chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: received a pediatric dose of Engerix-B; received a pediatric dose of Engerix-B; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult patient who received HBV (Engerix B) (batch number DD7k7, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th August 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 18th August 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Aug-2022 Reporter's comment: The pharmacist reported that an adult patient inadvertently received a pediatric dose of Engerix-B on 18th August 2022, during post-exposure vaccination.  The healthcare professional said that follow-up via phone call would be okay.  The reporter left follow-up section black due to standard follow-up methods being postal and email. The consent to follow-up was granted. Additional Supportive Information: An adult patient inadvertently received pediatric dose instead of an adult one, which led to accidental underdose and adult use of a child product.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received only one dose on 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received 1st dose of Shingrix in 2019.).   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: 22-AUG-2022 Reporter's Comment: The pharmacist stated that a patient was over 70 year old that received only one dose of Shingrix on 2019. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the adjuvant portion; Administered only the adjuvant portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA730A, expiry date 30th September 2023) for prophylaxis.   On 22nd August 2022, the patient received the 1st dose of Menveo. On 22nd 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: 22-AUG-2022 Reporter's comment: Health Care Professional reported that a staff member forgot to reconstitute the Menveo and administered only the adjuvant portion of the vaccine to the patient. The reporter consented to follow-up via postal. Additional Supportive Information: The patient received only the adjuvant portion of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received a 22 days expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB36AA, 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 22nd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd 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: 23-Aug-2022:  Reporter's comments:  A pharmacist reported that a patient received a 22 days expired dose of Bexsero. The reporter consent to follow up. Additional Supportive Information: The patient was administered an expired dose of Besxero, which led to expired vaccine used.
Sex: U
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: 1st dose Trumenba and 2nd dose Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and TRUMENBA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: 23-AUG-2022 Reporter's comment: The health care professional (HCP) reported that patient received 1st dose being Trumenba and 2nd dose Bexsero. HCP called for guidance on how to proceed.  Ultimately, patient may receive 3rd Meningococcal B vaccines. (no additional vaccines had been administered besides the two above). The reporter did not consent to follow up. Additional Supportive Information: The patient received Trumenba and then Bexsero, which led to interchange of vaccine products.
Age: 1.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: 1 YO received Kinrix; extra dose of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Kinrix, Kinrix Pre-Filled Syringe Device, the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-Aug-2022 Reporters comment: A nurse reported that a 1 year old patient received an extra dose of Kinrix. The reporter reported that the extra dose was not administered on the same day, it was administered months after the 1st dose. The reporter consented to follow up. Additional Supportive Information: The patient received an extra dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration and extra dose administered.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Lip swelling, Urticaria
Clinical narrative: Hives on both sides of her body; lip swelling/upper lip, lower lip swelled; Fatigue; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of lip swelling in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to vaccine (Had allergy to Smallpox vaccine).   In April 2022, the patient received the 1st dose of Shingrix (intramuscular). In April 2022, several days after receiving Shingrix, the patient experienced fatigue and injection site pain. In May 2022, the patient experienced lip swelling. In June 2022, the patient experienced hives. On an unknown date, the outcome of the lip swelling, hives, fatigue and injection site pain were recovered/resolved.   It was unknown if the reporter considered the lip swelling, hives, fatigue and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine. The reporter sated that after few days of receiving Shingrix vaccine the patient experienced injection site pain and fatigue. One month after Shingrix she had swelling to her upper lip followed by swelling to her lower lip two days after the upper lip swelled. Two months after Shingrix she experienced hives on both sides of her body. The patient had nothing else to report. The reporter consented to follow up.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix given IM instead SC; This case was reported by a other health professional via sales rep and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis.   Co-suspect products included mmr vaccine pre-filled syringe device (Priorix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular) and Priorix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Priorix and Priorix Pre-Filled Syringe Device, the patient experienced subcutaneous injection formulation administered by other route. On an unknown date, the outcome of the subcutaneous injection formulation administered by other route 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: 23-AUG-2022 Reporter's Comments: The health care professional reported that the patient received a dose of Priorix intramuscularly instead of subcutaneously. The reporter asked what was the recommendation if Priorix was given intramuscularly instead of subcutaneously. This adverse event was being reported on behalf of a sales representative. Additional supportive information: The patient received a dose of Priorix, which led to subcutaneous injection formulation administered by other route.
