chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Sleep disorder, Tinnitus
Clinical narrative: Tinnitus / is still present / hearing high pitch sound; Did not let him fall asleep / using sleeping aid; This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a male patient who received Herpes zoster (Shingrix) (batch number 5DH34, expiry date 10th December 2021) for prophylaxis.   Previously administered products included SHINGRIX with an associated reaction of no adverse event (1st dose received in 9th March 2021,lot number 73E59, Expiry date 19th November 2021,No adverse event reported by the reporter for the 1st dose). Concomitant products included Herpes zoster (Shingrix).   On 22nd June 2021 14:00, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd June 2021, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced sleeplessness. On 22nd June 2021 18:30, the patient experienced tinnitus. The patient was treated with prednisone and lorazepam. On an unknown date, the outcome of the tinnitus was not recovered/not resolved and the outcome of the sleeplessness was recovering/resolving.   It was unknown if the reporter considered the tinnitus and sleeplessness to be related to Shingrix.  Additional case details were provided as follows: The case was reporter by the patient.  The age at vaccination was not reported. The patient received the 2nd dose of Shingrix vaccine around 2 pm and started experiencing tinnitus same day around 6:30 pm.  The patient elaborated tinnitus as hearing high pitch sound, which did not let him fall asleep.  The patient was using sleeping aid (lorazepam or Z-Quil) to help him go to sleep, also used noise maker (fan) so that it cancels out the high pitch sound for him to fall asleep.  Around 26th July 2021, the patient had been able to go to sleep with out sleeping aid or fan/external sound, however, tinnitus was still present. Health care professional (HCP) prescribed prednisone for 9 days, but that did not help.  The patient was also referred to see EENT (eyes/ears/nose/throat) doctor and was told that tinnitus should go away. The reporter consented to follow up. The reporter gave a consent to follow-up with HCP, however, he did not have fax number or email address
Age: 62.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose / given at 1 month; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old male patient who received HAV (Havrix) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   Concomitant products included HAV (Havrix).   On 12th August 2021, the patient received the 2nd dose of Havrix. On 12th August 2021, unknown after receiving Havrix and an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The nurse reported that the patient received 2nd dose earlier than the recommended interval, which led to shortening of vaccine schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient didn´t received / second dose at time; 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 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. 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 consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure/second /shot / in May of 2019/ in / 2021 / Shingles; Shingles rash; Rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient received the 1st dose of Shingrix. On 28th May 2021, 2 years after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details provided were as follows: The age at vaccination was unknown for 1st dose of Shingrix. This case was reported by the patient herself. The patient had her second Shingrix shot in unknown deltoid 2 years ago. In May 2021, she experienced Shingles and had shingles rash for over 12 weeks. It was not resolved. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. The patient was advised to take follow-up with her health care professional. No batch number and expiry date for the vaccine was provided. The reporter declined to provide health care professional information and did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: mildly sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient inquired about Shingrix vaccine and Guillain-Barré Syndrome. The patient stated that he had the first dose of Shingrix with no side effects with the exception of a mildly sore arm. The reporter was referred to health care professional. The reporter consented to follow up.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult/ received a pediatric dose of Havrix.; adult/ received a pediatric dose of Havrix.; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HAV (Havrix pediatric) (batch number YR532, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th August 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 13th August 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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 nurse reported that adult patient received a pediatric dose of Havrix, which led to underdose and adult use of child product. The HCP (health care professional) consented to follow-up.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received shingrix /was under 50 years /was not /immunocompromised; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2019, the patient received the 1st dose of Shingrix. On 10th November 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The patient received 1st dose and the patient was under 50 years of age and was not considered immunocompromised, which led to inappropriate age at vaccine administration. The patient never got the 2nd dose. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: vaccinated / with a non-approved diluent; Menveo reconstituted with a nonapproved; This case was reported by a nurse via call center representative and described the occurrence of incorrect dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA399A, expiry date 30th September 2021) for prophylaxis.   On 13th August 2021, the patient received the 1st dose of Menveo. On 13th August 2021, unknown after receiving Menveo, the patient experienced incorrect dose administered and wrong solution used in drug reconstitution. On an unknown date, the outcome of the incorrect dose administered and wrong solution used in drug reconstitution were unknown.  Additional details were provided as follows: The reporter stated that, the patient vaccinated with the powder portion of Menveo reconstituted with a non approved diluent, which led to  incorrect dose administered and wrong solution used in drug reconstitution.  The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Headache; Swollen arm; Pain in arm; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2021, the patient received the 1st dose of Shingrix .5 ml. On 11th August 2021, less than a day after receiving Shingrix, the patient experienced headache, swelling arm and pain in arm. On 12th August 2021, the outcome of the headache and swelling arm were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the headache, swelling arm and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient stated that, she received her first dose of Shingrix,  later that same day, she began to experience headache, swollen arm and pain in arm.  