chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear discomfort, Hyperacusis, Nasal congestion, Tinnitus
Clinical narrative: Ringing in ears; Feeling of stuffiness; Sensitivity to noise; This case was reported by a consumer and described the occurrence of ringing in ears in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2022, the patient received Shingrix. On 17th August 2022, immediately after receiving Shingrix, the patient experienced ringing in ears, ear feels clogged and hyperacusis. On an unknown date, the outcome of the ringing in ears, ear feels clogged and hyperacusis were not recovered/not resolved.   It was unknown if the reporter considered the ringing in ears, ear feels clogged and hyperacusis to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment:  The patient was the self reporter. The Reporter stated that soon after receiving vaccine the patient began to experience ringing in ears, along with a feeling of stuffiness and a sensitivity to noise. Since that date the symptoms had not lessened.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: Missed the 4th dose due to pandemic; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 3 accelerated doses on an unknown date).   On an unknown date, the patient did not receive the 4th dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient had 3 accelerated doses but he/she missed the 4th due to the pandemic. The patient stated that he/she was looking for help with Twinrix.. The patient traveled in 2019.  The patient had asked doctors and pharmacists if he/she was still protected or if he/she need to had the entire dosing again.  The patient had been told different things. The patient asked if he/she just need the 4th shot or he/she need a booster or he/she would need to start again and had all the doses. The patient also asked could he/she please get clarification on what to do as he/she was going away at the end of this month. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: vaccine is too painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's comment: This case was reported by the patient via interactive digital media. Reporter stated that the vaccine was too painful. Additional supportive information: Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose followed by 2nd only1 month later; This case was reported by a consumer via sales rep and described the occurrence of drug dose administration interval too short in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 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 Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: Reporter stated that 50 plus patients were given a dose of Shingrix followed by a second dose only 1 month later. Additional supportive information: Patients received second dose of Shingrix earlier then recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Illness, Pain, Rash
Clinical narrative: there's still some areas is sensitive to touch; rash is healing now; Shingles 2 weeks ago on left side of my leg and buttock area; very painful to walk and to sit; Sick for a week; 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.   In July 2022, the patient received the 1st dose of Shingles vaccine. In September 2022, between 2 and 3 months after receiving Shingles vaccine, the patient experienced shingles, pain upon movement and rash. On an unknown date, the patient experienced sickness and touch sensitivity increased. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles and pain upon movement were unknown and the outcome of the sickness was recovered/resolved and the outcome of the rash was recovering/resolving and the outcome of the touch sensitivity increased was not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain upon movement, sickness, rash and touch sensitivity increased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-Oct-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had shingles 2 weeks ago on left side of his/her leg and buttock area it was very painful to walk and to sit.  The antiviral medicine and cream helped a lot from the pain and spreading of the rash.  The patient had single vaccine shot 3 months ago.  The patient was sick for a week after the vaccine. The patient never got the second shot.  The patient had a rash which was healing but, there was still some areas which were sensitive to touch. Additional supportive information: Less than 3 months after vaccination the patient had sickness and touch sensitivity increased.   The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: FLUX
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: Coughing; Sore throat; This case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   In September 2022, the patient received Flu vaccine. On an unknown date, less than a week after receiving Flu vaccine, the patient experienced cough and sore throat. On an unknown date, the outcome of the cough and sore throat were not recovered/not resolved.   It was unknown if the reporter considered the cough and sore throat to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she was agree with he/she was not paying 95.00 dollars. The patient told his/her doctor if he/she got it doctor brings it up everytime he/she go plus the pneumonia shot. The patient received flu shot about a week ago and he/she was been coughing 3 days after sore throat. The patient stated that it was hard to trust these shots anymore. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received dose on 11/25/2020, but never had second; This case was reported by a consumer via interactive digital media 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 25th Nov 2020).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 05-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received the first dose of shingrix but never had the second dose. The patient asked that what should I do. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination .
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: breaking out after 2 Injections, last one 2 weeks ago; 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.   In September 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient wanted to know; anyone got a small breaking out after had their shingles shots. The patient thought that, he/she had shingles now and he/she had 2 injections of shingles.  The last one a little over 2 weeks ago. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain
Clinical narrative: had first one, going through Shingles; Pain; 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.   The patient's past medical history included pain (level of pain once before back in the early 60's).   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 and pain. On an unknown date, the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: This case was reported by patient via interactive digital media. The patient received a dose of Shingles vaccine and going through shingles now. The patient reported that he/she could only remember going through this level of pain once before back in the early 60's. The patient reported that hopefully on the downhill of this thing. The patient reported that as soon as he/she was cleared, he/she would getting that second shot. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Ear pain, Headache, Herpes zoster, Malaise
Clinical narrative: rash over eye extending to scalp; itchy bumps; ear ache; mild discomfort; doses two years apart, first dose December of 2020; fever; headache; malaise; mild case of Shingles; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In October 2021, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced fever, headache, malaise, rash, itchy rash, ear pain, discomfort and drug dose administration interval too long. On an unknown date, the outcome of the fever, headache, malaise, shingles, rash, itchy rash and discomfort were recovered/resolved and the outcome of the ear pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the fever, headache, malaise, shingles, rash, itchy rash, ear pain and discomfort to be related to Shingrix.     Additional Information: GSK receipt date: 6-Oct-2022 Reporter's comment: The patient received first dose of Shingrix and experienced mild case of shingles Less than 2 years after first vaccination, the patient had fever, headache and malaise which lasted for 2 days. The patient reported rash over left eye extending into the scalp and rash consist of itchy bumps.  The patient experienced ear ache during shingles episode and mild discomfort. The shingles episode lasted approximately 3 weeks. The patient asked that need to get another dose of Shingrix if first and second doses were two years apart. The reporter did not consent to follow-up. Additional supportive information: The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The case US2022143290 was identified as duplicate of US2022AMR143199. The case US2022143290 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: rash over eye extending to scalp; itchy bumps; ear ache; mild discomfort; doses two years apart, first dose December of 2020; fever; headache; malaise; mild case of Shingles; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In October 2021, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced fever, headache, malaise, rash, itchy rash, ear pain, discomfort and drug dose administration interval too long. On an unknown date, the outcome of the fever, headache, malaise, shingles, rash, itchy rash and discomfort were recovered/resolved and the outcome of the ear pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the fever, headache, malaise, shingles, rash, itchy rash, ear pain and discomfort to be related to Shingrix.     Additional Information: GSK receipt date: 6-Oct-2022 Reporter's comment: The patient received first dose of Shingrix and experienced mild case of shingles Less than 2 years after first vaccination, the patient had fever, headache and malaise which lasted for 2 days. The patient reported rash over left eye extending into the scalp and rash consist of itchy bumps.  The patient experienced ear ache during shingles episode and mild discomfort. The shingles episode lasted approximately 3 weeks. The patient asked that need to get another dose of Shingrix if first and second doses were two years apart. The reporter did not consent to follow-up. Additional supportive information: The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The case US2022143290 was identified as duplicate of US2022AMR143199. The case US2022143290 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Age: 71.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Gastric disorder
Clinical narrative: Fatigue; stomach issues; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 71-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   Concomitant products included Nucala.   On 5th October 2022, the patient received Influenza vaccine and COVID VACCINE. On 6th October 2022, 1 days after receiving Influenza vaccine, the patient experienced fatigue and gastric disorder. On an unknown date, the outcome of the fatigue and gastric disorder were not recovered/not resolved.  It was unknown if the reporter considered the fatigue and gastric disorder to be related to Influenza vaccine.     Linked case(s) involving the same patient:  US2021211498   Additional Information: GSK receipt date: 06-OCT-2022 Reporter's comment: The reporter was the patient who had self-injected his last dose of Nucala Al one month ago.  The reporter stated that he had received a covid vaccine and a flu vaccine on 05th October 2022 and had experienced fatigue and stomach issues on 06th October 2022.  The reporter was inquiring if he could take his planned dose of Nucala Al on 06th October 2022. Provided medical advice disclaimer and Healthcare Professional (HCP) referral.  The lot no and expiration date was unknown. Provided product education. The reporter had consented to follow-up with the Healthcare Professional (HCP). Additional supportive information: It was unknown if the reporter considered the fatigue and gastric disorder to be related to Covid Vaccine. This case was linked with US2021211498 which was reported for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021211498:same patient
