chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; Improperly stored adverse event with GARDASIL 9,; This spontaneous report was received from an office manager  referring to a 13 year old patient (gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-APR-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), dose:0.5 milliliter for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   The administered dose of the vaccine experienced a temperature excursion 35.2 degrees Fahrenheit for 480 hours/ 0 minutes, as recorded by a data logger. It was reported that the vaccines did not have previous temperature excursion. There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: herpes zoster; postherpetic neuralgia; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and the prevention of shingles (herpes zoster).  On an unspecified date, after receiving the vaccine, the patient suffered herpes zoster and postherpetic neuralgia. As a result of these symptoms, Plaintiff was seen and treated by medical providers and was still under their care. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), Plaintiff's symptoms have resulted in physical limitations not present prior to using the product. Plaintiffs also experience mental and emotional distress due to resulting physical limitations and seriousness of Plaintiffs' condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), Plaintiffs sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, Plaintiffs 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 Defendants' conduct, Plaintiffs have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram, Disease progression, Neoplasm, Skin irritation
Clinical narrative: This spontaneous report (conflicting information reported as "being in an unknown Clinical Trial") has been received from a consumer referring to himself, a 35-year-old male patient. The patient's concurrent conditions included drug hypersensitivity to penicillin and cephalosporin. His medical history included asthma, clostridium difficile infection and avian influenza. Concomitant medications included "inhalers" (unspecified) and a "narcolepsy medication" (unspecified). On unspecified date in June 2020 (also reported as "8 months ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, anatomical location, lot number and expiration date were not reported) administered  intramuscularly (IM) for prophylaxis. On that same day, he was also started with other suspect medications: benzylpenicillin (dose, lot number, expiration date and indication were not reported) administered IM. On unknown date, he was also started with other suspect medication: cephalosporin C (dose, route, lot number, expiration date and indication were not reported). On unspecified date in February 2021, the patient stated having "irritation where the tumor was" (skin irritation). He did not provide any additional details in regard to the tumor or where the tumor was located. Also, the patient stated that the irritation could be costochondritis, but stated that had not been diagnosed. The patient stated that there could be a new tumor, or the current tumor could be worsening (disease progression). The patient did not seek for medical attention. On unknown date, the patient also reported experiencing hives (an allergic reaction) (urticaria and hypersensitivity) with other suspect medications included benzylpenicillin and cephalosporin c. Moreover, on unknown date, a computerized tomography (CT) scans were completed with no results reported.  At the reporting time, he had not recovered from all the event. Additionally, the patient stated having tried reaching out to the study site, to report this adverse event, multiple times, but never received a response. The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was reported as not applicable (conflicting information also reported as therapy discontinued no); and regarding benzylpenicillin and cephalosporin c was not reported. The causal relationship between all the other events, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and other suspect medications: benzylpenicillin and cephalosporin c were not reported. Upon internal review, disease progression was considered a medically significant event.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Granuloma annulare, Sjogren's syndrome, Systemic lupus erythematosus
Clinical narrative: Lupus; Sjogren's syndrome; granuloma annulare; Infornation was received from a lawyer regarding a case in litigation and refers to a n erderly patient of unknown age and gender. On or about 01-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiry date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: granuloma annulare, Sjorgen's syndrome and lupus. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the events of Sjorgen's syndrome and lupus were considered to be medically significant.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details are available; patient received a dose of MMR II on 5/11/2021 that had expired on 5/9/2021; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. No information regarding the patient's concomitant medications, medical history, drug reactions or allergies was provided.  On 11-MAY-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA), 0.5 mL, lot # S014431, expiration date 09-MAY-2021 (route of administration was not provided) for prophylaxis. The reporter denied the product had had any temperature excursions. No adverse event was reported.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Neuropathy peripheral, Pain
Clinical narrative: blisters came and went / middle of the of back with blisters then blisters jumped to my front and big painful; jabbing, burning pain / blisters jumped to my front and big painful/am in a world of pain/left purple marks that are sore to touch; burning pain / woke up on fire ?? just the area that was affected by the Shingles; Prescription meds only made my hands, legs and feet swell painfully; Neuropathy; Got the shingles shot years ago / Got shingles 9 weeks ago; Suspected vaccination failure; This case was reported by a consumer via interactive digital media(Facebook) and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included COVID 19 VACCINE MODERNA for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID 19 VACCINE MODERNA. In April 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced neuropathy (serious criteria GSK medically significant), blister, pain, burning sensation and peripheral swelling. The patient was treated with non-drug therapy (Ice Pack (No Medication)), gabapentin and pregabalin (Lyrica). On an unknown date, the outcome of the vaccination failure, shingles, blister, pain, burning sensation and peripheral swelling were unknown and the outcome of the neuropathy was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles, blister, pain, burning sensation and peripheral swelling to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix year ago and got shingles 9 weeks ago, blisters came and went but jabbing, burning, pain still here. The prescription medicine only made hands, leg and feet swell painfully. The patient broke out on the middle of the of back with blisters then blisters jumped to front and big painful ones.  