chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report T/E for VAXNEUVANCE (PFS) HCP stated it was administered to 7 patient.   T/E occurred on 9/6/2024.  Permission to contact HCP was granted. No other information was known or provided. No additional AE or PQC reported.   T/E case#; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 06-SEP-2024, a temperature excursion occurred at 13 C for 6 hours 0 minutes 0 seconds. On 03-OCT-2024, the patient was vaccinated with an improperly storage dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X026480, expiration date: 12-JAN-2026, administered for prophylaxis (strength, dose, frequency, and route of administration were not provided) (Product storage error). No previous temperature excursion was reported. No additional adverse event reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2410USA013279: US-009507513-2410USA013415: US-009507513-2410USA013467: US-009507513-2410USA013358: US-009507513-2410USA013365: US-009507513-2410USA013374:
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Amnesia, Confusional state
Clinical narrative: Patient checked in for a Menquadfi appointment at 6:37pm on 10/28. The Vaccine Screening and Consent form she filled out was marked 'yes' for "Dizzy or faint before, during or after an immunization." When I approached to vaccinate her at 6:42pm, she seemed very nervous  so I had to calm her and went over the immunization procedure. I then proceeded to vaccinate the patient which she was totally fine and didn't feel a thing. Patient was advised to take her time and leave when she felt comfortable however, she left immediately after getting vaccinated. She then approached the drop off window a minute later and asked for water. I ran to guide her back to the vaccination room by walking her there. Once she was seated I went to grab water meanwhile I heard a noise and found her sitting on the floor with confusion right after. I asked what happened, and she had no recolection of what had occured. I then offered an icepack and a bag of chips to help her gain consciousness. She mentioned this happens to her all the time. Then her mom finally arrived after she called yelling at her mom saying "she is useless and was supposed to be by her side" while the Mom was in line at the store. We advised that she doesn't drive and for her mom to drive her home. Patient said she was okay and ready to leave with her Mom.
Age: 0.67
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5, RV5
Symptoms: Unevaluable event
Clinical narrative: UNKNOWN.
Age: 0.67
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: UNKNOWN.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Injection site pain, Injection site rash, Peripheral swelling, Pruritus
Clinical narrative: Evening after receiving the vaccine swollen arm, red & very very itchy. 2nd day, tichy, bumps all over the area where vaccine was given. This continued 8 days proceeding the vaccine and pain in the site of shot.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Rash pruritic
Clinical narrative: Evening after receiving the vaccine swollen arm, red & very very itchy. 2nd day, tichy, bumps all over the area where vaccine was given. This continued 8 days proceeding the vaccine and pain in the site of shot.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC15, RV5
Symptoms: Abdominal X-ray, Abdominal distension, Abnormal faeces, Faeces discoloured, Faeces soft
Clinical narrative: Mom called the after hours clinic at 10PM on 10/27/2024 with concerns of orange tinged stool. She was advised to follow up with pediatrician and/or go to emergency department if symptoms worsen. Mom called our office (patient's PCP) on 10/29/2024 with concerns of soft, foul smelling, red-colored stool in diaper. Patient had no other symptoms other than mild gaseous distention. Our provider advised her to go to emergency department to rule out intussusception. Hospital conducted an abdominal Xray and ultrasound in addition to a GI PCR panel. Xray was normal, ultrasound showed bowel edema, and GI PCR was positive for rotavirus.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC15, RV5
Symptoms: Gastrointestinal oedema, Rotavirus test positive, Ultrasound abdomen abnormal, X-ray normal
Clinical narrative: Mom called the after hours clinic at 10PM on 10/27/2024 with concerns of orange tinged stool. She was advised to follow up with pediatrician and/or go to emergency department if symptoms worsen. Mom called our office (patient's PCP) on 10/29/2024 with concerns of soft, foul smelling, red-colored stool in diaper. Patient had no other symptoms other than mild gaseous distention. Our provider advised her to go to emergency department to rule out intussusception. Hospital conducted an abdominal Xray and ultrasound in addition to a GI PCR panel. Xray was normal, ultrasound showed bowel edema, and GI PCR was positive for rotavirus.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Eye irritation, Eye pruritus
Clinical narrative: Complained of eyes itching which quickly turned into burning - gave her a bath (she's only 4-1/2) her eyes were burning so bad she tried to pour a cup of water in them - Gave benedryl she was better. Incident lasted 20 minutes
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: The patient called into the office this morning at around 10:00 am and the patient stated later in the day her left arm where she got her COVID-19 shot began to get sore and around 7 PM she notced a hard knot where the shot was given it was about 2 inches in diameter. She said the injection site also was itchy and she was having a headache. She said the only problem she is having today is that the injection site is still itching, she stated that she has used some cortizone cream to relieve the itching but it hasn't helped much. The patient also stated that her seasonal allergies have been really bad and she is having to take Claritin all the time.
