chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: The shingles shot hurt me like heck; My arm throbbed for days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: The shingles shot hurt me like heck.) and pain in arm (Verbatim: My arm throbbed for days). The outcome of the pain was not reported and the outcome of the pain in arm was recovered/resolved.   It was not reported if the reporter considered the pain and pain in arm to be related to Shingles vaccine.   It was not reported if the company considered the pain and pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 28-FEB-2023 The case was received from the patient via interactive digital media. The reporter stated that the shingles shot hurt him/her like heck.  The patient's arm throbbed for days but he/she would take the shot, over the disease,anytime. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: made my arm very sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23-FEB-2023, the patient received Shingles vaccine. In FEB-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: made my arm very sore). The outcome of the pain in arm was recovering/resolving.   It was not reported if the reporter considered the pain in arm to be related to Shingles vaccine.     It was not reported if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 28-FEB-2023 This case was reported by a patient via interactive digital media. The patient got the shot on Thursday. The shot made patients arm very sore and getting better today. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (first shot actually helped lessen his/her outbreak and was back to normal in a month). Previously administered products included Shingrix with an associated reaction of blister (had got the shot in 2012 and in 2020 had got blisters on the upper right side of his/her face around the eyes/eyelid and forehead).   In DEC-2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was not reported if the reporter considered the shingles to be related to Shingles vaccine.     It was not reported if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's comments: This case was reported by the patient via interactive digital media. The reporter stated that he/she had got the blister on his/her eyelid and had got treatment/checked out, his /her eyes was ok. He/She had no pain, but quite a few blisters.  He/She had got a new shot in December 2022 and was getting ready to get his/her second shot next month.  Shingles suck. Follow-up would not possible as no contact details were available.
Age: 51.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: was administered two expired doses; Drug dose administration interval too short; was administered two expired doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 51-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 01-JAN-2023) for prophylaxis.   Co-suspect products included HAB (Twinrix) (batch number 4F3YY, expiry date 01-JAN-2023) for prophylaxis.   On 17-FEB-2023, the patient received the 3rd dose of Twinrix. On 18-JAN-2023, the patient received the 2nd dose of Twinrix. On 18-JAN-2023, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: was administered two expired doses). On 17-FEB-2023, the patient experienced expired vaccine used (Verbatim: was administered two expired doses) and drug dose administration interval too short (Verbatim: Drug dose administration interval too short). The outcome of the expired vaccine used, expired vaccine used and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023032762   Additional Information: GSK Receipt Date: 28-Feb-2023 Reporter's Comments:  Pharmacist reports a patient was administered two expired doses of Twinrix.  One dose was given on 18th Jan 2023 and one was given on 17th February 2023.  Both doses expired on 1st January 2023. The reporter consented to follow up via email. Additional Supportive Information: the patient received two doses of expired Twinrix vaccine on 18th January and 17th February 2023, earlier than the recommended schedule, which led to shortening of the vaccination schedule and expired vaccine used.; Sender's Comments:  US-GSK-US2023032762:same reporter - FU1 - deleted
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix stored at temperatures ranged from 28 F to 56 F over the course of 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2022, the patients received Shingrix. On an unknown date, unknown after receiving Shingrix, the patients experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's comment: The pharmacist reported that Shingrix stored at temperatures ranged from 28 F to 56 F over the course of 6 months. The reporter enquired that if patient was outside of 6 month window, should series be restarted.  The health care professional  was unsure when patients received vaccinations and if patients vaccinations were within stability range.  The HCP  reported that approximately 30 patients had been vaccinated since the issue started on 31st August 2022.  No patient demographic data available at time of reporting. The reporter consented to follow up. Additional supportive information: The Shingrix vaccines were stored at temperatures ranged from 28 F to 56 F over the course of 6 months, which led to incorrect storage of drug.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Receiving first dose of Shingrix in September of 2021 and having not yet received the second dose.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 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: 28-FEB-2023 Reporter's comment: The patient self-reported this case. The patient had not yet received the second dose.  The reporter did not consented to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: It was awful; body ache; awake all night; stomachache; body chills / side effects; nausea; headache; Fatigue/still having a little bit of fatigue/Patient stated that on day 02/28/2023 she still had fatigue symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of feels awful in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 73PP9, expiry date 30-MAY-2024) for prophylaxis.   