chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer and referred to a currently 56 years old patient (pt) of unknown gender. The pt's historical condition, current condition and concomitant medication were not reported. On or about 17-MAY-2016, the pt was administered the zoster vaccine live(ZOSTAVAX) vaccine (dose, route, strength, lot number and expiration date were unknown) for the long-term prevention of shingles and zoster-related conditions by a healthcare provider. Subsequently, the pt was treated by a healthcare provider for the following injuries resulting from the pt's zoster vaccine live(ZOSTAVAX) use: shingles. The outcome of the event was unknown. The causality was related.
Sex: F
Vaccine: HEP, MMR
Symptoms: Therapeutic response shortened
Clinical narrative: Non-responder to the MMR vaccine and the Hep B vaccine series, mostly meaning I'm immune for a short time and it wears off quickly; This spontaneous report was received from a consumer via Pfizer referring to herself, a female patient of unspecified age. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On an unspecified date, the patient was administered hepatitis B vaccine (recombinant) (manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (doses, routes of administration, anatomical sites of vaccination, lot numbers and expiration dates were not reported) as prophylaxis.   The patient stated that she was a non-responder to hepatitis B vaccine (recombinant) (manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) vaccine series, mostly meaning that she was immune for a short time and "it wears off quickly" (therapeutic response shortened).   The outcome of the event was unknown. The causal relationship between the suspect vaccines and the event was not provided.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administration of an expired dose of MMR II [Lot: T018893, Exp: 06/2/2022 to a patient on 7/21/2022. Caller confirmed vaccine was stored at recommended storage range until date of administration.; No additional AE reported; This spontaneous report was received from a medical assistant concerning a 25-year-old male patient. His medical history, historical medications, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 21-JUL-2022, the patient was vaccinated with an expired single dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) with the verified lot number T018893 (expiration date: 02-JUN-2022) administered for prophylaxis (strength, volume of injection, and route of administration were not provided) (Expired vaccine used). Moreover, the reporter stated that the suspect vaccine had been stored at the recommended storage range until the date of administration. No additional information or adverse events were provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; an office manager informed her of MMRII with a labeled expiry of 5/29/2022 was administered; This spontaneous report was received from an office manager via employee and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUN-2022, the patient was vaccinated with one dose (quality: 1) of me asles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: rHA) subcutaneous injection, 0.5 milliliter for prophylaxis (lot #T018669, expiration date: 29-MAY-2022, strength and route of administration were not provided) (expired product administered). No additional adverse event was reported (no adverse event).  This is the one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA006816: US-009507513-2207USA007049: US-009507513-2207USA007041: US-009507513-2207USA007043: US-009507513-2207USA007052:
Age: 46.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Merck representative reporting an AE. Caller stated the customer indicated GARDASIL 9 was given to a 46 year old. Caller had no further information. Customer was not on call. No additional AE. No PQC.; No additional AE; This spontaneous report was received from a consumer via company representative and refers to a 46-year-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date, at the age of 46, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). There was no additional adverse event reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional information provided.; GARDASIL 9 has been administered to the patient after the excursion oc; This spontaneous report was received from a nurse prescriber and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 06-APR-2022, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot #T036444, expiration date: 09-APR-2023 (vaccination schedule, site and route of administration were not provided) for prophylaxis (product storage error). A temperature excursion evaluation was not performed at the time of reporting. The complete cumulative time and temperature details are unknown until the reporter returns the multiple excursion form that was submitted to her. No additional information provided (no adverse event).  This is one of several reports received from the same reporter.
