chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs reported; Administration of vaccines involved in a tempertature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 16-FEB-2022, the patient was vaccinated with one dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) which experienced a temperature excursion (lot # U024090 with an expiration date on 28-OCT-2023) for prophylaxis (product storage error) (strength, anatomical location, and route of administration were not reported).    The dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was exposed to a temperature excursion of 1.35°C degrees Celsius (°C) during a time frame of 1 hour.  No additional adverse events were reported.
Sex: U
Vaccine: HIBV, HIBV
Symptoms: Product storage error
Clinical narrative: No additional AEs reported; Administration of vaccines involved in a tempertature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 16-FEB-2022, the patient was vaccinated with one dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) which experienced a temperature excursion (lot # U024090 with an expiration date on 28-OCT-2023) for prophylaxis (product storage error) (strength, anatomical location, and route of administration were not reported).    The dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was exposed to a temperature excursion of 1.35°C degrees Celsius (°C) during a time frame of 1 hour.  No additional adverse events were reported.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pneumonia vaccine administered yearly; This spontaneous report as received from a lawyer refers to currently 79-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapy were captured in case # 1708USA004755.      On unknown dates (reported as "yearly"), the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported) (Inappropriate schedule of product administration).  This is one of 2 reports concerning the same patient.; Sender's Comments:  US-009507513-1708USA004755:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Skin burning sensation, Skin discomfort
Clinical narrative: burning; pain; trouble below the skin; This case was reported by a consumer via interactive digital media and described the occurrence of burning skin in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced burning skin, pain and skin discomfort. On an unknown date, the outcome of the burning skin, pain and skin discomfort were recovered/resolved.   It was unknown if the reporter considered the burning skin, pain and skin discomfort to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, after vaccination with Shingles shot had trouble below the skin at times, burning and pain. GSk note- since the narrative was not clear if the events occurred after single dose or after each dose, only one case processed for both doses.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR029148:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Illness, Pain in extremity
Clinical narrative: Very sore arm; Very sore shoulder; severe headache; sick in bed; 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 an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, shoulder pain, headache and sickness. On an unknown date, the outcome of the pain in arm, shoulder pain, headache and sickness were unknown.   It was unknown if the reporter considered the pain in arm, shoulder pain, headache and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient had very sore arm and shoulder, severe headache, was sick in bed for several days after 1st dose of Shingles vaccine. The patient would not receive 2nd dose of Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Night sweats, Pyrexia
Clinical narrative: High fevers 3 days after the shot; Also headaches; Muscle aches; Chills; Night sweats; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced fever, headache, muscle pain, chills and night sweat. On an unknown date, the outcome of the fever, headache, muscle pain, chills and night sweat were unknown.   The reporter considered the fever, headache, muscle pain, chills and night sweat to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient. The age at vaccination was not reported. The reporter asked was high fever 3 days after Shingrix was normal. On an unknown date, at an unknown time after receiving Shingrix, the patient also had headaches, muscle aches, chills and night sweats. The reporter stated that the vaccine was brutal.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Formication, Gait disturbance
Clinical narrative: I can barely walk / been mostly crawling on all fours; weakness; been mostly crawling on all fours; This case was reported by a consumer via call center representative and described the occurrence of walking difficulty in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2021, the patient received Shingrix. In February 2021, less than a month after receiving Shingrix, the patient experienced walking difficulty, weakness and crawling sensation. On an unknown date, the outcome of the walking difficulty, weakness and crawling sensation were unknown.   It was unknown if the reporter considered the walking difficulty, weakness and crawling sensation to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received Shingrix vaccine in an unknown arm. The patient could barely walk from taking the vaccine back in February. The patient stated that, had been mostly crawling on all fours since February. The patient had weakness and no tingling. The patient asked to refer primary care physician.
