chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Illness
Clinical narrative: feel like crap; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date:17-May-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient just received Shingles shot and felt like crap. The patient knew that it would not last.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Lymphoma, Vaccination failure
Clinical narrative: Had the shingles vaccine and still got them/Suspected vaccination failure; Lymphoma; Still got shingles; 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 (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), lymphoma (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, lymphoma and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, lymphoma and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-MAY-2022 Reporters comment: The case was reported via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles when he was first diagnosed with the lymphoma and he had a bad case at the time of passing. The patient stated that, stress could bring them on even though you have had the vaccine. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles was unknown at the time of reporting. Follow up would not be possible as contact details were not available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Vaccination failure
Clinical narrative: received Shingrix doses, diagnosed with shingles; shingles on one side of face and neck; blister out on face and leg; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 2nd dose of Shingrix. In August 2021, the patient received the 1st dose of Shingrix. In May 2022, less than 5 months after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 18-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient was diagnosed with shingles on one side of face and neck last week from the date of reporting. In the week of reporting, the patient had one blister came out on right side of face and right leg. The patient also just completed a week's prescription of Valacyclovir. The patient stated, this was not helpful. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles was unknown at the time of reporting. Follow up would not be possible as contact details were not available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Both times arm hurt; 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.   Linked case(s) involving the same patient:US2022AMR081302   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had no reaction with the first shingles shot but arm was hurt for a while. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR081302 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081302:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: Both times arm hurt; I had chills; 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.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2022AMR081295).   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 in arm and chills. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the pain in arm and chills to be related to Shingles vaccine.  Linked case(s) involving the same patient: US2022AMR081295   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had no reaction with the first shingles shot.  The patient had chills that night after having the second shot of shingles. The patient arm was hurt both times for a while. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081295:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Arm is red and hot; Arm is red and hot; Swollen arm; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15th May 2022, the patient received Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced erythema of extremities, extremities hot feeling of and swelling arm. On an unknown date, the outcome of the erythema of extremities, extremities hot feeling of and swelling arm were not recovered/not resolved.   The reporter considered the erythema of extremities, extremities hot feeling of and swelling arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient arm was red, swollen and hot from Shingles vaccine received on Sunday. It had spread. The patient wanted to know what he/she could do to return to normal. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on abdomen; This case was reported by a nurse via sales rep and described the occurrence of rash in a female 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comment: The patient developed rash on abdomen after taking Shingrix vaccine. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: 2 shingles vaccine,  I have had a severe painful breakout/suspected vaccination failure; painful breakout; painful breakout; 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), 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: 16-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient had a severe painful breakout. The patient was inquiring if GlaxoSmithKline ever issued a refund for vaccine that did not work. The patient was unemployed at the time of reporting and not in a position to pay for things that did not work. The patient was only asking to have reimbursed his/her out of pocket cost. The patient had included a copy of his/her insurance claim that he/she had to pay for the 2nd shot. His/her insurance covered the 1st shot. The patient also attached a picture of the breakout. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles was unknown at the time of reporting. Follow up would not be possible as contact details were not available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the shot years ago  I just got the shingles/Suspected vaccination failure; I just got the shingles about 3 months ago; 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. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. The patient received Shingles vaccine, years ago from the date of reporting. After receiving Shingles vaccine, the patient got shingles about 3 months ago from the date of reporting and they were absolutely very painful. The patient was put on a prescription which helped somewhat. The patient also used roll on aspirin cream and it actually helped a lot. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding completion of the primary immunization, time to onset for event and laboratory test confirming shingles was unknown at the time of reporting. Follow up would not be possible as contact details were not available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had both of them but I still get the shingles/suspected vaccination failure; I still get the shingles/mostly in my back under the skin only a very small place.; Painful; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles at 33 years of age, also dealt with them for 34 years). Previously administered products included Shingles vaccine (received very first time at the age of 60 years).   