chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Pruritus, Skin warm
Clinical narrative: Red, hot, lump, very itchy.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: 2 days after booster was administered, I started showing rash/bumps on the back of my head at base of hairline. Extremely itchy. I went to the dermatologist on 12/8/2021 to look at rash on back of head/neck. I was administered topical medication. Considered it to be potentially related to shampoo. Rash progressively got worse: extremely itchy red rash raised bumps on both arms, both elbows, upper back, chest and hands. Now on my hip. Extremely itchy. Now using Benadryl as well as topical cream and ointment prescribed. I now believe this was from the 12/2/2021 booster as the problems are continuing, despite stopping shampoo use on 12/8/2021.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: Itchiness, hives, and dermatographia has occured about two weeks after the booster shot. I was not knowingly allergic to anything, but the itchiness was almost unbearable. I started taking benadryl, zyrtec, and applying any anti-itch cream to affected areas. Areas affected are scalp, ears, arms, chest, and feet; but it seemed to occur on almost all parts of my body. About one week after side effects, it's still present, although zyrtec has helped with the symptons.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient states injection site was painful immediately after injection and has remained that way since (has been about 1.5 months). Directed patient to reach out to her PCP to rule out other possible causes of her prolong pain at the injection site.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Full blood count, Laboratory test, Seizure, Urine analysis
Clinical narrative: Generalized seizure lasting 2 minutes.  No prior h/o seizure.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Blood test, Chest X-ray, Chest pain
Clinical narrative: Started 5 days after 1st vaccine with headaches then severe joint pain that lasted for 5 days then the heart and chest pain started and has been going on now for 4 weeks. We went to urgent care the er and pediatrician. He had high levels of inflammatory marker and after a echocardiogram the ER doctor said most likely pericarditis. Pain in chest and lungs worse when laying down. My 9 you cannot walk long distances or at a fast pace cannot play and had been taking ibuprofen on and off for almost 4 weeks now. It is NOT heart burn because antacids do not help his shortness of breath and chest pain.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, Electrocardiogram, Exercise tolerance decreased, Headache
Clinical narrative: Started 5 days after 1st vaccine with headaches then severe joint pain that lasted for 5 days then the heart and chest pain started and has been going on now for 4 weeks. We went to urgent care the er and pediatrician. He had high levels of inflammatory marker and after a echocardiogram the ER doctor said most likely pericarditis. Pain in chest and lungs worse when laying down. My 9 you cannot walk long distances or at a fast pace cannot play and had been taking ibuprofen on and off for almost 4 weeks now. It is NOT heart burn because antacids do not help his shortness of breath and chest pain.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Loss of personal independence in daily activities, Pericarditis, Pulmonary pain
Clinical narrative: Started 5 days after 1st vaccine with headaches then severe joint pain that lasted for 5 days then the heart and chest pain started and has been going on now for 4 weeks. We went to urgent care the er and pediatrician. He had high levels of inflammatory marker and after a echocardiogram the ER doctor said most likely pericarditis. Pain in chest and lungs worse when laying down. My 9 you cannot walk long distances or at a fast pace cannot play and had been taking ibuprofen on and off for almost 4 weeks now. It is NOT heart burn because antacids do not help his shortness of breath and chest pain.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain, Tenderness
Clinical narrative: Swollen lymph nodes left side neck. Noticeable, tender, painful.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes left side neck. Noticeable, tender, painful.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 63 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 (dose number in series 1) (suspension for injection, route of admin, and batch number not reported) dose was not reported,1 total, therapy start date was not reported for prophylactic vaccination. No adverse event reported post primary vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, 1 total, administered on 15-DEC-2021 into left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-DEC-2021, the patient experienced administration of expired vaccine (dose number in series 2) and no other adverse events reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211235069.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Pain in extremity, Pruritus, Sensation of foreign body, Skin burning sensation
