chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B DNA assay, Hepatitis B core antibody positive, Hepatitis B e antigen positive, Hepatitis B surface antibody negative, Hepatitis B surface antigen
Clinical narrative: ACUTE HEPATITIS B; Therapy non-responder; Anti-HBs antibody negative;   Information has been received from the authors of a published literature article, regarding to a 32 year old male patient.   The patient's concurrent conditions was not reported. The patient's medical history included depression. Family history was notable for hemochromatosis in his father. He denied having unprofessional tattoos, IV drug use, heavy alcohol use, recent acetaminophen use, ingestion of non-commercial mushrooms or herbal supplements, but reported unprotected sexual intercourse with male partners.     On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), for prophylaxis (dose, route of administration, lot# and expiration date were not provided).         On an unknown date, the patient experienced hepatitis b, requiring hospitalization. On an unknown date, he was transferred to our hospital, for escalation of care, after presenting with 4-day history of nausea, vomiting, jaundice, body aches, abdominal pain, and worsening lethargy. Upon arrival, his lethargy resolved, but >jaundice and RUQ abdominal pain persisted. Initial labs showed elevated aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) of 3075/4895 IU, respectively; bilirubin of 16.3 mg/dL, INR greater than 2 and ferritin levels 17,000 ng/ml. Ceruloplasmin levels and alpha-1 antitrypsin clearance were within normal limits. Blood toxicology ruled out acetaminophen, alcohol, and salicylate toxicity. Evaluation for Hereditary Hemochromatosis showed a heterozygous H63D-mutation of HFE. However, Viral Hepatitis panel was positive for HBsAg, anti-HBc IgM, HBeAg, and negative for anti-HBs and a Viral Hep B DNA of 579000 copies. Hepatitis D Antigen and CMV evaluations were inconclusive. He improved over a few days with supportive care and n-acetylcysteine, until his transaminase levels dropped below 1000 (units not provided). No tenofovir or entecavir were required. He was then discharged with outpatient follow up. The outcome of acute hepatitis b was resolving. The outcome of therapy non-responder and hepatitis b surface antibody negative was unknown.     The reporter considered therapy non-responder, hepatitis b surface antibody negative and acute hepatitis b to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).     Upon internal review, Hepatitis b was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis D antigen, Hepatitis viral test, Hereditary haemochromatosis, International normalised ratio increased, Jaundice
Clinical narrative: ACUTE HEPATITIS B; Therapy non-responder; Anti-HBs antibody negative;   Information has been received from the authors of a published literature article, regarding to a 32 year old male patient.   The patient's concurrent conditions was not reported. The patient's medical history included depression. Family history was notable for hemochromatosis in his father. He denied having unprofessional tattoos, IV drug use, heavy alcohol use, recent acetaminophen use, ingestion of non-commercial mushrooms or herbal supplements, but reported unprotected sexual intercourse with male partners.     On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), for prophylaxis (dose, route of administration, lot# and expiration date were not provided).         On an unknown date, the patient experienced hepatitis b, requiring hospitalization. On an unknown date, he was transferred to our hospital, for escalation of care, after presenting with 4-day history of nausea, vomiting, jaundice, body aches, abdominal pain, and worsening lethargy. Upon arrival, his lethargy resolved, but >jaundice and RUQ abdominal pain persisted. Initial labs showed elevated aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) of 3075/4895 IU, respectively; bilirubin of 16.3 mg/dL, INR greater than 2 and ferritin levels 17,000 ng/ml. Ceruloplasmin levels and alpha-1 antitrypsin clearance were within normal limits. Blood toxicology ruled out acetaminophen, alcohol, and salicylate toxicity. Evaluation for Hereditary Hemochromatosis showed a heterozygous H63D-mutation of HFE. However, Viral Hepatitis panel was positive for HBsAg, anti-HBc IgM, HBeAg, and negative for anti-HBs and a Viral Hep B DNA of 579000 copies. Hepatitis D Antigen and CMV evaluations were inconclusive. He improved over a few days with supportive care and n-acetylcysteine, until his transaminase levels dropped below 1000 (units not provided). No tenofovir or entecavir were required. He was then discharged with outpatient follow up. The outcome of acute hepatitis b was resolving. The outcome of therapy non-responder and hepatitis b surface antibody negative was unknown.     The reporter considered therapy non-responder, hepatitis b surface antibody negative and acute hepatitis b to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).     Upon internal review, Hepatitis b was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: HEP
