chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got the shingles shot ASAP!! I had a mild case & still had it/ Suspected vaccination failure; So painful!!; I had a mild case & still had it; This case was reported by a consumer viainteractive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles once about 20 years ago from reporting date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she never knew that he/she could get shingles again either until he/she spoke to the doctor. The reporter had the Shingles shot and had a mild case and still had shingles for almost 3 months, was painful. The reporter suggested on definitely checking on getting the shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Vaccinated in 2017; pain of shingles for the last two weeks/ Suspected vaccination failure; Pain of shingles for the last two weeks; Pain of shingles, worst pain I've ever experienced; This case was reported by a consumer via interactive media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient was vaccinated in 2017 and had been dealing with the pain of shingles for the last two weeks. The reporter stated that, it was the worst pain he/she had ever experienced. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had shingles shot and still got the shingles. The patient's physician said that the patient could transmit them to another person, because it was a virus. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Crying, Frustration tolerance decreased, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure/I had the 2 shots, still get them; Still get them; So much pain; I burst out crying; It's so frustrating; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, crying and frustration. On an unknown date, the outcome of the vaccination failure, shingles, pain, crying and frustration were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, crying and frustration to be related to Shingles vaccine and Shingles vaccine.  Additional details provided were as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2 doses of Shingles vaccine and experienced shingles and pain. The patient really felt for the one that gets it. The patient burst out crying when nobody was watching, and it was so frustrating. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles after getting the shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got full blown shingles after getting the shot. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: It hurt; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccine with an associated reaction of injection site pain (received covid shot on an unknown date and experienced injection site pain).   In November 2021, the patient received Shingles vaccine. In November 2021, less than a week after receiving Shingles vaccine, the patient experienced injection site pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, she got her shot over the weekend and it hurted more than the Covid shot.  The patient took a Tylenol. The patient's husband told her that, she must be in pain, as she didn't take the medications. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: broke out in hives; This case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a dose of Shingrix vaccine last month and broke out with hives. The patient enquired if he/she should have the second dose or not. Follow-up would not be possible as no contact details available.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the adjuvant; administered only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number LF799, expiry date 31st January 2023) for prophylaxis.   On 1st November 2021, the patient received the 1st dose of Shingrix. On 1st November 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 practice manager. The reporter reported that the patient was administered only adjuvant component of the Shingrix vaccine in right deltoid inadvertently, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Nasal congestion, Pyrexia
Clinical narrative: Fatigue; Stuffy nose; Low grade fever; This case was reported by a consumer and described the occurrence of fatigue in a 57-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, less than a week after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced fatigue, nasal stuffiness and low grade fever. On an unknown date, the outcome of the fatigue, nasal stuffiness and low grade fever were unknown.   It was unknown if the reporter considered the fatigue, nasal stuffiness and low grade fever to be related to FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The case was reported by patient for herself. The patient received a dose of Flulaval vaccine on Friday and experienced a low grade fever, a stuffy nose and fatigue. The patient inquired about the ingredients of the Flulaval vaccine and the type of vaccine was it. The caller was provided with medical advice disclaimer. No additional details were provided by the reporter. The reporter provided permission to contact health care professional. The reporter consented to follow-up.
Age: 75.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Neuralgia
Clinical narrative: Nerves are irritated and raw; Shingles without rash or blisters or redness; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) 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 (Approximately 1 year ago, the patient developed shingles on his left side without blisters). Previously administered products included Zostavax (The patient received vaccine about ten years ago).   On 25th September 2021, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2021-2022 season. In September 2021, 2 days after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced shingles. On an unknown date, the patient experienced neuralgia. The patient was treated with gabapentin. On an unknown date, the outcome of the shingles was unknown and the outcome of the neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the shingles and neuralgia to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: This case was reported by the patient. The patient received the first dose of Shingrix and at the same time he received the Flu vaccine (high dose).  The patient could not recall which arm (deltoid) he received the Shingrix.  He stated that 2 days after receiving the Shingrix vaccine, he developed shingles on his right side - from right axilla to chest . He said there was no rash, redness, or blisters.  He stated that the nerves were irritated and raw. He was currently taking Gabapentin for treatment.   The patient asked if it was safe to get the second dose of the shingles vaccine.  The reporter consented to follow up.
