chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingles after I got the shot / suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The patient reported case for himself or herself. The age at vaccination was not reported. The patient got the shingles after he or she got the shot. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: My friend got Shingles shot and got severe case of shingles / suspected vaccination failure; severe case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient got Shingles shot and got severe case of shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: missed the Infanrix dose/ Use of Kinrix as the 4th DTaP; Wrong vacine administered/missed the Infanrix dose/Use of Kinrix as the 4th DTaP; This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a child male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received already the 3 doses of pediarix).   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient was 4 to 5 years of age. The nurse practitioner reported that, the patient received already the 3 doses of Pediarix and missed the Infanrix dose and probably would be administered Kinrix as 4th DTaP dose, which led to inappropriate schedule of vaccine administered and wrong vaccine administered. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster
Clinical narrative: shingles; burning sensation on left hip; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 22nd July 2021, 3 hrs after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced shingles and burning sensation. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the shingles and burning sensation to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix and right after experienced burning sensation on her left hip. The patient went to the health care professional who confirmed the case of shingles. The health care professional had  started the patient on acyclovir treatment. The patient said that the shingles were not cleared up completely. The reporter did not consented to follow up.  Note- there was discrepancy in the reported time to onset for the event burning sensation. In the event section of source document, TTO is provided as 3 hrs but in narrative it is mentioned as right after. However TTO for burning sensation and shingles captured as per structured field.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR175923:Vaccine case (Shingrix)
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Customer received 3 doses of shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2020) and Shingrix (2nd dose received in February 2021).   In August 2021, the patient received the 3rd dose of Shingrix. In August 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The registered pharmacist called on behalf of a customer who received 3 doses of shingrix at another pharmacy and was now concerned about his health, which led to extra dose administered. The health care professional also reported that the patient was not vaccinated at the pharmacy where the call was made. The reporter did not have the information since the patient received these doses at another pharmacy  The reporter did not consent to follow up.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Extra dose administered
Clinical narrative: Bexsero after Trumemba dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA68AA, expiry date 30th October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 31st March 2020, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and TRUMENBA. On 31st March 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that, the patient received a dose of Trumemba followed by a dose of Bexsero, which led to overdose. The reporter consented to follow up. No product details on Trumemba dose. The case has been linked with the case US2020238766 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020238766:Same reporter
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: reconstituting Menveo with saline water; reconstituting Menveo with saline water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva5218, expiry date 30th April 2022) for prophylaxis.   On 19th August 2021, the patient received Menveo. On 19th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: This case was reported by a nurse. The nurse reported that sterile water was used to reconstitute Menveo,which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consent to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: lyophilized portion of Menveo reconstituted with the wrong diluent; lyophilized portion of Menveo reconstituted with the wrong diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that the patient was administered with lyophilized portion of Menveo that had been reconstituted with a diluent other than the liquid conjugate portion of vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Health care professional did not have any other details at time of call than gender and age of patient. The reporter consented to follow up. This case is linked with case US2021025190 and US2020177025, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025190:Same reporter US-GLAXOSMITHKLINE-US2020177025:Same reporter
