chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received vaccine reconstituted with non GSK diluent; received vaccine reconstituted with non GSK diluent; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA751A, expiry date unknown) for prophylaxis.   In September 2022, the patient received Menveo. In September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter reported that, the patient received Menveo vaccine reconstituted with a non-GlaxoSmithKline diluent. The patients received Menveo powder reconstituted with saline diluent. After this conversation, a medical Information agent contacted the nurse by phone and confirmed the situation.  The reporter stated that, they have noticed that, patient that could possibly have gotten a partial dose of Menveo along the past week.  The reporter consented to follow up by email. Additional Supportive Information: The reporter reported that, the patient received Menveo vaccine reconstituted with a non-GlaxoSmithKline diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022137202:Same reporter US-GSK-US2022AMR137841:Same reporter US-GSK-US2022AMR137842:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received vaccine reconstituted with non GSK diluent; received vaccine reconstituted with non GSK diluent; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA751A, expiry date unknown) for prophylaxis.   In September 2022, the patient received Menveo. In September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter reported that, the patient received Menveo vaccine reconstituted with a non-GlaxoSmithKline diluent.  After this conversation, a medical Information agent contacted the nurse by phone and confirmed the situation.  The reporter stated that, they have noticed that, patient that could possibly have gotten a partial dose of Menveo along the past week.  The patient that received Menveo powder reconstituted with saline diluent. The reporter consented to follow up by email. Additional Supportive Information: The reporter reported that, the patient received Menveo vaccine reconstituted with a non-GlaxoSmithKline diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR137840:Same reporter US-GSK-US2022137202:Same reporter US-GSK-US2022AMR137842:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received vaccine reconstituted with non GSK diluent; received vaccine reconstituted with non GSK diluent; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA751A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter reported that, the patient received Menveo vaccine reconstituted with a non-GlaxoSmithKline diluent.  After this conversation, a medical Information agent contacted the nurse by phone and confirmed the situation.  The reporter stated that, they have noticed that, patient that could possibly have gotten a partial dose of Menveo along the past week.  The patient that received Menveo powder reconstituted with saline diluent. The reporter consented to follow up by email. Additional Supportive Information:The reporter reported that, the patient received Menveo vaccine reconstituted with a non-GlaxoSmithKline diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR137840:Same reporter US-GSK-US2022AMR137841:Same reporter US-GSK-US2022137202:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR137884   Additional Information: GSK receipt date: 23-SEP-2022 Reporters comment: This case was reported by patient. The patient got the shots when first available in 2018. The patient got sore arm from first Shingirx. But felt no soreness at all after the second and was afraid she might not be fully protected. Wonder if she repeats the shots. The patient stated that it was so unusual for her not to had sore arm, that she wonders if the second shot was effective. Additional Supportive information: For tolerance of Flu vaccine refer case US2022AMR137884, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR137884:Same reporter
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be related to Flu vaccine.   Linked case(s) involving the same patient:US2022AMR137883   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: This case was reported by a patient. The patient got sore arm from flu shot. Additional Supportive Information: The case had been linked to US2022AMR137883, reported by the same reporter, for a different product.; Sender's Comments:  US-GSK-US2022AMR137883:Same reporter
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: The MenA lyophilized  was reconstituted with saline; The MenA lyophilized  was reconstituted with saline instead of the Men C,W,Y liquid.; This case was reported by a pharmacist via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo (intramuscular). On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter reported the patient received Menveo as maladministration. The reporter stated that the only Men A component of the vaccine was administered intramuscularly. The Men A lyophilized powder was reconstituted with saline instead of the Men C, W, Y liquid. Therefore, the Men A vial was not reconstituted with the liquid Men C, W, Y vial, lot number was unknown.  The patient did not experience an adverse event as a result of the maladministration. The reporter did not consent to follow up. Additional supportive information: The patient received only the Men A portion only with saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: FLUX
Symptoms: Expired product administered
