chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles/Had the shots and had shingles. I believe I had a milder case with the shots; This 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 (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. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 24-Sep-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the Shingrix shot but still got shingles. The patient believed that this was a milder case with the shots. Additional Supportive Information: The follow up would not possible, as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shot, still got it in face/suspected vaccination failure; got shot, still got it in face; 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter stated that friend's mother (patient) got the shot for shingles and still got it on her face, but it was not be week. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case was one of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR134884:Same reporter US-GLAXOSMITHKLINE-US2022AMR134920:Same reporter US-GSK-US2022AMR134931:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shingles shot, still get 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 patients 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: 25-AUG-2022 Reporter's Comment: This case was reported via interactive digital media. Reporter asked that people who had Shingles shot can still got shingles without rash did and was very painful. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Additional supportive information: The follow up would not possible as no contact details were available. This case has been linked to the US2022AMR118438 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR118438:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had the 2 shot regimen, have had it (shingles) twice since/Suspected vaccination failure; Had the 2 shot regimen, have had it (shingles) twice since; Pain is really bad; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain. Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received when he/she was old enough then got shingles 15 years later, very painful but he/she was lucky to only had a silver dollar spot on his/her back).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles 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 and Shingles vaccine.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media and described the occurrence of suspected vaccination failure. The patient had the 2 shot regimen and had it (Shingles) twice since.  The patient stated that the pain was really bad but he/she guessed he/she was lucky that it hadn't gotten larger. The patient also stated that his/her doctor asked him/her only got it twice, patient guessed it could happen a lot. 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. This case had been linked with case US2022AMR140079, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR140079:tag at post
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got it even after getting the shingles vaccine/suspected vaccination failure; got it even after getting the shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's Comments: This case was reported by consumer via interactive digital media. The patient received a dose of Shingles vaccine and had got it (shingles). The reporter reported that one of the Covid vaccine's side effects. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Note: From the narrative it was not clear if the patient got Covid vaccine and experienced shingles hence not captured as suspect. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Got the vaccine too and I got shingles/Suspected vaccination failure; I got shingles; Nerve 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.   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 post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the Shingles vaccine and got shingles and nerve pain really bad. The patient still suffers from nerve pain. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case had been linked with US2022AMR139977, as tag in same interactive digital media post.; Sender's Comments:  US-GSK-US2022AMR139977:tag at post
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I still got them even with vaccinations/suspected vaccination failure; still got them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's Comments:  This case was received from patient via interactive digital media. The patient reported he/she still got them even after vaccination. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. Note:  Conservatively coded only one suspect due to insufficient info of dose number.  This case has been linked to the US2021AMR129948 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR129948:tag at post
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: was vaccinated for shingles, still got them/ Suspect vaccination failure; shingles; very 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.   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: 23-September-2022 Reporter's comment:  This case was reported by patient via interactive digital media. The patient was vaccinated with Shingles vaccine and still got shingles without the outbreak. Still very painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: broke out with SHINGLES; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the Shingles shot and two weeks later broke out with shingles. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Muscular weakness, Pain
Clinical narrative: Could not lift left hand/ could not get dressed; Movement was painful; Left arm is still weak; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 4 hrs after receiving Shingles vaccine, the patient experienced mobility decreased, pain upon movement and weakness of arms. The patient was treated with non-drug therapy (Physical Therapy). On an unknown date, the outcome of the mobility decreased and pain upon movement were recovering/resolving and the outcome of the weakness of arms was not recovered/not resolved.   The reporter considered the mobility decreased, pain upon movement and weakness of arms to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient received second dose of Shingles vaccine and four hours after vaccination the patient could not lift her left hand higher than her behind.  The patient could not dress herself and movement was painful. The patient took physical therapy and took 5 months to recover mostly. The patient reported that her left arm was still weak. The patient had no idea this might happen after the jab and neither doctor and patient saw reported reaction to VAERS.    Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Pain, Vaccine positive rechallenge
