chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: FLU FEELING; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced flu feeling, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and flu feeling was not reported. This report was non-serious.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: ARM WAS SORE AT THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 74 year old of unspecified sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced arm was sore at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm was sore at the injection site was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dysgeusia, Fatigue, Headache
Clinical narrative: JOINT PAIN; SEVERE HEADACHE; FATIGUE; METALLIC TASTE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included suffered hemorrhagic stroke, and aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 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 metallic taste. On 13-MAR-2021, the subject experienced joint pain. On 13-MAR-2021, the subject experienced severe headache. 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 metallic taste on 13-MAR-2021, and joint pain, severe headache, and fatigue on 14-MAR-2021. This report was non-serious. The case is associated with Product Quality Complaint number # 90000173161 The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.  Additional information was received from  Regulatory authorities on 17-MAR-2021. The following information was updated and incorporated into the case narrative: Product complaint investigation result was added.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: MILD FATIGUE; This spontaneous report received from a patient via a company representative concerned a 60 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-MAR-2021, the subject experienced mild fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Nodule, Pain in extremity, Skin warm
Clinical narrative: ARM SORENESS; BUMP/KNOT; WARMNESS TO THE TOUCH; ARM REDNESS; 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: 1802072, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced arm soreness. On 12-MAR-2021, the subject experienced bump/knot. On 12-MAR-2021, the subject experienced warmness to the touch. On 12-MAR-2021, the subject experienced arm redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm soreness, and warmness to the touch, and had not recovered from bump/knot, and arm redness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: HEADACHE; SHIVERING; TEMPERATURE IT WAS 105.3; 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, 1 total, administered on 03-MAR-2021 19:00 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 105.3. On 12-MAR-2021 03:00, the subject experienced shivering. On 12-MAR-2021 03:00, the subject experienced temperature it was 105.3. On an unspecified date, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of shivering and temperature it was 105.3 was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pallor
Clinical narrative: PALENESS; WEAKNESS; FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced paleness. On 11-MAR-2021, the subject experienced weakness. On 11-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paleness, weakness, and fatigue on 14-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER; BODY PAIN; 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 16-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 fever, and body pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and body pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Heart rate increased, Nausea
Clinical narrative: HEART BEAT RAISING; Trembling; TINGLING IN HANDS AND FEET; SUPER COLD; Itching; CHILLS; TIREDNESS; FEVERISH; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-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 heart beat raising. On MAR-2021, the subject experienced trembling. On MAR-2021, the subject experienced tingling in hands and feet. On MAR-2021, the subject experienced super cold. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced feverish. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart beat raising, tingling in hands and feet, super cold, and trembling, and the outcome of tiredness, chills, feverish, nausea and itching was not reported. This report was non-serious.; Sender's Comments: V.0 MAC not required per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Pyrexia, Tremor
Clinical narrative: HEART BEAT RAISING; Trembling; TINGLING IN HANDS AND FEET; SUPER COLD; Itching; CHILLS; TIREDNESS; FEVERISH; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-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 heart beat raising. On MAR-2021, the subject experienced trembling. On MAR-2021, the subject experienced tingling in hands and feet. On MAR-2021, the subject experienced super cold. On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced feverish. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart beat raising, tingling in hands and feet, super cold, and trembling, and the outcome of tiredness, chills, feverish, nausea and itching was not reported. This report was non-serious.; Sender's Comments: V.0 MAC not required per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORENESS ON THE INJECTION SITE; This spontaneous report received from a consumer concerned an 87 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included persistent back ache. The patient was previously treated with paracetamol for back pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 13-MAR-2021, the subject experienced soreness on the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness on the injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: NAUSEAS ON AND OFF; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced nausea on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nausea on and off was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: INJECTION SITE PAIN; LOW GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced injection site pain, and low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site pain and low grade fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Pain
