chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose back on 8/24/2020 / never received the second one; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th August 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix and never received the second one, which led to incomplete course of vaccination. The reporter inquired if they should give the second dose or restart the Shingrix series for this patient. The reporter was unable to provide vaccine or patient details. The reporter did not consent to follow-up. This case has been linked to US2021213496, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021213496:same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only received the adjuvant portion; Only received the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 5953S, expiry date 7th November 2022) for prophylaxis.   On 11th October 2021, the patient received the 1st dose of Shingrix. On 11th October 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was a medical assistant. The reporter stated that, the patient only received the adjuvant portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up. No additional details were provided by the caller.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021213505:FU deleted
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019 and has not received dose 2; This case was reported by a other health professional 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 2019).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter was Clinic Director and stated that, the patient received the first dose of Shingrix and had not received dose two till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/lack of effect; Her current outbreak is in eye; Her current outbreak is located on the left side of her: scalp, mouth; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (developed shingles in February 2020 refer case US2021AMR214345).   On 12th October 2019, the patient received the 2nd dose of Shingrix. On 18th July 2018, the patient received the 1st dose of Shingrix. On an unknown date, more than a year after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingrix.   Additional details were reported as follows: The case was reported by the patient. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule refer case US2021AMR214345. The patient currently had shingles and her current outbreak was located on the left side of her scalp, mouth, and eye. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles were unknown. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR214345:same reporter
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Pt was given only the diluent portion/12 years old patient received half dose of Menveo; Pt was given only the diluent portion/12 years old patient received half dose of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva391a, expiry date 30th September 2021) for prophylaxis.   On 2nd September 2021, the patient received Menveo. On 2nd September 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was medical assistant. The patient was administrated by error only the diluent portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. In this way, the patient received only half dose of vaccine. No further events were reported. The reporter dropped before the call center representative could get any further information. There was no further information available since the call dropped. The reporter agreed to be contacted for follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021213528:Same reporter.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: pregnant woman received Infanrix; pregnant woman received Infanrix / DOB :04-MAR-1992; received Infanrix instead of Boostrix; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 29-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Infanrix at an unknown time during the pregnancy. On 12th October 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and adult use of a child product. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the inappropriate age at vaccine administration, adult use of a child product and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that a pregnant patient received Infanrix instead of Boostrix, which led to vaccine exposure during pregnancy, inappropriate age at vaccine administration and Adult use of a child product. The reporter consented to follow up by email.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received expired vaccine; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 35-year-old male patient who received HBV (Engerix B) (batch number P3ZF5, expiry date 5th July 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th October 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 15th October 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a dose of Engerix B which was expired on 5th July 2021, which led to expired vaccine used. No reactions were reported. The reporter consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: vaccine reconstituted with a non-supplied liquid diluent.; vaccine reconstituted with a non-supplied liquid diluent.; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The nurse reported that patient was administered a Hiberix vaccine reconstituted with a non-supplied liquid diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow- up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Given just the adjuvant portion; Given just the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number G9JA7, expiry date 15th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The medical assistant reported that, the patient was given just the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with cases US2021215490 and US2021215489, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215490:same reporter US-GLAXOSMITHKLINE-US2021215489:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given just the adjuvant portion; given just the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number G9JA7, expiry date 15th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The medical assistant reported that, the patient was given just the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with cases US2021215490 and US2021215486, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215490:same reporter US-GLAXOSMITHKLINE-US2021215486:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given just the adjuvant portion; given just the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number G9JA7, expiry date 15th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The medical assistant reported that, the patient was given just the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with cases US2021215489 and US2021215489, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215489:same reporter US-GLAXOSMITHKLINE-US2021215486:same reporter
Age: 0.17
Sex: U
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluarix QIV instead of Pediarix; Fluarix vaccines was given to a 2 months  baby; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 2-month-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 15th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that the Fluarix vaccine was given by error to a 2 months baby instead of Pediarix vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted  with 0.7mL of sterile water; reconstituted  with 0.7mL of sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2021, the patient received the 2nd dose of Shingrix. On 16th October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reports that a pharmacy technician reconstituted Shingrix with 0.7mL of sterile water instead of the supplied AS01b adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have further patient information or dose lot number or expiration date. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site cellulitis in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB57AA, expiry date 31st August 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 15th October 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 18th October 2021, 3 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was not recovered/not resolved.   It was unknown if the reporter considered the injection site cellulitis to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was a vaccine representative calling on behalf of the customer. The reporter reported that the patient received dose of Bexsero vaccine Friday (15th October 2021) in left arm and today (day of reporting) came back to HCP office and was diagnosed with cellulitis at injection site. The vaccine was given by an experienced MA, spoke per content. The reporter consented to follow up. This is one of the 2 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215480:Same reporter. Pt 2 of 2
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: vision problems; This case was reported by a consumer via call center representative and described the occurrence of abnormal vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, less than 2 weeks after receiving Shingrix, the patient experienced abnormal vision. On an unknown date, the outcome of the abnormal vision was not recovered/not resolved.   It was unknown if the reporter considered the abnormal vision to be related to Shingrix.   Additional details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. The patient received the Shingrix vaccine a week or so ago from the date of reporting.  The patient was concerned about vision problems. The patient inquired what type of health care professional she should see to address her concern. Referred her to optometrist or ophthalmologist.  The patient was provided with medical advice disclaimer.  The reporter did not consent to follow-up. No additional details were provided by reporter.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 38 year old received pediatric dose; Adult use of child product; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 38-year-old male patient who received HBV (Engerix B pediatric) (batch number 5295P, expiry date 27th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th October 2021, the patient received Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 8th October 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that, an adult patient received a 0.5 ml pediatric dose of Engerix B, which led to underdose and adult use of a child product. No symptoms reported. The reporter consented to follow up. This case has been linked to US2021AMR216452, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR216452:same reporter
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered saline diluent without lyophilized component; Administered saline diluent without lyophilized component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 3-year-old male patient who received Hib (Hiberix) (batch number PJ7ER, expiry date 13th November 2022) for prophylaxis.   On 24th September 2021, the patient received Hiberix. On 24th September 2021, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter administered 0.5ml of saline diluent without lyophilized component to the patient, which led to preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of the Engerix-B was administrated; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-month-old male patient who received HBV (Engerix B) (batch number 337a5, expiry date 26th November 2015) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th December 2015, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 18th December 2015, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a dose of Engerix B which was expired on 26th November 2015, which led to expired vaccine used. No further events were reported. The reporter agreed to be contacted and consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix mixed with normal saline and administered; Shingrix mixed with normal saline and administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2021, the patient received Shingrix. On 18th October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The Shingrix mixed with normal saline and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix administered to a two month old; ordered Kinrix instead of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-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.   On 12th October 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 12th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter inadvertently ordered Kinrix instead of Pediarix and it was administered to a two month old patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. The patient was fine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dosein December 2020, should pt receive 2nd 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 (received 1st dose in December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient's daughter. The age at vaccination was not applicable for this report. Till the time of reporting, the patient never get 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked, if the patient should receive the second dose now or restart the vaccine series. The reporter declined to provide additional details. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose: Oct2020, second did not receivd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient never get  2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expiration date: 10/14/2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received HBV (Engerix B) (batch number YL2L3, expiry date 14th October 2021) for prophylaxis.   On 19th October 2021, the patient received the 1st dose of Engerix B. On 19th October 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The pharmacist administered by error to a 19 year-old female colleague an Engerix-B expired pediatric dose, which led to expired vaccine used. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Twinrix expired was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 69-year-old female patient who received HAB (Twinrix) (batch number H4A37, expiry date 18th October 2021) 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.   On 19th October 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 19th October 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received expired dose of Twinrix, which led to expired vaccine used. No reactions reported. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: Tingling and redness at the injection site; Redness at injection site; Injection site was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingling and redness at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Injection site was sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A e) for COVID-19 vaccination.     Concomitant products included SPIRONOLACTONE, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ALPRAZOLAM (XANAX), FLUOXETINE HYDROCHLORIDE (PROZAC) and PRAVASTATIN for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Tingling and redness at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Injection site was sore). At the time of the report, VACCINATION SITE PARAESTHESIA (Tingling and redness at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Injection site was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-350630 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Reporter stated that vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Migraine, Pyrexia, Vomiting
Clinical narrative: MIGRAINE; EMESIS; SEVERE HEADACHE; SUBJECTIVE FEVER; This spontaneous report received from a health care professional concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis, and other pre-existing medical conditions included: The patient had No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced migraine, emesis, severe headache, and subjective fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, emesis, severe headache and subjective fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: SARS-COV-2 TEST POSITIVE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-OCT-2021, the patient experienced sars-cov-2 test positive. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sars-cov-2 test positive was not reported. This report was non-serious. This case, from the same reporter is linked to 20211033119.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Contusion, Gingival bleeding, Haematuria
Clinical narrative: BLEEDING GUMS/SEVER BLEEDING IN THE MOUTH; BRUISES TO ARMS; PLATELET COUNT LOW; HEMATURIA; This spontaneous report received from a patient (retired nurse) concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: hysterectomy in 1992, removed thyroid gland in 2019, dental implant in 25-SEP-2021, and thyroid problems. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: unknown) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-SEP-2021, the patient started to had hematuria, had blood in the urine. The color of the urine was like a cranberry color, then in the night there was some real blood clots observed in the urine. She spent a whole day in emergency room (ER). On 01-OCT-2021, 02-OCT-2021 and 03-OCT-2021, the patient started to had severe bleeding in the mouth/bleeding gums. She was very worried and she admitted to the hospital on 05-OCT-2021. On 17-OCT-2021 (last night), she started to bleed again from her mouth during her shower but she used some peroxide and put some sterile gauze and pressed on that area in her mouth and it stopped bleeding. Her dentist told her that there is no problem in the bones and the bleeding can be either from the soft tissue or due to the vaccine. On 18-OCT-2021 in the morning, she was doing some blood work. On an unspecified date in OCT-2021, the patient experienced bruises to her arms from many intravenous (IV's) while she was hospitalized for hematuria and severe bleeding in the mouth/bleeding gums. They did a several blood tests and didn't find out any reason for bleeding. During hospitalization, her platelets count was low as she was still bleeding and her hemoglobin was a little low. Two bags of plasma were received as a treatment. Patient discharged on 12-OCT-2021 and was hospitalized for 8 days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bleeding gums/sever bleeding in the mouth, and the outcome of hematuria, bruises to arms and platelet count low was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211034387.; Sender's Comments: V0: 20211032981-Covid-19 vaccine ad26.cov2.s-Hematuria, Bleeding gums/sever bleeding in the mouth, Bruises to arms, Platelet count low. This event(s) is considered unassessable. The event(s) 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(s).
Sex: U
Vaccine: COVID19
Symptoms: Diverticulitis, Drug ineffective, Pneumonia, Scan
Clinical narrative: PNEUMONIA; ATTACK OF DIVERTICULITUS; SHOT DID NOT WORK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic obstructive pulmonary disease (COPD), and peripheral arterial disease (PAD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) with unknown dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient went to hospital and had an attack of diverticulitis. Further patient underwent Scan and diagnosed with pneumonia. The patient experienced shot did not work. Patient believed since patient got the vaccine patient's lungs and breathings had been better.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pneumonia, attack of diverticulitus and shot did not work was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211033699-COVID-19 VACCINE AD26.COV2.S-Attack of diverticulitus. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211033699-COVID-19 VACCINE AD26.COV2.S-Pneumonia. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20211033699-COVID-19 VACCINE AD26.COV2.S-Shot did not work. This event is considered not related. 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 than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Computerised tomogram, Malignant neoplasm progression, Paralysis, Weight
Clinical narrative: ACTIVATED KIDNEY CANCER STAGE 4; PARALYZED AFTER TAKING JANSSEN COVID 19 VACCINE; JANSSEN COVID 19 VACCINE JUST TOOK LIFE; LOST WEIGHT; This spontaneous potential legal report received from a patient concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 19-OCT-2021. The patient's height, and weight were not reported. The patient's past medical history included: left kidney removed, and concurrent conditions included: kidney cancer stage 4, and kidney cancer metastasized into right hip. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 1 total, dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, Laboratory data included: Computerized Tomography (CT) scan normal which showed no activity with the tumor. On an unspecified date (after receiving the vaccine), the patient was paralyzed for a whole week and he had lost weight. On an unspecified date (within 4 months after vaccination), the patient experienced growth of full additional tumors from the original one and had a feeling that cancer got activated (activated kidney cancer stage 4). The patient also reported that he felt as Janssen Covid-19 vaccine just took his life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paralyzed after taking janssen covid 19 vaccine, and the outcome of activated kidney cancer stage 4, janssen covid 19 vaccine just took life and lost weight was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211033874-COVID-19 VACCINE AD26.COV2.S-Activated kidney cancer stage 4. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY V0 20211033874-COVID-19 VACCINE AD26.COV2.S-paralyzed after taking janssen covid 19 vaccine. This event(s) is considered unassessable. The event(s) 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(s).
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: ACTIVATED KIDNEY CANCER STAGE 4; PARALYZED AFTER TAKING JANSSEN COVID 19 VACCINE; JANSSEN COVID 19 VACCINE JUST TOOK LIFE; LOST WEIGHT; This spontaneous potential legal report received from a patient concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 19-OCT-2021. The patient's height, and weight were not reported. The patient's past medical history included: left kidney removed, and concurrent conditions included: kidney cancer stage 4, and kidney cancer metastasized into right hip. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 1 total, dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, Laboratory data included: Computerized Tomography (CT) scan normal which showed no activity with the tumor. On an unspecified date (after receiving the vaccine), the patient was paralyzed for a whole week and he had lost weight. On an unspecified date (within 4 months after vaccination), the patient experienced growth of full additional tumors from the original one and had a feeling that cancer got activated (activated kidney cancer stage 4). The patient also reported that he felt as Janssen Covid-19 vaccine just took his life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paralyzed after taking janssen covid 19 vaccine, and the outcome of activated kidney cancer stage 4, janssen covid 19 vaccine just took life and lost weight was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211033874-COVID-19 VACCINE AD26.COV2.S-Activated kidney cancer stage 4. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY V0 20211033874-COVID-19 VACCINE AD26.COV2.S-paralyzed after taking janssen covid 19 vaccine. This event(s) is considered unassessable. The event(s) 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(s).
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SEVERE BREAKTHROUGH CASE OF VACCINE / SUSPECTED COVID-19 INFECTION; This spontaneous potential legal report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 20-OCT-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the consumer reported that patient experienced a severe breakthrough case of the vaccine/suspected covid-19 infection. On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe breakthrough case of vaccine/suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000198020.; Sender's Comments: V0: Medical Assessment comment not required as per standard operating procedure for legal case.