chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Product administered at inappropriate site, Skin discolouration
Clinical narrative: small gray dot on leg; Vaccine administered at inappropriate site; This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number TS425, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (For tolerance of 2nd dose of Pediarix received on 28 Jul 2022 and refer case id US2022AMR149560) and Pediarix with an associated reaction of skin discolouration (For tolerance of 3rd dose of Pediarix received on 30 Sep 2022 and refer case id US2022AMR149561).   On 30th September 2022, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, the patient received ACTHIB and PREVNAR. On an unknown date, less than 2 weeks after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration and vaccine administered at inappropriate site. Rechallenge with Pediarix was positive. On an unknown date, the outcome of the skin discoloration was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR149560, US2022AMR149561   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: Prevnar and Acthib were also given with Pediarix in same leg so were not sure which vaccine caused the reaction. The faint grey dot was the adverse event that followed vaccination. It was unknown if the reporter considered the depigmentation spot to be related to Prevnar and Acthib. Additional Supportive Information: The case had been linked to US2022AMR148961, US2022AMR148962  and US2022AMR148919,reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2022AMR148962:same reporter US-GSK-US2022AMR148919:same reporter US-GSK-US2022AMR149560:same reporter US-GSK-US2022AMR149561:same reporter US-GSK-US2022AMR149551:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Pain, Peripheral coldness
Clinical narrative: Body aches all over, I hurt; Body is warm; Hands and feet cold; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2022, the patient received Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced general body pain, feeling of warmth and cold extremities. On an unknown date, the outcome of the general body pain, feeling of warmth and cold extremities were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, feeling of warmth and cold extremities to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got Shingrix vaccine the day before reporting.  The patient body aches all over and he/she had hurt.  The patient body was warm but hands and feet cold. The reporter wanted to know if he/she could take something like Tylenol or just ride it out. Additional Supportive Information: The follow up would not possible as no contact details were available.
Age: 0.25
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Skin discolouration
Clinical narrative: reaction/faint grey dot; This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 3-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (For tolerance of 1st dose of Pediarix ,refer case US2022AMR148962), Prevnar with an associated reaction of skin discolouration and Actihib with an associated reaction of skin discolouration.   On 17th August 2022, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, the patient received ACTHIB and PREVNAR. On an unknown date, less than 2 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration. Rechallenge with Pediarix was positive. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:US2022AMR148962   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: Prevnar and Acthib were also given with Pediarix in same leg so were not sure which vaccine caused the reaction. The faint grey dot was the adverse event that followed vaccination. Additional Supportive Information: This case is linked to the case US2022AMR148961, US2022AMR148919, US2022AMR149560 and US2022AMR149561 reported by the same reporter. It was unknown if the reporter considered the depigmentation spot to be related to Prevnar and Acthib.; Sender's Comments:  GSK-US2022AMR148919:same reporter GSK-US2022AMR149560:same reporter GSK-US2022AMR149561:same reporter GSK-US2022AMR148961:same reporter
Age: 0.33
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Product administered at inappropriate site, Skin discolouration
Clinical narrative: small gray dot on leg; Vaccine administered at inappropriate site; This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 4-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   Previously administered products included Pediarix (The patient received Pediarix 1st dose on 27th May 2022. Batch no X9HS4-Refer case US2022AMR148961.).   On 28th July 2022, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, the patient received ACTHIB and PREVNAR. On an unknown date, less than 3 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration and vaccine administered at inappropriate site. Rechallenge with Pediarix was positive. On an unknown date, the outcome of the skin discoloration was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-OCT-2022. Reporter's Comments: The reporter stated that Prevnar and Acthib were also given in same leg so were not sure which vaccine caused the reaction. The reporter stated that a dose of pediarix in the thigh, patient had a small gray dot on leg that has lasted and not gone away. Additional Supportive Information: It was unknown if the reporter considered the skin discoloration to be related to Prevnar and Acthib.  For 3rd dose refer case US2022AMR149561.; Sender's Comments:  GSK-US2022AMR148962:same reporter GSK-US2022AMR148919:same reporter GSK-US2022AMR149551:same reporter GSK-US2022AMR148961:same reporter GSK-US2022AMR149561:same reporter GSK-US2022AMR148962:same reporter
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Product administered at inappropriate site, Skin discolouration
Clinical narrative: small gray dot on leg; Prevnar and Acthib were also given with Pediarix in same leg; This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 2-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   On 27th May 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device, ACTHIB and PREVNAR. On 27th May 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR148961, US2022AMR149560   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: Prevnar and Acthib were also given with Pediarix in same leg so were not sure which vaccine caused the reaction. The faint grey dot was the adverse event that followed vaccination. It was unknown if the reporter considered the skin discoloration to be related to Prevnar and Acthib. Additional Supportive Information: The case had been linked to case US2022AMR148961 and US2022AMR149560 for other doses.; Sender's Comments:  GSK-US2022AMR148962:same reporter GSK-US2022AMR148919:same reporter GSK-US2022AMR149551:same reporter GSK-US2022AMR149560:same reporter GSK-US2022AMR148961:same reporter GSK-US2022AMR148962:same reporter
