chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Iritis, Nausea, Uveitis
Clinical narrative: 8 hours after vaccine patient had a severe headache and nausea. Gradually over the course of the next 24 hours the headache became unbearable and the patient went to the ER where he was diagnosed with iritis/uveitis , given prescription drops and told to follow up with primary care physician.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got sick for One day; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received last shot in 2014 (name not specified). The patient recently received shingles shot and got sick for 1 day. The patient mentioned that, it was some thing the older people needed. The follow up would not be possible as no contact details were available. For the 2nd dose, refer case US2021AMR113623, reported for the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR113623:same reporter, same pateint, same AE, different dose (2nd dose)
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got sick for One day; This case was reported by a consumer via  interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received dose  in 2014) and Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer case US2021AMR113617).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. Two weeks ago patient had received 2nd dose of shingles vaccine and got sick for 1 day. The reporter reported that was some thing the older people needed and yes older people need. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR113617:same reporter, same pateint, same AE, different dose (1st dose)
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis; Drug dose administration interval too long; This case was reported by a lawyer and described the occurrence of rheumatoid arthritis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information received via Medical record on 27May2021. As per the pharmacy record, the patient received Shingrix intramuscular in right deltoid 0.5 ml on 11 Sep 2018 and intramuscular in left deltoid 1 ml dose on 8 Apr 2019. Subsequently, patient drug dose administration interval too long. She had two doses administered with interval of 209 days. The patient experienced rheumatoid arthritis. On an unknown date, the outcome of the rheumatoid arthritis was unknown.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Facial pain, Herpes zoster, Hypoaesthesia, Ophthalmic herpes zoster
Clinical narrative: had the first dose in September 2020 / second dose in December 2020 / doctor said she had shingles/ completed vaccination failure; also had shingles in her eye; doctor said she had shingles; developed swelling and pain on right side of her face; developed swelling and pain on right side of her face; nose and face are numb; The blisters dried up; The blisters dried up, but she still has scars; This case was reported by a consumer via call center representative and described the occurrence of completed vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th May 2021, between 5 and 6 months after receiving Shingrix and between 8 and 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, facial swelling, facial pain, numbness facial, blister and scar. The patient was treated with antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles, facial swelling, facial pain, numbness facial, blister and scar were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, facial swelling, facial pain, numbness facial, blister and scar to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix vaccine in left arm in September 2020 and 2nd dose in right arm in December 2020. 3 weeks ago from the day of reporting, the patient developed swelling and pain on right side of her face. Her doctor said that, she had shingles.  The blisters had dried up, but the patient still had scars, her nose and face were numb. The patient also had shingles in her eye and took anti retroviral medication, but had not developed vision problems. The patient was not completely recovered.  The patient could not provide the lot number due to pharmacist writing. This case was considered as completed vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were known at the time of reporting. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Scar, Swelling face, Vaccination failure
Clinical narrative: had the first dose in September 2020 / second dose in December 2020 / doctor said she had shingles/ completed vaccination failure; also had shingles in her eye; doctor said she had shingles; developed swelling and pain on right side of her face; developed swelling and pain on right side of her face; nose and face are numb; The blisters dried up; The blisters dried up, but she still has scars; This case was reported by a consumer via call center representative and described the occurrence of completed vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th May 2021, between 5 and 6 months after receiving Shingrix and between 8 and 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, facial swelling, facial pain, numbness facial, blister and scar. The patient was treated with antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles, facial swelling, facial pain, numbness facial, blister and scar were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, facial swelling, facial pain, numbness facial, blister and scar to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix vaccine in left arm in September 2020 and 2nd dose in right arm in December 2020. 3 weeks ago from the day of reporting, the patient developed swelling and pain on right side of her face. Her doctor said that, she had shingles.  The blisters had dried up, but the patient still had scars, her nose and face were numb. The patient also had shingles in her eye and took anti retroviral medication, but had not developed vision problems. The patient was not completely recovered.  The patient could not provide the lot number due to pharmacist writing. This case was considered as completed vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were known at the time of reporting. The reporter consented to follow up.
