chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neck pain, Rash, Rash macular, Sensitive skin
Clinical narrative: neck pain, skin sensitivity, and red spots on the back of the scalp and was diagnosed with acute shingles; Information has been received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. The patient's concurrent conditions, concomitant medications and medical history were unknown. On or around 26-OCT-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (strength, dose, rout of administration, lot# and expire date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered neck pain, skin sensitivity, and red spots on the back of the scalp and was diagnosed with acute shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), his symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), he has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of acute shingles was not recovered. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).   The event of acute shingles was considered as disabled by the lawyer.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain
Clinical narrative: CHEST PAIN; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: UNKNOWN) dose was not reported, administered on 28-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-DEC-2021, the patient experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blindness, Cerebrovascular accident, Pain in extremity, Vision blurred
Clinical narrative: CONGESTIVE HEART FAILURE; This spontaneous report received from a consumer 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 (dose number in series-1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, 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 congestive heart failure, and shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of congestive heart failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211266112.; Sender's Comments: V0: 20211266078 - congestive heart failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure congestive
Clinical narrative: CONGESTIVE HEART FAILURE; This spontaneous report received from a consumer 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 (dose number in series-1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, 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 congestive heart failure, and shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of congestive heart failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211266112.; Sender's Comments: V0: 20211266078 - congestive heart failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: PAIN IN CHEST; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously received covid-19 vaccine ad26. cov2. s from an unspecified manufacturer (dose number in series: 1) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown), dose was not reported, 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following covid-19 vaccine (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total, administered  for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced pain in chest which goes away and comes again while working (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in chest. This report was non-serious.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No adverse event; The patient was accidentally administered an expired dose of MMR II; This spontaneous report was received from physician and refers to a 12-month-old patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-DEC-2021, the patient was accidentally administered with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #S035356, recombinant human albumin (rHA), expiration date: 05-NOV-2021, strength, and route of administration were not provided), once follow vaccine schedule. The physician confirmed the patient had not had any symptoms after being administered the expired dose of the vaccine. The vaccine did not have any temperature excursions.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose of GARDASIL 9 was administered to a patient; This spontaneous report was received from a Licensed Practical Nurse regarding a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On 21-DEC-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml for prophylaxis, lot number S004578 with expiration date on 29-SEP-2021 (strength, dose number, anatomical location and route of administration were not reported). No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Metastases to rectum
Clinical narrative: Gardasil 9 injections directly into the tumours; Gardasil 9 used for tumours caused by HPV which have spread from her liver to her anus as the patient read about this treatment in a medical journal/article; This spontaneous report was received from the patient's chef concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), directly into tumours caused by human papillomavirus (HPV) (intentional product use issue) which have spread from her liver to her anus (dose, strength, specific route of administration and lot number were not reported).  According to reporter, the patient read about this treatment in a medical journal/article.  At the reporting time, the patient's outcome was unknown.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: shingles outbreaks/shingles is currently recurring; Lack of effect; This spontaneous report was received from a consumer (patient) via GSK referring to herself, a female patient of unknown age. Concomitant medication and drug reactions/allergies were unknown. Prior to any doses of either shingles vaccines, the patient had recurrent shingles and she routinely took acyclovir for outbreaks.  In December 2014 (reported as 7 years ago), the patient took the single dose of zoster vaccine live (ZOSTAVAX) (strength, route, lot# and expiration date were unknown) for prophylaxis.   Approximately 4 years ago, the patient received both doses of varicella zoster vaccine rge (SHINGRIX) (strengths, routes, lot # and expiration dates were unknown) in her right arm. She stated the first dose was given in December and the second dose was given 15th-February of the following year. She thought it was February 2018.  She stated after the 2 doses of varicella zoster vaccine rge (SHINGRIX), she was symptom free of shingles for 4 years but her shingles was currently recurring now about once a month (lack of effect) (herpes zoster and vaccination failure). She described her shingles outbreaks were small clumps of a 5-6 blisters that itch and then burn and last a month before healing, before another patch pops up on a different location. Currently she had a patch on the palm of her hand and on her lower back near her tailbone.   The outcome of herpes zoster and vaccination failure was unknown.  The causality assessments between herpes zoster and zoster vaccine live (ZOSTAVAX) and varicella zoster vaccine rge (SHINGRIX) were not reported. The causality assessment between vaccination failure and zoster vaccine live (ZOSTAVAX) and varicella zoster vaccine rge (SHINGRIX) were related.