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: administration of Bexsero instead of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB298A, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Health care professional reported administration of Bexsero instead of Menveo to a patient which led to wrong vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: vaccine was given with a diluent  other than what is provided with it; vaccine was given with a diluent  other than what is provided with it; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On 20th August 2021, the patient received Hiberix. On 20th August 2021, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. Health care professional reported, Hiberix vaccine was given with a diluent (MMR diluent) other than what was provided with it, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Expired product administered
Clinical narrative: UNSPECIFIED ADVERSE EVENT; EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a patient of an 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: unknown, expiry: unknown) dose was not reported, frequency time was 1 total administered on 17-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-AUG-2021, the patient had used expired vaccine (reporter stated that the patient administered vaccine at approximately 22:00, it was administered approximately 23 hours after the beyond use date 16-AUG-2021). On an unspecified date, the patient experienced unspecified adverse event, and was hospitalized (reported as for an unrelated issue, not related to the vaccine) for an unspecified number of days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unspecified adverse event and expired vaccine used was not reported. The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and unspecified adverse event was not related. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210837798-covid-19 vaccine ad26.cov2.s-unspecified adverse event . 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulation factor V level, Dental necrosis, Thrombosis, Toothache, Venous occlusion
Clinical narrative: TOOTH WAS NOW DEAD; PAIN ON UPPER MOLAR RIGHT SIDE; ONE VEIN WAS COMPLETELY BLOCKED AND THREE OTHER VEINS PARTIALLY BLOCKED; BLOOD CLOT; This spontaneous report received from a patient concerned a 60 year old white male of unknown ethnicity. The patient's weight was 193 pounds, and height was 73 inches. The patient's concurrent conditions included drinks alcohol, and was non smoker. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, 1 total administered at left deltoid around 12:00 in noon on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the patient noticed red marking and pain on the right leg. On 05-AUG-2021, diminished the use of right leg and walk was affected. On 06-AUG-2021, patient went to emergency room and diagnosed with blood clot and one vein was completely blocked and three other veins partially blocked. As of 06-AUG-2021, the patient was started on Eliquis 20 mg per day for 7 days. On 11-AUG-2021, the patient begins to feel pain on upper molar right side, so patient went to dentist on 18-AUG-2021. The patient was informed that the tooth was now dead, may had been micro clot blocking of circulating. At the time of this report the patient was on Eliquis 10 mg daily and regimen will last for six months. On an unspecified date, patient underwent factor 5 genetic marker test which was negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tooth was now dead, and the outcome of blood clot in vein and one vein was completely blocked and three other veins partially blocked was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210838162- covid-19 vaccine ad26.cov2.s-blood clot, one vein was completely blocked and three other veins partially blocked, tooth was now dead. 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Eye swelling, Ocular hyperaemia, Product administration error
Clinical narrative: ACCIDENTAL EXPOSURE TO EYE (DOSE RESIDUE); SAFETY PROCESS HAVE BEEN DONE OUTSIDE THE ARM (ADMINISTRATION ERROR); MINOR REDNESS OF EYE; MINOR SWELLING OF EYE; This spontaneous report received from a pharmacist concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, and expiry: 21-OCT-2021) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-AUG-2021, the patient experienced accidental exposure to eye (dose residue). On 19-AUG-2021, the patient experienced safety process have been done outside the arm (administration error). On 19-AUG-2021, the patient experienced minor redness of eye. On 19-AUG-2021, the patient experienced minor swelling of eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from accidental exposure to eye (dose residue), and the outcome of minor redness of eye, minor swelling of eye and safety process have been done outside the arm (administration error) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple female patients of unknown race and ethnicity.  No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose, start therapy date were not reported 1 total, administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the consumer mentioned that women were having blood clots from the covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210840534-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: Guillain-Barre syndrome
