chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: SUSPECTED VACCINATION FAILURE; COVID FIVE MONTHS LATER THE SHOT; This spontaneous report received from a consumer via social media 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 not reported, batch number: Unknown and expiry: UNKNOWN) dose, 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. It was reported that five months later the shot, the patient had covid (suspected vaccination failure) and could not get the booster until JAN-2022.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid five months later the shot and suspected vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000207491 This case, from the same reporter is linked to 20211237969.; Sender's Comments: V0:20211238440-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: SHORTNESS OF BREATH; TIRED; This spontaneous report received from a patient concerned a male 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 (manufacturer not specified) (dose number series 1) (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. On an unspecified date, the patient had cold/hot flashes, not really dizzy and respiratory issues when treated with covid-19 vaccine ad26.cov2.s (dose number in series 1). It was unclear if these symptoms where from the primary vaccine or from the booster.  The patient additionally received covid-19 vaccine ad26.cov2.s (dose number series 2) (suspension for injection, route of admin, batch number and expiry date not reported) dose was not reported, 1 total, administered on 15-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  In DEC-2021, following administration the patient had shortness of breath and was tired (dose number in series 2). He heard on the news about Janssen Covid-19 vaccine causing blood clots and requested information on the signs of blood clots.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath and tired was unknown. This report was non-serious. This case, involving the same patient is linked to 20211251528 (dose number series 1)
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site haemorrhage, Joint swelling, Visual impairment, Wrong technique in product usage process
Clinical narrative: SWELLING BELOW RIGHT KNEE; BLEEDING AT INJECTION SITE; WRONG INJECTION TECHNIQUE; PAIN BELOW RIGHT KNEE; TROUBLE SEEING; This spontaneous report received from a patient concerned  81 years old female . The patient's height and weight were not reported. The patient's past medical history included: double knee replacement, patient stated that she had 2 knee replacements and doctor put in a part that was too big on the right knee (doctor said the retractor couldn't get skin back far enough), and concurrent conditions included: cancer right breast, brain tumor and brain aneurism. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported) dose, 1 total, administered on 02-Apr-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2. s.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin and batch number were not reported) dose, 1 total, start therapy date were not reported on left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included influenza vaccine (flu shot in same arm about 2 weeks before booster) for prophylactic vaccination. On an unspecified date, the patient had swelling and pain just below right knee, bleeding at injection site, Patient states that the RPh (Registered Pharmacist) was too busy to give booster shot and a trainee gave injection. She felt the administration was wrong, like it hit the wrong place and caused her to bleed. She said after taking off bandage noticed blood on bandage, about 1/2 teaspoon of blood (coded as wrong injection technique). She also reported trouble seeing. (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding at injection site, was recovering from pain below right knee, and swelling below right knee, and the outcome of wrong injection technique and trouble seeing was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; VERY ILL WITH COVID; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients of an unspecified age, sex, race and ethnicity. Initial information was processed along with additional information received on 20-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported and expiry: unknown) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination (dose series in number 1). The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported. On an unspecified date, the reported stated that, "I know too many that were vaccinated and hospitalized and very ill with covid" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very ill with covid and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000207767. The suspected product quality complaint has been confirmed to be the reporter complaint description, general notes, and source documents were merged into 90000207716. This record will be voided as a duplicate. therefore, only this complaint (90000207767) will be submitted for void and 90000207716 will be processed as a CI based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20211240566.; Sender's Comments: V0: 20211243153 -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. V0 20211243153 -covid-19 vaccine ad26.cov2.s - very ill with covid . 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: Vaccination complication
Clinical narrative: MINIMAL SIDE EFFECTS; This spontaneous report received from a patient 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 (Dose number in series: 1) (suspension for injection, route of admin not reported, and batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced minimal side effects. (Dose number in series: 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of minimal side effects was not reported. On an unspecified date, 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The reporter had not reported any adverse events following vaccination. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in perfect health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Blood test, Dysgeusia, Full blood count, International normalised ratio