Sex: U
Vaccine: VARZOS
Symptoms: Gait disturbance
Clinical narrative: can barely walk; This case was reported by a consumer via interactive digital media and described the occurrence of walking difficulty in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received Shingrix. In February 2022, less than 3 weeks after receiving Shingrix, the patient experienced walking difficulty. On an unknown date, the outcome of the walking difficulty was not recovered/not resolved.   It was unknown if the reporter considered the walking difficulty to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that he or she could barely walk from taking the vaccine back in February now what he or she could do to walk right again.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive her second dose; This case was reported by a consumer via other manufacturer 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 on an unknown date).   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 details were provided as follows: the patient self reported the case. The age at vaccination was not applicable for this report. The reporter stated that, till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule, and had seen commercials, which mentioned getting a 2nd dose within 6 months of the first.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the vaccine,  only had one mild case/suspected vaccination failure; mild case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles several times around right eye) and ophthalmic herpes zoster (had shingles several times on right eye).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown 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 details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient had shingles several times around and on his/her right eye.  The patient got the Shingles vaccine and had only one mild case since. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelled up; Arm still hurts; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm 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 swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm was unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that, he/she got the shingles vaccine and his/her arm still hurt. The patient further added, his/her arm swelled up and was kind of scared to get the 2nd one then. The follow-up would not be possible as no contact details were available.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles rash on the calf of leg and  ankle/ still got shingles after receiving the; Shingles rash on the calf of leg and  ankle; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.    Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was the reporting physician assistant's wife. The reporter thought the patient was 64 years old at time of vaccination. The patient received the Shingrix vaccine series (both doses) years ago (no specific date) and still got shingles after receiving the vaccine (did not know the timeline). The patient had shingles rash on the calf of one leg and on the ankle of the other leg. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided. The reporter did not want to be contacted at the time of reporting, but said that, the patient might want to be contacted, so the reporter would speak to the patient.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administration of expired vaccine; This case was reported by a other health professional and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number unknown, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th February 2022, unknown after receiving Kinrix and Kinrix 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 details were provided as follows: The patient received an expired dose of Kinrix, which led to expired vaccine used. No reactions were noted.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; 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, unknown after receiving Shingles vaccine, the patient experienced suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.                                        The age at vaccination was not reported. The patient received the shingles vaccine and had a case of shingles which was worst the doctor had seen. The patient did not have faith in vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles often even got the shot/Suspected vaccination failure; shingles in scalp, jaw, chest and groin; very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.  The age at vaccination was not reported. The patient got the Shingle shot and often got shingles. The patient reported that his/her shingles attack on scalp, jaw, chest and groin and it was very painful. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertedley administrated an expired dose of the vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received HBV (Engerix B) (batch number 9p9b5, expiry date 7th February 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 14th February 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 14th February 2022, unknown after receiving Engerix B and Engerix B 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 details were provided as follows: The reporter stated that, the patient was inadvertedley administrated an expired dose of the vaccine, which led to expired vaccine used. No further events were reported. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up. Note: The vaccination date in the structured field was reported as 4th March 2022 (future date), however was captured as 14th February 2022 as per the narrative.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered vaccine that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 16th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reportd by the Medical assistant. The patient was administered with Bexsero prefilled syringe and the reporter then noticed the vaccine had expired, which led to expired vaccine used. The reporter failed to ask if it was dose 1 or dose 2 and also failed to ask if the dose was given intramuscularly.  