On 27-FEB-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 27-FEB-2023, less than a day after receiving Shingrix, the patient experienced feels awful (Verbatim: It was awful), general body pain (Verbatim: body ache), sleeplessness (Verbatim: awake all night), stomach pain (Verbatim: stomachache), chills (Verbatim: body chills / side effects), nausea (Verbatim: nausea), headache (Verbatim: headache) and fatigue (Verbatim: Fatigue/still having a little bit of fatigue/Patient stated that on day 02/28/2023 she still had fatigue symptoms). On 28-FEB-2023, the outcome of the feels awful, general body pain, sleeplessness, stomach pain, chills, nausea and headache were recovered/resolved (duration 1 day). The outcome of the fatigue was not recovered/not resolved.   It was not reported if the reporter considered the feels awful, general body pain, sleeplessness, stomach pain, chills, nausea, headache and fatigue to be related to Shingrix.     It was not reported if the company considered the feels awful, general body pain, sleeplessness, stomach pain, chills, nausea, headache and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-FEB-2023 and 02-MAR-2023 Reporter's comments: The reporter was a consumer who had reported that, she got her 2nd dose of Shingrix vaccine at a pharmacy and was administered in her left arm.  The patient reported having body chills, body ache, fatigue, nausea, stomachache, was awake all night, and headache. The patient had reported that it was awful. All the symptoms had resolved except that patient reported having a little bit of fatigue at the time of reporting and had multiple side effects which lasted about 24 hours.  The reporter had consent to follow-up. Additional supportive information: The event onset for feels awful was captured conservatively based on the reported verbatim It was awful justifying all symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Nausea, Pain
Clinical narrative: It was awful; body ache; awake all night; stomachache; body chills / side effects; nausea; headache; Fatigue/still having a little bit of fatigue/Patient stated that on day 02/28/2023 she still had fatigue symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of feels awful in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 73PP9, expiry date 30-MAY-2024) for prophylaxis.   On 27-FEB-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 27-FEB-2023, less than a day after receiving Shingrix, the patient experienced feels awful (Verbatim: It was awful), general body pain (Verbatim: body ache), sleeplessness (Verbatim: awake all night), stomach pain (Verbatim: stomachache), chills (Verbatim: body chills / side effects), nausea (Verbatim: nausea), headache (Verbatim: headache) and fatigue (Verbatim: Fatigue/still having a little bit of fatigue/Patient stated that on day 02/28/2023 she still had fatigue symptoms). On 28-FEB-2023, the outcome of the feels awful, general body pain, sleeplessness, stomach pain, chills, nausea and headache were recovered/resolved (duration 1 day). The outcome of the fatigue was not recovered/not resolved.   It was not reported if the reporter considered the feels awful, general body pain, sleeplessness, stomach pain, chills, nausea, headache and fatigue to be related to Shingrix.     It was not reported if the company considered the feels awful, general body pain, sleeplessness, stomach pain, chills, nausea, headache and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-FEB-2023 and 02-MAR-2023 Reporter's comments: The reporter was a consumer who had reported that, she got her 2nd dose of Shingrix vaccine at a pharmacy and was administered in her left arm.  The patient reported having body chills, body ache, fatigue, nausea, stomachache, was awake all night, and headache. The patient had reported that it was awful. All the symptoms had resolved except that patient reported having a little bit of fatigue at the time of reporting and had multiple side effects which lasted about 24 hours.  The reporter had consent to follow-up. Additional supportive information: The event onset for feels awful was captured conservatively based on the reported verbatim It was awful justifying all symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose about 2 years ago, 2nd dose February 27, 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number FA277, expiry date 27-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, the patient received their first dose about 2 years ago).   On 27-FEB-2023, the patient received the 2nd dose of Shingrix. On 27-FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose about 2 years ago, 2nd dose February 27, 2023). The outcome of the drug dose administration interval too long was not reported.   Additional Information: GSK Receipt Date: 28-FEB-2023 The patient never had returned for their second dose until 27 February, 2023. Information about the vaccine and patient were given. The vaccine administration facility was the same as primary reporter.  The reporter had consented to follow-up. The patient had received the second dose of Shingrix vaccine later than the recommended interval, which had led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 10JUN2022, 2nd dose on 05JAN2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received on 10 June 2022).   On 05-JAN-2023, the patient received the 2nd dose of Shingrix. On 05-JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 10JUN2022, 2nd dose on 05JAN2023). The outcome of the drug dose administration interval too long was not reported.   Additional Information: GSK receipt date: 28-Feb-2023 Reporter comment: On 28th February 2023, a CPT called to report that the patient wanted to receive a dose of Shingrix.  According to the facility's registrations, the patient received two doses, meaning that the scheme was complete.  However, the patient stated that such first dose was never received (even though registered) and that another dose had to be administered.  Now, CPT had not administered the third dose.  The reporter did not consent to follow up. Additional Supportive Information: The patient received second dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Felt like crap; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 65-year-old female 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 feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     Additional Information: GSK Receipt date: 01-Mar-2023 Reporter's Comment: The patient was a friend of the reporter. The reporter stated that the patient felt like crap after the first dose of Shingrix. The reporter provided limited information. The reporter did not consent to follow up. Additional Supportive Information: The case is linked with cases US2023033391 and US2023033387, reported by same reporter.; Sender's Comments:  US-GSK-US2023033391:Same reporter US-GSK-US2023033387:Same reporter
