chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received HAV (Havrix 1440 adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. In October 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: The reporter reported that the patient received expired dose of Havrix vaccine. The reporter consented to follow up. Additional supportive information: The patient received Havrix which was already expired, which led to expired vaccine used. This case had been linked with US2022143252 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022143252:Same reporter
Age: 67.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 67-year-old male patient who received HAV (Havrix 1440 adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. In October 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comments: The reporter stated that the patient received an expired dose of Havrix which was expired on 30th September 2022. The reporter gave consent to follow up. Additional Supportive Information: A patient received an expire dose of Havrix which led to expired vaccine used. This case had been linked with US2022143251 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022143251:Same reporter
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd October 2022, unknown after receiving Kinrix and Kinrix 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: 06-OCT-2022 Reporter's Comment: The office staff member reported that a dose of Kinrix given to the patient and it was already expired.  No further details provided. Consent granted for safety to follow up. The reporter consented to follow up.  Additional Supportive Information: The use of Kinrix dose, which was already expired on 30th September 2022, which led to expired vaccine used.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Hiberix reconstituted with steril water; Hiberix reconstituted with steril water administeration; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 15-month-old male patient who received Hib (Hiberix) (batch number FY4E9, expiry date 20th June 2023) for prophylaxis.   On 3rd October 2022, the patient received Hiberix. On 3rd October 2022, unknown after receiving Hiberix, 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: 10-Oct-2022 Reporter's Comment: The reporter reported that, a patient received the lyophilized powder of Hiberix reconstituted with diluent not provided by GlaxoSmithKline (sterile water). The reporter consent to follow up. Additional Supportive Information: The patient received Hiberix vaccines reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case is linked to the case US2022143259, reported by the same reporter.; Sender's Comments:  US-GSK-US2022143259:Same reporter
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant woman received the Fluarix Qiv; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 34-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 4L5YX, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was 1st January 2023. The patient received Fluarix Quadrivalent 2022-2023 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   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: 06-Oct-2022 Reporter's Comments: The onsite nurse was reporting for documentation of the registry of pregnant woman that received the Fluarix Qiv. No other reactions were reported. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: tired; mild fever; is past the 6 months for getting her 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue, fever and incomplete course of vaccination. On an unknown date, the outcome of the fatigue and fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fatigue and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's comment: The patient self reported this case. The patient received the first dose of Shingrix vaccine and the next day she was tired and had a mild fever. The symptoms only lasted a day and had thus resolved. The patient was past the 6 months for getting her second Shingrix vaccine but did plan on getting the second vaccine.  The patient did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination. This case had been linked with case US2022143270, reported by the same reporter.; Sender's Comments:  US-GSK-US2022143270:same reporter - mother of the reporter´s case
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: vaccine given was expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HAV (Havrix) (batch number 0628ae, expiry date 26th January 2015) for prophylaxis.   On 11th February 2013, the patient received Havrix. On 11th February 2013, 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: 6-Oct-2022 Reporter's comment: The supervisor reported that she has a Hepatitis A vaccine, that may or may not be Havrix (GlaxoSmithKline).  The health care professional reported that the vaccine was given with two possible expiration dates of either 26th January 2013 or 26th January 2015.  The reporter was unable to confirm expiration date or manufacturer. The reporter stated that her paperwork for administration indicates the expiration date of 26th January 2015 with manufacturer of Merck, but the reporter believes it may be a GlaxoSmithKline product.  Search of lot number returned no results.  The reporter gave consent to follow up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used. As it was not clear that patient that received Havrix or other brand of Hepatitis A vaccine, therefore in worst approach Havrix was coded as suspect and follow-up clarification request was raised. Expiry date was captured as 26th January 2015 as per reported verbatim (HCP states her paperwork for administration indicates the expiration date of 01/26/2015 with manufacturer of Merck, but HCP believes it may be a GlaxoSmithKline product).
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, 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: 06-OCT-2022 Reporter's Comments: The reporter was the daughter of the patient.  The patient was given an expired Havrix vaccine (Expired Drug Used).  The reporter reported that the immunizer said it was okay that it was expired.  Caller believes the Havrix expired 30th September 2022.  The reporter will call her mother to get details and call back when she gets the lot number. The reporter gave no further information until she talks to her mother. The reporter did not give permission to contact the health care professional. Additional Supportive Information: The vaccine was already expired and was administered to the patient, which led to expired vaccine used.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 13Jul2022, 2nd on 06Oct2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22nd September 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 6th October 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 6th October 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comments: The reporter wants to know how to proceed with the Twinrix series. The patient received the first dose of Twinrix on 13th July 2022 and the second dose was administered 6th October 2022. The reporter wants to know when patient would need the third dose. The reporter did not give consent to follow-up. Additional Supportive Information: The patient received the second dose was on 6th October 2022 which lead to Drug dose administration interval too long.
Age: 16.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; Infanrix administered to a 16 y/o; 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 16-year-old female patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th March 2022, the patient received the 2nd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 2nd March 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 2nd March 2022, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 25th March 2022, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 06-OCT-2022 Reporter's Comment: Reporter stated that patient received 2 doses of Infanrix 1st dose on 2nd March 2022 and 2nd dose 25th March 2022. However, dose taken at the age of 16. The reporter consented to follow up. Additional supportive information: As patient received dose at inappropriate age which led to inappropriate age at vaccine administration
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at the time of injection on receipt of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: The reporter reported that, she knew several people who have complained about having pain at the time of injection on receipt of Shingrix. She said that, she could try to get more details but had no specifics about the people she referred to who complained about pain at time of call. The reporter preferred to remain anonymous (did not want profile created in database) but she agreed to follow up via email. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on Jun2021, 2nd on 05Oct2022; This case was reported by a pharmacist via sales rep and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose was received on June 2021).   On 5th October 2022, the patient received the 2nd dose of Shingrix. On 5th October 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: 06-OCT-2022 Reporter's comment: The pharmacist asked if there was any information over 12 months. The pharmacist reported that the patient had received a late dose of Shingrix. The first dose was received on June 2021 and the second dose administered on 05th May 2022. The reporter had consented to follow-up. Additional supportive information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 67.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 67-year-old female patient who received HAV (Havrix 1440 adult) (batch number KM72C, expiry date 18th 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 6th October 2022, the patient received the 1st dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 6th October 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comments:  The pharmacist reported that a patient received an expired dose Havrix.   The Havrix expired on 18th June 2022.   The date of vaccination was 6th October 2022 and this was the patients first dose. Additional Supportive Information: The patient received an expired dose Havrix which lead to Expired vaccine used.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix administrated instead of Pediarix; 6 month patient administrated with 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-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3ks4f, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 6th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: The medical assistance reported that the patient received a dose of Kinrix instead of Pediarix.  No adverse event reported. The reporter consented to follow up. Additional Supportive Information: The six month old patient received Kinrix instead of Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered.  This case had been linked with case US2022143284, US2022143285 and US2022143286 reported by the same reporter.; Sender's Comments:  US-GSK-US2022143284:Same reporter US-GSK-US2022143285:Same reporter US-GSK-US2022143286:Same reporter
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 6 month patient administrated with Kinrix; Kinrix was administrated instead of Pediarix; 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 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3ks4f, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 6th October 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: 06-OCT-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the 6 month old patient received Kinrix vaccine instead of Pediarix vaccine. The reporter did 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 Pediarix and inadvertently administered Kinirix instead of Pediarix, which led to wrong vaccine administered. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022143282:Same reporter US-GSK-US2022143286:Same reporter US-GSK-US2022143285:Same reporter
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 6 month patient administrated with Kinrix; Kinrix was administrated instead of Pediarix; 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 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3ks4f, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th October 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: 06-OCT-2022 Reporter's Comment: The medical assistance reported that the patient received a dose of Kinrix instead of Pediarix.  No adverse event reported. The reporter consented to follow up. Additional Supportive Information: The 6 months old patient received Kinrix instead of Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered.  This case had been linked with case US2022143284, US2022143286 and US2022143282 reported by the same reporter.; Sender's Comments:  US-GSK-US2022143284:Same reporter US-GSK-US2022143282:Same reporter US-GSK-US2022143286:Same reporter
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 month patient administrated with Kinrix; Kinrix was administrated instead of Infanrix; 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 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3ks4f, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th October 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: 06-OCT-2022 Reporter's Comment: The medical assistance reported that the patient received a dose of Kinrix instead of Infanrix.  No adverse event reported. The reporter consented to follow up. Additional Supportive Information: The four month old patient received Kinrix instead of Infanrix, which led to inappropriate age at vaccine administration and wrong vaccine administered.  This case had been linked with case US2022143284, US2022143285 and US2022143282 reported by the same reporter.; Sender's Comments:  US-GSK-US2022143284:Same reporter US-GSK-US2022143282:Same reporter US-GSK-US2022143285:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's comment: Medical student reported that the patient developed Guillain-Barre syndrome after receiving the second dose of Shingrix. It was not sure that the syndrome was related to vaccination and patient had no previous medical history of it.  The reporter did not have patient's identifiers, nor vaccine lot number, expiration date and date of administration. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Rash