The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 doses with a 6 weeks interval; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number y4la9, expiry date 25th May 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 15th February 2022, the patient received the 2nd dose of Shingrix. On 15th February 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was unknown. On 4th January 2022, the patient received 1st dose of Shingrix. The patient received the 2nd dose of Shingrix earlier than the recommended schedule with a 6 weeks interval, which led to shortening of vaccination schedule. No further events were reported. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: one dose in january 2021; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in Jan-2021, not yet been given second; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd January 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 details were provided as follows: The case was reported by the Nurse assistant. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of the Shingrix vaccine two years ago; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago from the day of reporting).   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 details were provided as follows: The case was reported by patient's wife. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter was inquiring if the patient should restart the series.  Provided medical advice disclaimer. Spoke from product information and content, was referred to Healthcare professional. No additional details were provided by the reporter. The reporter consented to follow up. The reporter provided permission to contact Healthcare professional.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received a dose of BEXSERO that expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 16th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case is reported by the Practice manager. The reporter stated that, a patient received a dose of Bexsero that was expired, which led to expired vaccine used. The mother of the patient was notified. The lot number was not available at this time. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: is late for the second of Shingrix / Only the first dose was administrated; This case was reported by a pharmacist 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 with an associated reaction of no adverse event (received 1st dose in 2019, Batch number- 44xx4 and expiry date- 27th May 2023 ).   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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. VAERS details were reported for 1st dose. The patient's identifiers and vaccination date were not provided. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: third dose of Shingrix by mistake; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date).   On 17th February 2022, the patient received the 3rd dose of Shingrix. On 17th February 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 3rd dose of Shingrix by mistake, which led to extra dose administered.   The reporter asked if the patient had anything particular to be concerned about. The reporter disconnected after call center representative asked for credentials.  No additional information was available. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Administered expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number n99p3, expiry date 19th October 2021) and (adjuvant batch number unknown, expiry date 28th February 2022) for prophylaxis.   On 17th February 2022, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 17th February 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received an expired dose of Shingrix, which led to expired vaccine used. The reporter consented to follow up. This case had been linked with case US2022029589, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022029589:Same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number n99p3, expiry date 19th October 2021) and (adjuvant batch number unknown, expiry date 28th February 2022) for prophylaxis.   On 17th February 2022, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 17th February 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received an expired dose of Shingrix, which led to expired vaccine used. The reporter consented to follow up. This case had been linked with case US2022029587, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022029587:Same reporter.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 41-year-old female patient who received HBV (Engerix B) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   On 14th February 2022, the patient received Engerix B. On 14th February 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received an expired dose of Engerix B, which led to expired vaccine used. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: Occupational exposure to product via eye; Occupational exposure to product via eye; This case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while administering product in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA689A, expiry date 31st October 2022) for prophylaxis.   On 17th February 2022, the patient received Menveo. On 17th February 2022, unknown after receiving Menveo, the patient experienced occupational exposure while administering product and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while administering product and exposure via eye contact were unknown.  Additional details were provided as follows: Medical assistant reporting an occupational exposure to Menveo to the patient, which led to occupational exposure while administering product.  The vaccine splashed into the patient's eye, which led to exposure via eye contact. Healthcare professional gave permission for safety team to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: 3 doses of Havrix and one of Non-GSK HepA Vx; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 5-year-old male patient who received HAV (Havrix pediatric) (batch number X34HF, expiry date 10th December 2020) for prophylaxis.   Previously administered products included Havrix pediatric (received 1st dose on an unknown date, batch number ZK374, expiry date 19th March 2020) and Havrix pediatric (received booster dose on an unknown date, batch number 3KT7B, expiry date 10th December 2020).   