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received 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 DTPa (Reduced antigen) (Boostrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-Oct-2022 Reporter's comment: The pharmacist reported that the patient received expired dose of Boostrix by error. The lot number was not available.  No other information was available now of the call.  The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered an expired dose of Boostrix by error, which led to expired vaccine used. This case is 1 out of 4 cases reported by the same reorter.; Sender's Comments:  US-GSK-US2022146819:same reporter US-GSK-US2022AMR147251:same reporter US-GSK-US2022AMR147250:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: got Shingles behind my ear; Incomplete course of vaccination; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the first shot when they started them and got them behind his/her ear. The patient stated that guess who got shingles last year.  Additional supportive information: Till the time of reporting, the patient did not receive second shot of Shingles vaccine, which led to incomplete course of vaccination. The case was processed in worst approach as it reported that the patient received the shot when they start them which seem the reporter wanted to say when GlaxoSmithKline started at that time patient got the shot, therefore suspect was coded as Shingles vaccine as generic vaccine. 2nd shot was also coded as suspect with event incomplete course of vaccination as GlaxoSmithKline had market vaccine in October 2017 (patient got the vaccine) and the recommended interval between doses were already passed and even outcome of event was unknown which was occurred with first shot.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, COVID-19, Chills, Fatigue, Retching
Clinical narrative: Felt tired; Had Cold Chills; Retching; As injecting, could taste it in tongue; Felt weak; Covid; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness, chills, retching, taste altered, weakness and covid-19. On an unknown date, the outcome of the tiredness, chills, retching, taste altered, weakness and covid-19 were unknown.   It was unknown if the reporter considered the tiredness, chills, retching, taste altered, weakness and covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's comment: The patient did not provide date of vaccine.  The customer reported that as they were injecting into her arm, she could taste it in her tongue.  The patient reported while driving home immediately she started retching, and felt weak, tired and had cold chills.  The patient reported it turned out she had Covid and did not know it when she got the Shingrix vaccine.  Not all information was available.  The customer declined to provide demographics or additional information for the adverse event report (lot/expiry date, injection site date when vaccine was provided). The permission for consent to follow-up was denied.
Sex: F
Vaccine: VARZOS
Symptoms: Taste disorder
Clinical narrative: Felt tired; Had Cold Chills; Retching; As injecting, could taste it in tongue; Felt weak; Covid; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness, chills, retching, taste altered, weakness and covid-19. On an unknown date, the outcome of the tiredness, chills, retching, taste altered, weakness and covid-19 were unknown.   It was unknown if the reporter considered the tiredness, chills, retching, taste altered, weakness and covid-19 to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's comment: The patient did not provide date of vaccine.  The customer reported that as they were injecting into her arm, she could taste it in her tongue.  The patient reported while driving home immediately she started retching, and felt weak, tired and had cold chills.  The patient reported it turned out she had Covid and did not know it when she got the Shingrix vaccine.  Not all information was available.  The customer declined to provide demographics or additional information for the adverse event report (lot/expiry date, injection site date when vaccine was provided). The permission for consent to follow-up was denied.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: MA reported they reconstituted the Menveo powder with a non-GSK diluent; MA reported they reconstituted the Menveo powder with a non-GSK diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA713A, expiry date 30th June 2023) for prophylaxis.   On 30th September 2022, the patient received Menveo. On 30th September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's comment: The medical assistant called for the enquiry and asked was the vaccine valid or effective. The medical assistant reported they reconstituted the Menveo powder with a non-GSK diluent and inadvertently administered to a patient on 30th September 2022. The medical assistant stated they just realized that they did not reconstituted with correct approved GSK diluent and the patient was involved. The reporter did not consent for follow-up. Additional Supportive Information: The medical assistant reported they reconstituted the Menveo powder with a non-GSK diluent and inadvertently administered to a patient on 30th September 2022, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix-B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received HBV (Engerix B) (batch number MY3RA, expiry date 21st September 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 27th September 2022, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 27th September 2022, unknown after receiving Engerix B and Engerix B 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 Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comments: The medical assistant reported that the patient was administered expired dose of Engerix-B series. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7UA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Havrix and Havrix 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 Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: Reporter stated that a nurse inadvertently administered an expired Havrix expiry date 30 September 2022 to a patient. The reporter called to inquired for any recommendations for this. The reporter unable to provide any patient details. Reporter did not consent to follow up. Additional supportive information: A patient was administered expired Havrix vaccine, which led to expired vaccine used.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; 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 B NVS (Bexsero) (batch number AVXB59AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Bexsero and Bexsero 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 Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: the healthcare professional administered expired Bexsero dose to a patient. Reporter did not consent to follow up. Additional supportive information: A patient was administered with expired Bexsero dose which led to expired vaccine used.