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a patient via pharmaceutical company  concerns a patient, sex, age, race, and ethnic origin not provided. The patient's height, weight, and medical history was not reported.   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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 Guillain-Barre syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient via pharmaceutical company concerns a patient of unknown age who experienced Guillain-Barre syndrome (GBS) unspecified time after vaccination.  Patient past medical history , concomitant medications and concurrent medications were not reported. No other pertinent details reported. The information available precludes a complete and meaningful assessment . Information regarding other potential etiologies was insufficient, and the occurrence of GBS could represent background incidence of such events in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Rhesus antibodies positive
Clinical narrative: NO LONGER ABLE TO DONATE BLOOD BECAUSE IT APPEARS TO BE RH SENSITIZED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Due to the rarity of A- blood type patient donates blood regularly. Patient had never been pregnant nor had a blood transfusion before vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced no longer able to donate blood because it appears to be rh sensitized. Laboratory data (dates unspecified) included: Rhesus antibodies (NR: not provided) Positive, Blood appears to be Rh sensitized. The action taken with covid-19 vaccine was not applicable. The outcome of no longer able to donate blood because it appears to be rh sensitized was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; 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 (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 118 pounds, and height was 62 inches. The patient's concurrent conditions included: primary immunodeficiency along with 3 to 4 other autoimmune diseases, dog allergy, cat allergy, and iodine allergy, and other pre-existing medical conditions included that he patient had allergy to various medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-MAY-2021, the patient tested positive for the Protein receptor binding domain (antibody) test (SARS-CoV-2 ELISA (Enzyme linked Immunoassay) test) (NR: not provided) 25.3. On 02-AUG-2021, the patient tested negative for SARS CoV-2 s1 IgA (Immunoglobulin A) IgG (Immunoglobulin G) test (SARS-CoV-2 IgA antibody test) (SARS-CoV-2 IgG antibody test) (NR: not provided) 0.13 (confirmed immunological vaccine failure).  The patient visited to the physician office. The immunologist suggested for a second shot of the Janssen Covid-19 (Corona virus) Vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210842932-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: PUNCTURED VIAL ADMINISTERED AFTER HALF AN HOUR OF EXPIRATION; OFF LABEL USE; This spontaneous report received from a health care professional 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: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 20-AUG-2021 for prevention of covid19. No concomitant medications were reported. On 20-AUG-2021, the patient experienced punctured vial administered after half an hour of expiration. On 20-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial administered after half an hour of expiration and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included that the patient had two heart attacks, and concurrent conditions included: cancer, and rheumatoid arthritis, and other pre-existing medical conditions included that the patient had no known drug allergies and was suffering from multiple ailments. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1082068 expiry: Unknown) dose was not reported, 1 total administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of reporting. On 11-AUG-2021, the patient visited her Infectious Disease doctor who carried out the COVID (Corona virus) antibody test which came out to be negative (confirmed immunological vaccine failure). The patient never had COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210842984-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Insomnia, Musculoskeletal stiffness, Myalgia
Clinical narrative: NERVE PAIN; INTENSE HEAT IN BACK AND BACK HOT TO TOUCH; COULD NOT SLEEP; COULD NOT BEND FINGERS ON SIDE RECEIVED INJECTION; HEART RACING IN HEAD AND EARS INTENSELY; ARM SWOLLEN; LEG PAIN ,SEVERE PAIN WHOLE ARM AND INTENSE PAIN FROM LEGS UP HER BACK; ARM WAS NUMB; UPPER ARM HARD TO THE TOUCH AND PAIN IN BICEPS AND TRICEPS; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A,expiry: 21-SEP-2021) dose was not reported, administered on 28-JUL-2021 10:00 for prophylactic vaccination. Concomitant medications included ibuprofen for leg and back pain.  On 28-JUL-2021, the patient experienced could not sleep. On 28-JUL-2021, the patient experienced could not bend fingers on side received injection. On 28-JUL-2021, the patient experienced heart racing in head and ears intensely. On 28-JUL-2021, the patient experienced arm swollen. On 28-JUL-2021, the patient experienced leg pain, severe pain whole arm and intense pain from legs up her back. On 28-JUL-2021, the patient experienced arm was numb. On 28-JUL-2021, the patient experienced upper arm hard to the touch and pain in biceps and triceps. On 29-JUL-2021, the patient experienced nerve pain. On 29-JUL-2021, the patient experienced intense heat in back and back hot to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerve pain, and intense heat in back and back hot to touch on 01-AUG-2021, could not sleep, and heart racing in head and ears intensely on 31-JUL-2021, could not bend fingers on side received injection on 02-AUG-2021, and arm swollen on 20-AUG-2021, was recovering from arm was numb, and the outcome of upper arm hard to the touch and pain in biceps and triceps and leg pain ,severe pain whole arm and intense pain from legs up her back was not reported. This report was non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Palpitations, Peripheral swelling
