chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: MODERATE PAIN IN VACCINATION ARM AREA; 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: Unknown, expiry: 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 moderate pain in vaccination arm area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of moderate pain in vaccination arm area was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Back pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: LOWER ABDOMINAL PAIN; BACK PAIN; BODY PAIN; RIGHT LEG PAIN; FEVER; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid problems, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A 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 body pain. On 11-APR-2021, the subject experienced right leg pain. On 11-APR-2021, the subject experienced fever. On 19-APR-2021, the subject experienced back pain. On 22-APR-2021, the subject experienced lower abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, right leg pain, and fever on 12-APR-2021, and had not recovered from back pain, and lower abdominal pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthropod bite
Clinical narrative: TICK BITE ( BUG BITE); 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 APR-2021, the subject experienced tick bite ( bug bite). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tick bite ( bug bite) was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Malaise, Pain in extremity
Clinical narrative: SLEEP EXCESSIVE; MALAISE; TIREDNESS/FATIGUE; SORENESS IN THE ARM; MILD HEADACHE; This spontaneous report received from a patient concerned a 76 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: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, treatment medications included: paracetamol. On 09-MAR-2021, the subject experienced soreness in the arm. On 09-MAR-2021, the subject experienced mild headache. On 10-MAR-2021, the subject experienced sleep excessive. On 10-MAR-2021, the subject experienced malaise. On 10-MAR-2021, the subject experienced tiredness/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleep excessive, malaise, and tiredness/fatigue on 11-MAR-2021, soreness in the arm on 23-MAR-2021, and mild headache on 10-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Headache, Heart rate, Heart rate increased
Clinical narrative: HIGHER THAN NORMAL HEART RATE; VIRAL NODULES; SHORTNESS OF BREATH; KNEE PAIN; FEET PAIN; MILD HEADACHE; This spontaneous report received from a patient concerned a 51 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 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced knee pain. On 23-MAR-2021, the subject experienced feet pain. On 23-MAR-2021, the subject experienced mild headache. On 30-MAR-2021, the subject experienced shortness of breath. On APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Viral nodules. On 02-APR-2021, the subject experienced viral nodules. On 08-APR-2021, the subject experienced higher than normal heart rate. Laboratory data included: Heart rate (NR: not provided) Higher than normal heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knee pain, and feet pain, and mild headache on 30-MAR-2021, was recovering from higher than normal heart rate, and had not recovered from shortness of breath, and viral nodules. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain in extremity, Ultrasound scan
Clinical narrative: HIGHER THAN NORMAL HEART RATE; VIRAL NODULES; SHORTNESS OF BREATH; KNEE PAIN; FEET PAIN; MILD HEADACHE; This spontaneous report received from a patient concerned a 51 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 22-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced knee pain. On 23-MAR-2021, the subject experienced feet pain. On 23-MAR-2021, the subject experienced mild headache. On 30-MAR-2021, the subject experienced shortness of breath. On APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Viral nodules. On 02-APR-2021, the subject experienced viral nodules. On 08-APR-2021, the subject experienced higher than normal heart rate. Laboratory data included: Heart rate (NR: not provided) Higher than normal heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knee pain, and feet pain, and mild headache on 30-MAR-2021, was recovering from higher than normal heart rate, and had not recovered from shortness of breath, and viral nodules. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: 36 HOURS OF THE WORST FLU EVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced 36 hours of the worst flu ever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 36 hours of the worst flu ever was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Diarrhoea, Dysuria, Fall, Influenza like illness
Clinical narrative: SEVERE DIARRHEA; BURNING RASH; NAUSEA; FLU-LIKE SYMPTOMS; SEVERE BODY ACHES; BURNING SENSATION WHEN URINATING; 4 FALLS; FELLS LIKE SOMETHING IN THROAT; BEDRIDDEN; REDUCED ABILITY TO PERFORM DAILY ACTIVITY; MEMORY PROBLEMS; TINNITUS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included cancer.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced burning sensation when urinating. On 2021, the subject experienced 4 falls. On 2021, the subject experienced fells like something in throat. On 2021, the subject experienced bedridden. On 2021, the subject experienced reduced ability to perform daily activity. On 2021, the subject experienced memory problems. On 2021, the subject experienced tinnitus. On 12-MAR-2021, the subject experienced severe body aches. On 12-MAR-2021, the subject experienced nausea. On 12-MAR-2021, the subject experienced extreme fatigue. On 13-MAR-2021, the subject experienced severe diarrhea. On 13-MAR-2021, the subject experienced flu-like symptoms. On 13-MAR-2021, the subject experienced burning rash. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea on 22-APR-2021, was recovering from burning rash, and nausea, had not recovered from extreme fatigue, memory problems, flu-like symptoms, and severe body aches, and the outcome of 4 falls, burning sensation when urinating, bedridden, reduced ability to perform daily activity, fells like something in throat and tinnitus was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Memory impairment, Nausea, Pain, Rash
