chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Tremor
Clinical narrative: paraesthesia; tremor; pain in extremity; chills; musculoskeletal chest pain; myalgia; Initial information received on 10-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 71-year-old female patient who experienced paraesthesia, tremor, pain in extremity, chills, musculoskeletal chest pain and myalgia after receiving COVID-19 vaccine prot. subunit (NVX CoV 2373) [Novavax COVID-19 Vaccine] and influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Drug hypersensitivity.  Concomitant medications included Hydrochlorothiazide, Losartan; Montelukast sodium (Singulair); Amlodipine, Raloxifene hydrochloride (Evista); Fluticasone Furoate, Vilanterol trifenatate (Breo ellipta); Calcium, Vitamin d ; Cetirizine ; and Aspirin.  On 04-Oct-2024, the patient received a  dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe of lot U8527CA (strength, expiry date: not reported) via intramuscular route in the right arm and suspect Novavax COVID-19 Vaccine not produced by Sanofi Pasteur of lot 3042388 (formulation, strength, expiry date: not reported) via intramuscular route in the right arm for prophylactic vaccination.  On 08-OCT-2024 the patient developed paraesthesia, tremor, pain in extremity, chills, musculoskeletal chest pain, myalgia (latency: 4 days).   Reportedly, four days after injection of both COVID and FLU HD ,chills, shaking later pain left arm, left trapezious muscle, left chest wall, continued increasing pain with tingling of left 4th and 5th fingers forearm pain, continues with increasing level of pain in that area to filling date 11/5/2024.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: someone took something out of their fridge, causing the temperature excursion when the fridge was opened/ highest temp was 9.76°C with human error, with no reported adverse event; unsuitable product administered post-excursion, with no reported adverse event; Initial information received on 10-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to US-SA-2024SA367885, US-SA-2024SA374188, US-SA-2024SA372779, US-SA-2024SA372845, US-SA-2024SA374262 and US-SA-2024SA367426.  This case involves a 30 years old male patient who had unsuitable product administered post-excursion as someone took something out of their fridge, causing the temperature excursion for Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] when the fridge was opened/ highest temp was 9.76°c with human error, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Nov-2024, the patient received a dose 1 of unsuitable product post-excursion with dosage 0.5 ml of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot UT8423NA, expiry: 30-Jun-2025, with standard strength) via intramuscular route in the right deltoid as influenza immunization, with no reported adverse event (poor quality product administered) (Latency: same day).  On an unknown date someone took something out of their fridge, causing the temperature excursion when the fridge was opened/ highest temp was 9.76°c with human error, with no reported adverse event (product storage error) (unknown latency).  Reportedly, this incident occurred last September and October, and she only noticed it today. Max/low temperature reached: 8.05°C sept, oct: 9.7°C She stated that on September the high temp was 8.05°C; and in October the highest temp was 9.76°C.Duration: She mentioned that she believes each incident in September and October lasted less than half an hour. However, because no one cleared the alerts from the data logger, it incorrectly recorded the temperature excursions as lasting 5 days in September and 3 days in October. There was no Previous Excursion.    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-2024SA367885:02337515 US-SA-2024SA374188:02337652 US-SA-2024SA372779:02337654 US-SA-2024SA372845:02337657 US-SA-2024SA374262:02337658 US-SA-2024SA367426:02337554
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: someone took something out of their fridge, causing the temperature excursion when the fridge was opened; temperature reached: 8.05°C sept, oct: 9.7°C; each incident in September and October lasted less than half an hour with no reported adverse ev; unsuitable product administered post-excursion, with no reported adverse event; Initial information received on 10-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to US-SA-2024SA367885, US-SA- 2024SA374262, US-SA-2024SA372779, US-SA-2024SA372845, US-SA-2024SA374266 and US-SA-2024SA367426.  This case involves a 46 years old female patient who had unsuitable product administered post-excursion as someone took something out of their fridge, causing the temperature excursion for Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] when the fridge was opened/ highest temp was 9.76°c with human error, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Nov-2024, the patient received a dose  of unsuitable product post-excursion with dosage 0.5 ml of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot UT8423NA, expiry: 30-Jun-2025, with standard strength) via intramuscular route in the right deltoid as influenza immunization, with no reported adverse event (poor quality product administered) (Latency: same day).  On an unknown date someone took something out of their fridge, causing the temperature excursion when the fridge was opened/ highest temp was 9.76°c with human error, with no reported adverse event (product storage error) (unknown latency).  Reportedly, this incident occurred last September and October, and she only noticed it today. Max/low temperature reached: 8.05°C sept, oct: 9.7°C She stated that on September the high temp was 8.05°C; and in October the highest temp was 9.76°C.Duration: She mentioned that she believes each incident in September and October lasted less than half an hour. However, because no one cleared the alerts from the data logger, it incorrectly recorded the temperature excursions as lasting 5 days in September and 3 days in October. There was no Previous Excursion.    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-2024SA374266:02337652
