chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Physician called to report a dose of GARDASIL 9 was administered to a 15 month old patient. HCP stated no side effects or symptoms have been reported. Lot and expiration date unknown by HCP. No further information reported. No AE/PQC.; This spontaneous report was received from physician and refers to a 15-month-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-JUL-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The patient was vaccinated at the age of 15-months which was too young (Product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine and still got shingles/ Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the vaccine and still got shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUL-2024 This case was reported by consumer via interactive digital media. Reporter reported that the received the Shingles vaccine and still got shingles seems like it never really goes away. Reporter reported that it was terrible. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Therapeutic response unexpected, Vaccination failure, Weight decreased
Clinical narrative: suspected vaccination failure; had the shingles shot twice and still had them; the only good thing is I lost 10 pounds; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had the shingles shot twice and still had them) and unexpected therapeutic effect (Verbatim: the only good thing is I lost 10 pounds). The outcome of the vaccination failure, shingles and unexpected therapeutic effect were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUL-2024 This case was reported by the patient via interactive digital media. The patient had the Shingles shot twice and still had them.  Further he/she reported that the shingles were not to be taken lightly. The only good thing was happened with him/her that he/she lost 10 pounds. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: Product Complaint; Shingrix adjuvant exploded' and leaked all of the adjuvant onto the table and the Medical Assistant; Shingrix adjuvant exploded' and leaked all of the adjuvant onto the table and the Medical Assistant; This non-serious case was reported by a other health professional via call center representative and described the occurrence of exposure via skin contact in a patient who received Herpes zoster (Shingrix) (batch number 2KD99, expiry date 18-APR-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On 17-JUL-2024, an unknown time after receiving Shingrix, the patient experienced exposure via skin contact (Verbatim: Shingrix adjuvant exploded' and leaked all of the adjuvant onto the table and the Medical Assistant) and occupational exposure while preparing product for administration (Verbatim: Shingrix adjuvant exploded' and leaked all of the adjuvant onto the table and the Medical Assistant). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the exposure via skin contact, occupational exposure while preparing product for administration and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt date: 17-JUL-2024 An HCP reported that one vial of Shingrix adjuvant exploded' and leaked all of the adjuvant onto the table and the Medical Assistant who was preparing the dose.  Confirmation that all operations were performed appropriately before defect was discovered.  Details of the complaint written in clear, concise sentences with proper grammar  During preparation for administration the defect was discovered, and the product was not administered its discarded.  The customer did not inject air from the syringe into the vial during preparation. The vial rubber stopper/metallic skirt did not detach or become loose during handling or without any manipulation.  The suspect vial and syringe have been discarded.
Age: 0.17
Sex: M
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received MMR (Priorix) (batch number 7T3HD) for prophylaxis.   On 19-JUL-2024, the patient received Priorix. On 19-JUL-2024, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age). 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: 19-JUL-2024 The nurse reported that one of the medical assistant gave an MMR, a Priorix to a two month patient. The reporter also mentioned that patient also got another vaccines that day but did not specify which ones. The patient received a dose of Priorix at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: an expired dose of Hiberix was administered to a patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received Hib (Hiberix) (batch number 7525P, expiry date 12-JUL-2024) for prophylaxis.   On 15-JUL-2024, the patient received Hiberix. On 15-JUL-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: an expired dose of Hiberix was administered to a patient.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 22-JUL-2024 Clinic manager reported that an expired dose of Hiberix was administered to a patient which led to expired vaccine used.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 6 months later had the second dose administered; Suspected vaccination failure; diagnosed with shingles/outbreak occurred on his back; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In AUG-2023, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed with shingles/outbreak occurred on his back). On an unknown date, the patient experienced drug dose administration interval too long (Verbatim: 6 months later had the second dose administered). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 2 weeks) and the outcome of the drug dose administration interval too long was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 23-JUL-2024 The case was reported by consumer. The reporter stated that he posted on Facebook that he had complete Shingrix series administered and was diagnosed with shingles (lack of effect). The reporter states that he was advised to call GlaxoSmithKline to report. The consumer was unable to provide the dates of vaccination but stated that he had his first dose and six months later had the second dose administered. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The consumer stated that he was diagnosed with shingles in August 2023, the outbreak was occurred on his back. The patient went to urgent care and was given an antiviral to take for 6 to 7 days, applied anti itch cream and outbreak was resolved within 2 weeks. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed events which is considered related to GSK vaccine Shingrix (Dose 1) and Shingrix (Dose 2).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles after full vaccination with Shingrix/Shingles was reported as worsened; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles after full vaccination with Shingrix/Shingles was reported as worsened). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JUL-2024 and 25-JUL-2024 The physician reported that a subsequent dose of Shingles received by the patient and she experienced shingles which was reported as worsened but not serious. Further, the field representative sent message on behalf of health care professional to report a Shingrix problem that patient was fully immunized with vaccine had recurring case of shingles. No other product received by the patient. No more information was provided. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed events which is considered related to GSK vaccine Shingrix.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: RECOMBIVAX HB was inadvertently administered to a 3-month-old baby; not reported an additional AEs; This spontaneous report was received from a physician and refers to a 3-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first and second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, as per standard dosing schedule at 0 and 1 months respectively (strengths, specific dosages, routes of administration, anatomical site sof application, lot numbers and expiration date swere not provided), and the third dose was inadvertently administered at 1 dosage form to the 3-month-old patient (lot number, expiry date, anatomical location and route of administration were not provided) (Inappropriate schedule of product administration), all of them administered for prophylaxis. Physician confirmed that patient had not reported an additional adverse events (No adverse event).  Lot # is being requested and will be submitted if received.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Sinusitis
Clinical narrative: got a secondary sinus infection; got a secondary sinus infection from COVID; This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (got a secondary sinus infection) and COVID-19 (got a secondary sinus infection from COVID) in a 76-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 09-Jul-2024, the patient experienced SINUSITIS (got a secondary sinus infection) and COVID-19 (got a secondary sinus infection from COVID). At the time of the report, SINUSITIS (got a secondary sinus infection) and COVID-19 (got a secondary sinus infection from COVID) had not resolved.            No concomitant medication was reported.  No treatment information was reported.
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red spot and swelling at the injection site; Red spot and swelling at the injection site; This vaccine was the most painful vaccine for her baby; This is a spontaneous report received from a Nurse from a sales representative.  An infant male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "Red spot and swelling at the injection site"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "This vaccine was the most painful vaccine for her baby". It was unknown if therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pain.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive 9 days ago. Tested negative 4 days ago. Tested positive today.; Tested positive 9 days ago. Tested negative 4 days ago. Tested positive today. Primary symptom is bronchitis and stuffy nose and cough. No fever either time.; Tested positive 9 days ago. Tested negative 4 days ago. Tested positive today. Primary symptom is bronchitis and stuffy nose and cough. No fever either time.; This is a spontaneous report received from an Other HCP.  An 81-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bronchiectasis" (unspecified if ongoing). Concomitant medication(s) included: AZITHROMYCIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jul2024, outcome "recovered" (24Jul2024) and all described as "Tested positive 9 days ago. Tested negative 4 days ago. Tested positive today. Primary symptom is bronchitis and stuffy nose and cough. No fever either time."; DISEASE RECURRENCE (medically significant) with onset 28Jul2024 at 03:45, outcome "not recovered", described as "Tested positive 9 days ago. Tested negative 4 days ago. Tested positive today.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2024) Positive, notes: Tested positive 9 days ago; (24Jul2024) Negative, notes: Tested negative 4 days ago; (28Jul2024) Positive, notes: at 03:45. Therapeutic measures were not taken as a result of drug ineffective, covid-19, disease recurrence. Clinical course: Patient had all recommended vaccines and boosters. Patient had no known allergies.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for the event drug ineffective. This case will be reassessed upon receipt of additional information.
