chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Coccydynia, Electric shock sensation, Herpes zoster, Musculoskeletal pain, Pain
Clinical narrative: I had the vaccine and I still get them; I still get them, not wide spread/ they'e always around the scar and buttocks; Sharp electric like pain from tailbone to buttocks; Always when there's stress, get very sharp electric like pain; 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.   The patient's past medical history included surgery (4 back surgery).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and stress. On an unknown date, the outcome of the vaccination failure, shingles, pain and stress were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and stress to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The patient had the vaccine and he/she still got them just not as widespread.  Always when there was stress, or he/she got very sharp electric like pain from tailbone to buttocks.  The patient had 4 back surgeries and they were always around the scar and buttocks. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Stress, Vaccination failure
Clinical narrative: I had the vaccine and I still get them; I still get them, not wide spread/ they'e always around the scar and buttocks; Sharp electric like pain from tailbone to buttocks; Always when there's stress, get very sharp electric like pain; 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.   The patient's past medical history included surgery (4 back surgery).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and stress. On an unknown date, the outcome of the vaccination failure, shingles, pain and stress were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and stress to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The patient had the vaccine and he/she still got them just not as widespread.  Always when there was stress, or he/she got very sharp electric like pain from tailbone to buttocks.  The patient had 4 back surgeries and they were always around the scar and buttocks. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Have it now, Had vaccinated doubled shots; Have it now, Had vaccinated doubled shots; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 30-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The patient stated that he/she had it now (at the time of reporting), just would not go away. The patient had vaccinated doubled shots Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Second time having them, and I had the vaccine; Second time having them, shingles; painful; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-Aug-2022 Reporter's Comments: The reporter reported the case via interactive digital media. The patient stated that he/she had them second time, so painful, and he/she had the Shingles vaccine. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Gastrointestinal disorder, Herpes zoster, Pain, Rash
Clinical narrative: Had both shots but still got it/Suspected vaccination failure; Stomach seizures; Still got it / left side / attacking my stomach; Rash; Back pain; Excrusiating pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), gastrointestinal disorder, shingles, rash, back pain and pain. The patient was treated with muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the vaccination failure, shingles, rash, back pain and pain were unknown and the outcome of the gastrointestinal disorder was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, gastrointestinal disorder, shingles, rash, back pain and pain to be related to Shingles vaccine and Shingles vaccine.  Additional Information: GSK Receipt Date: 27-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had both shingles shots but still got shingles bad. The patient went to ER (emergency room) with back pain but they never took his/her tee-shirt off so did not see the rash so it was misdiagnosed and they sent him/her home with muscle relaxers.  The patient went to doctor 3 days later because it had gone around his/her left side and across half his/her stomach attacking his/her stomach.  The patient had excruciating pain. The patient stated that, it had been 2 years and still had stomach seizures daily. Additional Supportive Information: 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 would not possible as no contact details were available. Note: As it was not clear what kind of stomach seizure patient had after the vaccination so it was coded with gastrointestinal disorder conservatively.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Had both shots but still got it/Suspected vaccination failure; Stomach seizures; Still got it / left side / attacking my stomach; Rash; Back pain; Excrusiating pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), gastrointestinal disorder, shingles, rash, back pain and pain. The patient was treated with muscle relaxants (Muscle Relaxant). On an unknown date, the outcome of the vaccination failure, shingles, rash, back pain and pain were unknown and the outcome of the gastrointestinal disorder was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, gastrointestinal disorder, shingles, rash, back pain and pain to be related to Shingles vaccine and Shingles vaccine.  Additional Information: GSK Receipt Date: 27-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had both shingles shots but still got shingles bad. The patient went to ER (emergency room) with back pain but they never took his/her tee-shirt off so did not see the rash so it was misdiagnosed and they sent him/her home with muscle relaxers.  The patient went to doctor 3 days later because it had gone around his/her left side and across half his/her stomach attacking his/her stomach.  The patient had excruciating pain. The patient stated that, it had been 2 years and still had stomach seizures daily. Additional Supportive Information: 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 would not possible as no contact details were available. Note: As it was not clear what kind of stomach seizure patient had after the vaccination so it was coded with gastrointestinal disorder conservatively.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had all of the vaccinations. Got a mild case/Suspected vaccination failure; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with acyclovir. 