chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: leg pain; Drug dose administration interval too short; This case was reported by a other health professional via call center representative and described the occurrence of leg pain in a adult female patient who received Herpes zoster (Shingrix) (batch number 44dx9, expiry date 28th October 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9k4t4, expiry date 8th October 2022) for prophylaxis.   On 10th July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th July 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced leg pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the leg pain was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the leg pain to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 12-Apr-2022 Reporter's comment: A pharmacy student stated that a patient in her 50's reported that she received both of her Shingrix vaccines in left arm and was having leg pain.   The patient was currently having leg pain.   The caller was unsure if the pain began after the first or second vaccine.  The caller had no further information in regard to the patient or symptoms reported. The reporter consented to follow-up. Additional Supportive Information: The patient received 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022064011:case created in error for 1st dose
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: raised skin after administration; red, area after the administration; tender, and hot area after the administration; hot area after the administration; knot unther the skin; This case was reported by a nurse via other manufacturer and described the occurrence of injection site swelling in a male patient who received HAV (Havrix) (batch number B23EA, expiry date unknown) for prophylaxis.   On 21st January 2022, the patient received Havrix. On an unknown date, less than 3 months after receiving Havrix, the patient experienced injection site swelling, injection site erythema, injection site tenderness, injection site warmth and injection site induration. The patient was treated with non-drug therapy (Warm Compress). On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site tenderness and injection site warmth were recovered/resolved and the outcome of the injection site induration was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site tenderness, injection site warmth and injection site induration to be related to Havrix.     Additional Information: GSK Receipt Date: 14-Apr-2022 Reporter's comments: The patient received Havrix in the left upper anterior lateral thigh. The patient experienced a raised, red, tender, and hot area after the administration of Havrix that was 2 inches in diameter. The patient still had a knot under the skin. The physician recommended treatment with a warm compress. The patient was fine except that the patient still had a knot under his skin and no further recommendations from the Physician was provided.  No additional adverse events reported. No product quality complaints reported. No further details were provided.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen lymph node; painful spot I believe it's the lymph node under my arm; This case was reported by a consumer via interactive digital media and described the occurrence of enlargement of lymph nodes in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th April 2022, the patient received Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced enlargement of lymph nodes and lymph node pain. On an unknown date, the outcome of the enlargement of lymph nodes and lymph node pain were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes and lymph node pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Apr-2022 Reporter's comments: This case was received from interactive digital media. This case was reported by the patient. The patient received Shingrix on the day before the reporting and had very painful spot which the patient believed as lymph node under arm. The patient experienced swollen lymph node.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Euphoric mood, Swelling, Tenderness
Clinical narrative: Raised area after administration, 3" diameter; Red area 3 inches diameter; Tender area 3 inches diameter; Hot area 3 inches diameter; This case was reported by a nurse via other manufacturer and described the occurrence of swelling in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, less than 9 months after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced swelling, erythema, tenderness and feeling hot. The patient was treated with non-drug therapy (Warm Compress). On an unknown date, the outcome of the swelling, erythema, tenderness and feeling hot were recovered/resolved.   It was unknown if the reporter considered the swelling, erythema, tenderness and feeling hot to be related to Kinrix and Kinrix Pre-Filled Syringe Device. 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: 14-APR-2022 Reporter's comment: The patient was administered Kinrix in the left upper anterior lateral thigh and experienced a raised, red, tender, and hot area after the administration of Kinrix that was 3 inches in diameter.  The physician recommended treatment with a warm compress.  The nurse reported that the patient was fine and no further recommendations from the physician was provided. No further details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node in armpit; This case was reported by a consumer via interactive digital media and described the occurrence of axillary lymph nodes enlarged in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th April 2022, the patient received the 2nd dose of Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced axillary lymph nodes enlarged. On an unknown date, the outcome of the axillary lymph nodes enlarged was unknown.   It was unknown if the reporter considered the axillary lymph nodes enlarged to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 13-APR-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had a swollen lymph node in his/her armpit. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza, Myalgia, Pyrexia
