chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Pain in extremity
Clinical narrative: Very sore arm; Very tired; Can't sleep well; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th September 2022, the patient received the 2nd dose of Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm, fatigue and sleeplessness. On an unknown date, the outcome of the pain in arm, fatigue and sleeplessness were unknown.   It was unknown if the reporter considered the pain in arm, fatigue and sleeplessness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Sep-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the second shot yesterday (day before reporting). The patient experienced sore arm, very tried and could not sleep well. The patient was guessing that this was a small price to pay for a few days compared to actually getting it (shingles). Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: 7 doses mixed with non-supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number BA975, expiry date 16th May 2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, 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: 20-SEP-2022 Reporter's Comment: The medical assistant reported staff discovered that 7 doses of Hiberix were potentially mixed with non-supplied diluent when they were reconstituted for administration.  It was believed the doses were reconstituted with sterile water diluent from Merck that was used for reconstituting proquad vaccines. The reporter did not have patient details at the time of call.  The reporter did not know dates of administration. The reporter consent to follow up. Additional supportive information: Hiberix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution. This was one of the 7 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR136360:Same reporter. US-GSK-US2022AMR136361:Same reporter. US-GSK-US2022AMR136362:Same reporter. US-GSK-US2022AMR136363:Same reporter. US-GSK-US2022AMR136364:Same reporter. US-GSK-US2022AMR136365:Same reporter.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: 7 doses mixed with non-supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number BA975, expiry date 16th May 2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, 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: 20-SEP-2022 Reporter's Comment: The medical assistant reported staff discovered that 7 doses of Hiberix were potentially mixed with non-supplied diluent when they were reconstituted for administration.  It was believed the doses were reconstituted with sterile water diluent from Merck that was used for reconstituting proquad vaccines. The reporter did not have patient details at the time of call.  The reporter did not know dates of administration. The reporter consent to follow up. Additional supportive information: Hiberix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution. This was one of the 7 cases reported by the same reporter; Sender's Comments:  US-GSK-US2022AMR136348:Same reporter. US-GSK-US2022AMR136361:Same reporter. US-GSK-US2022AMR136362:Same reporter. US-GSK-US2022AMR136363:Same reporter. US-GSK-US2022AMR136364:Same reporter. US-GSK-US2022AMR136365:Same reporter.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: 7 doses mixed with non-supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number BA975, expiry date 16th May 2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, 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: 20-SEP-2022 Reporter's Comment: The medical assistant reported staff discovered that 7 doses of Hiberix were potentially mixed with non-supplied diluent when they were reconstituted for administration.  It was believed the doses were reconstituted with sterile water diluent from Merck that was used for reconstituting proquad vaccines. The reporter did not had patient details at the time of call.  The reporter did not know dates of administration. The reporter consented to follow up. Additional supportive information: Hiberix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution. This was one of the 7 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR136360:Same reporter. US-GSK-US2022AMR136348:Same reporter. US-GSK-US2022AMR136362:Same reporter. US-GSK-US2022AMR136363:Same reporter. US-GSK-US2022AMR136364:Same reporter. US-GSK-US2022AMR136365:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot in JAN-2022; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on January 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received first dose of Shingrix on January 2022 and the 2 to 6 month time had exceeded. The reporter wanted to know patient need to start again by getting two shots spaced apart 2 to 6 months or one more shot in next week will be fine. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on Oct/Nov2021, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received intramuscularly in October or November of 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: 26-SEP-2022 Reporter's comment: The case was reported by the patient's husband. The reporter stated that the patient not yet received her second Shingrix vaccine. The reporter did not give permission to contact HCP (Health Care Professional). The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination. This case had been linked with case US2022137995, reported by the same reporter.; Sender's Comments:  US-GSK-US2022137995:Same reporter/ husband case
Sex: U
Vaccine: FLUX