Age: 96.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant portion / without reconstituting the powder with the gE antigen; received only the adjuvant portion / without reconstituting the powder with the gE antigen; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 96-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th May 2021, the patient received Shingrix. On 18th May 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter informed that, a patient received only the adjuvant portion from the shingrix without reconstituting the powder with the gE antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case is linked with the case- US2021114065, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021114065:Same Reporter
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Dyspnoea, Feeling abnormal, Hypersomnia, Illness
Clinical narrative: 100 PERCENT IN BED; FELT ALMOST DIED WHEN HE GOT SINGLE DOSE OF VACCINE; SHORTNESS OF BREATH; SLEPT FOR 18 HOURS; SICK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (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 number No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the subject experienced 100 percent in bed, felt almost died when he got single dose of vaccine, shortness of breath, slept for 18 hours, and sick. The action taken with covid-19 vaccine  was not applicable. The patient recovered from sick, and the outcome of felt almost died when he got single dose of vaccine, shortness of breath, slept for 18 hours and 100 percent in bed was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis
Clinical narrative: BLOOD CLOT IN RIGHT ARM; ARM SWOLLEN; This spontaneous report received from a patient concerned a 56 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol use (beer at home), and smoker. The patient experienced drug allergy when treated with acetylsalicylic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 05-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient did not feel sick after vaccination. On an unspecified date in 2021, the patient believed that, she had a blood clot in right arm. In past 2-3 weeks, it had been getting bigger and was moving up in her arm. She probably had the clot for longer but started noticing it more 2-3 weeks ago. Clot was moving from her elbow to the shoulder blade and arm was getting big. Patient did not have any pain but her arm was swollen and due to dark skinned she could not tell if her arm was red. Patient called emergency medical service and told them that she had a blood clot, she could feel and see the blood clot and it was told that she needs to go to the doctor but she did not bother. The blood clot kept moving up. Patient had a regular doctor but she did not inform her doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in right arm and arm swollen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210547027-covid-19 vaccine ad26.cov2.s- blood clot in right arm. This event 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.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Nausea
Clinical narrative: DIARRHEA; SEVERE NAUSEA; FEELING BAD; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced feeling bad. On 23-MAY-2021, the subject experienced diarrhea. On 23-MAY-2021, the subject experienced severe nausea. The action taken with covid-19 vaccine  was not applicable. The patient recovered from severe nausea on 23-MAY-2021, had not recovered from diarrhea, and the outcome of feeling bad was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Pyrexia, Vision blurred
Clinical narrative: CHEST PAIN; BLURRED VISION; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 81.64 kilograms, and height was 160.02 centimeters. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAY-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAY-2021, the subject experienced chest pain. On 24-MAY-2021, the subject experienced blurred vision. On 24-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.0. The action taken with covid-19 vaccine  was not applicable. The outcome of the chest pain, blurred vision and fever was not reported. 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.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 250 pounds, and height was 70 inches. The patient's past medical history included back pain, and concurrent conditions included pre-diabetic. The patient had no known allergies. The patient had no history of headache for several years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the patient developed a headache. Heath care professional (HCP) told him that he probably had been experiencing stroke symptoms from 02 to 04-MAY-2021. On 04-MAY-2021, the patient went to the hospital and was diagnosed with a stroke. He was hospitalized for 7 days. He experienced cognitive issues, like taking time to get his thoughts together, but no paralysis. He has been out of work. HCP has started him on aspirin (acetylsalicylic acid), but he could not remember what medications he was taking. He stated that until getting the vaccination, had no problems with his health. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210548992-covid-19 vaccine ad26.cov2.s-stroke. 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).
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a parent 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 (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 subject experienced fever. Laboratory data (dates unspecified) included: Fever (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The outcome of fever was not reported. This report was non-serious.