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the liquid portion; administered only the liquid portion. This was the 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA747A, expiry date 31st October 2023) for prophylaxis.   On 7th October 2022, the patient received the 2nd dose of Menveo. On 7th October 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: 11-OCT-2022 Reporter's comment:  Medical Assistant stated that she inadvertently administered only the liquid portion of the Menveo to a patient. This was the patient's second dose and the error occurred because Medical Assistant stated she was in a rush, running behind, and was not familiar with Menveo administration (she typically administers Menactra or Menquadfi, which only have one vial). No further details provided. The reporter was consented to follow up. Additional Supportive Information: The patient administered only the liquid portion of the Menveo, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Sex: M
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, Syringe issue
Clinical narrative: Needle leaked during administration; one dose on 7Oct2022, second one on 10Oct2022, twice leaked; Needle leaked during administration; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number j39g3, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 10th October 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On 10th October 2022, the patient experienced incomplete dose administered and drug dose administration interval too short. On an unknown date, the outcome of the incomplete dose administered, incomplete dose administered and drug dose administration interval too short 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: 11-Oct-2022 Reporter's comment: The pharmacist reported that the patient was administrated with Flulaval QIV and the needle was leaked.  Adverse event was not reported. Twice the vaccine was leaked. The pharmacist thinks it was because of a problem with the needle gauge.  They were using 25g instead of 21g and 23Gg. The patient's identifiers was not provided The reporter consented to follow up. Additional Supportive Information: The patient was administrated with Flulaval QIV twice and the needle was leaked, which led to incomplete dose administered. The patient received 2nd dose of Flulaval QIV earlier than recommended interval, which led to shortening of vaccine schedule. The case was linked with case US2022146210 reported by same reporter for different patient. As it was not clear that 10th October 2022 dose was replacement or not therefore it was considered as 2nd dose and event drug dose administration interval too long was coded along with incomplete dose administered as it was stated that twice the vaccine was leaked.; Sender's Comments:  US-GSK-US2022146210:Same reporter
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: Needle leaked during administration; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number j39g3, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 11th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's comment:  The pharmacist reported that the patient was administrated with Flulaval QIV and the needle was leaked.  Adverse event was not reported. The pharmacist thought it was because of a problem with the needle gauge.  They were using 25g instead of 21g and 23Gg. The patient's identifiers was not provided The reporter consented to follow up. This case had been linked with, US2022146208, reported by same reporter, Additional Supportive Information: The patient was administrated with Flulaval QIV and the needle was leaked, which led to incomplete dose administered.; Sender's Comments:  US-GSK-US2022146208:Same reporter
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration
Clinical narrative: Subcutaneous administration; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a child male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix (subcutaneous) and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, 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.   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-OCT-2022. Reporter's Comments: The reporter stated that the patient had a Kinrix vaccine given via subcutaneous route. HCP disconnected chat prior to providing any product details (Lot number and expiration date, date of administration). HCP disconnected prior to being asked about consent for follow-up by Safety Team. Adverse event submitted with data provided during chat, prior to disconnection by HCP. Additional Supportive Information: The patient received Kinrix vaccine via subcutaneous route which led to intramuscular formulation administered by other route.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 20sep2022, 2nd 12Oct2022; 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 12-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 79ED9, expiry date 30th June 2023) 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 12th October 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 12th October 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: 12-Oct-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received second dose of Flulaval earlier than the recommended interval, which led to shortening of vaccine schedule.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Axillary mass
Clinical narrative: lump under armpit on same side the vaccination was administered; This case was reported by a pharmacist via call center representative and described the occurrence of axillary lump in a 58-year-old patient who received Herpes zoster (Shingrix) (batch number DP2X9, expiry date 10th May 2023) and (batch number NF442, expiry date 10th May 2023) for prophylaxis.   On 10th October 2022, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. In October 2022, less than a week after receiving Shingrix, the patient experienced axillary lump. On an unknown date, the outcome of the axillary lump was unknown.   It was unknown if the reporter considered the axillary lump to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's comments: The pharmacist had reported on 13 October 2022 by a chat channel that the patient had received Shingrix on 10th October 2022 as the first dose and the patient had reported lump under armpit on same side the vaccination was administered. The Vaccine administration facility was the same as primary reporter. No details of lot number, expiration date of Shingrix were provided. No patient's identifiers were provided. The reporter had consented to follow-up. Additional supportive information: The lot for antigen was reported under DX series and for diluent was reported under series.