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 Shingrix.     Additional Information: GSK receipt date : 28-Aug-2022 Reporters comment: This case was reported by a consumer via interactive digital media  The patient had mild case of shingles after received shingrix  vaccine. The patient also stated that he/she had all of the vaccinations. The patient took the Acyclovir in high dosage for three days. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and she's still 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 female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Aug-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient did not know what to say about her friend.  The patient got the shingles shot and she still had shingles she had them for 2 months now. The follow-up would not possible, as no contact details were available. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary immunization, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Scar, Vaccination failure
Clinical narrative: had both of them and still got the shingles / suspected vaccination failure; shingles / I had spent 11 days on the hospital because they were so bad just this April 2022; scaring and the nerve damage; scaring and the nerve damage; the pain never ever goes away; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In April 2022, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant) and shingles (serious criteria hospitalization). On an unknown date, the patient experienced nerve damage, scar and pain. On an unknown date, the outcome of the vaccination failure, shingles, nerve damage and scar were unknown and the outcome of the pain was not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. It was unknown if the reporter considered the nerve damage, scar and pain to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR126722   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter was a consumer who stated that, it did not matter if you get the vaccine, believe me. He/She had both of them and still got the shingles. He/She had spent 11 days on the hospital because they were so bad just this April 2022. It had been a nightmare ever since. The scaring and the nerve damage was indescribable and the pain never ever went away. The shingles vaccine was like the flu vaccine you could still get the shingles.  Additional supportive information: 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. This case was linked with US2022AMR126722 for same patient and other product. Follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR126722:same patient, other product
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Pain, Paraesthesia
Clinical narrative: Spot on forehead bothering me, could it be shingles without a rash; Tingly hurts; Tingly hurts; This 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.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort, tingling and pain. On an unknown date, the outcome of the discomfort, tingling and pain were unknown.   It was unknown if the reporter considered the discomfort, tingling and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter stated that he/she had both of the shingles vaccines. So he/she had this spot on his/her forehead it was bothering him/her. The reporter stated that he/she could not see a rash but it tingly hurts. The reporter stated that he/she could not see anything there and enquired that could that be shingles without a rash. Additional supportive information: No follow-up was possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headaches; Muscle aches; Tiredness; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th August 2022, the patient received Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced headache, muscle pain and tiredness. On an unknown date, the outcome of the headache, muscle pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the headache, muscle pain and tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-AUG-2022.  Reporter's Comments:  This case was reported by patient via interactive digital media. The patient received the injection the day before reporting and having headaches, muscle aches and tiredness.  The patient wanted to ask that how long could he/she expect symptoms last. Additional Supportive Information: The follow up would not be possible as contact details were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness postural, Pain
Clinical narrative: Felt achy; Dizzy when stands up; Upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2022, the patient received Shingrix. On 25th August 2022, 1 days after receiving Shingrix, the patient experienced pain, dizziness upon standing and upset stomach. On an unknown date, the outcome of the pain, dizziness upon standing and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the pain, dizziness upon standing and upset stomach to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: This case was reported by the patient's husband interactive digital media. The patient got Shingrix shots yesterday (24th August 2022) and Today (25th August 2022), patient was felt achyand dizzy when stands up and an upset stomach. The reporter asked was this normal.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Peripheral swelling, Pyrexia
Clinical narrative: Fever; Chills; Arm is swollen; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever, chills and swelling arm. On an unknown date, the outcome of the fever, chills and swelling arm were unknown.   It was unknown if the reporter considered the fever, chills and swelling arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient got his/her last dose of shingle shot and had fever, chills and arm was swollen. The patient hope he/she would never have one again. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Rash is getting bigger; Rash getting warm; This case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash and skin warm. On an unknown date, the outcome of the rash and skin warm were not recovered/not resolved.   The reporter considered the rash and skin warm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter stated that he/she had a rash from his/her shingles shot that was getting bigger and warm. Additional supportive information: No follow-up was possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Aug-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient just got his/her first Shingles shot, and despite reading about the awful side effects, he/she had a sore arm for 2 days, nothing more.  