Sex: F
Vaccine: MMR
Symptoms: Adenovirus test, Blood immunoglobulin M, Cytomegalovirus test negative, Epstein-Barr virus test negative, HIV test negative
Clinical narrative: positive for rubella PCR which was later confirmed to be the vaccine strain; historical condition: hematopoietic cell transplant (HCT); Literature Report:   Information has been received from the authors in a published literature article entitled as stated above concerning a 37-year-old female, who had a history of acute lymphoblastic leukemia and had undergone a matched unrelated donor myeloablative allogeneic (HCT) 542 days before vaccination.    On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (formulation, exact dose, route of administration, vaccination scheme frequency, anatomical location, lot numbers and expiration date were not reported) for prophylaxis. (measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine is a live-attenuated vaccine usually contraindicated within the first 2 ears of hematopoietic cell transplant (HCT) (Product use issue).   On the day of vaccination, she was on maintenance ponatinib (tyrosine kinase inhibitor, BCR-ABL pathway), her total lymphocyte count was 1.7 K/mcL, and she reported feeling well. Twelve days after, she presented with a maculopapular rash that initially appeared on the face and progressed to the shoulders, arm, and chest. She denied any associated symptoms such as fever, conjunctivitis, cough, coryza, or arthralgia. She was briefly hospitalized out of an abundance of caution because of an initial suspicion that the rash could be measles. IgM serology for measles and rubella was negative. Extensive workup for other infectious diseases, including parvovirus B19, adenovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), human immunodeficiency virus (HIV), herpes simplex virus (HSV), and varicella-zoster virus (VZV), was negative.   A nasopharyngeal swab returned negative for measles polymerase chain reaction (PCR) but positive for rubella PCR, which was later confirmed to be the vaccine strain (genotype 1a). The patient fully recovered without complications.  The authors considered the causal relationship between rubella event and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was related.  This is one of two reports received from the same source.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2112USA010068:
Sex: F
Vaccine: MMR
Symptoms: Herpes simplex test negative, Lymphocyte count, Parvovirus B19 test negative, Rash, Rash maculo-papular
Clinical narrative: positive for rubella PCR which was later confirmed to be the vaccine strain; historical condition: hematopoietic cell transplant (HCT); Literature Report:   Information has been received from the authors in a published literature article entitled as stated above concerning a 37-year-old female, who had a history of acute lymphoblastic leukemia and had undergone a matched unrelated donor myeloablative allogeneic (HCT) 542 days before vaccination.    On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (formulation, exact dose, route of administration, vaccination scheme frequency, anatomical location, lot numbers and expiration date were not reported) for prophylaxis. (measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine is a live-attenuated vaccine usually contraindicated within the first 2 ears of hematopoietic cell transplant (HCT) (Product use issue).   On the day of vaccination, she was on maintenance ponatinib (tyrosine kinase inhibitor, BCR-ABL pathway), her total lymphocyte count was 1.7 K/mcL, and she reported feeling well. Twelve days after, she presented with a maculopapular rash that initially appeared on the face and progressed to the shoulders, arm, and chest. She denied any associated symptoms such as fever, conjunctivitis, cough, coryza, or arthralgia. She was briefly hospitalized out of an abundance of caution because of an initial suspicion that the rash could be measles. IgM serology for measles and rubella was negative. Extensive workup for other infectious diseases, including parvovirus B19, adenovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), human immunodeficiency virus (HIV), herpes simplex virus (HSV), and varicella-zoster virus (VZV), was negative.   A nasopharyngeal swab returned negative for measles polymerase chain reaction (PCR) but positive for rubella PCR, which was later confirmed to be the vaccine strain (genotype 1a). The patient fully recovered without complications.  The authors considered the causal relationship between rubella event and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was related.  This is one of two reports received from the same source.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2112USA010068:
Sex: F
Vaccine: MMR
Symptoms: Rubivirus test positive, Varicella virus test negative, Viral test
