chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Pain, Pain in extremity
Clinical narrative: Tired; Waves feeling sick to her stomach; Lots of pain; Lots of pain including fingers; This case was reported by a consumer via sales rep and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) unknown for pain and pain in fingers.   On 22nd July 2022, the patient received the 1st dose of Shingrix. In July 2022, the patient started Tylenol at an unknown dose and frequency. On 23rd July 2022, 1 days after receiving Shingrix, the patient experienced pain and pain in fingers. On 25th July 2022, the patient experienced tiredness and upset stomach. The action taken with Tylenol was unknown. On an unknown date, the outcome of the pain, pain in fingers, tiredness and upset stomach were unknown.   It was unknown if the reporter considered the pain, pain in fingers, tiredness and upset stomach to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments: The patient was in lots of pain including fingers.   3 days after receiving Shingrix, the patient was tired and in waves feeling sick to her stomach.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: It kicked my butt; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (started from 5th January 2022).   On 19th July 2022, the patient received the 2nd dose of Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     Additional Information: GSK receipt date: 23-JUL-2022 Reporter's comments: This case was reported by consumer via interactive digital media. The patient had shingles on face starting from 5th January 2022 that went into right eye.  The patient had 10 visits to eye doctor and patient's vision was still not 100 percent as the time of reporting.  Got second dose of Shingrix this past Tuesday (from date of reporting) and it was reported that it kicked patient's butt as bad as it was. The patient could not take a chance on facial shingles again. The follow up would not be possible as contact details were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swollen at the injection site; arm was very sore; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient got the Shingles vaccine shot and her arm was very sore and swollen at the injection site for about a week. However, it was nothing compared to the shingles that her husband was suffering with for 5 weeks so far.  Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: two doses before adequate time elapses; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA653A, expiry date 28th February 2023) for prophylaxis.   In July 2022, the patient received the 2nd dose of Menveo. In July 2022, unknown after receiving Menveo, 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 Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The nurse reported that two patients received early second dose with unknown details, while only one patient had an incorrectly reconstituted dose administered. 3 patients were vaccinated with the same lot so the reporter was asking what happened if a patient receive two complete doses of Menveo .  All patients were vaccinated on July 2022. No more information regarding patients were available at the moment, clarified by both agent and the reporter. The reporter consented to follow up. The case is for 1 of 3 linked patients, reported by same reporter. Additional supportive information: The patient received second dose earlier than the recommended interval, which led shortening of vaccine schedule.; Sender's Comments:  US-GSK-US2022111770:Same reporter US-GSK-US2022AMR112790:Same reporter
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: two doses before adequate time elapses; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA653A, expiry date 28th February 2023) for prophylaxis.   In July 2022, the patient received the 2nd dose of Menveo. In July 2022, unknown after receiving Menveo, 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 Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The nurse reported that two patients received early second dose with unknown details, while only one patient had an incorrectly reconstituted dose administered. 3 patients were vaccinated with the same lot so the reporter was asking what happened if a patient receive two complete doses of Menveo .  All patients were vaccinated on July 2022. The reporter consented to follow up. The case is for 1 of 3 linked patients, reported by same reporter. Additional supportive information: The patient received second dose earlier than the recommended interval, which led shortening of vaccine schedule.; Sender's Comments:  US-GSK-US2022AMR112789:Same reporter US-GSK-US2022111770:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: large red circle on arm; This case was reported by a consumer via interactive digital media and described the occurrence of localized erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received Shingles vaccine. In July 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was not recovered/not resolved.   It was unknown if the reporter considered the localized erythema to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-JUL-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient had the Shingles vaccine 2 weeks ago from the date of reporting and still had a large red circle on him/her arm. The follow up would not possible since contact details not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: forgot to take 2nd shot/ more than 6 months; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 29-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient received 1st Shingrix shot and forgot to went back for the 2nd one. The patient asked that he/she did need to start over or could take the 2nd even though it had been more than 6 months. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd shot of Shignrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Induration