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), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   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: 18-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. The patient first got shingles at 33 years of age when she lost her 9 years old son in an accident. Doctors back then said she was too young for the shingles, they were wrong.  10 years ago, from the date of reporting, she lost her husband and had dealt with them for 34 years.  The patient had the very first vaccine at 60 then when the new 2 dose vaccine came out, she had both of them.  The patient had the shots for almost a year and had shingle breakouts numerous times. The Pharmacist told her that it would lessen the severity and it did, but she still got the shingles.  It was mostly in her back, now breaking out under the skin and only a very small place came out. Still very painful but she had them a lot worse. The patient did recommend the new shingles shots because they were not as severe.  The patient stated that, the vaccine would not keep you from getting the shingles, it would lessen the severity of them. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding laboratory test confirming shingles was unknown at the time of reporting. Follow up would not be possible as contact details were not available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain after injection; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK receipt date: 19-MAY-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient enquired, could he/she take ibuprofen for arm pain after Shingrix injection. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Had my 2nd dose yesterday and now have body aches; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th May 2022, the patient received the 2nd dose of Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-May-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self-reported this case. The patient received 2nd dose of Shingrix one day before the reporting and now patient had body aches. The patient asked that was this event was common. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had vaccine but still got shingles/suspected vaccination failure; shingles; pain horrible for weeks; 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 and shingles were unknown and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. The patient did not have rash, but pain was horrible for weeks. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding completion of the primary immunization, time to onset for event and laboratory test confirming shingles was unknown at the time of reporting. Follow up would not be possible as contact details were not available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shots hurt; 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 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.     Linked case(s) involving the same patient: US2022AMR081873   Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the dose of Shingles vaccine and shot hurt but so worth it to never go through that again. The patient reported that it was one of the most painful thing he/she ever gone through. Additional supportive information: The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081873:Same reporter
Age: 41.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: it was 142 days between second and third dose, 1st dose: 11/3/21, 2nd dose: 12/13/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 41-year-old male patient who received HAB (Twinrix adult) 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 3rd November 2021).   On 13th December 2021, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 13th December 2021, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, 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.   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: 12-MAY-2022 Reporter's Comment: Pharmacist called in to enquire about Twinrix dosing. Pharmacist stated it was 142 days between second and third dose, was this okay, a week early. )n 4th May 2022, patient received 3rd dose of Twinrix. Did not consent to follow-up. Additional Supportive Information: The patient received 3rd dose of Twinrix within 142 days after 2nd dose, earlier than recommended interval, which led to shortening of vaccination schedule. The patient received 2nd dose, later than recommended interval, which led to lengthening of schedule.
Age: 86.0
Sex: M
Vaccine: UNK, UNK, VARZOS
Symptoms: Arthralgia, Condition aggravated, Herpes zoster, Product use in unapproved indication, Rash
Clinical narrative: seen by a dermatologist who stated that the patients rash was shingles; the rash was worse as it was creeping down his leg and spreading below his knee; 1st dose same day that was seen by the physician because of a rash in his inner thigh and knee pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included cephalexin (Keflex) unknown for rash and hydrocortisone ointment for rash.   Previously administered products included Zostavax (received dose on an unknown date). Concurrent medical conditions included rash (rash in inner thigh) and knee pain.   On 10th May 2022, the patient received the 1st dose of Shingrix, Keflex at an unknown dose and frequency and hydrocortisone at an unknown dose and frequency. On 10th May 2022, unknown after receiving Shingrix and not applicable after starting Keflex, the patient experienced drug use for unapproved indication. On 11th May 2022, the patient experienced shingles and rash aggravated. The patient was treated with acyclovir. Keflex was discontinued. Hydrocortisone was discontinued. On an unknown date, the outcome of the shingles, rash aggravated and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the shingles and rash aggravated to be related to Shingrix and Keflex.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's Comments: Reporter was the wife of the patient.   The reporter stated, the patient received his first dose of Shingrix on Tuesday and the patient also was seen by the physician that day complaining of a rash in his inner thigh and knee pain.  The patient was prescribed Keflex and Hydrocortisone ointment for the rash.   The following day, on 11th May 2022, the rash was worse as it was creeping down his leg and spreading below his knee.   On 12th May 2022, Thursday, the patient was seen by a dermatologist who stated that the patients rash was shingles.   The dermatologist stopped the Keflex and Hydrocortisone cream and applied Acyclovir. Reporter did not have information regarding the specifics of the Shingrix vaccine The reporter consented to follow up. On 11th May 2022, 1 day after receiving Keflex and Hydrocortisone and Shingrix vaccine, the patient experienced rash aggravated and shingles. It was unknown if the reporter considered the rash aggravated and shingles to be related to Hydrocortisone. Additional Supportive Information: The patient received 1st dose of Shingrix, on same day that was seen by the physician because of a rash in his inner thigh and knee pain, which led to drug use for unapproved indication.