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Oct 2022, 3rd Mar2023; 1st dose Oct 2022, 2nd Dec 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 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, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   In March 2023, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In December 2022, the patient received the 2nd dose of Twinrix. In December 2023, the patient started Twinrix Pre-Filled Syringe Device. In December 2022, not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device and unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. In March 2023, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short and drug dose administration interval too long 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: 03-MAR-2023 Reporter's Comments: The reporter was patient's wife called on behalf of her husband. The reporter did not provide demographic information.  Adverse event filled. The reporter did not consent to follow up. Additional Supportive Information:  The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Twinrix earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: HEPAB
Symptoms: Accidental underdose, Product complaint, Product quality issue, Syringe issue, Underdose
Clinical narrative: Syringe leaked during administration; Syringe leaked during administration; Syringe leaked during administration; This non-serious case was reported by a other health professional via sales rep and described the occurrence of accidental underdose in a patient who received HAB (Twinrix adult) (batch number h3sg9, expiry date 03-JAN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced accidental underdose (Verbatim: Syringe leaked during administration), syringe leak (Verbatim: Syringe leaked during administration) and pharmaceutical product complaint (Verbatim: Syringe leaked during administration). The outcome of the accidental underdose and pharmaceutical product complaint were unknown and the outcome of the syringe leak was not reported.   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: 03-MAR-2023 The reporter called to report PQC (product quality complaint) with Twinrix syringes on behalf of healthcare professional (HCP).  The reporter did not have any demographics for the patient.  The syringes leaked while administering to patient.  The patient was affected (Related adverse event - underdose).  The reporter contacted HCP (Medical Assistant) for more information regarding PQC.  The defect was discovered after partial use of the box.  The healthcare professional stated that two doses administered prior did not have any issues. The reporter confirmed that Luer Lok needles were used. All syringes leaked between the Luer Lok device and the syringe barrel. The syringe was not pre-assembled with needle some time before administration - syringes were assembled immediately before administration.20 gauge 1 in needle was used.  The blister and/or carton was not damaged. The luer lok was not damaged.  The needle which was used was not available for return. There was no damage/breakage on the syringe barrel.  The HCP did not have suspect product to return , syringes was disposed of.  The GlaxoSmithKline had to issue a credit for dose of Twinrix to GSK direct account.  The reporter consented to follow up. The syringes leaked while administering to patient and the patient dose was affected, which had led to underdose, syringe leak and pharmaceutical product complaint. This was 1 of 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR035219:Same reporter US-GSK-US2023AMR035220:Same reporter
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only  liquid conjugate given; Only  liquid conjugate given; 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 Men ACWY-CRM NVS (Menveo) (batch number AMXA758A, expiry date 31st October 2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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: 06-JAN-2023 Reporter's Comments: A health care professional (HCP) did not answered if follow-up was ok, email was above if follow-up needed. Additional Supportive Information:  The patient was administered only the liquid conjugate portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 73.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 73 YO received Pediatric dose; 73 YO received Pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 73-year-old male patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   On 2nd March 2023, the patient received Havrix. On 2nd March 2023, unknown after receiving Havrix, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 03-MAR-2023 Reporter's Comments: The patient was back in clinic on the day of reporting and medical assistant intends to re-administer the age-appropriate dose on the day of reporting.  The medical assistant granted permission for safety follow up. Additional Supportive Information:  One day before reporting, the patient was inadvertently given a pediatric dose of Havrix, which led to underdose and adult use of a child product.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Not shaking preparation; Not shaking preparation; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe 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: 03-MAR-2023 Reporter's Comments: The registered nurse reported not shaking syringes in preparation for administration, as the package insert stated. PQC Unrelated. PQC and adverse event share same case number. The reporter did not consent to follow-up. Additional Supportive Information:  The syringe of Pediarix vaccine were not shaken in preparation for administration, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Alopecia
