chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: localized shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not reported. The pharmacist reported the patient experienced shingles after dose one of Shingrix vaccine. The health care professional described shingles as a localized outbreak that began approximately 4-5 days after dose one of Shingrix. The health care professional could not provide lot numbers or expiration dates of the dose given. The reporter consented to follow-up. For tolerance of second dose refer linked case US2021AMR202711, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202711:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Constipation, Genital lesion, Herpes zoster, Pain, Vaccination failure
Clinical narrative: after vaccine series, recurrent shingles/ suspected vaccination failure; recurrent shingles, lower back; recently was diagnosed with chickenpox/chickenpox after getting the Shingrix vaccine; Genital lesions; Painful; Constipation; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, chickenpox, genital lesion, pain and constipation. The patient was treated with linaclotide (Linzess) and acyclovir. On an unknown date, the outcome of the vaccination failure, chickenpox and pain were unknown and the outcome of the shingles was recovering/resolving and the outcome of the genital lesion and constipation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, chickenpox, genital lesion, pain and constipation to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that after receiving the Shingrix vaccine series, she developed genital lesions, recurrent shingles outbreaks on lower back, that was painful, and began having constipation. The patient was prescribed acyclovir for the genital lesions and lower back. Linzess was also prescribed to patient by healthcare professional for constipation.  The patient also disclosed that she recently was diagnosed with chickenpox by her healthcare professional. The patient's healthcare professional referred patient to dermatologist and the patient had not yet seen dermatologist but planned to. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: after vaccine series, recurrent shingles/ suspected vaccination failure; recurrent shingles, lower back; recently was diagnosed with chickenpox/chickenpox after getting the Shingrix vaccine; Genital lesions; Painful; Constipation; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, chickenpox, genital lesion, pain and constipation. The patient was treated with linaclotide (Linzess) and acyclovir. On an unknown date, the outcome of the vaccination failure, chickenpox and pain were unknown and the outcome of the shingles was recovering/resolving and the outcome of the genital lesion and constipation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, chickenpox, genital lesion, pain and constipation to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that after receiving the Shingrix vaccine series, she developed genital lesions, recurrent shingles outbreaks on lower back, that was painful, and began having constipation. The patient was prescribed acyclovir for the genital lesions and lower back. Linzess was also prescribed to patient by healthcare professional for constipation.  The patient also disclosed that she recently was diagnosed with chickenpox by her healthcare professional. The patient's healthcare professional referred patient to dermatologist and the patient had not yet seen dermatologist but planned to. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: powder reconstituted with unapproved diluent; may have received powder reconstituted with unapproved diluent; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 age at vaccination was not reported. The pharmacist reported finding extra Shingrix diluents, thought a patient might have received a powder vial reconstituted with an unapproved diluent, which led to  wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had not received second dose, first dose over 2 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No specific patient or vaccine information were shared by reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: a dose from the recalled batch was meant to be administrated; pharmacy dispensed a dose from the recall batch; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 9lh3y, expiry date 7th February 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On 6th April 2021, unknown after receiving Shingrix, the patient experienced drug dispensing error. On an unknown date, the patient experienced recalled drug administered. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The pharmacist reported that their pharmacy dispensed a dose of Shingrix on 6th April 2021 from the recall batch, which led to recalled drug administered and drug dispensing error.  The vaccine was meant to be administrated to a male patient but the facility was unaware of the date of the administration. No further events were reported.  The reporter consented to follow up. This case was linked with US2021202999 and US2021203000, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021202999:same reporter US-GLAXOSMITHKLINE-US2021203000:same reporter