Age: 1.17
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Decreased appetite, Peripheral swelling, Product storage error, Pyrexia
Clinical narrative: lost of appetite,; fever,; cough; swollen leg on where the patient received KINRIX; one patient received improperly stored PROQUAD; This spontaneous report was received from a physician and refers to a 14-month-old female patient. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 13-JUL-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 1 dose, lot #W010525, expiration date: 25-SEP-2023 (exact dose, vaccination schedule and route of administration were not provided) administered on a leg (unspecified) for prophylaxis (product storage error).  On the same day, the patient was vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) (formulation, dose, lot #, expiry date, and route of administration were not provided) administered on the opposite leg for prophylaxis.  On 13-JUL-2022, the patient experienced loss of appetite, fever, cough, and developed swollen leg on where the patient received diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX).  At the time of reporting, the outcome of the events: loss of appetite, fever, cough, and swollen leg was unknown.   The causal relationship between the events loss of appetite, fever, cough, swollen leg, and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; PEDVAXHIB has been administered to the patient after the excursion occ; This spontaneous report was received from a nurse prescriber and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 ml, lot #U024090, expiration date: 28-OCT-2023 (vaccination schedule, anatomical location and route of administration were not provided) for prophylaxis (product storage error). Temperature excursion evaluation was not performed at the time of the call. The complete cumulative time and temperature details are unknown until the customer returns the multiple excursion form that was submitted to her. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007323: US-009507513-2207USA007365: US-009507513-2207USA007382: US-009507513-2207USA007383: US-009507513-2207USA007612: US-009507513-2207USA007630: US-009507513-2207USA007632:
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: The patient did not report any adverse event so far; they accidentally gave a dose of MMR instramusculary as opposed to subcutaneously; This spontaneous report was received from a pharmacist referring to a 40-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 21-JUL-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, at a dose of 0.5 milliliters (ml) (lot #U006488 with an expiration date on 26-FEB-2023), administered intramuscularly for prophylaxis (strength was not provided).  On 21-JUL-2022, approximately 30 minutes prior to the reporting time, accidentally was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) intramuscularly as opposed to subcutaneously (incorrect route of product administration). The injection was given in the patient's right arm. The patient did not report any adverse events so far.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs or PQC reported.; Caller reported MMR II was administered IM instead of SQ.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a registered nurse and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 21-JUL-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 0.5 milliliter (also reported as mg), lot #U013035, expiration date: 23-APR-2023 (vaccination schedule was not provided) intramuscularly instead of subcutaneously, for prophylaxis (Incorrect route of product administration). No other information was provided, no additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient had no adverse effects or other symptoms as a result of administration.; vaccine was administered following multiple temperature excursions.; This spontaneous report has been received from a office manager referring a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, and previous drug allergies or reactions were not provided.Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On 13-JUL-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5ml once, lot number W006583, expiration date: 23-AUG-2023 (route of administration was not provided)as prophylaxis following a temperature excursion for total time of 96 minutes. Excursions occurred between 11-MAY-2022 and 28-JUN-2022, no excursions prior to 11-MAY-2022, on 06-JUN-2022 a temperature of 5.9  Fahrenheit degrees (F) for 6 minutes, on 11-MAY-2022 a temperature of 5.7 F for 7 minutes, on 27-MAY-2022 a temperature of 5.7 F for 5 minutes, on 27-MAY-2022 a temperature of 5.9  F for 6 minutes, on 09-JUN-2022 a temperature of 5.4  F for 4 minutes, on 14-JUN-2022  a temperature of 5.7  F for 7 minutes, on 17-JUN-2022 a temperature of 29.1 F for 39 minutes, on 20-JUN-2022  a temperature of 7.2 F for 10 minutes, on 22-JUN-2022 a temperature of 8.4 F for 3 minutes, and on 28-JUN-2022 a temperature of 5.2 F for 15 minutes. Patient has no adverse effect or other symptoms as a result of the vaccine administration (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2207USA007832:Case Number 02211246 US-009507513-2207USA007847:Case Number 02211343 US-009507513-2207USA007826:Case Number 02211351 US-009507513-2207USA007928:Case Number 02211355
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, COVID-19, Electric shock sensation, Headache, Herpes zoster