Clinical narrative: Headache; Body aches; 1st dose on 2019, 2nd dose on 20Sep2022; This case was reported by a consumer via patient support programs and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose in 2019 and also experienced body aches, refer case US2022AMR136388).   On 20th September 2022, the patient received the 2nd dose of Shingrix. On 20th September 2022, less than a day after receiving Shingrix, the patient experienced headache, general body pain and drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, general body pain and drug dose administration interval too long were unknown.   The reporter considered the headache and general body pain to be possibly related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR136388   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comments: The patient had headache and body aches. The reporter thought that the event might had been related to Shingrix. The reporter did not give consent to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than recommended time interval, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2022AMR136388:Same reporter/ 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Headache (similar symptoms); Body aches (similar symptoms); This case was reported by a consumer via patient support programs and described the occurrence of headache in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th September 2022, the patient received the 1st dose of Shingles vaccine. On 20th September 2022, less than a day after receiving Shingles vaccine, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were unknown.   The reporter considered the headache and general body pain to be possibly related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR136373   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comments: The reporter stated that the patient had similar symptoms in 2019 with her dose. Reporter stated patient had headache and body aches. The reporter considered the events might had been to be related to shingles vaccine. The reporter did not consent to follow up. Additional supportive information: For tolerance of 2nd dose refer case US2022AMR136373.; Sender's Comments:  US-GSK-US2022AMR136373:Same reporter/ 2nd dose
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 21-Sep-2020, second on 16-Mar-2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received the first dose of Havrix on 21st September 2020).   On 16th March 2021, the patient received the 2nd dose of Havrix. On 16th March 2021, unknown after receiving Havrix, 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: 20-SEP-2022 Reporter's Comment: The office manager to confirm the situation and get more information.  The reporter contact information was sent by email. The reporter accepted follow up. Additional Supportive Information: The patient received 2nd dose of Havrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: pharmacy mailed the Shingrix to their home for the patient to bring in office to be administered/ No refrigeration was used by pharmacy; This case was reported by a nurse via sales rep and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The nurse reported that 4 patients that had an prescription which was sent to pharmacy, the pharmacy mailed the Shingrix to their home for the patient to bring in office to be administered. These were patients. No refrigeration was used by pharmacy. In one case the Shingrix vials were put in a pill bottle and mailed. All doses were spoiled, and patients sent back to pharmacy. The nurse was checking with patients to see if the patient had got the vaccination after that. The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive Information: All doses were spoiled, and patient had not received the doses, which led to Intercepted product storage error. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR136885:Same reporter-Patient 3 US-GSK-US2022AMR136883:Same reporter-Patient 1 US-GSK-US2022AMR136884:Same reporter-Patient 2
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: No refrigeration used/In one case the Shingrix vials were put in a pill bottle and mailed.; This case was reported by a nurse via sales rep and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.    Additional Information: GSK receipt date: 22-SEP-2022 Reporters comment:  The reporter reported that 4 patients that had a prescription sent to pharmacy the pharmacy mailed the Shingrix to their home for the patient to bring in office to be administered. These were patients. No refrigeration was used by pharmacy. In one case the Shingrix vials were put in a pill bottle and mailed.All doses were spoiled, and patients sent back to pharmacy.  The nurse was checking with patients to see if the patient had got the vaccination after that. The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive Information: All doses were spoiled, and patient had not received the doses, which led to Intercepted product storage error. This case was 1 of 4 cases for the patient reported by same reporter; Sender's Comments:  US-GSK-US2022AMR136884:Same reporter- Patient 2 US-GSK-US2022AMR136885:Same reporter- Patient 3 US-GSK-US2022AMR136866:Same reporter- Patient 4
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included throat cancer (The patient had previously battled throat cancer) and covid-19 (patient was diagnosed with Covid within the last year). Previously administered products included monoclonal antibody treatment (The patient received monoclonal antibody treatment). Concurrent medical conditions included skin cancer (The patient was currently battling skin cancer) and immunocompromised (The patient was very immunocompromised).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Linked case(s) involving the same patient:US2022136444   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comment: The case was reported by patient's sister-in-law. The reporter reported that, patient experienced malaise after receiving a Shingrix.  The reporter did not consent to follow-up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022136444; Sender's Comments:  US-GSK-US2022136444:Same patient, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This case was reported by a other health professional via interactive digital media and described the occurrence of allergic reaction 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had an allergic reaction to Shingrix. The patient had asked advised for the second dose. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: tired/slight recation; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got his/her second shot slight recation or it was the weather making he/she tired. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: That second shot hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that be prepared, that the second shot hurt but worth it in the long run. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Fatigue, Pain, Pruritus
