chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: their right arm was numb all the way up and down the arm; This spontaneous report was received from a registered pharmacist (R. Ph.) concerning to a 36-year-old male patient.  The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On 09-JUL-2024, the patient received routine vaccination concomitantly at pharmacy with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, 0.5 milliliter/two or three dose series, lot #X022735, expiration date 12-APR-2026, administered intramuscularly (IM) in the left arm as prophylaxis; and the 1st dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX) (exact dose, formulation, lot #, and expiry date were not provided) administered IM in the right arm for human papilloma virus immunisation.  On the same date, the patient experienced vaccination site hypoaesthesia. It was reported that on 10-JUL-2024, patient returned to the pharmacy to report his right arm was numb all the way up and down the arm. Pharmacist stated that they directed the patient to seek medical attention from their physician or came back to the pharmacy if the symptoms did not go away.  Pharmacist then stated that the patient returned on 16-JUL-2024 (also reported as "today"), to inform that numbness had not gone away and was mostly in the right hand down the index/middle fingers. Pharmacist directed the patient to seek medical attention from their physician regarding their symptoms once again. It was stated that patient did not provide any details regarding if he sought any medical attention or was provided any treatments for their symptoms after being administered the vaccines.  At the reporting time, the patient had not recovered from the event. Reporter stated they did not have any additional details to report regarding this adverse event.  The causal relationship between vaccination site hypoaesthesia and the suspect vaccines was not reported.
Age: 3.0
Sex: U
Vaccine: HEPA, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE where product was administered to a patient; This spontaneous report has been received from other health care professional concerning to a 3-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 14-JUN-2024, the hepatitis A vaccine, inactivated (VAQTA) vaccine experienced a temperature excursion (TE) above 47 Fahrenheit degrees (F) (51.0 F) for 446 hours 0 minutes and 0 seconds, and subsequently, on 19-JUN-2024, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) 25/0.5 (units not provided) intramuscular injection, at a dose of 0.5 mL, lot number X015939 that was verified to be a valid lot number (expiration date reported and validated as 05-DEC-2024) as prophylaxis (scheme frequency, route and anatomical location of administration were not provided) (product storage error). No prior excursions and no additional adverse event (AE) were reported.  No further information was provided.
Age: 3.0
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE; TE where product was administered to a patient; This spontaneous report has been received from other health care professional concerning to a 3-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 14-JUN-2024, the hepatitis A vaccine, inactivated (VAQTA) vaccine experienced a temperature excursion (TE) above 47 Fahrenheit degrees (F) (51.0 F) for 446 hours 0 minutes and 0 seconds, and subsequently, on 19-JUN-2024, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) 25/0.5 (units not provided) intramuscular injection, at a dose of 0.5 mL, lot number X015939 that was verified to be a valid lot number (expiration date reported and validated as 05-DEC-2024) as prophylaxis (scheme frequency, route and anatomical location of administration were not provided) (product storage error). No prior excursions and no additional adverse event (AE) were reported.  No further information was provided.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additional AE/PQC; HCP called to report TE where product was administered to a patient. No further information provided. No Additional AE/PQC.    VAQTA:x015939  exp: 12/05/2024  ABOVE 47°F (51.0F) for 240 hours 0 minutes and 0 seconds - CURRENT NO PRIOR EXCURSIONS; This spontaneous report was received from a Health Care Professional (HCP) concerning a 12-year-old patient. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 14-JUN-2024, a temperature excursion (TE) of hepatitis a vaccine, inactivated (VAQTA) occurred. Above 47°F (51.0F) for 446 hours 0 minutes and 0 seconds. On 18-JUN-2024, the patient was vaccinated with the hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot # X015939, expiration date: 05-DEC-2024 (route and frequency were not reported) for prophylaxis (product storage error).       No prior excursions. No Additional AE/PQC.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; VARIVAX was administered after temperature excursion.; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 09-AUG-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # X001000, expiration date 09-JAN-2025 (dose, route and frequency were not reported) for prophylaxis.     The vaccine was exposed to a temperature of -6°C during 48 hours. There were no previous temperature excursions. No additional adverse events or PQC were reported.
