chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Testicular pain, Testicular swelling
Clinical narrative: TESTICULAR SWELLING; TESTICULAR PAIN; FEVER; This spontaneous report received from a parent 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 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced testicular swelling. On 2021, the subject experienced testicular pain. On 2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.3 Unit not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, testicular swelling, and testicular pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Defaecation urgency, Fatigue, Headache, Myalgia
Clinical narrative: HEADACHE; FELT TIRED; MUSCLE PAIN; NAUSEA; WHOLE BODY HURT; URGENCY TO POOP; JOINT PAIN AND HURTING IN KNEES; 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced whole body hurt. On APR-2021, the subject experienced urgency to poop. On APR-2021, the subject experienced joint pain and hurting in knees. On APR-2021, the subject experienced felt tired. On APR-2021, the subject experienced muscle pain. On APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle pain, joint pain and hurting in knees, and whole body hurt, and the outcome of headache, felt tired, nausea and urgency to poop was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: HEADACHE; FELT TIRED; MUSCLE PAIN; NAUSEA; WHOLE BODY HURT; URGENCY TO POOP; JOINT PAIN AND HURTING IN KNEES; 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced whole body hurt. On APR-2021, the subject experienced urgency to poop. On APR-2021, the subject experienced joint pain and hurting in knees. On APR-2021, the subject experienced felt tired. On APR-2021, the subject experienced muscle pain. On APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle pain, joint pain and hurting in knees, and whole body hurt, and the outcome of headache, felt tired, nausea and urgency to poop was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; FACIAL REDNESS; LOW GRADE FEVER; MILD HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 78 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced facial redness. On 09-APR-2021, the subject experienced low grade fever. On 09-APR-2021, the subject experienced mild headache. On 09-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 09-APR-2021, and facial redness, low grade fever, and mild headache on 12-APR-2021, and had not recovered from fatigue. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Rash
Clinical narrative: RASH ON THE ARM; HEADACHE; CHARLIE HORSE FROM ARM TO BACK OF HEAD, BEHIND RIGHT EAR; This spontaneous report received from a patient concerned a 38 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: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced charlie horse from arm to back of head, behind right ear. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced rash on the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on the arm, charlie horse from arm to back of head, behind right ear, and headache. 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vision blurred
Clinical narrative: BAD HEADACHE; BLURRY VISION; 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 asthma, antiphospholipid syndrome, and allergy, and other pre-existing medical conditions included family history of stroke and heart attack. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced bad headache, and blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad headache and blurry vision was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: FELT TIRED; FLU-LIKE SYMPTOMS (CHILLS AND HEADACHE); SORE LEFT ARM; BOTH HANDS HURTING AS WELL; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced flu-like symptoms (chills and headache). On 12-APR-2021, the subject experienced sore left arm. On 12-APR-2021, the subject experienced both hands hurting as well. On 13-APR-2021, the subject experienced felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms (chills and headache), sore left arm, and both hands hurting as well on 13-APR-2021, and felt tired on 14-APR-2021. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Skin disorder
Clinical narrative: SKIN BREAKDOWN (ON ARMS AND TORSO AREA AND LITTLE BIT REDNESS); LITTLE BIT OF REDNESS; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight was 190 pounds, and height was 180 centimeters. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies, had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced skin breakdown (on arms and torso area and little bit redness). On 13-APR-2021, the subject experienced little bit of redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from skin breakdown (on arms and torso area and little bit redness), and the outcome of little bit of redness was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Insomnia, Pain in extremity
Clinical narrative: LOSS OF ENERGY; TIRED; HEADACHE; DIFFICULTY SLEEPING; PAIN IN THE ARM; 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 concurrent conditions included mango allergy, and shellfish allergy. The patient experienced drug allergy when treated with cefaclor, and erythromycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine.  On 10-APR-2021, the subject experienced difficulty sleeping. On 10-APR-2021, the subject experienced pain in the arm. On 10-APR-2021, the subject experienced tired. On 10-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced loss of energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty sleeping on 11-APR-2021, and was recovering from pain in the arm, loss of energy, tired, and headache. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, COVID-19, Feeling hot, Headache, Pruritus
