chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Felt bad 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-AUG-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine on Wednesday and felt bad for 2 days. The patient felt fine now. The patient stated that marked safe from shingles. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: slight fever; little headache; body aches; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date, for tolerance refer case US2022AMR122523).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, headache and general body pain. On an unknown date, the outcome of the fever, headache and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, headache and general body pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR122523   Additional Information: GSK Receipt Date: 14-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had a little headache, slight fever and body aches for 12 hours with the second dose. The patient reported that's called an immune response, which means they were producing antibodies to fight off a shingles infection. The follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR122523:Same reporter
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered liquid portion only; administered liquid portion only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA6588, expiry date 20th January 2023) for prophylaxis.   On 15th August 2022, the patient received Menveo. On 15th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-Aug-2022 Reporter's comments: The medical assistant reported that patient was administered the liquid portion only of Menveo without prior reconstitution. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient was administered only the liquid portion of Menveo without prior reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: while reconstituting Shingrix, liquid squirted into eyes; while reconstituting Shingrix, liquid squirted into eyes; This case was reported by a nurse via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 35-year-old female patient who received Herpes zoster (Shingrix) (batch number GC744, expiry date 28th August 2023) for prophylaxis.   On 14th August 2022, the patient received Shingrix. On 14th August 2022, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comments: The nurse reported that while she was reconstituting Shingrix some of the liquid squirted into her eyes. She washed her eye with plenty of water. She was looking for information about any possible side effect. This happened on 14th August 2022. The reporter consented to follow-up. Additional supportive information: Reconstituted Shingrix was accidentally splashed into nurse' eye, which led to occupational exposure while preparing product for administration and exposure via eye contact.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Pruritus
Clinical narrative: itchiness on scalp, back and abdominal area; Her arm still hurts; injection site pain; unable to lift arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox. Concurrent medical conditions included psoriasis.   In August 2022, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2022, 12 days after receiving Shingrix, the patient experienced pruritus. In August 2022, the patient experienced injection site pain, injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, pruritus and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, pruritus and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's comments: The reporter was the patient herself. She had received her first Shingrix dose about 2 weeks ago. She immediately had experienced injection site pain. Her arm still hurts and she was unable to lift it due to the pain. About 2 days ago she had experienced itchiness to areas on her scalp, back and abdominal area. She felt that the itchiness to scalp may be due to her psoriasis. She had nothing else to report. The reporter had declined to provide DOB or contact information (other than email). The reporter did not consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Intermitent shoulder pain; Intermitent shoulder stiffness; Very painful; Pain at injection site/intermitent sharp stabbing pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th July 2022, several minutes after receiving Shingrix, the patient experienced injection site pain. On 11th August 2022, the patient experienced shoulder pain, stiffness shoulder and pain. On an unknown date, the outcome of the injection site pain, shoulder pain, stiffness shoulder and pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, shoulder pain, stiffness shoulder and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-AUG-2022 and 15-AUG-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine. the reporter stated that after minutes of received vaccine patient experienced injection site pain. On 11 August 2022 the patient experienced sharp stabbing pain at injection site, Shoulder pain and shoulder stiffness. The sharp stabbing pain at injection site, Shoulder pain and shoulder stiffness was intermittent and lasts for few seconds but these are unresolved. The reporter stated that the patient had recurrence of a weird side effects with the Shingrix vaccine and it was very painful. The reporter declined date of birth and the batch number and expiration date was unknown. The reporter consented to follow up. Additional supportive information: The case US2022119079 was identified as duplicate of case US2022119045. All future correspondence would be added in case US2022119079, which stands as case of record for this patient and the case US2022119045 would be deleted.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient outside of 6 month window; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.  Additional Information: GSK Receipt Date: 15-Aug-2022. Reporter's comment: The registered pharmacist (RPH) reported that the patient was outside of 6 month window, for receiving 2nd dose of Shingrix. Since reporter was not clear if the 2nd dose was administrated or not. The reporter did not consent to follow up. Additional Supportive Information: The patient was outside of 6 month window, for receiving 2nd dose of Shingrix, which led to inappropriate schedule of vaccine administered.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: experiencing rednessat the injection site; experiencing swelling at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2022, the patient received the 1st dose of Shingrix (intramuscular). In August 2022, less than a week after receiving Shingrix, the patient experienced injection site redness and injection site swelling. On an unknown date, the outcome of the injection site redness and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site redness and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comments: The pharmacist reported that a patient had experienced redness and swelling at the injection site (left arm) after receiving the Shingrix. The reporter gave Consented to follow up.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia
Clinical narrative: Has been tired; Sleepless; This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2022, the patient received the 1st dose of Shingrix. On 14th August 2022, less than a day after receiving Shingrix, the patient experienced sleeplessness. On 15th August 2022, the patient experienced tiredness. On an unknown date, the outcome of the sleeplessness was recovered/resolved and the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the sleeplessness and tiredness to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comment: The reporter was the patient. The patient received Shingrix vaccine and on the same night patient was sleepless and she had been tired since the following day. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: received Pediarix at 3 , 5 and 10 months of age, received additional Engerix B; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received HBV (Engerix B) (batch number 97KT7, expiry date 15th March 2024) for prophylaxis.   Previously administered products included Hepatitis B vaccine (the patient had received one birth dose of hepatitis B vaccine (unknown brand)), Pediarix (1st dose of Pediarix received at 3 months of age), Pediarix (2nd dose of Pediarix received at 5 months of age) and Pediarix (3rd dose of Pediarix received at 10 months of age).   On 16th August 2022, the patient received Engerix B 10 µg. On 16th August 2022, unknown after receiving Engerix B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comment: The reporter was medical assistant. The patient received an additional 10mcg dose of Engerix B. The reporter consented to follow up. Additional Supportive Information: The patient received an additional 10mcg dose of Engerix B, which led to extra dose administered.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Dose 1 sep 12th 2016, dose 2 June 21st 2021; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA415A, expiry date 30th September 2021) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 12th September 2016).   On 21st June 2021, the patient received the 2nd dose of Menveo. On 21st June 2021, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments: This case was reported by a healthcare professional. The reporter stated that the patient received 2nd dose 8 days earlier before his 16th birthday. The reporter stated that as per school requirements, school does not accept it, as it says its 8 days before his 16th birthday. The adverse event was filed because they gave it too early based on school requirements. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Menveo, which led to extra dose administered.
Age: 20.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 October 1st 2021, 2nd dose Aug 12th 2022/ TWINRIX LATE 2ND DOSE; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 20-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) 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 (on 1st October 2021, the patient received 1st dose of Twinrix, expiry date: 8th February 2022 and batch number: DK23D).   On 12th August 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 12th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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: 16-AUG-2022 Reporter's Comment: The reporter reported that the patient received late 2nd dose of Twinrix.  The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's comment: The reporter was the friend of the patient. The reporter states her friend received the first dose of Shingrix the day before reporting. Her friend was experiencing a headache. The reporter did not consent to follow-up. The reporter provided limited information. Additional supportive information: This case has been linked to the case US2022122084 reported by the same reporter.; Sender's Comments:  US-GSK-US2022122084:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Neck pain, Pain
Clinical narrative: Very bad pain in neck and brest area; Very bad pain in neck and brest area; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (2 months prior to the reporting date).   On 16th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced neck pain and pain. On an unknown date, the outcome of the neck pain and pain were unknown.   It was unknown if the reporter considered the neck pain and pain to be related to Shingrix.     Additional Information: GSK receipt date: 16-Aug-2022 Reporter's comments: The patient had very painful shingles. The patient received the shot and will receive another one in September. The patient had the shingles 2 months prior to the reporting. The reporter tried to clarify if the patient experienced shingles after 1st dose and he/she stated after but then stated yes, had shingles first.  When reporter again asked if he or she had an episode of shingles after receiving the first dose of Shingrix, he or she stated, no but had Very bad pain in neck and over breast area. The reporter asked for the patient's information, but they did not provide it.  No additional information was provided. The reporter did not consent to follow up. Additional supportive information: Note: No clear information was given regarding event shingle as well at last stated that patient did not had shingle so not code as event.