Sex: M
Vaccine: MMR
Symptoms: Eyelid ptosis
Clinical narrative: patient received MMR vaccine, within a few days, patient developed a "droopy eye"; This spontaneous report was received from the patient's father via company representative concerning a male patient of unknown age. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (also reported as MMR vaccine) injection, administered for prophylaxis (strength, dose, frequency, lot #, expiry date, route of administration, and anatomical location were not provided).  On an unknown date (also reported as within a few days), the patient developed a droopy eye and was seeing by a pediatrician. The outcome of the event was unknown.  Causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the event was not provided.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; current below excursions where products were administered.; This spontaneous report was received from a Medical Assistant and refers to a 12-month-old female patient.  The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 12-AUG-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection 2.5/0.5, at a dose of 0.5 milliliter, lot #Y008285, expiration date: 24-NOV-2025, administered for prophylaxis (anatomical location and route of administration were not provided). The vaccine administered experienced two temperature excursions, one of 0.9 degree Celsius for 24 hours, 40 minutes and 0 seconds and one of minus 1.1 degree Celsius for 0 hours, 20 minutes and 0 seconds (product storage error). There were no previous excursions, and no additional adverse event reported.
Sex: F
Vaccine: HEPA
Symptoms: Device connection issue, Occupational exposure to product, Syringe issue
Clinical narrative: luer lok kept spinning and the contents of the syringe splattered out onto the medical assistant attempting to administer the vaccine; luer lok kept spinning and the contents of the syringe splattered out onto the medical assistant attempting to administer the vaccine; leak between the syringe tip and luer lock/luer lock kept spinning; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received HAV (Havrix 1440 adult) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Havrix 1440 adult. On an unknown date, an unknown time after receiving Havrix 1440 adult, the patient experienced occupational exposure while preparing product for administration (Verbatim: luer lok kept spinning and the contents of the syringe splattered out onto the medical assistant attempting to administer the vaccine), inadvertent exposure to vaccine (Verbatim: luer lok kept spinning and the contents of the syringe splattered out onto the medical assistant attempting to administer the vaccine), syringe leak (Verbatim: leak between the syringe tip and luer lock/luer lock kept spinning) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the occupational exposure while preparing product for administration was resolved and the outcome of the inadvertent exposure to vaccine and syringe leak were not reported and the outcome of the pharmaceutical product complaint 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: 06-AUG-2024 The reporter was the nurse and clinical manager at the Healthcare professional office. Reported that while attempting to administer the Havrix Adult vaccine, the luer lock kept spinning (PQC) and the contents of the syringe splattered out onto the medical assistant attempting to administer the Havrix. All operations were performed appropriately. The nurse was experienced.  The defect was discovered during preparation for administration.  There was no product administered. The component involved was the pre-filled syringe.  It was Luer lok needle prevent McKesson, 25-gauge 1 inch, safety hypodermic needle. The customer did not continue to screw it on. The nurse attempted to rotate it locked, however it kept spinning and did not lock. Yes, it did leak between the syringe tip and LLA causing it to splatter on the MA hands and arm.  There was only the syringe that was available for return. The needle was placed in sharps immediately following this incident.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number KJ937, expiry date 11-JUN-2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th March 2022) and Shingrix (2nd dose received on 08th July 2022).   On 14-NOV-2022, the patient received the 3rd dose of Shingrix. On 14-NOV-2022, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose was administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 06-AUG-2024 A pharmacist called to inform that back in 2022, a patient had received a 3rd dose of Shingrix which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2023, Batch number 7L777, expiry date 23 August 2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 06-AUG-2024 Pharmacist explained that a patient got first dose of Shingrix in August 2023 and now they are looking to get a 2nd dose but it would be later than 6 months. Caller did not have any patient demographics. Pharmacist gave consent to follow up with Safety Team but only by phone, and did not want to provide an email address. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax and Shingrix (1st dose received on 19th April 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 06-AUG-2024 The reporter stated that she was told she had Shingrix dose 1 on 19 April 2021. Lot number 53156 (not found in GSK system). The print out information she received stated it was given at her Obgyn. She called the Healthcare professional office and they stated they do not have or give Shingrix there. She spoked with registered pharmacist and told her the stated makes mistakes all the time and to reach out to the State Health department to verify. They could not help her with the information. She was adamant about not getting Shingrix ever. She did state she had Zostavax years ago. She will call the insurance company she had in 2021 to see if they have any information.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: MENB
Symptoms: Incorrect route of product administration
Clinical narrative: Bexsero administered Subcutaneous route; This non-serious case was reported by a physician via sales rep and described the occurrence of intramuscular formulation administered by other route in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero (subcutaneous). On an unknown date, an unknown time after receiving Bexsero, the patient experienced intramuscular formulation administered by other route (Verbatim: Bexsero administered Subcutaneous route). The outcome of the intramuscular formulation administered by other route 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: 06-AUG-2024 A request was made from a field representative for a healthcare professional with the question that Bexsero was administered Subcutaneous and was it still effective or does it need to be re-administered intramuscular which led to intramuscular formulation administered by other route. No more information was provided. This case is linked to US2024099776, same reporter.; Sender's Comments:  US-GSK-US2024099776:Same reporter
Age: 15.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: 15 year old patient accidentally received Infanrix instead of Boostrix; 15 year old patient accidentally received Infanrix instead of Boostrix; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received DTPa (Infanrix) (batch number 42RC4) for prophylaxis.   Previously administered products included Dtp vaccine (1st dose received on 5th October 2009), Dtp vaccine (2nd dose received on 4th December 2009), Dtp vaccine (3rd dose received on 17 February 2010), Dtp vaccine (4th dose received on 03 November 2010) and Dtp vaccine (5th dose received on 22nd October 2015).   On 01-SEP-2020, the patient received Infanrix. On 01-SEP-2020, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 15 year old patient accidentally received Infanrix instead of Boostrix) and accidental underdose (Verbatim: 15 year old patient accidentally received Infanrix instead of Boostrix). The outcome of the inappropriate age at vaccine administration and accidental underdose 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: 06-AUG-2024 Physician stated that they just realized that a 15 year old patient accidentally received Infanrix instead of Boostrix back on September 1st 2020 which led to inappropriate age at vaccine administration and accidental underdose. Patient received 5 prior Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccines (unknown if it was also Infanrix, since lot number and expiration date were unknown by caller).
Sex: U
Vaccine: COVID19, UNK
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: DEEP VEIN THROMBOSIS (DVT); PULMONARY EMBOLISM (PE); This solicited report received from a patient via Janssen. 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 (dose series 1), administered on 01-NOV-2020 for COVID-19 prophylaxis. The batch number was not reported. The company is unable to request the batch number. The patient was treated with rivaroxaban (film-coated tablet, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication.  No concomitant medications were reported.  On 07-Aug-2024, the patient developed a Deep Vein Thrombosis (DVT) and a Pulmonary Embolism (PE) (dose series 1) after taking the Covid-19 Vaccine. The action taken with rivaroxaban was not reported, and action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the deep vein thrombosis (DVT) and pulmonary embolism (PE) was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s and rivaroxaban, and deep vein thrombosis (dvt), and pulmonary embolism (pe) was  not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: COVID-19 VACCINE AD26.COV2.S: The event shows an incompatible temporal association, hence causality for the event is assessed as INCONSITENT with vaccine administration  for both the events RIVAROXABAN :  The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. Therefore, these events are considered not related.