Sex: U
Vaccine: RSV
Symptoms: Syringe issue
Clinical narrative: the part broken was the diluent syringe. When they attached the needle the end snapped off; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received respiratory syncytial virus vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown, Expiration Date: 01Mar2025) for immunisation, Device Lot Number: HA3218, Device Expiration Date: Mar2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (medically significant), outcome "unknown", described as "the part broken was the diluent syringe. When they attached the needle the end snapped off".  The reporter considered "the part broken was the diluent syringe. when they attached the needle the end snapped off" not related to respiratory syncytial virus vaccine prot.subunit pref 2v. Causality for "the part broken was the diluent syringe. when they attached the needle the end snapped off" was determined associated to device constituent of respiratory syncytial virus vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for respiratory syncytial virus vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Based on the given information, the Company confirms that the event syringe issue is unrelated to the suspected drug RSV VACCINE PROT.SUBUNIT PREF 2V and most likely to the device constituent of the RSV VACCINE PROT.SUBUNIT PREF 2V.,Linked Report(s) : US-PFIZER INC-202400225060 Same reporter and event, different device;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jun2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "tested positive for COVID". The patient reported via the Paxlovid Call Center stating that she had a booster shot in Jun2024 and she got exposed and tested positive for COVID-19. The patient underwent the following laboratory tests and procedures as aforementioned. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Sepsis; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEPSIS (medically significant), outcome "unknown". Clinical course: Eventually the Covid 19/MRNA would be updated. The reasons were because at the time patient had Sepsis and there might be minor issues with the vaccine that they were not really seeing yet. So for these prevention there would also be a natural blood cleanser that was a red flower extract with vitamins for stagnat blood. Hepatitis clearance, 2 or 3 more vaccines. Being mailed in, patient had a lot going on being in the Military and not being in the house right, so patient requested for some time. Patient will let Pfizer know more details soon.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 4.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was given adacel incorrectly instead of daptacel with no reported adverse event; Initial information received on 22-Jul-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who was administered Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] incorrectly instead of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (jeryl lynn), Rubella Vaccine Live (Wistar RA 27/3), Varicella Zoster Vaccine Live (OKA/Merck) (Proquad), Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Infanrix) and Poliomyelitis Vaccine (inactivated) (IPOL) all for Immunisation.  On 17-Jul-2024, the patient received 0.5 ml of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) incorrectly instead of daptacel with no reported adverse event (wrong product administered) (latency: same day) (lot U8122AA) (expiry date and strength not reported) via intramuscular route in the right vastus lateralis.  Reportedly, Nurse advised that patient has already received 4 doses of DTAP. 3 doses from Infanrix dated 25-Sep-2019 - first dose, 26-Nov-2019 - second dose, 27-Jan-2020 - third dose and DAPTACEL on 26-Oct-2020 as fourth dose.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: DTAP, DTAPIPV, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received DAPTACEL and PCV15, instead of Kinrix and Proquad, with no reproted adverse event; Initial information received on 23-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient who received Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] and PCV15, instead of kinrix and proquad, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PCV 15.   On an unknown date, the patient received a unknown dose of suspect Kinrix and Proquad not produced by Sanofi Pasteur lot number, formulation, strength not reported via unknown route in unknown administration site for all Prophylactic vaccination (Immunization).  On 22-Jul-2024, the patient received a dose of 0.5 ml of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (lot 2CA2AC1 , Expiry date: 04-Nov-2024, strength was unknown) via intramuscular route in the left arm for Prophylactic vaccination (Immunization) and daptacel and pcv15, instead of kinrix and proquad, with no reported adverse event (wrong product administered) following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: Immunisation reaction
Clinical narrative: allergic reaction to vaccines, given in 2013; Initial information received on 25-Jul-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is related to case- 2024SA222414  This case involves an unknown age and unknown gender patient who had allergic reaction to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], given in 2013.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2013, the patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, Suspension for injection, lot U4689BA via unknown route in unknown administration site for immunization (strength, dose, expiry date unknown).  On 19-NOV-2013 the patient had allergic reaction to vaccines, given in 2013 (allergy to vaccine) (unknown latency).  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 allergic reaction to vaccines, given in 2013.; Sender's Comments:  US-SA-2024SA222414:
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 66 year old patient received adacel with no reported adverse event; Initial information received on 25-Jul-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 66 years old female patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-Jul-2024, the patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection TOTAL lot U800AA expiry-10-Feb-2026 via intramuscular route in the left deltoid for immunization (strength, dose unknown) with no reported adverse event (product administered to patient of inappropriate age) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: The patient reported that she noticed some tenderness at the injection site the following day.  Since then, on 7/22/24, she noticed a knot about the size of a marble under the skin where the vaccine was administered.   She reported that she had manipulated the site yesterday thinking that it would help to resolve the knot but reported that it is more tender today and warm to the touch.  She denied fever and reported that there was no wound or drainage in the area.  She confirmed only localized tenderness with the knot.   She was advised to use cool compresses and use OTC pain reliever if needed and to avoid manipulation of the area.  She was also advised that if her symptoms worsen or do not resolve to see her MD.
