chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Formication, Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: had the 2 shingles shots, got the shingles/Suspected vaccination failure; had shingles, right side, up right breast, over shoulder, down back, down back of right arm and armpit; Itching burning pain; burning pain; feels like bugs crawling under and on top of skin; 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.   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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the 2 shingles shots, got the shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had shingles, right side, up right breast, over shoulder, down back, down back of right arm and armpit), pruritus (Verbatim: Itching burning pain), pain burning (Verbatim: burning pain) and formication (Verbatim: feels like bugs crawling under and on top of skin). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pruritus, pain burning and formication were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, pain burning and formication to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus, pain burning and formication to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 01-March-2023 This case was reported by a patient via interactive digital media. The patient received the 2 shingles shots and had 2 months interval between the 2 shots at a year ago,  The patient have had shingles for the last 2 months, physician said it's my nerves, shingles was horrible, feels like bugs crawling under and on top of skin, itching burning pain, have it only on right side, up right breast, over shoulder, down back, down back of right arm and armpit.  The patient was on valtrex 2 weeks when it began and nothing helps. The physician reported that got shots you can still get shingles. The follow up would not possible, as no contact, details were available. This case was considered as vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Immune system disorder, Immunoglobulin therapy, Sciatica, Vaccination failure
Clinical narrative: Still had shingles after being vaxxed/Suspected Vaccination Failure; still had shingles; Breakeouts on hip following sciatic nerve; deficient immune system; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (have had shingles 3 times). Previously administered products included Shingles vaccine (received shingles vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Still had shingles after being vaxxed/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: still had shingles), sciatica (Verbatim: Breakeouts on hip following sciatic nerve) and immune system disorder (Verbatim: deficient immune system). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure, shingles, sciatica and immune system disorder were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, sciatica and immune system disorder to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, sciatica and immune system disorder to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 01-March-2023 This case was reported by a patient via interactive digital media. The patient have had shingles 3 times.  The patient received original Shingles vaccine and Shingrix 2 dose of vaccine. The patient still had shingles after being vaccinated. The patient had deficient immune system and take IVIG infusions every 28 days.  The physician recommended to started on prophylactic Valtex daily to keep it from coming back.  The patient had breakouts on hip following sciatic nerve. It was not reported if the reporter considered the vaccination failure, shingles and sciatica to be related to Zostavax. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; have had shingles multiple times; I've had 4 shingles shots; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 4th dose of Shingles vaccine, the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: have had shingles multiple times) and extra dose administered (Verbatim: I've had 4 shingles shots). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case was received from the patient's wife via interactive digital media. The patient had 4 Shingles shots and have had shingles multiple times per year for the past 40 years. The patient stated that it never ends. 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 patient received 3rd and 4th dose of Shingles vaccine, which led to extra dose administered. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Broke out again; Pain; 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.   The patient's past medical history included shingles.   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), shingles (Verbatim: Broke out again) and pain (Verbatim: Pain). The outcome of the vaccination failure, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got a Shingle shot after he/she heard you could had it more than once. The patient stated that three years later he/she was in emergency room. The patient broke out again and it was worst pain ever. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; PHN; nerve damageon his thigh and groin; 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.   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), shingles (Verbatim: Shingles), post herpetic neuralgia (Verbatim: PHN) and nerve damage (Verbatim: nerve damageon his thigh and groin). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia and nerve damage were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and nerve damage to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia and nerve damage to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case was received from the patient's wife via interactive digital media. The patient got the worst case of shingles from the Shingles vaccine booster and 1 year plus later, he/she was still suffering from PHN nerve damage on his thigh and groin. 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: U
Vaccine: VARZOS, VARZOS
Symptoms: Autoimmune disorder, Bell's palsy, Deafness permanent, Herpes zoster, Herpes zoster oticus
Clinical narrative: fatal autoimmune disease; had shots still had them twice/ suspected vaccination failure; lost hearing forever totally deaf; Bells Palsy; shingles in ear; still had them twice; Vertigo; This serious case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced autoimmune disorder (Verbatim: fatal autoimmune disease) (serious criteria GSK medically significant and life threatening), vaccination failure (Verbatim: had shots still had them twice/ suspected vaccination failure) (serious criteria GSK medically significant), deafness (Verbatim: lost hearing forever totally deaf) (serious criteria GSK medically significant), bell's palsy (Verbatim: Bells Palsy) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: shingles in ear) (serious criteria GSK medically significant), shingles (Verbatim: still had them twice) and vertigo (Verbatim: Vertigo). The outcome of the autoimmune disorder, vaccination failure, bell's palsy, herpes zoster otitis externa, shingles and vertigo were not reported and the outcome of the deafness was not recovered/not resolved.   It was unknown if the reporter considered the autoimmune disorder, vaccination failure, deafness, bell's palsy, herpes zoster otitis externa, shingles and vertigo to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the autoimmune disorder, vaccination failure, deafness, bell's palsy, herpes zoster otitis externa, shingles and vertigo to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shots for shingles and still had them twice . The reporter reported that last time had the shingles in patients ear and totally lost all hearing forever. The reporter reported that It did not come back so patient was totally deaf. The patient was also hit at the same time with Bells Palsy and Vertigo and also had a fatal autoimmune disease. This case was considered as suspected vaccination failure as details regarding 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, VARZOS
Symptoms: Vaccination failure, Vertigo
Clinical narrative: fatal autoimmune disease; had shots still had them twice/ suspected vaccination failure; lost hearing forever totally deaf; Bells Palsy; shingles in ear; still had them twice; Vertigo; This serious case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced autoimmune disorder (Verbatim: fatal autoimmune disease) (serious criteria GSK medically significant and life threatening), vaccination failure (Verbatim: had shots still had them twice/ suspected vaccination failure) (serious criteria GSK medically significant), deafness (Verbatim: lost hearing forever totally deaf) (serious criteria GSK medically significant), bell's palsy (Verbatim: Bells Palsy) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: shingles in ear) (serious criteria GSK medically significant), shingles (Verbatim: still had them twice) and vertigo (Verbatim: Vertigo). The outcome of the autoimmune disorder, vaccination failure, bell's palsy, herpes zoster otitis externa, shingles and vertigo were not reported and the outcome of the deafness was not recovered/not resolved.   It was unknown if the reporter considered the autoimmune disorder, vaccination failure, deafness, bell's palsy, herpes zoster otitis externa, shingles and vertigo to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the autoimmune disorder, vaccination failure, deafness, bell's palsy, herpes zoster otitis externa, shingles and vertigo to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shots for shingles and still had them twice . The reporter reported that last time had the shingles in patients ear and totally lost all hearing forever. The reporter reported that It did not come back so patient was totally deaf. The patient was also hit at the same time with Bells Palsy and Vertigo and also had a fatal autoimmune disease. This case was considered as suspected vaccination failure as details regarding 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, Pain, Vaccination failure
Clinical narrative: Got inoculation and got shingles/ suspected vaccination failure; Shingles; Horrible and 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 inoculation and got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Horrible and painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. The reporter stated that, it was horrible and painful, she knew several people including her poor late husband who had got the inoculation and had shingles again in spite of the inoculation another equivocated result. 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. Follow-up would not possible, as no contact, details were available. This case was linked with US2023AMR039354 which was reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR039354:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Gillian bar syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: Gillian bar syndrome) (serious criteria GSK medically significant and life threatening). The outcome of the guillain barre syndrome was not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2023 This case was reported by a patient's friend via interactive digital media. The patient almost died from Gillian Bar Syndrome and was still not right. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Gait disturbance, Pain in extremity
