chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Pyrexia, SARS-CoV-2 test, Vision blurred
Clinical narrative: BLURRED VISION; MIGRAINE; HOT FLASHES; PALE; SWEATING; FEVER; MUSCLE ACHES; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mitral valve prolapse, drug allergies: compazine, and non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 10:30 for prophylactic vaccination. Concomitant medications included metoprolol tartrate for mitral valve prolapse. On 12-MAR-2021 07:00, the subject experienced blurred vision. On 12-MAR-2021 07:00, the subject experienced migraine. On 12-MAR-2021 07:00, the subject experienced hot flashes. On 12-MAR-2021 07:00, the subject experienced pale. On 12-MAR-2021 07:00, the subject experienced sweating. On 12-MAR-2021 07:00, the subject experienced fever. On 12-MAR-2021 07:00, the subject experienced muscle aches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.9 F, and COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision on 14-MAR-2021, and migraine, and muscle aches on 13-MAR-2021, and had not recovered from fever, hot flashes, pale, and sweating. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers The outcome of sore arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 INFECTION (FATIGUE, HEADACHE,LOSS OF TASTE & SMELL); 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 pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-MAR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced covid-19 infection (fatigue, headache, loss of taste & smell). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 infection (fatigue, headache, loss of taste & smell). This report was non-serious. This case, from the same reporter is linked to 20210350851.  Version created to amend previously reported information on 15/Mar/2021. Upon review the following information was amended: In the event tab, events of  horizontal line on skin that looked like a scar on arm & felt ropy, tenderness at the injection site was removed,; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: SORE THROAT; MILD-SEVERE COUGHING; 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced sore throat. On 11-MAR-2021, the subject experienced mild-severe coughing. On 11-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sore throat and mild-severe coughing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Palpitations
Clinical narrative: CHILLS; HEADACHE; NAUSEA; FATIGUE; HEART POUNDING; 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, intramuscular, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 14-MAR-2021 04:20 on left arm for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced heart pounding. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart pounding on 14-MAR-2021, and chills, headache, nausea, and fatigue on 15-MAR-2021. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Discomfort, Injection site pain, Insomnia, Muscular weakness
Clinical narrative: TIGHT BURNING FEELING IN UPPER RIGHT BACK AND RIGHT ELBOW; CRIPPLING CONSTANT PAIN; MUSCLE WEAKNESS TO THE RIGHT ARM; TIGHTNESS ON UPPER RIGHT SIDE ON BACK NEAR RIGHT SHOULDER; INJECTION SITE PAIN; INITIAL BURN WHEN VACCINATED; DISCOMFORT; DID NOT SLEEP WELL AT NIGHT; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced discomfort. On MAR-2021, the subject experienced did not sleep well at night. On 11-MAR-2021, the subject experienced muscle weakness to the right arm. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced tight burning feeling in upper right back and right elbow. On 11-MAR-2021, the subject experienced crippling constant pain. On 11-MAR-2021, the subject experienced tightness on upper right side on back near right shoulder. On 11-MAR-2021, the subject experienced initial burn when vaccinated. Treatment medications (dates unspecified) included: ibuprofen, naproxen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-MAR-2021, was recovering from tight burning feeling in upper right back and right elbow, crippling constant pain, did not sleep well at night, discomfort, initial burn when vaccinated, and tightness on upper right side on back near right shoulder, and had not recovered from muscle weakness to the right arm. This report was non-serious.  Additional information was received on 19/Mar/2021. The following information was updated and incorporated into the case narrative. Reporter details added, patient information (date of birth, sex, ethnic origin, race) added. patient allergy details, batch number of suspect, site of administration, Vaccine facility details, events: injection site pain and muscle weakness to the right arm were added.; Sender's Comments: V1:Medical assessment comments not required as per the standard procedure as the case is considered non serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: TIGHT BURNING FEELING IN UPPER RIGHT BACK AND RIGHT ELBOW; CRIPPLING CONSTANT PAIN; MUSCLE WEAKNESS TO THE RIGHT ARM; TIGHTNESS ON UPPER RIGHT SIDE ON BACK NEAR RIGHT SHOULDER; INJECTION SITE PAIN; INITIAL BURN WHEN VACCINATED; DISCOMFORT; DID NOT SLEEP WELL AT NIGHT; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced discomfort. On MAR-2021, the subject experienced did not sleep well at night. On 11-MAR-2021, the subject experienced muscle weakness to the right arm. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced tight burning feeling in upper right back and right elbow. On 11-MAR-2021, the subject experienced crippling constant pain. On 11-MAR-2021, the subject experienced tightness on upper right side on back near right shoulder. On 11-MAR-2021, the subject experienced initial burn when vaccinated. Treatment medications (dates unspecified) included: ibuprofen, naproxen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-MAR-2021, was recovering from tight burning feeling in upper right back and right elbow, crippling constant pain, did not sleep well at night, discomfort, initial burn when vaccinated, and tightness on upper right side on back near right shoulder, and had not recovered from muscle weakness to the right arm. This report was non-serious.  Additional information was received on 19/Mar/2021. The following information was updated and incorporated into the case narrative. Reporter details added, patient information (date of birth, sex, ethnic origin, race) added. patient allergy details, batch number of suspect, site of administration, Vaccine facility details, events: injection site pain and muscle weakness to the right arm were added.; Sender's Comments: V1:Medical assessment comments not required as per the standard procedure as the case is considered non serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain
Clinical narrative: CHILLS; SORENESS AT INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and 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 chills. On 12-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAR-2021, and was recovering from soreness at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pelvic pain, Spinal pain
Clinical narrative: JOINT PAIN IN SPINE; JOINT PAIN IN PELVIC AREA; 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 back pain. 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 12-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen, and paracetamol. On 13-MAR-2021 11:00, the subject experienced joint pain in spine. On 13-MAR-2021 11:00, the subject experienced joint pain in pelvic area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain in spine, and joint pain in pelvic area. This report was non-serious. This case associated with Product Quality Complaint number. The suspected product quality complaint has been confirmed to be confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHES; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210328609.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: HIGH TEMPERATURE OF 100.2; 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 09-MAR-2021 for prophylactic vaccination. The batch number is 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 high temperature of 100.2. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high temperature of 100.2. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment is not required per standard   procedure as the case includes non-serious event.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: MILD FEVER; ACHY MUSCLES; 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,)  dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On MAR-2021, the subject experienced mild fever. On MAR-2021, the subject experienced achy muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever and achy muscles was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: COUGHING; SORE THROAT; 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, batch number: JJ 1805020, and batch number: JJ 1805020 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 coughing. On 12-MAR-2021, the subject experienced sore throat. Laboratory data included: COVID-19 PCR test (NR: not provided) Negative, and SARS-CoV-2 rapid diagnostic test (NR: not provided) Negative. Treatment medications (dates unspecified) included: guaifenesin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the coughing and sore throat was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Pain in extremity
Clinical narrative: LIGHTHEADED; SORE ARM; MUSCLE SORENESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 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 lightheaded. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, muscle soreness and lightheaded was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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 lung cancer with only the middle node of lung on the right side. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: VERY MILD REACTIONS; This spontaneous report received from a patient via a company representative concerned a 74 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 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 very mild reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very mild reactions was not reported. This report was non-serious.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; This spontaneous report received from a patient concerned a 76 year old male. The patient's weight was 120 pounds, and height was 65 inches. The patient's past medical history included heart attack, and concurrent conditions included pollen/seasonal allergy, alcohol use, and non smoker, and other pre-existing medical conditions included the patient did not have history of drug abuse or illicit drug usage. The patient was previously treated with fexofenadine hydrochloride for pollen, seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and  expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021 around 14:00, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: ITCHY AT INJECTION SITE; RED AT INJECTION SITE; PAINFUL AT INJECTION SITE; SWELLING AT INJECTION SITE; WARM; 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 13:10 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced warm. On 11-MAR-2021, the subject experienced itchy at injection site. On 11-MAR-2021, the subject experienced red at injection site. On 11-MAR-2021, the subject experienced painful at injection site. On 11-MAR-2021, the subject experienced swelling at injection site. Treatment medications (dates unspecified) included: hamamelis virginiana extract. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from painful at injection site, had not recovered from red at injection site, itchy at injection site, and swelling at injection site, and the outcome of warm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: BAD SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. No concomitant medications were reported.  On an unspecified date, the subject experienced bad side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis
Clinical narrative: COLD LIKE SYMPTOMS; FELT FATIGUE; 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 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced cold like symptoms. On 12-MAR-2021, the subject experienced felt fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold like symptoms and felt fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Injection site pain
Clinical narrative: INJECTION SITE SORENESS; CHILLS; 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 and expiry: unknown) 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 12-MAR-2021, the subject experienced injection site soreness. On 12-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Injection site pain, Injection site reaction, SARS-CoV-2 test positive, Scar
Clinical narrative: HORIZONTAL LINE SCAR ON ARM; ROPY FEELING AT THE INJECTION SITE; TENDER AT INJECTION SITE; COVID 19 INFECTION (FATIGUE, HEADACHE, AGEUSIA, ANOSMIA SUBSUMED); This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-MAR-2021 17:00 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced confirmed Covid 19 infection. Laboratory data included: COVID-19 virus test positive (NR: not provided) positive. On 12-MAR-2021, the subject experienced horizontal line scar on arm. On 12-MAR-2021, the subject experienced ropy feeling at the injection site. On 12-MAR-2021, the subject experienced tender at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid 19 infection, horizontal line scar on arm, ropy feeling at the injection site and tender at injection site was not reported. This report was non-serious.; Sender's Comments: V0.Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lip swelling
Clinical narrative: UPPER LIP WAS SWOLLEN TO TWICE ITS NORMAL SIZE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: diphenhydramine hydrochloride ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for swollen lips. No concomitant medications were reported. On an unspecified date, the subject experienced upper lip was swollen to twice its normal size. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of upper lip was swollen to twice its normal size was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urticaria
Clinical narrative: RASH / HIVES TO NECK, CHEST, AND FACE; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: 25-MAY-2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced rash/ hives to neck, chest, and face. On 10-MAR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight headache, and was recovering from rash/hives to neck, chest, and face. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: BODY ACHES; HIGH GRADE FEVER OF 103; This spontaneous report received from a patient concerned a 46 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, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced high grade fever of 103. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. The patient was recovering from body aches, and high grade fever of 103. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Fatigue, Flushing, Headache, Pain in extremity
Clinical narrative: ITCHINESS THROUGHOUT THE BODY AND  ON THE TOP OF FOOT; ITCHY EYES; FLUSHED FACE; SNEEZING; HEADACHE; FATIGUE; SORENESS ON THE SITE ARM; 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) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced soreness on the site arm. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced itchy eyes. On 13-MAR-2021, the subject experienced flushed face. On 13-MAR-2021, the subject experienced sneezing. On 14-MAR-2021, the subject experienced itchiness throughout the body and on the top of foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy eyes, and flushed face on 14-MAR-2021, sneezing on 15-MAR-2021, soreness on the site arm on 10-MAR-2021, headache on 11-MAR-2021, and fatigue on 12-MAR-2021, and was recovering from itchiness throughout the body and on the top of foot. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sneezing
Clinical narrative: ITCHINESS THROUGHOUT THE BODY AND  ON THE TOP OF FOOT; ITCHY EYES; FLUSHED FACE; SNEEZING; HEADACHE; FATIGUE; SORENESS ON THE SITE ARM; 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) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced soreness on the site arm. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced itchy eyes. On 13-MAR-2021, the subject experienced flushed face. On 13-MAR-2021, the subject experienced sneezing. On 14-MAR-2021, the subject experienced itchiness throughout the body and on the top of foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy eyes, and flushed face on 14-MAR-2021, sneezing on 15-MAR-2021, soreness on the site arm on 10-MAR-2021, headache on 11-MAR-2021, and fatigue on 12-MAR-2021, and was recovering from itchiness throughout the body and on the top of foot. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise, Pyrexia
Clinical narrative: SHORTNESS OF BREATH; FEVER; NOT FEELING VERY WELL; This spontaneous report received from a pharmacist 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, expiry: unknown) 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 11-MAR-2021, the subject experienced shortness of breath. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced not feeling very well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, fever, and not feeling very well. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue, Headache
Clinical narrative: Shortness of breath; Diarrhea; body aches; chills; fever; fatigue; headache; nausea; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 MAR-2021, the subject experienced shortness of breath. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, shortness of breath, fatigue, body aches, headache, nausea and diarrhea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Shortness of breath; Diarrhea; body aches; chills; fever; fatigue; headache; nausea; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 MAR-2021, the subject experienced shortness of breath. On MAR-2021, the subject experienced diarrhea. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, shortness of breath, fatigue, body aches, headache, nausea and diarrhea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling drunk, Headache, Pain, Paranoia