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: I have them right now, I got them on my stomach and back; pain; blisters; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles) and hospitalization (got out of the hospital back in 2018).   In September 2022, the patient received Flu vaccine. In September 2022, 48 hrs after receiving Flu vaccine, the patient experienced shingles, pain and blister. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the pain and blister were unknown.   It was unknown if the reporter considered the shingles, pain and blister to be related to Flu vaccine.     Additional Information: GSK receipt date: 22-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient have had them right now 48 hours after he/she got my flu shot. It started with the pain and then the blisters. The patient stated that have not had this bad ,since he/she got out of the hospital back in 2018. This time he/she got them on my stomach and back, totally a different place than usually.  Now the patient could not get his/her COVID booster until they clear up and could not get shingles shot for 2 to 6 weeks.  Since covid this was what the patient have to deal with booster or shingle shot.  The patient stated that knew patient's pain. Additional supportive information: The follow-up could not be possible as no contact details were available. As it was stated that right now have had shingles 48 hours after shot according to that vaccination date and onset date was captured as September 2022.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Area was red; Area felt warm to touch; Swelling up; This case was reported by a consumer via interactive digital media and described the occurrence of erythema 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 erythema, feeling of warmth and swelling. On an unknown date, the outcome of the erythema, feeling of warmth and swelling were recovered/resolved.   It was unknown if the reporter considered the erythema, feeling of warmth and swelling to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR139422   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had the same reaction (as with 2nd dose) with the first dose of Shingles vaccine minus the bones ache.  The reporter reported that the area was red, felt warm to the touch and swelling. Additional Supportive Information: Follow-up would not possible as no contact details were available. For tolerance of 2nd dose refer case US2022AMR139422, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR139422:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Vaccine positive rechallenge
Clinical narrative: Bit red; Didn't swell up as much; This case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of erythema (received 1st dose on an unknow date and also experienced feeling of warmth and swelling, refer case US2022AMR139412).   In July 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced erythema and swelling. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the erythema and swelling were recovered/resolved.   It was unknown if the reporter considered the erythema and swelling to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR139412   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient got the second dose of Shingles vaccine this past July 2022. The patient stated the second dose of Shingles vaccine was not as bad as first dose, just a bit red and did not swelled up as much.  The reaction lasted less than the first Shingles vaccine dose.  Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR139412:Same reporter
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, TDAP
Symptoms: Wrong technique in product usage process
Clinical narrative: Pediarix, Boostrtix, Infanrix, Engerix-B, Kinrix, Havrix administered without shaking it; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in drug usage process in an unspecified number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B, Kinrix, Kinrix Pre-Filled Syringe Device and Havrix. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Boostrix, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B, Kinrix, Kinrix Pre-Filled Syringe Device and Havrix, 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.   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: 19-Sep-2022 and 21-Sep-2022 Reporter's comment: Healthcare professional was aware that they should shake Pediarix before administration. Some of Healthcare professionals colleagues did not follow this instruction and administered the vaccine without shaking it. The consent to follow-up was granted. Upon callback to Healthcare professional, he reported that this had been happening with Boostrtix, Infanrix, Engerix-B, Kinrix, Havrix as well as not shaking before administration and had been going on for over a year. Additional Supportive Information: There were some healthcare professionals colleagues who did not followed the instruction and administered the vaccine without shaking it, which led to wrong technique in drug usage process.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix-B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received HBV (Engerix B adult) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   On 21st September 2022, the patient received Engerix B adult. On 21st September 2022, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's comment: The registered nurse reported that a dose of Engerix B adult given to the patient in their facility and it was already expired. The reporter asked how to proceed.  The reporter did not consent to follow up. Additional Supportive Information: The use of Engerix B adult dose, which was already expired on 11th September 2022, which led to expired vaccine used.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix 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 HAV (Havrix) (batch number unknown, expiry date 9th September 2022) for prophylaxis.   On 16th September 2022, the patient received Havrix. On 16th September 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 21 September 2022 Reporter's comment: Health care professional reported an expired dose of Havrix was administered to a patient. Expired on 9th September 2022. Reporter did not consent to follow. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient received a pediatric dose; adult patient received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) (batch number unknown, expiry date 17th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-September-2022 Reporter's comment: This case was reported by nurse. The nurse reported that an adult patient received a pediatric dose of Engerix-B. Reporter consented to follow up. Additional supportive information: As patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 3rd dose not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on an unknown date) and Twinrix (2nd dose received on an date more than 12 months ago).   On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 21-SEP-2022 Reporter's Comments:  Reported stated that a patient still did not receive the third dose of Twinrix. Reporter consented to follow up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: powder reconstituted with another diluent; powder reconstituted with another diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 424JG, expiry date 28th July 2023) and (batch number FA95N, expiry date unknown) for prophylaxis.   In August 2022, the patient received Shingrix. On an unknown date, the dose was an unknown dose. In August 2022, unknown after receiving Shingrix, 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: 21-Sep-2022 Reporter's comment: The clinical coordinator called for enquiry.  The reporter asked was there any safety information or any harm to patient.  The reporter asked what should they do.  The call center reported that they found 3 vials of Shingrix diluent and were doing an investigation, was unsure if three patients were given the powder reconstituted with another diluent.  The call center was unsure and did not had a specific person/patient involved at that moment due to Healthcare professional investigating back from 15th August 2022 to 29th August 2022.  The permission for consent to follow-up was denied. Additional Supportive Information: The patient was given the powder reconstituted with another diluent, which led to Wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with US2022135797 and US2022135798 reported by same reporter. Two different batch numbers were reported were 424JG and FA95N.; Sender's Comments:  US-GSK-US2022135797:Same reporter US-GSK-US2022135798:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 11th Dec 2021, 2nd dose not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th December 2021).   On an unknown date, the patient 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: 21-Sep-2022 Reporter's comment: The patient had a chat with pharmacist. The reporter would like to know what was the protocol for the 2nd dose of Shingrix for a patient that had passed the 6 month interval. The reporter had a patient that got their first dose at a pharmacy and asked him/her to give them their second dose, but it had past the 6 month interval. 11th December 2021 was to be exact date. The reporter wanted the follow up via postal. The consent to follow up was granted. 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: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 05/22/2019, second 09/21/2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 2J5BF, expiry date 6th October 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd May 2019.).   On 21st September 2022, the patient received the 2nd dose of Shingrix. On 21st September 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: Reporter's Comments: Reporter stated patient received their first dose of Shingrix on 22nd May 2019 at another pharmacy and their second dose today 21st September 2022. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to drug dose administration interval too long.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of the liquid component only; Administration of the liquid component only; 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: 21-SEP-2022 Reporter's Comments: The reporter reported that that patient thought only administered only the liquid component of Menveo. And then when tried to collect data about the said that actually there was no patient involved.  The reporter did not consent to follow up. The reporter refused to share personal information. Additional supportive information: The patient received only liquid component of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number N959G, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th September 2022, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra 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: 21-Sep-2022 Reporter's Comments:  The pharmacist reported the administration of an expired dose of Flulaval to a patient. Dose was given on 14th Sep 2022 and vaccine expiration date was June 30th 2022, The reporter give consent to follow up. Additional Supportive Information: The patient received expire vaccine which leads to expire vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Oral herpes, Oropharyngeal pain, Pyrexia
Clinical narrative: feeling unwell; fever that got as high as 104; Sore throat; Headache; Swollen tongue; painful blisters on the tongue; suffering from oral Shingles; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included throat cancer and covid-19 (was diagnosed within the last year). Previously administered products included Monoclonal antibodies and Shingrix with an associated reaction of malaise (received 1st dose 120 days before the 2nd vaccine. Refer case US2022AMR136887). Concurrent medical conditions included kidney transplant rejection and skin cancer. Concomitant products included immunosuppressants nos (Immunosuppressants).   On 15th September 2022, the patient received the 2nd dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), sore throat (serious criteria hospitalization), headache (serious criteria hospitalization), swollen tongue (serious criteria hospitalization), tongue blistering (serious criteria hospitalization) and oral herpes (serious criteria hospitalization). On 18th September 2022, the patient experienced feeling unwell (serious criteria hospitalization). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the fever, sore throat, headache, swollen tongue, tongue blistering and oral herpes were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, fever, sore throat, headache, swollen tongue, tongue blistering and oral herpes to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments:  The reporter was sister in law of patient.  The reporter stated that reported patient received first dose of Shingrix approximately 120 days before the second dose but was unsure of the date.  The reporter stated 3 days after Shingrix patient began feeling unwell on 18th Sep 2022.  The patient developed a fever that got as high as 104, sore throat, headache, a swollen tongue, and painful blisters on the tongue. The patient was taking immunosuppressant drugs to prevent rejection of kidney transplant.  The reporter mentioned patient was previously battled throat cancer and was currently battling skin cancer and was very immunocompromised.  The patient was diagnosed with COVID within the last year and received monoclonal antibody treatment.  The reporter stated patient might be suffering from oral Shingles based on symptoms but notes patient has not been diagnosed with Shingles. The reporter stated patient was currently hospitalized due to symptoms. The reporter did not give consent to follow-up.; Sender's Comments:  US-GSK-US2022AMR136887:for 1st dose
Sex: M
Vaccine: VARZOS
Symptoms: Swollen tongue, Tongue blistering
Clinical narrative: feeling unwell; fever that got as high as 104; Sore throat; Headache; Swollen tongue; painful blisters on the tongue; suffering from oral Shingles; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included throat cancer and covid-19 (was diagnosed within the last year). Previously administered products included Monoclonal antibodies and Shingrix with an associated reaction of malaise (received 1st dose 120 days before the 2nd vaccine. Refer case US2022AMR136887). Concurrent medical conditions included kidney transplant rejection and skin cancer. Concomitant products included immunosuppressants nos (Immunosuppressants).   On 15th September 2022, the patient received the 2nd dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), sore throat (serious criteria hospitalization), headache (serious criteria hospitalization), swollen tongue (serious criteria hospitalization), tongue blistering (serious criteria hospitalization) and oral herpes (serious criteria hospitalization). On 18th September 2022, the patient experienced feeling unwell (serious criteria hospitalization). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the fever, sore throat, headache, swollen tongue, tongue blistering and oral herpes were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, fever, sore throat, headache, swollen tongue, tongue blistering and oral herpes to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments:  The reporter was sister in law of patient.  The reporter stated that reported patient received first dose of Shingrix approximately 120 days before the second dose but was unsure of the date.  The reporter stated 3 days after Shingrix patient began feeling unwell on 18th Sep 2022.  The patient developed a fever that got as high as 104, sore throat, headache, a swollen tongue, and painful blisters on the tongue. The patient was taking immunosuppressant drugs to prevent rejection of kidney transplant.  The reporter mentioned patient was previously battled throat cancer and was currently battling skin cancer and was very immunocompromised.  The patient was diagnosed with COVID within the last year and received monoclonal antibody treatment.  The reporter stated patient might be suffering from oral Shingles based on symptoms but notes patient has not been diagnosed with Shingles. The reporter stated patient was currently hospitalized due to symptoms. The reporter did not give consent to follow-up.; Sender's Comments:  US-GSK-US2022AMR136887:for 1st dose
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Kinrix administered as 1st dose in DTaP series; Kinrix administered as 1st dose in DTaP series; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the wrong vaccine administered and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's comment: Nurse reported that a 4 year old patient was administered Kinrix as the first dose in the DTaP series. At the time of call, the nurse did not have the patient details, date of administration, lot number and expiration date. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: The 4 year old patient was administered Kinrix as the first dose in the DTaP series, which led to Wrong vaccine administered and Inappropriate schedule of vaccine administered. This was one of the five cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022136456:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136459:Same reporter US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136466:Same reporter US-GSK-US2022136465:Same reporter
Sex: F
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: Bexsero 2nd late dose; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 23-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 1st dose of bexsero when the patient was 16 years old).   On an unknown date, the patient did not receive the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 22-Sep-2022 Reporter's comment:  The patient went to the facility for administration with the second dose of Bexsero, but physician did not administer the vaccine as the patient declared once in the facility that she was not sure about first or second doses of Bexsero received in the past.  The physician called GlaxoSmithKline to request medical information on three doses of Bexsero, but at the moment of the communication did not administer the patient with a bexsero vaccine dose. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Gait inability, Guillain-Barre syndrome, Inappropriate schedule of product administration, Mobility decreased
