chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Frequent bowel movements, Malaise, Mouth ulceration, Restlessness
Clinical narrative: ULCERATIONS IN HIS MOUTH; FREQUENT TOILETING; RESTLESSNESS; CHILLS; MALAISE; 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) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 01-APR-2021, the subject experienced ulcerations in his mouth. On 01-APR-2021, the subject experienced frequent toileting. On 01-APR-2021, the subject experienced restlessness. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, malaise, ulcerations in his mouth, frequent toileting, and restlessness. 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: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced 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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Therapeutic response unexpected, Vision blurred
Clinical narrative: PAIN WENT AWAY FROM LEGS/PAIN AWAY FROM LEFT ARM; CLEAR FILM OVER EYES; DIZZINESS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included her legs have been hurting for a long time due to fractured back that healed crooked, and concurrent conditions included allergy to cat.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 03-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced clear film over eyes. On 03-APR-2021, the subject experienced dizziness. On an unspecified date, the subject experienced pain went away from legs/pain away from left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on APR-2021, had not recovered from clear film over eyes, and the outcome of pain went away from legs/pain away from left arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: KNOCKED FLAT; 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. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced knocked flat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of knocked flat was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash
Clinical narrative: BUMP AT INJECTION SITE; SLIGHT TENDERNESS AT INJECTION SITE; 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: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced bump at injection site, and slight tenderness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bump at injection site and slight tenderness at injection site was not reported. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Nausea, Night sweats
Clinical narrative: NIGHT SWEATS; CHILLS; FEVER; NAUSEA; MUSCLE ACHES; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19. 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 02-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced muscle aches. Laboratory data included: Body temperature (NR: not provided) 100.1 degree F. On 04-APR-2021, the subject experienced night sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, nausea, muscle aches and night sweats was not reported. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: NIGHT SWEATS; CHILLS; FEVER; NAUSEA; MUSCLE ACHES; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19. 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 02-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced muscle aches. Laboratory data included: Body temperature (NR: not provided) 100.1 degree F. On 04-APR-2021, the subject experienced night sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, nausea, muscle aches and night sweats was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: ACHY; STRUGGLING TO DO THINGS; This spontaneous report received from a consumer 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: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced achy, and struggling to do things. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy and struggling to do things was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain in extremity, Pyrexia
Clinical narrative: TENDER ARM; LETHARGIC; MODERATE 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: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 03-APR-2021, the subject experienced tender arm. On 04-APR-2021, the subject experienced moderate fever. On 05-APR-2021, the subject experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from moderate fever on 05-APR-2021, and the outcome of tender arm and lethargic was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Flushing, Headache, Hyperhidrosis, Increased appetite
Clinical narrative: This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included marjuana, and concurrent conditions included allergy to skunks, non alcohol user, and non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: not reported) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced flush. On 02-APR-2021, the subject experienced ringing in ears. On 02-APR-2021, the subject experienced sweating to feet. On 02-APR-2021, the subject experienced sore arm/aching to legs. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced aching to back. On 03-APR-2021, the subject experienced morning wood. On 03-APR-2021, the subject experienced increased appetite. On 03-APR-2021, the subject experienced aching to neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flush, and headache on 02-APR-2021, ringing in ears, and aching to back, and sweating to feet on 04-APR-2021, was recovering from sore arm/aching to legs, had not recovered from increased appetite, and morning wood, and the outcome of aching to neck was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Spontaneous penile erection, Tinnitus
Clinical narrative: This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's past medical history included marjuana, and concurrent conditions included allergy to skunks, non alcohol user, and non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: not reported) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced flush. On 02-APR-2021, the subject experienced ringing in ears. On 02-APR-2021, the subject experienced sweating to feet. On 02-APR-2021, the subject experienced sore arm/aching to legs. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced aching to back. On 03-APR-2021, the subject experienced morning wood. On 03-APR-2021, the subject experienced increased appetite. On 03-APR-2021, the subject experienced aching to neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flush, and headache on 02-APR-2021, ringing in ears, and aching to back, and sweating to feet on 04-APR-2021, was recovering from sore arm/aching to legs, had not recovered from increased appetite, and morning wood, and the outcome of aching to neck was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: PUKING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-APR-2021, the subject experienced puking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vomiting was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site bruising, Injection site pain, Lethargy, Nausea