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 52-year-old female patient who received HBV (Engerix B) (batch number HN5BE, expiry date 16th September 2021) for prophylaxis.   On 27th September 2021, the patient received Engerix B. On 27th September 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The nurse reported that female patient received expired dose of Engerix-B, which led to expired vaccine used.  The reporter consented to follow up.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 age at vaccination was not reported. Office supervisor reporting had administered vaccine after temperature excursion outside of stability data, which led to incorrect storage of drug. Caller unable to provide any adverse event details, other than administration date. Health care professional stated that  she would have those available at a later date through their risk management process. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: knocked him down" for 3 days; This case was reported by a consumer via call center representative and described the occurrence of unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unwell. On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was calling regarding her physician and the physician who was also the patient. The reporter stated that, her physician told her that, he personally got 1st Shingrix shot and it knocked him down for 3 days but he had no problems with his 2nd Shingrix shot. This is 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021203774:same reporter US-GLAXOSMITHKLINE-US2021203778:same reporter
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (history of shingles). Previously administered products included Shingrix (received 1st dose of Shingrix on April 2021).  On 27th September 2021, the patient received the 2nd dose of Shingrix. On 28th September 2021, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself. Age at vaccination was not reported. The patient received the second dose and experienced outbreak of shingles at the time of reporting. No health care professional details were provided. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling
Clinical narrative: knee pain; knee swelling; This case was reported by a nurse via call center representative and described the occurrence of knee pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a day after receiving Shingrix, the patient experienced knee pain and swelling of knees. On an unknown date, the outcome of the knee pain and swelling of knees were recovered/resolved.   It was unknown if the reporter considered the knee pain and swelling of knees to be related to Shingrix.  Additional details provided were as follows: The case was reported by nurse for herself. Age at vaccination was not reported. The nurse reported that she received a dose of Shingrix three weeks ago and within 12 hours she experienced knee pain. The patient also experienced knee swelling. The left knee swelling resolved after 8 to 10 days.The left knee was worse than the right, It was not intermittent but not constant like before. The caller declined to provide additional information. The reporter did not consent to follow-up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: Sore arm; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 2232K, expiry date 13th November 2022) for prophylaxis.   On 26th August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th September 2021, 30 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced pain in arm. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   The reporter considered the shingles to be related to Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient's husband reported the case. The  patient received shingrix vaccine and she had a sore arm afterwards (no date provided), which had since resolved. The patient also developed shingles along her lower back. The patient currently taking Valtrex to treat the condition. The reporter did not consented to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: GOT VERY SICK FROM THE SHOT ALMOST  DEATH; This spontaneous report received from a patient via a company representative 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced got very sick from the shot almost death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got very sick from the shot almost death was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal
Clinical narrative: This spontaneous report received from a patient concerned a 76 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was at high risk of diabetes. The patient received COVID-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the patient experienced low antibodies against covid virus. Laboratory data included: Antibody test (NR: not provided) Antibodies were at 2. The action taken with covid-19 vaccine was not applicable. The outcome of low antibodies against covid virus was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnic origin. 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, batch number: unknown, expiry: unknown) dose and start therapy date were not reported, with frequency 1 total used for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the consumer called to learn more about the Janssen COVID-19 vaccine and if it was a Gene therapy and being forced on people. Then, she started yelling and cursing that 3 people died from COVID-19 along with her grandmother. However, she was unsure whether these patients died after the vaccine or not and claimed that Johnson & Johnson was hunting her family and blood line. They were storing her ancestor Deoxyribonucleic acid (DNA) and forced people to get the vaccine. She also claimed that Johnson & Johnson was responsible for the death of her family members and friends from COVID-19 and then trying to cover up things. On an unspecified date, the patient experienced suspected clinical vaccination failure and patient died from covid-19. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with a Product Quality Complaint. This case, from the same reporter is linked to 20210950686, 20210950479 and 20210950539.; Sender's Comments: V0- 20210950658-Covid-19 vaccine ad26.cov2.s -Covid 19. 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). 20210950658-Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19
Sex: U
Vaccine: COVID19
Symptoms: Death, Thrombocytopenia
Clinical narrative: DEATH; THROMBOCYTOPENIA; This spontaneous report received from a health care professional via social media (media) concerned multiple patients of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose, 1 total, 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.  The reporter stated that "he was aware of media reports and various other avenues of reporting for 6 deaths (cause of death unspecified) and other severe adverse events like thrombocytopenia following vaccination with Janssen covid-19 vaccine." The reporter stated he could not recall where or when they first heard of these media reports and had no additional information to provide. It was not reported if an autopsy was performed for the patients who died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombocytopenia was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210952656 - Covid-19 vaccine ad26.CoV-2.s- Death, Thrombocytopenia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Feeling abnormal, Gait inability, Influenza like illness
Clinical narrative: COULD NOT WALK; COULD NOT STAND UP; CAUGHT A FLU OR A COLD; BAD REACTION/REACTION TO VACCINATION; EXTREME PAIN IN SPINE/BURNING SENSATION IN SPINE; LUNG HURTS/ BURNING SENSATION IN LUNG; COULD NOT DO ANYTHING FOR HER SELF; MESSED UP; EXTREME PAIN IN HIP AND JOINTS/BURNING SENSATION IN HIP; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stronger reaction to common cold, and stronger reaction to other illness, and concurrent conditions included: nerve damage in hips, chronic nerve pain, chronic illness, food intolerances, disabled, castor oil allergy, abstains from alcohol, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage, never had a reaction or anything like this in the past with a vaccine. He was very very comfortable getting a vaccine. The patient experienced drug allergy when treated with amoxicillin for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced could not walk, could not stand up, caught a flu or a cold, bad reaction/reaction to vaccination, extreme pain in spine/burning sensation in spine, lung hurts/ burning sensation in lung, could not do anything for her self, messed up, and extreme pain in hip and joints/burning sensation in hip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not walk, could not stand up, caught a flu or a cold, bad reaction/reaction to vaccination, extreme pain in spine/burning sensation in spine, lung hurts/ burning sensation in lung, could not do anything for her self, messed up, and extreme pain in hip and joints/burning sensation in hip. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Nonspecific reaction, Pulmonary pain, Spinal pain
