chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 7y/o; Kinrix administered as 3rd dose in DTaP series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-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 an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The nurse reported that a 7 year old patient was administered Kinrix as the third dose in the DTaP series. At the time of reporting, the nurse did not have the patient details, date of administration, lot number/expiration date, or the information of what vaccines were given for the first two DTaP series.  The vaccine administration facility was the same as primary reporter.   The consent to follow up was granted. Additional Supportive information: The 7 year old patient was administered Kinrix as the third dose in the DTaP series which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. This case was one of 10 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136459:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136466:Same reporter
Sex: U
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 7y/o; Kinrix administered as 1st and 2nd dose DTaP series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-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, 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 inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The nurse reported that a 7 year old patient was administered Kinrix as the first and second dose in the DTaP series. At the time of reporting, the nurse did not have the patient details, date of administration, lot number/expiration date. The vaccine administration facility was the same as primary reporter.   The consent to follow up was granted. Additional Supportive information: The 7 year old patient was administered Kinrix as the first and second dose in the DTaP series which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.  This case was one of 10 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022136455:Same reporter US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136456:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136466:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136461:Same reporter
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired diluent administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA585A, expiry date 30th April 2023) and (batch number AMAA585A, expiry date 31st August 2022) for prophylaxis.   On 21st September 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 21st September 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's Comments: The reporter was a medical assistant. The reporter stated that administration of expired dose, diluent expired 31st Aug 2022. The reporter consented to follow up. Additional Supportive Information: The patient received expired Menveo vaccine which led to expire vaccine used.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2 year old was administered Kinrix; Administered Kinrix instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-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.   Previously administered products included Pentacel (dose received on 17th November 2020).   On 7th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th March 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comment: The reporter reported that the 2 year patient received Kinrix vaccine instead of Infanrix. The reporter stated that she did not had lot number and expiration date of the vaccine. The vaccine facility administration was same as the primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received Kinirix instead of Infanrix, who was younger than the indicated age which led to inappropriate age at vaccine administration and wrong vaccine administered. This case was one of 10 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022136455:Same reporter US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136456:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136466:Same reporter US-GSK-US2022136459:Same reporter
Age: 10.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 10 year old given Pediarix; given Pediarix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th August 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 11th August 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's comment: Registered nurse reported that the 10 year old patient was given Pediarix instead of Boostrix. At the time of reporting, the nurse did not have the lot number and expiration date and the information of what vaccines were given previously. The reporter consented to follow-up. Additional Supportive Information: The 10 year old patient was given Pediarix instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. This was one of the 11 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022136461:Same reporter US-GSK-US2022136459:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136456:Same reporter US-GSK-US2022136466:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in december 2019, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received intramuscular in December 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-SEP-2022 Reporter's Comment: The reporters were a patient and pharmacist. The reporter reported that the patient did not received second dose of Shingrix vaccine. The patient plans to receive second dose. The reporter had nothing else to report. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case had been linked with US2022136473, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022136473:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: They got 1st shot, 2nd didn't within the 6 month window; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients 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 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-SEP-2022 Reporter's Comments: The reporter was a retail pharmacist. The reporter reported that a few people, might be 3 people had informed her that they got 1st shot of Shingrix but then did not get 2nd shot within the 6 months window. No further information was provided. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case had been linked with US2022136468, reported by same reporter.; Sender's Comments:  US-GSK-US2022136468:Same reporter
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Diluent without the lyophilized powder; Diluent only administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number MK9Y2, expiry date 1st July 2023) for prophylaxis.   On 20th September 2022, the patient received Shingrix. On 20th September 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: 22-SEP-2022 Reporter's Comments: The pharmacist called to inquire about any information. The nurse administered the Shingrix diluent without the lyophilized powder component to a patient. The reporter did not consent to follow up. Additional Supportive Information: The patients received Shingrix vaccines without the lyophilized powder component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site pruritus, Injection site rash
Clinical narrative: Mild allergic reaction; 6-inch long rash below the injection site; Mildly itchy (rash); This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2022, the patient received the 1st dose of Shingrix (intramuscular). On 15th July 2022, 4 days after receiving Shingrix, the patient experienced rash and itchy upper limbs. On an unknown date, the patient experienced allergic reaction. On 19th July 2022, the outcome of the rash and itchy upper limbs were recovered/resolved. On an unknown date, the outcome of the allergic reaction was unknown.   The reporter considered the rash to be related to Shingrix. It was unknown if the reporter considered the itchy upper limbs and allergic reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's comment: This case was self-reported by patient. The patient received the first dose of Shingrix intramuscularly on right deltoid. Less than 3 months after vaccination, the patient developed delayed mild allergic reaction to Shingrix.  After 4 days of the injection, the patient developed a 6-inch long rash below the injection site, located a couple inches below the right shoulder, which was mildly itchy and lasted a couple days. It was mostly gone by 18th July 2022 and it was completely gone by 19th July 2022.  The reporter consent to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 22nd September 2022, the patient received Havrix. On 22nd September 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: 22-SEP-2022 Reporter's comment: Medical Assistant (MA) had called to inquire if any information was available. Medical Assistant (MA) had reported that a patient was administered an expired Havrix dose on 22nd September 2022.  Reporter was unable to provide any patient details. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose JAN-2022, not yet received second; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2022).   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-SEP-2022 Reporter's Comments: The reporters were a medical assistant and a physician. The patient had not yet received her second dose of Shingrix. The health care professional asked how to proceed with vaccination. The reporter did not provide the lot number and expiration date of Shingrix first dose vaccine. The reporter consented 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. The case US2022136497 was identified as duplicate of case US2022136494. The case US2022136497 would be deleted and all future correspondence would be added in the present case US2022136494 which stands as case of record.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 5YO receive Boostrix; Patient received Boostrix instead of Kinrix; 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 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 3rd November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 27th August 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the 5 years old child patient received Boostrix vaccine instead of Kinrix. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received Boostrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter reported that, they were intending to administered Kinrix and inadvertently administered Boostrix instead of Kinrix, which led to wrong vaccine administered.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix administered to 2 YO; Patient received Kinrix instead of Daptacel; 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-year-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 22nd September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 22nd September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter reported that the nurse administered Kinrix vaccine to the 2 year child patient instead of Daptacel. The reporter stated that the patient vaccine history with Penta was not clear. The reporter did not consent to follow up. Additional supportive information: The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter reported that, they were intending to administered Daptacel and inadvertently administered Kinrix instead of Daptacel, which led to wrong vaccine administered.
Age: 31.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with different diluent; Menveo administered with different diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 31-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA732A, expiry date 31st October 2023) for prophylaxis.   On 23rd September 2022, the patient received Menveo. On 23rd September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, the administration of Menveo which was reconstituted with a different diluent than the supplied meningococcal CYW-135 (MenCYW-135) liquid to a patient. The reporter asked how to proceed with patient vaccination. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, the administration of Menveo which was reconstituted with a different diluent than the supplied meningococcal CYW-135 (MenCYW-135) liquid to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero admiistered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB39AA, 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 September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd September 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-SEP-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, they administered an expired Bexsero to a patient. The reporter called to inquire how to proceed The reporter consented to follow up. Additional Supportive Information: The reporter reported that, they administered an expired Bexsero to a patient, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain
Clinical narrative: Patient refused to get 2nd dose; Sore around the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments: The patient was sore for week around the injection site.  The reporter said it was the 1st dose not sure if other vaccines was given. The reporter stated patient refused to get 2nd dose. 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.; Sender's Comments:  US-GSK-US2022137220:Same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received three doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number GJ549, expiry date 15th September 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th September 2021) and Shingrix (2nd dose received on 11th March 2022).   On 23rd September 2022, the patient received the 3rd dose of Shingrix. On 23rd September 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: 23-SEP-2022 Reporter's Comments: The pharmacist reported that a female patient received three doses of Shingrix.. They received the three doses on the same day and they were a husband and wife. Additional supportive information: The patient received 3rd dose, which led to extra dose administered.; Sender's Comments:  US-GSK-US2022137209:Same reporter
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given only the liquid componen; given only the liquid componen; 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 male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA731A, expiry date 30th September 2023) for prophylaxis.   On 21st September 2022, the patient received Menveo. On 21st September 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: 23-SEP-2022 Reporter's comment: The reporter asked if a patient was given only the liquid component of Menveo, how long did they need to wait to administer this vaccine correctly. HCP (Health Care Professional) declined to provide initials. The reporter consented to follow-up via postal. Additional Supportive Information: The patient was given only the liquid component of Menveo, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 13-JUL-2022, second on 18-JUL-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) (batch number LG3B4, expiry date 8th April 2023) for prophylaxis.   Concurrent medical conditions included hiv infection. Concomitant products included Herpes zoster (Shingrix).   On 18th July 2022, the patient received the 2nd dose of Shingrix. On 18th July 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's comment: Pharmacist reported that a patient inadvertently received his first dose of Shingrix on 13th July 2022 and the second dose on 18th July 2022. The pharmacist opted out of providing additional information. The reporter did not consider the patient to be immunocompromised due to the patient's blood levels. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fatigue; Fever; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd September 2022, 1 days after receiving Shingrix, the patient experienced fatigue and fever. On an unknown date, the outcome of the fatigue and fever were not recovered/not resolved.   It was unknown if the reporter considered the fatigue and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments:  The patient stated that she got the first Shingrix vaccine and on the day of reporting she was experienced fatigue and fever. The patient did not have time to supply anymore information regarding demographics or information about the vaccine. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Swelling around injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments:  The caller stated that the patient had a lot of swelling around injection site.  The caller was not sure if other vaccines were given with this product.  The caller stated this was all the information the Nurse gave her. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022137214:Same reporter
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vertigo, Vomiting
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (severe attack of vertigo  head was spinning), FATIGUE (she has been feeling extremely tired ever since/I cannot tell you how tired I have been) and VOMITING (She was throwing up) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M21A, 033F21A, 006B21A and 016M20A) for COVID-19 vaccination. Patient did not have COVID positive test or diagnosis. Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE on 21-Oct-2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Adhesive tape allergy, Allergy to antibiotic (Amoxicillin allergy), Allergy to antibiotic (Bactrim allergy), Blood pressure high and Thyroid disorder NOS. Concomitant products included OLMESARTAN for Blood pressure high, LEVOTHYROXINE SODIUM (LEVOXYL) for Thyroid disorder NOS. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (she has been feeling extremely tired ever since/I cannot tell you how tired I have been). On 21-Sep-2022, the patient experienced VERTIGO (severe attack of vertigo , head was spinning) and VOMITING (She was throwing up). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at a dose of 25 milligram. At the time of the report, VERTIGO (severe attack of vertigo , head was spinning) had resolved, FATIGUE (she has been feeling extremely tired ever since/I cannot tell you how tired I have been) had not resolved and VOMITING (She was throwing up) outcome was unknown. Patient did not have problems with any previous doses. Patient's lab data included MRI, EEG and unspecified other tests in the emergency room on 21-Sep-2022. Patient stayed in the ER for several and was sent home. Patient did not experience a similar event in the past. Patient was prescribed Meclizine 25 mg as standby medication for recurrence of vertigo.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses with no reported adverse event; Initial information received on 21-Sep-2022 regarding an unsolicited valid non-serious case received from health professional.  This case involves unknown gender (over 65 years) elderly patient who was given expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] for with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA392579, 2022SA400367, 2022SA400987, 2022SA400369, 2022SA400371, 2022SA401056, 2022SA400981 , 2022SA400131 and 2022SA401104.