Age: 86.0
Sex: M
Vaccine: UNK, UNK, VARZOS
Symptoms: X-ray limb normal
Clinical narrative: seen by a dermatologist who stated that the patients rash was shingles; the rash was worse as it was creeping down his leg and spreading below his knee; 1st dose same day that was seen by the physician because of a rash in his inner thigh and knee pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included cephalexin (Keflex) unknown for rash and hydrocortisone ointment for rash.   Previously administered products included Zostavax (received dose on an unknown date). Concurrent medical conditions included rash (rash in inner thigh) and knee pain.   On 10th May 2022, the patient received the 1st dose of Shingrix, Keflex at an unknown dose and frequency and hydrocortisone at an unknown dose and frequency. On 10th May 2022, unknown after receiving Shingrix and not applicable after starting Keflex, the patient experienced drug use for unapproved indication. On 11th May 2022, the patient experienced shingles and rash aggravated. The patient was treated with acyclovir. Keflex was discontinued. Hydrocortisone was discontinued. On an unknown date, the outcome of the shingles, rash aggravated and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the shingles and rash aggravated to be related to Shingrix and Keflex.     Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's Comments: Reporter was the wife of the patient.   The reporter stated, the patient received his first dose of Shingrix on Tuesday and the patient also was seen by the physician that day complaining of a rash in his inner thigh and knee pain.  The patient was prescribed Keflex and Hydrocortisone ointment for the rash.   The following day, on 11th May 2022, the rash was worse as it was creeping down his leg and spreading below his knee.   On 12th May 2022, Thursday, the patient was seen by a dermatologist who stated that the patients rash was shingles.   The dermatologist stopped the Keflex and Hydrocortisone cream and applied Acyclovir. Reporter did not have information regarding the specifics of the Shingrix vaccine The reporter consented to follow up. On 11th May 2022, 1 day after receiving Keflex and Hydrocortisone and Shingrix vaccine, the patient experienced rash aggravated and shingles. It was unknown if the reporter considered the rash aggravated and shingles to be related to Hydrocortisone. Additional Supportive Information: The patient received 1st dose of Shingrix, on same day that was seen by the physician because of a rash in his inner thigh and knee pain, which led to drug use for unapproved indication.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Patient 3 years and 6 month old inadvertently received a dose; It was the 3 dose of the TDAP series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 21st April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 16-MAY-2022 Reporters comment: Nurse reported that the patient inadvertently received a dose of Kinrix at the age of 3 years 6 months. It was the 3rd dose of the TDAP series. The reporter consented to follow up. Healthcare professional wanted to remain anonymous but gave consent to follow up. Additional supportive information: The patient inadvertently received a dose of Kinrix at the age of 3 years 6 months, which led to inappropriate age at vaccine administration which was the 3rd dose of the TDAP series, which led to inappropriate schedule of vaccine administered.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 11-nov-21,2nd dose on 12-apr-22; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 28-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (the patient received 1st dose of Engerix B on 11th November 2021).   On 12th April 2022, the patient received the 2nd dose of Engerix B. On 12th April 2022, unknown after receiving Engerix B, 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: 16-MAY-2022 Reporter's Comment: The healthcare professional reported that, the patient did not come back for the second dose after receiving the first dose and received it on 12th April 2022 and the third dose was not administered yet. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose later then recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in November 2021/came back in 6 months and would like to know how to proceed; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female 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 (patient received the first dose of Twinrix vaccine in November 2021).   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: 16-MAY-2022 Reporter's Comment: The reporter reported that, the patient should have came in 1 month, but came back in 6 after 1st dose and would like to know how to proceed. The reporter consented to follow-up but did not give information to follow-up as she did not want anything to be sent over in her name. The reporter preferred someone follow-up by phone to the manager of the store, as that was not her regular store. Additional Supportive Information: The reporter reported that, the patient should have came in 1 month, but came back in 6 after 1st dose and would like to know how to proceed, which led to incomplete course of vaccination.