Age: 59.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site rash, Malaise, Pyrexia
Clinical narrative: fever/sick for   for 2-3 days, rash at the site of injection
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: Patient had  prolonged pain of the left deltoid (over one week) and 10 days following administration of vaccination developed a large, approximately 5-6cm blister/wound over the L deltoid. Reports pus and discharge from wound initially with surrounding erythema.  Did not develop any systemic signs of infection. Was not seen by health care professional  until 29 days after administration at which time the wound had scabbed over and was decreasing in size. No signs of acute infection at the time of evaluation.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Dysphagia, Hypersensitivity, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Pt states that approximately 20 minutes after her vaccination  as she was driving home, she began to have chest tightness, difficulty swallowing, lip, finger, and leg numbness and tingling. She became concerned and immediately drove to a nearby Clinic. She was seen by an NP and observed only for about an hour until symptoms resolved, then was discharged home. The NP told her that she had had an allergic reaction to the vaccine and should not have another of the same type.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Pt states that approximately 20 minutes after her vaccination  as she was driving home, she began to have chest tightness, difficulty swallowing, lip, finger, and leg numbness and tingling. She became concerned and immediately drove to a nearby Clinic. She was seen by an NP and observed only for about an hour until symptoms resolved, then was discharged home. The NP told her that she had had an allergic reaction to the vaccine and should not have another of the same type.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Mass, Rash
Clinical narrative: Knot under skin, rash & swelling at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: Fever (tmax 102.8) that began the next day followed by rash that spread from face to shoulders/chest to trunk and groin associated with itching. Fever for 3 days.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Patient had routine blood work taken and then after Bexero injection was given, the patient had a brief syncopal episode lasting 3-5 seconds.  He was given orange juice and a bottle of water and felt better. EMS was called and evaluated and the mother decided that the patient felt better and she decided to bring him home.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: MMRV and Varicella given SQ in two separate injections instead of MMR and Varicella.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient felt lightheaded and dizzy. Visited emergency department where she received IV fluids and was discharged shortly after.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: Patient was due for DTap and patient's sister, also at the appointment was due for DTap-Hep B-IPV.  Due to administrative error,  patient was given Pediarix instead of Infanrix. I immediately notified the provider and the guardian. Patient did not experience any adverse effects, however the doses of Hep B and Polio were too early and will be invalid.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Hypoacusis, Magnetic resonance imaging, Otorrhoea, Scan with contrast
Clinical narrative: My hearing was slowly going went to the urgent care and they said there was drainage going on in my left ear they then recommended that I take some over the counter medicine which was Sudafed and nose spray. I went to my primary care doctor, she referred me to the ENT visiting the ENT they recommended that I have an MRI under contrast and without contrast. My follow up at the  ENT was devastating after hearing that I was completely deaf in my left ear. I have continuous ringing and wind blowing sounds all throughout the day in my left ear.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: My hearing was slowly going went to the urgent care and they said there was drainage going on in my left ear they then recommended that I take some over the counter medicine which was Sudafed and nose spray. I went to my primary care doctor, she referred me to the ENT visiting the ENT they recommended that I have an MRI under contrast and without contrast. My follow up at the  ENT was devastating after hearing that I was completely deaf in my left ear. I have continuous ringing and wind blowing sounds all throughout the day in my left ear.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: REDNESS AT THE INJECTION SITE LASTS FOR 5 DAYS. REFERED THE PATIENT TO THE PRIMARY PHYSICIAN FOR TREATMENT.