Clinical narrative: 2nd Moderna shot in May 2022 led to armpit rash that lasted a day or so. Aches, pains, and fatigue were issues as well.   3rd Moderna shot (booster) on 12/5/21. Only symptom was arm soreness that lasted a couple days. Then on the morning of 12/16/21, I broke out into hives that have not gone away entirely (writing on 12/21/21). Seriously itchy/burning hives that migrate around the body?started on chest, then moved to neck, head, arms, hands and feet, stomach, legs, hips. They continue to migrate. When I woke up on 12/18/21 with swollen eyes and a feeling that I had something stuck in my throat, I went to urgent care. They gave me a Benadryl IV and a course of prednisone (steroids), as well as over the counter Benadryl, Zertyc, and Benadryl cream. These have helped only intermittently, and I am still getting bouts of hives at least twice a day.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 2nd Moderna shot in May 2022 led to armpit rash that lasted a day or so. Aches, pains, and fatigue were issues as well.   3rd Moderna shot (booster) on 12/5/21. Only symptom was arm soreness that lasted a couple days. Then on the morning of 12/16/21, I broke out into hives that have not gone away entirely (writing on 12/21/21). Seriously itchy/burning hives that migrate around the body?started on chest, then moved to neck, head, arms, hands and feet, stomach, legs, hips. They continue to migrate. When I woke up on 12/18/21 with swollen eyes and a feeling that I had something stuck in my throat, I went to urgent care. They gave me a Benadryl IV and a course of prednisone (steroids), as well as over the counter Benadryl, Zertyc, and Benadryl cream. These have helped only intermittently, and I am still getting bouts of hives at least twice a day.
Sex: U
Vaccine: COVID19
Symptoms: Cold sweat, Feeling hot, Hypersensitivity, Mechanical urticaria, Pruritus
Clinical narrative: Fully body hives. Hives are produced from physical touch known as dermatographia. Hives can be produced from clothing to skin contact, self touch, or being touched by anything. The hives are very itchy once they occur and take about 30 minutes to subside after irritation first occurs. I have experienced these hives on my face, neck, chest, abdomen, hips, genitalia, thighs, calves, ankles, tops of feet, and palms of my hands. The palms of my hands are in a constant state of itchiness and feel hot and clammy as I am always using them.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Fully body hives. Hives are produced from physical touch known as dermatographia. Hives can be produced from clothing to skin contact, self touch, or being touched by anything. The hives are very itchy once they occur and take about 30 minutes to subside after irritation first occurs. I have experienced these hives on my face, neck, chest, abdomen, hips, genitalia, thighs, calves, ankles, tops of feet, and palms of my hands. The palms of my hands are in a constant state of itchiness and feel hot and clammy as I am always using them.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Ongoing hives 10 days pose vaccine
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Immunoglobulin therapy, Myocarditis, Myositis, Pulmonary haemorrhage
Clinical narrative: Severe myositis complicated with rhabdomyolysis and non-oliguric acute kidney injury, thrombocytopenia, myocarditis with pulmonary edema, and pulmonary hemorrhage. The patient was treated with five days course of intravenous (IV) methylprednisolone and IV immunoglobulin with a good response. He was hospitalized for sixteen days and discharged home on a tapering dose of oral prednisolone for a total of 6 weeks.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary oedema, Rhabdomyolysis, Thrombocytopenia
Clinical narrative: Severe myositis complicated with rhabdomyolysis and non-oliguric acute kidney injury, thrombocytopenia, myocarditis with pulmonary edema, and pulmonary hemorrhage. The patient was treated with five days course of intravenous (IV) methylprednisolone and IV immunoglobulin with a good response. He was hospitalized for sixteen days and discharged home on a tapering dose of oral prednisolone for a total of 6 weeks.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Cognitive disorder, Dizziness, Gait inability, Unresponsive to stimuli
Clinical narrative: 12 hours after vaccine, patient experienced dizziness and balance problems.  unable to ambulate to the bathroom without assistance from her husband.  Also experienced cognitive delays and not able to respond to questions.  Patient stayed home and did not seek medical attention.  Her symptoms gradually resolved after 4 days.