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: this patient had already received a flu dose back in January 2022; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 19-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 42M9S, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Flu vaccine (received a dose of Flu vaccine in January 2022 was not manufactured by GlaxoSmithKline).   On 12th May 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 12th May 2022, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra 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: 16-May-2022 Reporter's comment: Licensed vocational nurse reported that the patient received Flulaval dose and on the day of reporting they realized that this patient had already received a flu dose back in January 2022.  The reporter consented to follow-up. Additional Supportive Information: The patient received Flulaval  as an extra dose of Flu vaccine, which led to extra dose administered.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Erythema, Herpes zoster, Immunisation reaction
Clinical narrative: blisters behind ear, back of head, neck and chest; 2 by 3 inch red streak down left arm/red streak below injection site; pain to elbow, hand and forearm; elbowpain; shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles to face and cornea when she was 4 years old and again at 27 years). Previously administered products included Zostavax (received Zostavax at age 60).   On 10th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th May 2022, 1 days after receiving Shingrix, the patient experienced erythema of extremities. In May 2022, the patient experienced shingles, pain in arm and pain in elbow. On 17th May 2022, the patient experienced blister. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles, erythema of extremities and pain in elbow were unknown and the outcome of the pain in arm and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles, erythema of extremities, pain in arm, blister and pain in elbow to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comments: The reporter was the patient and also a nurse. The patient received first dose of Shingrix into left deltoid. A day and a half later patient developed a two by three inch red streak down her left arm. The red streak started below the injection site. Last week patient had pain to her left elbow, hand and forearm. On the day of reporting  patient had blisters behind her left ear, back of head, left side of neck and left side of chest. The patient saw her doctor on the day of reporting and was diagnosed with shingles and prescribed Acyclovir.  The doctor told her Shingrix caused the shingles outbreak. The reporter did not know batch number or expiration date. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site streaking, Pain in extremity
Clinical narrative: blisters behind ear, back of head, neck and chest; 2 by 3 inch red streak down left arm/red streak below injection site; pain to elbow, hand and forearm; elbowpain; shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles to face and cornea when she was 4 years old and again at 27 years). Previously administered products included Zostavax (received Zostavax at age 60).   On 10th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th May 2022, 1 days after receiving Shingrix, the patient experienced erythema of extremities. In May 2022, the patient experienced shingles, pain in arm and pain in elbow. On 17th May 2022, the patient experienced blister. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles, erythema of extremities and pain in elbow were unknown and the outcome of the pain in arm and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles, erythema of extremities, pain in arm, blister and pain in elbow to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comments: The reporter was the patient and also a nurse. The patient received first dose of Shingrix into left deltoid. A day and a half later patient developed a two by three inch red streak down her left arm. The red streak started below the injection site. Last week patient had pain to her left elbow, hand and forearm. On the day of reporting  patient had blisters behind her left ear, back of head, left side of neck and left side of chest. The patient saw her doctor on the day of reporting and was diagnosed with shingles and prescribed Acyclovir.  The doctor told her Shingrix caused the shingles outbreak. The reporter did not know batch number or expiration date. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix administration after temperature excursion/vaccines were exposed to freezing conditions; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received DTPa (Reduced antigen) (Boostrix) (batch number J7E93, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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:17-May-2022 Reporter's comments: The pharmacist reported the Boostrix maladministration as Boostrix vaccines were exposed to freezing conditions The consent to follow up was given. Additional Supportive Information: The patient received Boostrix that was exposed to freezing conditions, which led to incorrect storage of drug.