Clinical narrative: ACHE; DIZZY; FOGGY; 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced ache. On 15-MAR-2021, the subject experienced dizzy. On 15-MAR-2021, the subject experienced foggy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ache, dizzy, and foggy. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: PAIN UNDER LEFT SHOULDER BLADE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included acetaminophen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced pain under left shoulder blade. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain under left shoulder blade. This report was non-serious.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Chills, Dyspnoea, Erythema
Clinical narrative: SHOULDER PAIN; MALAISE; HEADACHE; OUT OF BREATH; RED CHEEKS; FEELING COLD; CHILLS/SHIVERING; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation, leaky valves, pacemaker, and latex allergy. The patient experienced drug allergy when treated with ibuprofen, levofloxacin, prednisone, tramadol, and tramadol hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180029,  expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included latanoprost for glaucoma, alprazolam, amlodipine, apixaban, and flecainide. On 15-MAR-2021, the subject experienced feeling cold. On 15-MAR-2021, the subject experienced red cheeks. On 15-MAR-2021, the subject experienced chills/shivering. On 16-MAR-2021, the subject experienced out of breath. On 16-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced malaise, and shoulder pain. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Urine analysis (NR: not provided) Unknown, and X-ray (NR: not provided) Unknown. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, out of breath, shoulder pain, malaise, and red cheeks, and the outcome of chills/shivering and feeling cold was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Headache, Malaise, Urine analysis, X-ray
Clinical narrative: SHOULDER PAIN; MALAISE; HEADACHE; OUT OF BREATH; RED CHEEKS; FEELING COLD; CHILLS/SHIVERING; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation, leaky valves, pacemaker, and latex allergy. The patient experienced drug allergy when treated with ibuprofen, levofloxacin, prednisone, tramadol, and tramadol hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180029,  expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included latanoprost for glaucoma, alprazolam, amlodipine, apixaban, and flecainide. On 15-MAR-2021, the subject experienced feeling cold. On 15-MAR-2021, the subject experienced red cheeks. On 15-MAR-2021, the subject experienced chills/shivering. On 16-MAR-2021, the subject experienced out of breath. On 16-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced malaise, and shoulder pain. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Urine analysis (NR: not provided) Unknown, and X-ray (NR: not provided) Unknown. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, out of breath, shoulder pain, malaise, and red cheeks, and the outcome of chills/shivering and feeling cold was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Discomfort, Eye disorder, Headache
Clinical narrative: SHOULDER PAIN; MALAISE; HEADACHE; OUT OF BREATH; RED CHEEKS; FEELING COLD; CHILLS/SHIVERING; This spontaneous report received from a patient concerned an 87 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation, leaky valves, pacemaker, and latex allergy. The patient experienced drug allergy when treated with ibuprofen, levofloxacin, prednisone, tramadol, and tramadol hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180029,  expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included latanoprost for glaucoma, alprazolam, amlodipine, apixaban, and flecainide. On 15-MAR-2021, the subject experienced feeling cold. On 15-MAR-2021, the subject experienced red cheeks. On 15-MAR-2021, the subject experienced chills/shivering. On 16-MAR-2021, the subject experienced out of breath. On 16-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced malaise, and shoulder pain. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, Urine analysis (NR: not provided) Unknown, and X-ray (NR: not provided) Unknown. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, out of breath, shoulder pain, malaise, and red cheeks, and the outcome of chills/shivering and feeling cold was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Rash, Urticaria