Clinical narrative: I had the vaccine and got Shingles/Suspected vaccination failure; I had the vaccine and got Shingles; COVID; worst pain; pain in my back is still there; headache; nausea; electrical shock type feelings; This case was reported by a consumer via interactive digital media and described the occurrence of 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, covid-19, pain, back pain, headache, nausea and electric shock sensation. On an unknown date, the outcome of the vaccination failure, shingles, covid-19, pain, headache and nausea were unknown and the outcome of the back pain and electric shock sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, covid-19, pain, back pain, headache, nausea and electric shock sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had the Shingles vaccine before Covid and he/she still got Shingles.  The patient said it was the worst pain, headache and nausea ever felt. The shingles were dried up but the pain in his/her back was still there and still had electrical shock type feelings throughout his/her body daily. Additional Supportive Information: This case was considered as suspected vaccination failure as the details regarding completion of primary vaccination, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Pain, Vaccination failure
Clinical narrative: I had the vaccine and got Shingles/Suspected vaccination failure; I had the vaccine and got Shingles; COVID; worst pain; pain in my back is still there; headache; nausea; electrical shock type feelings; This case was reported by a consumer via interactive digital media and described the occurrence of 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, covid-19, pain, back pain, headache, nausea and electric shock sensation. On an unknown date, the outcome of the vaccination failure, shingles, covid-19, pain, headache and nausea were unknown and the outcome of the back pain and electric shock sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, covid-19, pain, back pain, headache, nausea and electric shock sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had the Shingles vaccine before Covid and he/she still got Shingles.  The patient said it was the worst pain, headache and nausea ever felt. The shingles were dried up but the pain in his/her back was still there and still had electrical shock type feelings throughout his/her body daily. Additional Supportive Information: This case was considered as suspected vaccination failure as the details regarding completion of primary vaccination, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: DTP
Symptoms: Abnormal behaviour, Brain injury, Injury, Pertussis, Seizure
Clinical narrative: Intractable seizures; Brain damage; Pertussis; Profoundly injured; functions like 2 to 3 years old; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a 47-year-old female patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced seizure (serious criteria GSK medically significant), brain damage (serious criteria GSK medically significant), pertussis (serious criteria GSK medically significant), injury and behavior abnormal. On an unknown date, the outcome of the seizure, brain damage, pertussis, injury and behavior abnormal were unknown.   It was unknown if the reporter considered the seizure, brain damage, pertussis and behavior abnormal to be related to DTP vaccine. The reporter considered the injury to be related to DTP vaccine.     Additional Information: GSK Receipt Date: 19-Jul-2022. Reporter's Comments: This case was reported by a patient's parent via interactive digital media. The patient was profoundly injured from first dose of DPT vaccine.  The pertussis caused brain damage and intractable seizures. The patient functions like 2 to 3 years old. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inflammation, Inflammatory bowel disease, Vaccination failure
Clinical narrative: Suspected vaccination failure; young male with IBD; experienced a mild case of Herpes Zoster; signs of inflammation; This case was reported by a physician via other manufacturer and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ibd (serious criteria GSK medically significant), herpes zoster and inflammation. The patient was treated with ustekinumab (Stelara) and tofacitinib citrate (Xeljanz). On an unknown date, the outcome of the vaccination failure, ibd, herpes zoster and inflammation were unknown.   It was unknown if the reporter considered the vaccination failure, ibd, herpes zoster and inflammation to be related to Shingrix and Shingrix.  Additional Information: GSK Receipt Date: 20-Jul-2022. Reporter's Comments: The physician reported that young male with IBD (inflammatory bowel disease) was being treated with Stelara was uncontrolled due to inflammation and stricture was added on tofacitinib 10 mg bid.  The patient had history of 2 doses of Shingrix prior to starting on IBD treatments. The patient went into REM with dual Stelara and Tofacitinib combo and then discontinued Stelara when REM was attained. The patient experienced a mild case of Herpes Zoster while on tofacitinib 10 mg bid. The patients tofacitinib dose was then reduced to 10 mg daily. The patient was now showing signs of inflammation again so the plan to increase tofacitinib dose to 10 mg bid again. The events took place after use of product. The reporter did not wish to be contacted for follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming Herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine, have shingles/Suspected vaccination failure; now I have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In July 2022, more than 2 years 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 not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine 2 years ago and now have had shingles at the moment. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Facial pain, Headache, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/had both shots for shingles, and getting over them; getting over them; so painful (top of my head, right side and forehead, side of my face, down to eyebrow); so painful (top of my head, right side and forehead, side of my face, down to eyebrow); This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles, headache and facial pain. On an unknown date, the outcome of the vaccination failure, shingles, headache and facial pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, headache and facial pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 19-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both shots for shingles, and getting over them , going on six weeks.  The patient stated that so painful (top of his/her head, right side and forehead- side of his/her face, down to eyebrow). The patient stated that no joking, would not wish them on his/her worst enemy, that bad. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Gaze palsy
