chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: had a shot got shingles / suspected vaccination failure; 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.   The patient's past medical history included shingles.   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 itself. The age at vaccination was not reported. The patient had the shingles had a shot got shingles again. 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: had 6 or 7 times, even with the shot / suspected vaccination failure; had 6 or 7 times; 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 itself. The age at vaccination was not reported. The patient stated that it was something, that he or she had it 6 or 7 times, even with 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: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: got shingles after I had the shot / suspected vaccination failure; shingles; it was awful; 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), shingles and feels awful. On an unknown date, the outcome of the vaccination failure, shingles and feels awful were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got shingles after he or she had the shot and was awful. 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: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: was vaccinated and still got them / suspected vaccination failure; still got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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 wife. The age at vaccination was not reported. The patient was vaccinated and still got them. The reporter had it as a child and was very painful. 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: got the shot then got shingles /suspected vaccination failure; 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 details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got the shot then got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: vaccinated 1 yr ago, Got shingles a month ago /suspected vaccination failure; shingles; little itching; 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. In August 2021, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got vaccinated 1 year ago, got shingles a month ago and still had a little itching. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the two dose shot, got shingles /Vaccination failure; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the two dose shot and still got shingles 2 years later it probably would have been worse if I did not have the shot. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Vaccination failure
Clinical narrative: had both of Shingle vaccine. I just now was diagnosed with Shingles / Suspected Vaccination failure; diagnosed with Shingles / It is very uncomfortable; uncomfortable; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and discomfort. On an unknown date, the outcome of the vaccination failure, shingles and discomfort were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and discomfort to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had both of Shingle vaccine and just now was diagnosed with Shingles and informed that his or her case should be mild. It was very uncomfortable. The reporter hate to see what it would be like without the vaccinations and informed to get the shots. This case was considered as suspected vaccination failure, as details regarding 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, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the two shots, a year later got shingles / Suspected Vaccination Failure; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 1 year 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 and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the shingles twice and got the shot. Then got the other shot a couple months later and now year later patient got the shingles again. The shot always did not work yeah, but it did not work they said it was only 90 percentage. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation was unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Peripheral swelling
Clinical narrative: almost had anaphylaxis; my arm was swollen down to my elbow; This case was reported by a consumer via interactive digital media and described the occurrence of anaphylaxis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant) and swelling arm. On an unknown date, the outcome of the anaphylaxis and swelling arm were unknown.   It was unknown if the reporter considered the anaphylaxis and swelling arm to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had two shingles shots a couple months apart. After the first one patient almost had anaphylaxis and his or her arm was swollen down to elbow and the swelling almost went to neck. Even though the patient had this adverse reaction he or she was still wanting to take the shot because he or she did not want to get shingles. The patient heard how horrible it was so. For tolerance of 2nd dose refer case US2021AMR187628. The follow up was not required.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187628:same patient, same reporter
Age: 2.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 2 year old male patient received the TWINRIX vaccine; Adult product administered to child; Drug dose administration interval too long; This case was reported by a physician via call center representative and described the occurrence of overdose in a 2-year-old male patient who received HAB (Twinrix) (batch number 57E3G, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Patient received VAQTA (Hep A vaccine) and ENGERIX-B (Hep B vaccine) on the 11/02/2020 (received VAQTA on 11th February 2020) and Engerix B (received Engerix B on 11th February 2020).   On 24th August 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 24th August 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced overdose, adult product administered to child and drug dose administration interval too long. The action taken with Twinrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the overdose, adult product administered to child and drug dose administration interval too long 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 medical doctor reported that the 2 year patient received the Twinrix vaccine, which led to overdose, adult product administered to child and lengthening of vaccination schedule for hepatitis B component. No further events were reported. The reporter consented to follow up by email.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient accidentally received a third dose / patient receiving a 3 dose by accident; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number AEQJ4, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 5th January 2020) and Shingrix (2nd dose received on 24th June 2020).   On 23rd August 2021, the patient received the 3rd dose of Shingrix. On 23rd 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 reporter stated that, the patient accidentally received a third dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: inadvertently administered Bexsero instead of Menveo; This case was reported by a consumer 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 ABXA94A, expiry date 2nd February 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 12th August 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 12th 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 provided as follows: The office manager reported that a 12 year patient was inadvertently administered the Bexsero vaccine instead of the Menveo vaccine required by the school, which led to wrong vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Injection site pain
Clinical narrative: pain at injection site / left arm; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included shingles.   On 19th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 19th March 2021, 5 hrs after receiving Shingrix, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved.  The patient reported that pain and tiredness lasted for 3 days. It was unknown if the reporter considered the injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. This case was self-reported by the patient. The patient received 1st dose of Shingrix and experienced injection site pain and tiredness 5 hours after vaccination. The patient reported that pain and tiredness lasted for 3 days. The reporter consented to follow up. For tolerance of second dose, refer case US2021AMR183233.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183233:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received Shingrix third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concomitant products included Herpes zoster (Shingrix).   On 27th August 2021, the patient received the 3rd dose of Shingrix. On 27th August 2021, unknown after receiving Shingrix and an unknown time 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 pharmacist stated that, the patient received Shingrix third dose a month apart from Shingrix second dose by error, which led to extra dose administered. Adverse event was already reported by pharmacist´s colleague but there was no reference number or any other detail about this situation. The reporter did not consent to follow up.