Sex: U
Vaccine: COVID19
Symptoms: Intracardiac thrombus, Pulmonary thrombosis
Clinical narrative: BLOOD CLOT TO HEART; BLOOD CLOT TO LUNGS; This spontaneous report received from a consumer and concerned a patient 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 (Janssen series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 14-DEC-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 14-DEC-2021, the patient experienced blood clot to heart and lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot to heart and blood clot to lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211235366-  covid-19 vaccine ad26.cov2.s- Blood clot to heart, Blood clot to lungs. 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: PAIN IN THE ARM; FEVER; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a 27 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 (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on an unspecified date in MAY-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2. s. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered on 21-NOV-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 21-NOV-2021, in the afternoon the patient had pain in the arm (from the shot), fever, and tiredness (Dose number in series 2). She felt like it was normal side effects and don't want to be contacted or take this further. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, tiredness and pain in the arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: RECURRENCE OF FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age, race and ethic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 08-MAR-2021, the patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN), 1 in total, dose was not reported, for prophylactic vaccination (Dose series in number 1).  On MAR-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced flu like symptoms. (Dose series in number 1). The patient recovered from flu like symptoms on an unspecified date. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 02-DEC-2021 for prophylactic vaccination (Dose series in number 2). No concomitant medications were reported.  On an unspecified date in DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced recurrence of flu like symptoms (Dose series in number 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from recurrence of flu like symptoms on an unspecified date in DEC-2021. This report was non-serious. This case, involving the same patient is linked to 20211237910 (Dose series in number 1).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  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: 1820095 expiry: 02-OCT-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211239223 and 20211239215.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Eye pain, Headache, Influenza like illness
Clinical narrative: BENIGN CYST ON PITUITARY GLAND; HEADACHE; FLU LIKE SYMPTOMS; PRESSURE IN SINUSES NOSE/EYE AREA; PAIN BEHIND EYES; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinus issues, glaucoma/ocular hypertension, migraine headaches, hypothyroidism, and chronic sinusitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, (Dose number in series was 1), administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced flu like symptoms, pressure in sinuses nose/eye area, and pain behind eyes. On 13-APR-2021, the patient experienced headache. On 23-JUN-2021, the patient experienced benign cyst on pituitary gland (Dose number in series was 1),. Laboratory data included: CT scan (NR: not provided) cyst on pituitary gland. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Everything came back normal, and MRI (NR: not provided) no sinus obstruction/disorder. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 07-APR-2021, was recovering from pain behind eyes, and headache, had not recovered from pressure in sinuses nose/eye area, and the outcome of benign cyst on pituitary gland was not reported. This report was non-serious. This case, involving the same patient is linked to 20211238514 (Dose number in series 2).
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Paranasal sinus discomfort, Pituitary cyst
Clinical narrative: BENIGN CYST ON PITUITARY GLAND; HEADACHE; FLU LIKE SYMPTOMS; PRESSURE IN SINUSES NOSE/EYE AREA; PAIN BEHIND EYES; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinus issues, glaucoma/ocular hypertension, migraine headaches, hypothyroidism, and chronic sinusitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, (Dose number in series was 1), administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced flu like symptoms, pressure in sinuses nose/eye area, and pain behind eyes. On 13-APR-2021, the patient experienced headache. On 23-JUN-2021, the patient experienced benign cyst on pituitary gland (Dose number in series was 1),. Laboratory data included: CT scan (NR: not provided) cyst on pituitary gland. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Everything came back normal, and MRI (NR: not provided) no sinus obstruction/disorder. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 07-APR-2021, was recovering from pain behind eyes, and headache, had not recovered from pressure in sinuses nose/eye area, and the outcome of benign cyst on pituitary gland was not reported. This report was non-serious. This case, involving the same patient is linked to 20211238514 (Dose number in series 2).