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: The FLUZONE NP may have been unsuitable for use due to a negative disposition and was administered to a patient with no adverse event; Max/low temperature reached: 8.05°C sept, oct: 9.7°C with no reported adverse event; Initial information received on 10-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves, a 72 years old male patient who received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] post excursion max/lowtemperature reached: 8.05°c in Sep-2024, Oct-2024: 9.7°c with no reported adverse event and may have been unsuitable for use due to a negative disposition was administered to a patient with no adverse event.  The patient's past medical history, medical treatment(s), concomitant, vaccination(s) and family history were not provided.  On 15-Nov-2024, the patient received 0.5 ml (Standard) (once) of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection (lot UT8423NA) via intramuscular route in the right deltoid for Influenza after max/low temperature reached: 8.05°c in Sep-2024, Oct-2024: 9.7°c with no reported adverse event (product temperature excursion issue) and the fluzone np may had been unsuitable for use due to a negative disposition and was administered to a patient with no adverse event (poor quality product administered) (latency-same day).  Reportedly, Caller stated that she believed someone took something out of their fridge, causing the temperature excursion when the fridge was opened. This prompted the data logger to alert them.However, because no one cleared the alerts from the data logger, it incorrectly recorded the temperature excursions as lasting 5 days in Sep-2024 and 3 days in Oct-2024, for less than half an hour, and she only noticed it today. No Previous Excursion. Human error- Yes. Administered post-excursion-Yes   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: 62.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/low temperature reached: 8.05°C sept, oct: 9.7°C  with no reported adverse event; Max/low temperature reached: 8.05°C sept, oct: 9.7°C  with no reported adverse event; Initial information received on 10-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 62 years old male patient received influenza USP trival A-B subvirion no preservative vaccine [Fluzone] which was exposed to temperature excursion and max/low temperature reached: 8.05°c sept, oct: 9.7°c  with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date influenza USP trival A-B subvirion no preservative vaccine Suspension for injection (strength- standard, lot UT8423NA and expiry date- 30-Jun-2025) exposed to temperature excursion and max/low temperature reached: 8.05°c sept, oct: 9.7°c  with no reported adverse event (product storage error). On 15-Nov-2024, the patient received 0.5 ml of influenza USP trival A-B subvirion no preservative vaccine via intramuscular route in the right deltoid for Influenza with no reported adverse event (poor quality product administered) (latency- same day).   Reportedly, reporter stated that she believes someone took something out of their fridge, causing the temperature excursion when the fridge was opened. This prompted the data logger to alert them. However, this incident occurred last September and October, and reporter only noticed it today. Max/low temperature reached: 8.05°C sept, oct: 9.7°C. Reporter stated that on September the high temp was 8.05°C; and in October the highest temp was 9.76°C. Duration: Reporter mentioned that she believes each incident in September and October lasted less than half an hour. However, because no one cleared the alerts from the data logger, it incorrectly recorded the temperature excursions as lasting 5 days in September and 3 days in October. There was no previous excursion. Human error was involved.   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: 30.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: someone took something out of their fridge, causing the temperature excursion when the fridge was opened/ highest temp was 9.76°C with human error, with no reported adverse event; unsuitable product administered post-excursion, with no reported adverse event; Initial information received on 10-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to US-SA-2024SA367885, US-SA-2024SA374188, US-SA-2024SA372779, US-SA-2024SA372845, US-SA-2024SA374266 and US-SA-2024SA367426.  