chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient).     No concomitant medications were reported.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No relevant concomitant medications were reported. Vaccine was moved from freezer to refrigerator on 12/02/22. Of the ten vials in question 43 injections were given and 7 doses were wasted. No treatment medication reported.  This case contains information for the 5th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: in the hospital with the flu; Initial information received on 19-Dec-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-health-care professional  This case involves an unknown age male patient who experienced in the hospital with the flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation ,strength, dose, route and  lot number: not reported) in unknown administration site as prophylactic vaccination,.  On an unknown date,  it was reported We got our flu shots but the patient was the hospital with the flu(influenza)(latency: unknown).  It is unknown if there were lab data/results available.   Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the event (in the hospital with the flu).  Outcome: unknown  Seriousness criteria: hospitalization for the event; Sender's Comments: Sanofi company comment dated 23-Dec-2022: This case involves an unknown age male patient who was vaccinated with Influenza vaccine (produced  by unknown manufacturer) and got flu and subsequently hospitalized . The time to onset is not reported with the role of the vaccine. The clinical course was not provided. Furthermore, additional information regarding condition at the time of vaccination, diagnostic workup, s would be needed for a complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient Had his flu shot, but it still got to him; Initial information received from on 21-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves Adult and unknown gender patient who reported that he/she had a flu shot, but it still got to him after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (with unknown formulation, strength, route, lot number, Expiry date and at unknown administration site) for flu(influenza) .  On an unknown date, the patient was diagnosed with flu (influenza) (unknown latency) following the administration of Influenza vaccine.  No lab data were reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got Influenza A; Initial information received on 21-Dec-2022 regarding an unsolicited valid Social Media non-serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got influenza A after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.    On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for flu.  On an unknown date the patient had a non-serious event of got influenza a (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported  I got the shot and then got Influenza A  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 48.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Hyperventilation, Tremor
Clinical narrative: Systemic: Hyperventilation-Severe, Systemic: Shakiness-Medium, Additional Details: Patient left after receiving the vaccine then the patient's son came back and she was having trouble breathing, the store manager called 911, the patient was given a blanket to keep warm and she drink some water while waiting in the car. The ambulance came, EMT techs took a vitals and transported her to the hospital
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lichen planus
Clinical narrative: Systemic: Lichen planus-Severe
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other concerns issues noted; Nurse calling to report that a patient was administered and expired PNEUMOVAX 23 (pfs) on 11/28/2022./ EXP: Jan 27th 2022; This spontaneous report has been received from a nurse referring to a patient of unspecified age or gender. Information of concurrent condition, medical history, concomitant medication and drug reactions/allergies was not reported.  On 28-NOV-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot# T009743, expiration date 27-JAN-2022, strength, dose, anatomical location and route of administration were unknown) for prophylaxis (expired product administered). No other concerns issues noted (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; GARDASIL 9 was administered after a temperature excursion; This spontaneous report has been received from a medical assistant referring to a patient of unspecified age or gender. Information of concurrent condition, medical history, concomitant medication and drug reactions/allergies was not reported.  On 07-DEC-2022, the patient administered with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot# U019413, expiration date 01-NOV-2023, once, strength, anatomical location and route of administration were unknown) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions at 55 degree Fahrenheit (F) for 15 minutes (product storage error). There was no previous temperature excursion. No additional adverse event (AE) was reported (no adverse event).