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SORE ARM; TIRED AS HELL; This spontaneous report received from a patient via social media (Facebook) from a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously received covid-19 vaccine ad26. cov2. s (form of admin, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). The patient did not have any adverse event following covid-19 vaccine ad26. cov2.s. (Dose number in series 1). 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, 1 total administered for prophylactic vaccination (Dose number in series 2). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced sore arm, and was "tired as hell" for a day. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired as hell, and the outcome of sore arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) 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/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000207496.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED  VACCINE; This spontaneous report received from a health care professional 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: 1820095, expiry: 02-OCT-2021) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On an 24-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211238177 and 20211239215.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: BODY BASICALLY WENT ON A 2 DAY VACATION BOTH TIMES, FELT AS IF HE WAS GLUED TO THE FLOOR; ARM WAS A LITTLE SORE; 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. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced body basically went on a 2 day vacation both times, felt as if he was glued to the floor, and arm was a little sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body basically went on a 2 day vacation both times, felt as if he was glued to the floor and arm was a little sore was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Headache
Clinical narrative: SEVERE FLU-LIKE SYMPTOMS; LOSS OF APPETITE; FELT LIKE HIT BY SOMETHING/ IN A FOG; SLEPT A LOT; BODY ACHES; FROZEN SHOULDER; VERY SICK; POOR INJECTION TECHNIQUE; SORE ARM; CHILLS; FATIGUE; FEVER OF 102F; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 127 pounds, and height was 64 inches. The patient's concurrent conditions included: fibromyalgia, thyroid disease, supraventricular tachycardia/svt, penicillin allergy, sulfa allergy, and latex allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: 23-AUG-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the patient experienced severe flu-like symptoms, loss of appetite, felt like hit by something/ in a fog, slept a lot, body aches, frozen shoulder, very sick, poor injection technique, sore arm, chills, fatigue, fever of 102f, and headache. Laboratory data included: Fever (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick on 06-APR-2021, was recovering from severe flu-like symptoms, headache, sore arm, chills, fatigue, loss of appetite, felt like hit by something/ in a fog, slept a lot, body aches, frozen shoulder, and fever of 102f, and the outcome of poor injection technique was not reported. This report was non-serious. This case, involving the same patient is linked to 20211240493.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Illness, Influenza like illness, Pain, Pain in extremity
Clinical narrative: SEVERE FLU-LIKE SYMPTOMS; LOSS OF APPETITE; FELT LIKE HIT BY SOMETHING/ IN A FOG; SLEPT A LOT; BODY ACHES; FROZEN SHOULDER; VERY SICK; POOR INJECTION TECHNIQUE; SORE ARM; CHILLS; FATIGUE; FEVER OF 102F; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 127 pounds, and height was 64 inches. The patient's concurrent conditions included: fibromyalgia, thyroid disease, supraventricular tachycardia/svt, penicillin allergy, sulfa allergy, and latex allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: 23-AUG-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the patient experienced severe flu-like symptoms, loss of appetite, felt like hit by something/ in a fog, slept a lot, body aches, frozen shoulder, very sick, poor injection technique, sore arm, chills, fatigue, fever of 102f, and headache. Laboratory data included: Fever (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick on 06-APR-2021, was recovering from severe flu-like symptoms, headache, sore arm, chills, fatigue, loss of appetite, felt like hit by something/ in a fog, slept a lot, body aches, frozen shoulder, and fever of 102f, and the outcome of poor injection technique was not reported. This report was non-serious. This case, involving the same patient is linked to 20211240493.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis, Pyrexia, Wrong technique in product usage process