This case involves a 30 years old female patient who had unsuitable product administered post-excursion as someone took something out of their fridge, causing the temperature excursion for Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] when the fridge was opened/ highest temp was 9.76°c with human error, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Nov-2024, the patient received a dose  of unsuitable product post-excursion with dosage 0.5 ml of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot UT8423NA, expiry: 30-Jun-2025, with standard strength) via intramuscular route in the right deltoid as influenza immunization, with no reported adverse event (poor quality product administered) (Latency: same day).  On an unknown date someone took something out of their fridge, causing the temperature excursion when the fridge was opened/ highest temp was 9.76°c with human error, with no reported adverse event (product storage error) (unknown latency).  Reportedly, this incident occurred last September and October, and she only noticed it today. Max/low temperature reached: 8.05°C sept, oct: 9.7°C She stated that on September the high temp was 8.05°C; and in October the highest temp was 9.76°C.Duration: She mentioned that she believes each incident in September and October lasted less than half an hour. However, because no one cleared the alerts from the data logger, it incorrectly recorded the temperature excursions as lasting 5 days in September and 3 days in October. There was no Previous Excursion.    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-2024SA374266:02337658
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: did not reconstitute the ACT-HIB component with the DTaP-IPV component (with no reported adverse event); Initial information received on 11-Dec-2024 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 7 months old female patient and reporter stated that person did not reconstitute the ACT-HIB component with the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] component (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 Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunization; COVID-19 vaccine (COVID-19 vaccine) for Immunization; and Hepatitis b vaccine (Hepatitis b vaccine) for Immunization.  On 26-Nov-2024 the person did not reconstitute the ACT-HIB component with the 0.5 ml of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (Unknown strength) with lot UK043AA and expiry date 31-Aug-2025 via unknown route in unknown administration site for Immunization component (with no reported adverse event) (single component of a two-component product administered)   Reportedly, Medical assistant was calling from doctor's office and had a question regarding pentacel. They discovered that the person who administered the vaccine to one of the children did not reconstitute the ACT-HIB component with the DTaP-IPV component, so the patient only got the DTaP-IPV part. They wanted to know what to do in the situation. MIS informed them from the attached SRD that the ACT-HIB component must be reconstituted only with either the DTaP-IPV solution supplied with the pentacel or a specific ACT-HIB saline diluent.  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: 51.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: 2-doses of FLUZONE Np was Administered post-excursion with no reported adverse event; Initial information received on 13-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked cluster case US-SA-2024SA374013.  This case involves a 51 years old female patient had one of  2-doses of influenza USP trival A-B subvirion no preservative vaccine [Fluzone NP] was administered post-excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Dec-2024, the patient received one dose of suspect influenza USP trival A-B subvirion no preservative vaccine, Suspension for injection, (lot U8518CA; expiry date: 30-Jun-2025) via unknown route in unknown administration site for  Immunization post-excursion with no reported adverse event (poor quality product administered) ( latency: same day).  1st excursion on 04-Nov-2024 Max/low temperature reached: 48 degrees F Duration: 30 minutes, 2nd excursion on 12Dec2024 Reason: an UTR issue with the fridge Max/low temperature reached: negative 0.1 degrees C Duration: 37 minutes, No Human error.    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-2024SA374013:02342103
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received 2 doses of FLUZONE HD 3 days apart with no reported adverse event; Initial information received on 16-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 76 years old female patient who received 2 doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] 3 days apart 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 TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 immunisation.  On 13-Dec-2024, the patient received a Dose 1 of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (dose, strength,expiry and route: unknown).   On 16-Dec-2024 she also received a  dose 2, 0.5 ml of vaccine via intramuscular route in the left arm with no adverse event (extra dose administered) (latency same day).  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.    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: 9.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: FLUZONE prefilled syringes was administered to patient after excursion, with no reported AE; Initial information received on 16-Dec-2024 regarding an unsolicited non-valid  non-serious case received from a other healthcare professional.  This case diphtheria/tetanus adsorbed toxoids thiomersal free adult [Diftavax] exposed to cold chain break for 60 hours at a maximum of 22.7 C due to human error with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications,  vaccination(s) and family history were not provided.  On an unknown date, the suspect diphtheria/tetanus adsorbed toxoids thiomersal free adult Suspension for injection (Unknown strength and expiry date) with lot X3D288V via unknown route in unknown administration site for Prophylactic Vaccination (immunization) exposed to cold chain break for 60 hours at a maximum of 22.7ºc due to human error with no reported adverse event (product storage error)  Reportedly, there is an impact on the quality of the product.   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: 70.0
