chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Pain, Rhinorrhoea
Clinical narrative: FALLING MORE AND WALKS WITH A CANE DUE TO WEAKNESS; SORE MUSCLES; BODY ACHES; RUNNY NOSE; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 200.2 pounds, and height was 65 inches. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. patient does not remember the name of the blood pressure medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204a21a, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced runny nose. On 02-JUL-2021, the subject experienced body aches. On 02-JUL-2021, the subject experienced sore muscles. On 06-JUL-2021, the subject experienced falling more and walks with a cane due to weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, sore muscles, runny nose, and falling more and walks with a cane due to weakness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: HAVE NOT GET PERIOD CYCLE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced have not get period cycle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of have not get period cycle was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: VOMITING; CHILLS; NAUSEA; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, non alcoholic, non smoker, and diabetes, and other pre-existing medical conditions included patient has no known drug allergies. no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: 07-AUG-2021) dose was not reported, administered on 07-JUL-2021 19:00 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced vomiting. On 08-JUL-2021, the subject experienced chills. On 08-JUL-2021, the subject experienced nausea. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, and nausea on 08-JUL-2021. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: EYES FELT SWOLLEN/ RANDOM FEELING OF EYES BEING FULL OR SWOLLEN, EVEN THOUGH THEY DID NOT APPEARED SWOLLEN; GLOSSY AND RED EYES AS THOUGH SHE HAD BEEN CRYING; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced eyes felt swollen/ random feeling of eyes being full or swollen, even though they did not appeared swollen. On 24-MAR-2021, the subject experienced glossy and red eyes as though she had been crying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eyes felt swollen/ random feeling of eyes being full or swollen, even though they did not appeared swollen, and glossy and red eyes as though she had been crying. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Incorrect dose administered
Clinical narrative: RECEIVED VACCINE TWICE (TWO DOSES); MORE TIRED THAN USUAL; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included no known drug allergies, reported no health conditions and no current medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021, and 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 received vaccine twice (two doses), and more tired than usual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received vaccine twice (two doses) and more tired than usual was not reported. This report was non-serious.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood disorder, Myalgia, Tachypnoea
Clinical narrative: THINNING BLOOD; TACHYPNEA; MUSCLE PAIN; WEAKNESS; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight was 166 pounds, and height was 72 inches. The patient's past medical history included diabetic right foot neuropathy, and concurrent conditions included hypertension, type 2 diabetes mellitus, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient has no known allergies. no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. Concomitant medications included insulin detemir for diabetes mellitus, insulin lispro for diabetes mellitus 2, enalapril for hypertension, and hydrochlorothiazide for hypertension. On 02-JUL-2021, the subject experienced thinning blood. On 02-JUL-2021, the subject experienced tachypnea. On 02-JUL-2021, the subject experienced muscle pain. On 02-JUL-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, muscle pain, and thinning blood, and the outcome of tachypnea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: SOME BODY ACHES; FEVER 100; 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 pre-existing medical conditions included the patient had no known allergies and unknown drug abuse or illicit drug usage. Patient never had covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced some body aches, and fever 100. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever 100, and some body aches. This report was non-serious. This report was associated with product quality complaint: 90000185398
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: ALMOST NO ARM SORENESS; LITTLE FLASH FEVER; 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. No past medical history or concurrent conditions were 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced almost no arm soreness, and little flash fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the almost no arm soreness and little flash fever was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: MILD FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: ibuprofen. On 25-MAR-2021, the subject experienced mild flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild flu like symptoms on 29-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: COVID ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, 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 covid arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER, BEGAN EXPERIENCING AT 5:00 