Clinical narrative: side eyes lasted for 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of gaze palsy 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 gaze palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the gaze palsy was recovered/resolved.   It was unknown if the reporter considered the gaze palsy to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter stated that his/her side eyes lasted for 4 days. The reporter mentioned, it was horrible and he/she afraid to get the second dose. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure/got shingles on my head; Shingles on head; PHN bad; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 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 and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix.     Additional Information: GSK receipt date: 21-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported that he/she need to speak to the physician about his/her experience with Shingrix. The patient got the shingles on his/her head and have had post herpetic neuralgia bad. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As post herpetic neuralgia is a sign and symptom of shingles, conservatively outcome was captured as not recovered for both the events.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shingles shots/suspected vaccination failure; Shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of 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, 3 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both the shots and 3 years later the patient got the shingles twice. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shingles shot/Suspected vaccination failure; Got Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly 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 Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter knew that the patient in his 70s had the shingles shot and got the shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/got vaccinated for shingles, still got them; Still got them shingles/still have them/going on 5 months; This case was reported by a consumer via interactive digital media and described the occurrence of 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 not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got vaccinated for shingles and still got them and still have them and going on 5 months. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/had both shots, had shingles 2 times since; have had shingles 2 times since; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles at 49 years of age).   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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got shingles at 49 years of age and when he/she turned 50, the patient had to get on a waitlist for vaccination.  Successfully the patient had both shots in required amount of time, but have had shingles 2 times since. The patient would say they were not as severe of cases, but no fun. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Age group was captured as per reported information.
Sex: F
Vaccine: HPVX
Symptoms: Paralysis
Clinical narrative: a young lady that got it [HPV vaccines] and it paralyzed her for 5 months; This case was reported in a literature article and described the occurrence of paralysis in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.  On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced paralysis (serious criteria GSK medically significant and other: serious as per reporter). On an unknown date, the outcome of the paralysis was recovered/resolved.   The reporter considered the paralysis to be related to HPV vaccine.   Additional Information: GSK Receipt Date: 19 Jul 2022 Author Comment: This case refers for a female patient from table no 4 theme 3 as described in the article. The author aimed to identify human papillomavirus (HPV) and HPV vaccine-related knowledge, attitudes, and beliefs among women aged 27-45 years, who became eligible for HPV vaccination in 2018. This study was in the region. The author conducted eight semi-structured text-based synchronous focus groups using an virtual chatroom. Focus group questions covered three areas: 1) knowledge and beliefs about HPV and HPV vaccination, 2) attitudes toward HPV vaccination for oneself, and 3) barriers and facilitators to HPV vaccine uptake. Concerns about HPV vaccine-related side effects were common and identified among participants across all racial/ethnic groups and education levels. The reporter stated that the patient got human papillomavirus vaccine. The reporter had a concern about HPV vaccine side effect and safety vaccination had a serious side effect. The reporter stated that the patient had paralysis for 5 months. "Unanswered questions, low awareness about eligibility, lack of knowledge about the benefits of vaccination after sexual debut, concerns and mistaken beliefs about side effects and safety, and perceived social stigma may serve as key barriers to shared clinical decision-making about HPV vaccination for women ages 27-45 years. Promising intervention strategies for addressing these KAB-related barriers include 1) disseminating basic information about HPV vaccine eligibility, safety, and efficacy that was specific to women aged 27-45 and 2) framing HPV vaccination as taking control of one's health and preventing illness, even after sexual debut."
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Pain at the injection site; Mild fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and fever. On an unknown date, the outcome of the injection site pain and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2022107252   Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine into left arm and experienced pain at the injection site and a mild fever. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2022107252:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: injection site was red; Injection site was warm; Injection site was swollen; injection site was tender; Debilitating body aches; Debilitating body aches; This case was reported by a consumer via sales rep and described the occurrence of injection site erythema in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In July 2022, unknown after receiving Shingrix, the patient experienced general body pain and debility. On an unknown date, the patient experienced injection site erythema, injection site warmth, injection site swelling and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling, injection site tenderness, general body pain and debility were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling, injection site tenderness, general body pain and debility to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-JUL-2022 and 18-JUL-2022 Reporter's Comment: The case was reported by the patient. The patient had debilitating body aches last night/this morning to where went into the hospital over concerns of the reaction. The reporter agreed to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: injection site was red; Injection site was warm; Injection site was swollen; injection site was tender; Debilitating body aches; Debilitating body aches; This case was reported by a consumer via sales rep and described the occurrence of injection site erythema in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In July 2022, unknown after receiving Shingrix, the patient experienced general body pain and debility. On an unknown date, the patient experienced injection site erythema, injection site warmth, injection site swelling and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling, injection site tenderness, general body pain and debility were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling, injection site tenderness, general body pain and debility to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-JUL-2022 and 18-JUL-2022 Reporter's Comment: The case was reported by the patient. The patient had debilitating body aches last night/this morning to where went into the hospital over concerns of the reaction. The reporter agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: big itchy rash; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash 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 itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got 1 shot and had a big itchy rash reaction from the shot. The nurse said it was normal. The patient heard there was a 2 shot series and asked if he/she would need to get another one and when. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Neck pain, Sensory disturbance
Clinical narrative: if something is on the nerves; so much pain after having a shingle shot/neck is where the pain is; so much pain after having a shingle shot/shoulder is where the pain is; This case was reported by a consumer via interactive digital media and described the occurrence of abnormal sensation of limbs 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 abnormal sensation of limbs, neck pain and shoulder pain. On an unknown date, the outcome of the abnormal sensation of limbs, neck pain and shoulder pain were unknown.   It was unknown if the reporter considered the abnormal sensation of limbs, neck pain and shoulder pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-JUL-2022 Reporter's comments; This case was reported by a patient via interactive digital media. The patient never get any answer for their question. They had been in much pain after having the single shot of vaccine The patient never had this kind of pain even though they had trouble with their left hand where there was no pain at all and all of the pain was in shoulder and neck pain as if something was on their nerve. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: muscle pain; some fever; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain and fever. On an unknown date, the outcome of the muscle pain and fever were recovered/resolved.   It was unknown if the reporter considered the muscle pain and fever to be related to Shingrix.     Additional Information: GSK receipt date: 18-Jul-2022 Reporter's comment: The case was reported by the patient via interactive digital media. The reporter reported that the patient received first dose of Shingrix and had very harsh side effects. The patient had 3 days of severe muscle pain and some fever. The patient's pharmacist suggested that patient might not need a second dose. Patient asked was it true. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blood test abnormal, Herpes simplex test positive, Herpes virus infection
Clinical narrative: herpes/hepers 2; This case was reported by a consumer via interactive digital media and described the occurrence of herpes virus infection 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 herpes virus infection. On an unknown date, the outcome of the herpes virus infection was unknown.   It was unknown if the reporter considered the herpes virus infection to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comment: This case was reported by the patient. Patient stated had the Shingle Vaccine, since then had a blood test done and was diagnosed with herpes 2. Patient also asked would this be related to the Shingles shot. Reporter did not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: vaccine #1 June 4, 2018, There was no 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 4th June 2018,the patient received 1st dose of Shingrix and batch number ZY3X4).   On an unknown date, the patient did not receive 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: GSK Receipt Date: 20-JUL-2022 Reporter's Comment: The case was reported by the patient.  The second vaccine was not administered.  The reporter wanted to know was the first still valid or should it be repeated. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: mild case breaking out; 1st dose over a year ago, never got 2nd; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix and received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and between 1 and 2 years after receiving Shingrix, 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 Shingrix.     Additional Information: GSK Receipt Date: 19-July-2022 Reporters comment: The patient had 1st dose of Shingrix over a year ago and never got the 2nd dose yet but the patient thinks that he or she might had a mild case breaking out. The patient asked if he or she could get second dose now. The reporter did not consent to followup. Additional Supportive Information: Till the time of reporting the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: fridge warmed up, curious if Shingrix is still good; This case was reported by a consumer via interactive digital media and described the occurrence of incorrect storage of drug 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 incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 18-Jul-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter stated that the power went out and the fridge warmed up and he/she was curious if Shingrix was still good or needed to be disposed of. Additional Supportive Information: The reporter stated that the power went out and the fridge warmed up and he/she was curious if Shingrix was still good or needed to be disposed of, which led to incorrect storage of drug. The follow-up would not be possible as no contact details were available.