chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Off label use
Clinical narrative: has the intention of giving Shingrix to a 43 year-old patient; This case was reported by a physician via call center representative and described the occurrence of off label use in a 43-year-old female patient who received Herpes zoster (Shingrix) (batch number P57AA, expiry date 7th May 2021) and (batch number 7L355, expiry date 28th August 2021) for prophylaxis.   Concurrent medical conditions included herpes zoster (chronic in nature). Concomitant products included acyclovir.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The reporter stated that, he had the intention of giving Shingrix to a 43 year-old patient because the patient had zoster chronic and she was taking Acyclovir, which was a off label use. The reporter had bought this Shingrix vaccines 2 years ago of the reporting date and stored appropriately in the fridge for 2 years between 36 to 46 degree F. Lot Number for powder was 7L355 and expiry date 28th August 2021 and Lot Number for liquid portion was reported as TS7AA which was corrected to P57AA as per sales data sheet and expiry date 7th May 2021. Also, the batch number reported for powder seems to be of shingrix adjuvant as per sales data and therefore kept as per sales data sheet. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: The patient was given three doses / 1. 12/12/2019 / 2. 12/19/2020 / 3. 4/9/2021; first Shingrix vaccine / on December 12, 2019; the second / on December 19, 2020.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 95JR5, expiry date 5th November 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th December 2019).   On 9th April 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 19th December 2020, the patient received the 2nd dose of Shingrix. On 19th December 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 9th April 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Shingrix, which led to extra dose administered. All information was not available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: delayed for their second dose of shingrix/ First dose / Nov 2049; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if patient can continue with 2nd dose or should restart the series. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021080779:same reporter - same patient
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Choking sensation, Dysphonia, Fatigue, Headache, Lethargy
Clinical narrative: does not feel right.; tightening of her throat; felt like she was choking; severe fatigue; muscle aches / described / felt like her legs were going to fall off; headaches; lethargy; sore throat progressively worsened; raspy voice; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2021 06:30, the patient received the 1st dose of Shingrix (intramuscular). In April 2021, 12 hrs after receiving Shingrix, the patient experienced fatigue, myalgia of lower extremities, headache, lethargy, sore throat, hoarse voice and choking sensation. On an unknown date, the patient experienced feeling unwell and throat tightness. On an unknown date, the outcome of the fatigue, myalgia of lower extremities, headache, lethargy, sore throat, hoarse voice, feeling unwell, choking sensation and throat tightness were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, myalgia of lower extremities, headache, lethargy, sore throat, hoarse voice, feeling unwell, choking sensation and throat tightness to be related to Shingrix.  Additional details were reported as follows: The patient reported receiving her first dose of the Shingrix vaccine at 6:30PM. The patient stated that she does not feel right. The patient further described this feeling by describing her symptoms. She stated that on the next morning at 9:30AM, she started to have severe fatigue, muscle aches, headaches, lethargy, raspy voice, and a sore throat. She stated that her sore throat progressively worsened and she felt like she was choking on the evening of 8th April 2021 and had to drink water. She further described her sore throat by describing it as a tightening of her throat. She further described her muscle aches by stating that it felt like her legs were going to fall off. She states that the fatigue, muscle aches, headaches, lethargy, raspy voice, and sore throat was still present and not resolved. Patient declined to provide an address or fax number for herself. Patient was unable to provide an email address or fax number for her HCP as well as the dosage and lot number or expiration date for the first Shingrix dose she received. GRC rep did not obtain the phone number of the health care professional. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Oropharyngeal pain, Throat tightness