The headache and arm swelling resolved by the next day on 12th August 2021. The patient stated that, the soreness in her arm has not resolved.  No lot number or expiration date of the vaccine was known.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received /first dose /on/2019/ not / the second 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 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 had no patient or vaccine data. The reporter consented to follow up via email.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the liquid adjuvant; Patient received only the liquid adjuvant; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 3N3GH, expiry date 28th January 2023) for prophylaxis.   On 14th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 14th July 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 are as follows: The reporter was the doctor. The patient received only the liquid adjuvant of Shingrix intramuscularly without the active component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The lot number of the powder vial in the box (which was not administered) was 75xa2, expiration date 28th January 2023. The reporter consented to follow-up. This case has been linked with case US2021171383, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021171383:Same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the liquid adjuvant; Patient received only the liquid adjuvant; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 3N3GH, expiry date 28th January 2023) for prophylaxis.   On 21st July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 21st July 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 are as follows: The patient received only the liquid adjuvant of Shingrix intramuscularly without the active component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The lot number of the powder vial in the box (which was not administered) was 75xa2, expiration date 28th January 2023. The reporter consented to follow-up. The case has been linked with case US2021171382 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021171382:Same reporter.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 1 year old / received an adult dose; 1 year old / received an adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 1-year-old male patient who received HAV (Havrix 1440 adult) (batch number HA9Y9, expiry date 17th 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 13th August 2021, the patient received the 1st dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 13th August 2021, unknown after receiving Havrix 1440 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 were provided as follows: The medical assistant reported that, a 1 year old patient received an adult dose of Havrix instead of a pediatric dose, which led to adult product administered to child and overdose  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Blood bilirubin increased
Clinical narrative: Total bilirubin was 1.7 in June, after receiving first dose; This case was reported by a consumer via call center representative and described the occurrence of bilirubin total increased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix. In June 2021, less than a month after receiving Shingrix, the patient experienced bilirubin total increased. On an unknown date, the outcome of the bilirubin total increased was recovering/resolving.   It was unknown if the reporter considered the bilirubin total increased to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for himself. The age at vaccination was not reported. The patient reported that, he received 1st dose of Shingrix vaccine and total bilirubin was 1.7 in june. The reporter did not consent to follow-up. The limited demographics and details obtained, due to reporter disconnecting call abruptly after being told that they would not receive a copy of the adverse event report and definitive confirmation of whether Shingrix caused the increased total bilirubin. For tolerance of 2nd dose refer case US2021AMR172235.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR172235:Same reporter.
Sex: U
Vaccine: MENB
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Two patients / completed / series / younger than / preferred age; Inappropriate age at vaccine administration; Series was repeated / received / four doses; Extra dose administered; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration 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, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 2nd dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 3rd dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 4th dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, inappropriate age at vaccine administration, extra dose administered and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration, extra dose administered and extra dose 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 age at vaccination was not reported. The physician stated that, the patients who completed the series at a different practice were younger than the centers for disease control and prevention preferred age range of 16 to 18, which led to inappropriate age at vaccine administered. And the series was repeated to ensure maximum protection during peak risk ages, which led to extra dose administered. The patients received a total of four doses.  The reporter consented to follow up. The physician did not have additional patient details at the time of reporting, but she does provide permission for safety to follow up via email if additional details were needed. This is 1 of the 2 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR172252:Same reporter. Pt 2 of 2.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cognitive disorder, Crying, Feeling abnormal, Impaired work ability, Panic attack