Age: 72.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: patient received a pediatric dose of Havrix on 04Oct2022; This was a 3rd dose of the vaccine; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 72-year-old male patient who received HAV (Havrix pediatric) (batch number 4CY9H, expiry date 28th April 2023) for prophylaxis.   On 4th October 2022, the patient received the 3rd dose of Havrix pediatric .5 ml. On 4th October 2022, unknown after receiving Havrix pediatric, the patient experienced adult use of a child product and extra dose administered. On an unknown date, the outcome of the adult use of a child product and extra dose administered were unknown.      Additional Information: GSK receipt date: 04-OCT-2022 Reporters comment: The patient received a pediatric dose of Havrix and this was a 3rd dose of the vaccine. The reporter consent to follow-up. Additional Supportive information: The patient received a pediatric dose of Havrix and was a 3rd dose of the vaccine, which led to extra dose administered and adult use of child product.
Age: 48.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Havrix on 04Oct2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 48-year-old male patient who received HAV (Havrix) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   On 4th October 2022, the patient received the 1st dose of Havrix. On 4th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 04-OCT-2022 Reporters comment:  The patient received patient received an expired dose of Havrix on 04th Oct 2022.  The dose expired on 20th May 2022. No symptoms reported. The reporter consent to follow-up. Additional Supportive information: The patient received an expired dose of Havrix on 04th Oct 2022 which led to Expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB59AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Bexsero and Bexsero 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 Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comments:  The reporter stated that an expired dose of Bexsero was administered to a patient. The reporter give consent to follow up. Additional Supportive Information: The patient received expire dose of Bexsero which lead to expire vaccine used.
Age: 60.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Chills, Drug ineffective, Fatigue, Headache, Injection site erythema
Clinical narrative: Pain in the injection site; Redness in the injection site; Muscle pain; Tiredness; Headache; Shivering; Drug ineffective; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for muscle pain, tiredness, headache, shivering, injection site pain and injection site erythema.   On 4th October 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and Tylenol at an unknown dose and frequency. On 4th October 2022, 8 hrs after receiving Shingrix, the patient experienced injection site pain, injection site erythema, muscle pain, tiredness, headache, shivering and drug ineffective. The action taken with Tylenol was unknown. On an unknown date, the outcome of the injection site pain, injection site erythema, muscle pain, tiredness, headache and shivering were not recovered/not resolved and the outcome of the drug ineffective was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, muscle pain, tiredness, headache and shivering to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: The reporter was a patient's wife. The reporter reported that the patient received Shingrix vaccine in the right arm. The reporter stated in the last night patient had pain and redness at the injection site, muscle pain, tiredness, headache and Shivering. The patient received Tylenol as treatment and that did not help patient. It was unknown if the reporter considered the drug ineffective to be related to Tylenol. The reporter stated that he will contact healthcare professional if symptoms are not start to resolve in a few days. The reporter did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: Pain in the injection site; Redness in the injection site; Muscle pain; Tiredness; Headache; Shivering; Drug ineffective; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for muscle pain, tiredness, headache, shivering, injection site pain and injection site erythema.   On 4th October 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and Tylenol at an unknown dose and frequency. On 4th October 2022, 8 hrs after receiving Shingrix, the patient experienced injection site pain, injection site erythema, muscle pain, tiredness, headache, shivering and drug ineffective. The action taken with Tylenol was unknown. On an unknown date, the outcome of the injection site pain, injection site erythema, muscle pain, tiredness, headache and shivering were not recovered/not resolved and the outcome of the drug ineffective was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, muscle pain, tiredness, headache and shivering to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: The reporter was a patient's wife. The reporter reported that the patient received Shingrix vaccine in the right arm. The reporter stated in the last night patient had pain and redness at the injection site, muscle pain, tiredness, headache and Shivering. The patient received Tylenol as treatment and that did not help patient. It was unknown if the reporter considered the drug ineffective to be related to Tylenol. The reporter stated that he will contact healthcare professional if symptoms are not start to resolve in a few days. The reporter did not consent to follow up.