Clinical narrative: ITCHING ALL OVER WITHOUT A RASH; FEELING FEVERISH; HEADACHE; FEELING HOT LIKE A FEVER; BONE PAIN; 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 asthma, alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies. no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: COVID-19 (NR: not provided) Negative. On 12-APR-2021, the subject experienced feeling hot like a fever. On 12-APR-2021, the subject experienced bone pain. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced itching all over without a rash. On 13-APR-2021, the subject experienced feeling feverish. 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 feeling hot like a fever, bone pain, headache, itching all over without a rash, and feeling feverish. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ITCHING ALL OVER WITHOUT A RASH; FEELING FEVERISH; HEADACHE; FEELING HOT LIKE A FEVER; BONE PAIN; 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 asthma, alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies. no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: COVID-19 (NR: not provided) Negative. On 12-APR-2021, the subject experienced feeling hot like a fever. On 12-APR-2021, the subject experienced bone pain. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced itching all over without a rash. On 13-APR-2021, the subject experienced feeling feverish. 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 feeling hot like a fever, bone pain, headache, itching all over without a rash, and feeling feverish. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia
Clinical narrative: JOINT PAIN; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included tachycardia, bactrim allergy, flagyl allergy, and keflex allergy, and other pre-existing medical conditions included bactrim, flagyl, keflex allergy, when taken hives occurs with one, and c. diff with hospitalization occurs with the other. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included propranolol for tachycardia. On 10-APR-2021, the subject experienced joint pain. On 10-APR-2021, the subject experienced low grade fever. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, and low grade fever on 11-APR-2021. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Dizziness, Dysstasia, Erythema
Clinical narrative: PALMS AND FEETS AND FACE OBSERVED SOME BLUISH PATCHES; LIGHT HEADED; RIGHT HAND NOTICED AT THE BASE OF INDEX FINGER'S KNUCKLE SOME DEEP RED AND BIG BLUE COLORED CIRCLE WHICH LOOKED LIKE A BRUISE; COULD NOT STAND UP; BOTH OF HANDS BACK SIDE BRIGHT RED COLORED; FELT CHILLS; HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced palms and feets and face observed some bluish patches. On 12-APR-2021, the subject experienced light headed. On 12-APR-2021, the subject experienced right hand noticed at the base of index finger's knuckle some deep red and big blue colored circle which looked like a bruise. On 12-APR-2021, the subject experienced could not stand up. On 12-APR-2021, the subject experienced both of hands back side bright red colored. On 12-APR-2021, the subject experienced felt chills. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand noticed at the base of index finger's knuckle some deep red and big blue colored circle which looked like a bruise on APR-2021, and the outcome of felt chills, palms and feets and face observed some bluish patches, headache, fever, nausea, light headed, could not stand up and both of hands back side bright red colored was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Skin discolouration
Clinical narrative: PALMS AND FEETS AND FACE OBSERVED SOME BLUISH PATCHES; LIGHT HEADED; RIGHT HAND NOTICED AT THE BASE OF INDEX FINGER'S KNUCKLE SOME DEEP RED AND BIG BLUE COLORED CIRCLE WHICH LOOKED LIKE A BRUISE; COULD NOT STAND UP; BOTH OF HANDS BACK SIDE BRIGHT RED COLORED; FELT CHILLS; HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced palms and feets and face observed some bluish patches. On 12-APR-2021, the subject experienced light headed. On 12-APR-2021, the subject experienced right hand noticed at the base of index finger's knuckle some deep red and big blue colored circle which looked like a bruise. On 12-APR-2021, the subject experienced could not stand up. On 12-APR-2021, the subject experienced both of hands back side bright red colored. On 12-APR-2021, the subject experienced felt chills. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hand noticed at the base of index finger's knuckle some deep red and big blue colored circle which looked like a bruise on APR-2021, and the outcome of felt chills, palms and feets and face observed some bluish patches, headache, fever, nausea, light headed, could not stand up and both of hands back side bright red colored was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: POSSIBLE UNEXPECTED BENEFIT (DID NOT WAKE UP IN THE MIDDLE OF THE NIGHT WITH HEAVY SWEATING. PREVIOUSLY PATIENT WAS WAKING UP 2 TO 3 TIMES WITH SAME AND IT WAS REALLY BAD); 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 pre-existing medical conditions included history of woke up in the middle of the night with heavy sweating. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced possible unexpected benefit (did not wake up in the middle of the night with heavy sweating. previously subject was waking up 2 to 3 times with same and it was really bad). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible unexpected benefit (did not wake up in the middle of the night with heavy sweating. previously patient was waking up 2 to 3 times with same and it was really bad) was not reported. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 45 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: Unknown) dose was not reported, administered on 10-APR-2021 09:30 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 flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210427236.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Muscle mass
Clinical narrative: BRUISE ON THE CALF MUSCLE; LUMPS ON THE CALF MUSCLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-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 APR-2021, the subject experienced bruise on the calf muscle. On APR-2021, the subject experienced lumps on the calf muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruise on the calf muscle and lumps on the calf muscle was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoacusis, Hypoaesthesia, Influenza like illness, Paraesthesia