Clinical narrative: expired Flu vaccine administered; This case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in an unspecified number of patients who received Flu unspecified (Flu vaccine) (batch number 3NA4M, expiry date 30th June 2022) for prophylaxis.   On 26th September 2022, the patient received Flu vaccine. On 26th September 2022, unknown after receiving Flu vaccine, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 26-Sept-2022 Reporter's comment: The pharmacist stated that GlaxoSmithKline Flu vaccine 2021-22 formulation was administered to more than 20 employees during their fall 2022 flu campaign on the day of reporting.  The reporter did not had additional details regarding recipient names, but will obtain it from nursing personnel. The reporter asked to mail form to complete additional details.  No adverse clinical sequelae had been reported by recipients at this time. The reporter consented to follow-up. Additional supportive information: The patients had received an expired dose of Flu vaccine, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: mild pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 4 months after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR139909   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shot of shingles vaccine in June so it was mild pain. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR139909.; Sender's Comments:  US-GSK-US2022AMR139909:same patient, other dose
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: small area of rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (For tolerance of 1st dose, refer case US2022AMR139883).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Linked case(s) involving the same patient:US2022AMR139883   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shot of shingles vaccine second time.  The patient stated that, just a small area of rash. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR139883:same patient, other dose
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Varicella
Clinical narrative: broke out in Chicken Pox; This case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included covid-19 vaccine (Covid Vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (patient received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and Covid Vaccine at an unknown dose and frequency. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-SEP-2022 Reporter's comment: This case was reported via interactive digital media. Patient reported that he/she had taken double vaccine in 2019 and he/she had broken out in Chicken Pox.  The reporter believed that it was a precursor to the Covid vaccine and thought it was fake and just for big pharma dollars.  Additional supportive information: Follow-up would not possible, as no contact, details were available. From the narrative it was not clear if the event was occurred after or before Covid vaccine, hence conservatively considered as suspect. It was unknown if the reporter considered the chickenpox to be related to Covid vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: It was so painful; My arm still hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid (received covid vaccine on an unknown date) and pneumonia (received pneumonia vaccine on an unknown date).   On 20th September 2022, the patient received the 1st dose of Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced pain and pain in arm. On an unknown date, the outcome of the pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the pain and pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR140045   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got his/her 1 shot on Tuesday (from the date of reporting) it was so painful his/her arm still hurts.  The patient got all the vaccines flu, Covid, pneumonia and this by far was the worse, the doctor on Wednesday gave the flu shot not a problem.  The patient got 1st vaccine and it was worse shot the patient ever had, and on the day of reporting got the flu shot piece of cake. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR140045:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: So painful; they reared their ugly head; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the pain and shingles were not recovered/not resolved.   It was unknown if the reporter considered the pain and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-SEP-2022 Reporter's comment: This case was reported via interactive digital media. The patient reported that he/she had one shot and the day before his/her second one they reared their ugly head. It was so painful and had to take Valtrex for a week. Still not gone completely. Additional supportive information: Since it was a case, they reared their ugly head was conservatively captured as Shingles. Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; Achiness; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient had Shingles and it was horrible. The reporter stated that you can had shingles more than once, so the patient received vaccination. The reporter stated that had a reaction after receiving vaccination was fairly common. The reporter stated that after received vaccination patient experienced fever and achiness. The patient was still recommended it, it was better than the shingles again. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Fear, Impaired quality of life, Pruritus
Clinical narrative: disrupted her quality of life; Body itching (disrupted quality of life)/that was very bothersome; This case was reported by a physician via sales rep and described the occurrence of generalized pruritus in a female 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 generalized pruritus and impaired quality of life. On an unknown date, the outcome of the generalized pruritus was recovered/resolved and the outcome of the impaired quality of life was unknown.   The reporter considered the generalized pruritus and impaired quality of life to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's comment: Physician had friend who received Shingrix first dose and experienced full body itching for 3 months that was very bothersome and disrupted her quality of life.  Physician also stated that the patient looked at all possible causes and could only conclude it was due to vaccination with Shingrix. The patient did see physician multiple tirne for evaluation and treatment.  The patient was afraid to get second dose of Shingrix and will not get second dose. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Discomfort, Pain, Spinal X-ray normal
