chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number unknown, expiry date 31st January 2022) for prophylaxis.   On 1st February 2022, the patient received Menveo. On 1st February 2022, 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 patient received expired dose of Menveo, which led to expired vaccine used. The reporter did not have further information about the patient or the vaccine. The reporter did not consent to follow up.
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: doses less than one month 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 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 MENINGOCOCCAL B VACCINE (BEXSERO).   On 31st January 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 31st January 2022, 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 age at vaccination was not reported. The patient recently received two doses of Bexsero less than one month apart, which led to shortening of vaccination schedule. No other information available. The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Bruxism, Chills, Decreased appetite, Fatigue, Hyperhidrosis
Clinical narrative: developing allergy to food; Fever; Fatigue; Malaise; Chills; Sweats; constant clenching of the jaw; Nausea; Loss of appetite; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old 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 on an unknown date with no adverse event).   On 16th January 2020 14:10, the patient received the 2nd dose of Shingrix. In January 2020, 12 hrs 20 min after receiving Shingrix, the patient experienced fever, fatigue, malaise, chills, sweating, bruxism, nausea, appetite lost and food allergy. On an unknown date, the outcome of the fever, fatigue, malaise, chills, sweating, bruxism, nausea and appetite lost were recovered/resolved and the outcome of the food allergy was not recovered/not resolved.   It was unknown if the reporter considered the fever, fatigue, malaise, chills, sweating, bruxism, nausea, appetite lost and food allergy to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received 2nd dose of Shingrix in right arm. The patient received dose of Shingrix on 16th January 2020 at 2:10pm  and on 17th January 2020 at 2:30am experienced fever of 102.6, fatigue, malaise, chills, sweats, a constant clenching of the jaw, nausea, and loss of appetite. The patient reported that, all of the symptoms began simultaneously and all of these symptoms subsided 3 days later. The patient reported developing an allergy to all food items except corn, rice, and chicken within a week to 10 days of receiving the second dose of Shingrix. The food allergy were ongoing. The patient reported experiencing no side effects after first dose of Shingrix. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: developing allergy to food; Fever; Fatigue; Malaise; Chills; Sweats; constant clenching of the jaw; Nausea; Loss of appetite; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old 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 on an unknown date with no adverse event).   On 16th January 2020 14:10, the patient received the 2nd dose of Shingrix. In January 2020, 12 hrs 20 min after receiving Shingrix, the patient experienced fever, fatigue, malaise, chills, sweating, bruxism, nausea, appetite lost and food allergy. On an unknown date, the outcome of the fever, fatigue, malaise, chills, sweating, bruxism, nausea and appetite lost were recovered/resolved and the outcome of the food allergy was not recovered/not resolved.   It was unknown if the reporter considered the fever, fatigue, malaise, chills, sweating, bruxism, nausea, appetite lost and food allergy to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received 2nd dose of Shingrix in right arm. The patient received dose of Shingrix on 16th January 2020 at 2:10pm  and on 17th January 2020 at 2:30am experienced fever of 102.6, fatigue, malaise, chills, sweats, a constant clenching of the jaw, nausea, and loss of appetite. The patient reported that, all of the symptoms began simultaneously and all of these symptoms subsided 3 days later. The patient reported developing an allergy to all food items except corn, rice, and chicken within a week to 10 days of receiving the second dose of Shingrix. The food allergy were ongoing. The patient reported experiencing no side effects after first dose of Shingrix. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Overdose
Clinical narrative: Engerix-B - Pediarix administered on same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old male patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 5th October 2023) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received Engerix B pediatric, Pediarix and Pediarix Pre-Filled Syringe Device. On 2nd February 2022, unknown after receiving Engerix B pediatric, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 reporter was a nurse. The patient received a dose of Engerix B and Pediarix on the same day, which led to overdose of hepatitis B vaccine. Consent to follow up was granted.