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  (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 25-MAY-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This report was associated with product quality complaint :90000180844
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF DRUG; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 34 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  (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 26-JUN-2021) dose was not reported, administered on 25-MAY-2021 13:21 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced out of specification product use. On an unspecified date, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine was not applicable. The outcome of the out of specification product use and incorrect storage of drug was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Neuralgia
Clinical narrative: NEUROPATHIC PAIN (HAVING SENSATIONS IN HEAD SUCH AS COLD, HOT, TINGLES) DUE TO WHICH UNABLE TO PERFORM NORMAL ACTIVITIES; DISCOMFORTING SENSATION IN HEAD; This spontaneous report received from a patient concerned a 40 year old of unspecified 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, treatment medications included: gabapentin. On 05-MAY-2021, the subject experienced neuropathic pain (having sensations in head such as cold, hot, tingles) due to which unable to perform normal activities. On 05-MAY-2021, the subject experienced discomforting sensation in head. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from discomforting sensation in head, and neuropathic pain (having sensations in head such as cold, hot, tingles) due to which unable to perform normal activities. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Body temperature, Chest X-ray, Cold sweat
Clinical narrative: PASSING OUT; SLIGHTLY DEHYDRATED; LITTLE RED SPOTS ON CHEST, BACK, ARM, TORSO AND BELOW BREAST; WEAK; TERRIBLE HEADACHE; FEVER 103; DOUBLE VISION; DIZZY; THREW UP; STOMACH PAINS; HARD COLD SWEATS; COULD NOT BREATH; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. After vaccination on 20-MAY-2021, the patient waited in the pharmacy for 20 mins. The patient got into car, the patient could not breath, began to sweat, threw up, experienced double vision and stomach pains. On same day, the patient was dizzy and had fever of 103 F. On 24-MAY-2021, the patient went to the emergency room (ER) by ambulance as the patient had passing out and when patient woke up patient was in ambulance on the way to the ER. The patient continued to have terrible headache, double vision, weak, and sweats which started on the day of vaccination. The patient had cold sweats. The patient still had stomach pains. On 24-MAY-2021, at ER the patient had an X-ray of chest, CT of head and neck. In the ER, patient received Dilaudid for terrible headache and some fluids as patient was slightly dehydrated. The patient had tiny red spots to chest, torso, arm, back an below breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terrible headache, weak, double vision, fever 103, dizzy, little red spots on chest, back, arm, torso and below breast, stomach pains, and hard cold sweats, and the outcome of threw up, could not breath, passing out and slightly dehydrated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210549340-covid-19 vaccine ad26.cov2.s-Loss of consciousness. 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).
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Computerised tomogram neck, Dehydration, Diplopia, Dizziness
Clinical narrative: PASSING OUT; SLIGHTLY DEHYDRATED; LITTLE RED SPOTS ON CHEST, BACK, ARM, TORSO AND BELOW BREAST; WEAK; TERRIBLE HEADACHE; FEVER 103; DOUBLE VISION; DIZZY; THREW UP; STOMACH PAINS; HARD COLD SWEATS; COULD NOT BREATH; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. After vaccination on 20-MAY-2021, the patient waited in the pharmacy for 20 mins. The patient got into car, the patient could not breath, began to sweat, threw up, experienced double vision and stomach pains. On same day, the patient was dizzy and had fever of 103 F. On 24-MAY-2021, the patient went to the emergency room (ER) by ambulance as the patient had passing out and when patient woke up patient was in ambulance on the way to the ER. The patient continued to have terrible headache, double vision, weak, and sweats which started on the day of vaccination. The patient had cold sweats. The patient still had stomach pains. On 24-MAY-2021, at ER the patient had an X-ray of chest, CT of head and neck. In the ER, patient received Dilaudid for terrible headache and some fluids as patient was slightly dehydrated. The patient had tiny red spots to chest, torso, arm, back an below breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terrible headache, weak, double vision, fever 103, dizzy, little red spots on chest, back, arm, torso and below breast, stomach pains, and hard cold sweats, and the outcome of threw up, could not breath, passing out and slightly dehydrated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210549340-covid-19 vaccine ad26.cov2.s-Loss of consciousness. 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).