Clinical narrative: KIND OF DRUNK FEELING; WHOLE BODY ACHING; URINATE EVERY HALF HOUR; "SEEING THINGS AS A THIRD PERSON"  LIKE SHES WATCHING IT; BAD HEADACHE; ARM WAS ON FIRE; 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: 1805025, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced arm was on fire. On 15-MAR-2021, the subject experienced kind of drunk feeling. On 15-MAR-2021, the subject experienced whole body aching. On 15-MAR-2021, the subject experienced urinate every half hour. On 15-MAR-2021, the subject experienced "seeing things as a third person" like shes watching it. On 15-MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was on fire on 15-MAR-2021, and had not recovered from kind of drunk feeling, bad headache, whole body aching, urinate every half hour, and "seeing things as a third person" like shes watching it. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: KIND OF DRUNK FEELING; WHOLE BODY ACHING; URINATE EVERY HALF HOUR; "SEEING THINGS AS A THIRD PERSON"  LIKE SHES WATCHING IT; BAD HEADACHE; ARM WAS ON FIRE; 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: 1805025, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced arm was on fire. On 15-MAR-2021, the subject experienced kind of drunk feeling. On 15-MAR-2021, the subject experienced whole body aching. On 15-MAR-2021, the subject experienced urinate every half hour. On 15-MAR-2021, the subject experienced "seeing things as a third person" like shes watching it. On 15-MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was on fire on 15-MAR-2021, and had not recovered from kind of drunk feeling, bad headache, whole body aching, urinate every half hour, and "seeing things as a third person" like shes watching it. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: GENITAL HERPES OUTBREAK; 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 genital herpes.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 no was not known and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced genital herpes outbreak. Patient received vaccination on Wednesday evening the 10th. The next day, started having indications of genital herpes outbreak. Patient had this condition for years and know the symptoms. Patient not had an outbreak in over a year. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of genital herpes outbreak was not reported. This report was  non-serious.; Sender's Comments: MAC not required per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; HEADACHE; FATIGUE; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fatigue, fever, body aches and chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20210336193.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: EVERYONE IS GETTING VERY SICK; 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. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the subject experienced everyone is getting very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of everyone is getting very sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: FEW MINUTES LATER FELT A STINGING SENSATION; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 12:00 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 few minutes later felt a stinging sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from few minutes later felt a stinging sensation on 13-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Polymerase chain reaction, Pyrexia
Clinical narrative: NAUSEA; FEVER; WHOLE BODY JOINT ACHES; 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 18:05 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced whole body joint aches. On 16-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: PCR (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, fever, and whole body joint aches. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: ITCHING ON LEGS,CHEST,BACK; RASH ON SEVERAL PARTS OF THE BODY; This spontaneous report received from a patient concerned a 41 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: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced itching on legs, chest, back. On 15-MAR-2021, the subject experienced rash on several parts of the body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on legs, chest, back, and rash on several parts of the body. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: LIMITED ARM MOBILITY; ARM PAIN AND SORENESS; 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 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced limited arm mobility. On MAR-2021, the subject experienced arm pain and soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain and soreness, and limited arm mobility. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pain in extremity
Clinical narrative: BODY ACHES; SORE ARM; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. 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 (vaccinated on left arm) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced headaches. On 14-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 body aches, and the outcome of headaches, sore arm and nausea was not reported. This report was non-serious.  Additional information was received from patient on 19-Mar-2021. The following information was updated and incorporated into the case narrative: (Patient gender and dosage text (in narrative only) was updated).
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Oropharyngeal pain, Pain in extremity
Clinical narrative: SORENESS TO RIGHT ARM; INJECTION SITE SORENESS; SORE THROAT (MILD); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included 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 batch number: 1805018 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 sore throat (mild). On 12-MAR-2021, the subject experienced soreness to right arm. On 12-MAR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site soreness, sore throat (mild) and soreness to right arm was not reported. This report was non-serious.