chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received An Expired Dose of Heplisav-B; Initial Report Received on 07-Sep-2022  A compliance/privacy officer and quality improvement director at a doctor's office reported that a 52-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On 07-Sep-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934975, expiration date 13-Aug-2022, NDC # 43528-003-05, route not reported) in the right arm.    No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received An Expired Dose of Heplisav-B; Initial Report Received on 08-Sep-2022  An office manager from a medical group reported that a 44-year-old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history, concomitant medications, and allergies at the time of vaccination were unknown.  On 07-Sep-2022, the patient received an expired dose of HEPLISAV-B (Lot # 934975, expiration date 13-Aug-2022, NDC # 435280003-05; route not reported) in the deltoid (unknown if right or left). No adverse events were reported by the patient.   No further information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Received Heplisav-B While 21 Weeks Pregnant; Initial Report Received on 09-Sep-2022  A 32-year old pregnant patient (race and ethnicity not provided) reported that she received her first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization when she was 21 weeks pregnant.  Medical history, concomitant medications, and allergies at the time of vaccination were unknown. The last menstrual period date, estimated date of delivery, pregnancy history, and pregnancy risk factors were not reported.  On 05-Aug-2022, the patient, who was 21 weeks pregnant, received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported). The patient denied any adverse reactions and had spoken with the Pregnancy Registry.   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Oral pain, Stomatitis
Clinical narrative: Painful Sores in Mouth; Initial Report Received on 09-Sep-2022  A nurse practitioner reported that a 38-year-old male patient (race and ethnicity unknown) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then developed painful sources in his mouth.  Medical history and concomitant medications at the time of vaccination were unknown. The patient had an allergy to amoxicillin, which caused a rash.  On 01-Sep-2022, the patient received the first dose of HEPLISAV-B (Lot # 937781, expiration date 20-Sep-2023, NDC # unknown) intramuscularly in the left deltoid.   On 02-Sep-2022, one day after receiving the HELPLISAV-B injection, the patient developed "pretty painful" sores in his mouth. The reporter denied that the patient had any other adverse reactions.  At the time of the report, the mouth sores were almost gone.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot a year later got shingles / suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient reported that got the shot a year later got shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: I don't feel good; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-NOV-2022 Reporter's comment: This case was reported by the patient via  interactive digital media.  The reporter stated that he/she had went to the pharmacy for second dose of Shingrix and now he/she does not feel good and was wondering if he/she had got the 1st one twice. Additional supportive information: Since, it was a case and until the time of reporting, it was not clear whether the patient had received the second dose or not and also if they have received the first dose twice, then also the vaccination schedule is completed and hence no medication error was coded into the case. Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to two patients; This case was reported by a physician and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   On 8th November 2022, the patient received Havrix. On 8th November 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: 08-NOV-2022 Reporter's comments: The reporter asked information on stability of Havrix. The reporter reported that he/she had a medication error wherein a dose of expired vaccine was given to 2 patients on the day of reporting. The reporter asked about data on stability of this vaccine after the official expiration date. It was properly stored since it was arrival at reporter's clinic in a refrigerator whose temperature was monitored daily. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used. This case is linked to the case US2022163626, US2022AMR163547 and US2022AMR164695 as reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR163547:Same reporter. Patient 2. US-GSK-US2022AMR164695:same reporter US-GSK-US2022163626:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Hypoaesthesia, Pain