Clinical narrative: BRUISING AT THE SITE OF INJECTION; SORENESS AT THE SITE OF INJECTION; LETHARGIC; FATIGUED; SLEPT THROUGHOUT THE WHOLE WEEKEND; NAUSEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included von willebrand disease.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 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced slept throughout the whole weekend. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced lethargic. On 03-APR-2021, the subject experienced fatigued. On 04-APR-2021, the subject experienced bruising at the site of injection. On 04-APR-2021, the subject experienced soreness at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on APR-2021, was recovering from lethargic, and fatigued, had not recovered from soreness at the site of injection, and bruising at the site of injection, and the outcome of slept throughout the whole weekend was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: BRUISING AT THE SITE OF INJECTION; SORENESS AT THE SITE OF INJECTION; LETHARGIC; FATIGUED; SLEPT THROUGHOUT THE WHOLE WEEKEND; NAUSEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included von willebrand disease.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 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced slept throughout the whole weekend. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced lethargic. On 03-APR-2021, the subject experienced fatigued. On 04-APR-2021, the subject experienced bruising at the site of injection. On 04-APR-2021, the subject experienced soreness at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on APR-2021, was recovering from lethargic, and fatigued, had not recovered from soreness at the site of injection, and bruising at the site of injection, and the outcome of slept throughout the whole weekend was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: ACHES; RUN DOWN; 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) dose was not reported, administered on //2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch number. No concomitant medications were reported.  On //2021, the subject experienced aches. On //2021, the subject experienced run down. On //2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from run down, sore arm and aches. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: CHEST HEAVINESS; BODY ACHE; FEVER; CHILLS; FATIGUE; This spontaneous report received from a consumer concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic type 2, hypertension, hyperlipidemia, and social alcohol drinker, and other pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 11:00 for prophylactic vaccination on left arm. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, ascorbic acid for drug used for unknown indication, ergocalciferol for drug used for unknown indication, losartan for drug used for unknown indication, atorvastatin, empagliflozin, fish oil, and metformin. On 03-APR-2021, the subject experienced body ache. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fatigue. On 04-APR-2021, treatment medications included: paracetamol. On 05-APR-2021, the subject experienced chest heaviness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body ache, chills, and fatigue, and had not recovered from fever, and chest heaviness. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: MUSCLE ACHE; CHILLS; FATIGUE; 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, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, muscle ache, and chills. This report was non-serious. This case, from the same reporter is linked to 20210411696.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: ARM HURTING AT THE INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced arm hurting at the injection site. 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 arm hurting at the injection site. This report was non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Pyrexia
Clinical narrative: DIZZINESS; LOOSE STOOL; WEAKNESS; CHILLS; FEVER; This spontaneous report received from a patient concerned an 81 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 01-APR-2021 11:00 at left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-APR-2021, the subject experienced dizziness. On 02-APR-2021, the subject experienced loose stool. On 02-APR-2021, the subject experienced weakness. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, loose stool, weakness, chills, and fever on 03-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: CHRONIC PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number was not reported Per procedure, no follow up will be requested for this case and expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination.  Concomitant medications included ibuprofen for drug used for unknown indication. On an unspecified date, the subject experienced chronic pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chronic pain was not reported. This report was non-serious.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: FLU-LIKE SYMPTOMS; MUSCLE ACHES; This spontaneous report received from a patient concerned a 55 year old of unspecified sex. 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: 043A21A and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced flu-like symptoms. On 03-APR-2021, the patient experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, and muscle aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: SWELLING OF HALF OF THE RIGHT SIDE OF TOP LIP; 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 allergy to fire ants. 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 13:00 at left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, treatment medications included: diphenhydramine hydrochloride. On 05-APR-2021, the subject experienced swelling of half of the right side of top lip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of half of the right side of top lip. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Headache, Pyrexia
Clinical narrative: BLISTERS ON THE RIGHT ARM; HEADACHE; FEVER; 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 tested positive for covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 16:30 at right deltoid for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 101 F. On 05-APR-2021, the subject experienced blisters on the right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever, and had not recovered from blisters on the right arm. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: SORENESS; FEVER; This spontaneous report received from a consumer concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A,  expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 on right arm  for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced soreness, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and soreness was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: LEG CRAMPS; This spontaneous report received from a patient concerned a 68 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 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced leg cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg cramps on 04-APR-2021. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: SEVERE BODY ACHES TOO PAINFUL TO LAY DOWN ON BED; CHILLS; FEVER; VERY PAINFUL HEADACHE FELT LIKE BLOOD VESSELS  IN HEAD WERE SQUEEZING HIS BRAIN; FATIGUE; PAIN AT INJECTION SITE; This spontaneous report received from a vaccine facility concerned a 20 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced severe body aches too painful to lay down on bed. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced very painful headache felt like blood vessels in head were squeezing his brain. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches too painful to lay down on bed, chills, fever, and very painful headache felt like blood vessels in head were squeezing his brain on 03-APR-2021, and was recovering from fatigue, and pain at injection site. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SEVERE BODY ACHES TOO PAINFUL TO LAY DOWN ON BED; CHILLS; FEVER; VERY PAINFUL HEADACHE FELT LIKE BLOOD VESSELS  IN HEAD WERE SQUEEZING HIS BRAIN; FATIGUE; PAIN AT INJECTION SITE; This spontaneous report received from a vaccine facility concerned a 20 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced severe body aches too painful to lay down on bed. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced very painful headache felt like blood vessels in head were squeezing his brain. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches too painful to lay down on bed, chills, fever, and very painful headache felt like blood vessels in head were squeezing his brain on 03-APR-2021, and was recovering from fatigue, and pain at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle discomfort, Pain in extremity, Pyrexia
Clinical narrative: WEIRD FEELING IN ARM; SORE ARM; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 20 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 09:30 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021 14:30, the subject experienced weird feeling in arm. On 05-APR-2021 14:30, the subject experienced sore arm. On 05-APR-2021 14:30, the subject experienced fever. On 05-APR-2021 14:30, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, fatigue, sore arm and weird feeling in arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHILLS; HEADACHE; FEVER; 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 concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient have no known allergies and 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: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 04:00, the subject experienced body ache. On 06-APR-2021 04:00, the subject experienced chills. On 06-APR-2021 04:00, the subject experienced headache. On 06-APR-2021 04:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and headache, and the outcome of body ache and chills was not reported. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Fatigue, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: CHANGE IN VOICE; SWEATING; SORE THROAT; COUGH (THROAT WAS RASKY); TIREDNESS AND FATIGUE; FEVER; This spontaneous report received from a patient concerned a 64 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 04-APR-2021, the subject experienced tiredness and fatigue. On 04-APR-2021, the subject experienced sweating. On 04-APR-2021, the subject experienced sore throat. On 04-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced cough (throat was rasky). On 04-APR-2021, the subject experienced change in voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and fatigue, sweating, sore throat, fever, cough (throat was rasky) and change in voice was not reported. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: CHANGE IN VOICE; SWEATING; SORE THROAT; COUGH (THROAT WAS RASKY); TIREDNESS AND FATIGUE; FEVER; This spontaneous report received from a patient concerned a 64 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 04-APR-2021, the subject experienced tiredness and fatigue. On 04-APR-2021, the subject experienced sweating. On 04-APR-2021, the subject experienced sore throat. On 04-APR-2021, the subject experienced fever. On 04-APR-2021, the subject experienced cough (throat was rasky). On 04-APR-2021, the subject experienced change in voice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and fatigue, sweating, sore throat, fever, cough (throat was rasky) and change in voice was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Palpitations
Clinical narrative: HEART RACING; HEAVY HEAD; VERY TIRED; 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) dose was not reported, administered on 03-APR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced heart racing. On 03-APR-2021, the subject experienced heavy head. On 03-APR-2021, the subject experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy head, and very tired, and the outcome of heart racing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Eating disorder, Muscle spasms, Pain, Pyrexia
Clinical narrative: MUSCLE SPASMS; SEVERE BODY ACHES; SEVERE PAIN; CAN BARELY EAT ANYTHING; 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: Unknown) dose was not reported, administered on 05-APR-2021 on left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-APR-2021, the subject experienced muscle spasms. On 05-APR-2021, the subject experienced severe body aches. On 05-APR-2021, the subject experienced severe pain. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced can barely eat anything. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, muscle spasms, severe pain, severe body aches, and can barely eat anything. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Libido increased
Clinical narrative: INCREASED IN LIBIDO; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced increased in libido. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of increased in libido was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: PATIENT NOW DYING; 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: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced subject now dying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient now dying was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Breath odour, Dysgeusia
Clinical narrative: TONGUE IS PUTRID; SOUR TASTE; 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced tongue is putrid. On 22-MAR-2021, the subject experienced sour taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tongue is putrid, and sour taste. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Heart rate increased, Injection site pain, Pyrexia, Vomiting
Clinical narrative: VOMITING; FEVER; ARM SORENESS AT INJECTION SITE; FAST HEART BEAT; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included patient had series of rabies vaccines last year., and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:00 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced fast heart beat. On 05-APR-2021, the subject experienced arm soreness at injection site. On 05-APR-2021 21:00, the subject experienced fever. On 06-APR-2021 02:00, the subject experienced vomiting. On 06-APR-2021 03:10, 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 had not recovered from fever, vomiting, arm soreness at injection site, and fast heart beat. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: CONTRACTED THE COVID VIRUS; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced contracted the covid virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of contracted the covid virus 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: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: FINGER JOINT PAIN/MIDDLE FINGER JOINT PAIN,CANNOT MAKE A FIST/LEFT FINGER JOINTS(CAN MAKE A FIST) ARE TIGHT/RIGHT RING FINGER VERY PAINFUL; 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 concurrent conditions included melanoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, vaccinated in right arm,  administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced finger joint pain/middle finger joint pain, cannot make a fist/left finger joints (can make a fist) are tight/right ring finger very painful. On 02-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from finger joint pain/middle finger joint pain ,cannot make a fist/left finger joints(can make a fist) are tight/right ring finger very painful. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and headaches. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Parosmia
Clinical narrative: POOR SLEEP; SENSATION OF SMELLING ROAST BEEF; CHILLS; HEADACHE FOCUSED AROUND EYES ,FORHEAD AND SINUS; MUSCLE ACHE; INTERMITTENT FEVERS; SINUS CONGESTION; This spontaneous report received from a patient concerned a 58 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: 0U3A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On APR-2021, the subject experienced sinus congestion. On 05-APR-2021, the subject experienced poor sleep. On 05-APR-2021, the subject experienced sensation of smelling roast beef. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache focused around eyes, forehead and sinus. On 05-APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced intermittent fevers. On 06-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache focused around eyes ,forehead and sinus, muscle ache, chills, intermittent fevers, poor sleep, sensation of smelling roast beef and sinus congestion was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Pyrexia, Sinus congestion
Clinical narrative: POOR SLEEP; SENSATION OF SMELLING ROAST BEEF; CHILLS; HEADACHE FOCUSED AROUND EYES ,FORHEAD AND SINUS; MUSCLE ACHE; INTERMITTENT FEVERS; SINUS CONGESTION; This spontaneous report received from a patient concerned a 58 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: 0U3A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On APR-2021, the subject experienced sinus congestion. On 05-APR-2021, the subject experienced poor sleep. On 05-APR-2021, the subject experienced sensation of smelling roast beef. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache focused around eyes, forehead and sinus. On 05-APR-2021, the subject experienced muscle ache. On 05-APR-2021, the subject experienced intermittent fevers. On 06-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache focused around eyes ,forehead and sinus, muscle ache, chills, intermittent fevers, poor sleep, sensation of smelling roast beef and sinus congestion was not reported. This report was non-serious.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased, Pain in extremity
Clinical narrative: BLOOD SUGAR ELEVATED/BLOOD SUGAR READINGS REMAINED FAIRLY HIGH; SORENESS IN HANDS/ SLIGHT SORENESS; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's past medical history included flu shot in fall.  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 30-MAR-2021 on arm (deltoid) for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced blood sugar elevated/blood sugar readings remained fairly high, and soreness in hands/ slight soreness. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in hands/ slight soreness and blood sugar elevated/blood sugar readings remained fairly high was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MILD FEVER; This spontaneous report received from a vaccine facility concerned a 25 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 02-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 02-APR-2021, the subject experienced mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild fever was not reported. This report was non-serious.