The patient was ready for Shingles shot 2nd in 3 months.  The patient did not want this horrible thing. Additional Supportive Information: The follow-up would not possible as no contact details were available. This case was linked with case US2022AMR124752, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR124752:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm  is sore; This 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 27th August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-AUG-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient received first Shingles shot yesterday and experienced arm sore but better than the alternative. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Inappropriate schedule of product administration, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Interval between doses greater than 6 months; Feels miserable/ worse than ever; Cannot move/ cannot drive; Cannot move/ cannot drive; This case was reported by a pharmacist via call center representative and described the occurrence of feeling miserable in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 5cE5S, expiry date 23rd September 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd November 2021).   On 22nd August 2022, the patient received the 2nd dose of Shingrix (intramuscular). In August 2022, less than a week after receiving Shingrix, the patient experienced feeling miserable, mobility decreased and activities of daily living impaired. On 22nd August 2022, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the feeling miserable, mobility decreased and activities of daily living impaired were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the feeling miserable, mobility decreased and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comments: The reporter stated that the patient received Shingrix shot (and also received Fluzone) in the left deltoid at the same time. Less than a week after receiving Fluzone, the patient called the pharmacy to report that he felt miserable, worse than he had ever felt before, he could not move, he could not drive, and he did not know what was causing it. The reporter stated that there was inappropriate schedule of vaccine as interval between dose 1 and dose 2 of Shingrix was greater than 6 months. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of vaccination schedule. Fluzone was not captured in product tab as it was unclear if was a vaccine or other product.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose #2 25-August-2022, dose #1 late December 2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in late December 2021).   On 25th August 2022, the patient received the 2nd dose of Shingrix .5 ml. On 25th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received second dose of Shingrix vaccine 8 months after first dose in the left arm. The reporter stated that the patient does not remember the exact date of first dose but it was late December 2021. The reporter did not consent to follow up.  Additional supportive information: The patient received 2nd dose of Shingrix later than recommended time frame, which led to lengthening of vaccination schedule.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose was administered on 5-AUG-2022/ inadvertently received an early dose of Shingrix today 26-AUG-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number P7k5p, expiry date 10th September 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 26th August 2022, the patient received the 2nd dose of Shingrix. On 26th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 26-Aug-2022 Reporter's comment: The pharmacist stated that the patient inadvertently received an early dose of Shingrix today on 26th August 2022.  The first dose was administered on 05th August 2022.  The patient was not immunocompromised. The consent to follow up was granted. The Healthcare professional stated that follow-up via email was okay. Additional supportive information: The patient received the 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 37.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received Havrix that expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 37-year-old male patient who received HAV (Havrix) (batch number 5816082643, expiry date 14th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th August 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 26th August 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comments: The health care professional (HCP) reported that patient received Havrix that was expired on 14th Jun 2022. No other reactions reported. The vaccine administration facility was the same as Primary Reporter The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: 1st dose Dec2020,late for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in December 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-Aug-2022 Reporter's Comments: The pharmacist reported on 29th August 2022 that a female patient was late for the second dose of Shingrix.  The first dose was administrated in December 2020.  No adverse event was reported. The reporter was consented to follow up. The first dose was administrated on another facility No LOT number and expiration date provided. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo not properly reconstituted/not mixed with powder; administered only the liquid portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA703A, expiry date April 2023) for prophylaxis.   On 15th August 2022, the patient received the 1st dose of Menveo. On 15th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Aug-2022 Reporter's comment: The pharmacist reported that the patient received Menveo vaccine that was not properly reconstituted and it was administered only the liquid portion without mixing it with the powder. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient was administered only the liquid portion without mixing it with the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 40.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired EngerixB administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 40-year-old patient who received HBV (Engerix B) (batch number LG5RN, expiry date 20th August 2022) for prophylaxis.   On 29th August 2022, the patient received Engerix B. On 29th August 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comments: Office manager reporting an expired dose of Engerix-B was administered on 29th August 2022.  Dose expired on 20th August 2022. The reporter consented to follow up. AE report contains all details provided by HCP.  Additional Supportive Information: The patient was administered with Engerix-B vaccine that was already expired on 20th August 2022.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain in extremity