Clinical narrative: in discomfort and pain; arm fell asleep; in discomfort and 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.   Previously administered products included Shingles vaccine (already received the first dose).   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 pain, numbness of upper extremities and discomfort. On an unknown date, the outcome of the pain, numbness of upper extremities and discomfort were recovered/resolved.   It was unknown if the reporter considered the pain, numbness of upper extremities and discomfort to be related to Shingles vaccine.     Additional Information: GSK receipt date: 06-Nov-2022 Reporter's comment:  This case was reported by a patient via interactive digital media. The patient already received first dose of Shingles vaccine. The patient never had pain after a first dose. The patient now experienced that arm fell asleep (numbness of upper extremities) and had discomfort and pain for about two days. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Age: 1.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 16 month old patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th November 2022, the patient received Kinrix .5 ml and Kinrix Pre-Filled Syringe Device. On 9th November 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: 09-NOV-2022 Reporter's Comment: The nurse reported that the 16th month old patient inadvertently received dose of kinrix vaccine. The vaccine administration facility was same as the primary reporter. Additional supportive information: A 16th month old patient inadvertently received dose of kinrix vaccine, which led to Inappropriate age at vaccine administration. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Muscle tightness, Tremor
Clinical narrative: Diarrhea; Severe shaking; Tight muscles; This case was reported by a consumer via interactive digital media and described the occurrence of diarrhea in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th November 2022 18:30, the patient received the 2nd dose of Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced diarrhea, tremor and muscle tightness. On an unknown date, the outcome of the diarrhea, tremor and muscle tightness were not recovered/not resolved.   It was unknown if the reporter considered the diarrhea, tremor and muscle tightness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that yesterday (day before reporting) he/she received second dose of Shingles vaccine. Now he/she had diarrhea and more problems like some severe shaking and tight muscles. The patient wanted to know what he/she could do. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: FLU4
Symptoms: Intercepted product storage error
Clinical narrative: Temperature alarm on the device shipped/ advised to not use the product; This case was reported by a pharmacist via other and described the occurrence of intercepted product storage error in a patient who received Flu Seasonal QIV (FluLaval Tetra) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra. On an unknown date, unknown after receiving FluLaval Tetra, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: The customer reported receiving 40 cartons of flu vaccines shipped directly from GlaxoSmithKline, which they immediately put in temperature tracked refrigerators after delivery. All tracking numbers delivered next day, with no delay.  They did not open the boxes or inspect the contents, including the temperature monitors, prior to storing.  The customer then reported several boxes with a tag alert alarm 2 upon being removed from the fridge and opened.  Total doses impacted was 8 cartons of 21 units (1680 doses).  The customer requested an exception to return these doses. The reporter reviewed the request and based on our current returns policy and exception processed, this did not qualify for an exception.  The shipping and handling guidelines posted on GlaxoSmithKline direct state that all cold chain containers must be opened immediately upon receipt and the temperature monitor reading verified.  There was no delay in refrigerating the product (confirmed by customer) and an alarm reading of 2 would only occur with delivery delays, or in the event the tag alert device was improperly handled i.e. put in a fridge.  Additionally, we ruled out a personal disaster claim because the vaccines were stored upon receipt. The exception to return the impacted vaccines was not approved. However, we did not advise the customer to use the product.  The customer cited a couple things that, caused them to store the vaccines without opening the boxes.  Namely, the quantity delivered (16,500 doses in 40 cartons) necessitated unpacking the shipping containers and storing the boxes efficiently.  They also mentioned that, the new shipping containers for flu vaccines; each container has 2 cartons and one temperature monitor so each carton would have to be opened. The customer did not handle the vaccines correctly by not inspecting each container.  The reporter could not confirm the stability of the vaccines upon receipt because the boxes were not opened. Additional Supportive Information: The customer did not handle the vaccines correctly by not inspecting each container, alert device was improperly handled and put in a fridge, which led to intercepted product storage error.