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Tenderness around the injection site /Pain around the injection site; Redness around the injection site; Swelling around the injection site; Rash/ rash that ran across the patient's chest; Shortness of breath; This case was reported by a physician via sales rep and described the occurrence of injection site tenderness in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In February 2022, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site tenderness, injection site erythema, injection site swelling, rash and shortness of breath. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site swelling were unknown and the outcome of the rash and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, injection site erythema, injection site swelling, rash and shortness of breath to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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 was the internal Glaxosmithkline representative. The age at vaccination was not reported. The patient received dose of Bexsero and had pain, redness, swelling, and tenderness around the injection site. The patient had rash that ran across the patient's chest and was experiencing shortness of breath. The reporter stated that, on the day of reporting, the patient came into the doctor's office for follow up the rash and shortness of breath have resolved. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast tenderness, Immediate post-injection reaction, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Itch at injection site; Pain at injection site; scabbing at injection site, 10 areas; breast tenderness; Post menopause period; Swelling at injection site; nodule at injection site; This case was reported by a dentist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site scab and breast tenderness. On 19th November 2021, the patient experienced injection site pain. On 3rd December 2021, the patient experienced postmenopausal syndrome. On an unknown date, the patient experienced injection site nodule and injection site itching. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site nodule, injection site itching, injection site scab and postmenopausal syndrome were recovered/resolved and the outcome of the breast tenderness was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site nodule, injection site itching, injection site scab, postmenopausal syndrome and breast tenderness to be related to Shingrix.  Additional details were provided as follows: The case was reported by dentist herself.  The patient, immediately experiencing pain at the injection site, that subsided after a couple of days and experienced swelling at the injection site a couple of days after receiving first dose of Shingrix and swelling gradually got bigger and lasted approximately two weeks.  She had nodule at injection site and nodule persists for approximately two weeks and had a consistent itch for the duration of that time.  The patient reported the nodule was painful if slept on.  She experienced scabbing at the injection site approximately 12-14 days after receiving first dose of Shingrix.  The patient informed that there were approximately 10 scabbed areas around the injection site and scabbing persisted for 4-5 days, possibly longer.  She got a period on 3rd December 2021 , despite being post menopausal before receiving first dose of Shingrix.  The patient's period lasted 5 days and experienced breast tenderness a week prior to onset of period, reported having not had another period, since this occurrence. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site scab, Injection site swelling, Menopausal symptoms
Clinical narrative: Itch at injection site; Pain at injection site; scabbing at injection site, 10 areas; breast tenderness; Post menopause period; Swelling at injection site; nodule at injection site; This case was reported by a dentist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site scab and breast tenderness. On 19th November 2021, the patient experienced injection site pain. On 3rd December 2021, the patient experienced postmenopausal syndrome. On an unknown date, the patient experienced injection site nodule and injection site itching. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site nodule, injection site itching, injection site scab and postmenopausal syndrome were recovered/resolved and the outcome of the breast tenderness was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site nodule, injection site itching, injection site scab, postmenopausal syndrome and breast tenderness to be related to Shingrix.  Additional details were provided as follows: The case was reported by dentist herself.  The patient, immediately experiencing pain at the injection site, that subsided after a couple of days and experienced swelling at the injection site a couple of days after receiving first dose of Shingrix and swelling gradually got bigger and lasted approximately two weeks.  She had nodule at injection site and nodule persists for approximately two weeks and had a consistent itch for the duration of that time.  The patient reported the nodule was painful if slept on.  She experienced scabbing at the injection site approximately 12-14 days after receiving first dose of Shingrix.  The patient informed that there were approximately 10 scabbed areas around the injection site and scabbing persisted for 4-5 days, possibly longer.  She got a period on 3rd December 2021 , despite being post menopausal before receiving first dose of Shingrix.  The patient's period lasted 5 days and experienced breast tenderness a week prior to onset of period, reported having not had another period, since this occurrence. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired dose administrated; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, 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 2nd February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd 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 reported as follows: On 2nd February 2022,the patient received a vaccine which was already expired on 31st January 2022, which led to expired vaccine used. Consent to follow up was denied.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: expired dose planned to be given; expired dose planned to be given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 3rd February 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced expired vaccine used and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the expired vaccine used and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The case was reported by the registered nurse. The age at vaccination was not applicable for this report. The reporter wanted to administer Shingrix and realised that the dose had expired. The reporter wanted to know for how long would the vaccine be good after expiration date. On 4th February 2022, Shingrix was planned to be given, which led to expired vaccine used and circumstance or information capable of leading to medication error. No demographic details or lot number of Shingrix was given. The reporter did not consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Facial swelling; This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11th May 2023) for prophylaxis.   