Age: 11.0
Sex: M
Vaccine: DTAP, DTAP, DTAPIPVHIB, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: patient was supposed to be administered ADACEL then MENACTRA, but instead of MENACTRA, the patient was administered DAPTACEL, with no reported adverse event; Initial information received on 07-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who was supposed to be administered Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] then menactra, but instead of Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra], the patient was administered Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] , with no reported adverse event and Infanrix (Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a  dose of 0.5 ml of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine  (suspension for injection) lot C4800AA,expiry date: 10-Feb-2026, strength was unknown via intramuscular route in unknown administration site for prophylactic vaccination (Immunization). On 26-Feb-2013, the patient received a  dose of 0.5 ml of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine (solution for injection) lot 67908AB via intramuscular route in unknown administration site, received a  dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Powder and suspension for suspension for injection) lot UJ800AA,expiry date : 02-Oct-2026,strength was unknown via intramuscular route in the right arm and also received a  dose of suspect Infanrix not produced by Sanofi Pasteur formulation, strength, expiry date, lot number not reported via unknown route in unknown administration site for all Prophylactic vaccination (Immunization).  On 07-AUG-2024 the patient was supposed to be administered adacel then menactra, but instead of menactra, the patient was administered daptacel, with no reported adverse event (wrong product administered) (unknown latency) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, Meningococcal A-C-Y-W135 (D CONJ) Vaccine, (latency: 11 years 5 months 12 days) following the administration of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine,  Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine and Infanrix.   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: 86.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of expired dose of tenivac with no reported adverse event; Initial information received on 08-Aug-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to case Ids- 2024SA238706, 2024SA237643, 2024SA238692, 2024SA237702, 2024SA237436, 2024SA237469, 2024SA237418  This case involves a 86 years old female patient with inappropriate use due to administration of expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Oct-2023, the patient received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, 0.5 ml TOTAL, Suspension for injection lot U7183AA expiry date-24-Sep-2023 via intramuscular route in the right deltoid for Prophylactic vaccination (Immunisation) (strength unknown) with no reported adverse event (expired product administered) (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.; Sender's Comments:  US-SA-2024SA237418: US-SA-2024SA237469: US-SA-2024SA237436: US-SA-2024SA237702: US-SA-2024SA237643: US-SA-2024SA238706:
Age: 80.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: received the expired vaccine (with no adverse event); Initial information received on 08-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to 2024SA239137, 2024SA237469, 2024SA237702, 2024SA237436, 2024SA237643, 2024SA237436,.  This case involves a 80 years old female patient who received the expired Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] vaccine (with no adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) ,Concomitant medications and family history were not provided.   On 10-May-2024, the patient received a dose of 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (Suspension for injection) (lot U7183AA, Expiry date: 24-Sep-2023, strength was unknown) via intramuscular route in the left deltoid for Immunization and received the expired vaccine (with no adverse event) (expired product administered) (latency: same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administering an expired dose of TENIVAC to patients."  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.; Sender's Comments:  US-SA-2024SA239137: US-SA-2024SA237469: US-SA-2024SA237702: US-SA-2024SA237436: US-SA-2024SA237643:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear pain, Fatigue, Headache, Injection site erythema
Clinical narrative: Pain, redness, swelling at injection site. Muscle pain, aching body, tiredness, headache, shivering, fever, earache, sore throat.  Told to take Tylenol, stay hydrated and rest.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Oropharyngeal pain, Pain
Clinical narrative: Pain, redness, swelling at injection site. Muscle pain, aching body, tiredness, headache, shivering, fever, earache, sore throat.  Told to take Tylenol, stay hydrated and rest.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain, redness, swelling at injection site. Muscle pain, aching body, tiredness, headache, shivering, fever, earache, sore throat.  Told to take Tylenol, stay hydrated and rest.
Age: 62.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Per patient, the next day, she started feeling fever, tired, and had some redness that went away (at the injection site). On Monday, patient reports having redness around 1 inch below vaccination site where it was extremely red , heat coming off of skin, and itchiness. On Thursday, patient reports that the redness and swelling has decreased. Patient has been using warm compress on her arm.
Age: 62.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Pyrexia
Clinical narrative: Per patient, the next day, she started feeling fever, tired, and had some redness that went away (at the injection site). On Monday, patient reports having redness around 1 inch below vaccination site where it was extremely red , heat coming off of skin, and itchiness. On Thursday, patient reports that the redness and swelling has decreased. Patient has been using warm compress on her arm.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (over 2 years ago received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 06-AUG-2024 A reporter reported that a patient received 1st dose of Shingrix over 2 years ago and was back today (06 August 2024) to receive the 2nd dose.  Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 33.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; Inappropriate age at vaccine administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 33-year-old female patient who received Men B NVS (Bexsero) (batch number FH443, expiry date 30-SEP-2027) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On 08-AUG-2024, the patient received the 2nd dose of Bexsero. On 11-JUL-2024, the patient received the 1st dose of Bexsero. On 11-JUL-2024, not applicable after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On 08-AUG-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-AUG-2024 The pharmacist reported that, he administered Bexsero second dose at the pharmacy to a patient but was day 28 instead of day 30.  The patient was 33 and received 2 dosed of Bexsero which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Decreased appetite, Malaise, Nausea, Nightmare, Pyrexia
Clinical narrative: Fever 101 degrees for 2 days , nausea and vomiting , lack of appetite , general malaise , nightmares ,
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: Fever 101 degrees for 2 days , nausea and vomiting , lack of appetite , general malaise , nightmares ,
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: redness around the injection area extended to about 4-5inch diameter, pt had fever.