On an unknown date, the patient received Havrix pediatric. On an unknown date, unknown after receiving Havrix pediatric, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 3 doses of Havrix which led to extra dose administered. The patient also received one dose of another manufacturer's Hepatitis A vaccine, which led to extra dose administered.   The reporter stated 4 vaccines were given over 4-years period. The reporter requested to speak to Medical Information for advice.   The reporter consented to follow up. Note- As it was unknown which dose was received in 2018, hence not captured for any dose.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: administered three doses; first in OCT-2019, second in NOV-2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number DP2D3, expiry date 25th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 03rd October 2019).   On 3rd November 2021, the patient received the 2nd dose of Shingrix. On 17th February 2022, the patient received the 3rd dose of Shingrix. On 3rd November 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On 17th February 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient also received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered a dose that was not reconstituted; administered a dose that was not reconstituted; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number of the accompanying lyophilized portion that was not administered was FS52T, expiry date 11th June 2023) for prophylaxis.   On 16th February 2022, the patient received the 1st dose of Shingrix. On 16th February 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 details were provided as follows: The patient inadvertently administered a dose of Shingrix that was not reconstituted, so the patient only received the AS01B adjuvant portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.   The vaccine was administered by a physician.   Reporter did not have the lot number of adjuvant portion.   At the time of reporting, the patient had not been re dosed. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered AS01B Adjuvant; administered AS01B Adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 52LX4, expiry date 4th April 2023) for prophylaxis.   On 10th February 2022, the patient received the 2nd dose of Shingrix. On 10th February 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 details were provided as follows: The patient received AS01B adjuvant of Shingrix without the lyophilized antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Erythema, Feeling abnormal, Hypoaesthesia
Clinical narrative: SWOLLEN, PAINFUL FEET; RED PATCHES OVER MY BODY; LOOKS LIKE VARICOSE VEINS IN FEET; LEGS FEEL STRANGE FROM KNEES DOWN; CAN NOT SLEEP LONG AT A TIME; FEEL LIKE HELL; CAN NOT STAND ON FEET BUT A FEW MINUTES AT A TIME; CAN NOT DO HOUSEWORK; SLEEPY ALL DAY LONG; PANICKED; BUTT GOES TO SLEEP; WEAK; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no family history of varicose veins. The patient was previously treated with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. 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 swollen, painful feet, red patches over my body, looks like varicose veins in feet, legs feel strange from knees down, can not sleep long at a time, feel like hell, can not stand on feet but a few minutes at a time, can not do housework, sleepy all day long, panicked, butt goes to sleep, and weak (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen, painful feet, red patches over my body, looks like varicose veins in feet, legs feel strange from knees down, can not sleep long at a time, feel like hell, weak, can not stand on feet but a few minutes at a time, can not do housework, sleepy all day long, panicked and butt goes to sleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Impaired work ability, Insomnia, Panic attack, Peripheral swelling, Sensory disturbance
Clinical narrative: SWOLLEN, PAINFUL FEET; RED PATCHES OVER MY BODY; LOOKS LIKE VARICOSE VEINS IN FEET; LEGS FEEL STRANGE FROM KNEES DOWN; CAN NOT SLEEP LONG AT A TIME; FEEL LIKE HELL; CAN NOT STAND ON FEET BUT A FEW MINUTES AT A TIME; CAN NOT DO HOUSEWORK; SLEEPY ALL DAY LONG; PANICKED; BUTT GOES TO SLEEP; WEAK; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no family history of varicose veins. The patient was previously treated with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. 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 swollen, painful feet, red patches over my body, looks like varicose veins in feet, legs feel strange from knees down, can not sleep long at a time, feel like hell, can not stand on feet but a few minutes at a time, can not do housework, sleepy all day long, panicked, butt goes to sleep, and weak (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen, painful feet, red patches over my body, looks like varicose veins in feet, legs feel strange from knees down, can not sleep long at a time, feel like hell, weak, can not stand on feet but a few minutes at a time, can not do housework, sleepy all day long, panicked and butt goes to sleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence, Varicose vein
Clinical narrative: SWOLLEN, PAINFUL FEET; RED PATCHES OVER MY BODY; LOOKS LIKE VARICOSE VEINS IN FEET; LEGS FEEL STRANGE FROM KNEES DOWN; CAN NOT SLEEP LONG AT A TIME; FEEL LIKE HELL; CAN NOT STAND ON FEET BUT A FEW MINUTES AT A TIME; CAN NOT DO HOUSEWORK; SLEEPY ALL DAY LONG; PANICKED; BUTT GOES TO SLEEP; WEAK; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no family history of varicose veins. The patient was previously treated with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. 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 swollen, painful feet, red patches over my body, looks like varicose veins in feet, legs feel strange from knees down, can not sleep long at a time, feel like hell, can not stand on feet but a few minutes at a time, can not do housework, sleepy all day long, panicked, butt goes to sleep, and weak (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen, painful feet, red patches over my body, looks like varicose veins in feet, legs feel strange from knees down, can not sleep long at a time, feel like hell, weak, can not stand on feet but a few minutes at a time, can not do housework, sleepy all day long, panicked and butt goes to sleep was not reported. This report was non-serious.