chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: Prescription to administer Shingrix to 44 year-old; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 44-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that she received a prescription to administer Shingrix vaccine to the patient that was 44 years old. The reporter stated that the patient was not immunosuppressed or immunocompromised. The reporter would clarify with the prescriber. The reporter stated that the vaccination had not been administered at the time of reporting. Additional supportive information: The reporter received the prescription to administer the Shingrix vaccine to the 44 years old patient which was less than the approved age and the patient did not received the vaccine, which led to intercepted drug prescribing error. Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 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 27th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 27th October 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: 28-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received expired dose of Bexsero vaccine which was expired on 30th September 2022. No symptoms was reported. The reporter did not had the patient initials, gender and date of birth. Consent unspecified inadvertently forgot to request for consent. Additional supportive information: The patient received a Bexsero which was already expired, which led to expired vaccine used.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 13Oct2022, 2nd on 28Oct2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number 4S37J, expiry date 23rd November 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 28th October 2022, the patient received the 2nd dose of Shingrix. On 28th October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information:  GSK Receipt Date: 28-OCT-2022. Reporter's Comments: Pharmacist reporting having administered Shingrix 2nd dose at less than recommended interval. The first dose was administered on 13th October 2022. Adverse event report contained all reported information. HCP consented to safety team follow up. The reporter had consented to follow-up. Additional supportive information: The patient had received the second dose of Shingrix prior to the recommended interval, which had led to shortening of vaccination schedule. Note- query was raised for the batch no and expiry date confirmation and was coded for both the batch conservatively.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, HEP
Symptoms: Overdose
Clinical narrative: Vaxelis and Engerix-B administered on the same day; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 6-month-old male patient who received HBV (Engerix B) (batch number YY2R3, expiry date 12th May 2024) for prophylaxis.   Co-suspect products included VAXELIS for prophylaxis.   Previously administered products included Engerix-B (The first dose was received on an unknown date).   On 24th October 2022, the patient received the 2nd dose of Engerix B and VAXELIS. On 24th October 2022, unknown after receiving Engerix B, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 28-OCT-2022. Reporter's Comments: The medical assistant had reported that a child patient was given Vaxelis (manufacture- Sanofi) and a 2nd dose of Engerix-B on the same day 24th October 2022. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. Additional supportive information: The patient had received the second dose of Engerix-B and Vaxelis on the same day, which had led to overdose of hepatitis B component.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Sick for days (terrible reaction); This case was reported by a consumer via call center representative and described the occurrence of sickness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Oct-2022 Reporter's Comment: The reporter was the patient. The patient stated had a terrible reaction to the 1st dose and was sick for days. Patient did not provide date of injection, site of injection, lot expiration information or the type of reaction experienced. No additional information was provided. Not all information was available. Reporter stated she does not like giving personal information. Reporter did not provide consent to follow up with HCP. Reporter did not consent to follow up.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Engerix-B 20 mcg administered instead of 10mcg dose; Engerix-B 20 mcg administered to 15y/o; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 15-year-old male patient who received HBV (Engerix B adult) (batch number 29RN7, expiry date 25th February 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2022, the patient received Engerix B adult 20 ug and Engerix B Pre-Filled Syringe Device. On 12th October 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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-OCT-2022 Reporters comment: The reporter stated that on 12th October 2022, an Engerix B 20 mcg vaccine was administered to a 15 years old patient.  The reporter reported that the Engerix B 20 mcg dose was administered instead of a 10 mcg dose.  No additional information was reported.  The reporter consented to follow up with HCP. Additional supportive information: The patient received 20 mcg vaccine instead of 10 mcg, which led to overdose and adult product administered to child.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix  administered; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a adult female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 28th October 2022, the patient received the 2nd dose of Havrix. On 28th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-Oct-2022 Reporter's comment: The patient was around thirties and received the second expired dose of Havrix vaccine.  The reporter consent to follow-up by email.  Additional supportive information: The patient received Havrix vaccine, which was already expired, which led to expired vaccine used.
Age: 1.33
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV, DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received 1 dose of Pediarix and followed by 2 doses of Pentacel; 16 month old administered Kinrix; Kinrix by mistake as a 4th dose of DTaP; Kinrix given by mistake instead of Pentacel; 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 16-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL for prophylaxis.   On 28th October 2022, the patient received the 4th dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 2nd dose of PENTACEL. On 28th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered, wrong vaccine administered and interchange of vaccine products 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-OCT-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received Kinrix vaccine by mistakenly at the age of 16 months who was supposed to received Pentacel. The reporter stated that the Kinrix vaccine was given as 4th dose of DTaP and IPV schedule. The reporter reported that the patient received 1st dose of Pediarix vaccine and the 2nd and 3rd dose of Pentacel vaccine before the Kinrix vaccine. The reporter did not consent to follow up. Additional supportive information: The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The patient received Kinirix received as 4th dose of DTap Series which led to  Inappropriate schedule of vaccine administered. The patient was administered with Pentacel vaccine after Pediarix , which led to interchange of vaccine products. The reporter reported that, they were intending to administered Pentacel and inadvertently administered Kinrix instead of Pentacel, which led to wrong vaccine administered.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: was given 2 dose of the Flulaval; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 32-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 2r5k7, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 28th October 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season (intramuscular) .5 ml and Flulaval Tetra Pre-Filled Syringe Device. On 28th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: No adverse symptoms were reported. No follow-up was needed. The reporter did not consent to follow-up. Additional supportive information: The patient received 2 doses of Flulaval Quadrivalent  in right arm versus the recommended 1 dose, which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: after Shingrix, his nerve damage and pain dramatically improved, relieved nerve pains in hands and feet; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included nerve damage and nerve pain.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR157004   Additional Information: GSK Receipt Date: 28-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. Prior to receiving vaccine, the patient suffered from severe nerve damage and pain from a cervical injury a couple years after the accident.  The patient received the Shingles vaccine in either 2019 or 2020 and it changed his life. The patient stated after receiving Shingles vaccine, almost instantly relieved of nerve pains in hands and feet and nerve damage and associated pain dramatically improved. Although it was short lived for about a week. The patient thought it was a new him, this happened again with second shot and again was short lived. The physician could not able to explain why this occurred.  The reporter did not consent to follow up. No additional details were provided by the reporter. Additional Supportive Information: For tolerance of 2nd dose refer case US2022AMR157004, reported by same reporter. Suspect product was captured as Shingles vaccine instead of Shingrix as per latest follow up information.; Sender's Comments:  US-GSK-US2022AMR157004:Same reporter
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received Flulaval 1 day after receiving a flu vaccine; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 5-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number PC53Y, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)).   On 28th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 28th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device and an unknown time after receiving FLU VACCINE (NAME UNKNOWN), 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 Information: GSK Receipt Date: 28-Oct-2022 Reporter's comment: The healthcare professionals stated that the patient received a dose of Flulaval on the day for reporting, but received another flu vaccine day before the reporting.  The vaccine brand was unknown.  The reporter consented to follow up via postal. Additional supportive information: The patient received dose of Flulaval on the day for reporting, but received another flu vaccine, later than the recommended interval, which led to shortening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2020, inquire about the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 20th Oct 2020 with batch number 97C2S and expiry date 14th May 2022).   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: 28-Oct-2022 Reporter's comment: The pharmacist called to inquired about the administration of the second vaccine in a patient whom received the first dose of Shingrix. The patient was 79 years old at the time of the vaccination. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: third dose was given late; Early second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 33-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 5th September 2017, the patient received the 3rd dose of Engerix B. On 19th March 2017, the patient received the 2nd dose of Engerix B. On 19th March 2017, not applicable after receiving Engerix B and unknown after receiving Engerix B, the patient experienced drug dose administration interval too short. On 5th September 2017, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too short and drug dose administration interval too long were unknown.   Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: The reporter was unknown about batch number and expiration date. The reporter consented to follow-up. Additional supportive information: The patient received the second dose earlier and third dose later than the recommended interval, which led to shortening of vaccine schedule and lengthening of vaccine schedule.