AND RESOLVED ON SAME EVENING; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-JUL-2021, the subject experienced fever, began experiencing at 5:00 and resolved on same evening. On 08-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, began experiencing at 5:00 and resolved on same evening on 08-JUL-2021, and had not recovered from headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance, Lymph node pain, Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH GLANDS TO THE LEFT ARMPIT; TENDER  LYMPH GLANDS TO THE LEFT ARMPIT; BALANCE ISSUES; TROUBLE WALKING STRAIGHT LINE; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's past medical history included prior vertigo from ear infection, cardiac arrest, and ear infection, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: TPH1802070, and expiry: 09-JUL-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced balance issues. On 13-APR-2021, the subject experienced trouble walking straight line. On 16-APR-2021, the subject experienced swollen lymph glands to the left armpit. On 16-APR-2021, the subject experienced tender lymph glands to the left armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from balance issues, and trouble walking straight line on 25-JUN-2021, and had not recovered from swollen lymph glands to the left armpit, and tender lymph glands to the left armpit. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: VOMITING (5 TIMES IN TOTAL SINCE THE ONSET); PERSISTENT CONSTANT/LIGHT NAGGING NAUSEA; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 160 pounds, and height was 64 centimeters. The patient's concurrent conditions included diabetic. 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 03-JUL-2021 for prophylactic vaccination. Concomitant medications included insulin for diabetes.  On 04-JUL-2021, the subject experienced vomiting (5 times in total since the onset). On 04-JUL-2021, the subject experienced persistent constant/light nagging nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent constant/light nagging nausea, and vomiting (5 times in total since the onset). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Pain
Clinical narrative: REALLY BAD REACTION; STILL HAVE CHRONIC PAIN FROM IT MONTHS LATER; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced really bad reaction, and still have chronic pain from it months later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still have chronic pain from it months later, and the outcome of really bad reaction was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Headache, Nausea
Clinical narrative: VOMITING (NOTHING CAME OUT); DIZZINESS; HAND SORENESS; WEAKNESS; FEVER OF 104; NAUSEA; HEADACHE (FELT SHE COULD SCREAM); This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced vomiting (nothing came out). On 09-JUL-2021, the subject experienced dizziness. On 09-JUL-2021, the subject experienced hand soreness. On 09-JUL-2021, the subject experienced weakness. On 09-JUL-2021, the subject experienced fever of 104. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced headache (felt she could scream). Laboratory data included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 104, nausea, vomiting (nothing came out), weakness, headache (felt she could scream), hand soreness and dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210724637.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: VOMITING (NOTHING CAME OUT); DIZZINESS; HAND SORENESS; WEAKNESS; FEVER OF 104; NAUSEA; HEADACHE (FELT SHE COULD SCREAM); This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced vomiting (nothing came out). On 09-JUL-2021, the subject experienced dizziness. On 09-JUL-2021, the subject experienced hand soreness. On 09-JUL-2021, the subject experienced weakness. On 09-JUL-2021, the subject experienced fever of 104. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced headache (felt she could scream). Laboratory data included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 104, nausea, vomiting (nothing came out), weakness, headache (felt she could scream), hand soreness and dizziness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210724637.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Nephrolithiasis, Pyrexia, Ultrasound scan
Clinical narrative: CHRONIC KIDNEY STONES; FEVER; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and smoker, and the patient does not have any no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient did not have any no known previous medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZ1A expiry: not reported) dose was not reported,1 total, administered on 04-JUN-2021 15:00 to left arm as prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021,at 9 PM after 6 hours of vaccination ,patient was feeling sick, he got fever and steadily got worse over 3 days. Patient went back to the normal before fever broke .On 5-JUN-2021  afternoon, he experienced the abdominal pain and pain steadily got worse. Patient experienced the pain in lower abdomen ,groin and shooting down his legs. Pain got worse and spread a little further. On 11-JUN-2021,following week patient went to the doctor. Patient reported that he was going to the doctor 6 to 8 times. Patient went to the hospital to get the ultrasound (NR: not provided) on lower abdomen, groin and chest. Ultrasound test results were normal. Patient had done a CAT scan (computerised tomogram) (NR: not provided) and found the Chronic kidney stone. Patient had the chronic kidney stones