chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Needle issue, Underdose
Clinical narrative: did not received the full dose/50% of the vaccine remain in the syringe; problem with the fitting of the needle; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KD4D, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 30th June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced accidental underdose and needle issue. On an unknown date, the outcome of the accidental underdose and needle issue were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the pediatric patient did not receive the full dose of Pediarix, due to problem with the fitting of the needle to the pre filled syringe, when administering the dose, 50 percent of the vaccine remained in the syringe, which led to accidental underdose. The reporter consented to follow up. This case has been linked to US2021172418, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021172418:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / 31-October-2021 / has not received / second dose; This case was reported by a consumer 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(0.5ml) received on 31st October 2019, by intramuscular route).   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 reporter was the patient. The age at vaccination was not applicable for this report. Till the time of vaccination the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient had not received her second dose but was planning to. The reporter did not consent to follow up with her MD. The VAERS details were reported for 1st dose of Shingrix
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / 03Jul2020 / has not received a 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd July 2020).   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 vaccination the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Rash papular
Clinical narrative: Rash on her arm at the injection site; Injection site / rash has little bumps; Injection site / rash / is itchy; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 15th August 2021, 2 days after receiving Shingrix, the patient experienced injection site rash, papular rash and injection site itching. On an unknown date, the outcome of the injection site rash, papular rash and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, papular rash and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix in left arm and 2 days after the vaccination the patient experienced rash on her arm at the injection site. The reporter stated that the rash had little bumps and it was itchy. The reporter mentioned that the symptoms were not resolved. The reporter did not consent to follow up. The did not give permission to contact HCP (Health care professional).
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain in the right arm that felt like "a thousand needles"; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date unknown) for prophylaxis.   On 1st August 2021, the patient received the 1st dose of Shingrix. On 8th August 2021, 7 days after receiving Shingrix, the patient experienced pain in arm. On 9th August 2021, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's wife. The patient received the 1st dose of Shingrix in left arm and 7 day after the vaccination the patient experienced pain in right arm. The reporter stated that  the pain felt like a thousand needles. The reporter stated that patient's pain resolved approximately 12 hours later. The reporter stated that the patient did not receive second dose of Shingrix vaccine yet. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first /2018 / 2nd dose until today (received the dose); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 9727R, expiry date 27th January 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2018).   On 16th August 2021, the patient received the 2nd dose of Shingrix. On 16th August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of the vaccine schedule. The reporter consented to follow up via email.
Age: 0.33
Sex: F
Vaccine: RV1, RV1
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: 4 month / received the first dose / April 2021 / second dose has not been administered yet; Rotarix + administration out of recommended; 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 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number ZY5YH, expiry date 7th April 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   In April 2021, the patient received the 1st dose of Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On an unknown date, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. In April 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device and not applicable after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for 2nd dose. The medical assistant reported that a patient of 4 month age received the 1st dose of Rotarix, which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive 2nd dose of Rotarix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 71.0
Sex: M
Vaccine: VARZOS, UNK
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: arm is still killing him / arm pain (at the injection site / it hurts; he raises his arm to shoulder level or above it hurts; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (Reeceived flu vaccine on unknown date), Pneumonia vaccine (Received Pneumonia vaccine on unknown date) and Covid vaccine (Received covid vaccine on unknown date).   On 13th July 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 14th July 2021, 1 days after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were not recovered/not resolved.   The reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient himself. The patient received the dose Flu vaccine,Pneumonia vaccine and Covid vaccine in past. The patient received the 1st dose of Shingrix in the top of the left arm (deltoid) and the day after the vaccination patient had arm pain (at the injection site) The patient stated it had been over a month and his arm was still killing him. The patient stated that the arm pain was not affecting his mobility. The patient stated that he was able to move the arm but he indicated that if he raised his arm to shoulder level or above it hurt. The patient stated that tried treating it with ice and he had tried treating it with heat and the pain would go away for about an hour and a half but then it returns. The patient stated that he would not be receiving Shingrix shot 2. The reporter stated that the injection site pain and pain in arm was related to the Shingrix use. The patient did not have the lot number/expiration date of the vaccine however he did provide the name and address of the pharmacy where it was administered. The reporter consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS, UNK