Clinical narrative: NERVE PAIN; INTENSE HEAT IN BACK AND BACK HOT TO TOUCH; COULD NOT SLEEP; COULD NOT BEND FINGERS ON SIDE RECEIVED INJECTION; HEART RACING IN HEAD AND EARS INTENSELY; ARM SWOLLEN; LEG PAIN ,SEVERE PAIN WHOLE ARM AND INTENSE PAIN FROM LEGS UP HER BACK; ARM WAS NUMB; UPPER ARM HARD TO THE TOUCH AND PAIN IN BICEPS AND TRICEPS; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A,expiry: 21-SEP-2021) dose was not reported, administered on 28-JUL-2021 10:00 for prophylactic vaccination. Concomitant medications included ibuprofen for leg and back pain.  On 28-JUL-2021, the patient experienced could not sleep. On 28-JUL-2021, the patient experienced could not bend fingers on side received injection. On 28-JUL-2021, the patient experienced heart racing in head and ears intensely. On 28-JUL-2021, the patient experienced arm swollen. On 28-JUL-2021, the patient experienced leg pain, severe pain whole arm and intense pain from legs up her back. On 28-JUL-2021, the patient experienced arm was numb. On 28-JUL-2021, the patient experienced upper arm hard to the touch and pain in biceps and triceps. On 29-JUL-2021, the patient experienced nerve pain. On 29-JUL-2021, the patient experienced intense heat in back and back hot to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nerve pain, and intense heat in back and back hot to touch on 01-AUG-2021, could not sleep, and heart racing in head and ears intensely on 31-JUL-2021, could not bend fingers on side received injection on 02-AUG-2021, and arm swollen on 20-AUG-2021, was recovering from arm was numb, and the outcome of upper arm hard to the touch and pain in biceps and triceps and leg pain ,severe pain whole arm and intense pain from legs up her back was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: SLIGHT HEADACHE; TIRED; This spontaneous report received from a patient via a company representative concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced slight headache, and tired. The action taken with covid-19 vaccine was not applicable. The patient recovered from slight headache, and tired. This report was non-serious. This case, from the same reporter is linked to 20210843246.
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Pyrexia
Clinical narrative: ULCERATIVE COLITIS FLAIR UP; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age with unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: ulcerative colitis. 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 1 total dose administered 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 ulcerative colitis flair up, and fever. The patient said he was 100 percent while reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ulcerative colitis flair up and fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210843019- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Ulcerative colitis flair up. 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: UNDERLYING DISEASE.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: LOSS OF APPETITE; NECK ACHE AT BASE; FELT HOT TO THE TOUCH; CHILLS; HEADACHE, IT WAS LIKE WHOLE HEAD HURT ALL OVER AND BACK OF HEAD; A LITTLE BIT OF NAUSEA FEELING; A LITTLE TIREDNESS BUT NOTHING EXTREME; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non smoker, and sulfa allergy, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced shortness of breath. On 17-AUG-2021, the patient experienced loss of appetite. On 17-AUG-2021, the patient experienced neck ache at base. On 17-AUG-2021, the patient experienced felt hot to the touch. On 17-AUG-2021, the patient experienced chills. On 17-AUG-2021, the patient experienced headache, it was like whole head hurt all over and back of head. On 17-AUG-2021, the patient experienced a little bit of nausea feeling. On 17-AUG-2021, the patient experienced a little tiredness but nothing extreme. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, loss of appetite, neck ache at base, chills, headache, it was like whole head hurt all over and back of head, a little bit of nausea feeling, and a little tiredness but nothing extreme on AUG-2021, and the outcome of felt hot to the touch was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Neck pain