Sex: U
Vaccine: DTAP
Symptoms: Incomplete course of vaccination
Clinical narrative: Patients do not have DTaP vaccine series completed on schedule by 7th birthday; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTPa vaccine (unspecified doses received on an unknown dates).   On an unknown date, the patient did not receive DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, 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: 17-May-2022 Reporter's comments: The physician reported that she was seeing more and more patients in practice that did not have DTaP vaccine series completed on schedule by 7th birthday. The vaccine details and patient details unavailable at the time of call. The consent to follow up was given.  Additional Supportive Information: The patients were not completing DTPa schedule by 7th birthday, which led to incomplete course of vaccination.This case had been linked with US2022079726, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022079726:Same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: 1st dose on 27-SEP-2019 2nd dose on 17-MAY-2022; During administration the patient move the arm so it was not a complete dose; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 5A9GE, expiry date 3rd June 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th September 2019, batch number KJ9N5, expiry date 17th October 2021).   On 17th May 2022, the patient received the 2nd dose of Shingrix. On 17th May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long and incomplete dose administered. On an unknown date, the outcome of the drug dose administration interval too long and incomplete dose administered were unknown.   Additional Information: GSK Receipt Date: 17-MAY-2022 Reporters comment: The patient received 2nd dose of Shingrix in an unknown arm. The patient received 2nd dose of Shingrix late but during the administration, the patient moved the arm, so it was not a complete dose. 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 but during the administration, the patient moved the arm, so it was not a complete dose, which led to incomplete dose administered.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022079744:Same Reporter
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: the adjuvant was not mixed with the lyophilized powder; the adjuvant was not mixed with the lyophilized powder; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 72A32, expiry date 8th July 2023) for prophylaxis.   On 18th May 2022, the patient received Shingrix. On 18th May 2022, 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: 18-May-2022 Reporter's comment: Pharmacist reported that the patient was administered Shingrix adjuvant only, the adjuvant was not mixed with the lyophilized powder. The reporter consented to follow-up. Additional Supportive Information: The patient only received Shingrix adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of Shingrix in 2017,  second dose on May 17th 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2017).   On 17th May 2022, the patient received the 2nd dose of Shingrix. On 17th May 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: 13-MAY-2022 Reporter's Comment: Registered pharmacist reported that a patient was administered second dose on 17th May 2022. Health care professional (HCP) wanted to knewwhat would be the best way to handle this situation Demographics from patient were asked but not provided by HCP neither lot number or expiration date The reporter accidentally forgot to ask for follow up Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: 11 y/o received 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 16th November 2021).   On 16th May 2022, the patient received the 2nd dose of Menveo. On 16th May 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comments: Health care professional (HCP) reported that a patient who received primary vaccination of Menveo and received 2nd dose of Menveo. The reporter consented to follow-up. Additional Supportive Information: The 11 year old patient received 2nd dose of Menveo, which led to extra dose administered.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody, Therapy non-responder
Clinical narrative: No protective antibodies against hep b; This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 1st dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comment: Nurse practitioner reported that a patient received three doses of hepatitis B vaccine (manufacturer unknown) and now patient had no protective antibodies against hepatitis B. Did not consent to follow-up. Additional Supportive Information: The patient received 3 doses of Hepatitis B and had no protective antibodies against hepatitis B, which led to therapy non-responder.