Symptoms: Lethargy, Nausea, Pain, Serum ferritin increased, Therapy non-responder
Clinical narrative: ACUTE HEPATITIS B; Therapy non-responder; Anti-HBs antibody negative;   Information has been received from the authors of a published literature article, regarding to a 32 year old male patient.   The patient's concurrent conditions was not reported. The patient's medical history included depression. Family history was notable for hemochromatosis in his father. He denied having unprofessional tattoos, IV drug use, heavy alcohol use, recent acetaminophen use, ingestion of non-commercial mushrooms or herbal supplements, but reported unprotected sexual intercourse with male partners.     On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), for prophylaxis (dose, route of administration, lot# and expiration date were not provided).         On an unknown date, the patient experienced hepatitis b, requiring hospitalization. On an unknown date, he was transferred to our hospital, for escalation of care, after presenting with 4-day history of nausea, vomiting, jaundice, body aches, abdominal pain, and worsening lethargy. Upon arrival, his lethargy resolved, but >jaundice and RUQ abdominal pain persisted. Initial labs showed elevated aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) of 3075/4895 IU, respectively; bilirubin of 16.3 mg/dL, INR greater than 2 and ferritin levels 17,000 ng/ml. Ceruloplasmin levels and alpha-1 antitrypsin clearance were within normal limits. Blood toxicology ruled out acetaminophen, alcohol, and salicylate toxicity. Evaluation for Hereditary Hemochromatosis showed a heterozygous H63D-mutation of HFE. However, Viral Hepatitis panel was positive for HBsAg, anti-HBc IgM, HBeAg, and negative for anti-HBs and a Viral Hep B DNA of 579000 copies. Hepatitis D Antigen and CMV evaluations were inconclusive. He improved over a few days with supportive care and n-acetylcysteine, until his transaminase levels dropped below 1000 (units not provided). No tenofovir or entecavir were required. He was then discharged with outpatient follow up. The outcome of acute hepatitis b was resolving. The outcome of therapy non-responder and hepatitis b surface antibody negative was unknown.     The reporter considered therapy non-responder, hepatitis b surface antibody negative and acute hepatitis b to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).     Upon internal review, Hepatitis b was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: HEP
Symptoms: Toxicologic test normal, Transaminases, Vomiting
Clinical narrative: ACUTE HEPATITIS B; Therapy non-responder; Anti-HBs antibody negative;   Information has been received from the authors of a published literature article, regarding to a 32 year old male patient.   The patient's concurrent conditions was not reported. The patient's medical history included depression. Family history was notable for hemochromatosis in his father. He denied having unprofessional tattoos, IV drug use, heavy alcohol use, recent acetaminophen use, ingestion of non-commercial mushrooms or herbal supplements, but reported unprotected sexual intercourse with male partners.     On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB), for prophylaxis (dose, route of administration, lot# and expiration date were not provided).         On an unknown date, the patient experienced hepatitis b, requiring hospitalization. On an unknown date, he was transferred to our hospital, for escalation of care, after presenting with 4-day history of nausea, vomiting, jaundice, body aches, abdominal pain, and worsening lethargy. Upon arrival, his lethargy resolved, but >jaundice and RUQ abdominal pain persisted. Initial labs showed elevated aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) of 3075/4895 IU, respectively; bilirubin of 16.3 mg/dL, INR greater than 2 and ferritin levels 17,000 ng/ml. Ceruloplasmin levels and alpha-1 antitrypsin clearance were within normal limits. Blood toxicology ruled out acetaminophen, alcohol, and salicylate toxicity. Evaluation for Hereditary Hemochromatosis showed a heterozygous H63D-mutation of HFE. However, Viral Hepatitis panel was positive for HBsAg, anti-HBc IgM, HBeAg, and negative for anti-HBs and a Viral Hep B DNA of 579000 copies. Hepatitis D Antigen and CMV evaluations were inconclusive. He improved over a few days with supportive care and n-acetylcysteine, until his transaminase levels dropped below 1000 (units not provided). No tenofovir or entecavir were required. He was then discharged with outpatient follow up. The outcome of acute hepatitis b was resolving. The outcome of therapy non-responder and hepatitis b surface antibody negative was unknown.     The reporter considered therapy non-responder, hepatitis b surface antibody negative and acute hepatitis b to be related to Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).     Upon internal review, Hepatitis b was considered to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: other zoster-related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68-year-old patient of unknown gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 01-JAN-2016, the patient was administered zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) at a pharmacy, for the long-term prevention of shingles and zoster-related conditions.         Subsequently, on an unknown date, the patient was treated by healthcare providers for the following injuries resulting from zoster vaccine live(ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was unknown.  The reporter considered herpes zoster and other zoster-related conditions to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Amnesia, Loss of consciousness, Speech disorder, Unresponsive to stimuli