Clinical narrative: LOSS OF APPETITE; NECK ACHE AT BASE; FELT HOT TO THE TOUCH; CHILLS; HEADACHE, IT WAS LIKE WHOLE HEAD HURT ALL OVER AND BACK OF HEAD; A LITTLE BIT OF NAUSEA FEELING; A LITTLE TIREDNESS BUT NOTHING EXTREME; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non smoker, and sulfa allergy, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced shortness of breath. On 17-AUG-2021, the patient experienced loss of appetite. On 17-AUG-2021, the patient experienced neck ache at base. On 17-AUG-2021, the patient experienced felt hot to the touch. On 17-AUG-2021, the patient experienced chills. On 17-AUG-2021, the patient experienced headache, it was like whole head hurt all over and back of head. On 17-AUG-2021, the patient experienced a little bit of nausea feeling. On 17-AUG-2021, the patient experienced a little tiredness but nothing extreme. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, loss of appetite, neck ache at base, chills, headache, it was like whole head hurt all over and back of head, a little bit of nausea feeling, and a little tiredness but nothing extreme on AUG-2021, and the outcome of felt hot to the touch was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media and concerned two male patients of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, 1 total administered, 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 patients died from unknown cause. It was unknown whether an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died (due to unknown cause) on an unspecified date. This report was serious (Death).; Sender's Comments: V0: 20210843032- Covid-19 vaccine ad26.cov2.s- Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. This report was non-serious. This case, from the same reporter is linked to 20210840767.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: LOW GRADE HEADACHE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with phenytoin for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced low grade headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade headache on 16-AUG-2021. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Rash pruritic
Clinical narrative: RASH THAT SHE HAS NEVER HAD BEFORE WITH ITCHY WHICH APPEARED ON BOTH LEGS NEAR HER ANKLES; RED SPOT WHICH APPEARED ON BOTH LEGS NEAR HER ANKLES; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was not reported and height was 61 inches. The patient's concurrent conditions included: hypertension, sleep apnea, and thyroid issues. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, and oxybutynin for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: 23-AUG-2021) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the patient experienced rash that she has never had before with itchy which appeared on both legs near her ankles. On 01-MAY-2021, the patient experienced red spot which appeared on both legs near her ankles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash that she has never had before with itchy which appeared on both legs near her ankles, and had not recovered from red spot which appeared on both legs near her ankles. This report was non-serious. This case, from the same reporter is linked to 20210843037.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: JANSSEN COVID-19 VACCINE WAS ADMINISTERED TO THE PATIENT AS  A BOOSTER DOSE, IN ERROR.; This spontaneous report received from a pharmacist concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: 21-SEP-2021) dose was not reported, administered on 20-AUG-2021 12:45 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination.  On 20-AUG-2021, the patient experienced janssen covid-19 vaccine was administered to the patient as a booster dose, in error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of janssen covid-19 vaccine was administered to the patient as a booster dose, in error. was not reported. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 23-AUG-2021) dose was not reported, administered on 07-MAR-2021 on left arm around 13:00 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-21 patient had an antibody test with her healthcare professional. On 19-AUG-2021 her doctor called her and told she had no antibodies, the test came back negative (confirmed immunological vaccine failure). On 20-AUG-21 patient had another antibody test was performed. The results from the second test came back on the day of report as negative and with no antibodies. Both tests were SARS COV2 Spike Protein and IGG antibody tests. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210843278-covid-19 vaccine ad26.cov2.s -Confirmed Immunological Vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cough, Dyspnoea, Headache, Hypopnoea, SARS-CoV-2 test
Clinical narrative: SHORTNESS OF BREATH (SOB); SHALLOW BREATHING; SOME COUGHING; SINUS CONGESTION; WHEEZING; MASSIVE HEADACHE; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. Non-company suspect drugs included: interferon beta-1a (injection, route of admin, and batch number were not reported) dose and frequency were not reported from 19-AUG-2021 for drug used for unknown indication. No concomitant medications were reported. On 20-AUG-2021, the patient experienced shortness of breath (sob). On 20-AUG-2021, the patient experienced shallow breathing. On 20-AUG-2021, the patient experienced some coughing. On 20-AUG-2021, the patient experienced sinus congestion. On 20-AUG-2021, the patient experienced wheezing. On 20-AUG-2021, the patient experienced massive headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath (sob), shallow breathing, massive headache, some coughing, sinus congestion, and wheezing. This report was non-serious.