Sex: F
Vaccine: COVID19, IPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient reports onset of pink coloring to the Left upper arm on Friday, 12/20/24 around 10 am. Adds that by Saturday morning the left upper arm had marked swelling and reddening in the same area. Acknowledged pain with movement, which was alleviate with Ibuporfen  400mg PRN. Reports having used cold, chamomile compresses to the area. Adds that PCP in home country advised she start taking Amoxicillin/Clavunate 875 mg-125 mg every 12 hours. Has taken for 2 days as of this report.  Patien reports the pain has improved and can lift the arm. Redness and heat to the area continue but denies progression/growth.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC13
Symptoms: Dyspnoea, Hypoxia, Tachypnoea
Clinical narrative: Patient complained of cough for 6 days prior to vaccination. After vaccination with 2 of the 2-month vaccinations patient experienced shortness of breath and appeared tachypneic. Was found to be temporarily hypoxic to 79% at RA.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Pruritus, Pyrexia
Clinical narrative: Chills, fever, severe body pains that lasted 2-3 days most of which forced me to stay in bed
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received two doses a year apart when only one vaccine is recommended after age 60, patient reports no side effects
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was not aware they had a previous shot of RSV, received two shots a year apart, had no negative reaction
Age: 42.0
Sex: F
Vaccine: PNC21
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient reported upper arm swelling and fever.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was ordered RSV vaccination by provider and vaccine given by LVN staff member. MD was working on her charting and realized the error. Called patient and explained situation but that although not necessary for second dose, it was still safe to get.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received a 2nd dose of Arexvy after already vaccinated in 2023.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Chest pain, Chills
Clinical narrative: Patient reported feeling chest pain, flutter, heaviness and chills starting 5 days ago. This started 1 day after receiving Comirnaty vaccine. Advised patient to seek medical attention as concerned with description of symptoms.
Age: 1.25
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There were no adverse effects.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administered wrong Covid 19 vaccine. Patient is 11 yo and was given the 12 and older vaccine.  Patients guardian contacted no sign or symptoms of adverse effects at this time.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose given in error
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient experienced a full body rash that has lasted at least 6 months and is still currently present. Started 4 days after vaccination. Provider confirmed not active shingles.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RV5, UNK, UNK
Symptoms: Breath holding, Crying, Cyanosis, Dyspnoea, Erythema
Clinical narrative: Breathing Difficulty: The patient experienced difficulty breathing around 5:30 PM yesterday, about three hours after receiving vaccinations. Initially calm, but began crying nonstop for about 3.5 to 4 hours. Would scream, turn red, have a blue tongue, and hold his breath. Body went limp intermittently, then resumed crying. Lips were blue for an hour. Around the 4 hour mark, ended up giving Tylenol, of which one hour later, calmed and went to sleep.  No fever that night, but slight fever noted next morning. Did not take temperature.  More tired next day but eating normally. Did not drink from bottle until around 10 PM yesterday after Tylenol administration.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RV5, UNK, UNK
Symptoms: Fatigue, Hypotonia, Pyrexia, Screaming, Tongue discolouration
Clinical narrative: Breathing Difficulty: The patient experienced difficulty breathing around 5:30 PM yesterday, about three hours after receiving vaccinations. Initially calm, but began crying nonstop for about 3.5 to 4 hours. Would scream, turn red, have a blue tongue, and hold his breath. Body went limp intermittently, then resumed crying. Lips were blue for an hour. Around the 4 hour mark, ended up giving Tylenol, of which one hour later, calmed and went to sleep.  No fever that night, but slight fever noted next morning. Did not take temperature.  More tired next day but eating normally. Did not drink from bottle until around 10 PM yesterday after Tylenol administration.
