chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: TOOTHACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced toothache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of toothache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Nausea
Clinical narrative: LITTLE DIZZINESS; WRIST ACHE; BIG WAVE OF NAUSEA; BIG FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced little dizziness, wrist ache, big wave of nausea, and big fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little dizziness, wrist ache, big wave of nausea, and big fatigue. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Rash
Clinical narrative: RASH AROUND BOTH ANKLES, LEFT ANKLE HAD A SLIGHTLY ITCHY RASH THAT WENT ALMOST COMPLETELY AROUND HIS ANKLE AND THE RIGHT ANKLE HAS A PATCH OF THE SAME RASH; HIP AND KNEE PAIN; CHEMICAL FEELING; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, the patient experienced chemical feeling. On 17-AUG-2021, the patient experienced hip and knee pain. On 28-AUG-2021, the patient experienced rash around both ankles, left ankle had a slightly itchy rash that went almost completely around his ankle and the right ankle has a patch of the same rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chemical feeling, and hip and knee pain on AUG-2021, and had not recovered from rash around both ankles, left ankle had a slightly itchy rash that went almost completely around his ankle and the right ankle has a patch of the same rash. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Back pain, Body temperature, Dizziness, Feeling abnormal
Clinical narrative: EVERYTHING SORE; BACK HURT; STOMACH SWELLING; DIZZINESS; CAN'T SLEEP WELL; FEELING OF MIGHT DIE AT ANY TIME; TEMPERATURE; ARM SORENESS; NOT FEELING WELL; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-AUG-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 AUG-2021, the patient experienced everything sore. On AUG-2021, the patient experienced back hurt. On AUG-2021, the patient experienced stomach swelling. On AUG-2021, the patient experienced dizziness. On AUG-2021, the patient experienced can't sleep well. On AUG-2021, the patient experienced feeling of might die at any time. On AUG-2021, the patient experienced temperature. On AUG-2021, the patient experienced arm soreness. On AUG-2021, the patient experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the everything sore, back hurt, stomach swelling, temperature, dizziness, not feeling well, can't sleep well, feeling of might die at any time and arm soreness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Pain, Pain in extremity
Clinical narrative: EVERYTHING SORE; BACK HURT; STOMACH SWELLING; DIZZINESS; CAN'T SLEEP WELL; FEELING OF MIGHT DIE AT ANY TIME; TEMPERATURE; ARM SORENESS; NOT FEELING WELL; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 25-AUG-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 AUG-2021, the patient experienced everything sore. On AUG-2021, the patient experienced back hurt. On AUG-2021, the patient experienced stomach swelling. On AUG-2021, the patient experienced dizziness. On AUG-2021, the patient experienced can't sleep well. On AUG-2021, the patient experienced feeling of might die at any time. On AUG-2021, the patient experienced temperature. On AUG-2021, the patient experienced arm soreness. On AUG-2021, the patient experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the everything sore, back hurt, stomach swelling, temperature, dizziness, not feeling well, can't sleep well, feeling of might die at any time and arm soreness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a patient concerned a 74 year old of unspecified sex of unknown race and ethnicity. The patient's height, and weight were not reported. The patient never had blood clot in past. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 567632 expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot after taking the shot. 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: V0:20210857229-COVID-19 VACCINE AD26.COV2.S-Blood clot. 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: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: THE COOLER WENT OUT OF RANGE A COUPLE OF TIMES (IT DROPPED DOWN FROM 3 TO 4 AM TO JUST BELOW 2 C FOR 5 TO 10 MINUTES, THEN FROM 6 TO 8 AM, IT WENT DOWN TO 0C FOR 30 MINUTES TO 1 HOUR, THEN AROUND 10 TO 11 AM, IT DROPPED TO -0.8 C ANOTHER 20 MINUTES,; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist 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: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced the cooler went out of range a couple of times (it dropped down from 3 to 4 am to just below 2 c for 5 to 10 minutes, then from 6 to 8 am, it went down to 0c for 30 minutes to 1 hour, then around 10 to 11 am, it dropped to -0.8 c another 20 minutes, then around 8 pm it went below 2c. total duration of out of range is 2 hours and 11 minutes). On 27-AUG-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the cooler went out of range a couple of times (it dropped down from 3 to 4 am to just below 2 c for 5 to 10 minutes, then from 6 to 8 am, it went down to 0c for 30 minutes to 1 hour, then around 10 to 11 am, it dropped to -0.8 c another 20 minutes, then around 8 pm it went below 2c. total duration of out of range is 2 hours and 11 minutes) and out of specification product use was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Lymphadenopathy, Nausea, Neck pain