Clinical narrative: still has the rash; received 1st dose years ago, didn´t get the 2nd; got Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly male 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 did not receive 2nd dose of Shingrix. In August 2022, several years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced rash and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's Comments: The patient received the first dose of the shingles vaccine a few years ago from reporting and not sure on the exact date. The patient got shingles in August but still had the rash now, and the patient would like to know when they could get the vaccine. The patient was now looking to get the second dose. The reporter did not have the date of the first vaccine dose, lot number or expiration date as it was administered at a different facility. The reporter consent to follow up via postal. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Note: Suspect vaccine name Shingrix was mentioned in structure field hence conservatively Shingrix was coded instead of shingles vaccine.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comments: The reporter asked for information about the administration of an expired dose of Bexsero to a 16 years old patient.  The reporter mentioned there not adverse reaction and wanted to know if patient had to be re-vaccinated.  The reporter was consented to follow up. Additional Supportive Information:  The vaccine was already expired and was administered to the patient, which led to expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: BLOOMING HEADACHE; This spontaneous report received from a patient via a company representative, concerned a patient of an unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose and start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (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: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 11-OCT-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-OCT-2022 following booster vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced blooming headache (Dose number in series: 2). The patient took took a 300 mg Tylenol (Treatment medication) (Tylenol unspecified). It was reported that the patient still hurts with event blooming headache at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s, and Tylenol was not applicable. The patient had not recovered from blooming headache. This report was non-serious. This case, involving the same patient is linked to 20221024366.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vertigo
Clinical narrative: SUSPECTED COVID-19 INFECTION; VERTIGO; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: breast cancer, pneumonia, tuberculosis (many years ago), and allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on AUG-2020 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 71 years old. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection, and vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, and suspected covid-19 infection. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT SO BAD; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced felt so bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt so bad was not reported. This report was non-serious. This case, from the same reporter is linked to 20221026356.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This case was associated with a product quality complaint: 90000255287.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from other company (Pfizer) via a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism. The patient was not having any drug allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, administered 1 in total to the left arm on 09-APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received non-company suspect vaccine included: tozinameran (Pfizer vaccine) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered to the left arm on 03-DEC-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 03-DEC-2021, the patient had revaccination with different covid-19 vaccine. On an unspecified date, the patient experienced suspected covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test Negative. The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 18-SEP-2022 to 23-SEP-2022 for treatment of COVID-19.  On an unspecified date ,the patient experienced Itchy throat, nasal congestion, and cough began 15 days after testing negative and finishing paxlovid anti viral pills. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran was not applicable, and with Paxlovid was drug discontinued. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    No concomitant medication was reported.    They reported that 15 patients received 0.5ml of the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657506, US-MODERNATX, INC.-MOD-2022-657547, US-MODERNATX, INC.-MOD-2022-657560 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657506:Master case (Crosslink case with same reporter) US-MODERNATX, INC.-MOD-2022-657560:Same reporter US-MODERNATX, INC.-MOD-2022-657547:
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Vaccination site lymphadenopathy
Clinical narrative: arm was red; very swollen lymph nodes; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (arm was red) and VACCINATION SITE LYMPHADENOPATHY (very swollen lymph nodes) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: Flu vaccination (In fall) in 2020 and Flu vaccination (In fall) in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccination and Flu vaccination. Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy), Hypercholesterolemia (No changes noticed after vaccination, condition present before vaccination), Arrhythmia (No changes noticed after vaccination, condition present before vaccination) and Arthritis (No changes noticed after vaccination, condition present before vaccination). Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) and SIMVASTATIN for an unknown indication.    On 06-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (arm was red) and VACCINATION SITE LYMPHADENOPATHY (very swollen lymph nodes). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (arm was red) and VACCINATION SITE LYMPHADENOPATHY (very swollen lymph nodes) had resolved.            Concomitant medications also included Hidrcor and Clovividol. It was reported that 24 hours later her arm was red, she had very swollen lymph nodes at the injection site. On 05-Mar-2021, patient received first dose of Moderna vaccine, lot number and dose were not reported.  On 05-Apr-2021, patient received second dose of Moderna vaccine, lot number and dose were not reported.  In Nov 2021, patient received Third dose of Moderna vaccine, lot number and dose were not reported.  In Apr 2022, patient received Fourth dose of Moderna vaccine, lot number and dose were not reported. On 06-Oct-2022, the patient received flu vaccine but on different arm.   This case was linked to MOD-2022-657572 (Patient Link).
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    Concomitant medications details were not reported by the reporter.  It was reported that patient received 0.5ml of the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine.  Treatment details were not reported by the reporter.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Patients received 0.5ml of the the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients received 0.5ml of the the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patients received 0.5ml of the the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients received 0.5ml of the the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients received 0.5ml of the the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine).    No concomitant drug was reported.  No treatment drug was reported.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). Concomitant medication details was not reported. The patient received 0.5ml of the dark blue cap vial vaccine that was intended for use in 6-11 years old age patient, instead of the new bivalent vaccine. Treatment details was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657506 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657506:Master case (Crosslink case with same reporter)