and was hospitalized. Patient reported that he was not having kidney stones before the vaccination. Patient did not remember when he went to the hospital. Patient told that he was prescribed with steroid. Patient reported that he had done with first round and at the time of reporting he was on the fourth day of second round. Patient told that, steroid not helped to his symptoms. Patient was also prescribed with muscle relaxer and Percocet as per need. Patient took only 3 pills of Percocet since 3 weeks ago because patient not like to take medicine. On 09-JUL-2021 the patient received the call from hospital to request a MRI on him. Patient reported that he was healthy like a horse before and now he felt like he was ready to die. Patient stated that pain had not recovered . Number of days of hospitalization were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from chronic kidney stones. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210722902-COVID-19 VACCINE AD26.COV2.S-Chronic kidney stones. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Dehydration, Dry throat, Dyspnoea, Fatigue
Clinical narrative: DIFFICULTY BREATHING; SWOLLEN ANKLES ON BOTH SIDES (MORE NOTICEABLY AFTER THE VACCINE); LEAKAGE/GOING TO THE BATHROOM CONSISTENTLY; HEADACHE; TIRED; HARDLY SLEPT; DEHYDRATED (THIRSTY/DRY MOUTH); DRY RIGHT DOWN IN THE THROAT; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included lung cancer, kidney infection, headache, swollen ankles, difficulty breathing, and leakage, and concurrent conditions included neuropathy, diabetic, and high blood pressure, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient's all medications were held at the time of vaccination. The patient was previously treated with oxygen for difficulty in breathing; and experienced drug allergy when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with naproxen sodium, chlortalidone, carvedilol, lisinopril, losartan, morphine, prednisone, tiotropium bromide, and rashes when treated with cobalt. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included paracetamol for headache. On MAY-2021, Laboratory data included: Allergy test (NR: not provided) Not reported. On 09-JUL-2021, the subject experienced dehydrated (thirsty/dry mouth). On 09-JUL-2021, the subject experienced dry right down in the throat. On 09-JUL-2021, the subject experienced hardly slept. On 10-JUL-2021, the subject experienced difficulty breathing. On 10-JUL-2021, the subject experienced swollen ankles on both sides (more noticeably after the vaccine). On 10-JUL-2021, the subject experienced leakage/going to the bathroom consistently. On 10-JUL-2021, the subject experienced headache. On 10-JUL-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dehydrated (thirsty/dry mouth), swollen ankles on both sides (more noticeably after the vaccine), leakage/going to the bathroom consistently, difficulty breathing, hardly slept, headache, tired, and dry right down in the throat. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Joint swelling, Oxygen saturation, Urinary incontinence
Clinical narrative: DIFFICULTY BREATHING; SWOLLEN ANKLES ON BOTH SIDES (MORE NOTICEABLY AFTER THE VACCINE); LEAKAGE/GOING TO THE BATHROOM CONSISTENTLY; HEADACHE; TIRED; HARDLY SLEPT; DEHYDRATED (THIRSTY/DRY MOUTH); DRY RIGHT DOWN IN THE THROAT; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included lung cancer, kidney infection, headache, swollen ankles, difficulty breathing, and leakage, and concurrent conditions included neuropathy, diabetic, and high blood pressure, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient's all medications were held at the time of vaccination. The patient was previously treated with oxygen for difficulty in breathing; and experienced drug allergy when treated with influenza vaccine for prophylactic vaccination, and drug allergy when treated with naproxen sodium, chlortalidone, carvedilol, lisinopril, losartan, morphine, prednisone, tiotropium bromide, and rashes when treated with cobalt. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included paracetamol for headache. On MAY-2021, Laboratory data included: Allergy test (NR: not provided) Not reported. On 09-JUL-2021, the subject experienced dehydrated (thirsty/dry mouth). On 09-JUL-2021, the subject experienced dry right down in the throat. On 09-JUL-2021, the subject experienced hardly slept. On 10-JUL-2021, the subject experienced difficulty breathing. On 10-JUL-2021, the subject experienced swollen ankles on both sides (more noticeably after the vaccine). On 10-JUL-2021, the subject experienced leakage/going to the bathroom consistently. On 10-JUL-2021, the subject experienced headache. On 10-JUL-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dehydrated (thirsty/dry mouth), swollen ankles on both sides (more noticeably after the vaccine), leakage/going to the bathroom consistently, difficulty breathing, hardly slept, headache, tired, and dry right down in the throat. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Chills, Fatigue, Headache