Clinical narrative: Heat; Hardness; This case was reported by a consumer via interactive digital media and described the occurrence of feeling hot in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling hot and induration. On an unknown date, the outcome of the feeling hot and induration were not recovered/not resolved.   It was unknown if the reporter considered the feeling hot and induration to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-JUL-2022. Reporter's Comments: The case was reported by the patient via interactive digital media. The patient had heat and hardness. The patient wanted to know if he or she can do anything to relieve heat and hardness. The follow-up could not be possible as no contact details were available
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo mixed with sterile diluent; Menveo with sterile diluent administered; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Jul-2022 Reporter's comment: The nurse reported that one of them gave Menveo to a patient but it was mixed with sterile diluent instead of the Menveo diluent. Additional supportive information: The patient received Menveo which was mixed with sterile diluent instead of the Menveo diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Night sweats, Pain, Peripheral swelling
Clinical narrative: Arm was still Swollen; Arm was still red; Arm still warm; Pain; Chills; Sweats every night; Pain threshold went down; Nausea; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced swelling arm, erythema, skin warm, pain, chills, night sweat, pain threshold decreased and nausea. On an unknown date, the outcome of the swelling arm, erythema, skin warm and night sweat were not recovered/not resolved and the outcome of the pain and pain threshold decreased were recovering/resolving and the outcome of the chills and nausea were unknown.   It was unknown if the reporter considered the swelling arm, erythema, skin warm, pain, chills, night sweat, pain threshold decreased and nausea to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-Jul-2022 Reporter comment: This case was reported by a patient via interactive digital media. The patient received the first dose of Shingrix and after 3 days patient experienced arm swollen, red and warm. At the first night, patient experienced horrible with the pain, chills, Nausea and sweats. The patient had sweats every night so far.  The patient's pain threshold had decreased. Additional Supportive Information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Arm was still Swollen; Arm was still red; Arm still warm; Pain; Chills; Sweats every night; Pain threshold went down; Nausea; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced swelling arm, erythema, skin warm, pain, chills, night sweat, pain threshold decreased and nausea. On an unknown date, the outcome of the swelling arm, erythema, skin warm and night sweat were not recovered/not resolved and the outcome of the pain and pain threshold decreased were recovering/resolving and the outcome of the chills and nausea were unknown.   It was unknown if the reporter considered the swelling arm, erythema, skin warm, pain, chills, night sweat, pain threshold decreased and nausea to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-Jul-2022 Reporter comment: This case was reported by a patient via interactive digital media. The patient received the first dose of Shingrix and after 3 days patient experienced arm swollen, red and warm. At the first night, patient experienced horrible with the pain, chills, Nausea and sweats. The patient had sweats every night so far.  The patient's pain threshold had decreased. Additional Supportive Information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site indentation, Injection site warmth
Clinical narrative: injection site is warm; injection site is a hard bump; This case was reported by a consumer via interactive digital media and described the occurrence of injection site warmth in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site warmth and injection site induration. On an unknown date, the outcome of the injection site warmth and injection site induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth and injection site induration to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JUL-2022 Reporter's Comments:  This case was received from patient via interactive digital media. The patient received Shingrix and his/her injection site was a hard bump and warm. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site pain
Clinical narrative: pain at the shot side, gotten worst since first noticed; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 63-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, between 1 and 2 months after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-JUL-2022. Reporter's Comments: The case was reported by the consumer via interactive digital media. The patient had first shot about 2 months ago.  The patient was currently in traveling and was started to had pain at the shot side. It had gotten worst since patient first noticed few days ago. Patient wanted to know was it normal. The follow-up could not be possible as no contact details were available
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Interchange of vaccine products