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Loss of consciousness, Pyrexia, Rash erythematous
Clinical narrative: PASSING OUT; SLIGHTLY DEHYDRATED; LITTLE RED SPOTS ON CHEST, BACK, ARM, TORSO AND BELOW BREAST; WEAK; TERRIBLE HEADACHE; FEVER 103; DOUBLE VISION; DIZZY; THREW UP; STOMACH PAINS; HARD COLD SWEATS; COULD NOT BREATH; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. After vaccination on 20-MAY-2021, the patient waited in the pharmacy for 20 mins. The patient got into car, the patient could not breath, began to sweat, threw up, experienced double vision and stomach pains. On same day, the patient was dizzy and had fever of 103 F. On 24-MAY-2021, the patient went to the emergency room (ER) by ambulance as the patient had passing out and when patient woke up patient was in ambulance on the way to the ER. The patient continued to have terrible headache, double vision, weak, and sweats which started on the day of vaccination. The patient had cold sweats. The patient still had stomach pains. On 24-MAY-2021, at ER the patient had an X-ray of chest, CT of head and neck. In the ER, patient received Dilaudid for terrible headache and some fluids as patient was slightly dehydrated. The patient had tiny red spots to chest, torso, arm, back an below breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terrible headache, weak, double vision, fever 103, dizzy, little red spots on chest, back, arm, torso and below breast, stomach pains, and hard cold sweats, and the outcome of threw up, could not breath, passing out and slightly dehydrated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210549340-covid-19 vaccine ad26.cov2.s-Loss of consciousness. 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).
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: PASSING OUT; SLIGHTLY DEHYDRATED; LITTLE RED SPOTS ON CHEST, BACK, ARM, TORSO AND BELOW BREAST; WEAK; TERRIBLE HEADACHE; FEVER 103; DOUBLE VISION; DIZZY; THREW UP; STOMACH PAINS; HARD COLD SWEATS; COULD NOT BREATH; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. After vaccination on 20-MAY-2021, the patient waited in the pharmacy for 20 mins. The patient got into car, the patient could not breath, began to sweat, threw up, experienced double vision and stomach pains. On same day, the patient was dizzy and had fever of 103 F. On 24-MAY-2021, the patient went to the emergency room (ER) by ambulance as the patient had passing out and when patient woke up patient was in ambulance on the way to the ER. The patient continued to have terrible headache, double vision, weak, and sweats which started on the day of vaccination. The patient had cold sweats. The patient still had stomach pains. On 24-MAY-2021, at ER the patient had an X-ray of chest, CT of head and neck. In the ER, patient received Dilaudid for terrible headache and some fluids as patient was slightly dehydrated. The patient had tiny red spots to chest, torso, arm, back an below breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terrible headache, weak, double vision, fever 103, dizzy, little red spots on chest, back, arm, torso and below breast, stomach pains, and hard cold sweats, and the outcome of threw up, could not breath, passing out and slightly dehydrated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210549340-covid-19 vaccine ad26.cov2.s-Loss of consciousness. 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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a 62 year old male patient. The patient's height, and weight were not reported. The patient's concurrent conditions included surgery, and past condition included multiple myeloma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 and expiry: UNKNOWN) dose was not reported,1 total administered on left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-APR-2021, COVID-19 antibody test result was negative which confirmed immunological vaccination failure. On same date, he had lab work done and results were unknown. On 20-MAY-2021, COVID-19 antibody test was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210549805-Covid-19 vaccine ad26.cov2.s- Confirmed immunological 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: U
Vaccine: COVID19
Symptoms: Disturbance in attention, Tunnel vision
Clinical narrative: TUNNEL VISION; LACK OF ABILITY TO CONCENTRATE; 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) dose was not reported, 1 total, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAY-2021, the patient experienced general side effects a kind of tunnel vision. Patient would not consider it dizziness, nausea or blurred vision. Patient had clear image of surroundings but it felt like vignette and another side effect was lack of ability to concentrate. Patient nearest experience like this was like being drunk or with anesthesia but with complete motor ability. After a good nap patient was ok, but the next day it went off again, less intense, but still annoying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tunnel vision, and lack of ability to concentrate. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210550348-covid-19 vaccine ad26.cov2.s -Tunnel vision. 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: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pain, Unevaluable event
Clinical narrative: UNEVALUABLE EVENT; INJECTION SITE PAIN; This spontaneous report received from a health care professional concerned a 73 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  (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. 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 unevaluable event, and injection site pain. The action taken with covid-19 vaccine  was not applicable. The patient recovered from injection site pain, and had not recovered from unevaluable event. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: JOINTS HURTING MORE THAN NORMAL; This spontaneous report received from a patient concerned a 38 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  (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose and frequency were not reported from MAY-2021 for hidradenitis suppurativa. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced joints hurting more than normal. The action taken with covid-19 vaccine was not applicable. The outcome of joints hurting more than normal was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS FLARE UP; This spontaneous report received from a patient concerned a female of unspecified age and ethnicity. The patient's height, and weight were not reported. The patient has no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) 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. Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced rheumatoid arthritis flare up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rheumatoid arthritis flare up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210550994-covid-19 vaccine ad26.cov2-Rheumatoid arthritis. This event(s) is considered not related. The event(s) has an unknown/unclear 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: CONMEDS-OTHER SUSPECT DRUGS.