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ772AA, expiry date date: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination (Immunization).  On an unknown date the patients developed a non-serious "received a box of expired Fluzone high dose for Jun 30, 2022 and gave all 10 doses with no reported adverse event" (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: vaccine exposure during pregnancy with no reported adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 28 years old female patient who was exposed to vaccine Influenza quadrival A-B vaccine [Fluzone QIV] in context of vaccine exposure during pregnancy with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported vaccine exposure during pregnancy with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date is 26-Feb-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no previous pregnancy/ies.   On 22-Sep-2022, the patient received a dose 1 of suspect Influenza quadrival A-B vaccine, suspension for injection (lot UT7682KA; strength and expiry date not reported) via unknown route in the left deltoid for prophylactic vaccination.  On 22-SEP-2022 the patient had vaccine exposure during pregnancy with no reported adverse event (exposure during pregnancy) (latency; on same day). Relevant prenatal testing after exposure was not reported.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event vaccine exposure during pregnancy with no reported adverse event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 0.58
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK administered to pediatric patient with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA402707(CLUSTER), 2022SA402396(CLUSTER), 2022SA402443(CLUSTER), 2022SA402500(CLUSTER), 2022SA402436(CLUSTER), 2022SA402514(CLUSTER), 2022SA402525(CLUSTER), 2022SA402505 (CLUSTER), 2022SA402662(CLUSTER), 2022SA402704(CLUSTER), 2022SA402707(CLUSTER), 2022SA402964(CLUSTER), 2022SA402510(CLUSTER) and 2022SA402530(CLUSTER).  This case reported  a 7 months old female patient and it was reported that Influenza Quadrivalent Recombinant Vaccine [Flublok] administered to pediatric patient with no reported adverse event .   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A). On 12-Sep-2022, the patient received suspect Influenza Quadrivalent Recombinant Vaccine at dose of 0.5 ml, once (formulation unknown) (lot UJ887AA, exp date: 09-Jun-2023) standard strength, via intramuscular route in the left deltoid for immunization at 7 months of age with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  On 12-Sep-2022 the patient was administered with flubok with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  No lab data was reported  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: flublok being administered to pediatric patients with no adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA402510(CLUSTER), 2022SA402530(CLUSTER), 2022SA402436(CLUSTER), 2022SA402500(CLUSTER), 2022SA402443(CLUSTER), 2022SA402514(CLUSTER), 2022SA402525(CLUSTER), 2022SA402505(CLUSTER) and 2022SA402619(CLUSTER).  This case involves a 10 years old male patient to whom INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK].being administered to pediatric patients with no adverse event.   The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation was unknown, lot UJ887AA and expiry date: 09-Jun-2023) via intramuscular route in the left deltoid for immunization.  On 13-Sep-2022 the patient developed a non-serious event of  flublok being administered to pediatric patients with no adverse event (product use issue) (latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Incorrect dose administered, Urticaria
Clinical narrative: broke out in hives; received a "1/2 dose" and didn't have any issues; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 82 years old female patient who had received influenza vaccine and broke out in hives and received a "1/2 dose" and didn't have any issues.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug allergy and Sulfonamide allergy.   In 2012, the patient had received a dose of suspect influenza vaccine produced by unknown manufacturer (with an unknown dose, frequency, strength, formulation, route, expiry date, batch number) in unknown administration site for Prophylactic vaccination. Then in 2013 she also received a  dose of the same vaccine and 1 other dose were administered on unknown dates for suspect influenza vaccine.  On an unknown date the patient had broke out in hives (urticaria) and received a "1/2 dose" and didn't have any issues  (incorrect dose administered)  (unknown latency) following the administration of influenza vaccine.She does not know the manufacturer or brand of any of the flu vaccines she has received. She states that she is allergic to 15 drugs. She is severely allergic to sulfa drugs. She did not provide specific names of any of the drugs.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome - Recovered / Resolved for the hives and Unknown for incorrect dose administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLUR3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: flublok administered to pediatric patients with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA402510(CLUSTER), 2022SA402707(CLUSTER), 2022SA402396(CLUSTER), 2022SA402443(CLUSTER), 2022SA402500(CLUSTER), 2022SA402436(CLUSTER), 2022SA402514(CLUSTER), 2022SA402525(CLUSTER), 2022SA402505(CLUSTER), 2022SA402704(CLUSTER), 2022SA402707(CLUSTER), 2022SA402964(CLUSTER), 2022SA402510(CLUSTER) and 2022SA402530(CLUSTER).  This case involves a 11 years old female patient and it was reported that Influenza Quadrivalent Recombinant Vaccine [Flublok] administered to pediatric patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI); and HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9).  On 23-Sep-2022, the patient received suspect Influenza Quadrivalent Recombinant Vaccine at dose of 0.5 ml, once (formulation unknown) (lot UJ887AA, expiry date: 09-Jun-2023) standard strength, via intramuscular route in the right  deltoid for immunization at 11 years of age with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.