Clinical narrative: Very hard to walk; Pain in feet, awful, it moves around; Pain got worse after 2nd dose; This non-serious case was reported by a consumer and described the occurrence of gait disturbance in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The first dose was received on August 2022. refer this case - US2023011057). Concurrent medical conditions included foot pain and walking difficulty.   In DEC-2022, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced gait disturbance (Verbatim: Very hard to walk), foot pain (Verbatim: Pain in feet, awful, it moves around) and condition aggravated (Verbatim: Pain got worse after 2nd dose). Rechallenge with Shingrix was positive. The outcome of the gait disturbance, foot pain and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the gait disturbance, foot pain and condition aggravated to be related to Shingrix.     It was unknown if the company considered the gait disturbance, foot pain and condition aggravated to be related to Shingrix.   Linked case(s) involving the same patient:  US2023011057   Additional Information: Additional Information: GSK Receipt Date: 01-MAR-2023 The patient stated that, she begin with the pains in her feet were from the Shingrix shot until she got the second one (shot) and it got even worsen. The patient went to multiple physician and had many blood tests.  Everything was normal and physician could not figure it out until she had the second shot. The pains in both her feet mostly the left had been awful, very hard to walk. It moved around so the patient  never know where the pain was going to be from day to day.; Sender's Comments:  US-GSK-US2023011057:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Nerve injury, Pain
Clinical narrative: Nerve receptor damage; Sharp stabbing pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve damage in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain (most pain ever).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve damage (Verbatim: Nerve receptor damage) and pain (Verbatim: Sharp stabbing pain). The outcome of the nerve damage and pain were not recovered/not resolved.   It was unknown if the reporter considered the nerve damage and pain to be related to Shingles vaccine.     It was unknown if the company considered the nerve damage and pain 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 reported he/she received the Shingles vaccine. The patient stated that after received Shingles vaccine he/she experienced side effects in which his/her nerve receptor damage and have sharp stabbing pain was bad as the shingles every day and it was sucked and never get better. According to the physician it can get worse every year. As it was unknown after which dose event is occurring and it would be incorrect to link to both or one dose only. So, only one suspect with blank dose number is kept as it is not clear after which dose event occur and to retain only once case. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR034520:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: misery; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable 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 feeling miserable (Verbatim: misery). The outcome of the feeling miserable was not reported.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the feeling miserable to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR034524   Additional Information: GSK Receipt Date: 01-MAR-2023 This case was reported by a patient via interactive digital media. The patient just had second of two shots and they set you back a couple days, but patient never want to be in that kind misery again. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR034524 by same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR034524:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Set you back, misery; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (on an unknown date patient received 1st dose refer link case US2023AMR034523).   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 feeling miserable (Verbatim: Set you back, misery). Rechallenge with Shingles vaccine was positive. The outcome of the feeling miserable was not reported.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the feeling miserable to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR034523   Additional Information: GSK Receipt Date: 01-MAR-2023 This case was reported by a patient via interactive digital media. The patient just had second of two shots and they set you back a couple days, but patient never want to be in that kind misery again. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR034523 by same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR034523:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got it so bad; This non-serious 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, 3 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got it so bad). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the 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 awful. The reporter thought that if she would had not received the shingles vaccine she would not gotten the shingles. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Concussion, Head injury
Clinical narrative: Upset stomach; Concussion; Hit back of head; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of upset stomach 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 upset stomach (Verbatim: Upset stomach), concussion (Verbatim: Concussion) and head injury (Verbatim: Hit back of head). The outcome of the upset stomach, concussion and head injury were not reported.   It was unknown if the reporter considered the upset stomach, concussion and head injury to be related to Shingles vaccine.     It was unknown if the company considered the upset stomach, concussion and head injury 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 reporter reported that did get the two shots vaccine, but a word of warning mentioned that did not use the bathroom if get an upset stomach like patient did.  The patient was ended up on the bathroom floor with a concussion and hit the back of his/her head on the way down on the tiled bath surround. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR034746:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2023AMR034747   Additional Information: GSK Receipt Date: 01-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that the patient had the Shingles shot a couple of weeks ago from reporting and stated it was like a flu shot arm a little sore the next day. The case had been linked to US2023AMR034747, reported by the same reporter, for a different product. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR034747:Same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 03-MAR-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site pain). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023035537   Additional Information: GSK Receipt date: 06-Mar-2023 The reporter was the patient. She only had injection site pain with her first Shingrix dose.  Nothing else was reported. The reporter declined to provide HCP contact information at that time as she was switching doctors.  They might follow up with the reporter. For tolerance of 2nd dose refer linked case US2023035537, reported by same reporter.; Sender's Comments:  US-GSK-US2023035537:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chemotherapy, Pruritus, Radiotherapy
Clinical narrative: itchy mess; This non-serious 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.   Concurrent medical conditions included cancer.   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 pruritus (Verbatim: itchy mess). The patient was treated with soap (nos) (Soap), benadryl (nos) (Benadryl), medication unknown (Cream (Medication Unknown)) and dermatologicals nos (Lotion). The outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     It was unknown if the company considered the pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2023 This case was reported by the patient via interactive digital media. The patient had one Shingles shot and doctor did not stated anything about the second one. The patient reported that right now after having chemotherapy and radiation the patient was in itchy mess. The patient reported that cancer doctor did not seem to care. The patient reported that he/she had used every cream, lotion, soap, and nothing works. The patient take Benadryl at night. The patient stated nothing work and asked any suggestions out there. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: FLUX
Symptoms: Central nervous system stimulation, Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 81-year-old patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Flu vaccine.     It was unknown if the company considered the shingles to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023. This case was reported by a patient via interactive digital media. The patient got shingles after a flu shot. The patient never went to the physician.  The patient used Transcutaneous Electrical Nerve (TENS) units 2 - cuz wore out the 1st one and patient thought it was l-arginine an amino acid The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles 2 days after vaccine; 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 Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles 2 days after vaccine). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 06-Mar-2023 The reporter reported the case via interactive digital media. The patient received shingles shot and got shingles 2 days later.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: her husband experienced shingles in November- December of 2022; 1st dose Oct2020, 2nd Jan2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JAN-2023, the patient received the 2nd dose of Shingrix. In OCT-2020, the patient received the 1st dose of Shingrix. In JAN-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose Oct2020, 2nd Jan2023). On an unknown date, the patient experienced shingles (Verbatim: her husband experienced shingles in November- December of 2022). The outcome of the shingles was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAR-2023 The reporter was patient's wife. The patient received Shingrix dose 1 around October 2020.  The patient experienced shingles in November - December of 2022.  The reporter did not want to provide any additional information. The reporter did not consent to follow-up.  The patient had received the second dose of Shingrix vaccine later than the recommended interval, which had led to lengthening of vaccination schedule. This case was linked with US2023033407, reported by same reporter.; Sender's Comments:  US-GSK-US2023033407:Same reporter adn differnt patient
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2018; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received dose 1 in 2018 in left arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 2018). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 06-Mar-2023 The reporter was the pharmacist.  Reporter stated that the patient missed second dose.  No other information provided.  Did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Some of the dose leaked out, maybe half of dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-MAR-2023, the patient received Shingrix (left deltoid). On 06-MAR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Some of the dose leaked out, maybe half of dose). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 6-Mar-2023 The pharmacist called in to inquired that how to proceed with Shingrix dose. The reporter was unable to provide any patient or vaccine details. The reporter did not consent to follow-up. The reporter reported that they administered Shingrix to a patient on the day of reporting in left deltoid and the syringe malfunctioned and some of the dose leaked out and the patient  only received might be half of the dose which led to incomplete dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 09/16/2018, 2nd dose not received; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 16th Sep 2023, with batch number 3NY58 and expiry date 7th Mar 2021).   