Clinical narrative: Pediarix dose was 4th dose of hep b/ Interchangeability Pentacel and Pediarix; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a male patient who received DTPa-HBV-IPV (Pediarix) (batch number 47cx9, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Pentacel for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and Pentacel at an unknown dose and frequency. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: Nurse had a male patient that received Pediarix as a 5th dose after 4 doses of Pentacel.  This Pediarix dose was the patient's 5th dose of dtap and ipv and 4th dose of hep b. The reporter consented to follow up. Additional Supportive Information: The patient was administered with Pediarix vaccine after Pentacel, which led to interchange of vaccine products.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only diluent portion of Menveo used; Only diluent  administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA721A, expiry date 20th October 2023) and (batch number AMAA721A, expiry date 20th August 2023) for prophylaxis.   On 27th July 2022, the patient received Menveo. On an unknown date, the dose was an unknown dose. On 27th July 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The medical assistant administered only the diluent portion of Menveo on the day of reporting. The adverse event contained all the reported information as per the health care professional. The reporter consented to follow-up. Additional supportive information: The patient was administered with only the diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only Shingrix diluent used; diluent only administered; 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 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 Information: GSK receipt date: 27-Jul-2022 Reporter's comment: A pharmacist reported that several months ago, a patient may have had received just the Shingrix diluent only. The reporter was sure that 2 patients received diluent only but believes this may have happened before since they have 2 extra lyophilized vials. The reporter had no details or information on this 1st patient. The reporter consented to follow-up. This case is for 1 of 2 patients. Additional supportive information: The patient received just the Shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022111741:Same reporter. Patient 2
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only shingrix diluent used; diluent only administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult male 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 Information: GSK receipt date: 27-Jul-2022 Reporter's comment: A pharmacist reported that a patient had received the Shingrix diluent only. The reporter did not had exact date of administration. The reporter consented to follow-up. This case is for 2 of 2 patients. Additional supportive information: The patient received the Shingrix diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022111740:Same reporter. Patient 1
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: had only one vial, administer an incomplete dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The registered nurse supervisor called and asking for a little silicone/ rubber tap/tag that helps them in the reconstitution process of Menveo. This helps the vials to stay attached.  The reporter had one vial missing and did not know if it was because they administer an incomplete dose of Menveo or it was broken and not documented.  As stated before, no more information was available to reporter, only the fact that one of the vials was missing, could not confirm if it was powder or liquid portion. The reporter had no more information that the provided. The reporter consented to follow-up. Additional supportive information: The patient was administered an incomplete dose of Menveo, which led to incomplete dose administered. With reported verbatim,'administer an incomplete dose of Menveo or it was broken and not documented', the case was kept valid with event incomplete dose administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administer powder portion with an unknow liquid; administer powder portion with an unknow liquid; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA653A, expiry date 28th February 2023) for prophylaxis.   In July 2022, the patient received Menveo. In July 2022, 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 Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The nurse reported that two patients received early second dose with unknown details, while only one patient had an incorrectly reconstituted dose administered. The reporter reported that they had one vial of the liquid component of Menveo left, so there was a patient who received an incomplete dose (they administered the powder portion with an unknown liquid). 3 patients were vaccinated with the same lot so the reporter was asking what happened if a patient receive two complete doses of Menveo .  All patients were vaccinated on July 2022. The reporter consented to follow up. The case is for 1 of 3 linked patients, reported by same reporter. Additional supportive information: The patient was administered the powder portion of Menveo with an unknown liquid, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022AMR112790:Same reporter US-GSK-US2022AMR112789:Same reporter
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently administered Kinrix instead of DTaP and Polio; administered to a 4 month old; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th July 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced wrong vaccine administered. 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 Information: GSK Receipt Date: 28-Jul-2022 Reporter's Comments: Licensed Practical Nurse (LPN) reported they inadvertently administered Kinrix to a 4-month-old patient on 19th July 2022. LPN called in to inquire how to proceed and what to look for. The reporter consented to follow up Additional Supportive Information: The patient was inadvertently administered Kinrix to the patient on 19th July 2022, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Shingrix on 12/MAR/19, 14/JUN/19 and 12/AUG/19; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th March 2019). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 12th August 2019, the patient received the 3rd dose of Shingrix (intramuscular). On 12th August 2019, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's Comments: The reporter was the HCP (pharmacist).  