Clinical narrative: PAIN IN NECK; HEADACHE; SWOLLEN LYMPH NODES; FEVER; NAUSEA; FEELS SO BAD; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto's, and gluten sensitivity dairy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced feels so bad. On 19-AUG-2021, the patient experienced swollen lymph nodes. On 19-AUG-2021, the patient experienced fever. On 19-AUG-2021, the patient experienced nausea. On 27-AUG-2021, the patient experienced pain in neck. On 27-AUG-2021, the patient experienced headache. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, swollen lymph nodes, nausea, pain in neck, and headache, and the outcome of feels so bad was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: PAIN IN NECK; HEADACHE; SWOLLEN LYMPH NODES; FEVER; NAUSEA; FEELS SO BAD; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto's, and gluten sensitivity dairy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced feels so bad. On 19-AUG-2021, the patient experienced swollen lymph nodes. On 19-AUG-2021, the patient experienced fever. On 19-AUG-2021, the patient experienced nausea. On 27-AUG-2021, the patient experienced pain in neck. On 27-AUG-2021, the patient experienced headache. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, swollen lymph nodes, nausea, pain in neck, and headache, and the outcome of feels so bad was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Headache, Inflammation, Neck pain
Clinical narrative: PAIN IN NECK; HEADACHE; SWOLLEN LYMPH NODES; FEVER; NAUSEA; FEELS SO BAD; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto's, and gluten sensitivity dairy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced feels so bad. On 19-AUG-2021, the patient experienced swollen lymph nodes. On 19-AUG-2021, the patient experienced fever. On 19-AUG-2021, the patient experienced nausea. On 27-AUG-2021, the patient experienced pain in neck. On 27-AUG-2021, the patient experienced headache. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, swollen lymph nodes, nausea, pain in neck, and headache, and the outcome of feels so bad was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count increased, Pyrexia
Clinical narrative: PAIN IN NECK; HEADACHE; SWOLLEN LYMPH NODES; FEVER; NAUSEA; FEELS SO BAD; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto's, and gluten sensitivity dairy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced feels so bad. On 19-AUG-2021, the patient experienced swollen lymph nodes. On 19-AUG-2021, the patient experienced fever. On 19-AUG-2021, the patient experienced nausea. On 27-AUG-2021, the patient experienced pain in neck. On 27-AUG-2021, the patient experienced headache. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, swollen lymph nodes, nausea, pain in neck, and headache, and the outcome of feels so bad was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Fatigue, Nausea, Pyrexia
Clinical narrative: ANXIETY TYPE FEELING IMMEDIATELY AFTER INJECTION; SLIGHT SORENESS AT INJECTION SITE; LITTLE NAUSEA IMMEDIATELY AFTER INJECTION; FATIGUE; LOW GRADE FEVER FOR 24 - 48 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced anxiety type feeling immediately after injection, slight soreness at injection site, little nausea immediately after injection, fatigue, and low grade fever for 24 - 48 hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade Fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anxiety type feeling immediately after injection, slight soreness at injection site, little nausea immediately after injection, fatigue, and low grade fever for 24 - 48 hours. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: ANXIETY TYPE FEELING IMMEDIATELY AFTER INJECTION; SLIGHT SORENESS AT INJECTION SITE; LITTLE NAUSEA IMMEDIATELY AFTER INJECTION; FATIGUE; LOW GRADE FEVER FOR 24 - 48 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced anxiety type feeling immediately after injection, slight soreness at injection site, little nausea immediately after injection, fatigue, and low grade fever for 24 - 48 hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade Fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anxiety type feeling immediately after injection, slight soreness at injection site, little nausea immediately after injection, fatigue, and low grade fever for 24 - 48 hours. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonitis
Clinical narrative: INFLAMMED LUNGS AFFECTING HEART; This spontaneous report received from a consumer via  social media via 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, expiry: unknown) dose, start therapy date were not reported, 1 total administered  for prophylactic vaccination. The batch number was not reported. As Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced inflammation of lungs that was affecting his heart, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inflammation of lungs was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210850188.; Sender's Comments: V0: 20210861653-COVID-19 VACCINE AD26.COV2.S- inflammation of lungs. This event(s) is considered unassessable. The event(s) has an unknown temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration, Skin ulcer
Clinical narrative: FINGER TIPS WERE BLUE; PAIN IN FINGERS; FINGER ULCERS ON FINGERS; This spontaneous report received from a parent concerned a 25 year old of unknown race and ethnicity female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUN-2021, the patient experienced pain in fingers and finger tips were blue, and was hospitalized (date unspecified).  On Next day (JUN-2021), the patient experienced finger ulcers on fingers and had seen many doctors who couldn't help her because they had said it is from the vaccine and they don't know what to do. Every day the patient goes to work in pain, comes home in pain, goes to bed in pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in fingers, and finger ulcers on fingers, and the outcome of finger tips were blue was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210900251-covid-19 vaccine ad26.cov2.s-pain in fingers and finger tips were blue. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Nausea, Therapy non-responder, Vomiting