Clinical narrative: does not feel right.; tightening of her throat; felt like she was choking; severe fatigue; muscle aches / described / felt like her legs were going to fall off; headaches; lethargy; sore throat progressively worsened; raspy voice; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2021 06:30, the patient received the 1st dose of Shingrix (intramuscular). In April 2021, 12 hrs after receiving Shingrix, the patient experienced fatigue, myalgia of lower extremities, headache, lethargy, sore throat, hoarse voice and choking sensation. On an unknown date, the patient experienced feeling unwell and throat tightness. On an unknown date, the outcome of the fatigue, myalgia of lower extremities, headache, lethargy, sore throat, hoarse voice, feeling unwell, choking sensation and throat tightness were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, myalgia of lower extremities, headache, lethargy, sore throat, hoarse voice, feeling unwell, choking sensation and throat tightness to be related to Shingrix.  Additional details were reported as follows: The patient reported receiving her first dose of the Shingrix vaccine at 6:30PM. The patient stated that she does not feel right. The patient further described this feeling by describing her symptoms. She stated that on the next morning at 9:30AM, she started to have severe fatigue, muscle aches, headaches, lethargy, raspy voice, and a sore throat. She stated that her sore throat progressively worsened and she felt like she was choking on the evening of 8th April 2021 and had to drink water. She further described her sore throat by describing it as a tightening of her throat. She further described her muscle aches by stating that it felt like her legs were going to fall off. She states that the fatigue, muscle aches, headaches, lethargy, raspy voice, and sore throat was still present and not resolved. Patient declined to provide an address or fax number for herself. Patient was unable to provide an email address or fax number for her HCP as well as the dosage and lot number or expiration date for the first Shingrix dose she received. GRC rep did not obtain the phone number of the health care professional. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Asking if patient can receive the second dose / Last dose / was in Oct 2018.; This case was reported by a nurse 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 (received 1st dose in Octoer 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if the patient should receive 2nd dose or should restart the series. The reporter did not consent to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Allergic to flu shot I end  up in the hospital; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic reaction (serious criteria hospitalization). On an unknown date, the outcome of the allergic reaction was recovered/resolved.   It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient was going on 67 years at the time of reporting. The age at vaccination was not reported. The patient had not had chicken pox. The patient was allergic to flu shot and ended up in the hospital. After three years the patient was ok and thought she should take Shingrix or zoster vaccine. The reporter consented to follow up.
Age: 0.08
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 2 month of age patient received a dose of Kinrix instead of Pediarix; A 2 month of age patient received a dose of Kinrix instead of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th March 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 15th March 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 2 month old patient received Kinrix instead of Paediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reported batch number was not found in sales data sheet, hence was updated to HB7L7. The reporter consented to follow up.
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave a Kinrix vaccine to a 4-month old baby; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The reported stated that one of his nurse gave a Kinrix vaccine to a 4 month old baby by error, which led to inappropriate age at vaccine administration.  At the moment of the call pharmacist did not have any patient´s details or exact date of occurrence so he asked for time to reach out with the nurse. The reporter consented to follow up.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Occupational exposure to product, Syringe issue
Clinical narrative: while reconstituting / the needle popped out from the syringe / some of the liquid got into the eye her eye; occupational exposure; This case was reported by a pharmacist via call center representative and described the occurrence of exposure via eye contact in a 45-year-old female patient who received Herpes zoster (Shingrix) (batch number X7Z52, expiry date 5th November 2022) for prophylaxis.   On 9th April 2021, the patient received Shingrix. On 9th April 2021, unknown after receiving Shingrix, the patient experienced exposure via eye contact and occupational exposure while preparing product for administration. On an unknown date, the outcome of the exposure via eye contact and occupational exposure while preparing product for administration were unknown.  Additional details were reported as follows: The patient received Shingrix that while reconstituting a Shingrix vaccine the needle popped out from the syringe and some of the liquid got into the eye her eye, this happened on the same day as reported which led to exposure via eye contact and occupational exposure while preparing product for administration. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of Engerix-B / given on 09Apr2021 / expired on 05Feb2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 97Y27, expiry date 5th February 2021) for prophylaxis.   On 9th April 2021, the patient received Engerix B (unknown). On 9th April 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received an expired dose of vaccine. The reporter could not provide follow up due to them not being able to be in the premises at any time in the future. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on 01-Aug-2020 / second dose on 05-Sep-2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 3AG4G, expiry date 28th March 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th September 2020, the patient received the 2nd dose of Shingrix. On 5th September 2020, unknown after receiving Shingrix,the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: On 1st August 2020, the patient received 1st dose of Shingrix. The patient received 2nd dose of Shingrix less than recommended time frame, which led to shortening of vaccination schedule. The reporter consented to follow up via phone.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccinereceived dose one of Shingrix and 2018 / has not received dose two; 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 in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The patient did not received the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. No further information reported.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose was given on 20Aug2019 / Second dose had not been administered at time of call; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 20th August 2019.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The patient did not received the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. No further information reported. The reporter consented to follow up. This case has been linked to US2021082155, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021082155:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose was given on 20Aug2019 / Second dose had not been administered at time of call; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The patient did not received the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. No further information reported. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021082156:same reporter
Age: 4.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; has received 3 doses of Menveo (1st - 23May2019, 2nd - 04Feb2020, 3rd - 28Jul2020).; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 4-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose received on 23rd May 2019). Concurrent medical conditions included sickle-cell anemia.   On 28th July 2020, the patient received the 3rd dose of Menveo. On 4th February 2020, the patient received the 2nd dose of Menveo. On 4th February 2020, not applicable after receiving Menveo and unknown after receiving Menveo, the patient experienced extra dose administered. On 28th July 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: The patient received 3 doses of Menveo, which led to extra dose administered. No symptoms reported. The health care professional did not provide the lot and expiry for each dose. The consent to follow-up was granted. This case had been linked with US2021082162, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021082162:same reporter
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; received 3 doses of Menveo (1st - 23May2019, 2nd - 04Feb2020, 3rd - 28Jul2020).; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 7-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose received on 23rd May 2019). Concurrent medical conditions included sickle-cell anemia.   On 28th July 2020, the patient received the 3rd dose of Menveo. On 4th February 2020, the patient received the 2nd dose of Menveo. On 4th February 2020, not applicable after receiving Menveo and unknown after receiving Menveo, the patient experienced extra dose administered. On 28th July 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 3 doses of Menveo, which led to extra dose administered. No symptoms reported. The health care professional did not provide the lot and expiry date for each dose. The consent to follow-up was granted. This case had been linked with US2021082161, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021082161:same reporter
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: given / Boostrix / subcutaneously in the left arm.; This case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 52-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 8th December 2020, the patient received Boostrix (subcutaneous). On 8th December 2020, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The patient reported case for herself. The age at vaccination was not reported, however could be 51 or 52 years. The patient was given an unknown formulation of Boostrix subcutaneously in the left arm, which led to intramuscular formulation administered by other route. The reporter did not consent to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A patient who was too young received a dose of Kinrix; This case was reported by a other health professional via sales rep 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 at an unknown dose 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 details were provided as follows: This case was reported by GlaxoSmithKline representative on behalf of healthcare professional. The age at vaccination was not reported.  The patient was too young received a dose of Kinrix, which led to inappropriate age at vaccine administration. The contact information was for the healthcare professional. The reporter consented to follow up. No further information was reported.
Sex: U
Vaccine: HEPA
Symptoms: Hypersensitivity
Clinical narrative: Experienced an allergy reaction following a dose of Havrix; This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was recovered/resolved.   It was unknown if the reporter considered the allergic reaction to be related to Havrix and Havrix 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 details were reported as follows: The age at vaccination was not reported. In 2018, the patient a dose of Havrix. The reporter asked about components of Havrix due to the patient experienced an allergy reaction following the dose of Havrix. No more information was reported. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose / in 2018 but did not receive 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on unknown date in 2018, 2 years ago from reporting day).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if to start the series. No further information was available. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Delayed second shingrix dose / first dose on Nov 25th 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 25th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report. The reporter inquired about delayed 2nd dose of Shingrix.  Till the date of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked should the series be continued or restarted. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / 1.25 years ago / never received the second / dose because / the coronavirus pandemic; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix 1.25 years ago).   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 details were provided as follows: The patient reported the case for herself. The age at vaccination was not applicable to this report. The patient never received the 2nd dose of Shingrix because the patient did not leave her home due to the coronavirus pandemic and till the time of reporting, the patient had not scheduled a 2nd dose of Shingrix. The patient declined to provide any demographic or contact information due to privacy concerns and stated she had prior negative experiences with privacy concerns. No further information was reported. The reporter did not consent to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st Shingrix Vaccine dose on September 13th, 2020 / 2nd dose / on April 12th, 2021 / second dose of Shingrix vaccine 7 months after receiving 1st dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th September 2020).   On 12th April 2021, the patient received the 2nd dose of Shingrix. On 12th April 2021, 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 details were provided as follows: The case was reported by the patient himself. The patient received 2nd dose of Shingrix on right arm later than recommended schedule, which led to lengthening of schedule. It was stated that patient was administered second dose of Shingrix vaccine 7 months after receiving 1st dose. The reporter did not consent to follow up.
Sex: F
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Hiberix / reconstituted using sterile water instead of the correspondent diluent; patient received Hiberix / reconstituted using sterile water instead of the correspondent diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 1-year-old female patient who received Hib (Hiberix) (batch number FT775, expiry date 25th June 2022) for prophylaxis.   On 9th April 2021, the patient received Hiberix. On 9th April 2021, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported but could be less than a year or 1 year. The patient received Hiberix that was reconstituted using sterile water instead of the correspondent diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not consent to follow up. The reported batch number SE775 for Hiberix was not available in sales data sheet, hence updated to FT775.
Sex: M
Vaccine: VARZOS
Symptoms: COVID-19, Dyspnoea, Feeling abnormal, Malaise, Oxygen therapy
Clinical narrative: sick with COVID; he was sick; short of breath; felt bad; breathing issues; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included transplant. Concurrent medical conditions included immunocompromised.   On 20th November 2020, the patient received the 1st dose of Shingrix. On 22nd November 2020, 2 days after receiving Shingrix, the patient experienced covid-19, sickness, shortness of breath, feeling bad and abnormal breathing. The patient was treated with oxygen. On an unknown date, the outcome of the covid-19, sickness, shortness of breath, feeling bad and abnormal breathing were recovered/resolved.   It was unknown if the reporter considered the covid-19, sickness, shortness of breath, feeling bad and abnormal breathing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had transplant in past and because of transplant patient was currently immunocompromised. The patient received the dose of Shingrix and 2 days after the vaccination patient was sick with COVID for 30 days The patient also experienced shortness of breath,felt bad and breathing issue. The patient did test for covid and result was neagative. The patient used oxygen for six days. The patient later visited pulmonologists through Jan and Feb 2021 for his breathing issues and by the 1st March 2021 patient felt better. The reporter did not consent to follow up. The patient refused to provide any demographic information or pharmacy information.
Sex: M
Vaccine: VARZOS
Symptoms: Respiration abnormal, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: sick with COVID; he was sick; short of breath; felt bad; breathing issues; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included transplant. Concurrent medical conditions included immunocompromised.   On 20th November 2020, the patient received the 1st dose of Shingrix. On 22nd November 2020, 2 days after receiving Shingrix, the patient experienced covid-19, sickness, shortness of breath, feeling bad and abnormal breathing. The patient was treated with oxygen. On an unknown date, the outcome of the covid-19, sickness, shortness of breath, feeling bad and abnormal breathing were recovered/resolved.   It was unknown if the reporter considered the covid-19, sickness, shortness of breath, feeling bad and abnormal breathing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had transplant in past and because of transplant patient was currently immunocompromised. The patient received the dose of Shingrix and 2 days after the vaccination patient was sick with COVID for 30 days The patient also experienced shortness of breath,felt bad and breathing issue. The patient did test for covid and result was neagative. The patient used oxygen for six days. The patient later visited pulmonologists through Jan and Feb 2021 for his breathing issues and by the 1st March 2021 patient felt better. The reporter did not consent to follow up. The patient refused to provide any demographic information or pharmacy information.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: itching on the injection site; swelling on the injection site; redness on the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LH9L, expiry date 4th October 2021) for prophylaxis.   On 10th February 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site itching, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient experienced a reaction (itching, redness and swelling) on the injection site after vaccination with Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: the first dose of Shingrix on 15Jun2020 / Second dose had not been given at time of call; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th June 2020, lot no:2737P; expiry date:22nd January 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter called to request information on how to proceed for the second dose for this patient.  The reporter consented to follow up. As per sales data sheet reported 1st dose batch number was changed from Z737P to 2737P.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of Engerix was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-day-old male patient who received HBV (Engerix B) (batch number 4G33C, expiry date 19th March 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 13th April 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that an expired dose of Engerix was given to a patient. No symptoms reported. The reporter consented to follow-up.
Age: 0.92
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 month old patient received a dose of Kinrix instead of the Pediarix; 11 month old patient received a dose of Kinrix instead of the Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 12th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made  without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 11 month old patient received dose of Kinrix instead of Pediarix in the left leg, which led to wrong vaccine administered and inappropriate age at vaccine administration. No other reactions reported. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received their Shingrix vaccines 3 yrs ago, late dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follow: The case was reported by consumer itself. The patient received 1st dose of Shingrix 3 years ago. The patient was late for 2nd dose of vaccination and led to incomplete course of vaccination. The information regarding 2nd dose administration was not provided. No further information was provided. This case is linked with US2021AMR084088 with same reporter for different patient (husband). The consumer did not consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR084088:same reporter (Husband´s case)
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix/ in January 2020 / never received / second dose because of COVID; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020 in left arm).   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 details were provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix because of COVID. The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Bursitis, Condition aggravated, Mobility decreased, Rash, Serum sickness
Clinical narrative: olecranon bursitis / left arm / also present in right arm; exacerbation of osteoarthritis in right arm; skin rash; I could hardly move my arm; its almost like a serum sickness; This case was reported by a consumer via call center representative and described the occurrence of olecranon bursitis in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID 19 VACCINE.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 7 days after receiving Shingrix, the patient experienced olecranon bursitis, osteoarthritis aggravated, rash, mobility decreased and serum sickness. The patient was treated with celecoxib (Celebrex), paracetamol (Tylenol), aspirin and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the olecranon bursitis, osteoarthritis aggravated and rash were not recovered/not resolved and the outcome of the mobility decreased and serum sickness were unknown.   It was unknown if the reporter considered the olecranon bursitis, osteoarthritis aggravated, rash, mobility decreased and serum sickness to be related to Shingrix.  Additional details were provided as follows: The reporter reported for himself. The patient received 1st dose of Shingrix 2 to 3 weeks ago on left arm. The patient about 7 days later had experienced olecranon bursitis (started with left arm, but now also present in right arm), skin rash, and exacerbation of osteoarthritis in right arm. The patient also stated that olecranon bursitis was present in the same arm the vaccine was given. The patient also had rash that does not look like chickenpox. The patient could hardly move his arm. he also stated that no side effects in lower extremities. The patient felt like a serum sickness. The patient received Covid vaccine in February. The patient mentioned that side effects were present but getting better. The patient was using ice, Celebrex, Tylenol as needed, and took aspirin for heart. The patient was not worried about the side effects because it was getting better, but would discuss with his healthcare provider on his next appointment. The patient did not have lot number or expiration date of Shingrix. No other information was provided. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose was on July 2019 / never received Shingrix second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was a pharmacist Intern. The age at vaccination was not applicable for this report. The patient never received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter was looking for guidance on a late Shingrix 2nd dose. The reporter consented to follow up by fax.