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Infantile vomiting, Oral administration complication, Product administered to patient of inappropriate age
Clinical narrative: A 3 day old patient received their first dose of ROTATEQ. HCP reports patient experienced vomiting immediately after administration.; 3 day old patient received their first dose of ROTATEQ; experienced vomiting immediately after administration; This spontaneous report was received from a nurse and referred to a 3-day-old female patient.  The patient's medical history included full term baby; no other medical history available at time of reporting. The patient's concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2024, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #Y006298, (expiration date: 04-APR-2025), administered orally for prophylaxis (strength and dose were not provided) (product administered to patient of inappropriate age).  The patient experienced vomiting immediately after administration (infantile vomiting, accidental underdose). No treatment was administered. The patient was in office at time of report. No other symptoms reported. Consent to correspond was provided. The outcome of infantile vomiting was unknown at the time of reporting.  The causal relationship between infantile vomiting and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This patient received their second dose in 05/2023 and they did not complete the series.; No symptoms reported and no additional details provided. No other AE and no PQC; This spontaneous report has been received from a pharmacist concerning a 21-year-old.  The patient's medical, concurrent conditions and concomitant therapies were not reported.   On an unknown date in May 2023, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) and they did not complete the series (Inappropriate schedule of vaccine administered). No symptoms reported and no additional details provided. The operator of device was health care professional.   Lot # is being requested and will be submitted if received.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Glaucoma
Clinical narrative: The patient is suffering from Glaucoma; This spontaneous case was reported by a patient and describes the occurrence of GLAUCOMA (The patient is suffering from Glaucoma) in a 75-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced GLAUCOMA (The patient is suffering from Glaucoma) (seriousness criterion medically significant). At the time of the report, GLAUCOMA (The patient is suffering from Glaucoma) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient was suffering from Glaucoma.  The patient did not received vaccine in the last 4 weeks.  Treatment information was not provided.  Company Comment: This is a Regulatory case concerning a 75-year-old male patient with no medical history reported, who experienced the serious (per medically significant) unexpected event of Glaucoma. The event occurred on an unknown date and onset latency after a dose of SPIKEVAX 2023-2024 received for COVID-19 Vaccination schedule. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. In view of the lack of biological plausibility and information on temporality causality remains not related. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-771658 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-771658:Wife case
Age: 4.0
Sex: F
Vaccine: HEPA, MMRV, PNC13, PNC20
Symptoms: Condition aggravated, Crying, Dermatitis atopic, Pruritus, Urticaria
Clinical narrative: Patient began to cry about and scratch at her skin that had a pre-existing severe flare up of atopic dermatitis. Suprasternal retraction was noted but lungs were clear. Few small urticarial lesions were noted on the face and trunk. Patient was given Cetirizine 5mg PO and Dexamethasone 10.4 mg.  Albuterol nebulizer was given but patient was only compliant for about 5 minutes. Patient was observed in the office for 75 minutes. She was discharged home with no further itching and decrease in urticaria.
Age: 4.0
Sex: F
Vaccine: HEPA, MMRV, PNC13, PNC20
Symptoms: Use of accessory respiratory muscles
Clinical narrative: Patient began to cry about and scratch at her skin that had a pre-existing severe flare up of atopic dermatitis. Suprasternal retraction was noted but lungs were clear. Few small urticarial lesions were noted on the face and trunk. Patient was given Cetirizine 5mg PO and Dexamethasone 10.4 mg.  Albuterol nebulizer was given but patient was only compliant for about 5 minutes. Patient was observed in the office for 75 minutes. She was discharged home with no further itching and decrease in urticaria.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Muscle contractions involuntary, Muscle twitching, Neck pain, Pain
Clinical narrative: pain radiating from her left shoulder area to her neck; pain radiating from her left shoulder; pain radiating from her left shoulder area to her neck; patient also reports muscle twitching; fasciculations; This non-serious case was reported by a consumer via call center representative and described the occurrence of radiating pain in a 35-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included wound (cut her pinky finger on her left hand 5th finger). Concomitant products included paracetamol (Acetaminophen).   On 12-JUN-2024, the patient received Boostrix (intramuscular, left deltoid) .5 ml. In JUN-2024, 12 hrs after receiving Boostrix, the patient experienced radiating pain (Verbatim: pain radiating from her left shoulder area to her neck), muscle twitching (Verbatim: patient also reports muscle twitching), fasciculation (Verbatim: fasciculations), shoulder pain (Verbatim: pain radiating from her left shoulder) and neck pain (Verbatim: pain radiating from her left shoulder area to her neck). In JUN-2024, the outcome of the radiating pain, shoulder pain and neck pain were resolved. The outcome of the muscle twitching and fasciculation were not resolved.   It was unknown if the reporter considered the radiating pain, muscle twitching, fasciculation, shoulder pain and neck pain to be related to Boostrix.     It was unknown if the company considered the radiating pain, muscle twitching, fasciculation, shoulder pain and neck pain to be related to Boostrix.   Additional Information: GSK Receipt Date: 17-JUL-2024 The reporter was a patient who cut her pinky finger on her left hand.  The patient received vaccine for tetanus prophylaxis for wound management. The patient did not had the lot number of vaccine. The patient stated that 12 hours after receiving the vaccine she had pain radiating from her left shoulder area to her neck. As per patient, the radiating pain resolved in 2 to 3 days. The patient also reported that muscle twitching throughout her body from her chin down occurring 12 hours after receiving the vaccine. The patient stated that the muscle twitching had not resolved yet. The patient concomitant included as supplements OTC vitamins and Magnesium. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Pain, Pain in extremity, Pruritus
Clinical narrative: I have terrible itching, stinging, and stabbing pain in my arm. It started right after I received the Shingrix injection in my left arm and lasted for a year off and on. It is worse at night. Then it moved to my right arm. It itches and hurts so bad sometimes that I want to scream. I break out with little pustules that ooze and bleed. My Doctor has suggested Ice, Acyclovir cream and pills, and lidocaine patches. All of them help for a while. I have to have ice or pain patch on my arm to sleep at night. I am going to see a neurologist next to try to get some relief. I have shingles every day!