Age: 101.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Vaccination complication
Clinical narrative: two weeks after first dose, right hand developed rheumatoid arthritis; very, very severe reaction; This spontaneous case was reported by a patient and describes the occurrence of RHEUMATOID ARTHRITIS (two weeks after first dose, right hand developed rheumatoid arthritis) in a 101-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RHEUMATOID ARTHRITIS (two weeks after first dose, right hand developed rheumatoid arthritis) (seriousness criterion medically significant) and VACCINATION COMPLICATION (very, very severe reaction). At the time of the report, RHEUMATOID ARTHRITIS (two weeks after first dose, right hand developed rheumatoid arthritis) and VACCINATION COMPLICATION (very, very severe reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment medication were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-297622 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Death
Clinical narrative: passed away; bubbles like blisters in the face/neck /back /arms / legs; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) and BLISTER (bubbles like blisters in the face/neck /back /arms /legs) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEATH (passed away) (seriousness criteria death and medically significant) and BLISTER (bubbles like blisters in the face/neck /back /arms / legs) (seriousness criterion death). The reported cause of death was bubbles like blisters in the face/neck /back /arms / legs. It is unknown if an autopsy was performed.            Concomitant products were not provided.  Treatment medication were not reported. Patient was healthy in his 80s. The patient had bubbles like blisters in the face and in the back of the neck, back and arms, and legs.  This is a case of death in a 80-year-old male patient after receiving vaccine. The patient also experienced blisters in the face and in the back of the neck, back and arms, and legs. Very limited information has been provided at this time.; Sender's Comments: This is a case of death in a 80-year-old male patient after receiving vaccine. The patient also experienced blisters in the face and in the back of the neck, back and arms, and legs.Very limited information has been provided at this time.; Reported Cause(s) of Death: passed away; bubbles like blisters in the face/neck /back /arms / legs
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Illness, Thrombosis
Clinical narrative: BLOOD CLOTS; STROKE; EXTREMELY SICK; DOES NOT FEEL WELL; This solicited report received from a patient via PPSCVM000808: Regulatory Authority-concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was treated with rivaroxaban (film-coated tablet, oral, batch number: UNKNOWN) dose, frequency, and therapy dates were not reported for an unspecified indication.  The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had blood clots and had not been taking her rivaroxaban in four days. The patient had been out of her medication for a week but she was taking it last week while in hospital. The patient was not feeling well, she took the covid-19 vaccine and became extremely sick. The patient also had a stroke. The action taken with covid-19 vaccine ad26.cov2.s, and rivaroxaban was not applicable. The outcome of the blood clots, stroke, extremely sick and does not feel well was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clots, stroke, and extremely sick was not related, and between covid-19 vaccine ad26.cov2.s, and does not feel well was related; and between rivaroxaban, and blood clots, stroke, and extremely sick was not related, and between rivaroxaban, and does not feel well was related.  This report was serious (Other Medically Important Condition). This case is a duplicate of 20210859193.  Additional information was received from patient on 27-AUG-2021. The following information was updated and incorporated into the case narrative: Janssen covid-19 vaccine was captured as company suspect and additional events stroke, extremely sick and does not feel well were added. It was determined that Manufacturer Case Number 20210859193 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20210843590.; Sender's Comments: V0- RIVAROXABAN-Thrombosis. This event(s) is considered not related. 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).
