chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot had shingles/Suspected Vaccination Failure; shingles 2 times; 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 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: 28-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the Shingles shot and had shingles 2 times. The patient stated get the shot it would help. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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: I glad I got the shot had a mild case/ Suspected Vaccination Failure; had a mild case; 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 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: 28-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient reported that if it was a mild, the patient glad to had the shot. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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: got the shot then a year later had Shingles anyways /Suspected vaccination failure; had Shingles, agony with 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. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot then a year later had Shingles anyways /Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had Shingles, agony with Shingles). 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: 28-FEB-2023 Reporter's comments: This case was reported by the patient's relative via interactive digital media.  The reporter stated that the Shingles belong on a roof.  The reporter stated that the patient got the shot then a year later had a massive Shingles attack. They had wasted a thousand dollars. Like Covid vaccine, no promise that it would work.  Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 6 months later got shingles/ suspected vaccination failure; 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. On an unknown date, 6 months 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: 28-FEB-2023 Reporter's comments: This case was reported by the patient via interactive digital media.  The reporter stated that he/she had got the shot and 6 months later also got shingles, so go figure it out. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had vaccine still got shingles/ Suspected vaccination failure; had vaccine still got 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. 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: 28-FEB-2023 Reporter's comments: This case was reported by the patient via interactive digital media.  The reporter stated that, he/she had the vaccine and still got the shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shots, still got it/suspected vaccination failure; Still got it; 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 PREDNISONE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and PREDNISONE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated anything, he/she had the shots and still got them which lasted 5 to weeks, even with the antiviral and prednisone. Additional supportive information: It was unknown if the reporter considered the shingles to be related to antiviral and prednisone. 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. As per narrative it seems that after receiving the antiviral and prednisone, the patient got the shingles, therefore, prednisone was coded as suspect and antiviral was not coded because it was reflecting group.
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Monoplegia, Pain, Pyrexia
Clinical narrative: Vx is so painful, liquid seems to stay; Not able to sleep because of pain; Got arm  Paralyzed; fever; This case was reported by a consumer via interactive digital media and described the occurrence of arm paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got them two weeks ago prior to first dose).   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 arm paralysis (serious criteria GSK medically significant), pain, fever and difficulty sleeping. On an unknown date, the outcome of the arm paralysis and fever were recovered/resolved and the outcome of the pain and difficulty sleeping were unknown.   It was unknown if the reporter considered the arm paralysis, pain, fever and difficulty sleeping to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the first dose of Shingles vaccine and got the arm paralyzed for three days and got two days of fever.  When the liquid was coming in seems that it was staying there, the vaccine was so painful that you could not sleep because of the pain. The patient will get the second dose on 17th March 2023. No contact details available.  Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had vaccine and still got shingles / suspected vaccination failure; still got shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had vaccine and still got shingles / suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was not reported if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 01-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that the shingles was not as severe as if the patient had not gotten the Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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; I had shingles; This serious 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had shingles). The outcome of the vaccination failure and shingles were not reported.   It was not reported if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date:28-FEB-2023 The case  was received from the patient via interactive digital media. The patient had the Shingles vaccine and years later he/she had shingles. The patient believed it was as mild as it was because he/she had had the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; she had never had shingles, she got them after the shot; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: she had never had shingles, she got them after the shot). The outcome of the vaccination failure and shingles were not reported.   It was not reported if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 28-FEB-2023 The case  was received from the patient's friend via interactive digital media. The reporter had shingles three times and the last one was in his/her eye and it was horrible pain. The patient got the Shingles shot and she never had shingles. The patient got shingles after the shot. The reporter stated that he/she would never get the shot after her friend's experience. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Post herpetic neuralgia, Vaccination failure