Clinical narrative: complete hair loss, no regrowth anywhere; This case was reported by a other health professional via call center representative and described the occurrence of hair loss in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number G7749, expiry date 3rd November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number AMVA659A, expiry date 31st January 2023) for prophylaxis and GARDASIL for prophylaxis.   On 8th August 2022, the patient received Boostrix (intramuscular), Boostrix Pre-Filled Syringe Device, Menveo (intramuscular) and GARDASIL. On 8th October 2022, 61 days after receiving Boostrix, Boostrix Pre-Filled Syringe Device and Menveo, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was not recovered/not resolved.   It was unknown if the reporter considered the hair loss to be related to Boostrix, Boostrix Pre-Filled Syringe Device and Menveo. 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: 03-MAR-2023 Reporter's comment: The Medical Assistant (MA) from a dermatology office to reported a patient suffering complete hair approximately 2 months after receiving 3 vaccines from their primary provider. The primary provider referred the patient to this dermatology office for treatment. The reporter reported that all three vaccines were given on were administered on same day. The healthcare professional believed that the hair loss maybe due to the vaccines. (no other specifics known, like which vaccine the healthcare professional believed was the culprit). The reporter reported that there had been no regrowth of hair anywhere on the patient's body.  No other details were known. The reporter gave permission for GlaxoSmithKline (GSK) to contact the HCP at her dermatology office.  61 days after receiving Gardasil, the patient experienced hair loss. It was unknown if the reporter considered the hair loss to be related to Gardasil. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose probably 2 yrs ago, 2nd never; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose probably two years ago).   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-MAR-2023 Reporter's Comments: A health care professional reported that a patient consulted in the facility where she worked to be administered with the 2nd dose of Shingrix as she received only one dose of Shingrix, according with the health care professional statement, in another facility. 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, which led to incomplete course of vaccination.
Age: 0.67
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 8-month-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 20th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-MAR-2023 Reporter's Comment: The reporter reported that 8 months old patient inadvertently received the Kinrix vaccine. The reporter did consent to follow up. Additional supportive information: The patient received Kinirix vaccine earlier than the indicated age which led to inappropriate age at vaccine administration.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 2-year-old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 17-FEB-2023, the patient received Kinrix. On 17-FEB-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given to a 2-year-old). The outcome of the inappropriate age at vaccine administration was not reported.   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: 03-MAR-2023 The registered nurse called and inquired that would this DTaP-IPV count towards the patient's immunization. The reporter wanted to know how to proceed with series. The nurse reported that 2 year old patient was inadvertently administered a Kinrix dose. The reporter unable to provide any additional patient or vaccine details. The reporter did not consent to follow up. Additional Supportive Information: 2 years old patient received Kinrix, which led to inappropriate age at vaccine administration.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; 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 HAV (Havrix) (batch number T57F3, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd March 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 3rd March 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-Mar-2023 Reporter comment: The nurse called to inform that earlier on the day of reporting, a patient had been administered a dose of Havrix that had expired on 16th February 2023.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 14Mar2021, 2nd 9Sep2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 18-month-old male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received on 14th March 2022 from lot number CN3J5 and expiry date 19th November 2023).   On 9th September 2022, the patient received the 2nd dose of Havrix. On 9th September 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 03-MAR-2023 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received first dose of Havrix on 14th March 2022 and second dose on 09th September 2022 which was 5 days earlier than recommended schedule. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received 2nd dose of Havrix early than recommended time frame, which led to shortening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Herpes zoster, Vaccination failure
Clinical narrative: Received Vx, then shingles/Suspected vaccination Failure; blind in right eye; shingles; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Received Vx, then shingles/Suspected vaccination Failure) (serious criteria GSK medically significant), blind right eye (Verbatim: blind in right eye) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and blind right eye were not reported and the outcome of the shingles was unknown.   It was not reported if the reporter considered the vaccination failure, blind right eye and shingles to be related to Shingrix.     It was not reported if the company considered the vaccination failure, blind right eye and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAR-2023 The case was reported by patient's friend. The reporter's other phone was ringing and she had to go before details could be collected. She did not have the details (date, lot, expiry date, etc) regarding the vaccination. The reporter consented to follow up via postal mail. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule ,time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case had been linked to US2023035548, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023035548:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had both doses, got shingles/Suspected vaccination failure; Shingles; Lot of pain; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male 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, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Had both doses, got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Lot of pain). The outcome of the vaccination failure, shingles and pain were unknown.   It was not reported if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.     It was not reported if the company considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 06-MAR-2023 The patient had a friend that had the Shingrix series administered (both doses) and got shingles (lack of effect).   The patient was in a lot of pain due to shingles. The reporter provided minimal information about her friend.   Minimal information obtained for adverse event. The reporter was not asked for consent to follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; STROKE; This spontaneous report received from a patient concerned a 72 year old  female. The patient's weight was 180 pounds, and height was 66 inches. The patient's past medical history included: In 2020 left knee replacement, (2019) back surgery, (2016) sprained foot, (2011) colonoscopy, (2011) fractured right foot, (2014) neck surgery (had two plates put in neck), and (2012) trigger fingers (patient had two trigger fingers, it locked down when you move it), and concurrent conditions included: sinus, non-smoker and alcohol user, and other pre-existing medical conditions included: Patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: unknown) dose was not reported, 1 total, administered on 29-APR-2021 left arm for covid-19 prophylaxis. Age at time of vaccination 72 years old. No concomitant medications were reported.  On MAY-2021, the patient had a stroke within 2 weeks after vaccination. On JAN-2022, the patient experienced suspected COVID-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and suspected COVID-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230320475.; Sender's Comments: V0: 20230320386-stroke . The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Thrombosis
Clinical narrative: CLOT IN LEG; CLOT ON THE LEFT SIDE OF THE BRAIN; STROKE ON THE LEFT SIDE OF THE BRAIN; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was very healthy before the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced clot in leg, and clot on the left side of the brain. On 13-JAN-2022, the patient experienced stroke on the left side of the brain, and was hospitalized (date unspecified). Patient spent 9 days in the ICU (Intensive care unit). It was reported that after the vaccine patient had pain in his legs and it was hard to walk after the vaccine shot. Reporter stated that after an ride, maybe a day or two later, a clot hit the patient on the left side of the brain and that the clot must have been in his leg. Patient had a stroke on the left side of the brain and was paralyzed on the right side due to a blood clot on the left side. Patient has aphasia and can hardly talk and had to pay for occupational therapy, physical therapy and speech therapy. Reporter stated that a wheel chair, a hospital bed and a lift had been provided for the patient. Patient was unhooked from the ICU after 9 days and with his eyes were rolling in the back of head and they put him in the corner room, he could not feed himself, they trained him how to work a lift and change diapers, wash him and roll him. Patient came home from hospital in a bed and had been in a bed since last year. Duration of hospitalization and discharge information were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke on the left side of the brain, and the outcome of clot in leg and clot on the left side of the brain was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20230321273.  It was determined that deletion was required for Manufacturer Report Number 20230321273 as it was duplicate of Manufacturer Case Number 20230320406. All relevant information regarding Manufacturer Report Number 20230321273 will be submitted under Manufacturer Case Number 20230320406.; Sender's Comments: V0: 20230320406- stroke on the left side of the brain, clot in leg, clot on the left side of the brain. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported, 1 total administered on an unspecified date for COVID-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient received additional dose of non-company suspect vaccine included: elasomeran (Moderna) (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with non-company suspect vaccine elasomeran (Moderna) (dose number in series 2). The patient received tozinameran (Pfizer Biontech) (dose number in series 3) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 08-SEP-2022 for covid-19 prophylaxis which was revaccination with different COVID-19 vaccine.  On an unspecified date, patient had COVID-19 for which patient took non company unspecified suspect (form of admin, route of admin, and batch number were not reported) dose not reported, administered on an unspecified date for COVID-19 treatment. After 6 days of medication, patient tested positive. On 27-FEB-2023, patient had symptoms (confirmed covid-19 infection) (dose number in series 3) which resulted to the confirmed clinical vaccination failure (dose number in series 1). In 2023, Laboratory data included: COVID-19 virus test Positive and COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000274483.; Sender's Comments: V0-20230322260-Confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood
Clinical narrative: IT MADE HAPPIER AND DANCE AROUND; This spontaneous report received from a patient concerned a female of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced it made happier and dance around (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of it made happier and dance around was not reported. This report was non-serious.