Sex: U
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: many people experienced vertigo; This case was reported by a consumer and described the occurrence of vertigo in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unknown.   It was unknown if the reporter considered the vertigo to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter stated that, he/she found many people experienced vertigo after getting a Shingrix vaccine. Additional Supportive Information: The case had been linked to US2019035269 and US2019035262, reported by the same reporter, for a different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019035262:Same reporter (reporter´s case) US-GLAXOSMITHKLINE-US2019035269:same reporter (friend of wife´s reporter´s case)
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received on November 4th 2022 the liquid portion only of Shingrix without the lyophilized portion; patient received on November 4th 2022 the liquid portion only of Shingrix without the lyophilized portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number kk3jm, expiry date 25th September 2023) for prophylaxis.   On 4th November 2022, the patient received Shingrix. On 4th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-Nov-2022 Reporter's comment: The license practical nurse reported that the patient received the liquid portion only of Shingrix without the lyophilized portion. The reporter did not consent to follow-up. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received the liquid portion only of Shingrix without the lyophilized portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 38.0
Sex: F
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 38-year-old female patient who received HAV (Havrix) (batch number 3F349, expiry date 9th August 2022) for prophylaxis.   On 3rd November 2022, the patient received Havrix. On 3rd November 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: 07-Nov-2022 Reporter's comment: The reporter was clinic manager. The reporter stated that that a patient was administered dose of Havrix that had expired.  The vaccine administration facility was the same as primary reporter. The reporter gave consent to follow up via email. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used. This is 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022162508:Same reporter US-GSK-US2022162503:Same reporter US-GSK-US2022162506:Same reporter US-GSK-US2022162505:Same reporter US-GSK-US2022162501:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 24Jun2019, 2nd uncertain; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th June 2019).   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: 07-NOV-2022 Reporter's Comment: The medical assistant reported that a patient received the 1st dose of Shingrix and believed she received a 2nd dose.  The HCP did not had record of 2nd dose and might give her another dose (potential late dose or 3rd dose). The reporter consent to follow up. 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: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate schedule of vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (an unknown date received 2 doses).   On 4th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. 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: 07-NOV-2022 Reporter's Comment: The LPN reported that child received Kinrix vaccine after receiving 2 doses of Pediarix and prior to 4th birthday.  The patient was 3 years 11 months 8 days at administration. The reporter consent to follow up. Additional Supportive Information: 3 years 11 months 8 days old patient received Kinrix, which led to inappropriate age at vaccine administration.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: was inadvertently given third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 20-year-old male 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 on 6th May 2022) and Bexsero (received 2nd dose on 6th June 2022).   On 7th November 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 7th November 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The healthcare professional reported that patient received 2 doses of Bexsero then was inadvertently given a third dose.  The reporter did not had the lot number or expiration date information for any of the doses at the time of reporting. The reporter did not want contact information saved in database but did give permission to follow-up with her via phone.   The contact information would be sent in email from case. The reporter consent to follow up. Additional Supportive Information: The patient received extra Bexsero dose, which led to extra dose administered.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: diluent only without lyophilized powder component; administered liquid diluent 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 53-year-old male patient who received Herpes zoster (Shingrix) (batch number BE24A, expiry date 19th March 2023) for prophylaxis.   On 7th November 2022, the patient received the 1st dose of Shingrix. On 7th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The medical assistant called to inquire for any side effects to look for and reported they inadvertently administered the Shingrix liquid diluent only without the lyophilized powder component to a patient in the left deltoid. The medical assistant confirmed diluent administered in their facility and was the attempted first dose of Shingrix. The reporter did not consent to follow up. Additional Supportive Information: The reporter reported that they inadvertently administered the Shingrix liquid diluent only without the lyophilized powder component to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: a 16 year old female patient, received the liquid component only of Menveo by error; a 16 year old female patient, received the liquid component only of Menveo by error; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA748A, expiry date 30th November 2023) for prophylaxis.   On 7th November 2022, the patient received Menveo. On 7th November 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 08-NOV-2022 Reporters comment:  The patient received the liquid component only of Menveo vaccine by error.  Health Care Professional details were sent by email The reporter consent to follow-up. Additional Supportive information: Inadvertent administration of only the liquid Meningococcal CWY Component of Menveo to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: swelling; redness, little lighter than before; This case was reported by a consumer via call center representative and described the occurrence of swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2022, the patient received Shingles vaccine. In November 2022, less than a week after receiving Shingles vaccine, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were not recovered/not resolved.   