Sex: M
Vaccine: COVID19
Symptoms: General physical condition abnormal, Neuropathy peripheral, T-lymphocyte count, T-lymphocyte count abnormal
Clinical narrative: NEUROPATHY; ABNORMALITY IN T-CELL COUNT; STILL IN BAD SHAPE; This spontaneous report received from a consumer 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 was not reported, 1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was hospitalized for a week (date unspecified) and was diagnosed with neuropathy and abnormality with T-cell count. It was reported that the patient was still in bad shape. Laboratory data (dates unspecified) included: T-lymphocyte count (NR: not provided) Abnormal.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still in bad shape, and the outcome of neuropathy and abnormality in T-cell count was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210540143.; Sender's Comments: V0:20210900314-COVID-19 VACCINE AD26.COV2.S-Neuropathy,  Abnormality in T-cell count- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: MULTIPLE BLOOD CLOTS; This spontaneous report received from a consumer concerned a 6 decade old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: not feeling well when the patient went in for his vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose and start therapy date were not reported, 1 total, 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 (11 days after vaccination), the patient experienced multiple blood clots and was hospitalized (dates and duration unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of multiple blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210902779-COVID-19 VACCINE AD26.COV2.S - Multiple blood clots. 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.
Sex: U
Vaccine: COVID19
Symptoms: Electromyogram, Guillain-Barre syndrome
Clinical narrative: ATYPICAL FORM OF GUILLAIN-BARRE SYNDROME/ AXONAL TYPE ACUTE INFLAMMATORY POLYNEUROPATHY; This spontaneous report received from a health care professional concerned a patient of unspecified age, sex, race and ethnicity.  The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that 2 weeks after vaccination the patient started developing signs of a fulminant inflammatory peripheral neuropathy. On AUG-2021 the electromyogram testing performed on patient confirmed an atypical form of guillain-barre syndrome/ axonal type acute inflammatory polyneuropathy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of atypical form of guillain-barre syndrome/ axonal type acute inflammatory polyneuropathy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210902802-covid-19 vaccine ad26.cov2.s-atypical form of Guillain-Barre syndrome/ axonal type acute inflammatory polyneuropathy. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report received from a pharmacist concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total 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. The pharmacist reported that on an unspecified date, the patient experienced passed out after receiving the Janssen covid-19 vaccine, Patient had been drinking heavily the night prior and did not have much food, which may have played a factor in the event The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210902863- COVID-19 VACCINE AD26.COV2.S -Passed out. 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: MEDICAL HISTORY
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Coma scale
Clinical narrative: BELLS PALSY; This spontaneous report received from a health care professional concerned a 21 year old male. The patient's weight was 200 pounds, and height was 72 inches. As patient's medical history, patient's blood pressure was elevated when he went to the hospital, patient had been a non-smoker and drinks alcohol (As socially, patient would drink his beer). The patient had no known allergies and did not have any drug abuse or illicit drug use. The patient had no known medication regimen. Patient's mother has diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-AUG-2021, the patient had numbness and tingling on the right side of his face with pain behind his right ear. It worsened through the day and later in the evening he was sent to the local hospital. Upon arrival at the hospital he was diagnosed with Bell's Palsy (G51.0). Patient had a neuro check on the patient and his Glasgow Coma Scale/Score (GCS) score for eye opening was 4, verbal was 5, with right sided numbness. In the discharge documentation comments, it said right sided numbness, paralysis. Patient had no fever and no eye pain, also denied hear ache pain and denied chest pain. No apparent distress, can close his right eye 80 percent - 7th nerve palsy on the right. For treatment, patient received Prednisone 60mg and Zovirax 800mg in the emergency room (ER). Prescriptions that were given to take home were Acyclovir 200mg, dispensed 50 pills to take 1pill 5 times a day and Prednisone 20mg, dispensed 10 pills to take 1 orally twice a day for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bells palsy.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210902915-covid-19 vaccine ad26.cov2.s -Bells palsy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Autonomic nervous system imbalance, Biopsy, Bone tuberculosis, Electromyogram, Muscle disorder
Clinical narrative: POTTS; SMALL FIBER NEUROPATHY; DYSAUTONOMIA; LOSING FUNCTION IN LEGS; VOMITING; This spontaneous report received from a patient concerned a male of unspecified age and unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included heart palpitations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, after vaccination the patient experienced vomiting for 6 hours. On an unspecified date in 2021, the patient said that he started to develop neurological issues including small fiber neuropathy, dysautonomia, potts, and began losing functions in legs. The patient also said that by MAY-2021 he was out of work and he had been visiting several specialists to manage his adverse events including a neurologist and cardiologist. The patient had upcoming appointment with his neurologist. The patient stated that he was experiencing a slow recovery. On 31-AUG-2021, Laboratory data included: Biopsy (NR: not provided) result not provided, and Electromyogram(EMG) (NR: not provided) result not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on APR-2021, and was recovering from small fiber neuropathy, potts, dysautonomia, and losing function in legs. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210903444- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Pott's. 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.