Clinical narrative: full on flu symptoms; muscle aches widespread; headache; chills; fever; This case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th April 2022, the patient received Shingles vaccine. In April 2022, less than a week after receiving Shingles vaccine, the patient experienced flu symptoms, muscle pain, headache, chills and fever. On an unknown date, the outcome of the flu symptoms, muscle pain, headache, chills and fever were unknown.   It was unknown if the reporter considered the flu symptoms, muscle pain, headache, chills and fever to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 13-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had got full on flu symptoms, muscle aches widespread, headache, chills and fever.  The patient honestly did not think that, he/she would feel like this. Hence, he/she was not getting booster. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Horrible rash all over torso and legs; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 8 days after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced a horrible rash all over his/her torso and legs. The patient received Shingles vaccine 8 days before the rash began. The patient asked could the vaccine had caused the rash. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient experienced rash after Shingles vaccine. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had 2 rounds of shingles, fully vaccinated/suspected vaccination failure; had 2 rounds of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 15th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient stated that he/she experienced 2 rounds of shingles after being fully vaccinated.  Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles not given.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles after having had the full vaccine.; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 16th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient reported that he/she contracted shingles after having full vaccination. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had 2 an just getting over shingles; Had 2 an just getting over shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 16th Apr 2022 Reporter's Comments: : This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient stated that shot did not help. The patient had 2 shots of shingles and just got over shingles.  Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: first dose 2 years ago, did not take second, sheltering during pandemic; This case was reported by a consumer via call center representative and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago of reporting date, at a local pharmacy).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: The reporter received a first dose of the Shingrix vaccine but did not take a second dose because he and his wife were sheltering during the worst part of the Covid pandemic. The reporter asked should they start the two-dose vaccine series from the beginning again or should they go ahead and take the second dose now. Additional Supportive Information: This case has been linked to US2022AMR066362, reported for patient's wife.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR066362:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: first dose 2 years ago, did not take second, sheltering during pandemic; This case was reported by a consumer via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 2 years ago of reporting date, at local pharmacy).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: The patient's husband reported the case. The patient received a first dose of the Shingrix vaccine but did not take a second dose because they were sheltering during the worst part of the Covid pandemic. The reporter asked should they start the two-dose vaccine series from the beginning again or should they go ahead and take the second dose now. Additional Supportive Information: This case has been linked to US2022AMR066360, reported for patient's wife.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR066360:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: never got the second, early days of the Covid lockdown; This case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (got 1st dose before Covid pandemic, was not sure about date but late 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient stated, got the first dose of Shingrix before Covid and never got the second as it was schedule in early days of the Covid lockdown. The patient asked, did he/she need to start over.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 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.   Previously administered products included Shingles  vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient came down with shingles right after second vaccine. The patient had not any boosters because he/she still afraid of might get shingles afterwards. Additional Supportive Information: The follow up would not be possible since no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the vaccine, got shingles anyway/Suspected vaccination failure; I got shingles anyway, in my 5th week; 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 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: 18th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient had the vaccine and never had chicken pox. The patient got shingles anyway. The patient was in 5 th week. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine and I still got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient got the vaccine and still got shingles. No guarantees. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the adjuvant part; received only the adjuvant part; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult female patient who received Herpes zoster (Shingrix) (batch number KZ455, expiry date 4th February 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. 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: 18-APR-2022 Reporter's Comments: Medical assistant reported that, the patient received only the adjuvant part of a shingrix vaccine. The reporter did not consent to follow-up. Additional Supportive Information: The patient received only the adjuvant part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the shot, but later had shingles also/Suspected vaccination failure; Later had shingles also.; 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: 17th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The case was reported by patient. The patient had shingles vaccine and later got shingles too. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, Feeling cold, Pain
Clinical narrative: Couldn't warm up the 1st night of vaccine; Body aches; Freakin burning up, temperature went up a bit; This case was reported by a consumer via interactive digital media and described the occurrence of feeling cold in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced feeling cold, general body pain and body temperature increased. On an unknown date, the outcome of the feeling cold, general body pain and body temperature increased were unknown.   It was unknown if the reporter considered the feeling cold, general body pain and body temperature increased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter self-reported the case. The patient could not warm up himself/herself the 1st night of vaccine with body aches and the next day, was freaking burning up, temperature even went up a bit.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got his vaccination and still got the Shingles/Suspected vaccination failure; Still got the 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) 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: 17th Apr 2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient had his shingles vaccine and still got the shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not given. The follow up would not be possible since no contact details provided.
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2nd Tdap catch-up dose was Infanrix; Patient 16 yo, 2nd Tdap catch-up dose was Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Boostrix (received 1st dose on 12th July 2021).   On 13th October 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 13th October 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong 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: 11-APR-2022  Reporter's Comments: Nurse stated a previously unvaccinated patient started catch-up immunizations at the age of 16.  The patient's first dose of the tetanus, diptheria, and pertussis series was a dose of Boostrix and the second catch-up dose was Infanrix. No further details provided.  Prior to transfer from first line specialist, the nurse became irritated and stated she did not want to answer any more questions.  Submitting event with limited details available. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Infanrix instead of Boostrix, which led wrong vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: Upset stomach, for approximately 1 year.; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a elderly 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 upset stomach. On an unknown date, the outcome of the upset stomach was unknown.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-Apr-2022 Reporter's comments: The reporter was an acquaintance of the patient. The reporter stated that the patient was in his seventies. The patient experienced upset stomach after receiving the Shingrix vaccine, which had continued for approximately 1 year.   The reporter did not consent to follow-up. The reporter provided limited information Additional Supportive Information: This case was linked with case US2022063355, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022063355:same reporter
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: circular swollen area at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA640Z, expiry date 30th November 2022) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 2G3PH, expiry date 27th October 2023) for prophylaxis.   On an unknown date, the patient received Menveo and Boostrix. On an unknown date, less than a month after receiving Menveo and Boostrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Menveo and Boostrix.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments:  The reporter states that the patient received Menveo and Boostrix on the same day then returned a few day later with a circular swollen area at the injection site. The reporter was provided outside phone number for GlaxoSmithKline medical information for future reference and warm transfer provided. The reporter consented to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered the kinrix vaccine at an inappropriate age; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 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: 12th Apr 2022 Reporter's Comments: The medical assistant reported that an unknown patient was administered the Kinrix vaccine at an inappropriate age.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Coronary arterial stent insertion, Myocardial infarction
Clinical narrative: Stents were placed at the LAD, RDA and the circumflex artery; Heart attack, at hospital 31-MAR-2022 to 2-APR-2022; This case was reported by a consumer via call center representative and described the occurrence of heart attack in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number Y537Z, expiry date 19th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st October 2021 with batch number 5P9DR and expiry date 20th March 2023).   On 5th January 2022, the patient received the 2nd dose of Shingrix. On 31st March 2022, 85 days after receiving Shingrix, the patient experienced heart attack (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced stent placement (serious criteria hospitalization). On an unknown date, the outcome of the heart attack and stent placement were unknown.   The reporter considered the heart attack to be related to Shingrix. It was unknown if the reporter considered the stent placement to be related to Shingrix.     Additional Information: GSK receipt date: 13-Apr-2022 Reporter's comment: The patient stated that she had a full workup of her heart last year in July 2021 and she had no issues at the time. The patient received 2 doses of Shingrix prior to discovery of heart attack.  On 31st March 2022, heart attack was discovered, when patient was getting a physical at her doctor's office. The patient was hospitalized on 2 separate occasions from 31st March 2022 to 2nd April 2022 and from 7th April 2022 to 8th April 2022 for placement of 3 stents.  Stents were placed at the LAD, RDA and the circumflex artery.  The patient reported never had any heart issues prior to receiving Shingrix and believed vaccine attributed to heart attack based upon that fact.  The patient reported having results, to support having no previous symptoms or evidence of heart disease/issues.  The patient reported clinic did not perform screening, so they (the patient) would have to provide those results. The reporter consented to follow up with healthcare professional. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site pruritus
Clinical narrative: injection site was red and very itchy; injection site was red and very itchy; did not receive the second injection until January of 2022; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female 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. On an unknown date, the patient received the 1st dose of Shingrix. In January 2022, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site itching and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-APR-2022  Reporter's Comments: The reporter was the patient.   She refused to provide demographics or answer questions.   The patient received her first dose of Shingrix in 2019 and the injection site was red and very itchy and did not receive the second injection until January of 2022.   Spoke per content.  No other information was provided concerning this event. The reporter declined to provide health care professional (HCP) information. The reporter did not consent to 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: 4.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Ear infection, Respiratory tract infection, Sneezing
Clinical narrative: respiratory tract infection; cough; sneezing; ear infection; This case was reported by a consumer via call center representative and described the occurrence of respiratory tract infection in a 4-year-old female patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   On 7th September 2021, the patient received the 1st dose of Engerix B pediatric (intramuscular) .5 ml. In September 2021, between 2 and 3 weeks after receiving Engerix B pediatric, the patient experienced respiratory tract infection, cough, sneezing and ear infection. On an unknown date, the outcome of the respiratory tract infection, cough, sneezing and ear infection were recovered/resolved.   It was unknown if the reporter considered the respiratory tract infection, cough, sneezing and ear infection to be related to Engerix B pediatric.     Additional Information: GSK receipt date: 13-Apr-2022 Reporter's comment: The reporter was the father of the patient.  The reporter's daughter received what the father believed to have been her first dose of Engerix-B into her left deltoid. Two and 1/2 weeks later she developed symptoms of a respiratory tract infection including cough, sneezing, and ear infection.  The reporter reported that the patient had these symptoms on and off until January 2022 when they symptoms resolved. Did not consent to follow-up. The reporter did not gave consent to contact health care professional.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong technique in product usage process
Clinical narrative: Incorrect Administration Procedure; This case was reported by a other health professional via call center representative and described the occurrence of wrong injection technique in a 61-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3A745, expiry date 12th March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 14th April 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong injection technique. On an unknown date, the outcome of the wrong injection technique 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: 15-APR-2022 Reporter's Comments: Pharmacy Intern reported that, the syringe plunger for Boostrix was jammed and she was not able to push the plunger when administering the vaccine to the patient. The patient did not receive the vaccine and she withdrew the needle and replaced the syringe with another needle, then was able to administer the vaccine. It was given in left deltoid. She used a 25g safety needle and therefore, product complaint ruled out. The agent informed the intern to use the LUER Lok needle going forward. Additional Supportive Information: Since the reporter used 25g safety needle instead of Luer lok needle, it led to wrong injection technique.
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child under 12 months of age was given Havrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old patient who received HAV (Havrix pediatric) (batch number 95ej7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th April 2022, the patient received the 1st dose of Havrix pediatric .5 ml and Havrix Pre-Filled Syringe Device. On 15th April 2022, unknown after receiving Havrix pediatric and Havrix 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: 15th Apr 2022 Reporter's Comments: The practice manager stating that a child under the age of 12 months was given Havrix.  She had no further demographics for the child.  The child was not having any side effects. The reporter consented to follow up. Additional Supportive Information: The 2 months old patient pediatric dose of havrix which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not gotten second dose; 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years before the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-Apr-2022 Reporter's comments: The pharmacist asked if the patient had her first shot of Shingrix 3 years ago and had not gotten her second dose, did she need to redo her first dose. The consent to follow up was given. No further details were provided via web form, submitted all available information. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Rash
Clinical narrative: Rash,  rash covered neck, arms, torso, and legs; swollen hands; severe Itching; Skin irritation; Pain; raised bumps; redness; This case was reported by a consumer via call center representative and described the occurrence of rash in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2022, the patient received the 1st dose of Shingrix. On 15th April 2022, 8 days after receiving Shingrix, the patient experienced rash, hand swelling, pruritus, skin irritation, pain, papular rash and erythema. The patient was treated with prednisone. On 17th April 2022, the outcome of the hand swelling was recovered/resolved. On an unknown date, the outcome of the rash, pruritus, skin irritation, pain, papular rash and erythema were not recovered/not resolved.   It was unknown if the reporter considered the rash, hand swelling, pruritus, skin irritation, pain, papular rash and erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: The patient self-reported this case. The patient reported developing swollen hands and a rash. The patient reported rash covered neck, arms, torso, and legs and was accompanied by severe itching, raised bumps, irritation, and redness.  The patient reported experiencing pain after scratching areas affected by the rash.  On 16-April-2022 the patient going to the urgent care and prescribed prednisone. The reporter stated prednisone had not helped in resolved the rash. On 17-April-2022, swelling in the hands was resolved. The rash and all symptoms associated with the rash (severe itching, redness, irritation, and raised bumps) were ongoing.  The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Skin irritation
Clinical narrative: Rash,  rash covered neck, arms, torso, and legs; swollen hands; severe Itching; Skin irritation; Pain; raised bumps; redness; This case was reported by a consumer via call center representative and described the occurrence of rash in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2022, the patient received the 1st dose of Shingrix. On 15th April 2022, 8 days after receiving Shingrix, the patient experienced rash, hand swelling, pruritus, skin irritation, pain, papular rash and erythema. The patient was treated with prednisone. On 17th April 2022, the outcome of the hand swelling was recovered/resolved. On an unknown date, the outcome of the rash, pruritus, skin irritation, pain, papular rash and erythema were not recovered/not resolved.   It was unknown if the reporter considered the rash, hand swelling, pruritus, skin irritation, pain, papular rash and erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: The patient self-reported this case. The patient reported developing swollen hands and a rash. The patient reported rash covered neck, arms, torso, and legs and was accompanied by severe itching, raised bumps, irritation, and redness.  The patient reported experiencing pain after scratching areas affected by the rash.  On 16-April-2022 the patient going to the urgent care and prescribed prednisone. The reporter stated prednisone had not helped in resolved the rash. On 17-April-2022, swelling in the hands was resolved. The rash and all symptoms associated with the rash (severe itching, redness, irritation, and raised bumps) were ongoing.  The reporter consented to follow up.