Sex: F
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal, Death, Fall
Clinical narrative: Sent out after fall on 10/18/24, CT @ hospital indicated "multiple strokes"; returned to facility 10/22/24 on Hospice Services. Expired 10/28/24.
Age: 6.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD may have been inadvertently administered to multiple patients after the TE occurred. Nurse reports TE occurred on 08/26/24 and could have been administered from 08/26/24 until today 9/17/24; Product administration error (Indicate at which point in the process the medication error ocurred: administration); This spontaneous report was received from a registered nurse, concerning an unspecified number of patients of unknown ages and genders.  The patients' medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 26-AUG-2024, measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) vaccines, experienced a temperature excursion (TE) of -12.7 degrees Celsius (C) during a time frame of 30 minutes. On an unknown dates in 2024 (reported as "from 26-AUG-2024 until today 17-SEP-2024"), after the TE occurred, multiple patients may have been inadvertently administered with the measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) injection, that suffered the TE (lot number Y008885 was verified to be valid, expiration date reported and confirmed as 03-NOV-2025) (Product storage error). The vaccines were administered as prophylaxis and exact doses, routes of administration, and anatomical locations were not provided. The vaccines administered did not experienced any other previous TE. No additional adverse event (AE) was reported.  The reporter was unable to provide demographics or any further details but did provide consent for office to be contacted.  Follow up information was received from a Registered Nurse on 23-OCT-2024.  This report refers to a 6-year-old male patient. On 30-AUG-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), administered intramuscularly at public health clinic/ hospital purchased with public funds. The point in the process the medication error occurred was reported as administration (Product administration error). The outcome of Product storage error and Product administration error was reported as recovered.    It was reported that from 26-AUG-2024 until 17-SEP-2024, 5 measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) were administered. Temperature excursion checked with the company; vaccines were still viable.   This is one of several reports received from the same reporter.   An Identifiable Patient was missing in the previous report (aware date: 17-SEP-2024).; Sender's Comments:  US-009507513-2410USA013460:Original Case : 2409USA006137 US-009507513-2410USA013459:Original Case : 2409USA006137 US-009507513-2410USA013458:Original Case : 2409USA006137 US-009507513-2410USA013461:Original Case : 2409USA006137
Age: 0.33
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: No additional AE; Consumer thinks that at infants 4 month visit, infant received a dose of RECOMBIVAX HB also; RECOMBIVAX HB at 2 and 6 month; This spontaneous report was received from a consumer and referred to a 7-month-old infant of unknown gender currently.  The patient's medical history, historical conditions, concurrent conditions and concomitant therapies were not reported.  On an unknown date in March 2024 (at birth), the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided) and then at 2 months and 6 months, the infant received hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided) (inappropriate schedule of product administration). Consumer thought that at infants 4 month visit, infant received a dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) also (extra dose administered). Consumer asked the clinic about this and records showed that infant did not receive hepatitis b vaccine (recombinant) (RECOMBIVAX HB)  however consumer had doubts and did not fully believe clinic. No further information provided. No additional adverse event (AE) reported.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported; HCP called to report T/E for VAXNEUVANCE (PFS) HCP stated it was administered to 7 patient.   T/E occurred on 9/6/2024.  Permission to contact HCP was granted. No other information was known or provided. No additional AE or PQC reported.   T/E case#; This spontaneous report was received from a medical assistance (M.A) concerning a patient (7) of unknown age and gender.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.    On 06-SEP-2024, the temperature excursion occurred. Temperature: 13.0 Celsius. Time frame: 6 hours 0 minutes 0 seconds. No previous temperature excursion. The call was no because of a data logger.  On 21-OCT-2024, the patient was vaccinated with the improperly storage dose (product storage error) of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) lot # X026480, expiration date: 12-JAN-2026 (dose, route and frequency were not reported) for prophylaxis. No additional Adverse Event (AE) or Product Quality Complaint (PQC) reported. ; Sender's Comments:  US-009507513-2410USA012969:
