chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First in 2/19. Does she need to start over?; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 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 are as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked that the patient need to start over. The follow-up could not be possible as no contact details were available.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Feeling cold, Hyperhidrosis, Influenza like illness, Pain
Clinical narrative: flu like symptoms; body aches; clammy; sweating profusely; cold/ His skin is cold to the touch; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Prior history of Covid shot(s).   On 25th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On 26th October 2021, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, clamminess, excess sweating and feeling cold. On an unknown date, the outcome of the influenza-like symptoms, general body pain, clamminess, excess sweating and feeling cold were not recovered/not resolved.   The reporter considered the influenza-like symptoms, general body pain, clamminess, excess sweating and feeling cold to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient and his wife. The patient received the Shingrix shot 1 yesterday from the day of reporting in the left arm.  He did not have the lot number or expiration date of the shot but did provide contact information for the military clinic where the shot was given.  On the day of reporting the patient was experiencing flu-like symptoms including body aches, also sweating profusely and the sweat was soaking through his clothing.  The patient was cold and clammy.  They had not taken his temperature to see if he had a fever but the patient's wife did not think her husband has a fever.  His skin was cold to the (her) touch.  The patient was not shivering.  These symptoms had not resolved.  They believed these symptoms were a result of the shot.  The reporter consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Excessive eye blinking, Hypersensitivity, Neurological symptom
Clinical narrative: allergic reaction; Neurological reaction; Obsessive blinking; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2017-2018 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced allergic reaction, neurologic reaction and excessive eye blinking. On an unknown date, the outcome of the allergic reaction, neurologic reaction and excessive eye blinking were unknown.   It was unknown if the reporter considered the allergic reaction, neurologic reaction and excessive eye blinking to be related to Influenza vaccine Quadrivalent 2017-2018 season.  Additional details were provided as follows: The case was reported by patient's mother. The age at vaccination was not reported. The patient received a flu vaccine manufactured by GlaxoSmithKline in 2017.   The patient had an allergic reaction to the flu vaccine.   The patient had a neurological reaction and obsessive blinking. The reporter inquiring about ingredients of the 2017 GlaxoSmithKline flu vaccines.   The package inserts were not available in resources . The reporter declined to provide any additional patient demographics or details. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: never completed either series; never completed either series; This case was reported by a nurse and described the occurrence of incomplete course of vaccination in a 38-year-old male patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis A (received 1st dose on an unknown date) and HepatitIs B (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Hepatitis A vaccine and the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination and incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination and incomplete course of vaccination were unknown.  Additional details were provided as follows: The age at vaccination was not applicable. No dates for the 1st doses of Hep A and B vaccines were known. The patient received 1st doses of Hep A and Hep B but never completed either series, which led to incomplete course of vaccination. They wanted to complete both series with Twinrix. The health care professional did not know which hep A or B vaccine the patient had received prior, follow up. The reporter consented to follow up.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Flushing, Malaise, Nausea
Clinical narrative: Feeling flushed; Mild nausea; Unwell; This case was reported by a consumer via call center representative and described the occurrence of flushing in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than 3 weeks after receiving Shingrix, the patient experienced flushing, nausea and unwell. The patient was treated with ambiguous medication nos (Cortisone (Nos)). On an unknown date, the outcome of the flushing, nausea and unwell were not recovered/not resolved.   It was unknown if the reporter considered the flushing, nausea and unwell to be related to Shingrix.   Additional details provided were as follows: The case was reported by patient himself. Age at vaccination was not reported. The patient stated that he and his wife both received their first dose of Shingrix 3 weeks ago. The patient stated that since receiving the vaccine he feels unwell, had periodic mild nausea and felt a little flushed (symptomatic).The patient  inquired if the side effects and their duration are common. Patient also inquired if he should get second dose. The patient stated his doctor prescribed Cortisone 20 mg once daily for 5 days for symptoms. No additional details provided by the patient. The reporter consented to follow-up. The case was linked with case US2021223578, reported by same reporter.
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2 doses, 3 weeks apart; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 16-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number PD237, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Fluarix QIV (received only 1 dose of fluarix quadrivalent in 2020). Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX QUADRIVALENT).   On 20th October 2021, the patient received the 3rd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 20th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 doses of Fluarix QIV 3 weeks apart by mistake, which led to shortening of vaccination schedule.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose on July 6, 2018, did not return to complete the series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th July 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The pharmacist stated that the patient did not return to complete the series.  Till the time of reporting the patient did not receive 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up. The pharmacist stated lot number was not available. The permission granted for safety to follow up via postal mail.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Fluarix given to patient who received Flulaval yesterday; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 4-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 95K95, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season).   On 27th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a school nurse. On 26th October 2021, the patient received Flulaval at her healthcare professional office. On the day of reporting, the patient received Fluarix, for flu vaccine this schedule was earlier than the recommended interval, which led to shortening of vaccine schedule. The reporter consented to follow up via email.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: both arms painful at injection sites; flu-like symptoms; This case was reported by a consumer and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix, Influenza vaccine Quadrivalent 2020-2021 season and PNEUMONIA VACCINE. On an unknown date, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.   Additional details provided were as follows: The case was reported by patient herself. The patient stated that she received the Shingrix vaccine in one arm and the flu and pneumonia shot in the other about a year ago (September 2020), she did not remember exact date and on which arm. The patient after hours of vaccinations felt pain at injection sites in the arm. She stated that the next morning 1 day after vaccinations, she waked up with flu-like symptoms that lasted about 3 or 4 days. The patient was encouraged to call other pharma companies to report adverse events and spoke per content. The patient was referred to health care professional. It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to Pneumonia vaccine.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Headache, Malaise
Clinical narrative: Pain in arm; Headache; Not feeling well; Exhausted / Very tired; Left of stomach really hurting; feet are cold, hands are cold; Feverish; Muscle pain; Joint pain; Throat hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On 26th October 2021, the patient received Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced pain in arm, headache, feeling unwell, exhaustion, stomach pain, cold extremities, fever, muscle pain, joint pain and throat pain. On an unknown date, the outcome of the pain in arm, headache, feeling unwell, exhaustion, stomach pain, cold extremities, fever, muscle pain, joint pain and throat pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, headache, feeling unwell, exhaustion, stomach pain, cold extremities, fever, muscle pain, joint pain and throat pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced pain in her arm, a headache, not feeling well, exhausted, very tired, left of her stomach really hurting, her feet were cold, hands were cold, she felt feverish, muscle pain, joint pain and her throat hurts. The patient was inquiring about recommendations for treatment. Provided medical advice disclaimer. GlaxoSmithKline provided Shingrix Frequent asked question's response in reference to what should a patient do if experiencing side effects after receiving shingrix. The patient referred to health care professional. No further information reported. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Oropharyngeal pain, Pain in extremity, Peripheral coldness, Pyrexia
Clinical narrative: Pain in arm; Headache; Not feeling well; Exhausted / Very tired; Left of stomach really hurting; feet are cold, hands are cold; Feverish; Muscle pain; Joint pain; Throat hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On 26th October 2021, the patient received Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced pain in arm, headache, feeling unwell, exhaustion, stomach pain, cold extremities, fever, muscle pain, joint pain and throat pain. On an unknown date, the outcome of the pain in arm, headache, feeling unwell, exhaustion, stomach pain, cold extremities, fever, muscle pain, joint pain and throat pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, headache, feeling unwell, exhaustion, stomach pain, cold extremities, fever, muscle pain, joint pain and throat pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced pain in her arm, a headache, not feeling well, exhausted, very tired, left of her stomach really hurting, her feet were cold, hands were cold, she felt feverish, muscle pain, joint pain and her throat hurts. The patient was inquiring about recommendations for treatment. Provided medical advice disclaimer. GlaxoSmithKline provided Shingrix Frequent asked question's response in reference to what should a patient do if experiencing side effects after receiving shingrix. The patient referred to health care professional. No further information reported. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Tremor
Clinical narrative: shaking chills; shaking chills; This case was reported by a physician via call center representative and described the occurrence of tremor in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 98C4B, expiry date 20th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 27th October 2021, the patient received the 2nd dose of Shingrix. On 27th October 2021, less than a day after receiving Shingrix, the patient experienced tremor and chills. On an unknown date, the outcome of the tremor and chills were not recovered/not resolved.   It was unknown if the reporter considered the tremor and chills to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's husband. In mid-August 2021, the patient received the 1st dose of Shingrix. The patient received the vaccine and developed shaking chills and till the time of reporting, it was ongoing. The reporter consented to follow up.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Accidental underdose, Needle issue, Product administration error
Clinical narrative: needle leaked, resulting in underdose; administration error; This case was reported by a physician via call center representative and described the occurrence of accidental underdose in a 4-year-old patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 20th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced accidental underdose and drug administration error. On an unknown date, the outcome of the accidental underdose and drug administration error 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 physician reported the patient  received a dose of Kinrix and the needle leaked during the administration, resulting in an underdose and accidental underdose and drug administration error.  The reporter did not consent to follow-up. No product quality complaint was reported for Kinrix by the reporter. The reported informed that due to an administration error the complete dose was not administered.