Age: 17.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Overdose
Clinical narrative: administration of two doses of Fluarix; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 17-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number T9HA2, 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, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number T9HA2, expiry date 30th June 2023) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th October 2022, the patient received Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 13th October 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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-OCT-2022 Reporter's Comments: The nurse asked for information regarding the administration of two doses of Fluarix on same day with same lot number and expiration date on same day. The reporter asked how to proceed with patient. The reporter consented to follow up. Additional Supportive Information: The patient received two doses of Fluarix on same day, which led to overdose.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: IV administration instead of IM; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) (batch number (10)G2979, 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 13th October 2022, the patient received Fluarix Tetra 2022-2023 season (intravenous) and Fluarix Tetra Pre-Filled Syringe Device. On 13th October 2022, unknown after receiving Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, 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.     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-OCT-2022 Reporter's Comment: Director stated an registered nurse at the facility gave a dose of Fluarix intravenous instead of intramuscular. No further details were provided.  The reporter consented to follow up. Additional Supportive Information: Director stated an registered nurse at the facility gave a dose of Fluarix intravenous instead of intramuscular, which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper
Clinical narrative: Stomach cramping/like labor pain or punching from the inside; This case was reported by a consumer via call center representative and described the occurrence of stomach cramps in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes mellitus, blood pressure high and blood cholesterol increased. Concomitant products included antihypertensives nos (High Blood Pressure Medication (Nos)), medication unknown (Cholesterol Meds (Medication Unknown)) and semaglutide (Ozempic).   On 7th October 2022, the patient received the 1st dose of Shingrix (intramuscular). On 7th October 2022, less than a day after receiving Shingrix, the patient experienced stomach cramps. On an unknown date, the outcome of the stomach cramps was not recovered/not resolved.   It was unknown if the reporter considered the stomach cramps to be related to Shingrix.     Additional Information: GSK receipt date: 14-OCT--2022 Reporters comment:  The patient received the first dose of shingrix and experienced stomach cramping that was last about a week she also described that was like labor pain or punching from the inside The patient took medications for HBP, Cholesterol and Ozempic The reporter declined to provide demographics customer states that she did not have a PCP The consent was not requested .