Age: 18.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Eye pain
Clinical narrative: Patient presented back to my office on 8/15/24 complaining of more than a week of arthralgias without arthritis, persistent ha, one episode of diarrhea and some mild nasal congestion that started after the shot was given.  She reports chills but no known fever.  Complains eyes aches for a day but is no better.  Dizziness briefly during this time frame as well.
Age: 18.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Nasal congestion
Clinical narrative: Patient presented back to my office on 8/15/24 complaining of more than a week of arthralgias without arthritis, persistent ha, one episode of diarrhea and some mild nasal congestion that started after the shot was given.  She reports chills but no known fever.  Complains eyes aches for a day but is no better.  Dizziness briefly during this time frame as well.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Feeling hot, Flushing, Rash
Clinical narrative: RASH ON FACE AND LEGS, FEELS FLUSHED/ WARM AND DIZZY
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Cardiac monitoring, Malaise
Clinical narrative: Felt sick, was in hospital
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site haematoma
Clinical narrative: Donor called center on 8/14/24 at 7pm and reported hematoma/bruise to right deltoid donor states hematoma is approx 3x2 inches in size.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Injection site pruritus, Local reaction, Oedema peripheral, Skin warm
Clinical narrative: FATHER BROUGHT PATIENT IN STATES PATIENT IS HAVING A REACTION DUE TO A VACCINE  IN THE RIGHT DELTOID. PATIENT HAD TDAP IN THE RIGHT DELTOID ON 8/12/24. FATHER STATES  REACTION BEGAN ON 8/13/24. FATHER STATES THEY HAVE NOT GAVE HER ANY MEDICATIONS  FOR REACTION. SMALL LOCAL REACTION SLIGHTLY WARM TO TOUCH MILD EDEMA PRESENT.  FATHER DOES STATES ARM LOOKS MUCH BETTER THIS MORNING (08/16/2024) THAN IT DID YESTERDAY. PHOTO SENT TO APN WITH FATHER VERBAL CONSENT SPOKE TO APN ON THE PHONE  SHE LOOKED AT PICTURE SENT. STATES FATHER TO PROVIDE COOL COMPRESS TO SITE, AND  GIVE BENADRYL IF SITE IS ITCHING AND NEEDED, AND GIVE PATIETNT TYLENOL AND IBUPROFEN  AS NEEDED. FATHER AWARE OF ALL THIS. PATIENT STATES SHE HAS BEEN SCRATCHING IT BUT IT  IS NOT AS " ITCHY " TODAY (08/16/2024). FATHER AWARE IF SITE GETS WORSE OR HAS ANY CONCERNS  CAN CONTACT THE HEALTH DEPARTMENT, TAKE CHILD TO THE NEAREST ER, OR FOLLOW UP  WITH HER PCP. PATIENT IS RETURNING TO SCHOOL THIS DATE.