On 4th February 2022, the patient received Shingrix. On 4th February 2022, 15 min after receiving Shingrix, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional information was provided as follows: The reporter was a Doctor of Pharmacy. The patient received Shingrix about fifteen minutes prior to the reporting call and experienced facial swelling at the time of reporting.  Outside phone number was given for future reference and warm transfer provided. The reporter consent to follow up.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric dose to an adult; Pediatric Engerix administered to an adult; This case was reported by a physician via call center representative and described the occurrence of underdose in a 34-year-old male patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B with an associated reaction of therapy non-responder (received 1st series on an unknown date and the patient did not respond to first series, refer case US2022AMR022533) and Engerix B (received 1st two doses of Engerix B of second series on an unknown date).   On 4th February 2022, the patient received the 3rd dose of Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 4th February 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR022533  Additional details were provided as follows: Medical doctor stated that a pediatric dose of Engerix B was administered to an adult patient, which led to underdose and adult use of a child product. The reporter stated that this was 3rd dose of second series due to which patient repeating the whole series because patient did not respond to first series. The reporter wanted to know how to proceed with Engerix B series. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR022533:Same patient, different series
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Inadvertently administered expired dose to a patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (batch number KG4M7, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made 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 reported by the Nurse supervisor. The reporter stated that, they inadvertently administered an expired Infanrix dose to a patient, which led to expired vaccine used. The reporter asked if the efficacy of vaccine was still good. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on November 12 2019/second dose on November 22 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 12th November 2019).   On 22nd November 2021, the patient received the 2nd dose of Shingrix. On 22nd November 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 patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. No demographics details were collected. The reporter did not consent to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Experienced greater head pain; This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles a year ago on 6th January 2021, which left her with nerve pain on the left side of her head), nerve pain (on the left side of her head) and headache. Concomitant products included pregabalin.   On 1st February 2022, the patient received the 1st dose of Shingrix. On 2nd February 2022, 1 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced greater head pain than she had previously. This head pain was unresolved. No further information reported. The reporter consented to follow-up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: pain at injection site; aches; fatigue; fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2022, the patient received the 1st dose of Shingrix. On 6th February 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, pain, fatigue and fever. On an unknown date, the outcome of the injection site pain, pain, fatigue and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, pain, fatigue and fever to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in upper left non-dominant arm and experienced pain at injection site, aches, fatigue, fever. The symptoms were still ongoing. The reporter consented to follow-up and obtained consent to contact consumer and health care professional.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2018, no second dose yet; 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 (received 1st dose in 2018).   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. No further details were provided. The consent to follow up was denied.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of only the liquid component; Administration of only the liquid component; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 7th February 2022, the patient received Menveo. On 7th February 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was inadvertently administrated only the liquid component of (MenCWY) of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No patients identifiers were provided.  No lot number or expiration date was provided. The Vaccine administration facility was the same as Primary reporter. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on Nov2018, no 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 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2018).   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. Details were reported for the 1st dose. No further events were reported. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (batch number kg4m7, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient was administrated with an expired dose of Infanrix, which led to expired vaccine used.  No adverse event was reported. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Dose administration; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received HBV (Engerix B) (batch number MN7XR, expiry date 18th January 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 7th February 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 7th 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 case was reported by the Medical assistant. The reporter stated that, the patient received an expired dose of Engerix B, which led to expired vaccine used. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 15 months old patient; 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 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number T24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 17th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported a kinrix maladministration as a 15 months old patient was administered with the vaccine, which led to inappropriate age at vaccine administration. The Prescribing information described that Kinrix was approved for patients between 4 to 6 years old. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles 10 days after 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included kidney transplant. Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included immunosuppression.   On 24th January 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd February 2022, 10 days after receiving Shingrix, the patient experienced shingles. The patient was treated with mycophenolic acid (Mycophenolate) and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her second Shingrix dose on her arm and ten days later she developed shingles. The patient was treating the shingles with Valtrex 1 gram daily. The reporter consented to follow up with her and her physician.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles 10 days after 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included kidney transplant. Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included immunosuppression.   On 24th January 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd February 2022, 10 days after receiving Shingrix, the patient experienced shingles. The patient was treated with mycophenolic acid (Mycophenolate) and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her second Shingrix dose on her arm and ten days later she developed shingles. The patient was treating the shingles with Valtrex 1 gram daily. The reporter consented to follow up with her and her physician.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: dose activated one day before administered; 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 Herpes zoster (Shingrix) (batch number Y537X, expiry date 19th May 2023) for prophylaxis.   On 8th February 2022, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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 age at vaccination was not reported. The patient received a Shingrix dose, activated one day before it was administered, which led to incorrect storage of drug. The reporter consented to follow up.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration to an underage patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made 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 Kinrix at the age of 3 years, which led to inappropriate age at vaccine administration. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in November 2019 but not 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   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 vaccination schedule. The reporter inquired, if the patient should restart the series. No additional patient or vaccine information was provided by the healthcare professional.  Follow up left blank as this was a webform request.  No address provided but email address was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never 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 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, one and half year ago from the date 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 age at vaccination was not applicable for this report. The patient received first dose at a different pharmacy, so pharmacist did not have exact date of dose, or lot number or expiration date of 1st dose.   Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 26 days between doses; 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 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th March 2021, the patient received the 2nd dose of Shingrix. On 29th March 2021, 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 not reported. The patient received 2nd dose of Shingrix, earlier than the recommended schedule, which led to shortening of vaccination schedule. No further events were reported.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administrated an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 42-year-old female patient who received HAV (Havrix) (batch number e9g4e, expiry date 29th December 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th February 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 8th February 2022, unknown after receiving Havrix and an unknown time after starting Havrix 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient inadvertently received a dose of expired Havrix, which led to expired vaccine used.  No further events were reported-  The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administration of 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 1-year-old female patient who received HAV (Havrix) (batch number y4fl4, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 1st February 2022, unknown after receiving Havrix and Havrix 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: An expired dose of Havrix was inadvertently administered to the patient, which led to expired vaccine used.  No further events were reported.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter. This case had been linked with case US2022022661, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022022661:Same reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: NIGHT SWEATS; This spontaneous report received from a patient concerned a 6 decade old female. The patient's height, and weight were not reported. The patient's past medical history included: blood clot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: 07-SEP-2021) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, APR-2021, the patient experienced night sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of night sweats was not reported. This report was non-serious. This case, involving the same patient is linked to 20220200457.
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a 68 year old male. Initial information was processed along with additional information received on 07-FEB-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: leukemia. The patient received ibrutinib (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for leukemia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient not able to develop antibodies to covid 19 vaccine after receiving Imbruvica for leukemia. (suspected immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s, and ibrutinib was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000216156; Sender's Comments: V0.20220211225-covid-19 vaccine ad26.cov2.s -Suspected immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY, SPECIAL SITUATIONS  20220211225-Ibrutinib-Suspected immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Chest pain, Insomnia
Clinical narrative: COULD NOT SLEEP; CHEST PAIN THAT WAS SORE BUT WAS MORE CENTRALIZED IN HEART MUSCLES; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure (under control), alcohol use (very little and rarely), and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 203A21A) dose was not reported, 1 total, administered on 06-JUL-2021 at left arm for prophylactic vaccination. The patient did not experience any adverse event after the first dose and reported that he was fine (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D214, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 28-JAN-2022 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 29-JAN-2022, next day after receiving the booster shot patient went to the gym and run on a treadmill with no shortness of breath, then he went into the locker room and felt a chest pain, patient described it like angina pain squeezing his heart. Patient drank water and reported that it got better. On 30-JAN-2022, patient experienced chest pain that was sore but was more centralized in heart muscles. Patient drank water and reported that it got better. On 31-JAN-2022 around 2:00 am patient woke up with chest pain and stated that he could not sleep. He drank water and it helped. On 31-JAN-2022, all the symptoms resolved and patient has been to the gym since then and stated that it has not happened again. Patient reported that he has not consulted his primary care physician (Dose number in series 2). Laboratory data (dates unspecified) included: Cholesterol (NR: not provided) fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain that was sore but was more centralized in heart muscles, and could not sleep on 31-JAN-2022. This report was non-serious. Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.