Clinical narrative: Throbbing in thoracic area; Burning sensation in thoracic area; discomfort; This case was reported by a consumer via call center representative and described the occurrence of throbbing pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (On an unknown date patient received 1st dose of Shingrix. Refer case US2022AMR137792).   In September 2022, the patient received the 2nd dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced throbbing pain, burning sensation and discomfort. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the throbbing pain and burning sensation were not recovered/not resolved and the outcome of the discomfort was unknown.   It was unknown if the reporter considered the throbbing pain, burning sensation and discomfort to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments:  The patient reported that, she received her second dose of Shingrix about two weeks ago of reporting in her left arm.   The patient had been experiencing a throbbing, burning sensation in the thoracic area of her body for about one week.   She stated this in the area where her bra was.  She took Tylenol for the discomfort The patient had a back x-ray done which was negative.   The reporter gave consent to follow up. For 1st dose refer case US2022AMR137792.; Sender's Comments:  US-GSK-US2022AMR137792:Same reporter
Age: 22.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Inappropriate age at vaccination; Infanrixadministered instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 22-year-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th August 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th August 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-September-2022 Reporter's comment: This case was reported by nurse. Nurse reported that a male patient received an Infanrix vaccine instead of Boostrix. This error happened on 15th August 2022. Additional supportive information: As patient received Infanrix vaccine instead of Boostrix. which led to wrong vaccine administered and inappropriate age at vaccine administration. Reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2018, 2nd not yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient did not  receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 23-September-2022 Reporter's comment: Reporter stated that patient had not received a second dose yet. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.. Reporter consent to follow up via email above in HCP details.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Needle issue, Underdose
Clinical narrative: leaked out around the needle onto patient skin; leaked out around the needle onto patient skin; unsure how much dose patient received; This case was reported by a pharmacist via call center representative and described the occurrence of exposure via skin contact in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 44T97, expiry date 18th September 2023) for prophylaxis.   On 23rd September 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd September 2022, unknown after receiving Shingrix, the patient experienced exposure via skin contact, inadvertent exposure to vaccine and incomplete dose administered. On an unknown date, the outcome of the exposure via skin contact, inadvertent exposure to vaccine and incomplete dose administered were unknown.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments: The registered pharmacist reported that the patient received first dose of Shingrix into left arm and reported that all operations were performed appropriately during reconstitution. The reporter stated that halfway through administration the medicine leaked out around the needle onto patient skin. PQC (product quality complaint) ruled out.  The reporter was unsure how much of a dose the patient received (thought about half). Education provided per package insert and content. The reporter did not consent to follow up. Additional Supportive Information: The reporter stated that halfway through administration the medicine leaked out around the needle onto patient skin and reporter was unsure how much of a dose the patient received, which led to inadvertent exposure to vaccine, exposure via skin contact and incomplete dose administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received vaccine reconstituted with non GSK diluent; received vaccine reconstituted with non GSK diluent; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA751A, expiry date unknown) for prophylaxis.   In September 2022, the patient received Menveo. In September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments: The nurse reported that the patient received a dose of Menveo that reconstituted with a non GlaxoSmithKline diluent. After this conversation, a Medical Information Agent contacted health care professional nurse by phone and confirmed the situation. The health care professional stated that they noticed that there were 4 patients that could possible have gotten a partial dose of Menveo along the past week. There were 4 possible patients that received Menveo powder reconstituted with saline diluent. The reporter consented to follow up by email. Additional supportive information: The patient received a dose of Menveo that reconstituted with a non GlaxoSmithKline diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was one of four cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR137840:Same reporter US-GSK-US2022AMR137841:Same reporter US-GSK-US2022AMR137842:Same reporter