Age: 73.0
Sex: M
Vaccine: TDAP
Symptoms: Accidental underdose, Syringe issue
Clinical narrative: underdose; underdose was giving due to a syringe malfuncion; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 73-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number e55xz, expiry date 24th May 2022) for prophylaxis.   On 27th October 2021, the patient received Boostrix. On 27th October 2021, unknown after receiving Boostrix, the patient experienced accidental underdose and syringe issue. On an unknown date, the outcome of the accidental underdose and syringe issue were unknown.  Additional details were provided as follows: The pharmacist reported the administration of less than the recommend dose to a patient, on the day of reporting and stated that an underdose was given due to a syringe malfunction, which led to accidental underdose and syringe issue. The dose of the vaccine came from a single dose vial according to the health care professional and into the syringe.  No further events were reported.  The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site; Redness at injection site; Swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 25th October 2021, the patient received the 1st dose of Shingrix and Boostrix. In October 2021, less than a week after receiving Shingrix and Boostrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix and Boostrix.  Additional information was provided as follows: The case was reported by patient himself. The patient received Shingrix and Boostrix vaccine in his right arm. The patient experienced pain, redness, and swelling at the injection site. The patient inquired how long the side effects would last and the recommendation for the timing of the second dose. The patient was referred to health care professional. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: hives on her left forearm; Warmth at injection site; Redness at injection site; Fever; feel pain where she received her vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid 19 vaccine (received 1st dose of Covid 19 vaccine followed by a second dose of Covid 19 vaccine then a booster of the Covid 19 vaccine in right arm on an unknown date). Concomitant products included INFLUENZA VACCINE.   On 24th October 2021, the patient received the 1st dose of Shingrix. On 24th October 2021, immediately after receiving Shingrix and an unknown time after receiving INFLUENZA VACCINE, the patient experienced injection site pain. On 25th October 2021, the patient experienced injection site warmth, injection site erythema and fever. On 28th October 2021, the patient experienced hives. On 28th October 2021, the outcome of the injection site pain and injection site warmth were recovered/resolved. On an unknown date, the outcome of the injection site erythema, fever and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, fever and hives to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. A few weeks ago from reporting date, the patient received one flu shot in right arm. The patient received a dose of Shingrix and immediately began to feel pain in the right arm where she received her vaccine. The pain was resolved. The following morning of 25th October 2021, 1 day after vaccination, she described that she had fever, redness at the injection site and warmth at injection site. The fever and redness at the injection site had not resolved. The warmth at the injection site was resolved. Finally, she noted on morning of 28th October 2021, 4 day after vaccination, she had some hives on her left forearm and they had not resolved. The reporter was provided with medical advice disclaimer and she said she had been in contact over the phone but would try to make an appointment to see her in person. The reporter gave permission to contact healthcare professional. The reporter consented to follow-up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives on her left forearm; Warmth at injection site; Redness at injection site; Fever; feel pain where she received her vaccine; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid 19 vaccine (received 1st dose of Covid 19 vaccine followed by a second dose of Covid 19 vaccine then a booster of the Covid 19 vaccine in right arm on an unknown date). Concomitant products included INFLUENZA VACCINE.   On 24th October 2021, the patient received the 1st dose of Shingrix. On 24th October 2021, immediately after receiving Shingrix and an unknown time after receiving INFLUENZA VACCINE, the patient experienced injection site pain. On 25th October 2021, the patient experienced injection site warmth, injection site erythema and fever. On 28th October 2021, the patient experienced hives. On 28th October 2021, the outcome of the injection site pain and injection site warmth were recovered/resolved. On an unknown date, the outcome of the injection site erythema, fever and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, fever and hives to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. A few weeks ago from reporting date, the patient received one flu shot in right arm. The patient received a dose of Shingrix and immediately began to feel pain in the right arm where she received her vaccine. The pain was resolved. The following morning of 25th October 2021, 1 day after vaccination, she described that she had fever, redness at the injection site and warmth at injection site. The fever and redness at the injection site had not resolved. The warmth at the injection site was resolved. Finally, she noted on morning of 28th October 2021, 4 day after vaccination, she had some hives on her left forearm and they had not resolved. The reporter was provided with medical advice disclaimer and she said she had been in contact over the phone but would try to make an appointment to see her in person. The reporter gave permission to contact healthcare professional. The reporter consented to follow-up.