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient should have received DTaP not Tdap (Boostrix); 18 month old  received BOOSTRIX; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9Zk5T, expiry date 7th October 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th August 2022, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 24th August 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comment: The medical assistant from a doctor's office reported that the 18 months old patient was administered with Boostrix (Tdap) at the time of reporting.  As per package insert Boostrix was Food and drug administration approved for individuals aged 10 years and older.  The patient should have received DTaP not Tdap. The injection was given intramuscularly in unspecified leg. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The patient was administered with Boostrix (Tdap) instead of DTaP at inappropriate age ,which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid component of Menveo; only liquid component was administrated; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amra677a, expiry date 30th April 2023) for prophylaxis.   On 5th August 2022, the patient received Menveo. On 5th 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: 24-Aug-2022:  Reporter's comments: The registered nurse reported that a patient was administered with only the liquid component of Menveo.  No adverse event was reported. The reporter did not consent to follow up. Additional Supportive Information: The registered nurse reported that a patient received only the liquid component of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Kinrix extra dose/Patient already had 5 Dtap, last one Kinrix; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (1st dose received on 1st December 2021) and Dtap vaccine (received 4 doses on an unknown date).   On 23rd August 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd August 2022, unknown after receiving Kinrix and Kinrix 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: 24-AUG-2022 Reporter's Comments: The nurse reported that patient received a dose ofKinrix as extra dose by error. Patient already had 5 Dtap vaccines where the last one was a Kinrix vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received by error a Kinrix extra dose which led to extra dose administered.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo liquid component only; patient received only liquid component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA729A, expiry date 30th September 2023) for prophylaxis.   On 23rd August 2022, the patient received Menveo. On 23rd 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: 24-AUG-2022 Reporter's Comments: The nurse reported that a patient received only the liquid component of Menveo on 23rd Aug 2022.  The reporter consent to follow up. Additional Supportive Information: The nurse reported that a patient received only the liquid component of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose on shignrix today on 08/24/2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shignrix (first dose was on 3rd January 2022). Concurrent medical conditions included diabetes. Concomitant products included Herpes zoster (Shingrix).   On 24th August 2022, the patient received the 3rd dose of Shingrix. On 24th August 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's comments: The Healthcare Professional (HCP) reported that a patient had received a 3rd dose on Shingrix today (day of reporting) on 24th August 2022.  The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received his 3rd dose, which led to Extra dose administered.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: received a dose reconstituted with sterile water; 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 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 30th September 2023) for prophylaxis.   On 23rd August 2022, the patient received Menveo. On 23rd 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: 24-AUG-2022 Reporter's Comments: The medical assistant reported that the patient received a dose of Menveo incorrectly reconstituted with sterile water. No symptoms were reported. The patient were twins. The reporter consented to follow up by email. Additional supportive information: The patient received a dose of Menveo incorrectly reconstituted with sterile water, which led to wrong solution used in drug reconstitution. This case was linked with case US2022123184 reported by same reporter.; Sender's Comments:  US-GSK-US2022123186:Same reporter
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: received dose reconstituted with sterile water; 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 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 30th September 2023) for prophylaxis.   On 23rd August 2022, the patient received Menveo. On 23rd 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: 24-AUG-2022 Reporter's Comments: The medical assistant reported that the patient received a dose of Menveo incorrectly reconstituted with sterile water. No symptoms were reported. The patient were twins. The reporter consented to follow up by email. Additional supportive information: The patient received a dose of Menveo incorrectly reconstituted with sterile water, which led to wrong solution used in drug reconstitution. This case was linked with case US2022123184 reported by same reporter.; Sender's Comments:  US-GSK-US2022123184:Same reporter
Age: 0.17
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to 2 months old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's comments: The reporter stated that the Kinrix was administered to 2 month old patient. No other details available. The reporter consented to follow up. Additional Supportive Information: The two month old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak after shingrix dose; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 4FK7Y, expiry date 29th September 2023) for prophylaxis.   On 9th August 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-Aug-2022 Reporters comment: A medical assistant reported that the patient developed a shingles outbreak after receiving the first dose of Shingrix. The reporter consented to follow up.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Boostrix instead of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 67749, expiry date 3rd November 2024) for prophylaxis.   Previously administered products included Dtap vaccine (received 2 doses on an unknown date).   On 24th August 2022, the patient received Boostrix. On 24th August 2022, unknown after receiving Boostrix, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 24-AUG-2022 Reporter's comments: Medical Assistant reported that patient received Boostrix instead of Kinrix vaccine.  