Clinical narrative: COULD NOT WALK; COULD NOT STAND UP; CAUGHT A FLU OR A COLD; BAD REACTION/REACTION TO VACCINATION; EXTREME PAIN IN SPINE/BURNING SENSATION IN SPINE; LUNG HURTS/ BURNING SENSATION IN LUNG; COULD NOT DO ANYTHING FOR HER SELF; MESSED UP; EXTREME PAIN IN HIP AND JOINTS/BURNING SENSATION IN HIP; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stronger reaction to common cold, and stronger reaction to other illness, and concurrent conditions included: nerve damage in hips, chronic nerve pain, chronic illness, food intolerances, disabled, castor oil allergy, abstains from alcohol, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage, never had a reaction or anything like this in the past with a vaccine. He was very very comfortable getting a vaccine. The patient experienced drug allergy when treated with amoxicillin for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced could not walk, could not stand up, caught a flu or a cold, bad reaction/reaction to vaccination, extreme pain in spine/burning sensation in spine, lung hurts/ burning sensation in lung, could not do anything for her self, messed up, and extreme pain in hip and joints/burning sensation in hip. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not walk, could not stand up, caught a flu or a cold, bad reaction/reaction to vaccination, extreme pain in spine/burning sensation in spine, lung hurts/ burning sensation in lung, could not do anything for her self, messed up, and extreme pain in hip and joints/burning sensation in hip. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death, Suspected COVID-19, Vaccination failure
Clinical narrative: DECEASED; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (DELTA VARIANT); This solicited report received from a consumer: concerned a 51 year old male of unknown race. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: Unknown) dose, start therapy date were not reported, 1 total administered in FEB-2021 or MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection (delta variant), and was hospitalized (date unspecified). Patient was released from the hospital and then re-admitted to the hospital. On SEP-2021 Patient was deceased. It was unspecified if autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection (delta variant) and suspected clinical vaccination failure was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and deceased was related, and between covid-19 vaccine ad26.cov2.s, and suspected clinical vaccination failure, and suspected covid-19 infection (delta variant) was not related.  This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210953828.; Sender's Comments: V0: 20210953961-covid-19 vaccine ad26.cov2.s-deceased. This event(s) is considered related. 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).  20210953961-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS  20210953961-covid-19 vaccine ad26.cov2.s-suspected covid-19 infection (delta variant). This event(s) is considered not related. The event(s) shows an incompatible temporal relationship.; Reported Cause(s) of Death: DECEASED
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Migraine, Vaccination failure
Clinical narrative: MIGRAINES; CHEST PAIN; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 48 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 1808609 expiry: unknown) dose was not reported, frequency time 1 total was administered on 23-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient had confirmed covid-19 infection. She started experiencing symptoms which included heavy congestion of the nose and sinuses, loss of smell and taste. On 24-SEP-2021, the patient started experiencing diarrhea and nausea. On 25-SEP-2021, the patient underwent COVID-19 rapid test and COVID-19 PCR test which was found to be positive, stated as breakthrough infection (confirmed clinical vaccination failure). On 26-SEP-2021, the patient also experienced shortness of breath and chest pain. On 27-SEP-2021, the patient experienced migraines. The migraines had been treated with the over the counter medication Excedrin (acetylsalicylic acid/caffeine/paracetamol/salicylamide). On 27-SEP-2021 and 28-SEP-2021, the patient stated that the chest pain was pretty significant. The patient visited physician office for all the symptoms/adverse effects she was experiencing. The action taken with covid-19 vaccine was not applicable. The patient recovered from diarrhea, was recovering from heavy congestion of the nose and sinuses, shortness of breath, chest pain and migraines, had not recovered from nausea and loss of smell and taste and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000195072.; Sender's Comments: V0:20210955502-COVID-19 VACCINE Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling cold, Headache, Hot flush, Hyperhidrosis
Clinical narrative: FELT WORSE AND WORSE; DID NOT WANTED TO MOVE, EVERYTHING HURT; WHEN WANTED TO GO TO SLEEP, SUDDENLY STARTED SWEATING FOR NO REASON WITH CESSATION; FREEZING ENDLESSLY IN AN ATTIC APARTMENT AT 25 DEGREES; ARM STILL HURTS A BIT; WHEN TRIED TO SHOWER FELT LIKE THERE WAS 1000 TINY NEEDLES STICKING; SLIGHT HEADACHE; HOT FLASHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-SEP-2021 08:00 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 SEP-2021, the patient experienced hot flashes. On SEP-2021, the patient experienced arm still hurts a bit. On SEP-2021, the patient experienced when tried to shower felt like there was 1000 tiny needles sticking. On SEP-2021, the patient experienced slight headache. On 24-SEP-2021, the patient experienced felt worse and worse. On 24-SEP-2021, the patient experienced did not wanted to move, everything hurt. On 24-SEP-2021, the patient experienced when wanted to go to sleep, suddenly started sweating for no reason with cessation. On 24-SEP-2021, the patient experienced freezing endlessly in an attic apartment at 25 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt worse and worse, did not wanted to move, everything hurt, when wanted to go to sleep, suddenly started sweating for no reason with cessation, and freezing endlessly in an attic apartment at 25 degrees on 27-SEP-2021, and when tried to shower felt like there was 1000 tiny needles sticking on SEP-2021, and had not recovered from slight headache, arm still hurts a bit, and hot flashes. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: FELT WORSE AND WORSE; DID NOT WANTED TO MOVE, EVERYTHING HURT; WHEN WANTED TO GO TO SLEEP, SUDDENLY STARTED SWEATING FOR NO REASON WITH CESSATION; FREEZING ENDLESSLY IN AN ATTIC APARTMENT AT 25 DEGREES; ARM STILL HURTS A BIT; WHEN TRIED TO SHOWER FELT LIKE THERE WAS 1000 TINY NEEDLES STICKING; SLIGHT HEADACHE; HOT FLASHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-SEP-2021 08:00 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 SEP-2021, the patient experienced hot flashes. On SEP-2021, the patient experienced arm still hurts a bit. On SEP-2021, the patient experienced when tried to shower felt like there was 1000 tiny needles sticking. On SEP-2021, the patient experienced slight headache. On 24-SEP-2021, the patient experienced felt worse and worse. On 24-SEP-2021, the patient experienced did not wanted to move, everything hurt. On 24-SEP-2021, the patient experienced when wanted to go to sleep, suddenly started sweating for no reason with cessation. On 24-SEP-2021, the patient experienced freezing endlessly in an attic apartment at 25 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt worse and worse, did not wanted to move, everything hurt, when wanted to go to sleep, suddenly started sweating for no reason with cessation, and freezing endlessly in an attic apartment at 25 degrees on 27-SEP-2021, and when tried to shower felt like there was 1000 tiny needles sticking on SEP-2021, and had not recovered from slight headache, arm still hurts a bit, and hot flashes. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphagia, Hypoaesthesia, Joint swelling, Nervous system disorder
Clinical narrative: MULTIPLE (7 OR 8) SEIZURES; PROBLEMS/ISSUE SWALLOWING; NERVE ISSUE; DIZZY; TROUBLE SEEING/VISION PROBLEMS; TINGLING KNEE/TINGLING LEG; NUMBNESS IN RIGHT LEG; SWOLLEN KNEE; SWOLLEN LEG; This spontaneous report received from a patient concerned a 62 year old male of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker, and marijuana drug abuse (every once in a while). The patient stated that he had no medical history and was very healthy. Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 206A21A, and expiry: unknown) dose was not reported, 1 total administered in left arm on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in MAY-2021, few weeks after the vaccination, the patient had numbing in the right leg above his knee that has gone into his foot. The numbness was only in the right leg, in the surface of his leg in the nerves or veins and it swelled and got worse because he's a tennis player. On 23-SEP-2021, the patient experienced multiple (7 or 8) seizures on the tennis court while playing and taken to the emergency room (ER) and was admitted to the hospital. The patient said that, doctors could not pinpoint what was going on but there were suspicions, and they were sure that the numbing in his leg was caused by the vaccine. While admitted he received Magnetic resonance imaging (MRI) scan (NR: not provided) result not reported and they put something on his head to record activity for 24 hours and determine if there were any more seizures to came. On an unspecified date, the patient had experienced dizzy, tingling knee/tingling leg, trouble seeing (vision problems) and problem/issues swallowing where if he drinks something very cold, he would gag. He reported that numbness in his leg was nothing that he had experienced before. He was prescribed with Levetiracetam 1000 milligram (mg) twice daily upon discharge. The patient was hospitalized for 4 days and discharged on 26-SEP-2021. The patient had made appointment with his primary care physician for next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from problems/issue swallowing, and had not recovered from numbness in right leg, nerve issue, dizzy, swollen knee, swollen leg, tingling knee/tingling leg, trouble seeing/vision problems, and multiple (7 or 8) seizures. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210955573-COVID-19 VACCINE AD26.COV2.S- Multiple (7 or 8) seizures. 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.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Peripheral swelling, Seizure, Visual impairment