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; THREW UP THREE TO FOUR TIMES OR VOMITING; NAUSEOUS; This spontaneous report received from a patient concerned a 63 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non smoker. The patient had no known allergies and drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included prednisone.  On 07-APR-2021, about four hours later patient got nauseous and threw up three to four times or vomiting then patient was perfectly fine couple of days later. The issue of patient was she on prednisone for eight months. The patient was on prednisone 9-10 milligram at the time of vaccination. On an unspecified date, the patient had antibody test showed suspected immunological vaccine failure. In the patient family nine doctors was their and they suggested to take another vaccine without mentioning that she already had the vaccine. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Low antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from threw up three to four times or vomiting, and nauseous on 10-APR-2021, and the outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint. This case, from the same reporter is linked to 20210901129 and 20210900823.; Sender's Comments: V0: 20210900297-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Electrocardiogram, Feeling abnormal, Gait disturbance
Clinical narrative: FELT SO WEIRD; 2 BLOOD CLOTS IN LUNGS; SEVERE LOWER BACK PAIN; BARELY WALK; This spontaneous report received from a patient concerned a 61 year old  female unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: idiopathic chest cavity pain, allergy to contrast dye, no alcohol use, and non-smoker, and other pre-existing medical conditions included: The Patient had history of no drug abuse or illicit drug usage. The patient was not pregnant at the time of report. The patient experienced drug allergy when treated with phenytoin (Dilantin). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered to left arm on 18-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. The patient was on unspecified medications for idiopathic chest cavity pain. On 18-MAY-2021, day of vaccination the patient took a nap and woke from severe lower back pain, the pain was really bad that she couldn't get up and could barely walk which lasted for about 3 days. The patient assumed it was supposed to happen after the vaccination and she considered it was okay, but never completely got over it, but was able to walk better. About a week or so after vaccination, on 25-MAY-2021, the patient experienced chest pain on and off (on for a couple of hours) and got worse on 29-AUG-2021. On 29-AUG-2021, the patient felt so weird. On the same day, the patient went to emergency room (ER) and checked for electrocardiograph (EKG) which showed heart normal and blood work results was received on 30-AUG-2021, and showed 2 blood clots in lungs one in each side. The patient was hospitalized for 2 days and was discharged on 30-AUG-2021. The patient stated that doctors at hospital would do further blood test to identify cause but as outpatient. The patient stated her family physician was made aware by hospital doctors of the event but she hasn't seen her yet and has an appointment for 09-SEP-2021. The patient mentioned that she will be on blood thinners for the rest of her life. At the time of report, the patient still has chest pain but just not as severe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe lower back pain, and barely walk, had not recovered from 2 blood clots in lungs, and the outcome of felt so weird was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210900298-covid-19 vaccine ad26.cov2.s-2 Blood clots in lungs, Felt so weird. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: FELT SO WEIRD; 2 BLOOD CLOTS IN LUNGS; SEVERE LOWER BACK PAIN; BARELY WALK; This spontaneous report received from a patient concerned a 61 year old  female unspecified ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: idiopathic chest cavity pain, allergy to contrast dye, no alcohol use, and non-smoker, and other pre-existing medical conditions included: The Patient had history of no drug abuse or illicit drug usage. The patient was not pregnant at the time of report. The patient experienced drug allergy when treated with phenytoin (Dilantin). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered to left arm on 18-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. The patient was on unspecified medications for idiopathic chest cavity pain. On 18-MAY-2021, day of vaccination the patient took a nap and woke from severe lower back pain, the pain was really bad that she couldn't get up and could barely walk which lasted for about 3 days. The patient assumed it was supposed to happen after the vaccination and she considered it was okay, but never completely got over it, but was able to walk better. About a week or so after vaccination, on 25-MAY-2021, the patient experienced chest pain on and off (on for a couple of hours) and got worse on 29-AUG-2021. On 29-AUG-2021, the patient felt so weird. On the same day, the patient went to emergency room (ER) and checked for electrocardiograph (EKG) which showed heart normal and blood work results was received on 30-AUG-2021, and showed 2 blood clots in lungs one in each side. The patient was hospitalized for 2 days and was discharged on 30-AUG-2021. The patient stated that doctors at hospital would do further blood test to identify cause but as outpatient. The patient stated her family physician was made aware by hospital doctors of the event but she hasn't seen her yet and has an appointment for 09-SEP-2021. The patient mentioned that she will be on blood thinners for the rest of her life. At the time of report, the patient still has chest pain but just not as severe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe lower back pain, and barely walk, had not recovered from 2 blood clots in lungs, and the outcome of felt so weird was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210900298-covid-19 vaccine ad26.cov2.s-2 Blood clots in lungs, Felt so weird. 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: Feeling abnormal, Myocardial infarction, Thrombosis