According to Vaccine Card, there were 2 Dtap on this patient's file. According to patient's chart, there were 5 Dtaps on the system.  The reporter consented to follow up via postal.  Permission to create a GSK account in system was declined. Additional Supportive Information: Patient received Boostrix instead of Kinrix vaccine, which led to Wrong vaccine administered.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Havrix pediatric administered to a 59 year old; Havrix pediatric administered to a 59 year old; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 58-year-old female patient who received HAV (Havrix pediatric) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th February 2022, the patient received Havrix pediatric .5 ml and Havrix Pre-Filled Syringe Device. On 11th February 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that on 11 February 2022 the patient received a Havrix pediatric vaccine and on 24 August 2022 patient received a Havrix adult dose of 1 ml. The reporter consented to follow up.  Additional Supportive Information: The adult patient was administered a pediatric dose of Havrix on 11th February 2022, which led to underdose and adult use of a child product
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose
Clinical narrative: Less than 0.5ml administered, significant amount leaked out; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comment: The pharmacist reported that the patient received a Shingrix second dose less than 0.5 ml. The amount of liquid that leaked out was significant. Final reconstituted volume of Shingrix less than the recommended dose. The reporter gave consent to follow up by email. Additional Supportive Information: The patient received less than recommended dose of Shingrix, which led to accidental underdose.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Dose reconstituted with another diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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: 24-AUG-2022.  Reporter's Comments: A nurse reported that the patient received a Shingrix dose reconstituted with another diluent than the recommended AS01B. The consent to follow up was granted. Additional Supportive Information: As patient reconstituted Shingrix dose with another diluent, which led to wrong solution used in drug reconstitution.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired dose was given to an adult patient; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HAB (Twinrix adult) (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 24th August 2022 12:00, the patient received Twinrix adult (intramuscular). On 24th August 2022, the patient started Twinrix Pre-Filled Syringe Device. On 24th August 2022 12:00, unknown after receiving Twinrix adult 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: 24-Aug-2022:  Reporter's comments: The healthcare professional reported that an adult patient received expired dose of Twinrix, on the day of reporting at noon on left deltoid.  The patient did not report any side effects.  The reporter did not consent to follow-up. Additional Supportive Information: The patient was administered an expired dose of Twinrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose 11/2021, second not yet received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (In November 2011 the patient received the 1st dose of shingrix. Batch no-HM24H Expiry date-25th March 2023.).   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: 24-AUG-2022 Reporter's Comment: The pharmacist reported late second dose of Shingrix, not yet received. The reporter gave consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. This case had been linked with US2022123224, reported by same reporter.; Sender's Comments:  US-GSK-US2022123224:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2018, can't remember getting the 2nd; This case was reported by a consumer 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 (1st dose received on 12th April 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: 24-AUG-2022 Reporter's Comments: The reporter was the patient. The patient could not remember if he received his second dose. He had nothing else to report. Additional Supportive Information: Till the time of reporting, it was unknown if the patient received his second dose which led to incomplete course of vaccination. This case was conservatively kept valid with event incomplete course of vaccination, clarification has been raised.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late second dose, not yet received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comments: The pharmacist reported that patient was late for second dose of Shingrix and not yet received.  The administration date of first dose of shingrix unavailable per pharmacist.  All other adverse event information unavailable at this time per pharmacist.  The health care professional gave permission for safety team  follow up. Additional Supportive Information: The patient was late for second dose of shingrix which was not yet received which led to Incomplete course of vaccination. This case was linked with US2022123223 reported by same reporter for Shingrix.; Sender's Comments:  US-GSK-US2022123223:Same reporter
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: shot #1 Dec2020, shot #2 01Aug2022.; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on December 2020 received 1st dose via intramuscular route on Unknown deltoid).   On 1st August 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 1st August 2022, unknown after receiving Shingrix, 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.       Additional Information: GSK Receipt Date: 24-AUG-2022 Reporter's Comments: The reporter was the patient.  The patient received 1st Shingrix shot in late December 2020 and Shingrix 2nd shot on 01 Aug 2022 in unknown deltoid.  As per package insert  Shingrix was given: first dose at month 0 followed by a second dose administered 2 to 6 months later. The reporter consent to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 19Jan2022, 2nd not yet received; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 23-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 19 January 2022 from lot number N4GA4 and expiry date 02nd January 2023).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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: 25-AUG-2022 Reporter's Comment: The reporter was a pharmacy technician. The reporter stated that the patient received first dose of Engerix-B on 19th January 2022 and the patient did not received second dose. The reporter consented 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: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue, Single component of a two-component product administered