Clinical narrative: TEMPERATURE RANGING BETWEEN 95-95.5; CHILLS; FATIGUE; A LITTLE BIT OF A HEADACHE; ARM SORENESS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204821A, expiry: UNKNOWN) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUL-2021, the subject experienced arm soreness. On 10-JUL-2021, the subject experienced fatigue. On 10-JUL-2021, the subject experienced a little bit of a headache. On 11-JUL-2021, the subject experienced temperature ranging between 95-95.5. On 11-JUL-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) ranging between 95-95.5. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, chills, temperature ranging between 95-95.5, and a little bit of a headache, and the outcome of arm soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: TEMPERATURE RANGING BETWEEN 95-95.5; CHILLS; FATIGUE; A LITTLE BIT OF A HEADACHE; ARM SORENESS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204821A, expiry: UNKNOWN) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUL-2021, the subject experienced arm soreness. On 10-JUL-2021, the subject experienced fatigue. On 10-JUL-2021, the subject experienced a little bit of a headache. On 11-JUL-2021, the subject experienced temperature ranging between 95-95.5. On 11-JUL-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) ranging between 95-95.5. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, chills, temperature ranging between 95-95.5, and a little bit of a headache, and the outcome of arm soreness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODE; PAINFUL LYMPH NODE; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21a, and expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-JUL-2021, the subject experienced swollen lymph node. On 10-JUL-2021, the subject experienced painful lymph node. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen lymph node, and painful lymph node. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Hangover, Injection site pain, Pain
Clinical narrative: WEIRD VISION DISTORTION; 9 HOURS LATER I STARTED GETTING WEIRD ACHES AND PAINS. LOCATED AROUND JOINTS IN MY BODY LIKE ANKLES, FINGERS, HIPS, KNEES, ETC; A VERY LIGHT FEVER (MIGHT NOT HAVE HAD A FEVER AT ALL BUT IT FELT LIKE A FEVER); WOKE UP FEELING HUNG OVER; AN HOUR LATER I STARTED TO GET CHILLS; INJECTION SITE BURN/STING AFTER INJECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 weird vision distortion, 9 hours later i started getting weird aches and pains. located around joints in my body like ankles, fingers, hips, knees, etc, a very light fever (might not have had a fever at all but it felt like a fever), woke up feeling hung over, an hour later i started to get chills, and injection site burn/sting after injection. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird vision distortion, a very light fever (might not have had a fever at all but it felt like a fever), woke up feeling hung over, an hour later i started to get chills, and injection site burn/sting after injection, and was recovering from 9 hours later i started getting weird aches and pains. located around joints in my body like ankles, fingers, hips, knees, etc. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: WEIRD VISION DISTORTION; 9 HOURS LATER I STARTED GETTING WEIRD ACHES AND PAINS. LOCATED AROUND JOINTS IN MY BODY LIKE ANKLES, FINGERS, HIPS, KNEES, ETC; A VERY LIGHT FEVER (MIGHT NOT HAVE HAD A FEVER AT ALL BUT IT FELT LIKE A FEVER); WOKE UP FEELING HUNG OVER; AN HOUR LATER I STARTED TO GET CHILLS; INJECTION SITE BURN/STING AFTER INJECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 weird vision distortion, 9 hours later i started getting weird aches and pains. located around joints in my body like ankles, fingers, hips, knees, etc, a very light fever (might not have had a fever at all but it felt like a fever), woke up feeling hung over, an hour later i started to get chills, and injection site burn/sting after injection. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird vision distortion, a very light fever (might not have had a fever at all but it felt like a fever), woke up feeling hung over, an hour later i started to get chills, and injection site burn/sting after injection, and was recovering from 9 hours later i started getting weird aches and pains. located around joints in my body like ankles, fingers, hips, knees, etc. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Eating disorder symptom, Headache, Injection site rash
Clinical narrative: FAINTNESS/FELT LIKE PASSED OUT; DIFFICULTY EATING; RED MARK/DOT ON VACCINATED ARM; JOINT SORENESS; MUSCLE SORENESS; NAUSEA/FELT TO VOMIT WHILE EATING; HEADACHE; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced throat swelled up when treated with amoxicillin. 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 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAY-2021, the subject experienced faintness/felt like passed out. On 26-MAY-2021, the subject experienced difficulty eating. On 26-MAY-2021, the subject experienced red mark/dot on vaccinated arm. On 26-MAY-2021, the subject experienced joint soreness. On 26-MAY-2021, the subject experienced muscle soreness. On 26-MAY-2021, the subject experienced nausea/felt to vomit while eating. On 26-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea/felt to vomit while eating, joint soreness, headache, faintness/felt like passed out, red mark/dot on vaccinated arm, difficulty eating, and muscle soreness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: FAINTNESS/FELT LIKE PASSED OUT; DIFFICULTY EATING; RED MARK/DOT ON VACCINATED ARM; JOINT SORENESS; MUSCLE SORENESS; NAUSEA/FELT TO VOMIT WHILE EATING; HEADACHE; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced throat swelled up when treated with amoxicillin. 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 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAY-2021, the subject experienced faintness/felt like passed out. On 26-MAY-2021, the subject experienced difficulty eating. On 26-MAY-2021, the subject experienced red mark/dot on vaccinated arm. On 26-MAY-2021, the subject experienced joint soreness. On 26-MAY-2021, the subject experienced muscle soreness. On 26-MAY-2021, the subject experienced nausea/felt to vomit while eating. On 26-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea/felt to vomit while eating, joint soreness, headache, faintness/felt like passed out, red mark/dot on vaccinated arm, difficulty eating, and muscle soreness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Musculoskeletal chest pain, X-ray