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 16yo received adult dose; 16yo received adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 16-year-old male patient who received HAV (Havrix adult) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 12th June 2022, the patient received Havrix adult. On 12th June 2022, unknown after receiving Havrix adult, 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.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments:  The reporter stated that one or two month ago, a patient received Havrix adult dose by error. The reporter give consent to follow up by email. Additional Supportive Information: The patient received Havrix adult dose by error, which led to overdose and adult product administered to child.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: male patient received three doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number GJ549, expiry date 15th September 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th September 2021) and Shingrix (2nd dose received on 11th March 2022).   On 23rd September 2022, the patient received the 3rd dose of Shingrix. On 23rd September 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     Additional Information: GSK receipt date: 23-SEP-2022 Reporters comment: The patient received three doses of Shingrix vaccine. The reporter consent to follow-up. They received the three doses on the same day and they were a husband and wife team. Additional Supportive information: The patient received three doses of Shingrix vaccine, which led to extra dose administered. This case is linked to the case US2022137212, reported by the same reporter.; Sender's Comments:  US-GSK-US2022137212:Same reporter
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 12 months old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 31st August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments:  The reporter stated that the Kinrix to a 12 months old patient. Reporter asked how to proceed with patient. The reporter mentioned that actually there were 2 patients who received the Kinrix vaccine, since these patients were twins. Did not consent to follow-up. Additional Supportive Information: The Kinrix to a 12 months old patient, which led to inappropriate age at vaccine administration. Refer case 1 of 2 twin case US2022137222; Sender's Comments:  US-GSK-US2022137222:Same reporter
Age: 1.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 12 months old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. 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: 23-SEP-2022 Reporter's Comments:  The reporter stated that the Kinrix to a 12 months old patient. Reporter asked how to proceed with patient. The reporter mentioned that actually there were 2 patients who received the Kinrix vaccine, since these patients were twins. The reporter did not consent to follow up. Additional Supportive Information: The Kinrix to a 12 months old patient which lead to Inappropriate age at vaccine administration. This case has been linked to the US2022137221 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022137221:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error, Wrong technique in product usage process
Clinical narrative: Reconstituted on 22Sep22/ 1.30PM, administered on 23Sep22/ 10AM; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in drug usage process in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2022 10:00, the patient received Shingrix. On 23rd September 2022 10:00, unknown after receiving Shingrix, the patient experienced wrong technique in drug usage process. On an unknown date, the outcome of the wrong technique in drug usage process was unknown.   Additional Information: GSK Receipt Date: 23-Sep-2022 Reporter's comment: The pharmacist reported that a dose of Shingrix reconstituted on 22nd September 2022 at 1.30 pm (local time) was administered to a patient on 23rd September 2022 at 10 am (local time). The pharmacist also reported that the Shingrix dose administered to this patient had been placed in refrigeration after reconstitution. The reporter consented to follow up. Additional Supportive Information: The Shingrix dose administered to this patient had been placed in refrigeration after reconstitution for more than recommended time, which led to wrong technique in drug usage process.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Glossodynia, Injection site erythema, Nasal congestion, Oropharyngeal pain
Clinical narrative: site redness; congestion; chest tightness; aching arms and legs; sore tongue; sore throat; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2022, the patient received the 2nd dose of Shingrix. On 23rd September 2022, 1 days after receiving Shingrix, the patient experienced injection site erythema, nasal congestion, chest tightness, pain in extremity, sore tongue and sore throat. On an unknown date, the outcome of the injection site erythema, nasal congestion, chest tightness, pain in extremity, sore tongue and sore throat were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, nasal congestion, chest tightness, pain in extremity, sore tongue and sore throat to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-Sep-2022 Reporter's comment: The patient self-reported this case. Next day of vaccination, the patient experienced sore throat, sore tongue, site red, aching arms and legs, chest tightness, congestion.  The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Respiratory tract congestion