Clinical narrative: the patient went "unconscious/unresponsive for about 30 seconds."; the patient went "unconscious/unresponsive for about 30 seconds."; The patient's eyes were open but they were not able to speak; the patient had no recollection of the event; This spontaneous report has been received from a healthcare professional (who was a nurse or medical assistant), referring to an 11-year-old female patient. Her pertinent medical history included anxiety. The patient's concomitant medications, previous drug reactions or allergies, and historical conditions were not reported.   On 07-SEP-2021, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), one dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), and one dose of meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) (doses, vaccine scheme, anatomical sites of vaccination, lot numbers and expiration dates were not provided), intramuscularly as prophylaxis.   On 07-SEP-2021, after the vaccination, the patient went unconscious (loss of consciousness) and unresponsive (unresponsive to stimuli) for about 30 seconds. Additionally, the reporter stated that the patient's eyes were open, but she was not able to speak (speech disorder) and when she regained consciousness, the patient had no recollection of the event (amnesia). The patient did not seek medical attention, and no treatment was given for the events. The patient recovered from loss of consciousness, unresponsive to stimuli, speech disorder and amnesia.   The reporter's causality assessment between the suspect vaccines and the events was not provided.   Upon internal review, the loss of consciousness and the unresponsive to stimuli were determined to be medically significant events.
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No further information is available; patient received improperly stored vaccine; This spontaneous report was received from a nurse referring to a 2 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 02-SEP-2021, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 dose, lot # S009234, expiration date 24-JAN-2022; strength, route and anatomical location were not reported) for prophylaxis (product storage error). The storage temperatures were 14.2 Celsius degrees for 3 hours 15 minutes. Previous temperature excursion were 17.5 Celsius degrees for 8 hours and 1.9 Celsius degrees for 3 hours. No product quality complaint (PQC) was reported. No further information was available.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: Blood clots in lungs; This is a solicited report from a non-Pfizer sponsored program, from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (BMS) (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-087002), license party for apixaban.  This 71-year-old female patient was involved in a patient support program. The patient received APIXABAN. The report describes a case of PULMONARY THROMBOSIS (Blood clots in lungs). Co-suspect products included tozinameran (Pfizer Biontech Covid-19 Vaccine) for an unknown indication. On an unknown date, the patient started APIXABAN (unknown route), (unspecified dose and frequency). On an unknown date, the patient experienced PULMONARY THROMBOSIS (seriousness criterion medically significant). The action taken with APIXABAN(Unknown) was unknown. At the time of the report, PULMONARY THROMBOSIS outcome was unknown. The patient took Pfizer Covid Vaccine and developed blood clots in lungs. For APIXABAN(Unknown), the reporter did not provide any causality assessments. The primary reporter was non-health professional. The indication for apixaban was unknown. Follow-up is unable to be performed.  The reporter's assessment of the causal relationship of the event with bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Agency medical evaluation comment: This patient had pulmonary thrombosis after receiving apixaban therapy along with co-suspect Covid-19 vaccine. Based on the limited information available regarding event details, relevant medical history, therapy details and indication, it cannot be ascertained with reasonable possibility that the suspect therapy contributed to the reported event.  Causality Assessment: The event thrombosis pulmonary was not related to apixaban per company (Bristol-Myers Squibb) and was no information per reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Pending the clinical course, temporal association, and relevant medical history, the company does not attribute the event pulmonary thrombosis to Pfizer suspected drug bnt162b2. The event is considered unrelated to apixaban by assessment.