Sex: F
Vaccine: HEPAB, HEPAB, HEPAB
Symptoms: Antibody test negative, Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: completed Twinrix series,  antibodies were not present; First dose on 13Jul2017, second on 23Aug2017, third 26Feb2018; This case was reported by a pharmacist and described the occurrence of therapy non-responder in a 60-year-old female patient who received HAB (Twinrix adult) (batch number Z75Y2, expiry date 15th March 2020) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix adult) (batch number EF773, expiry date 29th September 2018) for prophylaxis, hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix adult) (batch number EF773, expiry date 29th September 2018) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th February 2018, the patient received the 3rd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 23rd August 2017, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 13th July 2017, the patient received the 1st dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 23rd August 2017, not applicable after receiving Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult and Twinrix Pre-Filled Syringe Device, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix adult, Twinrix Pre-Filled Syringe Device, Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 3 dose of Twinrix adult and the patient's physician checked for antibodies and they were not present, which led to therapy non-responder. The physician told patient that she was not protected against Hepatitis A and Hepatitis B. The patient received 2nd dose of twinrix adult later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Patient did not receive full dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details provided were as follows: Age at vaccination was not reported. The pharmacist administered a second dose of the Shingrix to a patient, the vaccine suspension leaked out between the syringe and needle and patient did not receive full dose which led to incomplete dose administered. The pharmacist was unsure how much of the dose the patient received but it seemed like a substantial amount of it did leak out.  The pharmacist asked if he/she need to administer a second dose to the patient to make sure if he is fully vaccinated. The reporter consented to follow-up. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Got really sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The patient stated that, she received the 2nd dose of the shingrix vaccine in February 2021 and got really sick but did not wanted to provide additional details.  The reporter declined correspondence from safety team and declined to provide Healthcare professional information.  No further information was reported.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose November 14, 2019, has not received second 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 14th September 2019, 0.5 ml).   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 patient. The age at vaccination was not applicable for this report. The patient stated that she received her first dose of Shingrix and still had not received the second dose, which led to incomplete course of vaccination. No lot or expiration date was known. The reporter did not consent to follow-up.  The reporter declined to provide any demographics, date of birth or health care professional information.
Age: 14.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Kinrix, the intended vaccine was Boostrix; 14 year old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 14-year-old female patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made 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 inadvertently received Kinrix via intramuscular route in the left deltoid instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The reporter consented to follow up
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: adult dose of Engerix-B was administered to a 5 week old; Adult product administered to child; Engerix-B was administered, was supposed to receive Recombivax; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 5-week-old male patient who received HBV (Engerix B adult) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 9th November 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose, adult product administered to child and wrong vaccine administered. On an unknown date, the outcome of the accidental overdose, adult product administered to child and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse stated that, an adult dose of Engerix-B was administered to a 5 week old patient, which led to accidental overdose and adult product administered to child. The patient was supposed to receive Recombivax but received engerix b adult, which led and wrong vaccine administered. The reporter consented to follow up. This case has been linked to US2021158186, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021158186:same reporter
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose 2 weeks later than the first dose; 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 Herpes zoster (Shingrix) (batch number C7EX2, expiry date 26th January 2022) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 27th August 2020, the patient received the 2nd dose of Shingrix. On 27th August 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose on 14th August 2021, batch number: 73E59, expiry date:19th November 2021. The patient received the second dose of Shingrix 2 weeks later than the first dose, instead of 2 months, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered an expired Dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA392A, expiry date 31st October 2021) for prophylaxis.   On 5th November 2021, the patient received Menveo. On 5th 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 as follows: The age at vaccination was not reported. A pharmacist reported that, the patient was administered with an expired Menveo, which led to expired vaccine used.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on chest and back; This case was reported by a consumer and described the occurrence of rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th November 2021, 8 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. On 1st November 2021, the patient received 1st dose of Shingrix.  On the day of reporting, the patient developed a rash on her chest and back. The reporter did not wanted to provide any additional information. The reporter did not consent tofollow up.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered, Syringe issue, Underdose
Clinical narrative: patient did not get full dose; the needle was faulty and some vaccine leaked out while; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 56-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5277j, expiry date 12th November 2023) for prophylaxis.   On 8th November 2021, the patient received the 1st dose of Boostrix. On 8th November 2021, unknown after receiving Boostrix, the patient experienced incomplete dose administered and needle leak. On an unknown date, the outcome of the incomplete dose administered and needle leak were unknown.  Additional details provided were as follows: The health care professional reported that, Boostrix was administered to the patient and the needle was faulty and some vaccine leaked out while administering and patient did not get full dose which lead to incomplete dose administered. No Product complaint was filed. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary.