Clinical narrative: BLOOD CLOT IN RIGHT ARTERY; HEART ATTACK; FEELING POORLY; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown)1 total, dose was and start therapy date (earlier this year) 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, sometime after vaccination, the patient was feeling poorly and recently suffered heart attack due to a blood clot in right artery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling poorly, heart attack and blood clot in right artery was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210900330-covid-19 vaccine ad26.cov2.s -Heart attack due to a blood clot in right artery. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SORE ARM ABOUT TWO INCHES BELOW WHERE NEEDLE INSERTED; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 138 pounds, and height was 68 inches. The patient's concurrent conditions included: multiple sclerosis (MS), rheumatoid arthritis (RA), osteoarthritis (OA), emphysema, non- alcoholic, and ex smoker, and other pre-existing medical conditions included: Patient had no known allergies and did not have any drug abuse or illicit drug use. 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,1 total, administered on 16-MAR-2021 (in the morning) to right arm for prophylactic vaccination. Concomitant medications included fingolimod hydrochloride, fluconazole, prazosin, prednisone, and sulfasalazine. The patient was taking more medicine but could not remember the name of rest of the medicines. On 17-MAR-2021, the patient experienced sore arm about two inches below where needle was inserted, it started the day after vaccination and lasted either a day or a day and half. On 25-AUG-2021, the patient had protein spike test done and the result came as "zero" antibodies (confirmed immunological vaccine failure). Patient's primary care physician (PCP) ordered the test, so they were aware of the results. Patient was willing to get a copy of the results from the test if required. Patient stated that, no expiration date was written on the vaccination card. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm about two inches below where needle inserted on 18-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191699 This case, from the same reporter is linked to 20210900277.; Sender's Comments: V0: 20210900383-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
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: TWO STROKES; This spontaneous report received from a consumer via a company representative through social media 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) dose, start therapy date were not reported, 1 total administered 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.  It was reported that, on an unspecified date, the vaccine caused blood clotting throughout the patient's body resulting in two strokes and ultimately her death on 19-AUG-2021. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On 19-AUG-2021, the patient died from two strokes. This report was serious (Death).; Sender's Comments: V0: 20210900460 - JANSSEN COVID-19 VACCINE Ad26.COV2.S- Two strokes. 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: TWO STROKES
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: ITCHY RASH ON STOMACH TO RIGHT SIDE UNDER RIBS AND BREASTS AND ON RIGHT ARM ON THE TOP TO HER ELBOW/ ITCHY DOTS ON ARM; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 02-OCT-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced itchy rash on stomach to right side under ribs and breasts and on right arm on the top to her elbow/ itchy dots on arm. Treatment medications (dates unspecified) included: hydrocortisone, and calamine/glycerol/zinc oxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy rash on stomach to right side under ribs and breasts and on right arm on the top to her elbow/ itchy dots on arm. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, Somnolence
Clinical narrative: FELT SHAKY; SLEEPY; FELT CHILLED; FEVER; FELT TIRED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-AUG-2021, the patient experienced felt shaky. On 31-AUG-2021, the patient experienced sleepy. On 31-AUG-2021, the patient experienced felt chilled. On 31-AUG-2021, the patient experienced fever. On 31-AUG-2021, the patient experienced felt tired. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine was not applicable. The outcome of the felt chilled, fever, felt tired, felt shaky and sleepy was not reported. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: FELT SHAKY; SLEEPY; FELT CHILLED; FEVER; FELT TIRED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-AUG-2021, the patient experienced felt shaky. On 31-AUG-2021, the patient experienced sleepy. On 31-AUG-2021, the patient experienced felt chilled. On 31-AUG-2021, the patient experienced fever. On 31-AUG-2021, the patient experienced felt tired. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine was not applicable. The outcome of the felt chilled, fever, felt tired, felt shaky and sleepy was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blister, Joint swelling, Muscle spasms, Palpitations