Age: 24.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Biopsy skin, Hypersensitivity, Rash pruritic
Clinical narrative: HYPERSENSITIVITY; PRURITIC RASH; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included plaque psoriasis. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection, batch number: UNKNOWN, route of admin was not reported) dose and frequency were not reported from 17-MAR-2021 for plaque psoriasis. 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 2021, the subject experienced hypersensitivity. On 2021, the subject experienced pruritic rash. Laboratory data (dates unspecified) included: Skin biopsy (NR: not provided) Not reported. The action taken with covid-19 vaccine  was not applicable; and action taken with adalimumab was not reported. The outcome of the pruritic rash and hypersensitivity was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: SHARP STABBING HEART PAIN; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, non smoker, and non alcoholic, and the patient had no known allergies and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: unknown) dose was not reported, 1 total administered to left arm on 24-MAY-2021 at 11:00 for prophylactic vaccination. Concomitant medications included simvastatin for high cholesterol. On vaccination at about 15:00, the patient began experiencing side effect of sharp stabbing heart pain which was lasted for about 5-7 seconds. He took one low dose aspirin and was doing well now. He had reported this adverse event to the vaccine facility and was not going to see his doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp stabbing heart pain on 24-MAY-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210551413-Covid-19 vaccine ad26.cov2.s -Sharp stabbing heart pain. This event(s) is considered un-assessable. 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED A  EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805025, expiry: 25/MAY/2021) dose was not reported, administered on 26-MAY-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced subject received a expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of patient received a expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned multiple (two) 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: 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 had suspected immunological vaccine failure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) negative. 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). This case, from the same reporter is linked to 20210551575 and 20210550960.; Sender's Comments: V0: 20210551477-Covid-19 vaccine ad26.cov2.s-Suspected immunological vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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: U
Vaccine: COVID19
Symptoms: Electric shock sensation
Clinical narrative: ELECTRIC SHOCK SENSATIONS; This spontaneous report received from a patient concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular) The batch number was not reported and has been requested dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced electric shock sensations. The action taken with covid-19 vaccine  was not applicable. The outcome of electric shock sensations was not reported. This report was non-serious. This case, from the same reporter is linked to 20210438273.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 50 year old white, not Hispanic or Latino 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 administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 08-APR-2021 in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient had 2 antibody tests done and both came back negative. The first test (Covid-19 antibody IgG/IgM rapid point of care test) was done on 18-MAY-2021 (coded as confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) Negative. The second test was Blood test done on 21-MAY-2021. Laboratory data included: Blood test (NR: not provided) Negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210551688-COVID-19 VACCINE AD26.COV2.S-Confirmed 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
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Pyrexia, SARS-CoV-2 test, Urticaria
Clinical narrative: HIVES; CONFIRMED COVID-19 INFECTION; LOW GRADE FEVER (100 F); This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient had no known drug allergies. The patient had unremarkable past medical history.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 2D5AZ1A, and expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced low grade fever (100 f). Laboratory data included: Body temperature (NR: not provided) 100 F. Treatment medications included: paracetamol. On 21-MAY-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive (COVID-19), and COVID-19 virus test (NR: not provided) Positive (COVID-19). On an unspecified date, the subject experienced hives. Additional treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from hives, and low grade fever (100 f) on 28-APR-2021, and the outcome of confirmed covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000180784; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.