Age: 11.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Wrong product administered
Clinical narrative: received Boostrix instead of Flu vaccine; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and COVID-19 VACCINE for prophylaxis.   On 9th November 2021, the patient received Boostrix .5 ml, Boostrix Pre-Filled Syringe Device and COVID-19 VACCINE. On 9th November 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received dose of Boostrix in the left deltoid. The patient received Boostrix vaccine instead of Flu vaccine, which led to wrong vaccine administered. The reporter consented to follow up. This case was 1 of 4 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021231230:SAME REPORTER US-GLAXOSMITHKLINE-US2021231229:SAME REPORTER US-GLAXOSMITHKLINE-US2021231232:SAME REPORTER
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Flulaval QIV; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number DJ247, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe (batch number Unk, expiry date unknown) for prophylaxis.   On 5th November 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 5th November 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Flulaval QIV. The reporter consented to follow up. This case has been linked to US2021232171, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232171:same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: Weakness; Tiredness; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received Flu vaccine on an unknown date) and COVID Vaccine (received COVID vaccine on an unknown date).   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced weakness, tiredness and pain in arm. On an unknown date, the outcome of the weakness, tiredness and pain in arm were recovered/resolved.   It was unknown if the reporter considered the weakness, tiredness and pain in arm to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for herself. The age at vaccination was not reported. The  caller stated she had a dose of Shingrix in right arm in February of 2020 and she experienced flu like symptoms of weakness, tiredness and sore arm. The caller had limited information. The caller stated that further information might be obtained from Pharmacy at which she received the vaccine. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the 1st dose in 2018 and is late for the 2nd; 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 SHINGRIX. Previously administered products included SHINGRIX (received 1st dose in 2018 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. 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.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st August 2021) for prophylaxis.   On 21st September 2021, the patient received Menveo. On 21st September 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 as follows: The medical assistant reported that, the patient received expired dose of Menveo, which led to expired vaccine used. The reporter did not consent to follow up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232197:Same reporter US-GLAXOSMITHKLINE-US2021232198:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same reporter US-GLAXOSMITHKLINE-US2021232206:Same reporter US-GLAXOSMITHKLINE-US2021232194:Same reporter
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st August 2021) for prophylaxis.   On 21st September 2021, the patient received Menveo. On 21st September 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 as follows: The medical assistant reported that, the patient received expired dose of Menveo, which led to expired vaccine used. The reporter did not consent to follow up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232198:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same repoter US-GLAXOSMITHKLINE-US2021232206:Same reporter US-GLAXOSMITHKLINE-US2021232194:Same reporter
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVAA379A, expiry date 31st August 2021) for prophylaxis.   On 11th October 2021, the patient received Menveo. On 11th October 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 as follows: The medical assistant reported that, the patient received expired dose of Menveo, which led to expired vaccine used. The reporter did not consent to follow up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232197:Same reporter US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same reporter US-GLAXOSMITHKLINE-US2021232206:Same reporter US-GLAXOSMITHKLINE-US2021232194:Same reporter
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st August 2021) for prophylaxis.   On 20th September 2021, the patient received Menveo. On 20th September 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 as follows: The medical assistant reported that, the patient received expired dose of Menveo, which led to expired vaccine used. The reporter did not consent to follow up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232197:Same reporter US-GLAXOSMITHKLINE-US2021232198:Same reporter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same reporter US-GLAXOSMITHKLINE-US2021232206:Same reporter US-GLAXOSMITHKLINE-US2021232194:Same reporter
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Patient received expired dose of fluarix; Patient DOB: 13-SEP-2021; This case was reported by a other health professional and described the occurrence of expired vaccine used in a 7-day-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number HS75G, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 20th September 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used 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 medical assistant reported that, the patient received expired dose of fluarix, which led to expired vaccine used. The patient received Fluarix at the age of 7 days old, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232197:Same reporter US-GLAXOSMITHKLINE-US2021232198:Same reporter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same reporter US-GLAXOSMITHKLINE-US2021232206:Same reporter
Age: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of Fluarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number HS75G, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 20th September 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: Medical assistant reported that a patient received an expired dose of Fluarix, which led to expired vaccine used. The reporter did not consented to follow-up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232194:Same reporter US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232197:Same reporter US-GLAXOSMITHKLINE-US2021232198:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same reporter US-GLAXOSMITHKLINE-US2021232206:Same reporter
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose of fluarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number GF2DK, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: Medical assistant reported that a patient received an expired dose of Fluarix, which led to expired vaccine used. The reporter did not consented to follow-up. This case was 1 of 8 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232198:Same reporter US-GLAXOSMITHKLINE-US2021232194:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232197:Same repoter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232206:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose of engerix-B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 29ZB7, expiry date 29th September 2021) for prophylaxis.   On 10th November 2021, the patient received Engerix B. On 10th November 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The the patient received expired dose of Engerix B, which led to expired vaccine used. No other details were available. The reporter consented to follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis
Clinical narrative: SORE SHOULDER; SWEATS; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with influenza vaccine for drug used for unknown indication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect vaccine included mrna 1273 (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for drug used for unknown indication. No concomitant medications were reported. On MAR-2021, the patient experienced sweats, and chills. On an unspecified date, the patient experienced sore shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, sore shoulder, and sweats was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 70 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Carbon dioxide abnormal, Influenza like illness, Pneumonia
Clinical narrative: PNEUMONIA; FLU-LIKE SYMPTOMS/COULDN'T BREATHE; TOO MUCH CARBON DIOXIDE IN BODY; This spontaneous report received from a consumer concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: breathing problems, heavy smoker, intubation, and life support. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total dose administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter stated on an unspecified date, the patient experienced flu-like symptoms after getting the vaccine, couldn't breathe and ended up with pneumonia, and had too much carbon dioxide in her body required intubation. The patient was kept on life support and was flown to another city and was hospitalized (date unspecified). She was there for about a week or a week and a half . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms/couldn't breathe, pneumonia and too much carbon dioxide in body was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening). This case, from the same reporter is linked to 20211115315, 20211115400 and 20211115414.; Sender's Comments: V0: 20211115081-covid-19 vaccine ad26.cov2.s-Pneumonia, flu-like symptoms/couldn't breathe, too much carbon dioxide in body. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).