Sex: F
Vaccine: VARZOS
Symptoms: Pustule, Skin haemorrhage, Skin weeping, Sleep disorder
Clinical narrative: I have terrible itching, stinging, and stabbing pain in my arm. It started right after I received the Shingrix injection in my left arm and lasted for a year off and on. It is worse at night. Then it moved to my right arm. It itches and hurts so bad sometimes that I want to scream. I break out with little pustules that ooze and bleed. My Doctor has suggested Ice, Acyclovir cream and pills, and lidocaine patches. All of them help for a while. I have to have ice or pain patch on my arm to sleep at night. I am going to see a neurologist next to try to get some relief. I have shingles every day!
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Rash
Clinical narrative: The patient received a vaccine and 20 minutes after administration reported itching and rash in the back, chest, and neck area.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPV9
Symptoms: Electrocardiogram, Eye movement disorder, Hyperhidrosis, Opisthotonus, Pallor
Clinical narrative: Patient received her Hep B, Hep A and HPV vaccine in the office today. Roughly 10 minutes later, she was at check out with her mom and reportedly had a seizure. Mom reports Patient was standing at checkout when she arched her back, her eyes rolled back and she fell onto mom who was sitting in the chair at checkout. She began convulsing. Patient's eyes were open and fixed when I got to her, she was pale with dusty lips, she was not responding, there was no noted convulsing. Her legs were tangled beneath her and she was draped over moms R shoulder. Patient quickly started responding to me thereafter. We got an emesis bag just as she started dry heaving. She became very pale again with drenching diaphoresis, stated her vision was blurry. She asked to reposition herself in mom's lap.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPV9
Symptoms: Pupil fixed, Retching, Seizure, Unresponsive to stimuli, Vision blurred
Clinical narrative: Patient received her Hep B, Hep A and HPV vaccine in the office today. Roughly 10 minutes later, she was at check out with her mom and reportedly had a seizure. Mom reports Patient was standing at checkout when she arched her back, her eyes rolled back and she fell onto mom who was sitting in the chair at checkout. She began convulsing. Patient's eyes were open and fixed when I got to her, she was pale with dusty lips, she was not responding, there was no noted convulsing. Her legs were tangled beneath her and she was draped over moms R shoulder. Patient quickly started responding to me thereafter. We got an emesis bag just as she started dry heaving. She became very pale again with drenching diaphoresis, stated her vision was blurry. She asked to reposition herself in mom's lap.
Age: 38.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Axillary mass, Axillary pain, Injection site pain, Pain
Clinical narrative: Patient stated arm was sore to lift and sore at administration site since vaccine but she assumed that could happen. She stated reason for call was because a lump had formed under arm in armpit and was sore to lift
Age: 38.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain, Oedema peripheral, Pain
Clinical narrative: Patient stated arm was sore to lift and sore at administration site since vaccine but she assumed that could happen. She stated reason for call was because a lump had formed under arm in armpit and was sore to lift
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Pt had gotten a Meningococcal ACWY on 5/17/24 came to campus and I did not see the documented dose on 5/17/24. I gave an additional dose of MenQuadfi on 7/15/24