chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: took his first dose / over 2 years ago / forgot about the second shot.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix 2 years ago 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 provided as follows: The age at vaccination is not applicable to this report. The patient received 1st dose of Shingrix vaccination 2 years ago and forgot to receive the 2nd dose. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not have further information related to the patient. The reporter consented to follow-up.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose/ December 2020/did not have records/  received the second dose.; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B adult (received first dose in December 2020 with batch number 2224m and expiry date 1st March 2022).   On an unknown date, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at the vaccination was not applicable for this report. The Nurse Practitioner reported that till the time of reporting, the patient did not receive second dose of Engerix B adult, which led to incomplete course of vaccination. The reporter did not have records that the patient has received the second dose. No further information was provided. The vaccine administration facility was the same as primary reporter. The reporter did not consented to follow up.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Received an extra dose / on accident; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old male patient who received HBV (Engerix B) (batch number D423N, expiry date 1st June 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th July 2021, the patient received the 4th dose of Engerix B (intramuscular) .5 ml and Engerix B Pre-Filled Syringe Device. On 7th July 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that patient was fully vaccinated with Engerix-B and received an extra dose in accident,which led to extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Incomplete course of vaccination, Syringe issue
Clinical narrative: administration / less than recommended dose due to leaking needle; administration / less than recommended dose due to leaking needle; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd June 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 23rd June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete dose administered and syringe leak. On an unknown date, the outcome of the incomplete dose administered and syringe leak 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 details were provided as follows: The age at vaccination was not reported. The patient administered Bexsero vaccine less than recommended dose due to leaking syringe, which led to incomplete dose administered and syringe leak. The reporter stated that, the exact date of administration was unknown, reported as 2 weeks ago.  No additional information regarding lot number or expiration date or patient demographics was known by the health care professional  at the time of reporting. The reporter consented to follow up.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: patient received a pediatric dose / on July 7th, 2021; patient received a pediatric dose / on July 7th, 2021; patient received a pediatric dose / on July 7th, 2021; 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 25-year-old female patient who received HAV (Havrix 360 Junior) (batch number N592C, expiry date 12th June 2022) for prophylaxis.   On 7th July 2021, the patient received the 1st dose of Havrix 360 Junior. On 7th July 2021, unknown after receiving Havrix 360 Junior, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and underdose. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and underdose were unknown.  Additional details were reported as follows: The adult female patient received pediatric dose of Havrix. Health care professional called and asked if the patient can receive another pediatric dose of havrix to complete adult dose. The patient didn't received till second dose of havrix. Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose on 12/15/2020 / wondered if they can get the second dose today; This case was reported by a consumer 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 15th December 2020).   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 case was reported by the patient for herself. 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 patient wondered if she could get the 2nd dose on the day of reporting as she was at the pharmacy. The patient inquired if she can get the 2nd dose or she needed to start over. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Extra dose administered, Hepatitis B virus test positive, Inappropriate schedule of product administration, Viral titre increased
Clinical narrative: recently had titer testing / titers came back positive / Pharmacist definitely said "titers were positive"; received a 3 dose series of hepatitis B / (95, 29-june-95 and 9-feb-96) / received Engerix B / today; Drug dose administration interval too long; This case was reported by a pharmacist via call center representative and described the occurrence of hepatitis b positive in a 13-day-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On 8th July 2021, the patient received Engerix B. On 9th February 1996, the patient received the 3rd dose of Hepatitis B vaccine. On 29th June 1995, the patient received the 2nd dose of Hepatitis B vaccine. In 1995, the patient received the 1st dose of Hepatitis B vaccine. On 9th February 1996, not applicable after receiving Engerix B, Hepatitis B vaccine and Hepatitis B vaccine, unknown after receiving Hepatitis B vaccine, not applicable after receiving Engerix B, Hepatitis B vaccine and Hepatitis B vaccine and not applicable after receiving Engerix B, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced hepatitis b positive (serious criteria GSK medically significant) and extra dose administered. On an unknown date, the outcome of the hepatitis b positive, extra dose administered and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the hepatitis b positive to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine.  Additional details were provided as follows: The pharmacist reported that the patient had received 3 dose series of Hepatitis B in 1995 to 1996 and now checked the titer which came positive for Hepatitis B. The patient 3rd dose longer than recommended interval, which led to lengthening of vaccine schedule. The patient received Engerix B on same day of reporting, which led to extra dose administered. The medical program director was requiring patient to be fully vaccinated by 4th October. Pharmacist was not sure of Hepatitis B brand administered but thought Recombivax, later it was determined during conversation with caller that it may not be Recombivax. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: Patient who is off schedule / received / 1st or 2nd doses / in 2020 and due to covid are / coming / to finish / series; This case was reported by a nurse via call center representative and described the occurrence of social problem in a adult male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st and 2nd dose received in 2020).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced social problem. On an unknown date, the outcome of the social problem 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 age at vaccination was not reported. The patient received their 1st or 2nd doses of Twinrix in 2020 and due to covid are not coming back in to finish their series, which led to social problem. The reporter consent to follow up vis email. This case has been linked with case US2021AMR150415 and US2021AMR150416 reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR150415:Same reporter. "Some patients" who only got 1st dose. US-GLAXOSMITHKLINE-US2021AMR150416:Same reporter. "Some patients" who only got 1st and 2nd dose.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Incomplete course of vaccination, Injection site bruising, Injection site pruritus, Injection site swelling
Clinical narrative: received her first / vaccine on September, 26, 2019 / never got her second dose; about 10 minutes after receiving her vaccine / arm began itching and lasted a while; arm was bruised from her injection site down to her elbow and it lasted for days; arm was swollen; felt tired on the day of her vaccination; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 26th September 2019, 10 min after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site itching, injection site bruising, injection site swelling and tiredness. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the injection site itching and injection site bruising were recovered/resolved and the outcome of the injection site swelling, tiredness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the injection site itching, injection site bruising, injection site swelling and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The patient received 1st dose of Shingrix and about 10 minutes after receiving vaccine her arm began itching and lasted a while.  The patient also stated that her arm was bruised from her injection site down to her elbow and it lasted for days, arm was swollen and patient felt tired on the day of her vaccination. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient stated that she never got her second dose. No additional information provided by the patient. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received her first Shingrix vaccine a year ago and never got the second vaccine; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of 0.5 ml by intramuscular route received 1 year ago from the date of reporting).   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 case was reported by the patient's for herself. The age at vaccination was not applicable for this report. She reported that, the patient never got the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Infanrix instead of Boostrix; 11 year-old patient may have received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 30th June 2021, unknown after receiving Infanrix and Infanrix 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 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 patient had received Infanrix dose in error instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration  The reporter clarified after the report of that their investigation showed that the patient who received the Infanrix dose in error could be the patient of or the patient of the case. The reporter consented to follow up. This case is linked to the case US2021149593 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021149593:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the diluent portion of the Shingrix vaccine; only the diluent portion of the Shingrix vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9lt3g, expiry date 25th October 2022) for prophylaxis.   On 29th June 2021, the patient received Shingrix. On 29th June 2021, 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 details were provided as follows: The age at the vaccination was not reported. The patient had administered only the diluent portion of the Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further events were reported. The reporter consented follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received 3 doses /Dose 1: 11/5/2020/ Dose 2:01/7/2021/ Dose 3:07/01/2021; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number J454X, expiry date 4th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 5th November 2020, (batch number zj432, expiry date 27th May 2022)) and Shingrix (received 2nd dose on 7th January 2021, (batch number zj432, expiry date 27th May 2022)).   On 1st July 2021, the patient received the 3rd dose of Shingrix. On 1st July 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: Age at vaccination was not reported. The reporter reported that the patient received 3 doses of Shingrix, which led to extra dose administered. The vaccine administration facility was the same as primary reporter. No further information reported. The reporter consented to follow up.
Sex: F
Vaccine: MEN
Symptoms: Hyposplenism, Product administered to patient of inappropriate age
Clinical narrative: functional asplenia; a 68 year-old / 6 years ago received a conjugated vaccine (either Menactra or Menveo); This case was reported by a pharmacist via call center representative and described the occurrence of functional asplenia in a 68-year-old female patient who received Men ACWY-CRM NVS (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On an unknown date, unknown after receiving Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, the patient experienced functional asplenia (serious criteria GSK medically significant) and inappropriate age at vaccine administration. On an unknown date, the outcome of the functional asplenia and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the functional asplenia to be related to Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The 68 year old patient had functional asplenia that 6 years ago received a conjugated vaccine (either Menactra or Menveo), which led to inappropriate age at vaccine administration and there was no records on that shot. The reporter consented to follow up.  No lot or expiration date of product since not received at that location.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a Bexsero second dose early/ First dose: Jun 22nd 2021/Second dose: Jul 7th 2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA70BA, expiry date 31st October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 9th July 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 9th July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and an unknown time after receiving Bexsero, 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.   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: Nurse reported that, the patient received a Bexsero second dose early than the minimum recommended interval, which led to shortening of vaccination schedule. Nurse was looking for information about Bexsero accelerated schedule. No further information reported. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: fever spiked to 101 degrees; developed a headache; was tired; her RIGHT arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 7th July 2021, 3 hrs after receiving Shingrix, the patient experienced pain in arm. On 8th July 2021, the patient experienced fever, headache and tiredness. The patient was treated with ibuprofen (Advil). On 8th July 2021, the outcome of the pain in arm was recovered/resolved. On 9th July 2021, the outcome of the headache and tiredness were recovered/resolved. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fever, headache and tiredness to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient herself. The patient received 1st dose of Shingrix and about 3 hours later her right arm was sore, which was resolved next day. On the next day in the afternoon her fever spiked to 101 degrees, she developed a headache and was tired. The fever was down to 99, but not completely resolved.  The reporter stated that her pharmacist instructed her to take advil for the fever. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix about 2 years ago and has not received the second dose yet; This case was reported by a other health professional 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 of shingrix 2 years ago from reporting 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 provided as follows: The reporter was a pharmacy intern. The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the 2nd dose of Shingrix, which led to incomplete course of vaccination. The Vaers details were reported for 1st dose. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included shingrix (received 1st dose in November 2020). 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 provided were as follows: The reporter was patient's husband. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not get the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. No additional details were provided by the reporter.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient was administrated with an expired dose of Engerix -b on April 9 2021/vaccine expired on February 22 2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 22nd February 2021) for prophylaxis.   On 9th April 2021, the patient received Engerix B. 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 details provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient was administered an expired dose of Engerix B, the vaccine was expired on 22nd February 2021, which led to expired vaccine used. No adverse event was reported. No patient identifier and no lot number was provided. The reporter declined to follow-up.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 18 year old patient received and adult dose of Havrix; 18 year old patient received and adult dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HAV (Havrix adult) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th July 2021, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 9th July 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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 details provided as follows: Health care provider reported that 18 year old patient received adult dose of Havrix which led to overdose and adult product administered to child. The health care provider wanted to know how to proceed in this case. The reporter consented to follow-up.
Sex: U
Vaccine: HEPA
Symptoms: Wrong technique in product usage process
Clinical narrative: a nurse accidently grab the wrong dose of HepA and now I have a PFS with capped needle on it, how long is it good for?"; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process 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 wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process 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 reported as follows: The age at vaccination was not applicable for this report. The reporter was licensed practitioner nurse and asked how long would Havrix A PFS good for when syringe was opened and capped with a needle. The reporter had a nurse who accidently grabbed the wrong dose of HepA and now the reporter had that PFS with capped needle on it and asked how long would it good for. The reporter did not consent to follow-up.  No further information was shared. The reporter's consent for follow up was not asked since the case was received on chat
Age: 1.92
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A  23 month old patient / was vaccinated on June9th with Boostrix; 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 23-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9L39Z, expiry date 8th October 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th June 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 9th June 2021, unknown after receiving Boostrix and Boostrix 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: The health care professional reported that a 23 months old patient had received Boostrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Dose #1 on January 06,2021 / wants to know when he should get dose #2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th January 2021, intramuscularly).   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: This case was reported by the patient himself/ herself. The age at vaccination was not applicable for this report. The patient received first dose of Shingrix and till the time of reporting did not receive the second dose, which led to incomplete course of vaccination. The patient wanted to know when he could take the second dose. Limited information was provided by the patient. The patient also stated that he was in a hurry.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1st dose / on 03Sep2018 and is late for the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 3rd September 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. The pharmacist reported that the patient was late for the 2nd dose and did not receive it, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: was administrated with an early second dose / dose was administrated 21 days after the first dose; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, 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.   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. The patient received first dose of Bexsero and 21 days after was administered second dose, which led to drug dose administration interval too short. No adverse event was reported. The vaccine administration facility is the same as primary reporter. No patient's identifiers was provided, no lot number and expiration date was provided, no vaccination date provided. The reporter did not consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient is late for the second dose / first dose was administrated on May 24 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-b (received 1st dose on 24th May 2019).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Engerix-b vaccine, which led to incomplete course of vaccination. No adverse events was reported. No patient's identifiers was provided No LOT number and expiration date was provided The reporter did not consented to follow up.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Seizure
Clinical narrative: had a seizure after getting the Bexsero vaccine / has other seizures since getting the Bexsero vaccine; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 15-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Menactra (received on an unknown date).   On 22nd July 2019, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 2 years after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was not recovered/not resolved.   It was unknown if the reporter considered the seizure to be related to Bexsero and Bexsero 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 reporter was mother of the patient. The patient received 1st dose of Bexsero on 22nd July 2019 on an unknown arm. The patient had received the Menactra vaccine prior to getting the Bexsero vaccine, no information on the date or side effects were reported. The patient had a seizure after getting the Bexsero vaccine and has other seizures since getting the Bexsero vaccine.  The mother reports her son was on medication for seizures but did not disclose the name of the medication. The reporter would not provide any address, name of son, or any other details of her son's adverse events until someone from safety contacts her regarding the Bexsero vaccine her son received. The reporter did not consent to followup.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient had first shingrix shot in 2018 do they need to restart series; 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 (received 1st dose 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 for this report. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter asked did they need to restart series. The reporter had no further detail, including details regarding patient or product.  The reporter stated that the patient not actually our patient just came in asking. The consent to follow up was not asked for this reason.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received an Engerix-B dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received HBV (Engerix B) (batch number 2NK52, expiry date 28th February 2021) for prophylaxis.   On 10th July 2021, the patient received Engerix B. On 10th July 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 details were reported as follows: On 10th July 2021, patient received a dose of Engerix B, which was expired on February 2021. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose /on 10/21/2020 /not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on 21st October 2020).   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, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination  No further events were reported. The health care professional agreed to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose/ on 05Aug2019 / second dose/not /been administered; 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 in 5th 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 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 pharmacist was unable to locate lot number and expiration date of first dose. No further information was reported. The pharmacist gave permission for follow up. The case had been linked with US2021151021, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151021:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose of Shingrix received on 5th 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 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 pharmacist was unable to locate lot number and expiration date of first dose. No further information was reported. The pharmacist provided permission for follow-up. The case had been linked with US2021151018, reported by the same reporter; Sender's Comments: US-GLAXOSMITHKLINE-US2021151018:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Overdose
Clinical narrative: received 0.6 mL of Shingrix instead of 0.5 mL; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .6 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were reported as follows: The patient received 0.6 mL of Shingrix instead of 0.5 mL, which led to overdose. No more information available since reporter was not at work. Due to communication issues, a lot of information was not requested or tried to be confirmed after reporter mentioned the limited data available due to them not being at work. The reporter consented to follow up. This case has been linked with case ID US2021151036, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151036:Same reporter
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: vaccine in May 2021 / was diagnosed with bell's palsy in June 2021 / has not fully resolved; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2021, the patient received the 1st dose of Shingrix. In June 2021, less than 2 months after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not reported however it could be 73 or 74 years. The Patient had received the first dose of shingrix in May 2021 and he was diagnosed with bell's palsy in June 2021. He was currently taking medication for the bell's palsy. The bell's palsy had not fully resolved. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: The first dose was administrated on 2019./No 2nd dose was administrated yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date in 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. No adverse event was reported after 1st dose.  Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. Patient's identifiers, LOT number, expiration date and vaccination date was not provided. The health care professional needed to look for all the information regarding the first dose. The reporter consented to follow up