Symptoms: Injection site pain
Clinical narrative: arm is still killing him / arm pain (at the injection site / it hurts; he raises his arm to shoulder level or above it hurts; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (Reeceived flu vaccine on unknown date), Pneumonia vaccine (Received Pneumonia vaccine on unknown date) and Covid vaccine (Received covid vaccine on unknown date).   On 13th July 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 14th July 2021, 1 days after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were not recovered/not resolved.   The reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient himself. The patient received the dose Flu vaccine,Pneumonia vaccine and Covid vaccine in past. The patient received the 1st dose of Shingrix in the top of the left arm (deltoid) and the day after the vaccination patient had arm pain (at the injection site) The patient stated it had been over a month and his arm was still killing him. The patient stated that the arm pain was not affecting his mobility. The patient stated that he was able to move the arm but he indicated that if he raised his arm to shoulder level or above it hurt. The patient stated that tried treating it with ice and he had tried treating it with heat and the pain would go away for about an hour and a half but then it returns. The patient stated that he would not be receiving Shingrix shot 2. The reporter stated that the injection site pain and pain in arm was related to the Shingrix use. The patient did not have the lot number/expiration date of the vaccine however he did provide the name and address of the pharmacy where it was administered. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: gave only the "diluent"; gave only the "diluent"; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 age at vaccination was not reported. The reporter stated that, nurse gave only the diluent of Shingrix to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter inquired about replacement or credit. The reporter did not have any of the information needed for adverse event.( no pt initials, dob, gender. no date or site of administration, no lot ). The nurse would have pharmacy call back to provide the details. Phone and case number provided.limited information available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose 4 years ago; This case was reported by a pharmacist 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 (1st dose received 4 years ago in 2017 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 age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The Pharmacist stated that, please advise if series needed to be repeated or second dose need to be administered as soon as possible. The reporter stated that, would not able to provide patient information as it was HIPAA related. The reporter consented to follow up via email.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Incomplete course of vaccination
Clinical narrative: Headache; first dose /October 2020 /not gotten second dose; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number D924E, expiry date 8th March 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced headache and incomplete course of vaccination. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided are as follows: The patient received a dose of Shingrix in left arm and had developed a headache fall in 2020. Till the time of reporting, patient did not received 2nd dose Shingrix, which led to incomplete course of vaccination. The reporter was unsure if the headache occurred before or after the vaccine. The reporter consented to follow-up.
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered 20days after the first dose; 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 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.   Concomitant products included Men B NVS (Bexsero).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. Second dose of Bexsero vaccine administered 20 days after the 1st dose instead of 30 days, which led to shortening of vaccination schedule. The reporter asked if there was any potential side effects that patient should be aware of with early dosing. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: received /1st dose / in May 2019; received /1st dose / in May 2019 /2nd dose on 11Aug2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose in May 2019).   On 11th August 2021, the patient received the 2nd dose of Engerix B. On an unknown date, the patient received the 3rd dose of Engerix B. On 11th August 2021, unknown after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.  Additional details provided were as follows: The age at vaccination was not reported for 2nd dose and it was not applicable for 3rd dose of Engerix B. The patient received 2nd dose of Engerix B on 11th August 2021, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination. The pharmacist did not have the patient's initials, date of birth, batch number and expiry date at the time of report. The reporter consented to follow-up.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received a booster dose /before the six month mark; 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 19-month-old male patient who received HAV (Havrix) (batch number 7HJ74, expiry date unknown) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 2nd March 2021).   On 17th August 2021, the patient received the 2nd dose of Havrix. On 17th August 2021, unknown after receiving Havrix, 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 provided were as follows: Health care professional called to report that the patient had received a booster dose of the Havrix vaccine before the six month mark which led to shortening of vaccination schedule. The reporter consented to follow-up by mail.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient missed the 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose on 8th March 2021).   