Clinical narrative: ANKLE STARTED TO SWELL AND BECAME HOT, RED; SOME BLISTERS APPEARED ON ANKLE; HEART RACING; LEG CRAMPING; STOMACH HURTING; ARM FELT FUNNY; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced heart racing. On 27-AUG-2021, the patient experienced leg cramping. On 27-AUG-2021, the patient experienced stomach hurting. On 27-AUG-2021, the patient experienced arm felt funny. On 28-AUG-2021, the patient experienced ankle started to swell and became hot, red. On 28-AUG-2021, the patient experienced some blisters appeared on ankle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg cramping, heart racing, stomach hurting, arm felt funny, ankle started to swell and became hot, red and some blisters appeared on ankle 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: ANKLE STARTED TO SWELL AND BECAME HOT, RED; SOME BLISTERS APPEARED ON ANKLE; HEART RACING; LEG CRAMPING; STOMACH HURTING; ARM FELT FUNNY; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced heart racing. On 27-AUG-2021, the patient experienced leg cramping. On 27-AUG-2021, the patient experienced stomach hurting. On 27-AUG-2021, the patient experienced arm felt funny. On 28-AUG-2021, the patient experienced ankle started to swell and became hot, red. On 28-AUG-2021, the patient experienced some blisters appeared on ankle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg cramping, heart racing, stomach hurting, arm felt funny, ankle started to swell and became hot, red and some blisters appeared on ankle 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
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: ADMINISTRATION OF ONE DOSE OF JNJ COVID-19 VACCINE AND ANOTHER ONE DOSE OF PFIZER BIONTECH COVID-19 VACCINE; This spontaneous report received from a pharmacist concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 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 administration of one dose of jnj covid-19 vaccine and another one dose of pfizer biontech covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of one dose of jnj covid-19 vaccine and another one dose of pfizer biontech covid-19 vaccine was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Contusion
Clinical narrative: BRUISING AT AREA OF PREVIOUS INJURY OF LEFT ELBOW AND RIGHT ANKLE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included: banged her left elbow really bad, and hit her right ankle on a stick. 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, administered on 19-MAY-2021 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: semaglutide (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication; and insulin degludec (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 26-MAY-2021, the patient experienced bruising at area of previous injury of left elbow and right ankle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with semaglutide, and insulin degludec was not reported. The patient recovered from bruising at area of previous injury of left elbow and right ankle. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Glycosylated haemoglobin, Groin pain, White blood cell count
Clinical narrative: ABDOMINAL PAIN IS ON THE LOWER RIGHT SIDE AND IS ALSO RADIATING TO THE HIP AND AROUND THE BACK AND IS CONSISTENTLY THERE AND SOMETIMES GETS WORSE WITH  MOVEMENT; GROIN PAIN WAS ONGOING BUT COMES AND GOES; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cigarette smoker, and diabetes, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. Concomitant medications included glipizide for diabetes, metformin for diabetes, acetylsalicylic acid for drug used for unknown indication, apixaban for drug used for unknown indication, lisinopril for drug used for unknown indication, and simvastatin for drug used for unknown indication. On AUG-2021, treatment medications included: ibuprofen. On 19-AUG-2021, the patient experienced groin pain was ongoing but comes and goes. On 20-AUG-2021, the patient experienced abdominal pain is on the lower right side and is also radiating to the hip and around the back and is consistently there and sometimes gets worse with movement. On 22-AUG-2021, Laboratory data included: Blood test (NR: not provided) Not reported. On 23-AUG-2021, Laboratory data included: HbA1C (NR: not provided) high, and WBC count (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain is on the lower right side and is also radiating to the hip and around the back and is consistently there and sometimes gets worse with movement, and groin pain was ongoing but comes and goes. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Pain in extremity
Clinical narrative: BACK PAIN; SHIVERS; SORE LIMBS; JOINTS PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced back pain, shivers, sore limbs, and joints pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the back pain, shivers, sore limbs and joints pain was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PSORIASIS SYMPTOMS INCREASED IN INTENSITY AND SPREAD OVER LARGER PORTIONS OF BODY; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis, and other pre-existing medical conditions included: The patient had relatively healthy and strong except from psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 26-JUN-2021, the patient experienced psoriasis symptoms increased in intensity and spread over larger portions of body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from psoriasis symptoms increased in intensity and spread over larger portions of body. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Gastrointestinal disorder
Clinical narrative: GASTROINTESTINAL SYMPTOMS (GI); UPSET STOMACH; This spontaneous report received from a pharmacist via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 gastrointestinal symptoms (gi), and upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from gastrointestinal symptoms (gi), and upset stomach. This report was non-serious.