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blindness unilateral, Laboratory test
Clinical narrative: Lost of vision Of the left eye. I have been through a lot  of testing and still don't have a diagnostic. the vaccine was the only different thing i did around that time.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram head normal, Depressed level of consciousness, Drooling, Dysarthria, Facial paralysis
Clinical narrative: While napping, he began to exhibit tremors evident in legs and feet. He was difficult to arouse. When he was aroused, the left side of his face was droopy, he exhibited slurred speech, and was drooling.  This was over a matter of minutes. After two minutes, he was back to normal cognition but the facial droop and slurred speech remained. He was then taken to the emergency room.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Full blood count normal, Metabolic function test normal, Red blood cell sedimentation rate normal, Tremor
Clinical narrative: While napping, he began to exhibit tremors evident in legs and feet. He was difficult to arouse. When he was aroused, the left side of his face was droopy, he exhibited slurred speech, and was drooling.  This was over a matter of minutes. After two minutes, he was back to normal cognition but the facial droop and slurred speech remained. He was then taken to the emergency room.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: MOM NOTICED REDNESS AND SWELLING TO SITE WHEN REMOVING BANDAID BEFORE BATHTIME.  PT REPORTS SOME ITCHING AND DISCOMFORT.  SEEN IN THE ER ON 8-13-24 RIGHT ANTERIORTHIGHT WITH AREA APPROX 7CM DIAMETER WARM AND ERYTHEMATOUS, AREA OF INDURATION W/O FLATUANCE.  RETURNED TO ER ON 8-14-24 DUE TO INCREASING SIZE OF REDNESS, MEASURING APPROX 14.5-16 CM , WARM TO TOUCH AND ERYTHEMATOUS  NO FLACTUANCE OR INDURANTION.  SEEN IN CLINIC ON 8-15-24 @8AM RED,WARM TO TOUCH ERYTHEMATOUS AREA 20-24 CM.  PRESCRIBED KEFLEX, ZYRTEC AND COOL COMPRESSES.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: MOM NOTICED REDNESS AND SWELLING TO SITE WHEN REMOVING BANDAID BEFORE BATHTIME.  PT REPORTS SOME ITCHING AND DISCOMFORT.  SEEN IN THE ER ON 8-13-24 RIGHT ANTERIORTHIGHT WITH AREA APPROX 7CM DIAMETER WARM AND ERYTHEMATOUS, AREA OF INDURATION W/O FLATUANCE.  RETURNED TO ER ON 8-14-24 DUE TO INCREASING SIZE OF REDNESS, MEASURING APPROX 14.5-16 CM , WARM TO TOUCH AND ERYTHEMATOUS  NO FLACTUANCE OR INDURANTION.  SEEN IN CLINIC ON 8-15-24 @8AM RED,WARM TO TOUCH ERYTHEMATOUS AREA 20-24 CM.  PRESCRIBED KEFLEX, ZYRTEC AND COOL COMPRESSES.
Age: 77.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Severe redness, swelling, pain and itching around injection site has been  present since the date of the injection on Monday until the present date August 16.  It has diminished some since then but still red, swollen and itching.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose decreased, Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: patient's wife requested assistance because patient was having anaphylactic reaction she said but once i stepped over there to administer the epipen, she said his blood sugar was just really low. ems arrived, talked to the patient, then left and sent him home. i gave him a water and one of those glucose shots to raise his blood sugar., Other Vaccines:  VaccineTypeBrand: influenza (flublok trivalent); Manufacturer: sanofi; LotNumber: u8440aa; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 08/11/2024
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Bradycardia, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Unsustained bradycardia. Pt reported he felt like his mouth started to "salivate", Other Vaccines:  VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus; LotNumber: 946588; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: 08/11/2024, VaccineTypeBrand: Tdap; Manufacturer: Boostrix; LotNumber: 5YB5G; Route: IM; BodySite: Right arm; Dose: ; VaxDate: 08/11/2024
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Salivary hypersecretion, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Unsustained bradycardia. Pt reported he felt like his mouth started to "salivate", Other Vaccines:  VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus; LotNumber: 946588; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: 08/11/2024, VaccineTypeBrand: Tdap; Manufacturer: Boostrix; LotNumber: 5YB5G; Route: IM; BodySite: Right arm; Dose: ; VaxDate: 08/11/2024
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: severe shoulder pain-Severe, Systemic: Joint Pain-Severe, Additional Details: severe pain in shoulder. Spoke with mom and dad and refered pt to primary doctor
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Systemic: left foot pain and tingling sensation-Mild
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Tremor, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: pt was not responding when I asked questions-Mild, Additional Details: pt picked up rx and i asked if he wanted to get his hep B vaccine. It was his 2nd dose. at the time he seemed alert and was aware of the interaction. after the injection he said it hurt a little and after felt a little shaky. i gave him water and he sat down and i checked on him a couple of times. i asked if there was anyone i can call but he never responded and i told him i would call the paramedics just to check out if everything was okay. paramedics came and took him
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Flushing, Headache
Clinical narrative: Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Lethargy
Clinical narrative: Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fall, Gait disturbance, Injection site pain, Walking aid user
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: WEAKNESS, HAD A HARD TIME WALKING, NEED WALKER-Severe, Additional Details: PT FELL 1 TIME WHILE USING THE WALKER. HAD NO STRENGTH TO LIFT SELF UP. PT HAS AN APPOINTMENT WITH DR ON 8/13/24
Age: 5.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: nothing adverse occurred
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Fatigue, Gamma-glutamyltransferase increased, Hepatic enzyme increased
Clinical narrative: The patient was having fatigue and then was identified as having elevated liver enzymes on 8/10/24.  Repeat liver enzymes were obtained on 8/14/24 and were similar.  Admitted to the hospital on 8/15/24 with plan to do liver biopsy.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: localized redness and swelling at injection site. Mom describes it as hot to the touch and itchy.