The blind had dried up and gone but left purple marks that are sore to touch 3-4 days after Moderna vaccination was this a coincidence. Neuropathy seem to be subsiding, then it was time for 2nd Moderna vaccine.  The doctor said it would be fine.  Got vaccine and next day the patient woke up on fire just the area that was affected by the Shingles.  The patient was using ice pack and taking 5-6 mg of gabapentin and that day do anything. At the time of reporting on 100 mg Lyrica 3 times a day, nothing, but does make a little dizzy. It was unknown if the reporter considered the vaccination failure, neuropathy, shingles, blister, pain, burning sensation and peripheral swelling to be related to COVID 19 VACCINE MODERNA.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Peripheral swelling, Vaccination failure
Clinical narrative: blisters came and went / middle of the of back with blisters then blisters jumped to my front and big painful; jabbing, burning pain / blisters jumped to my front and big painful/am in a world of pain/left purple marks that are sore to touch; burning pain / woke up on fire ?? just the area that was affected by the Shingles; Prescription meds only made my hands, legs and feet swell painfully; Neuropathy; Got the shingles shot years ago / Got shingles 9 weeks ago; Suspected vaccination failure; This case was reported by a consumer via interactive digital media(Facebook) and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included COVID 19 VACCINE MODERNA for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID 19 VACCINE MODERNA. In April 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced neuropathy (serious criteria GSK medically significant), blister, pain, burning sensation and peripheral swelling. The patient was treated with non-drug therapy (Ice Pack (No Medication)), gabapentin and pregabalin (Lyrica). On an unknown date, the outcome of the vaccination failure, shingles, blister, pain, burning sensation and peripheral swelling were unknown and the outcome of the neuropathy was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, neuropathy, shingles, blister, pain, burning sensation and peripheral swelling to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix year ago and got shingles 9 weeks ago, blisters came and went but jabbing, burning, pain still here. The prescription medicine only made hands, leg and feet swell painfully. The patient broke out on the middle of the of back with blisters then blisters jumped to front and big painful ones.  The blind had dried up and gone but left purple marks that are sore to touch 3-4 days after Moderna vaccination was this a coincidence. Neuropathy seem to be subsiding, then it was time for 2nd Moderna vaccine.  The doctor said it would be fine.  Got vaccine and next day the patient woke up on fire just the area that was affected by the Shingles.  The patient was using ice pack and taking 5-6 mg of gabapentin and that day do anything. At the time of reporting on 100 mg Lyrica 3 times a day, nothing, but does make a little dizzy. It was unknown if the reporter considered the vaccination failure, neuropathy, shingles, blister, pain, burning sensation and peripheral swelling to be related to COVID 19 VACCINE MODERNA.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: The second one did give me the "flu" like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date.).   On 10th May 2021, the patient received the 2nd dose of Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. Patient thanked to all of them for the stories they told about shingles and courage to take the vaccine.   Patient received  Shingrix and experienced the flu like symptoms. The reporter knew a few who had shingles at their eye and went blind.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Accidental overdose, No adverse event
Clinical narrative: received his Pediarix vaccine and was prescribed a HIB vaccine / was instead administered a Pentacel vaccine; This case was reported by a other health professional via other manufacturer and described the occurrence of accidental overdose in a 6-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL (batch number S006471, expiry date unknown) for prophylaxis.   On 9th April 2021, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and PENTACEL (intramuscular) .5 ml. On 9th April 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received Pediarix vaccine and was prescribed the HIB vaccine as well, but was instead administered with Pentacel vaccine, with no reported adverse event, which led to accidental overdose of diphtheria and tetanus toxoid component.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: varicellaform rash; This case was reported by a physician via other manufacturer and described the occurrence of varicella-like rash in a adult 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 varicella-like rash. On an unknown date, the outcome of the varicella-like rash was unknown.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix vaccine and developed varicella form rash. No other information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: mild case of shingles because she had been vaccinated/ Suspected vaccination failure; Shingles; Rash; This case was reported by a pharmacist via sales rep and described the occurrence of suspected vaccination failure in a elderly female 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 rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was greater than 65 years of age, exact age was not known at time of report. The patient had shingles and when asked whether she had been vaccinated for shingles, patient reported yes but it was unclear if she had received Shingrix or Zostavax. The patient was experiencing rash mild symptoms. On 7th May 2021 (Friday), the patient presented for antiviral prescription at the pharmacy and had received an antiviral prescription that day. The reporter noted that efficacy of 100 percent would not be expected and perhaps the patient was experiencing a more mild case of shingles because she was vaccinated. The reporter consented to provide additional details at GSK safety follow up. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Shots are mildly painful in arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter had reported for himself/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. The patient stated that, the shingles shot was mildly painful in arm for four days but better than shingles. No other information was provided. This case is linked with US2021AMR104410, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103693:2nd dose US-GLAXOSMITHKLINE-US2021AMR104410:same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have friend had shots and he got them/Suspected vaccination failure; I have friend had shots and he got them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male 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 provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient had shots and he got shingles, he said 10 percent could get them even had the shot. 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. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR103703:same reporter
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 10May2021 to get a second dose, already late/ could not administer the dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The  reporter stated that, till the time of reporting, patient did not received 2nd dose of Engerix B, which led to incomplete course of vaccination. The reporter mentioned that, patient came back on 10th May2021 to get a second dose, but was already late, and also no adequate dose for a 19 year old patient was on stock and could not administer the dose and told patient to come back at a latter date when stock was replenished. The reporter consent to follow up. This case has been linked with case US2021103281, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Had soreness in injection site / slight soreness in the injection site; Headache for a couple of days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult 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 and headache. On an unknown date, the outcome of the injection site pain and headache were recovered/resolved.   It was unknown if the reporter considered the injection site pain and headache to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient for himself/herself. Age at vaccination was not reported. The age grp was selected as an adult as per vaccine indication. The patient had soreness in injection site for a couple of days and a headache that might or might not be as result of reaction. No rash occurred. The reporter reported that would not stop him/her from getting second shot. The patient was awaiting to get the second shot.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: I got both of the shots and still get shingles / had my last shot over a year ago already/suspected vaccination failure; I got both of the shots and still get shingles / had my last shot over a year ago already/ot long ago I had a patch on back of leg; from knee to ankle and it hurt; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and leg pain. On an unknown date, the outcome of the vaccination failure, shingles and leg pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and leg pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient stated that could not get them anymore it was not a miracle thing it might make so not as bad but trust the patient not long before the date of reporing the patient had a patch on back of leg from knee to ankle and it hurt like hell. The patient's physician informed that could still get shingles and had last shot over a year before the date of reporing already, shortly after it came out, so had it in plenty of time for the medicine to work, but they do not inform anyone about it. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suffered 3 times with Shingles even though had the shots./suspected vaccination failure; suffered 3 times with Shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a 80-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient suffered 3 times with Shingles even though had the shots and hoped to be immune at 80. 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. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Pain, Skin discolouration
Clinical narrative: Very painful; skin with ugly spots and blisters; skin with ugly spots and blisters; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid-19 vaccine (had the covid-19 vaccine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, blister and skin discoloration. On an unknown date, the outcome of the pain, blister and skin discoloration were unknown.   It was unknown if the reporter considered the pain, blister and skin discoloration to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient just received his/her preventative Shingles vaccine and stated that it was very painful and leaves your skin with ugly spots and blisters. The patient reported that it was made him/her feel like he/she had had the COVID-19 vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: have not received the second shot because of the pandemic; This case was reported by a consumer via call center representative and described the occurrence of social problem in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The age group was not reported but was captured as an adult as per vaccine indication. Till the time of reporting, patient did not received 2nd dos of Shingrix, due to pandemic. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Itching scar, Pruritus
Clinical narrative: My shingles scar / still itch intermittently years later; area around it still itch intermittently years later; This case was reported by a consumer via interactive digital media and described the occurrence of itching scar in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced itching scar and pruritus. On an unknown date, the outcome of the itching scar and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the itching scar and pruritus 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 age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingles vaccine and the shingles scar and area around it was still itch intermittently years later.  The patient got shingles vaccine as the Doctor told that he/she could get another case of shingles.  The patient had a reaction to the vaccine, but it was far easier to tolerate than the shingles. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows:  This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient got vaccinated with Shingles vaccine 3 years ago and experienced sore. After the 2nd dose the patient was ok, hardly any side effects. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104223:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Several years ago I got the shingles shot in October / got Inner shingles/ Suspected vaccination failure; got Inner shingles; Pain you can't scratch; Pain you can't scratch; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, between 2 and 4 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, pain and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. Several years before the reporting date, the patient got the shingles shot in October and got inner shingles in January.  The patient had never heard of inner shingles but patient's M.D. (Doctor of medicine) and a specialist confirmed.  The patient had pain that could not be scratched.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot and still got shingles, 11 months to the day/Suspected vaccination failure; I had the shot and still got shingles, 11 months to the day; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in an adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient had the shingle shot and still got the shingles, 11 months to the day and believe me it was not fun said by the patient. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot last year now I have the shingles/Suspected vaccination failure; I got the shot last year now I have the shingles; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less 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 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 case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got shot a year from reporting day and at the time of reporting patient had Shingles. Till the age of 58 years old, the patient did not had Shingles. The reporter stated that it said that it was preventable. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: an expired dose of Engerix B was given to a patient / The dose given expired on 4/13/2021; This case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number CP275, expiry date 13th April 2021) for prophylaxis.   On 13th May 2021, the patient received Engerix B .5 ml. On 13th May 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The reporter indicated that an expired dose of Engerix B was given to a patient, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and it gave him the shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's parent. The age at vaccination was not reported. The patient got the Shingles shot and it gave him the shingles. 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. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingle shot and still got the shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: Age group was captured as adult as per vaccine indication. The age at vaccination was not reported. The reporter knew someone who got the shingle shot and still got the shingles, what's up with that. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratoy test confirming shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. 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 were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain in extremity
Clinical narrative: Spent several days in bed sick afterwards; Arm hurt like hell for a week; This case was reported by a consumer via social media interactive digital media and described the occurrence of pain in arm in a adult 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 pain in arm and sickness. On an unknown date, the outcome of the pain in arm and sickness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received 1st dose of Shingrix and arm hurt really bad and spent several days in bed sick afterwards. The patient stated that it was better than getting shingles. The follow up would not possible as no contact details were available. For 2nd dose, refer case US2021AMR104402, reported for the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104402:2nd dose,same reporter,same AE
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm was sore for 3 days but worth it.; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient demographics were not reported,age group captured as adult as per vaccine indication. The age at vaccination was not reported. The patient received Shingles vaccine and experienced pain in arm for 3 days. The case is linked with Mother's case (US2021AMR104391).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104391:same reporter (mother´s case)
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose  / on February 1st 2020 / the second dose on May 13th 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st february 2020).   On 13th May 2021, the patient received the 2nd dose of Shingrix. On 13th May 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 patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. Batch number and expiry date was not reported. The follow-up was declined.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follow: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but captured as an adult as per vaccine indication. The patient had sore arm post vaccination. The patient stated that the sore arm was way better than shingles. For tolerance of 2nd dose refer case US2021AMR104421.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104421:Same patient, 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Get a shingles vaccine / Less than two weeks later, she had the worst case of them; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's best friend. The age at vaccination was not reported. The patient was convinced to get a shingles vaccine by her physician and was vaccinated. Less than two weeks post vaccination, the patient had the worst case of Shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Arm very sore and tender; This case was reported by a consumer and described the occurrence of pain in arm in a adult 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follow: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but captured as an adult as per vaccine indication. The patient had very sore and tender arm and stated that at least he/she won't get shingles. For tolerance of 2nd dose refer case US2021AMR104396.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR104396:Same patient, 2nd dose