Clinical narrative: SEVERE DIARRHEA; BURNING RASH; NAUSEA; FLU-LIKE SYMPTOMS; SEVERE BODY ACHES; BURNING SENSATION WHEN URINATING; 4 FALLS; FELLS LIKE SOMETHING IN THROAT; BEDRIDDEN; REDUCED ABILITY TO PERFORM DAILY ACTIVITY; MEMORY PROBLEMS; TINNITUS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included cancer.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced burning sensation when urinating. On 2021, the subject experienced 4 falls. On 2021, the subject experienced fells like something in throat. On 2021, the subject experienced bedridden. On 2021, the subject experienced reduced ability to perform daily activity. On 2021, the subject experienced memory problems. On 2021, the subject experienced tinnitus. On 12-MAR-2021, the subject experienced severe body aches. On 12-MAR-2021, the subject experienced nausea. On 12-MAR-2021, the subject experienced extreme fatigue. On 13-MAR-2021, the subject experienced severe diarrhea. On 13-MAR-2021, the subject experienced flu-like symptoms. On 13-MAR-2021, the subject experienced burning rash. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea on 22-APR-2021, was recovering from burning rash, and nausea, had not recovered from extreme fatigue, memory problems, flu-like symptoms, and severe body aches, and the outcome of 4 falls, burning sensation when urinating, bedridden, reduced ability to perform daily activity, fells like something in throat and tinnitus was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Tinnitus
Clinical narrative: SEVERE DIARRHEA; BURNING RASH; NAUSEA; FLU-LIKE SYMPTOMS; SEVERE BODY ACHES; BURNING SENSATION WHEN URINATING; 4 FALLS; FELLS LIKE SOMETHING IN THROAT; BEDRIDDEN; REDUCED ABILITY TO PERFORM DAILY ACTIVITY; MEMORY PROBLEMS; TINNITUS; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included cancer.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced burning sensation when urinating. On 2021, the subject experienced 4 falls. On 2021, the subject experienced fells like something in throat. On 2021, the subject experienced bedridden. On 2021, the subject experienced reduced ability to perform daily activity. On 2021, the subject experienced memory problems. On 2021, the subject experienced tinnitus. On 12-MAR-2021, the subject experienced severe body aches. On 12-MAR-2021, the subject experienced nausea. On 12-MAR-2021, the subject experienced extreme fatigue. On 13-MAR-2021, the subject experienced severe diarrhea. On 13-MAR-2021, the subject experienced flu-like symptoms. On 13-MAR-2021, the subject experienced burning rash. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea on 22-APR-2021, was recovering from burning rash, and nausea, had not recovered from extreme fatigue, memory problems, flu-like symptoms, and severe body aches, and the outcome of 4 falls, burning sensation when urinating, bedridden, reduced ability to perform daily activity, fells like something in throat and tinnitus was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Epistaxis, Muscle spasms, Nasal dryness, Rhinorrhoea
Clinical narrative: SMALL AMOUNT OF BLOOD IN NOSE; SMALL AMOUNT OF MUCUS IN NOSE; DRY NOSE; HARD TIME BEING HYDRATED; CRAMPING LEGS; This spontaneous report received from a consumer concerned a 50 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, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced small amount of blood in nose. On APR-2021, the subject experienced small amount of mucus in nose. On APR-2021, the subject experienced dry nose. On APR-2021, the subject experienced hard time being hydrated. On APR-2021, the subject experienced cramping legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the small amount of blood in nose, dry nose, hard time being hydrated, cramping legs and small amount of mucus in nose was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: BURNING AT THE INJECTION SITE; 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 concurrent conditions included asthma, and fibromyalgia, and other pre-existing medical conditions included the patient had no known allergies .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 burning at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning at the injection site on APR-2021. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: ACUTE HIVES FROM HEAD TO TOE OF BODY; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included permanent lung damage, and allergies to insect. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-APR-2021, the subject experienced acute hives from head to toe of body. Treatment medications (dates unspecified) included: hydrocortisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute hives from head to toe of body. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight was 140 pounds, and height was 66 inches. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: TOE TURNED BLUE; 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 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 toe turned blue. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from toe turned blue on APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: SICK; FEVER 101; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sick, and fever 101. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, and fever 101. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site bruising, Lymphadenopathy, Nausea