Clinical narrative: site redness; congestion; chest tightness; aching arms and legs; sore tongue; sore throat; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2022, the patient received the 2nd dose of Shingrix. On 23rd September 2022, 1 days after receiving Shingrix, the patient experienced injection site erythema, nasal congestion, chest tightness, pain in extremity, sore tongue and sore throat. On an unknown date, the outcome of the injection site erythema, nasal congestion, chest tightness, pain in extremity, sore tongue and sore throat were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, nasal congestion, chest tightness, pain in extremity, sore tongue and sore throat to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-Sep-2022 Reporter's comment: The patient self-reported this case. Next day of vaccination, the patient experienced sore throat, sore tongue, site red, aching arms and legs, chest tightness, congestion.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: shot 1 in received it around November 2021, but has not yet received shot 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in around November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 23-Sep-2022 Reporter's comment: The reporter was the patient sister. She did not wanted to share her email address. The patient was her brother. He lived in another country. He received the FDA approved Shingrix, shot 1 when he was visiting his sister. He was due to get Shingrix shot dose 2 around May 2022 but had not yet received Shingrix shot 2.  The reporter had limited information. The consent to follow-up was requested. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: administered Boostrix, the patient already had a dose; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 13-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 775YF, expiry date 22nd April 2023) for prophylaxis.   Previously administered products included Boostrix (had a dose back on 11th February 2020).   On 22nd September 2022, the patient received Boostrix. On 22nd September 2022, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments: The medical doctor called to inquire about how to proceed with Booster series. The physician reported that they inadvertently administered Boostrix to a patient the day before reporting. The patient already had a Boostrix dose back on 11th Feb 2020. The reporter did not consent to follow up. Additional Supportive Information: The patient received an dose of Boostrix who had already received it, which led extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on May2021, 2nd not received; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2021).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-Sept-2022 Reporter's comment: The reporter mentioned that so far the patient has not received the second dose. The call got disconnected before collecting the reporter´s information such as phone number, zip code and the title. Therefore, the reporter documented health care professional as Other Health Professional. Moreover, patient and vaccine data were not collected. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 18 YO received Havrix adult dose; 18 YO received Havrix adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HAV (Havrix adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 25th May 2022, the patient received the 1st dose of Havrix adult. On 25th May 2022, unknown after receiving Havrix adult, 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.   Additional Information: GSK receipt date: 27-Sept-2022 Reporter's comment: No symptoms were reported. The reporter consented to follow-up via email. Additional supportive information: The patient received an adult dose of Havrix, which led to overdose and adult product administered to child.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB39ab, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 27th September 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Sept-2022 Reporter's comment: Nothing was reported. The reporter consented to follow-up with prescriber. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male 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 26th September 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 26th 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: 28-Sept-2022 Reporter's comment: The reporter reported expired Infanrix administered to a patient. Additional supportive information: The patient received an expired dose of Infanrix, which led to expired vaccine used.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo powder reconstituted with non-GSK sterile diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA728A, expiry date 30th September 2023) for prophylaxis.   On 28th September 2022, the patient received Menveo. On 28th 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: 28-Sept-2022 Reporter's comment: The licensed practical nurse called to inquired that how to proceed and when they can revaccinate. The reporter did not consent to follow-up. Additional supportive information: The patient was inadvertently administered Menveo lyophilized powder component reconstituted with a unapproved non-GlaxoSmithKline sterile diluent, which led to wrong solution used in drug reconstitution.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 20 month old baby received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 20th July 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: 28-Sept-2022 Reporter's comment: The facility address of the incident (did not collect that address) was different from the mailing address. The reporter consented to follow-up. Additional supportive information: The patient (20 months old) received Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 22.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 26th June 2022, the patient received the 2nd dose of Havrix. On 26th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 29-Sept-2022 Reporter's comment: No side effects were reported. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.