Age: 13.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13 year-old patient received shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-year-old female patient who received Herpes zoster (Shingrix) (batch number 23YG7, expiry date 12th October 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the 13 years old patient received Shingrix vaccine. The reporter did consent to follow up. Additional supportive information: The patient received Shingrix who was younger than the indicated age which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 31 Oct 2022 Reporter comment: This case was self reported by the patient. The patient received both doses of Shingrix in 2019.  The patient recently experiencing Shingles. The reporter did not consent to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received in 2019).   On 13th October 2022, the patient received the 3rd dose of Shingrix. On 13th October 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.       Additional Information: GSK Receipt Date: 31-Oct-2022 Reporter's comment: The nurse was in a clinic and the patient inadvertently received a third dose of Shingrix.  The patient was not immunocompromised.  The nurse inquired via chat, but the patient chat ended by user before providing consent for follow up. Additional supportive information: The patient inadvertently received a third dose of Shingrix, which led to extra dose administered.
Age: 92.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Dehydration, Herpes zoster, Immediate post-injection reaction, Insomnia
Clinical narrative: Shingles in eye, 3rd visit to ER/The patient was diagnosed with shingles (in the eye and back of the head); The patient was diagnosed with shingles (in the eye and back of the head); First ER visit, was treated for a Urinary tract infection (UTI); Not eating, 4th time in ER; Not sleeping, 4th time in ER; Dehydration, sent to a rehab facility; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eye dryness (The patient had picked up a prescription for dry eye at the time he was vaccinated for Shingrix).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, urinary tract infection, appetite absent, insomnia and dehydration. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the ophthalmic herpes zoster, shingles, urinary tract infection, appetite absent, insomnia and dehydration were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, urinary tract infection, appetite absent, insomnia and dehydration to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: The reporter was the daughter of the patient. The patient was diagnosed with shingles in the eye and back of the head shortly after receiving the first dose of Shingrix. The patient had picked up a prescription for dry eye at the time he was vaccinated for Shingrix. The daughter was not sure of the date of vaccination, but it was prior to 11 September, 2022. Following the vaccination with Shingrix, the patient was seen in the Emergency Room (ER) no. 4 times within 7 days. The first ER visit was on 11 September, 2022, the patient was treated for a Urinary tract infection (UTI), had given antibiotics, and was sent home. The patient had went back to the ER on 12 September, 2022 and sent home. The third visit to the ER on 14 September, 2022, the patient was diagnosed with shingles and was sent home. Because the patient was not sleeping, or eating the patient ended up in the Emergency Room again on either 17 September or 18, 2022. He was treated for dehydration. He was subsequently sent to a rehab facility. The reporter and patient live in different states. The reporter had believed that the pharmacy below was where the patient had received the Shingrix vaccine. The reporter had consented to follow-up. Additional supportive information: The vaccination date was not reported and from the narrative it was not clear when the event was started the time to onset was captured as unknown for events. The case has been linked with case US2022157209 reported by same reporter.; Sender's Comments:  US-GSK-US2022157209:Same reporter.
Age: 92.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Urinary tract infection
Clinical narrative: Shingles in eye, 3rd visit to ER/The patient was diagnosed with shingles (in the eye and back of the head); The patient was diagnosed with shingles (in the eye and back of the head); First ER visit, was treated for a Urinary tract infection (UTI); Not eating, 4th time in ER; Not sleeping, 4th time in ER; Dehydration, sent to a rehab facility; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eye dryness (The patient had picked up a prescription for dry eye at the time he was vaccinated for Shingrix).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, urinary tract infection, appetite absent, insomnia and dehydration. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the ophthalmic herpes zoster, shingles, urinary tract infection, appetite absent, insomnia and dehydration were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, urinary tract infection, appetite absent, insomnia and dehydration to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: The reporter was the daughter of the patient. The patient was diagnosed with shingles in the eye and back of the head shortly after receiving the first dose of Shingrix. The patient had picked up a prescription for dry eye at the time he was vaccinated for Shingrix. The daughter was not sure of the date of vaccination, but it was prior to 11 September, 2022. Following the vaccination with Shingrix, the patient was seen in the Emergency Room (ER) no. 4 times within 7 days. The first ER visit was on 11 September, 2022, the patient was treated for a Urinary tract infection (UTI), had given antibiotics, and was sent home. The patient had went back to the ER on 12 September, 2022 and sent home. The third visit to the ER on 14 September, 2022, the patient was diagnosed with shingles and was sent home. Because the patient was not sleeping, or eating the patient ended up in the Emergency Room again on either 17 September or 18, 2022. He was treated for dehydration. He was subsequently sent to a rehab facility. The reporter and patient live in different states. The reporter had believed that the pharmacy below was where the patient had received the Shingrix vaccine. The reporter had consented to follow-up. Additional supportive information: The vaccination date was not reported and from the narrative it was not clear when the event was started the time to onset was captured as unknown for events. The case has been linked with case US2022157209 reported by same reporter.; Sender's Comments:  US-GSK-US2022157209:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Illness at time of vaccination included eye dryness.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: The reporter stated that the patient, who was the brother of her father's eye doctor, came down with shingles shortly after receiving a Shingrix vaccine.  Additional Supportive Information: The case had been linked to US2022157205, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2022157205:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received only first in June 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose (0.5 ml) intramuscularly on unknown arm, in June 2018).   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: 01-NOV-2022 Reporter's Comments: The reporter reported that one of her patients received only the first Shingrix.  The reporter would give her the second Shingrix vaccine on the day of reporting per CDC (Centers for Disease Control and Prevention) guidelines. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Got first shot in 2019, forgot to get second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comment: The reporter reported that the patent forgot to receive the second dose of Shingrix vaccine. The reporter wanted to know if the patient needs to start the series over. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got second dose over a year since first; 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) (batch number 557b3, expiry date 24th November 2023) for prophylaxis.   Previously administered products included Shingrix (it had been over a year since first).   On 1st November 2022, the patient received the 2nd dose of Shingrix. On 1st November 2022, 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 Information: GSK Receipt Date: 01-Nov-2022 Reporter's comment: The reporter reported as per chat do a person have to restart Shingrix series of second dose greater than 1 year.  GlaxoSmithKline provided yes to question regarding this inquiry involving a patient.  The patient just received the second dose. Someone told the reporter that they need to restart. The patient asked pharmacist but they declined to provide patient initials and date of birth. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late 2nd dose, 1 year since the 1st; 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 (1st dose received in February 2021).   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: 01-NOV-2022 Reporter's comment: The reporter asked could a patient receive 2nd dose of shringix if it had been over 1 year since the 1st dose.  The inquiry came via chat, chat dropped before any further details was provided. Additional Supportive Information: Till the time of reporting the did not receive the 2nd dose of Shingrix vaccine, which led to Incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 21Oct2020, 2nd not received; This case was reported by a physician 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 of Shingrix on 21st October 2020 (batch number:2ZN2D and expiry date:16th September 2022)).   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: 03-NOV-2022 Reporter's Comment: The reporter declined to provide patient details. The reporter reported that, the patient had not yet received second dose of Shingrix.  The reporter gave permission to follow-up via email. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS provided corresponded to the 1st dose of Shingrix as 2nd dose was not received.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache
Clinical narrative: Problem with right eye/it was painful and red; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Problem with right eye/it was painful and red) and HEADACHE (Headache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4782589) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe Rheumatoid Arthritis).   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced EYE PAIN (Problem with right eye/it was painful and red) and HEADACHE (Headache). At the time of the report, EYE PAIN (Problem with right eye/it was painful and red) and HEADACHE (Headache) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Inflammation, Pruritus
Clinical narrative: redness on arm/in the evening it got worse; itching on arm/in the evening it got worse; burning/in the evening it got worse; inflammation; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness on arm/in the evening it got worse), PRURITUS (itching on arm/in the evening it got worse), BURNING SENSATION (burning/in the evening it got worse) and INFLAMMATION (inflammation) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     There was no history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: flu vaccine (a few weeks ago) in 2022. Past adverse reactions to the above products included No adverse reaction with flu vaccine. Concurrent medical conditions included Nickel sensitivity (Nickel in the surface), Allergy (contact allergy) and Blood pressure abnormal. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 31-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Oct-2022, the patient experienced ERYTHEMA (redness on arm/in the evening it got worse), PRURITUS (itching on arm/in the evening it got worse), BURNING SENSATION (burning/in the evening it got worse) and INFLAMMATION (inflammation). The patient was treated with IBUPROFEN in 2022 at a dose of the first night. At the time of the report, ERYTHEMA (redness on arm/in the evening it got worse), PRURITUS (itching on arm/in the evening it got worse), BURNING SENSATION (burning/in the evening it got worse) and INFLAMMATION (inflammation) was resolving.            Concomitant medication included Calcium channel blocker generic drug for blood pressure and Statin. It was reported that these events only happened with this dose and she was worried about the duration of the symptoms. It was reported that AE did not cause patient to seek medical care, the patient did not experienced a similar event in the past.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was first punctured on 02-Nov-2022 at 06:00 pm and was administered on 03-Nov-2022 at 09:00 am; No Adverse Event; given vaccine from a vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given vaccine from a vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 02-Nov-2022 at 06:00 pm and was administered on 03-Nov-2022 at 09:00 am) and NO ADVERSE EVENT (No Adverse Event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2022 at 9:00 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022 at 9:00 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine from a vial punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 02-Nov-2022 at 06:00 pm and was administered on 03-Nov-2022 at 09:00 am) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given vaccine from a vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 02-Nov-2022 at 06:00 pm and was administered on 03-Nov-2022 at 09:00 am) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given vaccine from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Vial was first punctured on 02-Nov-2022 at 06:00 pm and was administered on 03-Nov-2022 at 09:00 am).    Concomitant drugs were not reported. Patient received 1st dose of Moderna on 29-Apr-2021 lot number 004C21A. Patient received 2nd dose on 27-May-2021 lot number 033B21A. Patient received 1st booster dose on 27-Nov-2021 lot number 027H21B. The 2.5 ml vial was initially stored in refrigerator on 31-Oct-2022. The vial was stored in room temperature post puncture and was exposed to room temperature for 13 hours. The vial did not undergo any temperature excursion. Treatment medications were not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Immunisation reaction, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: Bad reaction to the moderna covid vaccine; COLITIS; Injection site itching; Injection site hives; Injection site tenderness; Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Bad reaction to the moderna covid vaccine), COLITIS (COLITIS), URINARY TRACT INFECTION (Urinary tract infection), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE URTICARIA (Injection site hives) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis and Plaque psoriasis. Concomitant products included COVID-19 VACCINE for COVID-19 vaccination.   On 06-Sep-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2022, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). On an unknown date, the patient experienced IMMUNISATION REACTION (Bad reaction to the moderna covid vaccine), COLITIS (COLITIS), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE URTICARIA (Injection site hives) and INJECTION SITE PAIN (Injection site tenderness). At the time of the report, IMMUNISATION REACTION (Bad reaction to the moderna covid vaccine), COLITIS (COLITIS), URINARY TRACT INFECTION (Urinary tract infection), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE URTICARIA (Injection site hives) and INJECTION SITE PAIN (Injection site tenderness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 10 out of 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. The reporter's causality for the events of bad reaction to the Moderna covid vaccine, colitis, injection site reaction/ itchiness/hives/tenderness unknown onset, urinary tract infection with adalimumab solution for injection was not provided.