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: received lot number involved in the Recall; received lot number involved in the Recall; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 31st December 2023) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, 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 age at vaccination was not reported. The pediatric office receptionist reported that between 18th July and 25th August 2021, the patient received recall Engerix-B lot, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up. This case was 1 of 20 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR226422:same reporter
Age: 74.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Alopecia, Deafness unilateral, Mobility decreased, Peripheral swelling, Pharyngeal erythema
Clinical narrative: Swollen Left arm/ Swollen  Left hand; could not raise or move her left arm; Throat redness; Throat swelling; Throat burning; Hair loss; Hearing loss Left ear; This case was reported by a consumer via call center representative and described the occurrence of hearing loss unilateral in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 7742Z, expiry date 25th March 2023) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   The patient's past medical history included shingles and covid-19. Previously administered products included Zostavax. Concurrent medical conditions included hospice care and penicillin allergy.   On 19th October 2021, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2021-2022 season. In October 2021, less than 2 weeks after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced hearing loss unilateral (serious criteria GSK medically significant), mobility decreased, red throat, throat swelling, burning in throat and hair loss. On 20th October 2021, the patient experienced swelling arm. On an unknown date, the outcome of the hearing loss unilateral and mobility decreased were unknown and the outcome of the swelling arm, red throat, throat swelling, burning in throat and hair loss were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss unilateral, swelling arm, mobility decreased, red throat, throat swelling, burning in throat and hair loss to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix vaccine in left arm and flu vaccine in right vaccine at same time. The patient experienced hearing loss in her left ear, swollen left hand swollen left arm, throat redness, throat burning, throat swelling, and hair loss. The patient stated that she could not raise or move her left arm (she stated that she could not pick up a cup of coffee). The patient admitted that she was still having problems using her left arm but was better than it was on 20th October 2021. The patient enquired the efficacy of first dose and does not want to get second dose. The reporter did not consent to follow up.