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 30th January 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.   Concomitant products included MENINGOCOCCAL B VACCINE (BEXSERO) and MENINGOCOCCAL B VACCINE (BEXSERO).   On 8th October 2021, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 8th October 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose 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 Information: GSK receipt date- 17-Aug-2022 Reporter's comment: The nurse reported a patient received third dose of Bexsero. The reporter consented to follow up. Additional Supportive Information: The patient received the third dose of Bexsero, which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 and 1/2 years ago. 2nd dose not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received first dose 2 and half years ago from reporting).   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: 17-AUG-2022 Reporter's Comments: The patient had not yet received 2nd dose of Shingrix. The reporter gave consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose which led to incomplete course of vaccination.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Administered Menveo not properly reconstituted; 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 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA714A, expiry date 30th June 2023) for prophylaxis.   On 15th August 2022, the patient received Menveo. On 15th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: Health Care Provider reported that the patient received a Menveo vaccination that was not properly reconstituted as they used a non approved diluent.   The reporter consented to follow-up. Additional Supportive Information: The patient received dose of Menveo that was not properly reconstituted as they used a non approved diluent, which led to Wrong solution used in drug reconstitution.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Gait inability
Clinical narrative: Unable to walk; Severe back pain; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix (intramuscular). In June 2022, 1 week after receiving Shingrix, the patient experienced back pain. On an unknown date, the patient experienced unable to walk. On an unknown date, the outcome of the back pain was recovered/resolved and the outcome of the unable to walk was unknown.   It was unknown if the reporter considered the back pain and unable to walk to be related to Shingrix.     Additional Information: GSK receipt date: 17-AUG-2022 Reporter's comments: The reporter was the patient.  She received her first Shingrix dose on an unknown arm about two months ago from date of reporting.  One week later she experienced back pain. Less than a month after vaccination, she was unable to walk due to the severe back pain.  She did not visit doctor.  The pain resolved after 2 and 1/2 weeks. She had nothing else to report. The consent to follow up granted.
Sex: U
Vaccine: TDAP
Symptoms: Abdominal discomfort
Clinical narrative: Stomach discomfort; This case was reported by a pharmacist via call center representative and described the occurrence of stomach discomfort in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced stomach discomfort. On an unknown date, the outcome of the stomach discomfort was recovered/resolved.   It was unknown if the reporter considered the stomach discomfort to be related to Boostrix and Boostrix 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 Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: The patient received Boostrix 10 years ago from the reporting date and had stomach discomfort. The vaccine was administrated on another facility and no vaccination date provided.  The lot number and expiration date were not provided. The consent to follow up was not asked.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose Nov 6th 2018, never got second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received on 6 November 2018).   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: 17-AUG-2022 Reporter's Comment: The reporter was a pharmacist. The reporter stated that the patient never got the second dose of vaccine. The reporter consented to follow up Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4YO administered Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number YR7AA, expiry date 14th April 2024) for prophylaxis.   On 17th August 2022, the patient received Boostrix. On 17th August 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: The registered nurse reported that the four year old patient received a dose of Boostrix. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Boostrix at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Twinrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 17th August 2022, unknown after receiving Twinrix and Twinrix 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: 17-Aug-2022 Reporter's comment: The patient received an expired dose of Twinrix. The vaccine expired on 7 Aug 2022. The consent to follow up was granted. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient may have received only the adjuvant; Patient may have received only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2022, the patient received the 1st dose of Shingrix. On 18th June 2022, 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 Information: GSK receipt date: 17-Aug-2022 Reporter's Comments: A pharmacist stated that they were about to administer the 2nd dose of Shingrix and realized that the patient might had received only the adjuvant portion of the vaccine for the 1st dose (two powder vials in box, no adjuvant).  The healthcare professional did not have the lot number or expiry date at the time of the call. The reporter consented to follow up. Additional Supportive Information: The patient received only the adjuvant portion of Shingrix, which led to the inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB34AA, expiry date 31st July 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 17th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th August 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: 17-AUG-2022 Reporter's Comments: A pharmacist reported that a patient received an expired dose of Bexsero on 17th August 2022. The vaccine expired on 31st July 2022.  The reporter was consented to follow up. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact
Clinical narrative: Vaccine sprayed in the eye; Vaccine sprayed in the eye; This case was reported by a pharmacist via call center representative and described the occurrence of inadvertent exposure to vaccine in a female patient who received Herpes zoster (Shingrix) (batch number 95G27, expiry date 10th September 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inadvertent exposure to vaccine and exposure via eye contact. On an unknown date, the outcome of the inadvertent exposure to vaccine and exposure via eye contact were unknown.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: The pharmacist reported that she was administering the vaccine and the syringe malfunctioned.  The vaccine sprayed her in the eye. Related to patient. Chat was abandoned prior to getting more detail, email and contact number above was what she provided. Chat was picked up by another agent after health care professional reconnected where health care professional provided vaccine name, lot and exp date, she declined to provide her date of birth. The reported mentioned to saw case chat transcript if needed. Additional Supportive Information: The vaccine was sprayed in the patient eye, which led to inadvertent exposure to vaccine and exposure via eye contact.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Boostrix and Menveo administered on 08Aug and 16Aug; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA714A, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number YR7AA, expiry date 14th April 2024) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included MENVEO and DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 16th August 2022, the patient received the 2nd dose of Menveo, the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 16th August 2022, unknown after receiving Menveo, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose 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 Information: GSK receipt date- 17-Aug-2022 Reporter's comment: The nurse reported a patient received a dose of Boostrix and Menveo. The nurse inadvertently administered Boostrix and Menveo again. The reporter consented to follow up. Additional Supportive Information: The nurse inadvertently administered Boostrix and Menveo again, which led to extra dose administered.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Breast pain, Fatigue, Herpes zoster, Injection site pain
Clinical narrative: Shingles rash; red rash was all over the front of her right breast and under the breast, under her arm pit, and out onto the right side of her back, below the shoulder blade,rash was getting redder and redder; Blisters/More blisters were forming; Pain; temperature of 100.6; Pain in her right breast; left arm (injection site), did hurt; Tired; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2022, the patient received the 1st dose of Shingrix. On 6th August 2022, 1 days after receiving Shingrix, the patient experienced breast pain. On 7th August 2022, the patient experienced shingles, red rash, blister, pain and fever. In August 2022, the patient experienced injection site pain and tiredness. The patient was treated with paracetamol (Tylenol). On 8th August 2022, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the breast pain, red rash, blister and tiredness were unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, breast pain, shingles, red rash, blister, pain, fever and tiredness to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comment: The reporter stated the after received vaccine on next day the patient experienced pain in her right breast. On 7 August 2022, 2 days after received Shingrix vaccine patient experienced Shingles rash, blisters, pain and a temperature of 100.6 degree F. The patient had red rash was all over the front of her right breast and under the breast, under her arm pit and out onto the right side of her back, below the shoulder blade. Patient was also began to see blisters form.  Patient was also tired.  The patient temperature went away the next day, but her rash was getting redder and redder and more blisters were forming.  The patient was admitted that her left arm at injection site did hurt and lasted for couple of days. The patient had been taking Tylenol around the clock to control the pain and using calamine spray. The reporter consented to follow up.  Note- The treatment product was not getting coded in product tab with encode button, however it was mention in narrative.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash erythematous