A female patient received Shingrix doses on 12th March 2019, 14th June 2019 and 12th August 2019. The HCP had nothing else to report. The reporter had limited information at time of call. Additional Supportive Information: The patient received 3rd dose of Shingrix on 12th August 2019, which led to extra dose administered.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain at the injections site; redness at the injections site; swelling at the injections site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 90-year-old female patient who received Herpes zoster (Shingrix) (batch number 299J9, expiry date 1st July 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date). Concurrent medical conditions included stroke.   On 26th July 2022, the patient received the 2nd dose of Shingrix. On 26th July 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site redness and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site redness and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain, injection site redness and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's comment: The registered pharmacist called and reported that the patient had experienced swelling, redness and pain at the injections site.  The adverse event was filed.  The registered pharmacist gave medical disclaimer. The patient was referred to health care professional.  The patient spoke personal information and content.  The consent to follow up was given.  The vaccine administration facility was the same as primary reporter.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of Engerix-B administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-year-old female patient who received HBV (Engerix B pediatric) (batch number D423N, expiry date 1st June 2022) for prophylaxis.   On 7th July 2022, the patient received Engerix B pediatric. On 7th July 2022, unknown after receiving Engerix B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 28-JUL-2022 Reporter's comments: Pharmacy resident reporting expired dose of Engerix-B administered on 7th July 2022 which expired on 1st June 2022. The adverse event report contained all details provided by the health care professional (HCP). The health care professional (HCP) gave consent for safety team to follow up. Additional Supportive Information: The patient received Engerix B pediatric beyond expiry date, which led to expired vaccine used. This case has been linked to the case US2022112346 reported by the same reporter.; Sender's Comments:  US-GSK-US2022112346:Same reporter
Age: 0.58
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired dose of Hiberix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 7-month-old male patient who received Hib (Hiberix) (batch number TH93R, expiry date 13th July 2022) for prophylaxis.   On 14th July 2022, the patient received Hiberix. On 14th July 2022, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Linked case(s) involving the same patient:  US2022112341   Additional Information: GSK receipt date: 28-JUL-2022 Reporter comment: The pharmacy resident reported that expired dose of Hiberix was administered. Adverse event reported contains all reported information from healthcare professional. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Hiberix, which led to expired vaccine used. This case has been linked to the case US2022112341 reported by the same reporter
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12 YO patient received infanrix; Received  infanrix instead of dTpa vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. 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 Information: GSK Receipt Date: 28-Jul-2022 Reporter's Comments: Medical assistance (MA) reported a 12-year-old patient received an Infanrix on left deltoid instead of the tdap vaccine. The consent to follow up was granted. Additional Supportive Information: As 12 year patient received an Infanrix instead of the tdap vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Anticoagulant therapy, Hypoaesthesia, Movement disorder, Nerve injury, Pain
Clinical narrative: had damaged nerves from the swelling; hand pain is described as numbness; hand pain is described as numbness; could not move her hand and fingers; left arm started swelling/her arm and hand were swollen; blot clot in her left arm; This case was reported by a consumer via call center representative and described the occurrence of clot blood in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included mastectomy.   On 25th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced clot blood (serious criteria GSK medically significant) and swollen arm. In July 2022, the patient experienced nerve damage, numbness, pain and movement disorder. The patient was treated with medication unknown (Blood Thinner). On an unknown date, the outcome of the clot blood, nerve damage, swollen arm, numbness, pain and movement disorder were not recovered/not resolved.   It was unknown if the reporter considered the clot blood, nerve damage, swollen arm, numbness, pain and movement disorder to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's Comment: The case was reported by the patient. The patient received a dose of Shingrix on left deltoid and at the time of vaccination, the patient felt the shot all the way down to her fingertips. Three to four days later, her left arm started swelling. About 1 to 2 weeks later, she woke up one morning, and her arm and hand were swollen so bad that she could not move her hand and fingers. She had 2 visits to the Emergency Room due to the swelling. She had a vascular ultra sound done on 7th July 2022 which showed she a blot clot in her left arm. She recently went to a nerve and muscle specialist and she was told that she had damaged nerves from the swelling. Her hand pain was described as numbness that never goes away with a piercing pain at the same time. The patient was currently taking blood thinners for her blood clot, and was going to Physical Therapy for her hand. The patient did not want to receive her second dose of Shingrix. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Sensory disturbance, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: had damaged nerves from the swelling; hand pain is described as numbness; hand pain is described as numbness; could not move her hand and fingers; left arm started swelling/her arm and hand were swollen; blot clot in her left arm; This case was reported by a consumer via call center representative and described the occurrence of clot blood in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included mastectomy.   On 25th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced clot blood (serious criteria GSK medically significant) and swollen arm. In July 2022, the patient experienced nerve damage, numbness, pain and movement disorder. The patient was treated with medication unknown (Blood Thinner). On an unknown date, the outcome of the clot blood, nerve damage, swollen arm, numbness, pain and movement disorder were not recovered/not resolved.   It was unknown if the reporter considered the clot blood, nerve damage, swollen arm, numbness, pain and movement disorder to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's Comment: The case was reported by the patient. The patient received a dose of Shingrix on left deltoid and at the time of vaccination, the patient felt the shot all the way down to her fingertips. Three to four days later, her left arm started swelling. About 1 to 2 weeks later, she woke up one morning, and her arm and hand were swollen so bad that she could not move her hand and fingers. She had 2 visits to the Emergency Room due to the swelling. She had a vascular ultra sound done on 7th July 2022 which showed she a blot clot in her left arm. She recently went to a nerve and muscle specialist and she was told that she had damaged nerves from the swelling. Her hand pain was described as numbness that never goes away with a piercing pain at the same time. The patient was currently taking blood thinners for her blood clot, and was going to Physical Therapy for her hand. The patient did not want to receive her second dose of Shingrix. The reporter consented to follow up.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Rotarix was administered IM; This case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number K2FM7, expiry date 4th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 28th July 2022, the patient received the 1st dose of Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 28th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 28-JUL-2022 Reporter's Comments: The Rotarix was administered to the patient intramuscularly instead of by mouth. The reporter consented to follow up via postal. Additional Supportive Information: The patient received vaccine intramuscularly instead of by mouth, which led to inappropriate route of vaccination.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: dose was not reconstituted with the lyophilized powder; administered the liquid diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 92F7F, expiry date 9th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 28th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 28th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jul-2022 Reporter's comment: The nurse reported that a patient was administered the liquid diluent portion of Rotarix on the day of reporting. The dose was not reconstituted with the lyophilized powder. At the time of reporting, the dose had not been repeated. The reporter consented to follow-up. This case is for 1 of 2 patients. Additional supportive information: The patient was administered the liquid diluent portion of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022112353:same reporter, other patient
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: dose was not reconstituted with the lyophilized powder; administered the liquid diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 92F7F, expiry date 9th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 28th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 28th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jul-2022 Reporter's comment: The nurse reported that a patient was administered the liquid diluent portion of Rotarix on the day of reporting. The dose was not reconstituted with the lyophilized powder. At the time of reporting, the dose had not been repeated. The reporter consented to follow-up. This case is for 2 of 2 patients. Additional supportive information: The patient was administered the liquid diluent portion of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022112352:same reporter, other patient
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not yet administered, also due for the 3rd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included TWINRIX (1st dose received on 7th December 2021, batch number A955S, Expiry date 22nd May 2022).   On an unknown date, the patient did not received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-July-2022 Reporters comment: The pharmacist reported the patient was late for Twinrix 2nd dose, the second dose not yet administered and also due for the 3rd dose. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not received the 2nd dose, which led to incomplete course of vaccination.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number unknown, expiry date February 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 30th June 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 30th June 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 Information: GSK receipt date: 29-Jul-2022 Reporter's comment: A nurse reported that 18 year old patient received an expired dose of Bexsero. No symptoms were reported. The reporter did not had the lot or exact date of expiration at the time of report.  The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.