Clinical narrative: fatigued; super achy; my first was horrible, still looks awful red; burning; itching; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17th September 2022, the patient received the 1st dose of Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced fatigue, pain, erythema, burning sensation and pruritus. On an unknown date, the outcome of the fatigue, pain, erythema, burning sensation and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, pain, erythema, burning sensation and pruritus to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-September-2022 Reporter's comment: This case was reported by a patient via interactive digital media Patient reported that first dose was horrible everyone had shingles recommend even had reactions Patient still thinking whether second would be worse. On Saturday patient experienced awful red, burning and itching reactions. Patient was unsure about the second shot of vaccine. Patient's husband was in good health as his arm did not even turned red. Patient reported feeling super achy and fatigued.; Sender's Comments:  US-GSK-US2022AMR139374:same report, other patients
Sex: F
Vaccine: VARZOS
Symptoms: Electric shock sensation, Hypoaesthesia, Irritability, Paraesthesia
Clinical narrative: it's more irritating at night, mind bogling; numbness in tingling in both legs from knees; numbness in tingling in both legs from knees; This case was reported by a consumer via call center representative and described the occurrence of irritability in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 13th April 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th April 2022, less than a day after receiving Shingrix, the patient experienced irritability, numbness and tingling. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the irritability, numbness and tingling were not recovered/not resolved.   It was unknown if the reporter considered the irritability, numbness and tingling to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Sep-2022 Reporter's comment: The patient stated that at night from 11 pm to 5 am, she felt like her throughout whole body was being electrocuted.  The patient had almost went to hospital.  The patient almost went to Emergency Room both knees down constant feeling of prickly numbness, down to toes and bottom of feet. She still had tingling in both legs from knees down. The patient felt mind boggling.  It was more irritating at night.  She spoke with her Healthcare professional and had began taking Advil at night.  The patient was referred to Healthcare professional, medical information phone number was provided. The patient had gone through every February for physical.  The permission for consent to follow-up was denied.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient received pediatric 10 mcg dose; Adult patient received pediatric 10 mcg dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 48-year-old male patient who received HBV (Engerix B 10 mcg) (batch number YY2R3, expiry date 12th May 2024) for prophylaxis.   On 21st September 2022, the patient received Engerix B 10 mcg 10 ug. On 21st September 2022, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that an adult patient accidentally received a pediatric 10 mcg dose instead of the adult 20 mcg dose. The reporter wanted to know how should proceed. The reporter did not consent to follow up. Additional supportive information: The adult patient was administered a pediatric dose of Engerix B 10 mcg, which led to underdose and adult use of a child product.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: mixed the Hiberix with Sterile Water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.       Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comments: Clinic administrator reported the adverse event via web form. Reporter stated that his/her team member inadvertently mixed the Hiberix with sterile water vs. the provided 0.9 percent Sodium Chloride. Reporter needed to verify if this dose needs to be repeated since it was not mixed appropriately. No further details provided. Additional supportive information: Inadvertently mixed the Hiberix with sterile water vs. the provided 0.9 percent Sodium Chloride, which led to wrong solution used in drug reconstitution.
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Due to leakage, administered less than 0.5ml.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 39-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number L3GM3, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 21st September 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered 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: 21-SEP-2022 Reporter's comment: The pharmacist reported that a dose of Fluarix given to the patient and during administration there was leakage of the liquid, therefore the volume administered was lower than 0.5 ml (Milliliter). The reporter consented to follow up. Additional Supportive Information: The use of Fluarix to the patient and during administration there was leakage of the liquid, therefore the volume administered was lower than 0.5 ml, which led to incomplete dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Possible powder reconstituted with another diluent; Possible powder reconstituted with another diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 424JG, expiry date 28th July 2023) and (batch number FA95N, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, 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: 21-SEP-2022 Reporter's comment: The reporter was clinical coordinator.  The reporter stated that they had found 3 vials of Shingrix diluent and were doing an investigation, was unsure if three patients were given the powder reconstituted with another diluent.  The reporter had asked if there was any safety information provided or any harm to the patient.  The reporter had asked what he could do for it. The reporter was unsure and did not had a specific person/patient involved at that moment due to Healthcare professional investigating back from 15th August 2022 to 29th August 2022. The permission for consent to follow-up was denied. Additional Supportive Information: The patient was given the powder reconstituted with another diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with US2022135794 and US2022135797 reported by same reporter.; Sender's Comments:  US-GSK-US2022135794:Same reporter US-GSK-US2022135798:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Possible powder reconstituted with another diluent; Possible powder reconstituted with another diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 424JG, expiry date 28th July 2023) and (batch number FA95N, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, 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: 21-SEP-2022 Reporter's comment: The reporter was clinical coordinator.  