Age: 72.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Arthralgia, Visual impairment
Clinical narrative: Visual distortion of grey curtain over part of left eye vision, and knee pain after exercise
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Brain fog, Chest pain, Dizziness, Dizziness postural, Fatigue
Clinical narrative: Immediate dizziness, "brain fog", palpitations, exhaustion. No vision changes. Had chest pain the following day. Has dizziness with standing and position changes still and reports persistent "brain fog."
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Palpitations
Clinical narrative: Immediate dizziness, "brain fog", palpitations, exhaustion. No vision changes. Had chest pain the following day. Has dizziness with standing and position changes still and reports persistent "brain fog."
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site inflammation, Injection site swelling
Clinical narrative: GREENISH INFLAMED SWELLING AT SITE OF INJECTION
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient got administered the Flu shot by error since he had just gotten it 7/23/2024
Age: 63.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: We discovered internally that the patient was given two of the same vaccine. We have tried to contact the patient, but we have not received a call back from her.  As a result, we do not know of any adverse reactions or symptoms that have occurred.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Tuberculin test negative
Clinical narrative: As part of new hire protocols, the Hepatitis B vaccine is offered. Patient accepted and received the Hep B vaccine- Heplisav-B in her left deltoid muscle on 8/14/2024 around 1:45pm by the Infection Preventionist. She also received a TB skin test- PPD in her right forearm at this time. On 8/16/2024 she emailed the Infection Preventionist a picture of her left deltoid/upper arm area that was very red and swollen. This appeared to be a localized reaction but it appeared to be in a perfect circle around the injection site- the approx. size of an orange. TB PPD skin test: Tubersol solution, Manufacture: Sanofi Pasteur, Lot #: 3CA18C1, Exp. date: 4/2027. She did not have a reaction to this test.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: headache, general muscle aches with sore right arm and extreme deltoid muscle pain, fatigue, fever/chills, upset stomach. Flu like symptoms lasted around 5-6 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: headache, general muscle aches with sore right arm and extreme deltoid muscle pain, fatigue, fever/chills, upset stomach. Flu like symptoms lasted around 5-6 days.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: Tingling to left pinky and ring finger, starting immediate during injection, ongoing at 1 hour mark after vaccine
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient expired 8/15/2024.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Fall, Head injury, Headache, Loss of consciousness
Clinical narrative: The patient walked out of the vaccination room, then 2 minutes after the vaccination said she felt faint. She fell and hit her head on the floor of the pharmacy. I did not see her fall, but saw her tremoring and her eyes rolled while she was on the floor. She woke up after a few seconds and was alert and talking. She said her head hurt a lot. We called 911. The paramedics came and followed concussion protocol and took her to the hospital in an ambulance.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Tremor
Clinical narrative: The patient walked out of the vaccination room, then 2 minutes after the vaccination said she felt faint. She fell and hit her head on the floor of the pharmacy. I did not see her fall, but saw her tremoring and her eyes rolled while she was on the floor. She woke up after a few seconds and was alert and talking. She said her head hurt a lot. We called 911. The paramedics came and followed concussion protocol and took her to the hospital in an ambulance.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is under the described age rage for the vaccine.  Vaccine administered is for 12yr >, the patient's age is 10years
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Confusional state, Immediate post-injection reaction, Postictal state, Seizure, Syncope
Clinical narrative: Immediately following administration of vaccines, Patient collapsed and began to seize. Episode lasted appx 30 seconds. Post -ictal period patient was confused and tearful. At this time mom disclosed HX of prior similar episodes. May not be related to vaccine administration, however due to timing,  we are reporting.