Clinical narrative: positive for rubella PCR which was later confirmed to be the vaccine strain; historical condition: hematopoietic cell transplant (HCT); Literature Report:   Information has been received from the authors in a published literature article entitled as stated above concerning a 37-year-old female, who had a history of acute lymphoblastic leukemia and had undergone a matched unrelated donor myeloablative allogeneic (HCT) 542 days before vaccination.    On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (formulation, exact dose, route of administration, vaccination scheme frequency, anatomical location, lot numbers and expiration date were not reported) for prophylaxis. (measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine is a live-attenuated vaccine usually contraindicated within the first 2 ears of hematopoietic cell transplant (HCT) (Product use issue).   On the day of vaccination, she was on maintenance ponatinib (tyrosine kinase inhibitor, BCR-ABL pathway), her total lymphocyte count was 1.7 K/mcL, and she reported feeling well. Twelve days after, she presented with a maculopapular rash that initially appeared on the face and progressed to the shoulders, arm, and chest. She denied any associated symptoms such as fever, conjunctivitis, cough, coryza, or arthralgia. She was briefly hospitalized out of an abundance of caution because of an initial suspicion that the rash could be measles. IgM serology for measles and rubella was negative. Extensive workup for other infectious diseases, including parvovirus B19, adenovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), human immunodeficiency virus (HIV), herpes simplex virus (HSV), and varicella-zoster virus (VZV), was negative.   A nasopharyngeal swab returned negative for measles polymerase chain reaction (PCR) but positive for rubella PCR, which was later confirmed to be the vaccine strain (genotype 1a). The patient fully recovered without complications.  The authors considered the causal relationship between rubella event and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was related.  This is one of two reports received from the same source.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2112USA010068:
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and referred to a 3-month-old female patient. No information regarding the patient's concurrent condition, medical history, drug reactions or allergies and concomitant medications was provided. On 27-DEC-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), (lot # 1691299, expiration date 25-DEC-2021, 2 milliliter), orally for prophylaxis. It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ), that had expired on Christmas (25-DEC-2021), was administered to the patient on 27-DEC-2021 (expired product administered) and the nurse wanted to know if a re-dose was needed or was it okay. There was no temperature excursion reported. No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AEs; An expired dose of ROTATEQ was administered to a patient.; This spontaneous report has been received from other healthcare professional referring to a healthy 04-months old male patient. No information was provided about the patient's concurrent conditions, pertinent medical history, concomitant therapies, drug and/or allergies reactions.    On 27-DEC-2021, the patient was vaccinated with expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliters(ml), orally (Expired product administered) (lot number # T039454 has been verified to be a valid lot number, expiration date reported and established as 14-DEC-2021; vaccination schemes, frequencies, and anatomical site of vaccination were not reported) for prophylaxis. The nurse reported that the patient's health status was normal. The information regarding redosing guidance after administration of the expired vaccine was requested. It was advised that dose should be repeated and if  the expired dose was a live virus vaccine, should wait at least 4 weeks after the previous (expired) dose was given before repeating it or if the expired dose was not a live vaccine, the dose should be repeated as soon as possible  No additional adverse events reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report has been received from pharmacist referring to a patient of unreported age and gender. No information was provided about the patient's concurrent conditions, pertinent medical history, concomitant therapies, drug and/or allergies reactions. On 27-DEC-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(rHA) (M-M-R II), 0.5 milliliters, subcutaneously (SQ) (Expired product administered) (lot number # S035355 has been verified to be a valid lot number, expiration date reported and established as 05-NOV-2021; vaccination schemes, frequencies, and anatomical site of vaccination were not reported) for prophylaxis. No additional adverse events reported.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional information provided; Patient was administered an expired dose of ROTATEQ; This spontaneous report was received from a pharmacist referring to a 3-month-old patient. The patient's medical and drug history, current conditions, and concomitant medications were not provided.       On 27-DEC-2021, the 3-month-old patient was vaccinated with expired first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (expired product administered) (dose, vaccination scheme, route of administration, anatomical location of vaccination, and lot number were not reported). The dose expired on 25-DEC-2021.  No product quality compliant and no additional information provided (no adverse event) were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse event details; a supported temperature excursion was administered to one patient; This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHa (PROQUAD), 0.5 milliliter lot # T035393, expiration date 14-APR-2022 (route of administration and anatomical location not reported) for prophylaxis. Physician reported that with a supported temperature excursion was administered to one patient on 13-DEC-2021 (product storage error), temperature was 38F and time frame 16 hours and no previous temperature excursion. No additional adverse event details (no adverse event).