The reporter stated that they had found 3 vials of Shingrix diluent and were doing an investigation, was unsure if three patients were given the powder reconstituted with another diluent.  The reporter had asked if there was any safety information provided or any harm to the patient.  The reporter had asked what he could do for it. The reporter was unsure and did not had a specific person/patient involved at that moment due to Healthcare professional investigating back from 15th August 2022 to 29th August 2022. The permission for consent to follow-up was denied. Additional Supportive Information: The patient was given the powder reconstituted with another diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with US2022135794 and US2022135797 reported by same reporter; Sender's Comments:  US-GSK-US2022135794:Same reporter US-GSK-US2022135797:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: patient had an injection site blister after her first dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was unknown.   It was unknown if the reporter considered the injection site blisters to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's comment: The pharmacist had reported that the patient had an injection site blister after her first dose of Shingrix. Since, this was a chat therefore; the Healthcare Professional (HCP) did not have any vaccine information or lot and expiry date. The reporter consent to follow-up was not asked.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema
Clinical narrative: small, red, non-itchy blister below injection site; red, below injection site; This case was reported by a consumer via call center representative and described the occurrence of blister in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had shingles more than 40 years ago). Previously administered products included Shingles vaccine (Patient also received shingles vaccine approximately 10-15 years ago).   In September 2022, the patient received the 2nd dose of Shingrix. In September 2022, less than 2 weeks after receiving Shingrix, the patient experienced blister and erythema. On an unknown date, the outcome of the blister and erythema were not recovered/not resolved.   It was unknown if the reporter considered the blister and erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comments: The case was reported by patient's wife. The reporter reported that patient received second dose of Shingrix approximately two weeks ago, in the left arm. Reporter reported patient noticed a small, red, non-itchy blister just below the injection site.  Reporter reported patient had Shingles more than 40 years ago, but thought the blister had the same appearance of those that accompanied their previous Shingles outbreak.  Reporter did not consent to follow up.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered an Expired Engerix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HBV (Engerix B) (batch number MY3RA, expiry date 21st September 2022) for prophylaxis.   On 22nd September 2022, the patient received Engerix B. On 22nd September 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: 22-SEP-2022 Reporter's comment: The registered nurse reported that a dose of Engerix B given today (on the day of reporting) to the patient and it was already expired. The reporter reported that the patient came in for a Engerix booster dose for school due to testing. The reporter inquired how to proceed.  The reporter did not consent to follow up. Additional Supportive Information: The use of Engerix B dose, which was already expired on 21st September 2022, which led to expired vaccine used.
Age: 5.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered Kinrix as the third dose in the DTaP series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 5-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered 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: 22-SEP-2022 Reporter's Comments:  The nurse reported that the patient was administered Kinrix as the third dose in the DTaP series. At the time of call, the nurse did not have the patient details, date of administration, lot number, expiration date, or the information of what vaccines were given for the first two DTaP series. The vaccine administration facility was the same as primary reporter The reporter give consent to follow up. Additional Supportive Information:  The patient received Kinrix as the third dose in the DTaP series which leads to Inappropriate age at vaccine administration, Inappropriate schedule at vaccine administration and wrong vaccine administration. This is 1 of 5 link cases reported by same reporter.; Sender's Comments:  US-GSK-US2022136456:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136459:same reporter US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136466:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136465:Same reporter
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 28 year old patient received a pediatric dose; 28 year old patient received a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 28-year-old female patient who received HBV (Engerix B pediatric) (batch number CM294, expiry date 19th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2022, the patient received Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 22nd September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were 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: 22-SEP-2022 Reporter's Comments: The reporter reported that the 28 years old patient received a pediatric dose of Engerix B. Additional Supportive Information:  The patient received a pediatric dose of Engerix B, which led to underdose and adult use of a child product.
Age: 8.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an 8 year old was administered Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix 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: 22-SEP-2022 Reporter's comment: The nurse reported that the 8 years old patient was administered Kinrix vaccines.  At the time of call, the nurse did not have the patient details, date of administration, or the information of what vaccines were given.  The reporter did not have the lot number/expiration date information of the doses.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: 8 years old patient was administered Kinrix vaccine, which led to inappropriate age at vaccine administration. This case was 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022136456:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136459:same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136466:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136465:Same reporter