Clinical narrative: may be Guillain Barre Syndrome; Lost the ability to walk; Lost the ability to get up; 3rd dose of Shingrix administered; first dose of Shingrix on 19-Sep-2019, a second dose on 17-Sep-2020; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number LG2XJ, expiry date 10th September 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On19th Sep 2019 1st dose received).   On 21st September 2022 17:00, the patient received the 3rd dose of Shingrix. On 17th September 2020, the patient received the 2nd dose of Shingrix. On 17th September 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 21st September 2022, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization), mobility decreased (serious criteria hospitalization) and extra dose administered. On an unknown date, the outcome of the guillain barre syndrome, unable to walk, mobility decreased, extra dose administered and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the guillain barre syndrome, unable to walk and mobility decreased to be related to Shingrix.     Additional Information: GSK receipt date: 22-SEP-2022 Reporters comment:  The patient received a first dose of Shingrix on 19th Sep 2019, a second dose on 17th Sep 2020 and a third dose on 21st Sep 2022 around 5 PM (local time). The patient remained in the pharmacy for 10 to 15 minutes after received the third dose and, as per the reporting pharmacist, was asymptomatic when leaving the pharmacy. The pharmacist also reported that around 6PM local time on 21st Sep 2022, the patient was rushed to the hospital by a life squad.  On 21st September 2022, less than an hour after shingrix 3rd dose, the patient experienced guillain barre syndrome, unable to walk, mobility decreased. According to the reporter, the patient´s daughter told the pharmacy staff that on 22nd Sep 2022, the patient had been hospitalized and had lost the ability to get up and walk and that it may be Guillain Barre Syndrome The reporter consent to follow-up. Additional Supportive information: Till the time of reporting, the patient received 3 doses of shingrix, which led to Extra dose administered and first dose of Shingrix received on 19th Sep 2019, a second dose on 17th Sep 2020 which led to lengthening of vaccination schedule.  As the patient received 3rd dose of shingrix which led to extra dose administered.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: almost died. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19, and was hospitalized (date unspecified). Number of days of hospitalization were 2. Reporter reported that ""I ended up in hospital for 48 hours after JNJ shot. One and done. Maybe the omicron and delta were worse dude. I almost died in October 2019 and no one knew why there was a dead bat under my pillow. Am I patient zero" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0: 20220951453 -covid-19 vaccine ad26.cov2.s- Suspected COVID-19  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.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Eye pain, Hot flush, Hypertension, Intracranial pressure increased
Clinical narrative: HIGH BLOOD PRESSURE; HOT FLASHES; PAIN IN THE BACK OF HER EYES; INTERCRANIAL HYPERTENSION; This spontaneous report received from a consumer concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cherries allergy (Gets a rash), and alcohol user (occasionally), and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 27-SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 42 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced brain fog, hot flashes, pain in the back of her eyes, headaches, blurriness and high blood pressure. Laboratory data (dates unspecified) included: Blood pressure high. On 23-SEP-2022, the patient visited a physician and underwent MRI (Magnetic resonance imaging) scan which showed in intercranial hypertension. On 05-OCT-2022, MRV (magnetic resonance venography) had been scheduled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from hot flashes, and had not recovered from high blood pressure, pain in the back of her eyes, and intercranial hypertension. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220952025-covid-19 vaccine ad26.cov2.s-intercranial hypertension. The event(s) has a compatible/suggestive 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.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: HIGH BLOOD PRESSURE; HOT FLASHES; PAIN IN THE BACK OF HER EYES; INTERCRANIAL HYPERTENSION; This spontaneous report received from a consumer concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cherries allergy (Gets a rash), and alcohol user (occasionally), and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 27-SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 42 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced brain fog, hot flashes, pain in the back of her eyes, headaches, blurriness and high blood pressure. Laboratory data (dates unspecified) included: Blood pressure high. On 23-SEP-2022, the patient visited a physician and underwent MRI (Magnetic resonance imaging) scan which showed in intercranial hypertension. On 05-OCT-2022, MRV (magnetic resonance venography) had been scheduled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from hot flashes, and had not recovered from high blood pressure, pain in the back of her eyes, and intercranial hypertension. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220952025-covid-19 vaccine ad26.cov2.s-intercranial hypertension. The event(s) has a compatible/suggestive 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.