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; a patient received an expired dose of VARIVAX; This spontaneous report as received from a medical assistant refers to a 12-month-old male patient.  The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 23-DEC-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot # S038700, expiration date: 01-DEC-2021) (Expired product administered) 1 dose in the right thigh for prophylaxis (exact dose, route of administration, and frequency were not reported).    After the vaccine was given it was discovered that it was expired. The medical assistant wanted to know if there is anything specific that they should be concerned about, and if the patient should be re-vaccinated. No other adverse events were associated with the patient. The medical assistant would like to be contacted for further information regarding revaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Nausea, Somnolence, Vomiting
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included pain (Family History) (father), blister (Family History) (father), scab (Family History) (father) and shingles (Family History) (father). Previously administered products included Shingles vaccine with an associated reaction of injection site pain (on an unknown date received 1st dose and experienced tired, had soreness at injection site, felt a bit of tummy confusion refer case US2021AMR227225). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced nausea, vomiting, upset stomach and sleepiness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the nausea, vomiting, upset stomach and sleepiness were recovered/resolved. It was unknown if the reporter considered the nausea, vomiting, upset stomach and sleepiness 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 stated 2nd dose was not as kind. The patient woke up terribly nauseous the next morning. Vomited, but she might had been okay if she had not been hit by the smell of the leftovers from dinner as she packed hubby's lunch, so partially her error. The patient's tummy upset rest of day, and slept a good portion of it. However, 24 hours of inconvenience, which was all it was, compared to possibly lasting pain, or worse. Not much questions as to the benefit of the vaccine. The patient would do it again. No contact details were available; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR227225:same patient same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 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 reporter said there was only an 85 percent chance that a person would not get shingles again after having both shots. The patient had them twice after getting both shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that the shot causes shingles. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Weight increased
Clinical narrative: Weight gain; This case was reported by a consumer via interactive digital media and described the occurrence of weight gain 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 weight gain. On an unknown date, the outcome of the weight gain was unknown.   It was unknown if the reporter considered the weight gain to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix on an unknown date and experienced weight gain. Consent to follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injury, Retinal injury
Clinical narrative: One of retinas have permanent damage; This case was reported by a consumer via interactive digital media and described the occurrence of retinal damage in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 hrs after receiving Shingles vaccine, the patient experienced retinal damage (serious criteria GSK medically significant). On an unknown date, the outcome of the retinal damage was unknown.   It was unknown if the reporter considered the retinal damage 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 Shingles shot and 3 hours later had the worst reaction ever. Might be ok for some but be careful. The patient stated he/she was to the emergency room twice and the worst was it returns every so often. One of retinas had permanent damage. The patient stated he/she never had a reaction to an injection but guess there was a first time for everything. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/ not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, shingles were very painful. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. A month after receiving Shingles vaccine, the patient got shingles again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; still gets nerve pain; 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), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the post herpetic neuralgia was not recovered/not resolved.   The reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles from it. The reporter stated that, it took a long time to go away. Till the time of reporting, the patient still got nerve pain. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got my first Shingrix vaccine four years ago / my second one two months ago; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine 4 years ago from reporting date).   In October 2021, the patient received the 2nd dose of Shingrix. In October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received 2nd dose of Shingrix 2 months ago from the date of reporting, later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter asked, if needed 3rd dose of Shingrix. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: More than 6 months since 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 6 months 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 information was provided as follow: The patient self reported this case. The age at vaccination was not applicable for this report. The patient enquired what if longer than 6 months had passed since his/her first Shingrix vaccination. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Hurt badly; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and pain. On an unknown date, the outcome of the vaccination failure, herpes zoster and pain were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles anyway. The patient stated that, he/she had never hurt as badly. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: 1st dose hurt like crazy; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, the 1st dose for him/her hurt like crazy for over a week. The reporter also stated that, he/she knew he/she was interested in the second shot. The follow-up would not possible as no contact details were available.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Exercise tolerance decreased, Fatigue, Headache, Inappropriate schedule of product administration, Muscular weakness