Clinical narrative: GOT VACCINATED ON BOTH 09/MAR/2021 AND 16/MAR/2021; SEVERE RASH, BUMPS OVER HER FACE AND NECK; BUMPS OVER HER BODY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination; and covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced got vaccinated on both 09/mar/2021 and 16/mar/2021. On MAR-2021, the subject experienced severe rash, bumps over her face and neck. On MAR-2021, the subject experienced bumps over her body. The action taken with covid-19 vaccine ad26.cov2.s, and covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe rash, bumps over her face and neck and bumps over her body was not reported. This report was non-serious. This case, involving the same patient is linked to 20200903229.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: DEEP ACHE IN ARM; BURNING SENSATION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, ) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On MAR-2021, the subject experienced burning sensation. On 13-MAR-2021, the subject experienced deep ache in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deep ache in arm, and the outcome of burning sensation was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain
Clinical narrative: BODY ACHES; CHILLS; LITTLE MUSCLES ACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, body aches, and little muscles ache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, little muscles ache and body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Insomnia
Clinical narrative: SLEEPLESS; TIRED; PAIN AT INJECTION SITE; 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 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Lot # 1805020, expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included metformin, and metoclopramide. On 14-MAR-2021, the subject experienced sleepless. On 14-MAR-2021, the subject experienced tired. On 14-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site, and had not recovered from tired, and sleepless. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Mobility decreased, Somnolence
Clinical narrative: COULDN'T GET OUT OF BED; TIREDNESS; EXTREME SLEEPY; HEAVINESS; This spontaneous report received from a patient concerned an elderly 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 12-MAR-2021 08:00 at left deltoid for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 12-MAR-2021, the subject experienced extreme sleepy. On 12-MAR-2021, the subject experienced heaviness. On 12-MAR-2021, the subject experienced tiredness. On 16-MAR-2021, the subject experienced couldn't get out of bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme sleepy, tiredness, heaviness, and couldn't get out of bed. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: ACCIDENTLY RECEIVED JANSSEN VACCINE AFTER FEB DOSE OF MODERNA VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and hypertension, 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, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) .5 ml, administered on 16-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 16-MAR-2021, the subject experienced accidently received janssen vaccine after feb dose of moderna vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of accidently received janssen vaccine after feb dose of moderna vaccine was not reported. This report was non-serious.  Version created to amend previously reported information on 16-MAR-2021. Upon review the following information was amended: Concomitant Product (moderna vaccine) added and vaccination site updated in narrative.  .
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: TERRIBLE 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 was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-MAR-2021, the subject experienced terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dyspnoea, Headache, Injection site swelling
Clinical narrative: LOTS OF NASAL CONGESTION; COUGHING WITH PHLEGM; SHORTNESS OF BREATH; PAIN IN CHEST CAVITY; BODY ACHE; DIARRHEA; SORE ARM; SWELLING AT INJECTION LOCATION; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body ache. On 14-MAR-2021, the subject experienced diarrhea. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced swelling at injection location. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced pain in chest cavity. On 16-MAR-2021, the subject experienced lots of nasal congestion. On 16-MAR-2021, the subject experienced coughing with phlegm. On 16-MAR-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body ache, headache, swelling at injection location, diarrhea, pain in chest cavity, shortness of breath, sore arm, and nausea, and the outcome of lots of nasal congestion and coughing with phlegm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, Pain, Pain in extremity, Productive cough
Clinical narrative: LOTS OF NASAL CONGESTION; COUGHING WITH PHLEGM; SHORTNESS OF BREATH; PAIN IN CHEST CAVITY; BODY ACHE; DIARRHEA; SORE ARM; SWELLING AT INJECTION LOCATION; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body ache. On 14-MAR-2021, the subject experienced diarrhea. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced swelling at injection location. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced pain in chest cavity. On 16-MAR-2021, the subject experienced lots of nasal congestion. On 16-MAR-2021, the subject experienced coughing with phlegm. On 16-MAR-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body ache, headache, swelling at injection location, diarrhea, pain in chest cavity, shortness of breath, sore arm, and nausea, and the outcome of lots of nasal congestion and coughing with phlegm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: LOTS OF NASAL CONGESTION; COUGHING WITH PHLEGM; SHORTNESS OF BREATH; PAIN IN CHEST CAVITY; BODY ACHE; DIARRHEA; SORE ARM; SWELLING AT INJECTION LOCATION; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body ache. On 14-MAR-2021, the subject experienced diarrhea. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced swelling at injection location. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced pain in chest cavity. On 16-MAR-2021, the subject experienced lots of nasal congestion. On 16-MAR-2021, the subject experienced coughing with phlegm. On 16-MAR-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body ache, headache, swelling at injection location, diarrhea, pain in chest cavity, shortness of breath, sore arm, and nausea, and the outcome of lots of nasal congestion and coughing with phlegm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; 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 14-MAR-2021 for prophylactic vaccination. he batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and chills on 15-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Dysgeusia, Fatigue, Flushing
Clinical narrative: FLUSHING; CLAMMY SKIN; JOINT PAIN; HEADACHE; FATIGUE; METALLIC TASTE; EXCRUCIATING PAIN BELOW THE WAIST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included 3 heart attacks, total hysterectomy, laparotomy, 2 stents placed, and neurostimulator placed in back. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced excruciating pain below the waist. On 12-MAR-2021, the subject experienced metallic taste. On 13-MAR-2021, the subject experienced flushing. On 13-MAR-2021, the subject experienced clammy skin. On 13-MAR-2021, the subject experienced joint pain. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste on MAR-2021, and fatigue on 14-MAR-2021, had not recovered from headache, joint pain, flushing, and clammy skin, and the outcome of excruciating pain below the waist was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: FLUSHING; CLAMMY SKIN; JOINT PAIN; HEADACHE; FATIGUE; METALLIC TASTE; EXCRUCIATING PAIN BELOW THE WAIST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included 3 heart attacks, total hysterectomy, laparotomy, 2 stents placed, and neurostimulator placed in back. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced excruciating pain below the waist. On 12-MAR-2021, the subject experienced metallic taste. On 13-MAR-2021, the subject experienced flushing. On 13-MAR-2021, the subject experienced clammy skin. On 13-MAR-2021, the subject experienced joint pain. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste on MAR-2021, and fatigue on 14-MAR-2021, had not recovered from headache, joint pain, flushing, and clammy skin, and the outcome of excruciating pain below the waist was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: BODY PAIN; 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: 1805020 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced body pain. On 16-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and body pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness postural, Fatigue, Hypersomnia, Pallor
Clinical narrative: DIZZINESS UPON STANDING; SLEEPING 15 HOURS PER DAY; WEAKNESS; SEVERE FATIGUE; PALENESS; This spontaneous report received from a consumer concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included post heart attack, and concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergy patient was not doing any drug abuse or any illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced paleness. On 11-MAR-2021, the subject experienced sleeping 15 hours per day. On 11-MAR-2021, the subject experienced weakness. On 11-MAR-2021, the subject experienced severe fatigue. On 12-MAR-2021, the subject experienced dizziness upon standing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe fatigue, weakness, paleness, dizziness upon standing, and sleeping 15 hours per day. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: LEFT ARM SORE (INJECTION SITE); 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: 1805022 expiry: UNKNOWN) 1 in total, dose was not reported, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced left arm sore (injection site). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm sore (injection site). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: ACHES; CHILLS; HEADACHE; 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: 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced aches, chills, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, aches and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: SLEEPIER; 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 MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On MAR-2021, the subject experienced sleepier. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepier on MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: BONE PAIN; Dizziness; Fever; Headache; 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced bone pain, dizziness, fever, headache, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, bone pain, dizziness and muscle pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: BODY ACHES; RUNNY NOSE; MILD FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, runny nose, and mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, mild fever and runny nose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: BODY ACHES; DIZZINESS AND FEELING FAINT; Chills; LOW GRADE FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced dizziness and feeling faint. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, dizziness and feeling faint, chills, and low grade fever on MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: TRANSIENT ACHINESS; 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: 1805031, and batch number: 1805031 expiry: 13-MAR-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced transient achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from transient achiness on 14-MAR-2021. This report was non-serious.