Clinical narrative: 1st shot Nov 2019, 2nd not yet; left arm  hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comments: The patient self-reported the case via interactive digital media.  She had her first Shingrix shot on an unknown date in November of 2019 in the left arm.  She did not have the lot number of the injected vaccine.  Reporter stated that her left arm hurt, like someone hit me with a brick. She stated that it lasted for about a week then resolved.  She had not yet received 2nd shot yet and it had been more than 6 months since shot 1. Did not consent to follow-up.  Additional Supportive Information: 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: Inappropriate schedule of product administration
Clinical narrative: first dose in 2020, second August 9 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose in 2020).   On 9th August 2022, the patient received the 2nd dose of Shingrix. On 9th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was recovered/resolved.   Additional Information: GSK receipt date: 29-Aug-2022 Reporter's comment: The registered pharmacist called on behalf of the patient. The patient did not receive the second dose until 9th August 2022. No demographic details were reported. Did not consent to follow-up. Additional supportive information: The patient received second dose of Shingrix later than the recommended interval, which led lengthening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 2 years ago, recently received second; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately 2 years ago).   In August 2022, the patient received the 2nd dose of Shingrix. In August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 29-Aug-2022 Reporter's comment: The patient just received the second dose. Did not consent to follow-up. Additional supportive information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 17Jun2019, has not yet received another; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 17th June 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comments: Pharmacy Intern reported that the patient received first dose of Shingrix on 17th June 2019 and had not yet received another dose.  The lot number and expiration date of the first dose was not available to the reporter at the time of call. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 27th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-Aug-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Kinrix, which led to expired vaccine used.
Age: 64.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix expired vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 64-year-old male patient who received HAV (Havrix) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   On 29th August 2022, the patient received Havrix. On 29th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's comment: The reporter stated that an expired dose of Havrix vaccine was administered to the patient. The reporter did not consent to follow-up. The reporter declined permission to create an account at in database. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4F99G, expiry date 19th August 2022) for prophylaxis.   On 29th August 2022, the patient received Boostrix. On 29th August 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comment: The reporter reported that the patient received Boostrix vaccine which was expired. The reporter did not have any patient information. The reporter stated that at the time of reporting repeat dose had not been administered. The reporter consented to follow up.  Additional Supportive Information: The patient received a Boostrix which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2June2022, is at office for 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 2nd June 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's comment: The pharmacist reported that the patient was at the office for the second dose of Twinrix. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose earlier than 2 months; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 954kz, expiry date 14th September 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 31st August 2022, the patient received the 2nd dose of Shingrix. On 31st August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 31-Aug-2022 Reporter's comment: The case was reported by heath care professional on behalf of a patient. The reporter stated that the second dose was given too earlier(earlier than 2 months after her first dose) Did not consent to follow-up. Additional supportive information: The patient received the second earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on 29Mar2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 12-year-old patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 29th March 2021 at 11 years of age).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comments: pharmacist reported that a patient received the first dose of Engerix-B. The patient had not received any other doses of hepatitis B vaccinations as per the moment of this report. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination.
Age: 53.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Infanrix administered to an adult patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 53-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 31st August 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's comment: A health care provider reported that an adult patient received an Infanrix dose. The reporter consented to follow-up. Additional Supportive Information: An adult patient received an Infanrix dose, which led to inappropriate age at vaccine administration.