Clinical narrative: only liquid adjuvant of Shingrix; received only the liquid adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 4fk7y, expiry date 29th September 2023) for prophylaxis.   On 24th August 2022, the patient received Shingrix. On 24th August 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: 25-AUG-2022 Reporter's comment: The pharmacist reported that the patient received only the liquid adjuvant component of Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient received only the liquid adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: COVID19
Symptoms: Aortic thrombosis, Laboratory test, Scan adrenal gland abnormal, Thrombosis, Weight
Clinical narrative: RAPIDLY LOSING WEIGHT; LARGE CLOT IN ABDOMINAL AORTA (40 PERCENT BLOCKAGE); CLOT IN LEFT LEG; SPOT ON ADRENAL GLAND; This spontaneous report received from a parent concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: Unknown and expiry: Unknown ) dose was not reported, 1 total, administered on an unspecified date in 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021 patient developed severe abdominal pain ninety days later to vaccination (APR-2021 or MAY-2021) for which patient went to urgent care, ran tests, took images and found large clot in abdominal aorta, 40 percent blockage. Upon further testing patient found another clot in left leg and a spot on adrenal gland. On an unknown date in JUN-2022 patient started rapidly losing weight and patient was put on blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from large clot in abdominal aorta (40 percent blockage), spot on adrenal gland, rapidly losing weight, and clot in left leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220846125-covid-19 vaccine ad26.cov2.s -Large clot in abdominal aorta, clot in left leg. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are no other factors more likely to be associated with the event(s) than the drug. Therefore, this event(s) is considered related.
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: RAPIDLY LOSING WEIGHT; LARGE CLOT IN ABDOMINAL AORTA (40 PERCENT BLOCKAGE); CLOT IN LEFT LEG; SPOT ON ADRENAL GLAND; This spontaneous report received from a parent concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: Unknown and expiry: Unknown ) dose was not reported, 1 total, administered on an unspecified date in 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021 patient developed severe abdominal pain ninety days later to vaccination (APR-2021 or MAY-2021) for which patient went to urgent care, ran tests, took images and found large clot in abdominal aorta, 40 percent blockage. Upon further testing patient found another clot in left leg and a spot on adrenal gland. On an unknown date in JUN-2022 patient started rapidly losing weight and patient was put on blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from large clot in abdominal aorta (40 percent blockage), spot on adrenal gland, rapidly losing weight, and clot in left leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220846125-covid-19 vaccine ad26.cov2.s -Large clot in abdominal aorta, clot in left leg. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are no other factors more likely to be associated with the event(s) than the drug. Therefore, this event(s) is considered related.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Limb discomfort, Recalled product administered
Clinical narrative: This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. The drug was associated with Medication error. No concomitant medications were reported. On an unspecified date, the patient experienced issues with walking, recalled shot, and issues with arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the issues with walking, issues with arm and recalled shot was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000247526. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria, as this record describes a series of adverse reactions to the product subsequently administration. There was no product quality issue described and the case does not meet the definition for a product quality complaint (PQC) or explicitly allege a potency issue) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220848257 and 20220846104.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Urticaria
Clinical narrative: This spontaneous report received from a health care professional via other manufacturer (Pfizer) concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, hyperlipidemia, hypothyroidism, anxiety, depression, gout, OSA (Obstructive Sleep Apnea), insomnia, and allergy (unspecified). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 in total, on 09-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 49 years old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 11-NOV-2021 for covid-19 prophylaxis. On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2). The patient was treated with Paxlovid (form of administration not reported, oral, batch number: unknown, expiry: unknown) dose was not reported, administered from 10-AUG-2022 to 14-AUG-2022 for treatment of COVID-19. The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. On 14-AUG-2022, the patient experienced hives on bilateral lower extremities (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (Moderna Covid-19 Vaccine) was not applicable and with Paxlovid was not reported. The patient was recovering from hives on bilateral lower extremities, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included: lost part of the thyroid (taking thyroid medication a little over weight), and concurrent conditions included: hay fever, shellfish allergy, alcohol use (very rarely), and non-smoker. The patient previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 for covid-19 prophylaxis. The patient did not experienced any negative effects with the first shot and handled the Janssen vaccine well. No fever no tiredness (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, administered on 15-NOV-2021 for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced slightly sore arm that lasted for 24 hours. There was no other symptoms with both vaccination. No fever no tiredness (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly sore arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity.   The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 23-DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-DEC-2021, 2 days after vaccination, the patient died.  On 25-DEC-2021, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220846104.; Sender's Comments: V0:20220848257-covid-19 vaccine ad26.cov2.s-Died. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH