chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Immediate post-injection reaction, Incorrect dose administered, Injection site discharge
Clinical narrative: Some of the vaccine came shooting out of the injection site; During administration and some of the vaccine came shooting out of the injection site; During administration and some of the vaccine came shooting out of the injection site; Some of the vaccine came shooting out of the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number F9TG5, expiry date 18th September 2023) for prophylaxis.   On 9th September 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 9th September 2022, immediately after receiving Shingrix, the patient experienced injection site leaking, incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the injection site leaking, incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the reporter administered a Shingrix vaccine to a patient on the day of reporting. The reporter stated that the needle was retractable and refracted during administration and some of the vaccine came shooting out of the injection site when the needle was removed from arm. The reporter did not consent to follow up. Additional supportive information: The reporter stated that the needle was retractable and retracted during administration and some of the vaccine came shooting out of the injection site when needle removed from arm so complete dose not received, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: given a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HBV (Engerix B) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   On 12th September 2022, the patient received Engerix B. On 12th September 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comments: The pharmacist reported a patient was given a dose of Engerix-B that had expired the day prior.  The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up via email. Additional Supportive Information: The patient received expired Engerix B, which led to expired vaccine used.
Age: 49.0
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 49-year-old male patient who received HAV (Havrix) (batch number 532H4, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's comments:  The nurse reported that the patient received an expired dose of Havrix. The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up. Additional Supportive Information: The patient received expired Havrix, which led to expired vaccine used.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Giant cell arteritis, Headache, Impaired driving ability, Neck pain
Clinical narrative: Diagnosis- Polymyalgia Rheumatica; Diagnosis-Giant Cell Arteritis; headaches; shoulder pain/achy hips; neck pain; couldn't drive for more than an hour; This case was reported by a nurse via call center representative and described the occurrence of polymyalgia rheumatica in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2022, 3 weeks after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), giant cell arteritis, headache, shoulder pain, neck pain and driving ability disturbed. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the polymyalgia rheumatica, giant cell arteritis, headache, shoulder pain, neck pain and driving ability disturbed were recovered/resolved.   It was unknown if the reporter considered the polymyalgia rheumatica, giant cell arteritis, headache, shoulder pain, neck pain and driving ability disturbed to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The case was reported by the nurse and patient's wife. The patient received Shingrix in left deltoid and 3 weeks after that he experienced headaches, shoulder and neck pain, achy hips and could not drive for more than an hour.  He went to his primary care physician, neurologist, and finally his rheumatologist who diagnosed him with polymyalgia rheumatica and giant cell arteritis.  He was relieved with steroids (injections and pills). The Healthcare professional consented to follow up. The reporter consented to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: Diagnosis- Polymyalgia Rheumatica; Diagnosis-Giant Cell Arteritis; headaches; shoulder pain/achy hips; neck pain; couldn't drive for more than an hour; This case was reported by a nurse via call center representative and described the occurrence of polymyalgia rheumatica in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2022, 3 weeks after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), giant cell arteritis, headache, shoulder pain, neck pain and driving ability disturbed. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the polymyalgia rheumatica, giant cell arteritis, headache, shoulder pain, neck pain and driving ability disturbed were recovered/resolved.   It was unknown if the reporter considered the polymyalgia rheumatica, giant cell arteritis, headache, shoulder pain, neck pain and driving ability disturbed to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The case was reported by the nurse and patient's wife. The patient received Shingrix in left deltoid and 3 weeks after that he experienced headaches, shoulder and neck pain, achy hips and could not drive for more than an hour.  He went to his primary care physician, neurologist, and finally his rheumatologist who diagnosed him with polymyalgia rheumatica and giant cell arteritis.  He was relieved with steroids (injections and pills). The Healthcare professional consented to follow up. The reporter consented to follow up.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: Menveo administered via  SC; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 21-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA724Z, expiry date 30th September 2023) for prophylaxis.   On 11th September 2022, the patient received the 2nd dose of Menveo (subcutaneous). On 11th September 2022, unknown after receiving Menveo, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 12-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The health care professional reported that the menveo was administered via subcutaneous route, which led to intramuscular formulation administered by other route.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Infanrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Infanrix and Infanrix 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: 13-SEP-2022 Reporter's Comments: The nurse reported that a patient received Infanrix expired dose. The reporter did not consent to follow-up. Additional supportive Information: The patient received expire dose which lead to expired vaccine used.