Sex: F
Vaccine: UNK
Symptoms: Off label use, Underdose
Clinical narrative: the patient received the 0.25ml of Fluarix earlier this season; the patient received the 0.25ml of Fluarix earlier this season; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 76-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) 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 Flu vaccine (on an unknown date had adverse reactions after the flu vaccine in the past (brand name not reported, details of adverse reactions unknown).).   On 5th October 2022, the patient received Fluarix Quadrivalent 2022-2023 season .25 ml and Fluarix Tetra Pre-Filled Syringe Device. On 5th October 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced underdose and off label use. On an unknown date, the outcome of the underdose and off label use were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR143111   Additional Information: GSK receipt date: 05-OCT-2022 Reporters comment:  The reporter reported that patient received two 0.25ml doses of the Flu vaccine every season.  The reporter said that the patient received the 0.25ml of Fluarix earlier that season did not know if prefilled syringe or multidose vial and wanted to know if the patient could receive another 0.25ml from the Fluarix QIV prefilled syringe as a second dose for this season.  Follow-up declined Agent had selected as Vaccine involved on this case Fluarix QIV season 21-22" because there are no other option for this current season The reporter did not consent to follow-up. Additional Supportive information: The patient received the 0.25ml of Fluarix which led to Underdose and off label use; Sender's Comments:  US-GSK-US2022AMR143111:Same reporter - invalid case
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 19 year old received an adult dose; 19 year old received an adult dose; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old patient who received HBV (Engerix B adult) for prophylaxis.   On 5th October 2022, the patient received Engerix B adult 1 ml. On 5th October 2022, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.      Additional Information: GSK receipt date: 05-OCT-2022 Reporters comment:  Pharmacist reported that a 19 year old patient received an adult 1 ml dose of Engerix. The HCP was calling on behalf of HCP that administered the dose, she did not have patient details (date of birth, gender, etc) or vaccine details (lot number/expiry details, etc). HCP said she was told that the patient would be turning 20 years in 3 months. The reporter consented to follow-up. Additional Supportive information: The patient received an adult 1 ml dose of Engerix, which led to overdose and inappropriate age at vaccine administration.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2021-2022 season) (batch number unknown, 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.   On an unknown date, the patient received Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra 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 Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments: The project manager reported on that a patient was administrated with an expired dose of Fluarix QIV.  No adverse event was reported.  The reporter was consented to follow up.  No patient's identifiers provided no batch number and expiration date provided no vaccination date provided. Additional Supportive Information:  The vaccine was already expired and was administered to the patient, which led to expired vaccine used.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered 1st dose 09/30/2022 and 2nd dose 10/04/2022; 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 patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 4th October 2022, the patient received the 2nd dose of Engerix B. On 4th October 2022, unknown after receiving Engerix B, 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 Information: GSK receipt date: 05-OCT-2022 Reporter's comment: Medical assistant administered 1st dose of Engerix B on 30th September 2022.  HCP was unable to provide any additional detail. Adverse event contained all information provided. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Engerix B earlier than the recommended interval, which led to shortening of the recommended interval between vaccine doses.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administration of expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 5th October 2022, unknown after receiving Bexsero and Bexsero 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 Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments: A nurse practitioner called to ask for information about the administration of an expired dose of Bexsero to a 17 years old patient.  The reporter asked for recommendation about patient re-vaccination.  The reporter was consented to follow up. Additional Supportive Information:  The vaccine was already expired and was administered to the patient, which led to expired vaccine used.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 2nd dose 15 days early; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 15-year-old female patient who received HAV (Havrix 720) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 720 (1st dose of Havrix received on 20 Apr 2022.).   On 5th October 2022, the patient received the 2nd dose of Havrix 720 and Havrix Pre-Filled Syringe Device. On 5th October 2022, unknown after receiving Havrix 720 and Havrix 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 Information: GSK Receipt Date: 05-Oct-2022 Reporter's comment: The nurse practioner stated that the patient received second dose of Havrix 15 days early and it was due on the 20th October 2022.  The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Havrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 1 month after the 1st; 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 patient who received HAV (Havrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments: The patient received Havrix 2nd dose 1 month after the first dose instead of waiting for six months. No further information provided via form.  The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Havrix earlier than the recommended schedule, which led to shortening of vaccination schedule.