Clinical narrative: 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 concurrent conditions included: food allergy, pollen allergy, and sensitivity to medicines, and allergy to certain insects. The patient reported she had no drug allergies but she did not want the Moderna or Pfizer vaccine due to the PEG content.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A expiry: Unknown) dose was not reported, 01 total, administered on 30-JUL-2021 at left arm for prophylactic vaccination.  On 30-JUL-2021, around midnight,  the patient felt like her tongue tasted salty. On 31-JUL-2021, the patient experienced tiredness. On 14-AUG-2021, 2 weeks later, the patient was advised to go to ER (Emergency room) by someone from JNJ for a bruise on right arm even though injection was in left arm (dose number in series 1). At the hospital (ER) the patient had blood test and all was normal. Laboratory  tests included APTT (NR: not provided) Not reported, Basic metabolic panel (NR: not provided) Not reported, Blood test (NR: not provided) Normal, CBC (NR: not provided) Not reported, INR (NR: not provided) Not reported, Prothrombin time (NR: not provided) Not reported.  The patient recovered from tiredness on 31-JUL-2021, tongue tasted salty on 07-AUG-2021 and bruise in right arm on 18-AUG-2021 (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s  (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: Unknown) dose was not reported, 01 total, administered on 10-DEC-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 19-DEC-2021, in the morning, the patient experienced salty taste on tongue. On 20-Dec-2021, the patient experienced same sensation again (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tongue tasted salty (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20211245128.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Prothrombin time
Clinical narrative: 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 concurrent conditions included: food allergy, pollen allergy, and sensitivity to medicines, and allergy to certain insects. The patient reported she had no drug allergies but she did not want the Moderna or Pfizer vaccine due to the PEG content.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A expiry: Unknown) dose was not reported, 01 total, administered on 30-JUL-2021 at left arm for prophylactic vaccination.  On 30-JUL-2021, around midnight,  the patient felt like her tongue tasted salty. On 31-JUL-2021, the patient experienced tiredness. On 14-AUG-2021, 2 weeks later, the patient was advised to go to ER (Emergency room) by someone from JNJ for a bruise on right arm even though injection was in left arm (dose number in series 1). At the hospital (ER) the patient had blood test and all was normal. Laboratory  tests included APTT (NR: not provided) Not reported, Basic metabolic panel (NR: not provided) Not reported, Blood test (NR: not provided) Normal, CBC (NR: not provided) Not reported, INR (NR: not provided) Not reported, Prothrombin time (NR: not provided) Not reported.  The patient recovered from tiredness on 31-JUL-2021, tongue tasted salty on 07-AUG-2021 and bruise in right arm on 18-AUG-2021 (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s  (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, expiry: Unknown) dose was not reported, 01 total, administered on 10-DEC-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 19-DEC-2021, in the morning, the patient experienced salty taste on tongue. On 20-Dec-2021, the patient experienced same sensation again (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tongue tasted salty (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20211245128.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VIALS HAD A TEMPERATURE EXCURSION THEN ADMINISTERED TO PATIENTS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a multiple patients 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 patients was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) for (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) 1 total, dose was not reported, administered on unspecified day for prophylactic vaccination (Dose number in series 1). No known events were reported after vaccination. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A and expiry: 14-DEC-2021) 1 total, dose was not reported, administered on OCT-2021 for prophylactic vaccination (Dose number in series 2).  No concomitant medications were reported.  On an unspecified day in OCT-2021, vials had a temperature excursion then administered to patients and qualified for incorrect product storage. Pharmacy assistant reported that 6 unpunctured vials of Janssen COVID-19 vaccine had multiple temperature excursions between 20-OCT-2021 until 17-NOV-2021 where the minimum temperature reached was 0.6 degree Celsius and the maximum temperature reached was 9.6 degree Celsius. The excursion happened while the vials were in the fridge and the temperature readings were recorded every 5 minutes. The pharmacy checked the temperature excursion information online and found that there was no restriction in duration for storage of unpunctured vials excursion temperature range between 0 to 1 degree Celsius and also no restriction if between 9 to 10 degree Celsius so the pharmacy administered the vaccine from these vials. They administer 5 booster shots and 1 primary shot between Oct-2021 and NOV-2021 when the vials were not expired. The pharmacy assistant was calling to confirm that the temperature excursion information found online for those temperature ranges was correct and that the vials were not adversely affected. The patients who received the vaccine from these vials did not report any adverse events