Age: 0.17
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: baby, , given Havrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received HAV (Havrix pediatric) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2022, the patient received the 1st dose of Havrix pediatric (intramuscular) .5 ml and Havrix Pre-Filled Syringe Device. On 13th September 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-Sep-2022 Reporter's comment: The caller was the Healthcare professional to report an adverse event. The caller reported that a baby was given the dose of Havrix. There was inappropriate schedule of vaccine. The call was transferred to Medical information for further assistance. The consent to follow up was granted. Additional Supportive information: 2 month old patient was given the dose of Havrix, which led to inappropriate age at vaccine administration.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Administered Bexsero after exposed to 29.8 F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 459MC, expiry date 31st March 2024) 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 12th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 13-SEP-2022 Reporter's Comment: The Medical Assistant reported that the patient received Bexsero vaccine which was exposed to 29.8 F. The reporter consented to follow-up via mail. Additional supportive information: The Bexsero vaccine was exposed to temperature 29.8 F, which led to incorrect storage of drug. This was one of the 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022132076:Same reporter. US-GSK-US2022132079:Same reporter. US-GSK-US2022132075:Same reporter. US-GSK-US2022132078:Same reporter.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 14th September 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix on the day of reporting, which led to expired vaccine used.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 13Mar2019, 2nd dose on 23Sep2021; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 99C3K, expiry date 31st January 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th March 2019 with batch number ZP3P9 and expiry date 10th September 2021).   On 23rd September 2021, the patient received the 2nd dose of Shingrix. On 23rd September 2021, 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: 14-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of possible Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. As it was reported that possible Shingrix vaccine therefore Shingrix vaccine was coded as suspect.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the liquid portion; Administered only the liquid portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA71QA, expiry date 31st May 2023) for prophylaxis.   On 1st September 2022, the patient received Menveo. On 1st 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: 14-Sept-2022 Reporter's comment: No further details were provided. The reporter consented to follow-up. Additional supportive information: The patient was inadvertently given only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B pediatric given to adult.; Engerix-B pediatric given to adult.; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 63-year-old female patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 31st July 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 13th September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-Sept-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: inadvertently administered expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4F99G, expiry date 19th August 2022) for prophylaxis.   On 30th August 2022, the patient received Boostrix. On 30th August 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 14-Sept-2022 Reporter's comment: The office manager called to inquired that the patient should get revaccinated. Did not consent to follow-up. Additional supportive information: The patient inadvertently administered an expired dose of Boostrix, which led to expired vaccine used.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 13-yr old patient received an adult dose; 13-yr old patient received an adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 13-year-old male patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2022, the patient received the 2nd dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 14th September 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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: 14-Sept-2022 Reporter's comment: The reporter consented to follow-up via mail. Additional supportive information: The patient received an adult dose of Havrix 1440, which led to overdose and adult product administered to child.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administrated with only the adjuvant; Administrated with only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 3G33K, expiry date 10th July 2023) for prophylaxis.   On 13th September 2022, the patient received Shingrix. On 13th 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: 15-September 2022 Reporter's comment: No adverse event was reported. The reporter consented to follow-up. Additional supportive information:  The patient was administered with only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received Men CWY not reconstituted; Patient received Men CWY not reconstituted; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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:14-Sept-2022 Reporter's comment: The patient who received a dose of Men CWY before it was reconstituted with the lyophilized Men A component.  