Clinical narrative: MULTIPLE (7 OR 8) SEIZURES; PROBLEMS/ISSUE SWALLOWING; NERVE ISSUE; DIZZY; TROUBLE SEEING/VISION PROBLEMS; TINGLING KNEE/TINGLING LEG; NUMBNESS IN RIGHT LEG; SWOLLEN KNEE; SWOLLEN LEG; This spontaneous report received from a patient concerned a 62 year old male of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker, and marijuana drug abuse (every once in a while). The patient stated that he had no medical history and was very healthy. Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 206A21A, and expiry: unknown) dose was not reported, 1 total administered in left arm on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in MAY-2021, few weeks after the vaccination, the patient had numbing in the right leg above his knee that has gone into his foot. The numbness was only in the right leg, in the surface of his leg in the nerves or veins and it swelled and got worse because he's a tennis player. On 23-SEP-2021, the patient experienced multiple (7 or 8) seizures on the tennis court while playing and taken to the emergency room (ER) and was admitted to the hospital. The patient said that, doctors could not pinpoint what was going on but there were suspicions, and they were sure that the numbing in his leg was caused by the vaccine. While admitted he received Magnetic resonance imaging (MRI) scan (NR: not provided) result not reported and they put something on his head to record activity for 24 hours and determine if there were any more seizures to came. On an unspecified date, the patient had experienced dizzy, tingling knee/tingling leg, trouble seeing (vision problems) and problem/issues swallowing where if he drinks something very cold, he would gag. He reported that numbness in his leg was nothing that he had experienced before. He was prescribed with Levetiracetam 1000 milligram (mg) twice daily upon discharge. The patient was hospitalized for 4 days and discharged on 26-SEP-2021. The patient had made appointment with his primary care physician for next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from problems/issue swallowing, and had not recovered from numbness in right leg, nerve issue, dizzy, swollen knee, swollen leg, tingling knee/tingling leg, trouble seeing/vision problems, and multiple (7 or 8) seizures. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210955573-COVID-19 VACCINE AD26.COV2.S- Multiple (7 or 8) seizures. 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.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contusion, Dysphagia, Hypoaesthesia, Magnetic resonance imaging, Pruritus
Clinical narrative: MULTIPLE (7 OR 8) SEIZURES; PROBLEMS/ISSUE SWALLOWING; NERVE ISSUE; DIZZY; TROUBLE SEEING/VISION PROBLEMS; TINGLING KNEE/TINGLING LEG; NUMBNESS IN RIGHT LEG; SWOLLEN KNEE; SWOLLEN LEG; This spontaneous report received from a patient concerned a 62 year old male of unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, non-smoker, and marijuana drug abuse (every once in a while). The patient stated that he had no medical history and was very healthy. Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 206A21A, and expiry: unknown) dose was not reported, 1 total administered in left arm on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in MAY-2021, few weeks after the vaccination, the patient had numbing in the right leg above his knee that has gone into his foot. The numbness was only in the right leg, in the surface of his leg in the nerves or veins and it swelled and got worse because he's a tennis player. On 23-SEP-2021, the patient experienced multiple (7 or 8) seizures on the tennis court while playing and taken to the emergency room (ER) and was admitted to the hospital. The patient said that, doctors could not pinpoint what was going on but there were suspicions, and they were sure that the numbing in his leg was caused by the vaccine. While admitted he received Magnetic resonance imaging (MRI) scan (NR: not provided) result not reported and they put something on his head to record activity for 24 hours and determine if there were any more seizures to came. On an unspecified date, the patient had experienced dizzy, tingling knee/tingling leg, trouble seeing (vision problems) and problem/issues swallowing where if he drinks something very cold, he would gag. He reported that numbness in his leg was nothing that he had experienced before. He was prescribed with Levetiracetam 1000 milligram (mg) twice daily upon discharge. The patient was hospitalized for 4 days and discharged on 26-SEP-2021. The patient had made appointment with his primary care physician for next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from problems/issue swallowing, and had not recovered from numbness in right leg, nerve issue, dizzy, swollen knee, swollen leg, tingling knee/tingling leg, trouble seeing/vision problems, and multiple (7 or 8) seizures. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210955573-COVID-19 VACCINE AD26.COV2.S- Multiple (7 or 8) seizures. 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.