertraline hydrochloride for major depressive disorder. On 10-APR-2021, the subject experienced redness two x two area. On 10-APR-2021, the subject experienced acid reflux in stomach. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced arm swelling, redness two x two area, hardness at site. On 10-APR-2021 12:30, the subject experienced dizzy, equilibrium off, room spinning. On 11-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced fatigue/exhausted. On an unspecified date, the subject experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, equilibrium off, room spinning, acid reflux in stomach, and nausea on 11-APR-2021, and headache on 12-APR-2021, had not recovered from redness two x two area, arm swelling, redness two x two area, hardness at site, and fatigue/exhausted, and the outcome of migraine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: MUSCLE PAIN IN BOTH ARMS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 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 muscle pain in both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle pain in both arms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Oedema peripheral
Clinical narrative: SORENESS IN ARM; LEG PAIN; EDEMA OF LOWER EXTREMITIES; NAUSEA; HEADACHE; VOMITING; CHILLS; EXHAUSTION; 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 13-MAR-2021 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 chills. On 13-MAR-2021, the subject experienced exhaustion. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced edema of lower extremities, soreness in arm, leg pain, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, soreness in arm, chills, exhaustion, and nausea on 17-MAR-2021, had not recovered from edema of lower extremities, and leg pain, and the outcome of headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: SORENESS IN ARM; LEG PAIN; EDEMA OF LOWER EXTREMITIES; NAUSEA; HEADACHE; VOMITING; CHILLS; EXHAUSTION; 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 13-MAR-2021 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 chills. On 13-MAR-2021, the subject experienced exhaustion. On 14-MAR-2021, the subject experienced vomiting. On 14-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced edema of lower extremities, soreness in arm, leg pain, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, soreness in arm, chills, exhaustion, and nausea on 17-MAR-2021, had not recovered from edema of lower extremities, and leg pain, and the outcome of headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .8 ml, 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced overdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of overdose was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ALL OVER THE BODY; 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, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced rash all over the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash all over the body was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Migraine
Clinical narrative: MIGRAINE; DIARRHEA; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 05-MAR-2021, the subject experienced migraine. On 05-MAR-2021, the subject experienced diarrhea. On 05-MAR-2021, the subject experienced chills. On an unspecified date, the subject experienced bad shortness of breath, and couldn't climb a flight of stairs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad shortness of breath, migraine, and chills, and diarrhea on 05-MAR-2021, and was recovering from couldn't climb a flight of stairs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: SLIGHT FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 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 12-APR-2021, the subject experienced slight fever. On 12-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever and fatigue was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Bone pain, Ear pain
Clinical narrative: SORE THROAT; SORE ENTIRE UPPER BACK; RIGHT SHOULDER SORE; HEADACHE; SORE NECK; LEFT SHOULDER INJECTION SITE PAIN; ROOF OF MOUTH TENDER; EAR ACHE; RIGHT KNEE AND SHIN BONE PAIN; SORENESS FROM LEFT SIDE TO LEFT WRIST; FLUSHED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included severe allergies to grass, severe allergies to cat, and severe allergies to bees.  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 08-APR-2021 08:50 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced sore neck. On 08-APR-2021, the subject experienced roof of mouth tender. On 08-APR-2021, the subject experienced ear ache. On 08-APR-2021, the subject experienced right knee and shin bone pain. On 08-APR-2021, the subject experienced soreness from left side to left wrist. On 08-APR-2021, the subject experienced flushed. On 08-APR-2021, the subject experienced left shoulder injection site pain. On 10-APR-2021, the subject experienced sore entire upper back. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced right shoulder sore. On 10-APR-2021, the subject experienced headache. Laboratory data on 08-Apr-2021 included: Body temperature (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore neck, sore entire upper back, roof of mouth tender, ear ache, sore throat, and headache on 12-APR-2021, and flushed on 08-APR-2021, and had not recovered from right knee and shin bone pain, left shoulder injection site pain, right shoulder sore, and soreness from left side to left wrist. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Flank pain, Flushing, Headache, Injection site pain, Neck pain
Clinical narrative: SORE THROAT; SORE ENTIRE UPPER BACK; RIGHT SHOULDER SORE; HEADACHE; SORE NECK; LEFT SHOULDER INJECTION SITE PAIN; ROOF OF MOUTH TENDER; EAR ACHE; RIGHT KNEE AND SHIN BONE PAIN; SORENESS FROM LEFT SIDE TO LEFT WRIST; FLUSHED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included severe allergies to grass, severe allergies to cat, and severe allergies to bees.  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 08-APR-2021 08:50 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced sore neck. On 08-APR-2021, the subject experienced roof of mouth tender. On 08-APR-2021, the subject experienced ear ache. On 08-APR-2021, the subject experienced right knee and shin bone pain. On 08-APR-2021, the subject experienced soreness from left side to left wrist. On 08-APR-2021, the subject experienced flushed. On 08-APR-2021, the subject experienced left shoulder injection site pain. On 10-APR-2021, the subject experienced sore entire upper back. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced right shoulder sore. On 10-APR-2021, the subject experienced headache. Laboratory data on 08-Apr-2021 included: Body temperature (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore neck, sore entire upper back, roof of mouth tender, ear ache, sore throat, and headache on 12-APR-2021, and flushed on 08-APR-2021, and had not recovered from right knee and shin bone pain, left shoulder injection site pain, right shoulder sore, and soreness from left side to left wrist. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Oral pain, Oropharyngeal pain
Clinical narrative: SORE THROAT; SORE ENTIRE UPPER BACK; RIGHT SHOULDER SORE; HEADACHE; SORE NECK; LEFT SHOULDER INJECTION SITE PAIN; ROOF OF MOUTH TENDER; EAR ACHE; RIGHT KNEE AND SHIN BONE PAIN; SORENESS FROM LEFT SIDE TO LEFT WRIST; FLUSHED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included severe allergies to grass, severe allergies to cat, and severe allergies to bees.  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 08-APR-2021 08:50 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced sore neck. On 08-APR-2021, the subject experienced roof of mouth tender. On 08-APR-2021, the subject experienced ear ache. On 08-APR-2021, the subject experienced right knee and shin bone pain. On 08-APR-2021, the subject experienced soreness from left side to left wrist. On 08-APR-2021, the subject experienced flushed. On 08-APR-2021, the subject experienced left shoulder injection site pain. On 10-APR-2021, the subject experienced sore entire upper back. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced right shoulder sore. On 10-APR-2021, the subject experienced headache. Laboratory data on 08-Apr-2021 included: Body temperature (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore neck, sore entire upper back, roof of mouth tender, ear ache, sore throat, and headache on 12-APR-2021, and flushed on 08-APR-2021, and had not recovered from right knee and shin bone pain, left shoulder injection site pain, right shoulder sore, and soreness from left side to left wrist. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Fatigue, Headache
Clinical narrative: WEAKNESS; SEVERE HEADACHE; FEVER; STOMACH ACHE; VOMITING; BODY ACHES; DROWSINESS; CHILLS; DID NOT SLEEP WELL; VERY FATIGUE; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight was 170 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced did not sleep well. On APR-2021, the subject experienced very fatigue. On 08-APR-2021, the subject experienced stomach ache. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced drowsiness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced severe headache. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and fever on 10-APR-2021, and body aches, drowsiness, chills, and weakness on 09-APR-2021, was recovering from stomach ache, had not recovered from severe headache, and the outcome of did not sleep well and very fatigue was not reported. This report was non-serious.