Clinical narrative: Did not feel normal; Cognitive impairment / lack of comprehension/could not understand what people were saying to her; She left work (started to cry); Felt / (like a panic attack) / She could not work; could not work; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included brain injury (due to car accident in 2016) and concussion (due to car accident in 2016). Previously administered products included antibiotic (recent unspecified antibiotic caused side effects including foggy type feeling). Concurrent medical conditions included weird feeling (weird reactions to medications since brain injury) and brain disorder nos (PPI- partial permanent impairment of the brain due to the car accident).   On 27th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th September 2019, 3 days after receiving Shingrix, the patient experienced feeling abnormal, cognitive impairment, crying, panic reaction and impaired work ability. Shingrix was discontinued. On an unknown date, the outcome of the feeling abnormal, cognitive impairment, crying, panic reaction and impaired work ability were recovered/resolved.   It was unknown if the reporter considered the feeling abnormal, cognitive impairment, crying, panic reaction and impaired work ability to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received Shignrix shot in the upper arm. On 30th September 2019, the patient went to work as usual but did not feel normal. She stated that she could not understand what people were saying to her. She could not comprehend others.  The patient left work (started to cry) and called the pharmacy to ask if what she was feeling could be related to Shingrix patient states that other than the Shingrix shot nothing else had changed (example: she had not started any new medications).  The patient indicated that she remained in that state of cognitive impairment for a few days (2 to 4 days) and because she could not work; she indicated that she was felt very panicked (like a panic attack) during that time because of what was happening to her. All the symptoms were resolved after 2 to 4 days. The patient reported this experience to her physician and was advised not to get the second Shingrix shot. Therefore, she had not completed the series. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: patients / received a dose / from the recalled lot / received the recalled lot after the recall date; patients / received a dose / from the recalled lot / received the recalled lot after the recall date; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The medical assistant reported that the patients were administered with recalled Shingrix vaccine lot, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No symptoms reported. The reporter consented to follow up. The health care professional did not have the list compiled of patients who received the recalled lot after the recall date. The health care professional should be getting the list or details soon. The health care professional agreed to follow-up and noted that follow-up via email would be best.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of the / vaccine in October-2020 / has not received her second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 0.5 ml in 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. The patient received 1st dose of Shingrix and not received her second dose of Shingrix. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: administration of a second dose of Menveo; Instead of receiving Bexsero/ HCP administrated Menveo; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva467a, expiry date 31st March 2022) for prophylaxis.   Previously administered products included Menactra (1st dose received in 2015). Concomitant products included Men ACWY-CRM NVS (Menveo) and Men B NVS (Bexsero).   On 13th August 2021, the patient received the 2nd dose of Menveo. On 13th August 2021, unknown after receiving Menveo and an unknown time after receiving Menveo and Bexsero, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, the patient received 2nd dose of menveo on the day of reporting instead of Bexsero, which led to extra dose administered and wrong vaccine administered. The health care professional had no further information, agreed to be contacted for follow-up
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose / in December 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2018, batch number C7B9P, expiry date 27th February 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 /on 28-Oct-2019 /has not received dose two.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th October 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 via fax.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received /Kinrix/ before her 4th birthday.; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th July 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 15th July 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 provided were as follows: Health care professional reported that, the patient received a dose of Kinrix one day before her 4th birthday, which led to Inappropriate age at vaccine administration.  The reporter consented to follow-up.
Age: 9.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 9 YO F / was / administered the 1st(Jul-10-2021) / 2nd dose (Aug-4-2021) of the Pediarix; administered the 1st(Jul-10-2021) / 2nd dose (Aug-4-2021); 9 YO F / was / administered the 1st(Jul-10-2021) / 2nd dose (Aug-4-2021) of the Pediarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number MK9444, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date unknown) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 10th July 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 10th July 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device and not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short and inappropriate age at vaccine administration. On 4th August 2021, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration, drug dose administration interval too short 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: Nurse reported that, the 9 years old patient was inadvertently administered the 1st and 2nd dose of the Pediarix vaccine, which led to inappropriate age at vaccine administration. Also, the 2nd dose of Pediarix was given earlier than recommended time, which led to shortening of vaccination schedule. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021172397:same reporter
Age: 12.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 12 YO /was/ administered the 1st /& 2nd dose /of the Pediarix vaccine; administered the 1st(Jul-10-2021) & 2nd dose (Aug-4-2021); 12 YO /was/ administered the 1st /& 2nd dose /of the Pediarix vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number MK9444, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date unknown) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 10th July 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 10th July 2021, not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device and unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 4th August 2021, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration, drug dose administration interval too short 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 provided were as follows: Nurse called to reported that, the 12 year old patient received inadvertently administered the 1st dose and 2nd dose of Pediarix vaccine, which led to shortening of vaccination schedule and inappropriate age at vaccination. Also, the patient received 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule. Expiry date for 1st dose of Pediarix was not reported. The reporter consented to follow-up. This case is linked with case US2021172398 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021172398:same reporter