Sex: M
Vaccine: COVID19
Symptoms: Small fibre neuropathy, Vomiting
Clinical narrative: POTTS; SMALL FIBER NEUROPATHY; DYSAUTONOMIA; LOSING FUNCTION IN LEGS; VOMITING; This spontaneous report received from a patient concerned a male of unspecified age and unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included heart palpitations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, after vaccination the patient experienced vomiting for 6 hours. On an unspecified date in 2021, the patient said that he started to develop neurological issues including small fiber neuropathy, dysautonomia, potts, and began losing functions in legs. The patient also said that by MAY-2021 he was out of work and he had been visiting several specialists to manage his adverse events including a neurologist and cardiologist. The patient had upcoming appointment with his neurologist. The patient stated that he was experiencing a slow recovery. On 31-AUG-2021, Laboratory data included: Biopsy (NR: not provided) result not provided, and Electromyogram(EMG) (NR: not provided) result not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on APR-2021, and was recovering from small fiber neuropathy, potts, dysautonomia, and losing function in legs. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210903444- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Pott's. 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.
Sex: F
Vaccine: COVID19
Symptoms: Intervertebral disc degeneration, Osteoarthritis, Osteoporosis, Peripheral swelling
Clinical narrative: INDEX FINGER SWOLLEN; DEGENERATIVE DISC DISEASE IN LOWER BACK; OSTEOPOROSIS; OSTEOARTHRITIS; This spontaneous report received from a patient concerned a 62 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, intramuscular, batch number was not reported) dose was not reported, administered on 11-APR-2021 for covid-19 vaccination. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 index finger swollen, degenerative disc disease in lower back, osteoporosis, and osteoarthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from index finger swollen, and degenerative disc disease in lower back, and the outcome of osteoporosis and osteoarthritis was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: VERBALIZED BIG RED SPOT AT INJECTION SITE; INCORRECT ROUTE OF DRUG ADMINISTRATION; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, subcutaneous, batch number was not reported) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On 11-JUN-2021, the patient experienced incorrect route of drug administration. On an unspecified date, the patient experienced verbalized big red spot at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed.. The patient had not recovered from verbalized big red spot at injection site, and the outcome of incorrect route of drug administration was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: Lethargy; Chills; Fever; 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: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on MAR-2021 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. Non-company suspect drugs included: upadacitinib (oral, batch number: 1140288 expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  On MAR-2021, the patient experienced lethargy. On MAR-2021, the patient experienced chills. On MAR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, chills, and fever on 2021. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 2021, and dose was not reported, administered on 30-APR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On 16-AUG-2021, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Pain
Clinical narrative: CLOGGED EARS; SORE EVERYWHERE; HEADACHE; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, no history of drug abuse or illicit drug use. The patient was healthy and does not take any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-SEP-2021, the patient experienced clogged ears. On 01-SEP-2021, the patient experienced sore everywhere. On 01-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, clogged ears and sore everywhere was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, SARS-CoV-2 test, Sinus congestion
Clinical narrative: SORE THROAT; LITTLE COUGH; SOME CONGESTION; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and cigarette smoker, and other pre-existing medical conditions included: Patient had no known drug allergies or 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-SEP-2021, the patient experienced sore throat. On 01-SEP-2021, the patient experienced little cough. On 01-SEP-2021, the patient experienced some congestion. On 02-SEP-2021, Laboratory data included: COVID-19 virus test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, little cough and some congestion was not reported. This report was non-serious.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF-LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 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: 18-SEP-2021) dose was not reported, administered on 01-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient experienced off-label use. On 01-AUG-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off-label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious.