chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: VACCINE DID NOT WORK; This spontaneous report received from social media a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry date: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination  (dose number series: 1). 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, it was reported that "the vaccine doesn't work, either people die or they don't it's called the damn flu people need to realize that's all it is".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine did not work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220100090 -Covid-19 vaccine ad26.cov2.s - vaccine did not work (Drug ineffective) This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: OUT OF WORK FROM THE REACTION TO THE SHOT; This spontaneous report received from a consumer via social media via a company representative concerned a female (nurse) of unspecified age. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received two shots of covid-19 vaccine (Dose number in series 1, Unspecified manufacturer) (form of admin, route of admin and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination and she got sick with both the shots of covid-19 vaccine (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was 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, following vaccination with covid-19 vaccine ad26.cov2.s, the patient was out of work from the reaction to the shot (Dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of work from the reaction to the shot was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: A LITTLE ACHES; This spontaneous report received from a patient via a social media through company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s. (suspension for injection, route of admin, batch number and expiry date not reported) (dose number in series 1) 01 in total administered, dose was not reported for prophylactic vaccination on an unspecified date. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown), (dose number in series 2), 01 in total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had a little aches but she was good (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a little aches was not reported (dose number in series 2). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a social media via a company representative concerned 2 patients of unspecified age and sex. The patients' weight and height were not reported.  No past medical histories or concurrent conditions were reported. The patients previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin, and batch numbers were not reported) dose was not reported, 1 total, administrated on an unspecified date for prophylactic vaccination. It was unknown if patients had adverse reactions post vaccination (Dose number in series 1). The patients received covid-19 vaccine ad26.cov2.s (Dose number in series 2, unspecified manufacturer) (suspension for injection, route of admin, and batch numbers were not reported) dose was not reported, 1 total, administrated on an unspecified date for prophylactic vaccination. The batch numbers were 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 patients died after second dose (Dose number in series 2). It was reported as "We know of three people personally also who died within days of their 2nd Vax". The cause of death was unknown. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220100153.; Sender's Comments: V0: 20220100127-covid-19 vaccine ad26.cov2.s-Death. 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: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media via a company representative concerned a 21 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history was not reported. The patient previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total administrated, dose, start therapy date were not reported for prophylactic vaccination. It was unknown if patient had adverse reaction with covid-19 vaccine ad26. cov2. s. (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) 1 total administrated, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died after second dose. The patient died from unknown cause of death. It was unspecified if an autopsy was performed. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was fatal. This report was serious (Death). This case, from the same reporter is linked to 20220100127.; Sender's Comments: V0-20220100153-covid-19 vaccine ad26. cov2.s-Death. 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: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Chronic kidney disease, Glomerular filtration rate
Clinical narrative: STAGE 3 KIDNEY DISEASE; This spontaneous report received from a patient concerned an 80 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included: abstains from alcohol, non smoker, lactose intolerance, penicillin allergy, and gallstones (awaiting for surgery). The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808982 and expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 12-APR-2021 on left arm for prophylactic vaccination. Concomitant medications included gabapentin, levocetirizine, levothyroxine, Singulair (montelukast sodium), methocarbamol and rosuvastatin for drug used for unknown indication.  On 19-MAY-2021, following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1), the patient experienced stage 3 kidney disease (back pain on right side above hip and discomfort subsumed under stage 3 kidney disease). Patient also reported that 2 days prior to getting the booster, that "shet felt some discomfort and pain from the kidney disease when I bought a car from that lady". Laboratory data included: Estimated glomerular filtration rate (NR: not provided) 32 mL/min. On 20-OCT-2021, Laboratory data included: Estimated glomerular filtration rate (NR: not provided) 63 mL/min. She was glad that her kidney function has been improved from 32 to 63ml/min. On an unspecified date, Patient was frustrated that for 5 months from her first blood test she had been eating bananas, tomatoes, avocadoes, potatoes that would hurt her kidneys and her potassium levels were also quite high. Laboratory data (dates unspecified) included: Potassium level (NR: not provided) High. She did not receive any medications for her back pain or stage 3 kidney disease. Patient was also under the care of a kidney care nephrologist associate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported and batch number: 1808982) dose was not reported, 1 total, administered on 29-OCT-2021 in left arm and on same day received the flu shot into her right arm. It was unknown whether patient had any adverse events following vaccination with booster dose of covid-19 vaccine ad26.cov2.s. The outcome of stage 3 kidney disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220100154-covid-19 vaccine ad26.cov2.s-stage 3 kidney disease. 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: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nephrolithiasis, Pyrexia, Rash, Urinary tract infection
Clinical narrative: KIDNEY STONES; FREQUENT URINARY TRACT INFECTION WITH SKYRIZI/ URINARY TRACT INFECTION; VACCINATION MAY HAVE CAUSED RASH COVERING A FIFTH OF BODY; FEVER; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's past medical history included: urinary tract infections (in her early adulthood they stopped). The patient received covid-19 vaccine ad26.cov2.s, (dose number series 1) (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, 1 total administered on 15-SEP-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: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose and frequency were not reported from 12-JUN-2020 for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient was found to have two kidney stones and urinary tract infection which required two rounds of antibiotics and a month to go away. The physician did not think that the kidney stones were big enough to cause urinary tract infection. She was eleven days without Skyrizi (risankizumab). She had urinary tract infections in the past which had stopped during her early childhood, but since she started Skyrizi her condition had reemerged. She also had rash covering a fifth of body and fever which might have been because of vaccination. Treatment medications (dates unspecified) included: ondansetron (Zofran), cefalexin, meloxicam, and sulfamethoxazole/trimethoprim (Bactrim). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient recovered from vaccination may have caused rash covering a fifth of body and fever, had not recovered from frequent urinary tract infection/urinary tract infections with Skyrizi, and the outcome of kidney stones was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20220100187-COVID-19 VACCINE AD26.COV2.S-kidney stones . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Injection site erythema, Injection site pain, Lymphadenopathy
Clinical narrative: Pain and redness near injection site and Pain and swelling in left armpit. Overall fatigue and body aches.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain and redness near injection site and Pain and swelling in left armpit. Overall fatigue and body aches.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 212 pounds, and height was 65 inches. The patient's concurrent conditions included: high blood pressure, nerve problems, asthma, herpes, anxiety, penicillin allergy, pain, non alcohol user, and non smoker. The patient had no drug abuse or illicit drug usage. The patient was previously treated with acetylsalicylic acid (Aspirin) for drug used for unknown indication and experienced allergy.  The patient previously received covid-19 vaccine ad26. cov2. s (Janssen, Dose number series in 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administrated on an unspecified date in JUN-2021 (6 months before booster dose) for prophylactic vaccination. It was unknown if patient had adverse event for covid-19 vaccine ad26. cov2. s. (Dose number in series 1) The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 16-DEC-2021 into left arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included montelukast for allergy, budesonide/formoterol fumarate for asthma, salbutamol for asthma, hydrochlorothiazide/lisinopril for drug used for unknown indication, potassium for drug used for unknown indication, valaciclovir for herpes, sertraline for nerve problems, and anxiety, and meloxicam for pain. On 25-DEC-2021, the patient noticed her legs were swollen from groin down to her ankle. On 27-DEC-2021, the patient went to doctor and was sent to hospital and had done ultrasound and found blood clot and was sent to emergency room at same hospital for treatment and was discharged on same day from emergency room, and was put on Eliquis (apixaban) twice daily and was advised that it may take 3 months for her blood clots to recover, and she was advised to elevate her legs, patient stated she started to feel better. (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clots. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0:20220100209-COVID-19 VACCINE AD26.COV2.S-Blood clots. 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: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received two shots of non-company covid-19 vaccine (dose number in series 1, unspecified manufacturer) (form of administration, route of admin, and batch number were not reported) dose not reported, administered on an unspecified date for prophylactic vaccination. No adverse events reported post series 1 vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died of covid-19 infection (suspected covid-19 infection, and suspected clinical vaccination failure, dose number in series 2). The reporter reported as "A friend just died of covid after having both shots and booster". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from suspected covid-19 infection and the outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000209691.; Sender's Comments: V0: 20220100210- covid-19 vaccine ad26.cov2.s-suspected covid-19 infection . 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). 20220100210- covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: SUSPECTED COVID-19 INFECTION
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SOME EFFECTS; This spontaneous report received from a patient concerned a female 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, and batch number were not reported) dose, 1 total (dose number in series was 1) start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient reported that she had some effects and caught Covid but came out (coded as suspected covid-19 infection), suspected clinical vaccination failure (dose number in series was 1) and some effects (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, some effects, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000209719.; Sender's Comments: V0 20220100227-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: LOST HER GRANDMA TO VACCINE; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number: unknown, expiry: unknown) dose and start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date it was reported "a customer told me today she lost her grandma to the J&J vaccine on Christmas weekend". It was further reported "we had no idea it would have such an adverse reaction to the medicines she was currently taking". On an unspecified date in DEC-2021 (on Christmas weekend), the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220100492-COVID-19 VACCINE AD26.COV2.S- lost her grandma to vaccine. 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: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Vaccination failure, Vaccine breakthrough infection
Clinical narrative: BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative concerned multiple patients (family) of unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-NOV-2021, one of the family member after business trip became infected and later others (the entire family). It was reported that, the breakthrough occurred in a manner of two weeks (suspected clinical vaccination failure). The patients had more mild symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209764. This case, from the same reporter is linked to 20220100988.; Sender's Comments: V0: 20220100666-covid-19 vaccine ad26.cov2.s- Break through infection.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).  20220100666-Covid-19 vaccine ad26.cov2.s-Suspected clinical 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: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via social media concerned eleven patients. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose were not reported, 1 total, administered, start therapy date were not reported for prophylactic vaccination. The batch numbers were 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 patients died due to unknown cause of death. Reporter stated that "All I know it when this first started I had 11 friends who died". On an unspecified date, the patients died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220100991.; Sender's Comments: V0: 20220100700-COVID-19 VACCINE AD26.COV2.S-Death. This event is considered unassessable. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac dysfunction, Dyspnoea, Fluid retention, Heart rate
Clinical narrative: HEART FUNCTION SLOWED TO ONLY 10 PERCENT; LARGE THROMBOSIS (BLOOD CLOT); PNEUMONIA IN BOTH LUNGS; HARDLY BREATHE; NO LONGER ABLE TO WORK; CONSTANT FLUID BUILD UP IN MY BODY WHICH CAUSES ME TO SWELL; This spontaneous report received from a patient via a company representative via social media concerned a male of unspecified age, race, and ethnic origin. The patient's height and weight were not reported. The patient's past medical history included: heart cath. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 13-MAY-2021 for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 15-MAY-2021, the patient experienced heart function slowed to only 10 percent, large thrombosis (blood clot), pneumonia in both lungs (double pneumonia), hardly breathing and no longer able to work, and was hospitalized (date unspecified). The patient reported as "Patient took the Johnson and Johnson Covid-19 Vaccine on 13-May-2021 and symptoms started after 2 days. He developed pneumonia in both lungs, and his heart function slowed to only 10 percent. This allowed for a very large thrombosis (blood clot) to form in his lower heart. The patient is constantly being monitored. His blood pressure will drop due to certain meds and his heart rate stays elevated mostly. Patient had a constant fluid build-up in the body which causes swelling. When too full, the patient can hardly breathe. This battle they tell will go on for up to a year before the patient will see much improvement with his heart function. The patient was currently in Hospital.They did a heart cath, want to verify and make sure that patient was on the best path for this moving forward. He still only has 10% of my heart working, so his battle is still long and difficult. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pneumonia in both lungs, heart function slowed to only 10 percent, large thrombosis (blood clot), hardly breathe, no longer able to work, and constant fluid build up in my body which causes me to swell. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20220100738-covid-19 vaccine ad26.cov2.s -pneumonia in both lungs, heart function slowed to only 10 percent, large thrombosis (blood clot), hardly breathe, constant fluid build-up in the body which causes me to swell and no longer able to work.. 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: Impaired work ability, Intracardiac thrombus, Pneumonia
Clinical narrative: HEART FUNCTION SLOWED TO ONLY 10 PERCENT; LARGE THROMBOSIS (BLOOD CLOT); PNEUMONIA IN BOTH LUNGS; HARDLY BREATHE; NO LONGER ABLE TO WORK; CONSTANT FLUID BUILD UP IN MY BODY WHICH CAUSES ME TO SWELL; This spontaneous report received from a patient via a company representative via social media concerned a male of unspecified age, race, and ethnic origin. The patient's height and weight were not reported. The patient's past medical history included: heart cath. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 13-MAY-2021 for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 15-MAY-2021, the patient experienced heart function slowed to only 10 percent, large thrombosis (blood clot), pneumonia in both lungs (double pneumonia), hardly breathing and no longer able to work, and was hospitalized (date unspecified). The patient reported as "Patient took the Johnson and Johnson Covid-19 Vaccine on 13-May-2021 and symptoms started after 2 days. He developed pneumonia in both lungs, and his heart function slowed to only 10 percent. This allowed for a very large thrombosis (blood clot) to form in his lower heart. The patient is constantly being monitored. His blood pressure will drop due to certain meds and his heart rate stays elevated mostly. Patient had a constant fluid build-up in the body which causes swelling. When too full, the patient can hardly breathe. This battle they tell will go on for up to a year before the patient will see much improvement with his heart function. The patient was currently in Hospital.They did a heart cath, want to verify and make sure that patient was on the best path for this moving forward. He still only has 10% of my heart working, so his battle is still long and difficult. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pneumonia in both lungs, heart function slowed to only 10 percent, large thrombosis (blood clot), hardly breathe, no longer able to work, and constant fluid build up in my body which causes me to swell. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20220100738-covid-19 vaccine ad26.cov2.s -pneumonia in both lungs, heart function slowed to only 10 percent, large thrombosis (blood clot), hardly breathe, constant fluid build-up in the body which causes me to swell and no longer able to work.. 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: Malaise, Pain
Clinical narrative: BODY HURTS; NOT FEELING WELL; 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 previously received covid-19 vaccine ad26.cov2.s (dose number in series 1), unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered on an unspecified date for prophylactic vaccination. No adverse events reported post vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered on 29-DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced body hurts, and not feeling well (dose number in series 2). The patient wanted to know the nearest test facility and if he was positive for Covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body hurts and not feeling well was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: BLOOD CLOTS IN HER LEGS; BLOOD CLOTS IN LUNGS; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's 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) 1 total, dose was not reported, administered on MAR-2021 for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  The reporter stated that "My daughter had the vaccine last March now she has blood clots in her legs and in her lung and said she will have to be on Xarelto for the rest of her life". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots in her legs and blood clots in lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220100825-covid-19 vaccine ad26.cov2.s-  Blood clots in her legs ,Blood clots in lungs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Headache, Influenza like illness, Injection site pain, SARS-CoV-2 test
Clinical narrative: FLU LIKE SYMPTOMS; INJECTION SITE PAIN; STAYED IN BED FOR FEW DAYS; HEADACHE; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight was 181 pounds, and height was 71 inches. The patient's past medical history included: covid, and concurrent conditions included: hypertension well controlled, and allergy to most opioids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 23-AUG-2021) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination (dose number in series 1). No concomitant medications were reported. On SEP-2020, Laboratory data included: COVID-19 virus test (NR: not provided) Positive.  On 10-APR-2021, the patient experienced stayed in bed for few days, and headache. On an unspecified date, the patient experienced flu like symptoms with general body aches, and injection site pain (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, stayed in bed for few days, headache, and injection site pain. This report was non-serious. This case, involving the same patient is linked to 20211264309.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination failure, Vaccine breakthrough infection
Clinical narrative: BREAKTHROUGH OCCURRED AND BECAME INFECTED; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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, dose number in series was 1, administered 1 in total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-NOV-2021, the patient took a business trip and on NOV-2021, patient became infected. The breakthrough occurred in a manner of two weeks. On the first day, patient experienced joint aches and lack of energy. By the second day, patient felt improved until the fevers started on the third day. The patient became little weaker each day until the fever broke on the eighth day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from breakthrough occurred and became infected, and the outcome of Suspected Clinical Vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209763. This case, from the same reporter is linked to 20220100666.; Sender's Comments: V0:20220100988-Covid-19 vaccine ad26.cov2.s- Breakthrough occurred and became infected. 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). V0:20220100988-Covid-19 vaccine ad26.cov2.s-Suspected Clinical Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT THE VIRUS; This spontaneous report received from a consumer via a representative concerned 20 patients of unspecified gender, race and ethnicity. No past medical histories or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (unspecified manufacturer) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose and start therapy date were not reported for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine. Patients received booster of covid-19 vaccine (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 2). The batch numbers were not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, patients got the virus (dose number in series 2). The consumer reported, everyone is different. The action taken with covid-19 vaccine was not applicable. The outcome of got the virus was not reported. This report was non-serious. This report was associated with product quality complaint 90000209759. The suspected product quality complaint has been confirmed to be voided (this case does not qualify since the only indication was that patients had the virus but does not refer to any symptoms or lab test name/dates) based on the evaluation/investigation performed. This case, from the same reporter is linked to 20220100700.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Pruritus, Rash
Clinical narrative: NON-RAISED RASH ABOVE LEFT KNEE; ITCHING ON ARMS AND LEGS; DRY MOUTH; This spontaneous report received from a patient concerned a 64 year old white not hispanic or latino female. The patient's height, and weight were not reported. The patient's past medical history included: bursitis, and concurrent conditions included: allergy to antibiotics, environmental allergies, and drug allergy with lidocaine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 202A21A, expiry: Unknown) dose was not reported (dose number in series 1), 01 in total, administered on 07-APR-2021 at 13:00 hours on left deltoid for prophylactic vaccination.  On 07-APR-2021, within 15 minutes of vaccination, the patient had redness of face, and fever (dose number in series 1). It subsided within the next 15 minutes. On 08-APR-2021, in the evening, 24 hours after vaccination, the patient had bursitis type irritation (dose number in series 1) which didn't last very long. The patient also had headache in the back of the head on the right side on the base of the skull and felt like pulsating pain (dose number in series 1). The headache subsided within next 20 minutes. As per patient, she had Bursitis in the past and the vaccine seemed to trigger it, hence she contacted doctor's office at that time. The patient recovered from bursitis type irritation on an unspecified date, redness of face and fever on 07-APR-2021, and headache in the back of the head on the right side on the base of the skull and felt like pulsating pain on 08-APR-2021 (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 211D21A, expiry: Unknown) dose was not reported (dose number in series 2), 01 in total, administered on 30-DEC-2021 at right deltoid for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for environmental allergy.  On 31-DEC-2021, the patient experienced itching on arms and legs (dose number in series 2) in the middle of the night and it had continued till the morning of reporting, without a rash. On 01-JAN-2022 (in the morning), the patient had some pink dots/ non-raised rash above her knee on the left side (dose number in series 2). According to the patient, it might had happened due to itching. The patient reported that she did not have dry mouth in past. At the time of reporting patient's mouth was dry and she felt thirsty (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on arms and legs, and dry mouth, and the outcome of non-raised rash above left knee was not reported (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20220100909 (Dose number in series 1).
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: THROMBOSIS IN THE LUNGS; This spontaneous potential legal report received from a consumer concerned multiple female patients (8 women) of unspecified race and ethnicity. No past medical history or concurrent conditions were reported. The patient's received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Reporter stated that, she read on vaccine that on an unspecified date, the patients (8 women) had experienced thrombosis in the lungs also (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombosis in the lungs was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220100267.; Sender's Comments: V0: 20220102356 -covid-19 vaccine ad26.cov2.s-  Thrombosis in the lung . 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: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210843019. This report was associated with product quality complaint: 90000209879.