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an 11 year old /on 04-Aug-2021 / received a dose of / Infanrix; 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 11-year-old patient who received DTPa (Infanrix) (batch number NG5GS, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 4th August 2021, unknown after receiving Infanrix and Infanrix 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 provided were as follows: The patient's age at the time of vaccination was not confirmed to be 11 years but reporter commented so. The patient´s chart for an 11 year old showed that, the patient received a dose of Infanrix, 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: vaccinated on 06/18/2020 /  not receive the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th June 2020, batch number 924T3).   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. This case was linked with case US2021172402, reported by same reporter for different patient. The details were reported for 1st dose of Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021172402:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: vaccinated on 06/18/2020 / not receive the second dose yet; 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 on 18 June 2020, batch number 924T3).   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 vaccination 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 case US2021172401, reported by same reporter for different patient. The details were reported by 1st dose of Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021172401:same reporter
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: pain at the injection site; hot to touch at injection site; swelling at the injection site; redness at the injection site; body aches; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibromyalgia.   On 12th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2021, 3 hrs after receiving Shingrix, the patient experienced tiredness. On 14th August 2021, the patient experienced injection site pain, injection site warmth, injection site swelling, injection site erythema and general body pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, injection site warmth, injection site swelling, injection site erythema, general body pain and tiredness were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site swelling, injection site erythema, general body pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient reported that she received her 1st dose of Shingrix vaccine in the left arm.  Adverse reactions to the Shingrix vaccine included pain at the injection site, hot to touch at injection site, swelling at the injection site, redness at the injection site, body aches and tiredness.  About 3 hours after receiving the Shingrix vaccine tiredness started and all the other mentioned symptoms started 2 days after receiving the Shingrix vaccine. The reporter thought the side effects from the Shingrix might be related to her pre-existing Fibromyalgia, but the reporter ruled that out.  The patient had taken Advil and it helped a little with the symptoms.  The patient stayed in bed most of 14th and 15th August 2021.  The symptoms were better on the day of reporting, but none of the symptoms stated were completely resolved. The reporter did not consent to follow-up. The reporter also did not give permission to contact health care professional.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain at the injection site; hot to touch at injection site; swelling at the injection site; redness at the injection site; body aches; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibromyalgia.   On 12th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2021, 3 hrs after receiving Shingrix, the patient experienced tiredness. On 14th August 2021, the patient experienced injection site pain, injection site warmth, injection site swelling, injection site erythema and general body pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, injection site warmth, injection site swelling, injection site erythema, general body pain and tiredness were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site swelling, injection site erythema, general body pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient reported that she received her 1st dose of Shingrix vaccine in the left arm.  Adverse reactions to the Shingrix vaccine included pain at the injection site, hot to touch at injection site, swelling at the injection site, redness at the injection site, body aches and tiredness.  About 3 hours after receiving the Shingrix vaccine tiredness started and all the other mentioned symptoms started 2 days after receiving the Shingrix vaccine. The reporter thought the side effects from the Shingrix might be related to her pre-existing Fibromyalgia, but the reporter ruled that out.  The patient had taken Advil and it helped a little with the symptoms.  The patient stayed in bed most of 14th and 15th August 2021.  The symptoms were better on the day of reporting, but none of the symptoms stated were completely resolved. The reporter did not consent to follow-up. The reporter also did not give permission to contact health care professional.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the diluent portion of the vaccine; received only the diluent portion of the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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 vaccination was not reported. The reporter inquired if the diluent portion of Menveo has vaccine in it or it was only a diluent. The reporter stated that, they were doing inventory and found a lyophilized portion of the vaccine but could an not track down the diluent, noting that a patient might had received only the diluent portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered . No patient identified at the time of reporting. The reporter consented to follow up via email.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose of Shingrix in June 18th 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18 June 2018, batch number HG4P3, expiry date 13th July 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 vaccination 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 case US2021172401, reported by same reporter for different patient.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First / dose in 2020 but never received / second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 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 vaccination the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The Pharmacist did not have any further details such as the patient's initials or date of birth. The reporter consented to follow up.