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE's; received the MMR II vaccine intravenously versus subcutaneously; This spontaneous report was received from a female patient of unknown age, referring to herself. The patient's medical history, concurrent conditions, and concomitant medication were not provided.   On 09-DEC-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) intravenously instead of subcutaneously for prophylaxis (dose, lot # and expiration date were not reported) (Incorrect route of product administration). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HCP called to report a TE. VARIVAX was stored outside of recommended temperature range and administered to a patient.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-DEC-2022, the patient was vaccinated with an improperly stored dose (improper storage of product in use) of varicella virus vaccine live (oka/merck) (VARIVAX) once, lot #W018836, expiration date: 14-JUN-2024 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. No adverse event was reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No symptomatic side effects reported. No additional AE; MMR-II and VARIVAX were inadvertently administered intramuscularly instead of subcutaneously; This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 22-DEC-2022, the patient was vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (rHA) subcutaneous injection, 0.5 milliliter, (lot number W002787 has been verified to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (rHA), expiration date reported and confirmed as 25-JAN-2024); and with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (lot number W021743 has been verified to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported and confirmed as 10-JUL-2024), inadvertently administered intramuscularly instead of subcutaneously as prophylaxis (Incorrect route of product administration). Other suspect therapies included sterile diluent, solution for injection/infusion (lot number W030217 has been verified to be valid for sterile diluent, expiration date reported and confirmed as 23-MAY-2025) (strength, dose, route of administration, and indication were not provided).  No symptomatic side effects nor additional adverse events (AEs) were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Had a shingles vaccination, got them (shingles); Got them (shingles) for the second time; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The case was received from interactive digital media. The patient had the shingles vaccination and got them again for the second time. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Nervousness, Upper respiratory tract infection
Clinical narrative: Area has been hurting; Upper respiratory infection; Feel shaky; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2022, the patient received the 2nd dose of Shingles vaccine. In December 2022, between 2 and 3 weeks after receiving Shingles vaccine, the patient experienced injection site pain, upper respiratory tract infection and shaky feelings. On an unknown date, the outcome of the injection site pain, upper respiratory tract infection and shaky feelings were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, upper respiratory tract infection and shaky feelings to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-DEC-2022. Reporter's Comment: This case was received from consumer via interactive digital media. The reporter stated that the patient took second shingles shot about 3 weeks ago and for about a week now the area has been hurting and had feeling like the patient had a upper respiratory infection and the patient feel shaky. The reporter want to known could this be a side effect from the vaccine. The follow up would not possible, as no contact details were available.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Adult patient received Infanrix; Expired Infanrix administered; Infanrix instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 63-year-old male patient who received DTPa (Infanrix) (batch number G5BE3, expiry date 25th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th December 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 13th December 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced adult use of a child product, expired vaccine used and wrong vaccine administered. On an unknown date, the outcome of the adult use of a child product, expired vaccine used and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-DEC-2022 Reporter's Comment: The healthcare professional reported that an adult patient received an expired dose of Infanrix instead of Boostrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The adult patient used expired dose of Infanrix instead of Boostrix, which led to adult use of a child product, wrong vaccine administered and expired vaccine used.
Sex: U
Vaccine: RV1
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 09Aug2022, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 6-month-old patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Previously administered products included Rotarix (received 1st dose on 9th August 2022).   On an unknown date, the patient did not  receive the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16 DEC 2022 Reporter's comment: The pharmacist reported that the patient, had not given a second dose and now the patient was over 24 weeks of age.  Reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Rotarix which led to incomplete course of vaccination.
Age: 0.75
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 10 months-old; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th December 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th December 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-Dec-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter told that it would be better to follow-up by phone than by e-mail. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 35.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 35-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA639A, expiry date 31st October 2022) for prophylaxis.   On 14th December 2022, the patient received Menveo. On 14th December 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 16-Dec-2022 Reporter's comment: The health care professional's details were sent by email to safety because there was no permission too create an account on medical information system. The reporter consented to follow-up by email. Additional supportive information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA640Z, expiry date 30th November 2022) for prophylaxis.   On 16th December 2022, the patient received Menveo. On 16th December 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 16-Dec-2022 Reporter's comment: The reporter asked if the patient had to be revaccinated. The reporter did not provide patient information. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: onlydiluent portion was used; only the diluent portionwas administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA756A, expiry date 31st October 2023) for prophylaxis.   On 15th December 2022, the patient received Menveo. On 15th December 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 16-Dec-2022 Reporter's comment: The reporter consented to follow-up via postal. Additional supportive information: The patient received only diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 3.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: 4th DTaP dose at 3 years; 5th DTaP dose not received; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTap (received 3 doses on an unknown date).   On an unknown date, the patient received the 4th dose of DTaP vaccine and did not receive the 5th dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced inappropriate age at vaccine administration and incomplete course of vaccination. On an unknown date, the outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   Additional Information: GSK receipt date: 16-Dec-2022 Reporter's comment: The medical assistant called in to  inquired about the need to administer a 5th dose of Tdap to patient correcting herself later in the call  by saying that it was DTap and not Tdap.  The patient received a 4th dose of DTap when was 3 years old and 11 month of age, stating that they were not aware of the name and just mentioned Dtap, with the specifics of the vaccination not interrogated because the reporter did not know if a GlaxoSmithKline product was involved.  The reporter said that they understand that the 5th dose was not required if the patient receives the 4th dose after age 4 and that the patient was now 8 years old.  The reporter asked that the patient need a 5th dose or she did not knew if this 5th dose would be a GlaxoSmithKline product. The call was very muddled due to the fact that the reporter did not know the name of the vaccine nor the generic formulation of the vaccine which was applied when the patient was 3 years and 11 months old or the one that would be applied now.  The reporter consented to follow-up. Additional supportive information: The patient received 4th dose of DTap at inappropriate age, which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive the 5th dose of DTap, which led to incomplete course of vaccination. In worst approach, only inappropriate age at vaccine administration event was coded for 4th dose as we don't know proper vaccination details for past vaccinations and also it was not clear the interval between the 3rd dose and 4th dose to considered drug dose administration interval too long and the event incomplete course of vaccination was coded for 5th dose considering that the patient did not receive it till the time of reporting and the patient's has cross the age recommendation interval for the vaccination.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 18Jun2022, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 42-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received first dose on 18th June 2022 of batch number 4F3YY and expiry date 1st January 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-Dec-2022 Reporter's comment: The reporter consented to follow-up by postal. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Twinrix, which led to incomplete course of vaccination.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Had a procedure done the same day, it hurt; 21YO received pediatric dose; 21YO received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of pain in a 21-year-old female patient who received HBV (Engerix B pediatric) (batch number P49X7, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th December 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 16th December 2022, less than a day after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced pain, underdose and adult use of a child product. On an unknown date, the outcome of the pain, underdose and adult use of a child product were unknown.   The reporter considered the pain to be unrelated to Engerix B pediatric and Engerix B 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 Information: GSK receipt date: 16-Dec-2022  Reporter's comment: The reporter said that the patient also had a procedure done on the same day and it hurt but clarified that this was not due to the vaccine but to the procedure. The reporter consented to follow-up. Additional supportive information: The patient inadvertently received a pediatric dose of Engerix B, which led to underdose and adult use of a child product. As per reported information the event pain was coded conservatively with causality no and for the further clarification query was raised.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: fever; felt "crummy"; This case was reported by a pharmacist via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and feeling abnormal. On an unknown date, the outcome of the fever and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the fever and feeling abnormal to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-DEC-2022 Reporter's Comment: The reporter was a GSK representative who stated that he was speaking to an HCP(health care professional) pharmacist who shared that her mother experienced symptoms after receiving a dose of Shingrix. The patient experienced 2 days of fever and feeling crummy. The reporter reported that it was unknown if after 1st or 2nd dose of Shingrix The reporter did not consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: fewVx drops come out while administration; few drops come out onto patients arm; few drops come out onto patients arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th August 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 18th August 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK receipt date: 16-Dec-2022 Reporter's comment: The reporter was unsure if complete dose received because a small amount of vaccine seen running down patient's arm after Shingrix administration. The patient received the vaccine in left arm. The reporter did not consent to follow-up. Additional supportive information: While administering the vaccine, the reporter saw a few drops come out onto patient's arm, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; BREATHING ISSUES; This spontaneous report received from a patient via a company representative via social media 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: asthma. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. On an unspecified date, the patient had breathing issues within 20 min of vaccination and used Albuterol inhailer (Dose number in series 1). The outcome of the breathing issues was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had breathing issues (used Albuterol inhailer) within 20 min of vaccination and the patient was ok. The patient got covid (suspected covid-19 infection) and was sick for 5 weeks (Dose number in series 2). It was reported that "I took 2 shots and had breathing issues within 20 min. Each time I took a Covid shot. I had to use my Albuterol inhailer and I was ok. was afraid to take the third one. My doctor wanted me to take the third one and said I would still have the breathing issues with it too. I didn't take it. I got Covid and I was so sick for 5 weeks. Wasn't sure I was going to make it. I have asthma too ".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and breathing issues was not reported. This report was non-serious. This case, involving the same patient is linked. This report was associated with a product quality complaint:
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Dyspnoea, Pain
Clinical narrative: LIFE WENT FROM VERY HEALTHY TO INVALID BENT OVER WITH PAIN; SHORTNESS OF BREATH; OTHER ILLNESSES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was very healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced life went from very healthy to invalid bent over with pain, shortness of breath, and other illnesses. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from other illnesses, and the outcome of life went from very healthy to invalid bent over with pain and shortness of breath was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM STILL HURTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced arm still hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still hurts. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (Cleocin), and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting and the patient stated that she was taking other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: unknown) dose was not reported, 1 in total was administered on 20-MAR-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 56 years old. Concomitant medications included ibuprofen/pseudoephedrine hydrochloride (Advil cold and sinus)  The patient additionally received non-company suspect vaccine Pfizer Biontech Covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin, and were not reported, batch number: FH80Z8 expiry: unknown) dose was not reported, administered on 29-NOV-2021 to left arm for covid-19 prophylaxis.  The patient received non-company suspect vaccine Pfizer Biontech Covid-19 vaccine (tozinameran) (dose number in series 3) ( form of admin, route of admin, and were not reported, batch number: 33025BD expiry: unknown) dose was not reported, administered on 09-JUN-2022 to left arm for covid-19 prophylaxis which was an revaccination with different covid-19 vaccine (dose number in series 3). On NOV-2022, the patient experienced COVID-19 (suspected covid-19 infection) (dose number in series 3). On 29-NOV-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported for covid-19 treatment and last administered on 3-DEC-2022. The patient had reoccurrence of symptoms 3 days after symptoms ended. On 09-DEC-2022, six days after non company suspect drug paxlovid treatment (for covid) laboratory data included: COVID-19 rapid POC test Negative (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: BREATHING ISSUES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced breathing issues. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breathing issues. This report was non-serious. This case, involving the same patient is linked to 20221249819.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Hypothyroidism, Osteoarthritis, Rash
Clinical narrative: shingles rash and blisters on upper left back on scapula area; shingles rash and blisters on upper left back on scapula area; shingles rash and blisters on upper left back on scapula area; This case was reported by a consumer and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included omeprazole, metformin, bupropion, gabapentin and oxycodone.   On 10th December 2022, the patient received Shingrix. On 13th December 2022, 3 days after receiving Shingrix, the patient experienced shingles, rash and blister. On an unknown date, the outcome of the shingles, rash and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-Dec-2022. Reporter's Comment: On 14th October 2004, patient received Ariprozole and lioitir as concomitant for Osteoarthritis, schizophrenia bipolar type I, hypothyroidism. The reporter requested consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Schizoaffective disorder bipolar type, Type 1 diabetes mellitus
Clinical narrative: shingles rash and blisters on upper left back on scapula area; shingles rash and blisters on upper left back on scapula area; shingles rash and blisters on upper left back on scapula area; This case was reported by a consumer and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included omeprazole, metformin, bupropion, gabapentin and oxycodone.   On 10th December 2022, the patient received Shingrix. On 13th December 2022, 3 days after receiving Shingrix, the patient experienced shingles, rash and blister. On an unknown date, the outcome of the shingles, rash and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-Dec-2022. Reporter's Comment: On 14th October 2004, patient received Ariprozole and lioitir as concomitant for Osteoarthritis, schizophrenia bipolar type I, hypothyroidism. The reporter requested consent to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling; Pain; Large red area; This case was reported by a consumer and described the occurrence of swelling in a 66-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included paracetamol (Tylenol Extra Strength).   On 9th December 2022, the patient received Shingles vaccine. On 9th December 2022, less than a day after receiving Shingles vaccine, the patient experienced swelling. In December 2022, the patient experienced pain and erythema. On an unknown date, the outcome of the swelling was not recovered/not resolved and the outcome of the pain and erythema were unknown.   It was unknown if the reporter considered the swelling, pain and erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-DEC-2022 Reporter's Comment: The patient was self-reported this case. The patient reported that she received Shingles vaccine. The patient stated that after received Shingles vaccine she experienced swelling, pain and large red area. The patient stated that her doctor office was aware of situation and they know about her allergies and history of reactions. The patient did not receive the treatment for the swelling. The reporter did not consent to follow up. Additional supportive information: As per reported the concomitant product X S Tylenol conservatively coded Tylenol extra strength.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired vaccine; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and NO ADVERSE EVENT (No Adverse Event) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine).    No concomitant medication was reported. No treatment medication was reported.