The reporter asked that what potential adverse effects could arise from this. No further details available, provided all details as submitted via form The reporter consented to follow-up. Additional supportive information: The patient received Men CWY before it was reconstituted with the lyophilized Men A component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. As per clarification email suspect product was coded.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA763A, expiry date 20th November 2023) for prophylaxis.   On 2nd September 2022, the patient received Menveo. On 2nd September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 15-Sept-2022 Reporter's comment: Both of them received same Menveo lot number. The reporter consented to follow-up via email. This case is for 1 of 2 linked patients. Additional supportive information: The medical assistant reported that the patient received a Menveo vaccine (powder) reconstituted with sterile water, which led to wrong solution used in drug reconstitution.; Sender's Comments:  US-GSK-US2022133244:Same reporter
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA763A, expiry date 20th November 2023) for prophylaxis.   On 29th August 2022, the patient received Menveo. On 29th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.     Additional Information: GSK receipt date: 15-Sept-2022 Reporter's comment: Both of them received same Menveo lot number. The reporter consented to follow-up via email. This case is for 2 of 2 linked patients. Additional supportive information: The medical assistant reported that the patient received a Menveo vaccine (powder) reconstituted with sterile water, which led to wrong solution used in drug reconstitution.; Sender's Comments:  US-GSK-US2022133240:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Potential administration of only the diluent/ one vial of adjuvant missing; Potential administration of only the diluent/ one vial of adjuvant missing; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number AS01B, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 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: 15-Sept-2022 Reporter's comment: The pharmacist reported that a box of shingrix had at the moment of the conversation, five vials with lyophilized agent, and four vials with the diluent AS01B. The reporter called due to being short 1 diluent and stated that someone could have had gotten diluent only, but did not had any details about anyone specific. Additional supportive information: The patient might had received diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the adjuvant; administered only the adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number PA77M, expiry date 24th September 2023) for prophylaxis.   On 13th September 2022, the patient received the 1st dose of Shingrix. On 13th 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: 15-Sept-2022 Reporter's comment: The reporter consented to follow-up. This case is for 1 of 2 linked patients. Additional supportive information: The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022133247:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the adjuvant; administered only the adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number PA77M, expiry date 24th September 2023) for prophylaxis.   On 13th September 2022, the patient received the 1st dose of Shingrix. On 13th 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: 15-Sept-2022 Reporter's comment: The reporter consented to follow-up. This case is for 2 of 2 linked patients. Additional supportive information: The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022133245:Same reporter
Age: 54.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 54 year old received Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 54-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st August 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 21st August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Sept-2022 Reporter's comment: The pharmacist stated that the patient received dose one of Bexsero and as of this call dose two has not been administered. The first dose was given at another location. No further details were available or provided at the time of call. The reporter consented to follow-up. Additional supportive information: The patient received 1st dose of Bexsero at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received two doses within about a week; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 6-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 14th September 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Sept-2022 Reporter's comment: The medical professional reported that a patient inadvertently received two doses of FluLaval within about a week.  The dose was intended for another patient.  The lot number was not available. Additional supportive information: The patient received 2nd dose of FluLaval earlier than the recommended interval, which led to shortening of vaccine schedule. The reporter consented to follow-up via email.
Age: 0.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 3 months old patient received 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 3-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3KF4F, expiry date 22nd March 2024) for an unknown indication.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 15th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which inappropriate age at vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: VACCINES THAT WE TOOK BUT  DON'T WORK; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, 1 total, first dose start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medications included ethanol/thymol (Listerine Antiseptic Mouth wash) On an unspecified date, the patient's wife contracted the virus, then passed it on to the patient. The patient was happy to report that he and his wife both were covid free and never suffered medical problem, and he gave much of the credit, not to the vaccines that they took but don't work, but to Listerine that helped both to prevent the virus getting worse once both tested positive. The patient had covid but with the Listerine it was quickly recovered.  Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of vaccines that we took but don't work was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220919021. This case, from the same reporter is linked to 20220930558 and 20220918613. This report was associated with product quality complaint: 90000251621.; Sender's Comments: V0: 20220930432- covid-19 vaccine ad26.cov2.s- Vaccine that we took but don't work. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. Patient was working in a medical field treating covid-19 patients. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported administered 1 in total for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ethanol/thymol (Listerine). On an unspecified date, the patient contracted the virus, than passed it on to the husband. But both are Covid free and never suffered medical problem, and reporter give much of the credit, not to the vaccines that they took but don't work, but to Listerine that helped both to prevent the virus getting worse once both tested positive (Confirmed covid-19 infection). Laboratory data (dates unspecified) included: SARS-CoV-2 test Positive.- The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of vaccine that we took but don't work was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220930432 and 20220919021. This report was associated with product quality complaint: 90000251626; Sender's Comments: V0: 20220930558 -covid-19 vaccine ad26.cov2.s-vaccine that we took but don't work. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media through a company representative concerned (unspecified) multiple patients. The patient's weight, height, and medical history were not reported. The patients all had previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. It was unknown whether patients had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1). The patients all received booster dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. The batch numbers were not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced covid (suspected covid-19 infection) who were vaccinated and had their boosters and still got sick (Dose number in series 2). It was reported as, "that's why I'm never taking one the booster that is all the people I know who had covid were vaccinated and they had boosters and still got sick sham they want to keep you sick with something". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000251788.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: VOMITING; DIARRHEA; NAUSEA; 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 was not reported, administered on 2021 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 2021, the patient experienced vomiting, diarrhea, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, diarrhea, and nausea on 2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A spontaneous report was received from a Consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events throbbing arm in the same spot the vaccine was given/vaccination site pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On an known date, two weeks later throbbing arm in the same spot the vaccine was given/vaccination site pain. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The seriousness criteria of event was reported as serious other as per source document. On an unknown date the outcome of events, throbbing arm in the same spot the vaccine was given was not reported. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Paraesthesia, Tremor, Vision blurred
Clinical narrative: Anaphylaxis; Shaking; Tingling in Hands, chest, lips; Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug intolerance (Patient has an intolerance to many drugs).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced TREMOR (Shaking), PARAESTHESIA (Tingling in Hands, chest, lips) and VISION BLURRED (Blurred vision). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis), TREMOR (Shaking), PARAESTHESIA (Tingling in Hands, chest, lips) and VISION BLURRED (Blurred vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood pressure abnormal, Blood pressure measurement, Dyspnoea, Fatigue
Clinical narrative: A spontaneous report was received from a physical therapist concerning a 55-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis, felt warm/feeling hot, breathing problem/dyspnea, tired for the next couple of days/fatigue, increased heart rate, abnormal blood pressure. The patient's medical history was not provided. No relevant concomitant medications were provided. On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 31 Dec 2020, the patient developed anaphylaxis within seven to eight minutes after vaccination and was hospitalized. First, she felt warm and removed her sweater. Very rapidly, she had problems with breathing. She was discharged after six hours. She only had one rebound reaction. She was sent home after her heart rate and blood pressure were back to normal. She was tired for the next couple of days. Treatment medications included two epinephrine injection in the right thigh and IV diphenhydramine in the left arm. She reported that they gave her 15 litres of oxygen and another medication, which she cannot recall the name. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the reported events were considered as resolved. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate, Heart rate increased
Clinical narrative: A spontaneous report was received from a physical therapist concerning a 55-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis, felt warm/feeling hot, breathing problem/dyspnea, tired for the next couple of days/fatigue, increased heart rate, abnormal blood pressure. The patient's medical history was not provided. No relevant concomitant medications were provided. On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 31 Dec 2020, the patient developed anaphylaxis within seven to eight minutes after vaccination and was hospitalized. First, she felt warm and removed her sweater. Very rapidly, she had problems with breathing. She was discharged after six hours. She only had one rebound reaction. She was sent home after her heart rate and blood pressure were back to normal. She was tired for the next couple of days. Treatment medications included two epinephrine injection in the right thigh and IV diphenhydramine in the left arm. She reported that they gave her 15 litres of oxygen and another medication, which she cannot recall the name. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the reported events were considered as resolved. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.