Sex: U
Vaccine: ANTH
Symptoms: Syncope
Clinical narrative: Neurocardiogenic syncope; On 26AUG2021, a spontaneous report was received from another pharmaceutical company.  On an unknown date, a female patient (age at time of event unknown) experienced "Neurocardiogenic syncope" (PT: Syncope) after receiving BioThrax (anthrax vaccine) on an unknown date. No treatment for the event or outcome was reported.   The patients medical history included gulf war illness, asthma, allergies (unspecified), and Ehlers-Danlos syndrome. She was also being monitored for autoimmune disease. The patient also reported previous history of taking penicillin, doxycycline, clindamycin, Cymbalta, and "higher doses of sertraline."  No additional information with regards to this event was provided.  Company comment:  Vasovagal syncope is a self limited loss of consciousness caused by a neurological reflex that produces hypotension due to a lack of blood flow and almost always associated with bradycardia. Because it is produced in response to a stressful or emotional distress and not the vaccine, the Company considers that the vasovagal syncope is not related to BioThrax.  ?; Sender's Comments: Vasovagal syncope is a self limited loss of consciousness caused by a neurological reflex that produces hypotension due to a lack of blood flow and almost always associated with bradycardia. Because it is produced in response to a stressful or emotional distress and not the vaccine, the Company considers that the vasovagal syncope is not related to BioThrax.
Sex: F
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: already has Shingles/  severe skin issues.; no information was provided about needing a booster shot; This case was reported by a consumer and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE MRNA (MRNA 1273) (COVID 19 VACCINE MODERNA) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingles vaccine. On an unknown date, the patient received the 2nd dose of Shingles vaccine and COVID 19 VACCINE MODERNA. On an unknown date, less than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient had the shingles vaccine 2 years ago and in 2021, the patient received Moderna covid vaccine and less than 9 months after Moderna covid vaccine and the patient already had shingles. It was reported that the vaccine was supposed to be 90 percent effective for 5 years, and no information was provided about needing a booster dose shot, which led to incomplete course of vaccination. The reporter had a call coming in and had to hang up, so could not obtain further information. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Fall, Feeding disorder, Feeling abnormal
Clinical narrative: passed out; super dizzy; falling into the walls trying to walk; blood pressure plummets; can´t eat and then drive or do much of anything. It´s very strange; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of dizziness (1st dose received on an unknown date, and also experienced falling into the walls trying to walk, blood pressure plummets, refer case US2021AMR178275). Concurrent medical conditions included blood pressure high.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced passed out (serious criteria GSK medically significant), dizziness, walking difficulty, blood pressure decreased and feeling abnormal. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal were unknown.   It was unknown if the reporter considered the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at the vaccination was not reported. The patient came home super dizzy, falling into the walls tried too walk. Ever since the vaccine the patient, every time the patient ate his/her blood pressure plummets and had passed out once. The patient could not eat and then drive or do much of anything and it as very strange. The patient had a weekly medical consultation to try to figure out how to counter that.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178285:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178284:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178275:Same reporter, same patient, different dose (1st)
Sex: U
Vaccine: VARZOS
Symptoms: Gait disturbance, Impaired driving ability, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: passed out; super dizzy; falling into the walls trying to walk; blood pressure plummets; can´t eat and then drive or do much of anything. It´s very strange; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of dizziness (1st dose received on an unknown date, and also experienced falling into the walls trying to walk, blood pressure plummets, refer case US2021AMR178275). Concurrent medical conditions included blood pressure high.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced passed out (serious criteria GSK medically significant), dizziness, walking difficulty, blood pressure decreased and feeling abnormal. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal were unknown.   It was unknown if the reporter considered the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at the vaccination was not reported. The patient came home super dizzy, falling into the walls tried too walk. Ever since the vaccine the patient, every time the patient ate his/her blood pressure plummets and had passed out once. The patient could not eat and then drive or do much of anything and it as very strange. The patient had a weekly medical consultation to try to figure out how to counter that.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178285:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178284:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178275:Same reporter, same patient, different dose (1st)
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Dizziness, Feeding disorder, Feeling abnormal, Gait disturbance
Clinical narrative: passed out; super dizzy; falling into the walls trying to walk; blood pressure plummets; I can't eat and then drive or do much of anything. It's very strange; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included blood pressure high.   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 passed out (serious criteria GSK medically significant), dizziness, walking difficulty, blood pressure decreased and feeling abnormal. On an unknown date, the outcome of the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient came home super dizzy, falling into the walls tried too walk. Ever since the vaccine, the patient every time the patient ate his/her blood pressure plummets and had passed out once. The patient could not eat and then drive or do much of anything and it as very strange. The patient had a weekly medical consultation to try to figure out how to counter that. For 2nd dose, refer case US2021AMR169473, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178284:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178285:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR169473:Same reporter, same patient, different dose (2nd)
Sex: U
Vaccine: VARZOS
Symptoms: Impaired driving ability, Loss of consciousness
Clinical narrative: passed out; super dizzy; falling into the walls trying to walk; blood pressure plummets; I can't eat and then drive or do much of anything. It's very strange; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included blood pressure high.   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 passed out (serious criteria GSK medically significant), dizziness, walking difficulty, blood pressure decreased and feeling abnormal. On an unknown date, the outcome of the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient came home super dizzy, falling into the walls tried too walk. Ever since the vaccine, the patient every time the patient ate his/her blood pressure plummets and had passed out once. The patient could not eat and then drive or do much of anything and it as very strange. The patient had a weekly medical consultation to try to figure out how to counter that. For 2nd dose, refer case US2021AMR169473, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178284:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178285:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR169473:Same reporter, same patient, different dose (2nd)
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: another booster three weeks ago; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received a booster shot last year on an unknown date and experienced shingles, refer case US2021AMR186098).   In August 2021, the patient received Shingles vaccine. In August 2021, between 2 and 4 weeks after receiving Shingles vaccine, the patient experienced shingles. Rechallenge with Shingles vaccine was positive. 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 Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's neighbor. The age at vaccination was not reported. The patient had just got another booster dose of Shingles three week ago and now she had shingles. This case was linked with US2021AMR186098, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186098:same patient/ same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Product dose omission issue, Social problem
Clinical narrative: Covid hit, didn't receive second dose / doctor says that i need to start over; This case was reported by a consumer via (Shingrix GSK and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 20 months ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had received first dose of Shingrix just before Covid hit.  The patient did not receive second dose and it had been about 20 months since the first shot, which led to social problem. The patient's doctor said that the patient needed to start over-get two doses. The patient stated that the site said that there was no need to start over.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: big old red circles; itching; burning; This case was reported by a consumer via interactive digital media and described the occurrence of localized erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of injection site erythema (1st dose received on an unknown date refer case US2021AMR186889).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced localized erythema, localized itching and burning sensation. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the localized erythema, localized itching and burning sensation were unknown.   It was unknown if the reporter considered the localized erythema, localized itching and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine had a reaction both times big old red circles, itching and burning. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR186889:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Got really sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient got shingles vaccine and felt really sick hence second dose not received. The patients contact details was not provided hence follow up not possible.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: small shingles rash; This case was reported by a consumer and described the occurrence of vesicular rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were reported as follows: This patient self reported the case. The patient's 5 years old nephew got shingles from the chicken pox vaccine. He got shingles on his neck. It started the day after the shot. They took him to the doctor to confirm. He was 22 and had shingles 2 more times. The patient received Shingrix vaccine and got a small shingles rash the next day. The patient commented that, shingles are very painful though so did not regret his/her decision.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 1st vaccine which eventually proved to be about 30 percent effective.; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a female 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient's friend. Age at vaccination was not reported. The 1st vaccine which eventually proved to be about 30 percent effective.  No contact details were available. For tolerance in 2nd dose refer case US2021AMR187069.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187069:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Bed rest, Gouty arthritis, Mobility decreased, Pain
Clinical narrative: gouty arthritis; Pain; stayed in bed all day; This case was reported by a consumer and described the occurrence of gouty arthritis in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced gouty arthritis, pain and bed rest. On an unknown date, the outcome of the gouty arthritis, pain and bed rest were recovered/resolved.   The reporter considered the gouty arthritis, pain and bed rest to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter's mother. The age at vaccination was not reported. The reporter stated that, the patient received her first dose and experienced suspected gouty arthritis, the day after the Shingrix shot. The reporter stated that, could not recall the date, but the patient now fine at the time of reporting, after being in pain. The reporter stated that, no hospitalization or death, patient just stayed in bed all day. The patients thought it was related to Shingrix