On an unknown date, the patient not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose on 09/16/2018, 2nd dose not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 06-Mar-2023 The registered pharmacist (RPH) reported that the patient had not received 2nd dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination; Sender's Comments:  US-GSK-US2023035585:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 09/16/2018, 2nd dose not received; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 16th Sep 2018 with batch number 3NY58 and expiry date 7th March 2021).   On an unknown date, the patient not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose on 09/16/2018, 2nd dose not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 06-Mar-2023 The registered pharmacist (RPH) reported that the patient had not received 2nd dose. AE contains all reported information. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination; Sender's Comments:  US-GSK-US2023035583:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Electric shock sensation, Fatigue, Pruritus
Clinical narrative: Trouble breathing, 5 days in hospital; Shocks in chest; Fatigue; Itchiness on back; This serious case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included VARICELLA ZOSTER VACCINE RGE (SHINGRIX) for prophylaxis.   Concurrent medical conditions included emphysema and chronic obstructive pulmonary disease.   In OCT-2022, the patient received the 2nd dose of Shingrix (left arm). In AUG-2022, the patient received the 1st dose of SHINGRIX (left arm). In OCT-2022, 2 weeks after receiving Shingrix, the patient experienced shock (Verbatim: Shocks in chest) (serious criteria hospitalization and GSK medically significant), fatigue (Verbatim: Fatigue) (serious criteria hospitalization) and pruritus (Verbatim: Itchiness on back) (serious criteria hospitalization). On an unknown date, the patient experienced difficulty breathing (Verbatim: Trouble breathing, 5 days in hospital) (serious criteria hospitalization). The outcome of the difficulty breathing was not reported and the outcome of the shock, fatigue and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the difficulty breathing, shock, fatigue and pruritus to be related to Shingrix.     It was unknown if the company considered the difficulty breathing, shock, fatigue and pruritus to be related to Shingrix.   Additional Information: GSK receipt date: 8-Mar-2023 The patient stated that about 2 to 3 weeks after getting the second vaccine, he started experiencing fatigue, itchiness on the right side of his back, and shocks in his chest on the right side.   The patient stated that he was still having these symptoms, but they are better then when they first started.   The patient did not  had lot or expiry dates for the vaccines.  The patient also mentioned while on the call that he was in the hospital about a month ago for 5 days due to having trouble breathing related to his chronic obstructive pulmonary disease and emphysema. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Guillain-Barre syndrome, Incomplete course of vaccination, X-ray limb abnormal
Clinical narrative: GBS in thumbs, extremely unlikely diagnosis; Arthritis in hand, more than likely diagnosis; 1st dose on 01Sep2019, 2nd not received; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (prior vaccination with Zostavax).   In SEP-2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: GBS in thumbs, extremely unlikely diagnosis) (serious criteria GSK medically significant), hand arthritis (Verbatim: Arthritis in hand, more than likely diagnosis) and incomplete course of vaccination (Verbatim: 1st dose on 01Sep2019, 2nd not received). The outcome of the guillain barre syndrome was not recovered/not resolved and the outcome of the hand arthritis was not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the guillain barre syndrome and hand arthritis to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome and hand arthritis to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2023 The reporter was the patient.  He received Shingrix 1st shot in September 2019 and sometime after 1st shot during that period of time his primary care doctor diagnosed him with guillain-barre syndrome (GBS) in both thumbs since then he had had x-rays performed on his hands and the results of the x-rays were that more than likely the correct diagnosis was arthritis and extremely unlikely that the diagnosis was guillain-barre syndrome. The patient concomitant medication included as unspecified injections into his fingers/hands/thumbs.  The patient provided limited information. The reporter was unable to ask for his date of birth, doctor of medicine contact information, lot number etc. because he wanted to end the call.  The reporter did obtain his mailing address did inform him that safety might send him a letter. Till the time of reporting, the patient did not receive Shingrix 2nd shot yet (and more than 6 months had passed since shot 1), which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Fibrin D dimer, Fibrin D dimer increased
Clinical narrative: ELEVATED D DIMER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced elevated d dimer. Laboratory data (dates unspecified) included: Fibrin D dimer elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of elevated d dimer was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: husband contracted Covid after receiving the Moderna vaccine lot 057M21A; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (husband contracted Covid after receiving the Moderna vaccine lot 057M21A) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (husband contracted Covid after receiving the Moderna vaccine lot 057M21A). At the time of the report, COVID-19 (husband contracted Covid after receiving the Moderna vaccine lot 057M21A) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No treatment medications were reported No concomitant medications were reported    This case was linked to US-MODERNATX, INC.-MOD-2023-714020 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714020:Wife case