to the pharmacy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vials had a temperature excursion then administered to patients and incorrect product storage was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: DEATH; BLOOD CLOTS; This spontaneous report received from a consumer via a company representative via social media (Johnson and Johnson Corporate) 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 was vaccinated with covid-19 vaccine ad26. cov2. s (manufacturer not specified) (dose number series 1) (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported, 1 total, administered for prophylactic vaccination. No adverse events were reported following vaccination 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 not reported, batch number, and expiry: unknown) dose was not reported, 1 total, administered 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. Following booster administration, the patient came home and died (captured as death). On an unspecified date, an autopsy was performed and according to the autopsy result the patient had developed blood clots. On an unspecified date, the patient died (cause of death unknown) (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of blood clots was not reported (dose number in series 2). This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20211247547-covid-19 vaccine ad26.cov2.s -Death, 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH; Autopsy-determined Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Loss of personal independence in daily activities
Clinical narrative: BONES HURT FOR 5 DAYS AFTER RECEIVING THE BOOSTER DOSE; HARD TO GET UP AND DO THINGS; 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: neuropathy (he was disabled with neuropathy in his feet and cannot feel his feet, since 1997) he had gradually taught himself to walk with crutches and cane and with wheel chair, diabetes, smoker (Cigarettes (half a pack) but he does not let most of the smoke in) and abstains from alcohol, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug use. Patient had lyrica allergy (slept for 24 hours and his toes were feet) for drug used for unknown indication.  The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered on 01-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2. s.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 28-NOV-2021 on right arm for prophylactic vaccination. Concomitant drug included fentanyl. On 28-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2), the patient's bones hurt for 5 days after receiving the booster dose and he did not know whether that was the vaccine that did it and it was hard to get up and do things but it would go away when he started doing things but would come back when he sat down (dose number in series 2). They all resolved after 5 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bones hurt for 5 days after receiving the booster dose, and hard to get up and do things on 03-DEC-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: SHARP PAIN IN RIGHT HAND; ARM NUMBNESS; This spontaneous report received from a patient concerned a 59-year-old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, drug allergy to prednisone and codeine sulfate. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer)(suspension for injection, route was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination (Dose number in series 1). It was unknown whether the patient had any adverse event with (Dose number in series 1). The patient previously also received adalimumab (Humira) (had to come off due to unbearable pain-medication stopped working). The patient experienced drug allergy when treated with codeine sulfate, and prednisone. It was unknown whether the patient had any adverse event with (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, Unknown, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in NOV-2021 for prophylactic vaccination (Dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included golimumab (Simponi) (solution for injection in pre-filled pen, subcutaneous, batch number: LBS1SME expiry: 31-JAN-2024) 50 mg, 1 time every 28 days) for rheumatoid arthritis, acetylsalicylic acid, folic acid, ibuprofen, macrogol 400/propylene glycol, and methotrexate. On an unspecified date the Patient reported via patient care coordinator to speak with a nurse regarding her concerns with Simponi. The Patient stated that she was unsure if the medication was meeting her treatment expectations due to the last 3-4 weeks the patient had experienced sharp pain in right hand while waking up in morning, up and down arm, numbness, at the time of reporting it was in both arms (Dose number series 2). The Patient stated that all of her symptoms started after receiving the booster covid-19 vaccine ad26.cov2.s booster 3 weeks ago. The Patient had an appointment with her physician on 29-DEC-2021 to discuss her concerns.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pain in right hand, and arm numbness. This report was non-serious. This case, involving the same patient was linked to 20211232839.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Injection site pain, Injection site rash
Clinical narrative: SEVERE ABDOMINAL PAIN AT NIGHT AND IS LESS SEVERE DURING THE DAY TO JUST A SLIGHT PAIN; RED DOT AROUND THE INJECTION SITE AFTER BOOSTER 1/2 THE DIAMETER OF A DIME; SORENESS AT THE VACCINATION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN), 1 in total, dose was not reported, administered on 14-MAR-2021 on left shoulder for prophylactic vaccination (Dose series in number 1). It was unknown whether patient had any adverse event following covid-19 vaccine ad26.cov2.s (Dose series in number 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, and expiry: UNKNOWN) dose was not reported, 1 total administered on 18-DEC-2021 on left deltoid for prophylactic vaccination (Dose series in number 2). No concomitant medications were reported.  On 18-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced red dot around the injection site after booster which was half the diameter of a dime, and soreness at the vaccination site. On evening of 19-DEC-2021, the patient experienced abdominal pain which was severe in night and is less severe during the day just a slight pain (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe abdominal pain at night and is less severe during the day to just a slight pain, red dot around the injection site after booster 1/2 the diameter of a dime, and soreness at the vaccination site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: MUSCLE SPASMS FINALLY STOPPED 2 MONTHS AFTER VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced muscle spasms finally stopped 2 months after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle spasms finally stopped 2 months after vaccine. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Basedow's disease, Dehydration, Dizziness, Dyspnoea, Heart rate
Clinical narrative: DEHYDRATED; THROWING UP; INCREASED RESTING HEART RATE TO 110 TO 120 BEATS PER MINUTE/ INCREASED HEART RATE; HYPERTHYROIDISM; GRAVE'S DISEASE; LIGHT-HEADEDNESS; SHORTNESS OF BREATH; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: celiac disease, alcohol user, and non-smoker. The patient did not have any drug abuse or illicit drug use. The patient had a family history of thyroid related issue. The patient experienced drug allergy (vomiting) when treated with cefixime. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, dose number in series was 1, administered 1 in total to left arm on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, 2-3 weeks after vaccination, experienced lightheadedness, shortness of breath and started losing weight (by mid-June he lost 20 pounds out of a 155 pounds and he was gaunt) and he had a resting heart rate of 110-120 beats per minute. The patient also visited a nurse practitioner. On MAY-2021, patient saw an endocrinologist and was diagnosed with hyperthyroidism and Grave's disease and was put on methimazole and a B-blocker. On 16-DEC-2021, the patient was hospitalized because he had eaten gluten and was throwing up, got dehydrated and had an increased heart rate. The hospital would not discharge him until they spoke with the endocrinologist, which they ultimately spoke and that resulted in changing of dose of both methimazole and the B-blocker. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light-headedness, shortness of breath, increased resting heart rate to 110 to 120 beats per minute/ increased heart rate, hyperthyroidism, grave's disease, throwing up and dehydrated was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20211251042-covid-19 vaccine ad26.cov2.s- hyperthyroidism, grave's disease, increased resting heart rate to 110 to 120 beats per minute/ increased heart rate. 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). 20211251042- Covid-19 vaccine ad26.cov2.S-Throwing up, dehydrated. 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: MEDICAL HISTORY.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperthyroidism, Vomiting
Clinical narrative: DEHYDRATED; THROWING UP; INCREASED RESTING HEART RATE TO 110 TO 120 BEATS PER MINUTE/ INCREASED HEART RATE; HYPERTHYROIDISM; GRAVE'S DISEASE; LIGHT-HEADEDNESS; SHORTNESS OF BREATH; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: celiac disease, alcohol user, and non-smoker. The patient did not have any drug abuse or illicit drug use. The patient had a family history of thyroid related issue. The patient experienced drug allergy (vomiting) when treated with cefixime. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, dose number in series was 1, administered 1 in total to left arm on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, 2-3 weeks after vaccination, experienced lightheadedness, shortness of breath and started losing weight (by mid-June he lost 20 pounds out of a 155 pounds and he was gaunt) and he had a resting heart rate of 110-120 beats per minute. The patient also visited a nurse practitioner. On MAY-2021, patient saw an endocrinologist and was diagnosed with hyperthyroidism and Grave's disease and was put on methimazole and a B-blocker. On 16-DEC-2021, the patient was hospitalized because he had eaten gluten and was throwing up, got dehydrated and had an increased heart rate. The hospital would not discharge him until they spoke with the endocrinologist, which they ultimately spoke and that resulted in changing of dose of both methimazole and the B-blocker. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light-headedness, shortness of breath, increased resting heart rate to 110 to 120 beats per minute/ increased heart rate, hyperthyroidism, grave's disease, throwing up and dehydrated was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20211251042-covid-19 vaccine ad26.cov2.s- hyperthyroidism, grave's disease, increased resting heart rate to 110 to 120 beats per minute/ increased heart rate. 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). 20211251042- Covid-19 vaccine ad26.cov2.S-Throwing up, dehydrated. 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: MEDICAL HISTORY.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling of body temperature change, Respiratory disorder
Clinical narrative: COLD/HOT FLASHES; RESPIRATORY ISSUES; SHORTNESS OF BREATH; TIRED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, (Dose number in series:1), 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 cold/hot flashes, shortness of breath, tired and respiratory issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold/hot flashes, shortness of breath, tired and respiratory issues were not reported. This report was non-serious. This case, involving the same patient is linked to 20211241171 (dose number in series was 2).
Sex: U
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced developed a ball rash after getting the jab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of developed a ball rash after getting the jab was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Nasopharyngitis, Vaccination site pain
Clinical narrative: COLD; ARM HURT; 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. Patient's daughter had respiratory syncytial virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown expiry: unknown) dose, 1 total, start therapy date were not reported 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.  On an unspecified date, the patient experienced cold and arm hurt with Johnson and Johnson COVID shot (made her arm hurt with Humira) (dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the events was not reported.  Non-company suspect vaccine included: MRNA 1273 (Elasomeran) (form of admin unknown, intramuscular, batch number: unknown expiry: unknown), dose, start therapy date were not reported for prophylactic vaccination (dose number in series 2).  On an unspecified date, the patient experienced cold and arm hurt with Moderna booster (made her arm hurt with Humira) (dose number in series 2).  The action taken with MRNA 1273 was not reported.  The outcome of cold and arm hurt with Johnson and Johnson COVID shot and Moderna booster (made her arm hurt with Humira) was not reported.  Non-company suspect drugs included: adalimumab (Humira) (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. The action taken with adalimumab was not reported.  This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Unevaluable event
Clinical narrative: FEW TOUGH SYMPTOMS; MILD SYMPTOMS; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry unknown) dose was not reported, administered 1 in total, on 25-MAR-2021 for prophylactic vaccination as primary 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, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced few tough symptoms(unspecified) and afterwards felt fine (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patient recovered from few tough symptoms. The patient received booster dose of non-company suspect vaccine mrna 1273 ( form of admin, route of admin, and batch number: unknown, expiry unknown) dose was not reported, administered on 03-DEC-2021 for prophylactic vaccination (dose number in series 2).  On an unspecified date in DEC-2021, following vaccination with mrna 1273, the patient experienced mild symptoms (unspecified). (dose number in series 2) The action taken with mrna 1273 was not applicable. The outcome of mild symptoms was unknown. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Death, Off label use, Product administered to patient of inappropriate age
Clinical narrative: DEATH; ADVERSE REACTION TO THE JANSSEN AND JANSSEN VACCINE; OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a consumer via social media concerned a 4 year old of unspecified 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: unknown and expiry: unknown) dose, 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.  It was reported that the patient was 4 year old (child), it was not a approved age to receive vaccine (coded as product administered to patient of inappropriate age and off label use). On an unspecified date, the patient experienced an adverse reaction to the JANSSEN AND JANSSEN vaccine. On 23-DEC-2021, the patient died from an unknown cause of death. It was unspecified if an autopsy was performed. Reporter also stated that ''My friend's neighbor's 4 year old cousin just passed away after an adverse reaction to the J&J vaccine. Absolutely devastated for them. Please pray for their family.''. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 23-DEC-2021, and the outcome of adverse reaction to the JANSSEN AND JANSSEN vaccine, off label use and product administered to patient of inappropriate age was not reported. This report was serious (Death). This report was associated with product quality complaint: 90000208442.; Sender's Comments: V0:20211252331-COVID-19 VACCINE AD26.COV2.S- Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: HEALTH WENT STRAIGHT DOWNHILL; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced health went straight downhill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of health went straight downhill was not reported. This report was non-serious.; Sender's Comments:   Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and alcohol user (not frequently). The patient has no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  and batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, 1 total administered on 28-APR-2021 to the left arm for prophylactic vaccination. Dose number in series was 1. No concomitant medications were reported. On 13-DEC-2021 and 14-DEC-2021, patient developed cough and headache. On 21-DEC-2021 overnight, he developed fever, muscle aches, runny nose and fatigue. His fever broke as of in the morning on the day of reporting. On 22-DEC-2021 the patient tested positive for COVID-19 (suspected covid-19 infection and suspected clinical vaccination failure) by using a Binax Now Home Test Kit and had a doctor's appointment later to confirm. He believed that he might have been exposed to someone at work who had tested positive. He was in close contact with a co-worker who tested positive for COVID 19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number 90000208522.; Sender's Comments: V0. 20211254230-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: Pain, Pain in extremity
Clinical narrative: HARDLY SLEEP WITHOUT PAIN; HARDLY WALK  WITHOUT PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced hardly sleep without pain, and hardly walk without pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hardly walk without pain, and hardly sleep without pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: WORST SEVERE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced worst severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worst severe headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age and of unknown 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, start therapy date were not reported for prophylactic vaccination (dose number in series 1). No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  The reporter stated that "Vax killed my stepdad". The patient died from an unknown cause on an unspecified date. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20211256224-COVID-19 VACCINE AD26.COV2.S-Killed (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