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Gait disturbance, Pain in extremity
Clinical narrative: gouty arthritis; Pain; stayed in bed all day; This case was reported by a consumer and described the occurrence of gouty arthritis in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced gouty arthritis, pain and bed rest. On an unknown date, the outcome of the gouty arthritis, pain and bed rest were recovered/resolved.   The reporter considered the gouty arthritis, pain and bed rest to be related to Shingrix.  Additional details were provided as follows: The patient was the reporter's mother. The age at vaccination was not reported. The reporter stated that, the patient received her first dose and experienced suspected gouty arthritis, the day after the Shingrix shot. The reporter stated that, could not recall the date, but the patient now fine at the time of reporting, after being in pain. The reporter stated that, no hospitalization or death, patient just stayed in bed all day. The patients thought it was related to Shingrix
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got Shingles vaccine and made him/her sick. The patient bucked up to, however he/she had issues on how vaccine was given, between the restrooms at pharmacy. The patient asked that could he/she not get the shingles vaccine at the doctor's office and found that disgusting. The follow up would not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: were vaccinated to avoid Shingles! both 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 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 details were reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient were vaccinated with Shingles to avoid shingles and still got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187392:Same reporter, different patient
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I HAD TWO SHINGLE VACCINATION.SOME GOT SHJINGLE TWICE/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 73-year-old 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, unknown 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had 2 Shingles vaccination and got shingles. The patient said that some got shingles twice and some did not get 2nd for their lifetime. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case has been linked with the case US2021AMR187365, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: fever; body aches; got very ill; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included COVID-19 VACCINE (received on an unknown date) and Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer case US2021AMR187280).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, general body pain and illness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fever, general body pain and illness were unknown.   It was unknown if the reporter considered the fever, general body pain and illness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient reported that, he/she got shingles vaccine and got very ill, had fever, body aches and so on, but mentioned it worked,  just like the Covid vaccine. The contact details were not reported. This case has been linked with US2021AMR187280, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187280:same reporter, same patient, same vaccine, different dose
Age: 5.0
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: five year old female patient received doses of Ipol,and Kinrix; This case was reported by a pharmacist via other manufacturer and described the occurrence of overdose in a 5-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and POLIOMYELITIS VACCINE (IPOL) for prophylaxis.   On 9th August 2021, the patient received Kinrix .5 ml, Kinrix Pre-Filled Syringe Device and IPOL .5 ml. On 9th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received doses of Ipol and Kinrix (not produced by Sanofi Pasteur) vaccines via an unknown route at unknown administration site with no reported adverse event. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. It was a case of actual medication error due to overdose (Ipol and Kinrix latency on same day). It was reported that the reporter asks what to do about the patient receiving a double dose of the polio vaccine and what side effects that a 5 year of age patient might expect. Unable to find this information in the standards or PI (prescription information). At the time of report, no adverse event was reported. There would be no information available on the Ipol and Kinrix vaccine batch number for this case.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity, Skin exfoliation, Skin warm
Clinical narrative: as fever in arm; arm hurt; peeled offlike you had a sunburn; felt bad; This case was reported by a consumer via interactive digital media and described the occurrence of skin warm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced skin warm, pain in arm, skin peeling and feeling bad. On an unknown date, the outcome of the skin warm, pain in arm and skin peeling were unknown and the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the skin warm, pain in arm, skin peeling and feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had already Shingles vaccine but his/her physician said need the new one of Shingles vaccine, got it was bad arm hurt, had fever in it later it peeled off like had a sunburn and felt bad for several days. The patient stated that, wish he/she had not taken Shingles vaccine and have to get another one like 5 months later read where it says that the covid-19 vaccine could cause to get shingles so he/she think why physician said that this one was different would not get the second one. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: felt like I had the flu; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's daughter just had Shingles at age 30 and she was miserable). Previously administered products included shingles vaccine with an associated reaction of pain (received first dose on an unknown date and experienced pain, refer case US2021AMR188159) and Flu shot with an associated reaction of pain (received dose of Flu shot on an unknown date and experienced pain, refer case US2021AMR188157).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the second Shingles shot and felt like he/ she had the flu for a day. The patient stated that it was still better than getting shingles and strongly advise the shot. This case is one of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR188159:same reporter, same patient US-GLAXOSMITHKLINE-US2021AMR188158:same reporter, same patient