On an unknown date, the patient received the 2nd dose of Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, 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. Pharmacy technician reported that, the patient had received first dose of adult  Engerix B. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The patient missed the second dose The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / over a year ago; This case was reported by a pharmacist 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 (1st dose received over a year ago).   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 detils were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The information was copied and pasted from the chat transcript (as reported). No more information is available. The patient did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles / on a facial nerve; Shortage / not able to get the second; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old 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 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported for 1st dose. The age at the vaccination was not applicable for the 2nd dose. The patient received 1st dose of Shingrix in left deltoid and got shingles last year on facial nerve. Due to shortage at the time the patient was not able to get the 2nd dose till the time of reporting. The patient would like to know if she needed to restart the series or just finish the initial series. The patient stated that she was going to pharmacy today to complete the series. The patient gave medical disclaimer. Limited information was available via consumer for Health care professional. The reporter consented to follow-up.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number K5F5R, expiry date 3rd April 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Boostrix and Boostrix 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 expired dose of Boostrix, which led to expired vaccine administered. The reporter consented to follow up.
Age: 22.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 doses / less than 30 days apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 22-year-old male patient who received Men B NVS (Bexsero) (batch number abxb27aa, expiry date 22nd June 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.   Concomitant products included Men B NVS (Bexsero).   On 16th August 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 16th August 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient had received 2 doses of Bexsero less than 30 days apart, which led to shortening of vaccination schedule. No further events were reported. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Infanrix / by mistake instead of Boostrix; received Infanrix / by mistake; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 16th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Infanrix by mistake instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: pain at the injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2021, the patient received the 1st dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received a dose of Shingrix and experienced pain and redness at injection site and that resolved the next day. The reporter did not provide demographics. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered the reconstituted liquid adjuvant; administered the reconstituted liquid adjuvant; This case was reported by a physician via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The family doctor reported that one medical assistant administered the reconstituted liquid adjuvant of Shingrix to a patient, which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered. No more information was available.  The reporter did not consent nor decline to follow up.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received / a dose / that had expired on 08-Aug-2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number X2XJ7, expiry date 8th August 2021) for prophylaxis.   On 17th August 2021, the patient received Boostrix. On 17th August 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: On 17th August 2021, patient received a dose of Boostrix, which was already expired on 8th August 2021. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: used the wrong solution / mixed vaccine with saline; used the wrong solution / mixed vaccine with saline; This case was reported by a other health professional and described the occurrence of wrong solution used in drug reconstitution in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th August 2021, the patient received Shingrix. On 17th August 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was the Glaxosmithkline vaccine specialist. The reporter called to report adverse event provided by the nurse that, used the wrong solution and administered the vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter stated that, the nurse mixed vaccine with saline instead of provided adjuvant. The health care professional follow up for nurse that administered vaccine to the patient.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 26 year old / received Infanrix; Intended vaccine was Boostrix; 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 26-year-old female patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. The action taken with Infanrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The health care professional reported that the 26 years old patient inadvertently received Infanrix in the right deltoid, which led to inappropriate age at vaccine administration. The Intended vaccine was Boostrix , which led to wrong vaccine administered. The reporter consented to follow up. This is 1 of the 2  linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021173226:Same reporter
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Injection site pain