It was unknown if the reporter considered the swelling and erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: The patient received shingles vaccine 5 days ago and now had swelling and redness, though the redness was a little lighter than before but still present. No other information reported to the agent.  The patient disconnected from the call after reporting and agent was unable to verify product or any further details.  No contact information was able to be collected due to patient disconnecting from the call.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: 1st dose 2017-2018, 2nd not yet, vaccine shortage; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2017 or 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: The reporter was the patient.  The patient mentioned she received her first Shingrix dose but had not yet received the second dose. The patient attributes the delay to vaccine shortage. Nothing else was reported. The reporter did not consent to follow up. This case has been linked to the case US2022163651 reported by the same reporter.; Sender's Comments:  US-GSK-US2022163651:Same reporter
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 16-year-old patient was vaccinated with a Menveo reconstituted without the proper diluent; 16-year-old patient was vaccinated with a Menveo reconstituted without the proper diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA733A, expiry date 30th November 2023) for prophylaxis.   On 8th November 2022, the patient received Menveo. On 8th November 2022, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date: 08-NOV-2022 Reporters comment:  The patient received Menveo vaccine reconstituted without the proper diluent.  The reporter consent to follow-up via email Additional Supportive information: The patient received Menveo vaccine reconstituted without the proper diluent which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.    which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine given SC instead IM; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 4755H, expiry date 9th June 2023) for prophylaxis.   On 2nd August 2022, the patient received the 2nd dose of Shingrix (subcutaneous). On 2nd August 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 10-NOV-2022  Reporter's Comment: The reporter reported that, a customer stated that Shingrix was given to her subcutaneously and wanted to know if she needed another dose. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a customer stated that Shingrix was given to her subcutaneously, which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2017, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received the 1st dose of Havrix in 2017).   On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, 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: 10-NOV-2022 Reporter's Comment: The reporter did not have patient's DOB (date of birth) or exact date of vaccination.  The reporter believed that, patient was in her 30's and she stated patient said she received the 1st dose 5 years ago. The patient does not remember if it was the Havrix she received 5 years ago. The reporter reported that a patient would like to get the 2nd dose of Havrix. The reporter consented to follow up via mail. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Havrix, which led to incomplete course of vaccination.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Expired Fluarix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 42-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2021-2022 season) (batch number HZ2JR, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received Fluarix Tetra 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2022, unknown after receiving Fluarix Tetra 2021-2022 season and Fluarix 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: 10-NOV-2022 Reporter's Comment: The reporter wanted to know from the lot number if that was the accurate expiration date. So this expired vaccine was administered this month.  The reporter wanted to know was there a recommendation from GSK (GlaxoSmithKline) about revaccinating with a flu vaccine that was not expired for this flu season. The reporter did not have the exact date of administration, only that it was administered in October of this year.  The reporter consented to follow up via postal. Additional Supportive Information: The patient was administered with expired dose of Fluarix Quadrivalent 2021-2022 season, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, 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 (received 1st dose 2 years ago (the day before reporting)).   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: 10-NOV-2022  Reporter's comment: The case was self reported by the patient. The patient reported that she was not getting second dose of Shingrix. No other information reported to agent by the patient. The reporter did not consent to follow up. 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: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoacusis, Nausea, Pyrexia, Tinnitus
Clinical narrative: LOSS OF SOME HIGH FREQUENCY HEARING; TINNITUS; NAUSEOUS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 40 years old. No concomitant medications were reported. On 2021, the patient experienced headache, fever, and nauseous. On an unspecified date, the patient experienced ear problem of a loss of some high frequency hearing, and tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and nauseous on 2021, and the outcome of headache, loss of some high frequency hearing and tinnitus was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a 29-year-old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient stated that she was taking other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient was previously experienced significant vomiting when treated with oseltamivir phosphate(Tamiflu) and it was classified to be an allergic reaction.  