Age: 28.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Pain in extremity, Seizure, Syncope, Tremor
Clinical narrative: Pain and tremor in the arm, then severe dizziness, fainting and seizure.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dizziness, Fall
Clinical narrative: On 12/23/24 , Patient felt dizzy a few minutes after receiving her Covid vaccine; pfizer and when she was proceeding out of the store, she fell to the ground and does not remember much after the event. Paramedics were called and she went into the hospital.
Age: 17.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Blood glucose normal, Electrocardiogram normal, Hypotonia, Loss of consciousness, Seizure like phenomena
Clinical narrative: Pt received covid and flu vaccine. A few minutes later he slumped over, had seizure-like activity, and lost consciousness briefly.  Paramedics were called. Pt was assessed. Paramedics believe it was a syncopal event with seizure-like activity.
Age: 17.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Sinus rhythm, Syncope
Clinical narrative: Pt received covid and flu vaccine. A few minutes later he slumped over, had seizure-like activity, and lost consciousness briefly.  Paramedics were called. Pt was assessed. Paramedics believe it was a syncopal event with seizure-like activity.
Age: 60.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had received Arexvy in February immediately after turning 60.  He was instructed by his rheumatologist to complete all immunizations before he started on Humira due to suppression of immune system that would occur.  He received a second unnecessary immunization on December 22, 2024 per his request.
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Prior to administering the vaccine to the patient, a DUR screen was completed and no notification of prior receiving vaccine. After administration, we were notified that the patient had initially received a dose on 10/28/23. We have tried reaching out to the patient to inform him of this error but have been unsuccessful. We will continue to attempt to reach him.
Age: 62.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received the vaccine in 10/22/2023. Patient requested to be vaccinated again. Pharmacist misread the information in patient profile. Pharmacist administered same vaccine on 12/19/2024. Pharmacist followed up with patient after he received vaccine. Patient reported he does not have any side effects and he has no concerns about vaccine.
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Exposure during pregnancy, Nausea
Clinical narrative: Nausea and diarrhea
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling (L) thigh
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional information was known by reporter. No additional AE/PQC.; HCP called and reported that a patient received an expired dose of RECOMBIVAX HB. Vaccine expired on 07NOV2014 and was administered to a patient on 09DEC2014.; This spontaneous report was received from a medical assistant regarding to a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 09-DEC-2014, the patient was vaccinated with hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) intramuscular injection, lot number H018689 (lot number H018689 had been verified to be valid lot number for hepatitis B vaccine [recombinant]), expiration date 07-NOV-2014 (strength, dose, frequency, route of administration and anatomical injection site were not provided) for prophylaxis (expired product administered).   No additional information was known by reporter. No additional adverse event (AE)/product quality complaint (PQC).