Clinical narrative: suspected vaccination failure; get the after pain every so often take  a nerve endings for a few days; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 (had 4 times). Previously administered products included Shingles vaccine (received 1st shot on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), post herpetic neuralgia (Verbatim: get the after pain every so often take  a nerve endings for a few days) and pain (Verbatim: pain). The outcome of the vaccination failure, post herpetic neuralgia and pain were not reported.   It was not reported if the reporter considered the vaccination failure, post herpetic neuralgia and pain to be related to Shingles vaccine and Shingles vaccine.     It was not reported if the company considered the vaccination failure, post herpetic neuralgia and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 28-FEB-2023 The case  was received from the patient's wife via interactive digital media. The patient had 2 Shingles shot and had to pay for them.. The reporter stated that they were kind of costly for each one. The patient still got the after pain every so often took a nerve endings for pain for a few days. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case is linked with US2021AMR111381, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR111381:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got shingles / suspect vaccination failure; Shingles; painful; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles/ suspect vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: painful). The outcome of the vaccination failure, shingles and pain were not reported.   It was not reported if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 This case was reported by a patient via interactive digital media. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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: Erythema, Incomplete course of vaccination, Skin reaction
Clinical narrative: didn't go back for the 2nd shot.; topical reaction and arm was red; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse reaction (received 1st dose on unknown date as had a reaction).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: topical reaction and arm was red) and incomplete course of vaccination (Verbatim: didn't go back for the 2nd shot.). The outcome of the erythema was recovered/resolved (duration 1 week) and the outcome of the incomplete course of vaccination was unknown.   It was not reported if the reporter considered the erythema to be related to Shingrix.     It was not reported if the company considered the erythema to be related to Shingrix.   Additional Information: 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 the first shot and had a reaction to it and did not go back for the 2nd shot, which led to incomplete course of vaccination. The patient insurance covered it and had the original shot once was eligible to get it.  The patient mother had shingles so bad she could not put any clothing on back.  So the patient wanted the vaccine and couple of years ago they came out with a new shingle vaccine that was 2 part and 2 shots at different intervals.  Upon internal review the case was updated on 27-Feb-2023 The patient had a reaction from the first shot.  The patient did not go back for the second one.  The patient had the original shot years earlier. It was so long ago at the time of reporting that his/her mother had them. 40 to 45 plus years before, that he/she did not recall what the treatment was.  But when they came out with the for it.  The patient did not have any reaction to that one.  When they came out with the Shingrix vaccine he/she was told he/she should that even though he/she had had the original shot.  The patient got it and had a topical reaction.  The patient did not go back for the second one.  The patient got a pneumonia shot in November and he/she had the same topical reaction. The patient's upper arm was bright red for well over a week. Summary of Changes: New event was added. Narrative updated.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disturbance in attention, Headache, Nausea, Pyrexia
Clinical narrative: Nausea; Fever; Chills; Headache; hard time concentrating due side effects; This non-serious case was reported by a consumer via patient support programs and described the occurrence of nausea in a 55-year-old female patient who received Herpes zoster (Shingrix) for vaccination.   On 28-FEB-2023, the patient received Shingrix. On 01-MAR-2023, 1 days after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), fever (Verbatim: Fever), chills (Verbatim: Chills) and headache (Verbatim: Headache). In MAR-2023, the patient experienced attention concentration difficulty (Verbatim: hard time concentrating due side effects). The outcome of the nausea, fever, chills and headache were not recovered/not resolved and the outcome of the attention concentration difficulty was not reported.   It was not reported if the reporter considered the nausea, fever, chills, headache and attention concentration difficulty to be related to Shingrix.     It was not reported if the company considered the nausea, fever, chills, headache and attention concentration difficulty to be related to Shingrix.   Additional Information: GSK Receipt date: 01-Mar-2023. This case was reported by a consumer via patient support programs. This report was submitted via the reporting system. Patient stated she was having a hard time concentrating due to the side effects nausea, fever, chills and headache. The reporter denied consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: had shingles three times, had it right now; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: had shingles three times, had it right now). The outcome of the shingles was not recovered/not resolved.   It was not reported if the reporter considered the shingles to be related to Shingles vaccine.     It was not reported if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 This case was reported by a patient via interactive digital media. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEPAB
Symptoms: Accidental underdose, Product complaint, Product quality issue, Syringe issue, Underdose
Clinical narrative: Syringe leaked during administration/The patient was affected/Related AE - underdose; Syringe leaked during administration; Syringe leaked during administration; This non-serious case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received HAB (Twinrix adult) (batch number h3sg9, expiry date 03-JAN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced accidental underdose (Verbatim: Syringe leaked during administration/The patient was affected/Related AE - underdose), syringe leak (Verbatim: Syringe leaked during administration) and pharmaceutical product complaint (Verbatim: Syringe leaked during administration). The outcome of the accidental underdose, syringe leak and pharmaceutical product complaint were not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-MAR-2023 The GlaxoSmithKline (GSK) representative called to report PQC (product quality complaint) with Twinrix syringes on behalf of healthcare professional (HCP).  The syringes leaked while administering to patient. Three patient was affected (Related adverse event - underdose). The reporter contacted HCP Medical Assistant (MA) for more information regarding PQC. The defect was discovered after partial use of the box. The healthcare professional stated that 2 doses administered prior did not have any issues. The reporter confirmed that Luer Lok needles were used. All syringes leaked between the Luer Lok device and the syringe barrel. The syringe was not pre-assembled with needle some time before administration - syringes were assembled immediately before administration.20 gauge 1 in needle was used. The blister and/or carton was not damaged. The Luer lok was not damaged. The needles which were used was not available for return. There was no damage/breakage on the syringe barrel. The HCP did not have suspect product to return - all 3 syringes were disposed of. The GlaxoSmithKline (GSK) had to issue a credit for 3 doses of Twinrix to GSK direct account. The reporter did not have any demographics for the 3 patients. The reporter consented to follow up. This was 1 of 3 cases, reported by the same reporter. The syringes leaked while administering to patient and the patient dose was affected, which had led to syringe leak, accidental underdose and pharmaceutical product complaint.; Sender's Comments:  US-GSK-US2023034605:Same reporter US-GSK-US2023AMR035220:Same reporter
Sex: U
Vaccine: HEPAB
Symptoms: Accidental underdose, Product complaint, Syringe issue, Underdose
Clinical narrative: Syringe leaked during administration; Syringe leaked during administration; Syringe leaked during administration; This non-serious case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received HAB (Twinrix adult) (batch number h3sg9, expiry date 03-JAN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced accidental underdose (Verbatim: Syringe leaked during administration), syringe leak (Verbatim: Syringe leaked during administration) and pharmaceutical product complaint (Verbatim: Syringe leaked during administration). The outcome of the accidental underdose, syringe leak and pharmaceutical product complaint were not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-MAR-2023 The GlaxoSmithKline representative called to reported product quality complaint with Twinrix syringes on behalf of healthcare professional.  The syringes leaked while administering to patient.  Three patient was affected related adverse event underdose.  The reporter contacted healthcare professional medical assistant for more information regarding product quality complaint.  The defect was discovered after partial use of the box. The healthcare professional stated that two doses administered prior did not have any issues. The reporter confirmed that Luer Lok needles were used. All syringes leaked between the Luer Lok device and the syringe barrel. The syringe was not pre-assembled with needle some time before administration syringes were assembled immediately before administration 20 gauge 1 in needle was used.  The blister and/or carton was not damaged. The Luer lok was not damaged.  The needles which were used was not available for return. There was no damage/breakage on the syringe barrel.  The healthcare professional did not have suspect product to return all 3 syringes were disposed of.  The GlaxoSmithKline had to issue a credit for 3 doses of Twinrix to GSK direct account.  The reporter did not have any demographics for the 3 patients.  The reporter consented to follow up. Additional supportive information:  This was 1 of 3 cases, reported by the same reporter. The syringes leaked while administering to patient and the patient dose was affected, which had led to accidental underdose, Syringe leak and pharmaceutical product complaint.; Sender's Comments:  US-GSK-US2023034605:Same reporter US-GSK-US2023AMR035219:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: worse than covid shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included covid vaccine with an associated reaction of malaise (received shot on an unknown date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: worse than covid shot). The outcome of the feeling bad was not reported.   