Clinical narrative: Headache; Fatigue; Muscle weakness; Exercise intolerance; Photosensitivity; reporter confirmed it was more than 6 months before they received the second dose; Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2021AMR260605).   On 14th December 2021, the patient received the 2nd dose of Shingrix. On 14th December 2021, immediately after receiving Shingrix, the patient experienced fever, headache, fatigue, muscle weakness, exercise tolerance decreased, photosensitivity and drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the headache, fatigue, muscle weakness, exercise tolerance decreased and photosensitivity were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, headache, fatigue, muscle weakness, exercise tolerance decreased and photosensitivity to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The reporter reported immediately experiencing fever, headache, fatigue, muscle weakness, exercise intolerance and photosensitivity. The reporter confirmed it was more than 6 months before they received the second dose, which led to lengthening of vaccination schedule. The fever resolved after approximately 24 hours. The reporter reported all other symptoms were ongoing.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR260605:1st dose case
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Photosensitivity reaction, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Headache; Fatigue; Muscle weakness; Exercise intolerance; Photosensitivity; reporter confirmed it was more than 6 months before they received the second dose; Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2021AMR260605).   On 14th December 2021, the patient received the 2nd dose of Shingrix. On 14th December 2021, immediately after receiving Shingrix, the patient experienced fever, headache, fatigue, muscle weakness, exercise tolerance decreased, photosensitivity and drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the headache, fatigue, muscle weakness, exercise tolerance decreased and photosensitivity were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, headache, fatigue, muscle weakness, exercise tolerance decreased and photosensitivity to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The reporter reported immediately experiencing fever, headache, fatigue, muscle weakness, exercise intolerance and photosensitivity. The reporter confirmed it was more than 6 months before they received the second dose, which led to lengthening of vaccination schedule. The fever resolved after approximately 24 hours. The reporter reported all other symptoms were ongoing.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR260605:1st dose case
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 22-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 977EN, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (SEASONAL INFLUENZA VACCINE)) for prophylaxis. On 12th December 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 2nd November 2021, the patient received FLUZONE (SEASONAL INFLUENZA VACCINE). The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2021-2022 season at an unknown time during the pregnancy. On 12th December 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy and extra dose administered were unknown. The pregnancy was ongoing.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: Nurse called to report that a medical assistant administered a pregnant patient the FLUARIX vaccine (on the day of reporting) and after administration found out that the patient had received FLUZONE vaccine, which led to extra dose administered. 28 weeks and 1 day pregnant at exposure to Fluarix vaccine. Nurse would like to know if there were any adverse events that had been reported after administering 2 flu vaccines. Call abandoned whilst warm transferring call to Medical Information. The reporter consented to follow up.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Underdose
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 20-year-old male patient who received HBV (Engerix B 10 mcg) (batch number LR537, expiry date 3rd January 2022) for prophylaxis. Concomitant products included HEPATITIS B VACCINE (ENGERIX B 10). On 6th August 2021, the patient received the 2nd dose of Engerix B 10 mcg. On 6th August 2021, unknown after receiving Engerix B 10mcg, the patient experienced drug dose administration interval too long, adult use of a child product and underdose. On an unknown date, the outcome of the drug dose administration interval too long, adult use of a child product and underdose were unknown. Additional details were provided as follows: The reporter reported that the patient received pediatric dose of Engerix-b 10 mcg at age of 20 years of age, which led to adult use of a child product and underdose. The patient received 2nd dose later than the recommended interval, which led to drug dose administration interval too long. The reporter consented to follow up; Sender's Comments: US-GLAXOSMITHKLINE-US2021261520:FU1 - Deleted.