Clinical narrative: SWOLLEN LYMPH NODES; DISCOLORATION ON THE INJECTION SITE (BIG BRUISE); PAIN; VOMITING; HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included brain aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced swollen lymph nodes. On 13-MAR-2021, the subject experienced discoloration on the injection site (big bruise). On 13-MAR-2021, the subject experienced pain. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, pain, vomiting, swollen lymph nodes, discoloration on the injection site (big bruise), nausea, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: SWOLLEN LYMPH NODES; DISCOLORATION ON THE INJECTION SITE (BIG BRUISE); PAIN; VOMITING; HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included brain aneurysm. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced swollen lymph nodes. On 13-MAR-2021, the subject experienced discoloration on the injection site (big bruise). On 13-MAR-2021, the subject experienced pain. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, pain, vomiting, swollen lymph nodes, discoloration on the injection site (big bruise), nausea, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Muscle spasms, Pain in extremity
Clinical narrative: FLU-LIKE SYMPTOMS(FEVER,ACHES,HEADACHE,PAINS); TOE CRAMPED UP; SHOOTING CRAMP PAIN BEHIND KNEE CAP AND PAIN IN CALF; 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: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced toe cramped up. On 2021, the subject experienced shooting cramp pain behind knee cap and pain in calf. On 31-MAR-2021, the subject experienced flu-like symptoms (fever, aches, headache, pains). Laboratory data included: Body temperature (NR: not provided) 101.2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms(fever, aches, headache, pains) on 01-APR-2021, and the outcome of shooting cramp pain behind knee cap and pain in calf and toe cramped up was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: EXTREME LETHARGY; INTERMITTENT FATIGUE; 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 concurrent conditions included diabetes. The patient experienced nausea and vomiting when treated with sulfamethoxazole/trimethoprim, and itching and swelling when treated with neomycin.  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 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced extreme lethargy. On 12-APR-2021, the subject experienced intermittent fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme lethargy, and the outcome of intermittent fatigue was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Hypoaesthesia, Investigation, Ophthalmological examination
Clinical narrative: NUMBNESS OF EXTREMITIES; TINGLING OF EXTREMITY; MILD SORE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and auras with migraines. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Blood test (NR: not provided) cleared of blood clots, Ophthalmological examination (NR: not provided) clear eyes, and Screening test (NR: not provided) clear stomach, carotids were clear. On 09-APR-2021, the subject experienced mild sore arm. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced numbness of extremities. On 10-APR-2021, the subject experienced tingling of extremity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness of extremities, and tingling of extremity on APR-2021, and mild sore arm on 11-APR-2021, and the outcome of tiredness was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: NUMBNESS OF EXTREMITIES; TINGLING OF EXTREMITY; MILD SORE ARM; TIREDNESS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and auras with migraines. 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 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Blood test (NR: not provided) cleared of blood clots, Ophthalmological examination (NR: not provided) clear eyes, and Screening test (NR: not provided) clear stomach, carotids were clear. On 09-APR-2021, the subject experienced mild sore arm. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced numbness of extremities. On 10-APR-2021, the subject experienced tingling of extremity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness of extremities, and tingling of extremity on APR-2021, and mild sore arm on 11-APR-2021, and the outcome of tiredness was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Extraocular muscle disorder
Clinical narrative: EYE SPASM; 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: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-APR-2021, the subject experienced eye spasm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye spasm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: SEVERE BACK PAIN; SEVERE MUSCLE PAIN IN LEGS; TINGLING OF LEGS; NUMBNESS IN LEGS; DIFFICULTY IN WALKING/LIMPING; This spontaneous report received from a pharmacist concerned a 50 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 expiry: 21-Jun-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-APR-2021, the subject experienced severe back pain. On 20-APR-2021, the subject experienced severe muscle pain in legs. On 20-APR-2021, the subject experienced tingling of legs. On 20-APR-2021, the subject experienced numbness in legs. On 20-APR-2021, the subject experienced difficulty in walking/limping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe back pain, severe muscle pain in legs, tingling of legs, difficulty in walking/limping, and numbness in legs. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Tinnitus
Clinical narrative: BUZZING IN HIS EARS; RINGING IN HIS EARS; BAD RASH ALL OVER HIS BODY; BOTTOM OF HIS FEET HURT TO WALK ON; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included stomach disorder. The patient was previously treated with esomeprazole magnesium for stomach disorder.  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 buzzing in his ears, ringing in his ears, bad rash all over his body, and bottom of his feet hurt to walk on. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the buzzing in his ears, ringing in his ears, bad rash all over his body and bottom of his feet hurt to walk on was not reported. This report was non-serious. This case, from the same reporter is linked to.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Pain
Clinical narrative: SORENESS; VACCINE EXPOSURE DURING PREGNANCY; MILD FATIGUE; This spontaneous pregnancy report received from a parent concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and no alcohol use, and other pre-existing medical conditions included the patient was pregnant at the time of reporting. the patient had no known allergies. the patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced mild fatigue. On 08-APR-2021, the subject experienced soreness. On 08-APR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, and mild fatigue on 09-APR-2021, and had not recovered from vaccine exposure during pregnancy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Therapeutic response unexpected
Clinical narrative: BURSITIS IMPROVED; UNEXPECTED  THERAPEUTIC EFFECT; 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 bursitis. 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 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced bursitis improved, and unexpected therapeutic effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bursitis improved and unexpected therapeutic effect was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: HEADACHE; SORE ARM; This spontaneous report received from a patient concerned a 43 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: 205A21A, 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 sore arm. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 13-APR-2021, and headache on 20-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: MILD ACHINESS; 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: 1805018 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 mild achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild achiness on 09-APR-2021. This report was non-serious. This case, from the same reporter is linked to .
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: NUMBNESS; TINGLING; SLEEPINESS; SORE ARM; TIREDNESS; FEVER; This spontaneous report received from a patient concerned a 59 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, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced sleepiness. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced fever. On APR-2021, the subject experienced tingling. On APR-2021, the subject experienced numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on APR-2021, and the outcome of fever, tiredness, sleepiness, numbness and tingling was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: NUMBNESS; TINGLING; SLEEPINESS; SORE ARM; TIREDNESS; FEVER; This spontaneous report received from a patient concerned a 59 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, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced sleepiness. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced fever. On APR-2021, the subject experienced tingling. On APR-2021, the subject experienced numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on APR-2021, and the outcome of fever, tiredness, sleepiness, numbness and tingling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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. The company is unable to perform follow up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: A LOT OF RASHES; HIVES; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch /Lot number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced a lot of rashes, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a lot of rashes, and hives. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: DIZZINESS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included codeine allergy, and concurrent conditions included alcohol consumption, and high blood pressure. 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 09-APR-2021 for prophylactic vaccination. Concomitant medications included letrozole for drug used for unknown indication, enalapril for high blood pressure, and fluoxetine. On 23-APR-2021, the subject experienced dizziness. On 23-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 dizziness, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; TIRED(DAY AFTER VACCINATION); 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 body aches, chills, fever, and tired (day after vaccination). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body aches and tired(day after vaccination) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Blood testosterone decreased, Fatigue, Feeling abnormal
Clinical narrative: 10 LBS WEIGHT LOSS; SHRUNKEN TESTES; FELT LIKE A DIFFERENT PERSON; LACK OF ENERGY; FLU LIKE SYMPTOMS; SEVERE TESTICULAR PAIN; SEVERE ABDOMINAL PAIN; FELT MOODY; LOSS OF BLADDER FUNCTION AND CONTROL; HORMONE LEVELS ARE OFF; TESTOSTERONE LEVELS ARE OFF; FELT VERY TIRED; This spontaneous report received from a patient concerned a 40 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: 21/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe abdominal pain. On APR-2021, the subject experienced severe testicular pain. On APR-2021, the subject experienced hormone levels are off. On APR-2021, the subject experienced testosterone levels are off. On APR-2021, the subject experienced felt very tired. On APR-2021, the subject experienced felt moody. On APR-2021, the subject experienced loss of bladder function and control. Laboratory data included: Hormone level abnormal (NR: not provided) Unknown, and Testosterone decreased (NR: not provided) Unknown. On 09-APR-2021, the subject experienced flu like symptoms. Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced 10 lbs weight loss. On 10-APR-2021, the subject experienced shrunken testes. On 10-APR-2021, the subject experienced felt like a different person. On 10-APR-2021, the subject experienced lack of energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on APR-2021, and had not recovered from severe abdominal pain, severe testicular pain, lack of energy, 10 lbs weight loss, hormone levels are off, testosterone levels are off, felt very tired, shrunken testes, felt like a different person, felt moody, and loss of bladder function and control. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hormone level abnormal, Influenza like illness, Mood swings, Testicular atrophy, Testicular pain
Clinical narrative: 10 LBS WEIGHT LOSS; SHRUNKEN TESTES; FELT LIKE A DIFFERENT PERSON; LACK OF ENERGY; FLU LIKE SYMPTOMS; SEVERE TESTICULAR PAIN; SEVERE ABDOMINAL PAIN; FELT MOODY; LOSS OF BLADDER FUNCTION AND CONTROL; HORMONE LEVELS ARE OFF; TESTOSTERONE LEVELS ARE OFF; FELT VERY TIRED; This spontaneous report received from a patient concerned a 40 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: 21/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe abdominal pain. On APR-2021, the subject experienced severe testicular pain. On APR-2021, the subject experienced hormone levels are off. On APR-2021, the subject experienced testosterone levels are off. On APR-2021, the subject experienced felt very tired. On APR-2021, the subject experienced felt moody. On APR-2021, the subject experienced loss of bladder function and control. Laboratory data included: Hormone level abnormal (NR: not provided) Unknown, and Testosterone decreased (NR: not provided) Unknown. On 09-APR-2021, the subject experienced flu like symptoms. Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced 10 lbs weight loss. On 10-APR-2021, the subject experienced shrunken testes. On 10-APR-2021, the subject experienced felt like a different person. On 10-APR-2021, the subject experienced lack of energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on APR-2021, and had not recovered from severe abdominal pain, severe testicular pain, lack of energy, 10 lbs weight loss, hormone levels are off, testosterone levels are off, felt very tired, shrunken testes, felt like a different person, felt moody, and loss of bladder function and control. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Urinary incontinence, Weight decreased
Clinical narrative: 10 LBS WEIGHT LOSS; SHRUNKEN TESTES; FELT LIKE A DIFFERENT PERSON; LACK OF ENERGY; FLU LIKE SYMPTOMS; SEVERE TESTICULAR PAIN; SEVERE ABDOMINAL PAIN; FELT MOODY; LOSS OF BLADDER FUNCTION AND CONTROL; HORMONE LEVELS ARE OFF; TESTOSTERONE LEVELS ARE OFF; FELT VERY TIRED; This spontaneous report received from a patient concerned a 40 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: 21/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe abdominal pain. On APR-2021, the subject experienced severe testicular pain. On APR-2021, the subject experienced hormone levels are off. On APR-2021, the subject experienced testosterone levels are off. On APR-2021, the subject experienced felt very tired. On APR-2021, the subject experienced felt moody. On APR-2021, the subject experienced loss of bladder function and control. Laboratory data included: Hormone level abnormal (NR: not provided) Unknown, and Testosterone decreased (NR: not provided) Unknown. On 09-APR-2021, the subject experienced flu like symptoms. Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced 10 lbs weight loss. On 10-APR-2021, the subject experienced shrunken testes. On 10-APR-2021, the subject experienced felt like a different person. On 10-APR-2021, the subject experienced lack of energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on APR-2021, and had not recovered from severe abdominal pain, severe testicular pain, lack of energy, 10 lbs weight loss, hormone levels are off, testosterone levels are off, felt very tired, shrunken testes, felt like a different person, felt moody, and loss of bladder function and control. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: LEFT SIDED NECK PAIN; LEFT ARM SORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-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 left sided neck pain. On APR-2021, the subject experienced left arm sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left arm sore and left sided neck pain was not reported. This report was non-serious.