It was not reported if the reporter considered the feeling bad to be related to Shingles vaccine.     It was not reported if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-02-2023 The patient took the shot within a few days, he/she had shingles. He/she was told that he/she could not do anything about it.  The patient felt someone should pay him/her some money.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: bad shingles right after their boosters; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately 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 Information: GSK receipt date: 27-Feb-2023 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter asked that mRNA jab. The reporter knew that the patient got bad shingles right after the boosters. Additional supportive information: The follow-up could not be possible as no contact details were available. As per reported information it seems that reporter was reporting about the 2nd dose of Shingles vaccine which was considered as booster of shingles vaccine, therefore single suspect was coded with dose number 2 with immediate time to onset for shingles. This 1 of 3 linked cases reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR036631:Same reporter US-GSK-US2023AMR036632:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: bad shingles right after their boosters; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately 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 Information: GSK receipt date: 27-Feb-2023 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter asked that mRNA jab. The reporter knew that the patient got bad shingles right after the boosters. Additional supportive information: The follow-up could not be possible as no contact details were available. As per reported information it seems that reporter was reporting about the 2nd dose of Shingles vaccine which was considered as booster of shingles vaccine, therefore single suspect was coded with dose number 2 with immediate time to onset for shingles. This 1 of 3 linked cases reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR036625:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: bad shingles right after their boosters; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately 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 Information: GSK receipt date: 27-Feb-2023 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter asked that mRNA jab. The reporter knew that the patient got bad shingles right after the boosters. Additional supportive information: The follow-up could not be possible as no contact details were available. As per reported information it seems that reporter was reporting about the 2nd dose of Shingles vaccine which was considered as booster of shingles vaccine, therefore single suspect was coded with dose number 2 with immediate time to onset for shingles. This 1 of 3 linked cases reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR036625:Same reporter US-GSK-US2023AMR036631:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Insurance issue, Pruritus
Clinical narrative: itching; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR036652   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter reported the case via interactive digital media. The patient had shingles they were bad took. One vaccine fifty dollars Later got second vaccine 150 dollars said this was better insurance did not pay. The patient had itching every now and then. Note: it was unknown whether itching was after 1st dose or 2nd dose or after both doses. Therefore, conservatively captured for both doses; Sender's Comments:  US-GSK-US2023AMR036652:
Sex: U
Vaccine: VARZOS
Symptoms: Decreased appetite
Clinical narrative: lost appetite; pain; This case was reported by a consumer via interactive digital media and described the occurrence of appetite lost in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24-FEB-2023, the patient received Shingles vaccine. On 24-FEB-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: pain). On an unknown date, the patient experienced appetite lost (Verbatim: lost appetite). The patient was treated with paracetamol (Tylenol). On 01-MAR-2023, the outcome of the appetite lost was recovered/resolved. The outcome of the pain was unknown.   It was unknown if the reporter considered the appetite lost and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR036664   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter reported the case via interactive digital media. The patient had it on Friday morning by six in evening patient was in pain. The patient had liquid tea Tylenol but on the day of reporting much of his/ her appetite was back. The patient got his/her vaccine and lost appetite all weekend, at the time of reporting feeling much better.; Sender's Comments:  US-GSK-US2023AMR036664:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sicker; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID VACCINE).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sicker). The outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter reported the case via interactive digital media. The patient reported 1st dose makes one sicker than the covid vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: shots and got them in left leg pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of leg pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced leg pain (Verbatim: shots and got them in left leg pain). The outcome of the leg pain was unknown.   It was unknown if the reporter considered the leg pain to be related to Shingles vaccine.     It was unknown if the company considered the leg pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR036699   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter reported the case via interactive digital media. The patient had both shots and got them in the left leg pain. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose refer linked case US2023AMR036699, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR036699:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: shots got them in left leg pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of leg pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer linked case US2023AMR036695).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced leg pain (Verbatim: shots got them in left leg pain). Rechallenge with Shingles vaccine was positive. The outcome of the leg pain was unknown.   It was unknown if the reporter considered the leg pain to be related to Shingles vaccine.     It was unknown if the company considered the leg pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR036695   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter reported the case via  interactive digital media. The patient had both shots and got them in the left leg pain. Additional Supportive Information: The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR036695:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Limb discomfort, Pain in extremity
Clinical narrative: arm sore uncomfortable; arm sore uncomfortable; bad case; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of discomfort 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, an unknown time after receiving Shingles vaccine, the patient experienced discomfort (Verbatim: arm sore uncomfortable), pain in arm (Verbatim: arm sore uncomfortable) and shingles (Verbatim: bad case). The outcome of the discomfort, pain in arm and shingles were unknown.   It was unknown if the reporter considered the discomfort, pain in arm and shingles to be related to Shingles vaccine.     It was unknown if the company considered the discomfort, pain in arm and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter reported the case via interactive digital media. The first of the 2 shot made his/her arm sore and a little uncomfortable.  The reporter thought that you had to wait about 2 months (could not remember), before you get the second one.  The reporter said not to wait. They had the 1 shot deal and thought he/she was safe-surprise.  The reporter had a bad case so went and got the new 2 shot deal. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Muscle spasms, Pain
Clinical narrative: pain is awful; muscle spasms; now part of my shoulder is numb; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: pain is awful), muscle spasm (Verbatim: muscle spasms) and numbness in shoulder (Verbatim: now part of my shoulder is numb). The outcome of the pain and muscle spasm were not reported and the outcome of the numbness in shoulder was not recovered/not resolved.   It was not reported if the reporter considered the pain, muscle spasm and numbness in shoulder to be related to Shingles vaccine.     It was not reported if the company considered the pain, muscle spasm and numbness in shoulder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 This case was reported by the patient via interactive digital media. The patient took the vaccine and had it the pain was awful and the muscle spasms and now part of shoulder was numb. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort
Clinical narrative: The vaccine put me through the ringer; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced discomfort (Verbatim: The vaccine put me through the ringer). The outcome of the discomfort was not reported.   It was not reported if the reporter considered the discomfort to be related to Shingles vaccine.     It was not reported if the company considered the discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 28-FEB-2023 This case was reported by the patient via interactive digital media. The patient stated that no more needles. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Pain, Pruritus, Scar
Clinical narrative: Balance problems; Shingles all over head, neck, shoulders, some on back and upper left arm/ now some breaking on right forehead related to the shingles.; Very bad pain; I still had many scars; Still had intense itching on head; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Tylenol. In OCT-2022, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles all over head, neck, shoulders, some on back and upper left arm/ now some breaking on right forehead related to the shingles.), pain (Verbatim: Very bad pain), scar (Verbatim: I still had many scars) and pruritus (Verbatim: Still had intense itching on head). On an unknown date, the patient experienced balance difficulty (Verbatim: Balance problems). The action taken with Tylenol was unknown. The outcome of the shingles, scar and pruritus were not recovered/not resolved and the outcome of the pain was recovered/resolved and the outcome of the balance difficulty was not reported.   It was not reported if the reporter considered the shingles, pain, scar, pruritus and balance difficulty to be related to Shingrix.     It was not reported if the company considered the shingles, pain, scar, pruritus and balance difficulty to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-FEB-2023 This case was reported by a patient via interactive digital media. The patient had the worst case of shingles that anyone had seen. It was all over my head, my neck, shoulders, some on back and on my upper left arm. Very bad pain. Lived on extra strength Tylenol round the clock. It lasted over 8 weeks and I still have many scars and intense itching on my head. Mine started the 2nd week in October of 2022. Now patient had some breaking out on right forehead they think might be related to shingles. The patient had one shingrix shot but it caused to have balance problems, so patient did not take the second one. if patient had known shingles would have been as bad as they were, thought might have taken the 2nd shot anyway.  Additional supportive information: Follow-up would not possible as no contact details were available. It was not reported if the company considered the shingles, pain, scar, pruritus and balance difficulty to be related to Shingrix.