Age: 74.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pharyngeal swelling, Throat irritation
Clinical narrative: Swollen Left arm/ Swollen  Left hand; could not raise or move her left arm; Throat redness; Throat swelling; Throat burning; Hair loss; Hearing loss Left ear; This case was reported by a consumer via call center representative and described the occurrence of hearing loss unilateral in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 7742Z, expiry date 25th March 2023) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   The patient's past medical history included shingles and covid-19. Previously administered products included Zostavax. Concurrent medical conditions included hospice care and penicillin allergy.   On 19th October 2021, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2021-2022 season. In October 2021, less than 2 weeks after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced hearing loss unilateral (serious criteria GSK medically significant), mobility decreased, red throat, throat swelling, burning in throat and hair loss. On 20th October 2021, the patient experienced swelling arm. On an unknown date, the outcome of the hearing loss unilateral and mobility decreased were unknown and the outcome of the swelling arm, red throat, throat swelling, burning in throat and hair loss were not recovered/not resolved.   It was unknown if the reporter considered the hearing loss unilateral, swelling arm, mobility decreased, red throat, throat swelling, burning in throat and hair loss to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix vaccine in left arm and flu vaccine in right vaccine at same time. The patient experienced hearing loss in her left ear, swollen left hand swollen left arm, throat redness, throat burning, throat swelling, and hair loss. The patient stated that she could not raise or move her left arm (she stated that she could not pick up a cup of coffee). The patient admitted that she was still having problems using her left arm but was better than it was on 20th October 2021. The patient enquired the efficacy of first dose and does not want to get second dose. The reporter did not consent to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received a dose of expired Menveo; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA462A, expiry date 31st October 2021) for prophylaxis.   On 1st November 2021, the patient received Menveo. On 1st November 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided are as follows: The age at vaccination was not reported. Nurse reported that the patient received a dose of expired Menveo, which led to expired vaccine used. The reporter declined to provide the patient demographics. The reporter consented to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 4G942, expiry date 3rd February 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21st October 2019 with Lot number: H5495, no expiration data provided) and Shingrix (2nd dose received on 16th January 2020, with Lot number: 252N2, expiry date: 8th March 2022).   On 25th October 2021, the patient received the 3rd dose of Shingrix. On 25th October 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided are as follows: The reporter reported that a patient at their clinic received 3rd dose of Shingrix, which led to extra dose administered. The patient's vaccine record was not up to date. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet 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 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year ago).   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 are as follows: The age at vaccination was not applicable. Pharmacist reported that till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter had no written record of the exact date of the 1st dose administration, nor any additional information. No further events were reported. The reporter consented to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: first dose in March 2020; Body aches; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included renal cancer, nephrectomy and covid-19. Previously administered products included COVID vaccine and Flu vaccine.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In March 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the general body pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient experienced body aches starting at midnight the day of the vaccination. The reporter inquired about Shingles vaccine 2nd dosing.  Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up. The reporter provided limited information of the health care professional. This case is linked to the case US2021225709 and US2021225710, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021225709:same reporter US-GLAXOSMITHKLINE-US2021225710:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: more than 14 months since first dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 14 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that it was more than 14 months since the patient received her first dose of Shingrix.  The patient had planned on getting the second dose. Till the time of reporting the patient did not receive the dose, which led to incomplete course of vaccination. The reporter would like to remain anonymous and did not wish to provide any details.  The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: miss 2nd dose by over a year; 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 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: The age at vaccination was not applicable for this report. The reporter asked what if longer than 6 months for 2nd dose had been passed, would series repeated, if you miss 2nd dose by over a year what is procedure. The reporter disconnected the chat before confirming if there was patient involvement. The call center representative was unable to obtain follow up permission due to the HCP's abrupt disconnection. GSK note- it was unknown if patient was involved or not, so by considering worst case approach the case kept valid.
Age: 72.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered infanrix  instead of boostrix; 72 Y / administered infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 72-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st November 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 1st November 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 72 year old patient was administered the infanrix vaccine instead of the boostrix vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. She stated she had not yet spoken to the patient. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: not yet received the second dose / due to the pandemic; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not applicable for this report.  The patient had not yet received the second dose of Shingrix due to the pandemic. He had nothing else to report. The reporter did not consent to follow-up.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt was given Boostrix instead of Kinrix; 5 year old pt was given Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5F945, expiry date unknown) for prophylaxis.   On 1st November 2021, the patient received Boostrix (intramuscular). On 1st November 2021, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The reporter was physician Assistant. The reporter stated that, the 5 year old patient was administered the Boostrix vaccine instead of the Kinrix vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Dec2020, asking about getting the 2nd; This case was reported by a consumer 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 December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report.  The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter inquired the order in which she should take the 2nd Shingrix dose, Flu vaccine and COVID-19 BOOSTER and the side effects associated with the Shingrix vaccine.  The consent to follow up was declined. Unwilling to give any further demographic information and unable to collect HCP contact information
Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 08Oct2021, Second on 02Nov2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 12-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 3SE27, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX TETRA PFS).   On 2nd November 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 2nd November 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an early second dose of Fluarix 2021-2022, which led to shortening of vaccination schedule. Both vaccines had the same lot number and expiration date. The reporter consented to follow up.