Clinical narrative: SEVERE FLU-LIKE SYMPTOMS; LOSS OF APPETITE; FELT LIKE HIT BY SOMETHING/ IN A FOG; SLEPT A LOT; BODY ACHES; FROZEN SHOULDER; VERY SICK; POOR INJECTION TECHNIQUE; SORE ARM; CHILLS; FATIGUE; FEVER OF 102F; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 127 pounds, and height was 64 inches. The patient's concurrent conditions included: fibromyalgia, thyroid disease, supraventricular tachycardia/svt, penicillin allergy, sulfa allergy, and latex allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: 23-AUG-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the patient experienced severe flu-like symptoms, loss of appetite, felt like hit by something/ in a fog, slept a lot, body aches, frozen shoulder, very sick, poor injection technique, sore arm, chills, fatigue, fever of 102f, and headache. Laboratory data included: Fever (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick on 06-APR-2021, was recovering from severe flu-like symptoms, headache, sore arm, chills, fatigue, loss of appetite, felt like hit by something/ in a fog, slept a lot, body aches, frozen shoulder, and fever of 102f, and the outcome of poor injection technique was not reported. This report was non-serious. This case, involving the same patient is linked to 20211240493.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood glucose, Blood glucose increased, Body temperature, Chills
Clinical narrative: BLOOD GLUCOSE WAS AT 350 MG/DL/BLOOD GLUCOSE REACHING 420 MG/DL; LOST CONTROL OF BLADDER, THIS CONTINUED ON AND OFF; NOT TO FEEL WELL; SHAKE/FREEZING; FEVER; EVERY MUSCLE IN HER BODY WAS SORE; LICHEN PLANUS AUTOIMMUNE; WAS VERY SORE; 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: implanted tooth, and lichen planus autoimmune. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced lichen planus autoimmune, was very sore, and every muscle in her body was sore. On 10-MAR-2021, the patient experienced blood glucose was at 350 mg/dl/blood glucose reaching 420 mg/dl, lost control of bladder, this continued on and off, not to feel well, shake/freezing, and fever. Laboratory data included: Blood glucose (NR: not provided) 350 mg/dL, 420 mg/dL, Body temperature (NR: not provided) 100 F, and Oxygen saturation (NR: not provided) not reported. On 11-MAR-2021, Laboratory data included: Blood glucose (NR: not provided) 140 mg/dL, 210-220 mg/dl range. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) 22.5 antibodies, 173 antibodies, 66.9 antibodies, Body temperature (NR: not provided) 97 F, and SARS-CoV-2 antibody test (NR: not provided) positive. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood glucose was at 350 mg/dl/blood glucose reaching 420 mg/dl, lichen planus autoimmune, every muscle in her body was sore, and fever, and the outcome of not to feel well, shake/freezing, lost control of bladder, this continued on and off and was very sore was not reported. This report was non-serious. This report was associated with product quality complaint: 90000207694.
Sex: F
Vaccine: COVID19
Symptoms: Lichen planus, Malaise, Myalgia, Oxygen saturation, Pain
Clinical narrative: BLOOD GLUCOSE WAS AT 350 MG/DL/BLOOD GLUCOSE REACHING 420 MG/DL; LOST CONTROL OF BLADDER, THIS CONTINUED ON AND OFF; NOT TO FEEL WELL; SHAKE/FREEZING; FEVER; EVERY MUSCLE IN HER BODY WAS SORE; LICHEN PLANUS AUTOIMMUNE; WAS VERY SORE; 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: implanted tooth, and lichen planus autoimmune. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced lichen planus autoimmune, was very sore, and every muscle in her body was sore. On 10-MAR-2021, the patient experienced blood glucose was at 350 mg/dl/blood glucose reaching 420 mg/dl, lost control of bladder, this continued on and off, not to feel well, shake/freezing, and fever. Laboratory data included: Blood glucose (NR: not provided) 350 mg/dL, 420 mg/dL, Body temperature (NR: not provided) 100 F, and Oxygen saturation (NR: not provided) not reported. On 11-MAR-2021, Laboratory data included: Blood glucose (NR: not provided) 140 mg/dL, 210-220 mg/dl range. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) 22.5 antibodies, 173 antibodies, 66.9 antibodies, Body temperature (NR: not provided) 97 F, and SARS-CoV-2 antibody test (NR: not provided) positive. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood glucose was at 350 mg/dl/blood glucose reaching 420 mg/dl, lichen planus autoimmune, every muscle in her body was sore, and fever, and the outcome of not to feel well, shake/freezing, lost control of bladder, this continued on and off and was very sore was not reported. This report was non-serious. This report was associated with product quality complaint: 90000207694.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test, Urinary incontinence
Clinical narrative: BLOOD GLUCOSE WAS AT 350 MG/DL/BLOOD GLUCOSE REACHING 420 MG/DL; LOST CONTROL OF BLADDER, THIS CONTINUED ON AND OFF; NOT TO FEEL WELL; SHAKE/FREEZING; FEVER; EVERY MUSCLE IN HER BODY WAS SORE; LICHEN PLANUS AUTOIMMUNE; WAS VERY SORE; 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: implanted tooth, and lichen planus autoimmune. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced lichen planus autoimmune, was very sore, and every muscle in her body was sore. On 10-MAR-2021, the patient experienced blood glucose was at 350 mg/dl/blood glucose reaching 420 mg/dl, lost control of bladder, this continued on and off, not to feel well, shake/freezing, and fever. Laboratory data included: Blood glucose (NR: not provided) 350 mg/dL, 420 mg/dL, Body temperature (NR: not provided) 100 F, and Oxygen saturation (NR: not provided) not reported. On 11-MAR-2021, Laboratory data included: Blood glucose (NR: not provided) 140 mg/dL, 210-220 mg/dl range. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) 22.5 antibodies, 173 antibodies, 66.9 antibodies, Body temperature (NR: not provided) 97 F, and SARS-CoV-2 antibody test (NR: not provided) positive. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood glucose was at 350 mg/dl/blood glucose reaching 420 mg/dl, lichen planus autoimmune, every muscle in her body was sore, and fever, and the outcome of not to feel well, shake/freezing, lost control of bladder, this continued on and off and was very sore was not reported. This report was non-serious. This report was associated with product quality complaint: 90000207694.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a consumer 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive for covid-19. Laboratory data (dates unspecified) 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 tested positive for covid-19 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via 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 (dose number series-1) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total, start therapy date not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s and had Covid right now and was sick" which concluded as suspect covid-19 vaccination failure, and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000207769.; Sender's Comments: V0: 20211242067-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
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported and expiry: unknown) start therapy date were not reported, dose was not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the reporter stated that "Or tell that to my sister-in-law who died of a heart attack less than a day of getting the J and J vaccine." On an unspecified date, the patient died from heart attack. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211242284- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Heart attack. 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).; Reported Cause(s) of Death: HEART ATTACK
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: INJURED FOR THE REST OF THEIR LIVES; This spontaneous report received from a patient via social media concerned multiple patients. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced injured for the rest of their lives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injured for the rest of their lives was not reported. This report was non-serious. This case is a duplicate of 20211242746.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: ONLY SLIGHT SIDE EFFECTS; 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced only slight side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of only slight side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20211242092 and 20211242345.
Sex: M
Vaccine: COVID19
Symptoms: Penile size reduced
Clinical narrative: PENIS IS SMALL; This spontaneous report received from a patient 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: 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 patient experienced penis is small. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of penis is small was not reported. This report was non-serious. This report was associated with product quality complaint: 90000207754.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a patient via social media  a patient of unspecified age, race, ethnicity and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total dose was not reported, administered on MAY-2021 for prophylactic vaccination (dose series 1). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The patient reported "I got vaccine in May 2020. By mid June my toes started turning purple. It was discovered that I have a blood clot, I get to spend holiday having open heart bypass surgery. I used to be healthy." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211243049- COVID-19 VACCINE AD26.COV2.S- Blood clot. This event is considered unassessable. The event 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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lung cancer ( the middle lobe of her lung removed), and concurrent conditions included: crohn's disease (her small and large intestines removed), chemo neuropathy, osteoarthritis, and allerigic to nsaids, and other pre-existing medical conditions included: The patient was on oxygen therapy at the time of vaccination. The patient experienced drug allergy when treated with gabapentin, and oxycodone hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213O21A, and expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol for neuropathy, tramadol for neuropathy, ergocalciferol, metoprolol, and pyridoxine hydrochloride. On an unspecified date, the patient experienced sore arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and headache. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: COLD CHILLS; FEVER; WEAK; HEADACHE; FEELING VERY TIRED; This spontaneous report received from a patient 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: 1855194, and expiry: UNKNOWN) dose was not reported, administered on 18-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2021, the patient experienced cold chills, fever, weak, headache, and feeling very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, cold chills, weak, headache and feeling very tired was not reported. This report was non-serious.