Clinical narrative: PAIN IN RIBS WHILE BREATHING IN; SHORTNESS OF BREATH/HUFFING AND PUFFING; FEELS CONSTRICTING; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included metastatic breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-JUL-2021, the subject experienced pain in ribs while breathing in. On 09-JUL-2021, the subject experienced shortness of breath/huffing and puffing. On 09-JUL-2021, the subject experienced feels constricting. On 10-JUL-2021, treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Patient had a spot in ribs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath/huffing and puffing, pain in ribs while breathing in, and feels constricting. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. Initial information was processed with the additional information received on 12-JUL-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: not reported) dose was not reported,1 total, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-JUL-2021, the patient was tested positive for COVID-19 (suspected COVID-19 infection and suspected clinical vaccination failure). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected COVID-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000185610.; Sender's Comments: V0:20210723506-COVID-19 VACCINE AD26.COV2.S-SUSPECTED CLINICAL VACCINATION FAILURE. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINISTERED FROM A PUNCTURED VIAL KEPT AT REFRIGERATION TEMPERATURE FOR 7 HOURS AND 26 MINUTES; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient at the time of reporting was not pregnant. The patient experienced drug allergy when treated with chlorhexidine, clindamycin, doxycycline, oxazolam, and sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 10-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced vaccine administered from a punctured vial kept at refrigeration temperature for 7 hours and 26 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered from a punctured vial kept at refrigeration temperature for 7 hours and 26 minutes was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 27 year old male of unspecified ethnicity. The patient's height, and weight were not reported. The patient had no known allergies and no medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: unknown) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-JUL-2021, the patient experienced a low grade fever. On 07-JUL-2021, patient had loss of taste, smell and was coughing. On 10-JUL-2021, the patient underwent SARS COV-2 antigen test and results came as positive (suspected clinical vaccination failure, suspected covid-19 infection). It was reported that the patient's felt his symptoms would have probably worst without the vaccination. The patient had not seen his health case professional at the time of this report. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be not void (meet PQC) based on the PQC evaluation/investigation performed. This report was associated with product quality complaint: 90000185601.; Sender's Comments: V0: 20210723839-COVID-19 VACCINE AD26.COV2.S-SUSPECTED CLINICAL VACCINATION FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS: Suspected Vaccination failure.
Sex: U
Vaccine: COVID19
Symptoms: Paraplegia, Sensory loss
Clinical narrative: PARALYZED FROM THE WAIST DOWN; LOSS OF FEELING IN HANDS; This spontaneous report received from a patient from social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose were not reported,1 total, 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 patient was paralyzed from the waist down with loss of feeling in hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralyzed from the waist down with loss of feeling in hands. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210724242- Covid-19 vaccine ad26.cov2.s - Paralyzed from the waist down . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash. This report was non-serious. This case, from the same reporter is linked to 20210724371.
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder, Pain, Pyrexia
Clinical narrative: BODY ACHES; STOMACH ISSUES; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. 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, stomach issues, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, fever and stomach issues was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 33 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 13-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUL-2021, the patient did a IgM + IgG rapid antibody test and it came out negative. On 05-JUL-2021, the patient had a blood test for antibodies-SARS-CoV-2 (Anti-S) by the electrochemiluminescence method and it came back negative. Both test results indicated suspected immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210724419-covid-19 vaccine ad26.cov2.s-suspected immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS