chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Nausea, Pain
Clinical narrative: nausea; dizziness / increased in severity Jun/23/2021; Pain at injection site; BODY ACHES; This case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st June 2021, the patient received the 1st dose of Shingrix. On 21st June 2021, 30 min after receiving Shingrix, the patient experienced injection site pain and general body pain. On 22nd June 2021, the patient experienced dizziness. On 23rd June 2021, the patient experienced nausea. On 23rd June 2021, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the injection site pain, dizziness and nausea were unknown.   It was unknown if the reporter considered the injection site pain, general body pain, dizziness and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's child. The patient received first dose of shingrix and experienced injection site pain after 30 mins. On the same day in the evening the patient experienced body aches which ended in the morning of 23nd June 2021. One day after receiving vaccination the patient had dizziness that started in the morning of and increased in severity on 23rd June 2021. Two days after receiving vaccination the patient had nausea started in the morning.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Adult Havrix given to 5 patients under age 19; Adult Havrix given to 5 patients under age 19; This case was reported by a other health professional via sales rep and described the occurrence of adult product administered to child in a patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional information was provided as follow: The patient was under 19 years of age and received Havrix adult, which led to adult product administered to child and overdose. The reporter denied permission to follow up. This is 1 of the 5 cases reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137655:Same reporter US-GLAXOSMITHKLINE-US2021AMR137654:Same reporter US-GLAXOSMITHKLINE-US2021AMR137642:Same reporter US-GLAXOSMITHKLINE-US2021AMR137653:Same reporter
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Adult Havrix given to 5 patients under age 19; Adult Havrix given to 5 patients under age 19; This case was reported by a other health professional via sales rep and described the occurrence of adult product administered to child in a patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional information was provided as follow: The patient was under 19 years of age and received Havrix adult, which led to adult product administered to child and overdose. The reporter denied permission to follow up. This is 1 of the 5 cases reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137655:Same reporter US-GLAXOSMITHKLINE-US2021AMR137654:Same reporter US-GLAXOSMITHKLINE-US2021AMR137652:Same reporter US-GLAXOSMITHKLINE-US2021AMR137642:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: iT triggers IT! / FKD me up!/ suspected vaccination failure; iT triggers IT! / FKD me up!; This case was reported by a consumer via(Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, never had a flu one either and never needed that toxic stuff. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Age: 0.75
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9 month old received an adult dose of Hep-B vaccine; 9 month old received an adult dose of Hep-B vaccine; This case was reported by a other health professional via patient support programs and described the occurrence of overdose in a 9-month-old patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, 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.  Additional details provided were as follows: The 9 month old patient received an adult dose of Hepatitis B vaccine (Engerix B), which led to overdose and adult product administered to child. The reporter was told by the pediatrician that, there was nothing to worry about and the reporter therefore did not fill the PAE (patient adverse event) form and ended the call. No further details provided.
Sex: M
Vaccine: HEP
Symptoms: Immune system disorder, Skin disorder
Clinical narrative: skin broke out horribly / has serious skin issues / been suffering for years with skin issues; This shot altered his immune system; This case was reported by a consumer via interactive digital media and described the occurrence of skin breakdown in a male patient who received HBV (Engerix B) (batch number 5DE7C, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and hepatitis B vaccine pre-filled syringe device. On an unknown date, unknown after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, the patient experienced skin breakdown (serious criteria other: Serious per reporter) and immune system disorder. On an unknown date, the outcome of the skin breakdown and immune system disorder were unknown.   It was unknown if the reporter considered the skin breakdown and immune system disorder to be related to Engerix B and hepatitis B vaccine 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. The patient received Hepatitis B shot in 2016 and shot altered immune system. The reporter had another doctor wanting to make a test to see if this was the issue.  The patient skin broke out horribly and need a sample of this shot to provide to doctor.  The patient was saying that cannot get it but not giving up partnering as had serious skin issues.  The patient was suffering for years with skin issue.
Sex: M
Vaccine: VARZOS
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: administration /of the lless that 0,5 ml of the/ vaccine / While retrieving /the needle detached and a few drops fell of; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 59LK9, expiry date 18th December 2022) for prophylaxis.   On 18th June 2021, the patient received the 2nd dose of Shingrix. On 18th June 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported that patient received Shingrix and while retrieving the vaccine from the patient the needle detached and a few drops fell of, less than 0.5 ml of the Shingrix vaccine was administered, which led to accidental underdose. HCP did not consent nor deny follow up.  No further events were reported.
Age: 0.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave a 5 month old patient a dose of Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th June 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th June 2021, 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: A 5 month old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter agreed to follow-up preferably by email.
Age: 35.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: 3rd dose has not yet been administered; First dose / on 31-7-2019 and got another 6-11-2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 35-year-old male patient who received HAB (Twinrix) (batch number 3597P, expiry date 12th March 2022) 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, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received first dose on 31st July 2019).   On 6th November 2020, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 6th November 2020, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination 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 the vaccination was not applicable for the 3rd dose. The patient got another dose of Twinrix later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting patient had not received third dose which led to incomplete course of vaccination. The reporter consented to follow up. No additional information was shared.
Sex: F
Vaccine: TDAP
Symptoms: Product preparation issue
Clinical narrative: received a dose / that was not shaken vigorously to obtain a homogeneous, turbid, white suspension; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a 68-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number Z59N7, expiry date 8th October 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe (batch number Z59n7, expiry date 8th October 2022) for prophylaxis.   On 21st June 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 21st June 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate reconstitution technique. On an unknown date, the outcome of the inappropriate reconstitution technique was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were reported as follows: This case was reported by a pharmacist. Age at vaccination was not reported. Pharmacist reported  female patient received a dose of Boostrix that was not shaken vigorously to obtain a homogeneous, turbid, white suspension, which led to inappropriate reconstitution technique. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: varied from 13 to 18 months since their first dose / Second dose had not been given at time of report; 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 (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix (unknown). 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 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with cases US2021136326, US2021136325, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021136326:Same reporter US-GLAXOSMITHKLINE-US2021136325:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Incomplete course of vaccination
Clinical narrative: Patient experienced Bell's Palsy from their first Shingrix Vaccine; This case was reported by a physician via sales rep and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). Shingrix was discontinued. On an unknown date, the outcome of the bell's palsy was unknown.   The reporter considered the bell's palsy to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported a possible Shingrix adverse event for a patient of colleague from another health care professional practice. The patient had experienced Bell's Palsy from Shingrix.  The reporter's colleague had sent the patient to a neurologist who told the patient not to take the second Shingrix vaccine.  No information was known about the colleague or the patient who experienced Bell's Palsy. GSK representative gave permission to be contacted but health care professional did not give permission to be contacted by GSK .
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received her first dose in 7/2019.; 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 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 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 consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: On an unknown date in Dec2020 / received the first Engerix-B / did not return / to receive the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received HBV (Engerix B) 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 (1st dose received on December 2020, intramuscularly).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B 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 vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: have pain in her elbow under the injection site; had pain at the injection site for 3-4 days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain and pain in elbow. The patient was treated with diclofenac (Voltaren Gel). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the pain in elbow was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pain in elbow to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. Patient received dose of shingrix a month ago.  After getting the shot she stated that she had pain at the injection site for 3 to 4 days. She stated that the injection site pain resolved but she had developed and continued to have pain in her elbow under the injection site.  She had started rubbing voltaren gel on her elbow.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received their first dose on Jan 2020; 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 (1st dose received in January 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 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case was linked with case US2021137209, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021137209:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received their first dose on Jan 2020; 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 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 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case was linked with case US2021137206, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021137206:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, Product preparation issue
Clinical narrative: Found a lyophilized component / alone, without the adjuvant suspension; Found a lyophilized component / alone, without the adjuvant suspension; Circumstance or information capable of leading to medication error; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, they found a lyophilized component of Shingrix alone, without the adjuvant suspension. They were not aware of any patient receiving the adjuvant alone, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and circumstance or information capable of leading to medication error. The reporter consented to follow up.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Vaccination / with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (batch number G5BE3, expiry date 25th February 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix 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 age at vaccination was not reported. The reporter stated, about vaccination of a 15 month old female patient with an expired dose from infanrix the has been expirated since 25th February 2021. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: First dose / November 2019 / has not received the second / yet due to Covid pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 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 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. The reporter stated that, the patient did not received the second dose yet due to covid pandemic, which led to social problem. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st shot of Singrix 21 months ago and did 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 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 21 months ago, batch number - 3HX44, expiry date - 15 November 2021).   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 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose was administrated on 2018/The patient did not 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 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 for this report. Till the time of reporting, the patient did not receive nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: first dose of Shingrix on 12/20/2020/Due to personal reasons and COVID, she was not able to get second dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix received  on 20th 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 social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: This case was reported by patient. The age at the vaccination was not applicable. She did not have lot number and expiration date available.  Due to personal reasons and COVID, the patient was not able to get second dose of Shingrix within 2-6 months window was far out from the recommended schedule window and if she needs to restart the series. Therefore, the reporter do not have the following information dose, route of administration, date of administration and her date of birth and email address. The patient refused to provide any information about adverse event. The reporter does not want safety to follow-up with herself either. The reporter did not consent to follow-up.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12 yr old pt got infanrix; got  infanrix/ instead of 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 12-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 16th June 2021, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 16th June 2021, unknown after receiving Infanrix and Infanrix 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 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 12 year old patient received Infanrix instead of Boostrix, which led to inappropriate age at vaccine administered and wrong vaccine administered.  The reporter mentioned that, the patient had never received boostrix before.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first Shingrix vaccine on 6-30-2020. / will get his second Shingrix vaccine after speaking to his HCP; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 30th June 2020 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. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received second dose of Shingrix, which led to  incomplete course of vaccination. The reporter mentioned that, patient would get the second Shingrix vaccine after speaking to his health care professional. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: has received a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, 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:  The age at vaccination was not reported.  The patient has received a 3rd dose of Shingrix, which led to extra dose administered. No aware of vaccination Date, Lot Number or Expiry Date of vaccine were provided. All patient identifiers were reported but no other detail was provided when asked. The reporter consent to follow up.
Age: 10.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient/ received Kinrix as a 10-year-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old female 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 5th November 2018, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th November 2018, 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:  The nurse reported finding a vaccine record for a patient who received Kinrix as a 10 year old, which led to inappropriate age at vaccine administration. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose given on May 13th 2019/ is still valid in order to continue with 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 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th May 2019, batch number -9277N, expiry date 27th June 2021).   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 reporter asked if Shingrix first dose given on 13th May 2019 to a female patient was still valid in order to continue with shingrix second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: only did a single dose/ did not complete the two dose series; This case was reported by a physician 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 (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 follows: Ther 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. No more information was provided.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: administrated with an expired dose / on June 24 2021 / vaccine expired on June 14 2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 24th June 2021, unknown after receiving Pediarix and Pediarix 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 age at vaccination was not reported.  The patient was administrated with an expired dose of Pediarix, which led to expired vaccine used. No adverse event was reported. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: Patient under 50 years / showed with a prescription to get the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 37-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were provided are as follows: The age at the vaccination was not applicable. Pharmacist reported that a patient under 50 years of age showed with prescription to got her first dose of Shingrix ,which led to Intercepted drug prescribing error. The reporter was not sure if the patient was immunocompromised. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Redness/redness about a size of a golf ball/ was not raised or swollen.; Soreness; some warmth; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number DS754, expiry date 18th December 2022) for prophylaxis.   On 23rd June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th June 2021, 1 days after receiving Shingrix, the patient experienced erythema, pain and feeling of warmth. On an unknown date, the outcome of the erythema, pain and feeling of warmth were not recovered/not resolved.   It was unknown if the reporter considered the erythema, pain and feeling of warmth to be related to Shingrix.  Additional details were provided are as follows: The patient went back to doctor's office on 25th June 2021 to inform about adverse events from Shingrix. 1 day after vaccination in left deltoid, in late night, patient noticed redness about a size of a golf ball, soreness and some warmth. The reporter mentioned that the redness was not raised or swollen. The reporter provided her email address. The case was linked with case US2021103270 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021103270:same reporter
Sex: M
Vaccine: COVID19
Symptoms: Syndactyly
Clinical narrative: WEB TOES AND FINGERS; This spontaneous report received from a patient via a company representative from Social media concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had web toes and fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from web toes and fingers. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210635942-COVID-19 VACCINE AD26.COV2.S-Web toes and fingers . This event(s) is considered not related. The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Maternal exposure before pregnancy
Clinical narrative: MISCARRIAGE; VACCINE EXPOSURE DURING PREGNANCY; VACCINE EXPOSURE BEFORE PREGNANCY; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient never had miscarriage in life and had four healthy pregnancies carried to term. The patient was not pregnant at report time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient received vaccine in APR-2021 and in early MAY-2021, the patient became pregnant (vaccine exposure before pregnancy and vaccine exposure during pregnancy). The date of patient's last menstrual period and expected delivery date was not reported. In mid JUN-2021, the patient suffered a miscarriage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure before pregnancy, and vaccine exposure during pregnancy on JUN-2021, and the outcome of miscarriage was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210647257-covid-19 vaccine ad26.cov2.s-Miscarriage, This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210647257-covid-19 vaccine ad26.cov2.s-Vaccine exposure before pregnancy, Vaccine exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Angiocardiogram, Antinuclear antibody, Blood pressure measurement, Body temperature, C-reactive protein
Clinical narrative: ACUTE MYOCARDITIS; This spontaneous report was received from literature: Myocarditis Temporally Associated with COVID-19 Vaccination. Rosner et al.: Myocarditis after COVID-19 Vaccination. This report concerned a 28 year old male. The patient's height, and weight were not reported. The patient had no history of prior covid19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (3-7 days post vaccination), the patient was hospitalized for acute myocarditis-like illness. The patient also experienced acute onset chest pain and biochemical evidence of myocardial injury, by cardiac troponin I. The patient was hemodynamically stable and had no pericardial friction rub or rash. Electrocardiogram (ECG) patterns varied from normal to ST segment elevation. Echocardiograms showed left ventricular ejection fraction (LVEF) ranging from 35% to 62% with 5/7 having some degree of hypokinesis. The patient hospitalized for 2 days and symptoms resolved by hospital discharge. Treatment medication included beta-blocker, unspecified anti-inflammatory medication, aspirin, angiotensin converting Enzyme-Inhibitor(ACE-I) and clopidogrel (2 doses, stopped on discharge). Laboratory data (dates unspecified) included: ANA (NR: not provided) Negative, Blood pressure (NR: not provided) 145/82 mmHg, Body temperature (NR: not provided) 37 C, C-reactive protein (NR: not provided) 1.3 mg/dL, Cardiac MRI (NR: not provided) LVEF-50% (no regional wall motion abnormalities), Cardiac troponin I (NR: not provided) mean peak = 15.77ng/mL, median peak = 12.01ng/mL, Chest X-ray (NR: not provided) No acute pulmonary disease, Coronary angiograph (NR: not provided) No evidence of CAD, Echocardiogram (NR: not provided) LVEF-50%, LVIDd-4.8cm, IVS-1.0cm, RWMA-Mild global HKN, Electrocardiogram ST-T change (NR: not provided) 1mm ST elevation in II, V5-V6, Erythrocyte sedimentation rate (NR: not provided) 8 mm/h, Heart rate (NR: not provided) 70 bpm, PCR (NR: not provided) Negative, Respiratory viral panel (NR: not provided) Testing not obtained, SARS-CoV-2 IgG antibody test (NR: not provided) Negative, and WBC (NR: not provided) 8.08 (unit not reported).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute myocarditis. This case was reported to the vaccine adverse event reporting system (VAERS) and the CDC. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210650174- covid-19 vaccine ad26.cov2.s-Acute Myocarditis, . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).