Clinical narrative: Shingles rash; red rash was all over the front of her right breast and under the breast, under her arm pit, and out onto the right side of her back, below the shoulder blade,rash was getting redder and redder; Blisters/More blisters were forming; Pain; temperature of 100.6; Pain in her right breast; left arm (injection site), did hurt; Tired; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2022, the patient received the 1st dose of Shingrix. On 6th August 2022, 1 days after receiving Shingrix, the patient experienced breast pain. On 7th August 2022, the patient experienced shingles, red rash, blister, pain and fever. In August 2022, the patient experienced injection site pain and tiredness. The patient was treated with paracetamol (Tylenol). On 8th August 2022, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the breast pain, red rash, blister and tiredness were unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, breast pain, shingles, red rash, blister, pain, fever and tiredness to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comment: The reporter stated the after received vaccine on next day the patient experienced pain in her right breast. On 7 August 2022, 2 days after received Shingrix vaccine patient experienced Shingles rash, blisters, pain and a temperature of 100.6 degree F. The patient had red rash was all over the front of her right breast and under the breast, under her arm pit and out onto the right side of her back, below the shoulder blade. Patient was also began to see blisters form.  Patient was also tired.  The patient temperature went away the next day, but her rash was getting redder and redder and more blisters were forming.  The patient was admitted that her left arm at injection site did hurt and lasted for couple of days. The patient had been taking Tylenol around the clock to control the pain and using calamine spray. The reporter consented to follow up.  Note- The treatment product was not getting coded in product tab with encode button, however it was mention in narrative.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Myalgia
Clinical narrative: 1st dose 10Dec2021, not had 2nd dose; Muscle soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 10th December 2021, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced muscle soreness. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the muscle soreness was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: The patient self-reported this case. The patient received 1st dose of Shingrix vaccine and experienced muscle soreness that had since resolved. The patient stated that he did not receive his second dose of Shingrix as of now. The patient also stated that he will schedule an appointment to receive his second dose of Shingrix as soon as possible.  The patient gave medical disclaimer. Referred to HCP (Health Care Professional). Spoke per PI (package insert) and content. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Inappropriate schedule of product administration, Serology test, Therapy non-responder
Clinical narrative: received series, showed no immune response; Engerix-B series on 21Sep2001, 20Nov2001, and 27Jun2002; Engerix-B series on 21Sep2001, 20Nov2001, and 27Jun2002; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 20-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th June 2002, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 20th November 2001, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 21st September 2001, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 20th November 2001, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 27th June 2002, 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, drug dose administration interval too long 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 Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: The office manager reported that the patient received second dose of Engerix B on 20th November 2001 and third dose on 27th June 2002.  The doses were given at a different facility, so reporter did not had the lot number or expiration date information. The patient was going to be starting nursing school and recently had lab work that showed no immune response to hepatitis B. The plan was to revaccinate the patient, though this had not been initiated at the time of reporting. The reporter consented to follow up. Additional Supportive Information: The patient completed the series of Engerix B, but result showed no immune response, which led to therapy non-responder. The patient received the second dose and third dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 66.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 66-year-old female patient who received HAV (Havrix) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   On 17th August 2022, the patient received Havrix. On 17th August 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: 17-AUG-2022 Reporter's Comments: The nurse reported that a patient received an Havrix which was expired on 9th Aug 2022. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1:6/20/22, Dose 3: 8/17/2022; 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 1-month-old female patient who received HBV (Engerix B) (batch number CM294, expiry date 19th April 2024) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B) and HEPATITIS B VACCINE (ENGERIX B).   On 17th August 2022, the patient received the 3rd dose of Engerix B. On 17th August 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: 17-AUG-2022 Reporter's Comments: On 20th June 2022, the patient received 1st dose and on 19th July 2022, the patient received 2nd dose. The reporter consented to follow up. Additional Supportive Information: The patient received 3rd dose earlier than the recommended schedule, which led to shortening of the vaccination schedule.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: diluted with sterile water and administered it; diluted with sterile water and administered it; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA710A, expiry date 30th April 2023) and (batch number T014300, expiry date unknown) for prophylaxis.   On 15th August 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 15th August 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: 17-Aug-2022. Reporter's comment: The pharmacist stated they accidentally diluted Menveo with sterile water and administered it to patient. The reporter consented to follow up. Additional Supportive Information: Accidentally diluted Menveo with sterile water and administered it to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with the case US2022120207 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022120207:Same reporter