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: she experience fatigue; This non-serious case was reported by a nurse via sales rep and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: she experience fatigue). The outcome of the fatigue was resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     It was unknown if the company considered the fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-NOV-2024 The nurse reported that her mother (patient), age unknown, started Shingrix, dose unknown, on an unknown date, about when Shingrix was first available.  On an unknown date, she received a second dose of Shingrix.  On an unknown date, after her second dose of Shingrix, she experienced fatigue. On an unknown date, after a few days, explained as after the weekend, the fatigue resolved. All other information was unknown. This was 1 of the 3 linked cases, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024AMR148347:same reporter different patient US-GSK-US2024AMR148540:same reporter different patient
Sex: U
Vaccine: RSV
Symptoms: Paralysis
Clinical narrative: paralysis; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced paralysis (Verbatim: paralysis) (serious criteria GSK medically significant). The outcome of the paralysis was not reported.   It was unknown if the reporter considered the paralysis to be related to Arexvy.     The company considered the paralysis to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 09-DEC-2024 This case was reported by a patient via interactive digital media. The patient received Arexvy vaccine and experienced paralysis.; Sender's Comments: Paralysis is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: M
Vaccine: HPV9
Symptoms: Underdose
Clinical narrative: He also noticed some clear liquid on the bandage at the injection site. He thinks that it's some of liquid from GARDASIL 9.; he possibly received GARDASIL 9 less than recommended dose because the nurse wasted few drops while priming the syringe.; the nurse wasted few drops while priming the syringe.; This spontaneous report has been received from a consumer regarding to himself as a male patient of unknown age.  The patient's medical history, concurrent condition, concomitant therapies, and previous drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number, and expiration date were not provided).  On an unknown date, the patient reported that he possibly received less than recommended dose because the nurse wasted a few drops while priming the syringe (Underdose, Product preparation issue). He also stated that the nurse used the ''large needle with 20 or 22 gauge'', and he noticed some clear liquid on the bandage at the injection site, which he thought that was some liquid of the vaccine (Injection site discharge).  The causal relationship between injection site discharge and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No reported signs/symptoms of adverse effects. No additional AE/no PQC; HCP called to report TE on PROQUAD; This spontaneous report was received from a medical assistant referring to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JUN-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, lot #Y002099, expiration date: 09-JUL-2025, administered for prophylaxis (strength, dose and route of administration were not provided) which experienced temperature excursion (TE) (Product storage error). No reported signs/symptoms of adverse effects (No adverse event).
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP called to report a 74-year-old female was administered an expired dose of PNEUMOVAX 23. No side effects or symptoms reported. Product expired 11/22/2024 and was administered 12/17/2024, product did not undergo any temperature excursions.; HCP called to report a 74-year-old female was administered an expired dose of PNEUMOVAX 23. No side effects or symptoms reported. Product expired 11/22/2024 and was administered 12/17/2024, product did not undergo any temperature excursions.; This spontaneous report was received from a licensed practical nurse referring to a 74-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-DEC-2024, the patient was administered an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 milliliter, expiration date: 22-NOV-2024, administered for prophylaxis (strength, lot #, and route of administration were not provided) (Expired product administered). Operator of device was health professional. Product did not undergo any temperature excursions. No side effects or symptoms reported (No adverse event). No Additional information provided.
Sex: M
Vaccine: MMR
Symptoms: Measles post vaccine, Morbillivirus test positive, Rash, Vaccination failure
Clinical narrative: Measles post vaccine; Vaccination failure; Literature Report.  This literature report has been received from the authors of a published literature article, entitled as stated above, referring to a 1-year-old male patient. The patient pertinent medical history was not provided, nor previous drug reactions or allergies and concomitant medications. It was reported that the patient was shelter A resident.    On approximately 22-JAN-2024 (5 weeks before measles symptoms), the patient was vaccinated with 1 dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection as prophylaxis (dose, vaccine scheme, route and anatomical location of administration, lot number and expiration date were not provided).   On 26-FEB-2024, the patient developed a rash (Measles post vaccine), therefore, he was hospitalized on 27-FEB-2024, with suspected measles. On 04-MAR-2024, when the Department of Public Health (DPH) was first notified of the suspected case, confirmatory measles testing with real-time reverse transcriptionpolymerase chain reaction (RT-PCR) was requested by DPH (done on unknown date in 2024, with measles confirmed) (Measles post vaccine). Additionally, it was added that a full assessment of whether these infections are due to primary or secondary vaccine failure was ongoing (vaccination failure). The child had arrived in the United States more than 5 months earlier and had received 1 dose of measles, mumps, and rubella (MMR) vaccine 5 weeks before rash onset (approximately 22-JAN-2024, as describe above). He had no recent travel or known exposure to measles. Upon confirmation of wild-type measles infection by measles vaccine assay (MeVA) on 07-MAR-2024 (it was reported that laboratory confirmation included measles RT-PCR testing and to distinguish measles vaccine reaction from wild-type measles infection, laboratory confirmation required MeVA testing). Consequently, DPH alerted residents and staff members (of the shelter) the same evening and arranged a vaccination event for the next morning. Given the highly congregate nature of shelter A, DPH considered anyone who had been inside the shelter (during 22-FEB-2024-27-FEB-2024) the index patient's infectious period at shelter A, to be exposed. A shelter Aassociated case was defined as an RT-PCRconfirmed, wild-type measles infection in a person with a shelter A measles exposure, either by virtue of residing in, working at, or having a known epidemiologic link to persons from shelter A with a confirmed measles infection until 13-MAY-2024 (outcome recovered). The outcome of vaccination failure was not provided.   The causality assessment between both events and suspect vaccine was related.  A copy of the published article is attached as further documentation of the patient's experience.  Lot # is being requested and will be submitted if received.   This is one of 2 reports from the same literature article.; Sender's Comments:  US-009507513-2412USA008603:MSD
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: autism; This spontaneous report has been received from a consumer referring to a male patient of unknown age. Information about concurrent condition, medical history and concomitant medication was not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (strength, extact dose, lot #, expiration date and anatomical location were not provided)).  On an unknown date the patient experienced autism. The outcome of autism was unknown. The reporter believed that the patient's diagnosis of autism was related to his having received the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).  Upon internal review, autism was determined to be medically significant.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Death
Clinical narrative: Experienced Death after vaccination; This spontaneous case, initially received on 13-Dec-2024, was reported by a non health professional and concerns an elderly female patient.  Administration of company suspect drug(s): On 12-Nov-2024, the patient received Fluad (TIV) for Influenza vaccination, Dose regimen: .5 ml, Route of administration: Not reported, Lot number: batch number available and will be requested upon follow-up . Non-company suspect drugs: Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373))  Adverse reactions/events and outcomes: On 12-Nov-2024, the patient experienced Experienced Death after vaccination (outcome: Fatal; stop date: 12-Nov-2024).   Fluad (TIV) action taken: Not Applicable   The patient died on 12-Nov-2024. Cause of death: Experienced Death after vaccination.  Reporter Assessment: The reporter considered the event as serious and causality was not reported; Reporter's Comments: Causality: There is insufficient information about the cause of death, autopsy details and medical history. Considering close temporal association, the event death is assessed as related because the causal relationship cannot be excluded. The co-suspect Novavax COVID-19 Vaccine is considered as possible confounding factor.; Reported Cause(s) of Death: Experienced Death after vaccination
Sex: U
Vaccine: RVX
Symptoms: Product administered to patient of inappropriate age, Tinnitus
Clinical narrative: patient was in hospital for sounds; 25-years-old patient received RSV vaccine; This serious case was reported by a consumer and described the occurrence of ear discomfort in a 25-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced ear discomfort (Verbatim: patient was in hospital for sounds) (serious criteria hospitalization) and inappropriate age at vaccine administration (Verbatim: 25-years-old patient received RSV vaccine). The outcome of the ear discomfort was not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the ear discomfort to be related to RSV vaccine.     The company considered the ear discomfort to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 09-DEC-2024 The patient self-reported this case for himself/herself. The patient reported that he/she was in hospital for sounds. 25-years-old patient received RSV vaccine, which led to an inappropriate age at vaccine administration.; Sender's Comments: Ear discomfort  is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine.
Sex: F
Vaccine: RVX
Symptoms: Deafness
Clinical narrative: Hearing loss; This serious case was reported by a consumer and described the occurrence of hearing loss in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced hearing loss (Verbatim: Hearing loss) (serious criteria hospitalization and GSK medically significant). The outcome of the hearing loss was not resolved.   It was unknown if the reporter considered the hearing loss to be related to RSV vaccine.     The company considered the hearing loss to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 09-DEC-2024 The patient self-reported this case for herself. The patient reported that she was in hospital for hearing loss.; Sender's Comments: Deafness is an unlisted event which is considered unrelated to GSK vaccine RSV vaccine.