Clinical narrative: NUMBNESS IN ARMS; FEELING OF PINS AND NEEDLES; HEARING CHANGE; FLU-LIKE SYMPTOMS; SORENESS ON TOP OF HEAD; This spontaneous report received from a consumer concerned a 37 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced numbness in arms. On APR-2021, the subject experienced feeling of pins and needles. On APR-2021, the subject experienced hearing change. On APR-2021, the subject experienced flu-like symptoms. On APR-2021, the subject experienced soreness on top of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness in arms, feeling of pins and needles, hearing change, flu-like symptoms and soreness on top of head was not reported. This report was non-serious. This case, from the same reporter is linked to 20210427206.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: STIFFNESS IN NECK; DULL ACHE IN NECK; FOCUS ISSUE; BODY ACHE; FEVER; FATIGUE/EXHAUSTION; INTERMITTENT HEADACHE; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hydrocodone allergy. 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 26-MAR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced stiffness in neck. On 26-MAR-2021, the subject experienced dull ache in neck. On 26-MAR-2021, the subject experienced focus issue. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced fatigue/exhaustion. On 26-MAR-2021, the subject experienced intermittent headache. Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fever on 27-MAR-2021, and had not recovered from fatigue/exhaustion, intermittent headache, dull ache in neck, stiffness in neck, and focus issue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vision blurred
Clinical narrative: STIFFNESS IN NECK; DULL ACHE IN NECK; FOCUS ISSUE; BODY ACHE; FEVER; FATIGUE/EXHAUSTION; INTERMITTENT HEADACHE; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hydrocodone allergy. 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 26-MAR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced stiffness in neck. On 26-MAR-2021, the subject experienced dull ache in neck. On 26-MAR-2021, the subject experienced focus issue. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced fatigue/exhaustion. On 26-MAR-2021, the subject experienced intermittent headache. Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fever on 27-MAR-2021, and had not recovered from fatigue/exhaustion, intermittent headache, dull ache in neck, stiffness in neck, and focus issue. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; STOMACH DISCOMFORT; BODY ACHES; CHILLS; FEVER; NAUSEA; HEADACHE; TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the 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: 1808980,expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced flu like symptoms. On 08-APR-2021, the subject experienced stomach discomfort. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tired. On 13-APR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, flu like symptoms, headache, chills, stomach discomfort, and body aches, and the outcome of tired was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: FLU LIKE SYMPTOMS; STOMACH DISCOMFORT; BODY ACHES; CHILLS; FEVER; NAUSEA; HEADACHE; TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the 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: 1808980,expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced flu like symptoms. On 08-APR-2021, the subject experienced stomach discomfort. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tired. On 13-APR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, flu like symptoms, headache, chills, stomach discomfort, and body aches, and the outcome of tired was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: SORE KNEE; SORE THUMB; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer, mastectomy, chemotherapy, and radiation, and concurrent conditions included arthritis, cigarette smoker, abstains from alcohol, and chest tightness, and other pre-existing medical conditions included patient received injection for her arthritis in her back last month. The patient experienced drug allergy when treated with codeine, and paracetamol for drug used for unknown indication. 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-APR-2021 18:30 for an unspecified indication. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore knee, and sore thumb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore knee, and sore thumb. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Pain in extremity
Clinical narrative: ABDOMINAL PAIN; LEG PAIN; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced abdominal pain. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, abdominal pain and leg pain was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion
Clinical narrative: CONGESTION; FATIGUE; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced fatigue. On an unspecified date, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and congestion was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vision blurred
Clinical narrative: BLURRED VISION FOR THREE DAYS; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 193 pounds, and height was 64 inches. The patient's concurrent conditions included seizure disorder, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced blurred vision for three days. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision for three days on APR-2021, and headache, and tiredness on 12-APR-2021. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Insomnia, Nausea, Skin warm, Vomiting
Clinical narrative: VOMITING; RATTLING COUGH; NOT SLEEPING; TEMPERATURE-FEEL FOREHEAD WARM; NAUSEA; This spontaneous report received from a patient concerned a 64 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: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced rattling cough. On 10-APR-2021, the subject experienced not sleeping. On 10-APR-2021, the subject experienced temperature-feel forehead warm. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, rattling cough, not sleeping, nausea, and temperature-feel forehead warm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: COLD SYMPTOMS; FEVER; 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced cold symptoms. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms, and fever on 11-APR-2021. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: HEADACHE; FATIGUE; NAUSEA; FEVER OF 102F; TERRIBLE MUSCLE ACHES; This spontaneous report received from a consumer concerned a 19 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: 41A21A, and batch number: 41A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 09-APR-2021 18:30, the subject experienced headache. On 09-APR-2021 18:30, the subject experienced fatigue. On 09-APR-2021 18:30, the subject experienced nausea.  On 09-APR-2021 18:30, the subject experienced fever of 102f. On 09-APR-2021 18:30, the subject experienced terrible muscle aches. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, fatigue, nausea, fever of 102f, and terrible muscle aches on 11-APR-2021 09:00. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HEADACHE; FATIGUE; NAUSEA; FEVER OF 102F; TERRIBLE MUSCLE ACHES; This spontaneous report received from a consumer concerned a 19 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: 41A21A, and batch number: 41A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 09-APR-2021 18:30, the subject experienced headache. On 09-APR-2021 18:30, the subject experienced fatigue. On 09-APR-2021 18:30, the subject experienced nausea.  On 09-APR-2021 18:30, the subject experienced fever of 102f. On 09-APR-2021 18:30, the subject experienced terrible muscle aches. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, fatigue, nausea, fever of 102f, and terrible muscle aches on 11-APR-2021 09:00. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient via a company representative concerned a 64 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included obesity. 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 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced headache. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Chills, Hypoaesthesia, Insomnia, Pain
Clinical narrative: ANEMIA; INSOMNIA; BODY ACHES; CHILLS; ARM SORENESS; TINGLING IN TOES AND FINGERS; NUMBNESS IN TOES, KNEES &  FINGERS; This spontaneous report received from a patient concerned a 41 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021 16:30, the subject experienced tingling in toes and fingers. On 02-APR-2021 16:30, the subject experienced numbness in toes, knees & fingers. On 02-APR-2021 16:30, the subject experienced body aches. On 02-APR-2021 16:30, the subject experienced chills. On 02-APR-2021 16:30, the subject experienced arm soreness. On an unspecified date, the subject experienced anemia, and insomnia. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 03-APR-2021, had not recovered from tingling in toes and fingers, numbness in toes, knees & fingers, and arm soreness, and the outcome of anemia and insomnia was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: ANEMIA; INSOMNIA; BODY ACHES; CHILLS; ARM SORENESS; TINGLING IN TOES AND FINGERS; NUMBNESS IN TOES, KNEES &  FINGERS; This spontaneous report received from a patient concerned a 41 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021 16:30, the subject experienced tingling in toes and fingers. On 02-APR-2021 16:30, the subject experienced numbness in toes, knees & fingers. On 02-APR-2021 16:30, the subject experienced body aches. On 02-APR-2021 16:30, the subject experienced chills. On 02-APR-2021 16:30, the subject experienced arm soreness. On an unspecified date, the subject experienced anemia, and insomnia. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 03-APR-2021, had not recovered from tingling in toes and fingers, numbness in toes, knees & fingers, and arm soreness, and the outcome of anemia and insomnia was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: FEELING WARMTH IN LEFT LEG/BOTH FEET/HANDS; This spontaneous report received from a patient concerned a 43 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced feeling warmth in left leg/both feet/hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling warmth in left leg/both feet/hands. This report was non-serious.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Hypersomnia, Illness
Clinical narrative: DIARRHEA; SLIGHT FEVER; SLEEPING A LOT; SICKNESS; CHILLS; FEELING NOT WELL; NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned a 91 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 08-APR-2021, the subject experienced sleeping a lot. On 08-APR-2021, the subject experienced sickness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced feeling not well. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced slight fever. On 13-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, headache, chills, feeling not well, diarrhea, slight fever, sleeping a lot and sickness 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.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: DIARRHEA; SLIGHT FEVER; SLEEPING A LOT; SICKNESS; CHILLS; FEELING NOT WELL; NAUSEA; HEADACHE; This spontaneous report received from a consumer concerned a 91 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 08-APR-2021, the subject experienced sleeping a lot. On 08-APR-2021, the subject experienced sickness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced feeling not well. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced slight fever. On 13-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, headache, chills, feeling not well, diarrhea, slight fever, sleeping a lot and sickness 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pain
Clinical narrative: LIGHT PAIN; DIZZINESS; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included no known allergies. no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 12-APR-2021, the subject experienced light pain. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light pain, fatigue, dizziness, and nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-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 sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: VOMITING; DIZZINESS; BODY ACHES; DIARRHEA; NAUSEA; TIREDNESS; FEVER; HEADACHE; 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 covid19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced diarrhea.  On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced tiredness. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, body aches, diarrhea, nausea, fever, and headache on 09-APR-2021, and the outcome of dizziness and tiredness was not reported. This report was non-serious.