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only received the liquid portion; only received the liquid portion; 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-OCT-2022 Reporter's Comment: The reporter was medical assistant. The reporter stated that, they found an extra powder portion of Menveo so they know a patient only received the liquid portion of the vaccine. The reporter stated that, they have been able to narrow it down to four potential patients based on the lot number, but they could not tell which patient only received a partial dose.  No additional information was provided on the call, but reporter consented to follow up from safety. The reporter consented to follow up. Additional Supportive Information: The reporter stated that, they found an extra powder portion of Menveo so they know a patient only received the liquid portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site erythema
Clinical narrative: pain at the injection site.; redness at the injection site.; swelling at the injection site.; fever; shivering; headaches; loss of appetite; tiredness; pain in the legs/required and ED visit; pain in the buttocks/required and ED visit; This case was reported by a pharmacist 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, unknown after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, fever, shivering, headache, appetite lost, tiredness, leg pain and buttock pain. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, fever, shivering, headache, appetite lost, tiredness, leg pain and buttock pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fever, shivering, headache, appetite lost, tiredness, leg pain and buttock pain to be related to Shingrix.     Additional Information: Additional Information: GSK Receipt Date: 14-OCT-2022. Reporter's Comments: The reporter stated that after the administration the patient experienced pain, redness, and swelling at the injection site.  The reporter stated a week later the patient experienced fever, shivering, headaches, loss of appetite, tiredness, and pain in the buttocks and legs, which required and ED visit. The reporter was unwilling to provide consumer demographics and unable to provide product information. The vaccine administration facility is the same as primary reporter. The reporter did not gave consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: pain at the injection site.; redness at the injection site.; swelling at the injection site.; fever; shivering; headaches; loss of appetite; tiredness; pain in the legs/required and ED visit; pain in the buttocks/required and ED visit; This case was reported by a pharmacist 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, unknown after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, fever, shivering, headache, appetite lost, tiredness, leg pain and buttock pain. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, fever, shivering, headache, appetite lost, tiredness, leg pain and buttock pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fever, shivering, headache, appetite lost, tiredness, leg pain and buttock pain to be related to Shingrix.     Additional Information: Additional Information: GSK Receipt Date: 14-OCT-2022. Reporter's Comments: The reporter stated that after the administration the patient experienced pain, redness, and swelling at the injection site.  The reporter stated a week later the patient experienced fever, shivering, headaches, loss of appetite, tiredness, and pain in the buttocks and legs, which required and ED visit. The reporter was unwilling to provide consumer demographics and unable to provide product information. The vaccine administration facility is the same as primary reporter. The reporter did not gave consent to follow-up.
Age: 61.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Blindness, Cerebrovascular accident, Diplopia
Clinical narrative: Stroke; Blindness; Double vision; This case was reported by a consumer via call center representative and described the occurrence of stroke in a male patient who received Herpes zoster (Shingrix) (batch number XM22G, expiry date 31st August 2023) for prophylaxis.   Co-suspect products included ELASOMERAN (COVID-19 VACCINE MODERNA) for prophylaxis.   On 12th September 2022, the patient received the 1st dose of Shingrix (intramuscular) and COVID-19 VACCINE MODERNA. In September 2022, 3 days after receiving Shingrix, the patient experienced stroke (serious criteria medically significant), blindness (serious criteria medically significant) and double vision. On an unknown date, the outcome of the stroke, blindness and double vision were unknown.   It was unknown if the reporter considered the stroke, blindness and double vision to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR149038   Additional Information: Receipt Date: 12-OCT-2022 Reporter's comments: The patient reported that on 12 September 2022, he had his first dose of Shingrix vaccine on the left arm. The patient had reported that on the same day he had the fourth Covid dose (Moderna Booster) in his right arm.  The patient had reported that 3 days after Covid 19 vaccination, he had a stroke, double vision and became blind. Not all information was available. The patient stated that he was told that, 1 % of patients taking the Shingrix vaccine developed strokes, double vision, and blindness. The patient stated that his lawyer would be contacting Agency regarding this. It was unknown if the reporter considered the stroke, blindness and double vision to be related to COVID-19 VACCINE MODERNA. Additional supportive information: This case was linked with US2022AMR149038 which was reported for same patient.; Sender's Comments:  US-GSK-US2022AMR149038:Same reporter
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 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 an unknown date, 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 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-Oct-2022 Reporter's comment: The reporter declined to provide their credentials and disconnected the chat before providing any additional information. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero in error at clinic, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Incomplete course of vaccination, Loss of personal independence in daily activities
Clinical narrative: Became sick; Missed days at work; 2nd dose not received after 2 years; This case was reported by a consumer via call center representative and described the occurrence of illness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced illness, activities of daily living impaired and incomplete course of vaccination. On an unknown date, the outcome of the illness, activities of daily living impaired and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the illness and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: Reporter was an acquaintance of the patient. The reporter stated that the patient had not received the second dose of Shingrix even after 2 years since the first dose. The reporter stated that the patient became sick after the first dose and missed days at work because of it.  Reporter did not consent to follow up. Reporter provided limited information. Additional supportive information: As patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. This case is linked to the case US2022148320, reported by the same reporter.; Sender's Comments:  US-GSK-US2022148320:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: alopecia; This case was reported by a other health professional via call center representative and described the occurrence of alopecia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced alopecia. On an unknown date, the outcome of the alopecia was not recovered/not resolved.   It was unknown if the reporter considered the alopecia to be related to Shingrix.     Additional Information: GSK receipt date: 15-OCT-2022 Reporters comment: The reporter reported that the patient received the both doses of the shingrix vaccine experienced alopecia after the first dose and it continued after the second dose. Additional Supportive information: in narrative it was the alopecia started after the first dose, no resolution date was provided and on the contrary he stated that the event continued after the 2nd only one case was created for the 1st dose, no further details were provided
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Haematoma, Haemorrhage, Immediate post-injection reaction
Clinical narrative: bled after Fluarix administration; This case was reported by a nurse via call center representative and described the occurrence of hemorrhage in a 36-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number M3R5B, 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 14th October 2022, the patient received Fluarix Quadrivalent 2022-2023 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. On 14th October 2022, 39 sec after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced hemorrhage (serious criteria GSK medically significant). On an unknown date, the outcome of the hemorrhage was unknown.   It was unknown if the reporter considered the hemorrhage to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-OCT-2022. Reporter's Comments: The reporter stated that a patient experienced a hematoma about 39 seconds following administration of Fluarix.  The reporter mentioned that the hematoma was resolved by end of the day when patient follow-up was done.  The reporter stated that a patient was very muscular and bled after Fluarix administration and developed a hematoma. The registered nurse states she was very good about her IM technique for administration.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Administered only the powder, used non-GSK diluent; Administered only the powder, used non-GSK diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 12-year-old 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 dose of vaccine administered and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were unknown.   Additional Information: GSK Receipt Date: 17-OCT-2022. Reporter's Comments: The reporter stated that a nurse administered only the powder component of Menveo after using a non-GSK diluent.  The reporter did not give consent to follow-up. Additional Supportive Information: The patient received only the powder component of Menveo after using a non-GSK diluent which leads to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: pain at injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.   Linked case(s) involving the same patient:US2022AMR150538   Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient who reported that, she received her Shingrix vaccine in the left arm. The reporter reported that, she had some redness and pain at the injection site that resolved in a few days.  The reporter did not consent to follow-up. Additional Supportive Information: The case had been linked to US2022AMR150538,reported by the same reporter, for a different dose.; Sender's Comments:  US-GSK-US2022AMR150538:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Multiple organ dysfunction syndrome, Thrombosis
Clinical narrative: MULTIPLE ORGAN FAILURE; SEVERE BLOOD CLOTS; This spontaneous report received from a patient via a company representative via a social media concerned a 38 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was an former healthy woman. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered 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 following vaccination with covid-19 vaccine ad26.cov2.s, the patient had a severe reaction such as multiple organ failure and severe blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe blood clots and multiple organ failure was not reported. This report was serious (Other Medically Important Condition). This case was a duplicate of 20221031295.  Additional information was received from patient via a company representative via a social media on 13-OCT-2022. It was determined that 20221031295 was a duplicate of this case. All relevant information regarding this case will be submitted under 20220956930. The following information was updated and incorporated into the case narrative: Case validity updated (from invalid to valid).; Sender's Comments: V2: This follow-up version updates- that It was determined that 20221031295 was a duplicate of this case. All relevant information regarding this case will be submitted under 20220956930. The following information was updated and incorporated into the case narrative: Case validity updated (from invalid to valid). This follow up information received does not alter the assessment of prior company causality of previously reported events.  : 20220956930-covid-19 vaccine ad26.cov2.s-Multiple organ failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220956930-covid-19 vaccine ad26.cov2.s-Severe blood clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Diabetes mellitus, Myocarditis
Clinical narrative: FULL-BLOWN DIABETES; MYOCARDITIS; 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 previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. It was unknown whether the adverse event reported following to first dose of vaccine (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis.  On an unspecified date, the patient experienced full-blown diabetes, and myocarditis (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis and full-blown diabetes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221034107-covid-19 vaccine ad26.cov2.s-Full blown Diabetes. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20221034107--covid-19 vaccine ad26.cov2.s- Myocarditis- The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.