The patient previously received non-company suspect vaccine Moderna Covid-19 vaccine (elasomeran) (dose number in series 1) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, administered on 08-OCT-2021 to right arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with Moderna Covid-19 vaccine (elasomeran) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 1 in total was administered on 11-MAR-2022 to right arm for covid-19 prophylaxis which was an revaccination with different covid-19 vaccine (dose number in series 2). The batch number was not reported and has been requested. Age at time of vaccination 28 years old. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate, (D Amphetamine Salt Combo), and levonorgestrel (Mirena).  On an unspecified date in 2022, the patient experienced COVID-19 which was coded as suspected covid-19 infection (dose number in series 2). On 27-OCT-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported for covid-19 treatment and last administered on 01-NOV-2022. On 02-NOV-2022; 08:00, approximately 24 hours after non company suspect drug paxlovid treatment, the patient symptoms started to resurface that had previously disappeared particularly the patients cough/lung irritation (dose number in series 2). The patient never had nasal drainage at any point while having COVID and had all congestion in her chest. After finishing the non company suspect drug paxlovid treatment, On 02-NOV-2022, after paxlovid treatment the patient started to had an significant amount of nasal drainage. The patient was exhausted the entire time when she had COVID, however the exhaustion was significantly worse after finishing paxlovid (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was drug discontinued on 01-NOV-2022. The patient had not recovered from suspected covid-19 infection and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Catheter placement, Neuralgia, Renal disorder, Thrombosis
Clinical narrative: This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, it was reported that, the patient had been in and out of hospital since and experienced blood clots, unimaginable nerve pain in her legs, she had to have a catheter for the rest of her life and she experienced kidney problems and was hospitalized (date unspecified). The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from kidney problems, and catheter for the rest of life, and the outcome of blood clots and unimaginable nerve pain in legs was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20221134018. Following receipt of additional information from reporter on 11-NOV-2022. It was determined that nullification and deletion was required for Manufacturer Report Number (20221134018) as it was duplicate of Manufacturer Case Number (20221133176). All relevant information regarding Manufacturer Report Number (20221134018) will be submitted under Manufacturer Case Number (20221133176). Sender's Comments: V0: 20221133176-blood clot. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable. 20221133176-kidney problems, unimaginable nerve pain in her legs, catheter for the rest of her life. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Body temperature, COVID-19 immunisation, Illness, Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; LOTS OF BACK PAIN; SICKNESS; PAIN IN BOTH ARMS; FEVER 102F; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 7 decade old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: unknown) dose was not reported, 1 total, dose 1 was administered to right arm on 21-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 64 years old. No concomitant medications were reported. On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced flu like symptoms and fever 102F which lasted for about 5 days (Dose number in series 1). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The patient recovered from flu like symptoms and fever 102F. The patient received non-company suspect covid-19 vaccine (Bivalent booster) (Unspecified manufacturer) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: Unknown), dose and start therapy date were not reported, dose 2 was administered for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). On an unspecified date following vaccination with covid-19 vaccine (Unspecified manufacturer), the patient experienced sickness, lots of back pain and pain in both arms (Dose number in series 2). The outcome of lots of back pain, pain in both arms, revaccination with different covid-19 vaccine and sickness was not reported. The action taken with covid-19 vaccine ad26.cov2.s, and covid-19 vaccine (Unspecified manufacturer) was not applicable. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: FLU LIKE SYMPTOMS; LOTS OF BACK PAIN; SICKNESS; PAIN IN BOTH ARMS; FEVER 102F; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 7 decade old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: unknown) dose was not reported, 1 total, dose 1 was administered to right arm on 21-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 64 years old. No concomitant medications were reported. On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced flu like symptoms and fever 102F which lasted for about 5 days (Dose number in series 1). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The patient recovered from flu like symptoms and fever 102F. The patient received non-company suspect covid-19 vaccine (Bivalent booster) (Unspecified manufacturer) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: Unknown), dose and start therapy date were not reported, dose 2 was administered for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). On an unspecified date following vaccination with covid-19 vaccine (Unspecified manufacturer), the patient experienced sickness, lots of back pain and pain in both arms (Dose number in series 2). The outcome of lots of back pain, pain in both arms, revaccination with different covid-19 vaccine and sickness was not reported. The action taken with covid-19 vaccine ad26.cov2.s, and covid-19 vaccine (Unspecified manufacturer) was not applicable. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had some underlying health conditions. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on AUG-2021 for covid-19 prophylaxis. The patient had no adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on NOV-2021 for covid-19 prophylaxis. The patient had no adverse events following vaccination with second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2022 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug was associated with Off label use. No concomitant medications were reported.  On MAY-2022, the patient experienced off label dosing frequency (dose number in series 3). The patient also stated that protection decreased every month and she want to get another booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.