Clinical narrative: flare-up of Herpes; tender at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex (flare-up of a pre-existing case of Herpes on her lower back).   On 13th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2021, less than a day after receiving Shingrix, the patient experienced injection site tenderness. On 15th August 2021, the patient experienced herpes simplex aggravated. On an unknown date, the outcome of the injection site tenderness and herpes simplex aggravated were not recovered/not resolved.   It was unknown if the reporter considered the injection site tenderness and herpes simplex aggravated to be related to Shingrix.  Additional details provided were as follows: This case was reported by patient himself/herself. The patient received dose of Shingrix in left arm and stated that her arm was tender at the injection site from the day she received the Shingrix. Patient also experienced a flare-up of a pre-existing case of Herpes on her lower back. The patient was referred to health care professional. The patient did not gave permission to contact.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received / first dose on Dic 3rd 2020 / never received second dose; 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 (1st dose received on 3rd December 2020).   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 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   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 detaails were provided as follows: The age at vaccination was not applicable for thie report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter was not sute about 1st dose of Vaccination date, because was at a different pharmacy. The reporter consented to follow up.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   On 16th August 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided are as follows: The patient received Havrix after a temperature excursion (exposed to freezing temperatures at minus 8 degree Celsius for 7 hours and 24 minutes), which led incorrect storage of drug. The reporter consented to follow-up. The case has been linked with case US2021173234, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021173234:Same reporter
Age: 16.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Product storage error
Clinical narrative: temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received HBV (Engerix B) (batch number 5295P, expiry date 27th December 2022) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   On 16th August 2021, the patient received Engerix B and Havrix. On an unknown date, unknown after receiving Engerix B and Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The patient received Havrix and Engerix B after a temperature excursion (exposed to freezing temperatures at minus 8 degree C for 7 hours and 24 minutes, which led to incorrect storage of drug. The reporter consented to follow up by email. The case has been linked with the case US2021173232 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021173232:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose /in 2018 /second one back in June, 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2018).   In June 2021, the patient received the 2nd dose of Shingrix. In June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist wanted to know if they had to give a 3rd dose or restart the series of shingrix for the patient who had received her first dose of the vaccine in 2018 and the second one back in June 2021.  The patient received 2nd dose late than recommended interval, which led lengthening of vaccination schedule. No further events were reported at the time of reporting.  The reporter did not provide any patient demographics nor vaccine information. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo /powder portoin reconstituted with another diluent; Menveo /powder portoin reconstituted with another diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA569A, expiry date unknown) for prophylaxis.   On 17th August 2021, the patient received Menveo. On 17th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, the patient had been given an incorrectly reconstituted dose of Menveo, powder portion reconstituted with another diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The only lot number available was that of the liquid portion AMXA569A. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered / liquid component /without the Lyophilized component; administered / liquid component only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA519A, expiry date 30th April 2022) for prophylaxis.   On 12th August 2021, the patient received Menveo. On 12th August 2021, 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 details were provided as follows: The nurse reported that, they inadvertently administered the menveo, liquid component only to a patient without the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: received Boostrix intravenously by error; received on 2020 a Tdap vaccine (unknown brand)/received Boostrix intravenously by error; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 64-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Dtap vaccine (1st dose received in 2020 (Unknown brand)).   On 18th August 2021, the patient received the 2nd dose of Boostrix (intravenous). On 18th August 2021, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route and drug dose administration interval too short. On an unknown date, the outcome of the intramuscular formulation administered by other route and drug dose administration interval too short were unknown.  Additional details were provided are as follows: The patient received Boostrix intravenously by error which led to intramuscular formulation administered by other route. This was the patient's 2nd Dtap vaccine (Boostrix) earlier than the recommended interval, led to drug dose administration interval too long. No other information were provided. The reporter consented to follow-up via a email.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administered / an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA371A, expiry date 31st July 2021) for prophylaxis.   On 18th August 2021, the patient received Menveo. On 18th August 2021, unknown after receiving Menveo, 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 age at vaccination was not reported. The lab assistant called to report that, nurse from  their facility administered an expired dose of Menveo, which led to expired vaccine used. No data available from patient. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the liquid component / was administered; only the liquid component / was administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva466a, expiry date 31st March 2022) for prophylaxis.   In August 2021, the patient received the 1st dose of Menveo. In August 2021, 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 details were provided as follows: The age at vaccination was not reported. The nurse reported that, only the liquid component of Menveo was administered to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.