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No aditional adverse event reported; HCP called to report T/E for VAXNEUVANCE (PFS) HCP stated it was administered to 7 patient. T/E occurred on 9/6/2024.; This spontaneous report has been received from medical assistant referring to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.  On 06-SEP-2024 a temperature excursion occurred at a temperature excursion of 13.0 degrees Celsius (C) during a time frame of 6 hours. No previous temperature excursion was reported.   Then, on 24-OCT-2024, the patient was vaccinated with an improperly stored dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered as prophylaxis (Lot No. X026480 has been verified to be a valid lot number for [pneumococcal 15v conj vaccine (crm197], expiration date reported and upon internal validation established as 12-JAN-2026) (strength, dose number, exact dose quantity volume, route of administration, anatomical location of administration and vaccination scheme frequency were not provided) (product storage error). No additional adverse event (AE) was reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2410USA012969: US-009507513-2410USA012969: US-009507513-2410USA013415: US-009507513-2410USA013279: US-009507513-2410USA013467: US-009507513-2410USA013358: US-009507513-2410USA013365:
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported.; HCP called to report T/E for VAXNEUVANCE (PFS) HCP stated it was administered to 7 patient. T/E occurred on 9/6/2024.; This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concomitant therapies, dug reactions or allergies were not reported.  On 06-SEP-2024, temperature excursion (T/E) occurred to vaccine pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE).  On 24-OCT-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection, lot number X026480 (lot number X026480 had been verified to be valid lot number for pneumococcal 15v conj vaccine [CRM197]), expiration date 12-JAN-2026, administered for prophylaxis (strength, dose, frequency, route of administration and anatomical injection site were not provided), after experiencing a temperature excursion of 13.0 Celsius (C), with a time frame of 6 hours 0 minutes 0 seconds. Without previous temperature excursion (product storage error).  Permission to contact health care professional (HCP) was granted. No other information was known or provided. No additional adverse event (AE) or product quality complaint (PQC) reported. ; Sender's Comments:  US-009507513-2410USA013279: US-009507513-2410USA012969:
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; T/E for VAXNEUVANCE (PFS); This spontaneous report was received from a Medical Assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 06-SEP-2024, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X026480, expiration date: 12-JAN-2026, was underwent a temperature excursion of 13 degree Celsus (C) for 6 hours. No previous temperature excursion.   On 10-OCT-2024, the patient was vaccinated with the improperly stored pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X026480, expiration date: 12-JAN-2026, administered for prophylaxis (strength, dose and route of administration were not provided)(product storage error). No additional adverse events (AEs).  This is one of the several cases reported by the same reporter. ; Sender's Comments:  US-009507513-2410USA012969:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; just came down with shingles; hurts like heck; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: just came down with shingles) and pain (Verbatim: hurts like heck). The outcome of the vaccination failure, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-OCT-2024 This case was reported by a patient via interactive digital media. The patient got vaccinated last year and just came down with shingles, hurts like heck. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: no one knew if I only have to take 1 dose or if I need ... a vaccine schedule at some point, so I'm not sure how many of this shots I have to take; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 32-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced therapy non-responder (Verbatim: no one knew if I only have to take 1 dose or if I need ... a vaccine schedule at some point, so I'm not sure how many of this shots I have to take). The outcome of the therapy non-responder was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2024 The other healthcare professional reported that she had her normal Hep B vaccines series when she was a child and then she was a health care worker, the patient was tested, for the Hep B antibodies, when she started medical school, and at that point the patient was reactive, but during this pregnancy they test my status again and this time the patient was not reactive. So at some point, in the past 4 years, the patient guess the patient lost her immunity, so when her newest child was born, they gave me the Engerix-B vaccine at birth, when he was born, but no one knew if that the patient only have to take 1 dose or if the patient need a vaccine schedule at some point, so the patient was not sure how many of this shots she had to take. The caller was the physician and the patient on this case. The caller received the Engerix-B vaccine the day that the baby was born, however, they did not provide any information of the due date. The healthcare professional mentioned that the vaccines received when she was a child, was the Hep B vaccines, but never specified witch one as they escalated this case to a 2nd line agent. The healthcare professional mentioned to my coworker that she received this vaccine 6 weeks ago.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: 3rd dose of Menveo received; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number BL3ES, expiry date 31-DEC-2024) for prophylaxis.   Previously administered products included Menveo (1st dose received on 14 February 2017 lot number M16002) and Menveo  (2nd dose received on 22 February 2023 lot number AMVA751A).   On 10-JUN-2024, the patient received the 3rd dose of Menveo (right deltoid). On 10-JUN-2024, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: 3rd dose of Menveo received). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 21-OCT-2024 Reporter was a pharmacy student. Reported that a third dose of suspect vaccine was given to the patient. Four years did not lapse between the 2nd and the third dose. The patient received 3rd dose of Menveo which led to extra dose administered. This case is linked with US2023177364, same reporter.; Sender's Comments:  US-GSK-US2023177364:same reporter
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Extra dose administered
Clinical narrative: Extra Doses; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number X9EP5, expiry date 09-MAR-2026) for prophylaxis.   Co-suspect products included MMR (Priorix) (batch number X3M3D, expiry date 01-APR-2025) for prophylaxis.   Previously administered products included Kinrix (received on 22nd March 2024 Lot: 34MF9, expiry date 13 February 2026) and Priorix (received on 22nd March 2024 Lot: J9J2X, expiry date 01 June 2024).   On 11-OCT-2024, the patient received Pediarix and the 3rd dose of Priorix. On 11-OCT-2024, an unknown time after receiving Pediarix and Priorix, the patient experienced extra dose administered (Verbatim: Extra Doses). The outcome of the extra dose administered 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: 21-OCT-2024 HCP reported a patient received extra doses of Pediarix (dTap) and Priorix on October 11, 2024 which led to extra dose administered.
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix to a 12 months old child; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number NR5BX, expiry date 02-FEB-2026) for prophylaxis.   On 21-OCT-2024, the patient received Boostrix. On 21-OCT-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix to a 12 months old child). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: Nurse Practitioner reported that a 12 months old patient received by error Boostrix (Lot Patient has 3 previous Dtaps which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: only receiving one dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received the first dose over a year ago).   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: only receiving one dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-OCT-2024 Customer reported only receiving one dose of Shingrix. Customer date of birth and initials are not available. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: FLU3
Symptoms: Needle issue, Underdose
Clinical narrative: Product Complaint; Less than recommended dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2024-2025 season) (batch number DA7P5, expiry date 30-JUN-2025) for prophylaxis.   On 21-OCT-2024, the patient received Fluarix Tetra 2024-2025 season. On 21-OCT-2024, an unknown time after receiving Fluarix Tetra 2024-2025 season, the patient experienced accidental underdose (Verbatim: Less than recommended dose). On an unknown date, the patient experienced product complaint (Verbatim: Product Complaint). The outcome of the accidental underdose was unknown and the outcome of the product complaint was unchanged.   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: 21-OCT-2024 A pharmacist contacted GlaxoSmithKline to request information on how to proceed after a dose of Fluarix was accidentally administered at less than the recommended volume because of a needle leakage which led to accidental underdose. They requested to not have the data for the patient collected but accepted to receive follow up.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: extra dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 5-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Previously administered products included Kinrix (1st dose received when patient was 4 years old).   On 07-OCT-2024, the patient received the 2nd dose of Kinrix. On 07-OCT-2024, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: extra dose). The outcome of the extra dose administered 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: 21-OCT-2024 Reporter was the HCP (medical assistant) who stated that a patient accidentally received an extra dose of KINRIX. The patient received a dose of Kinrix when she was 4 years old and then again at 5 years old which led to extra dose administered.
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero given in error instead of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number TP294, expiry date 31-OCT-2024) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 21-OCT-2024, the patient received Bexsero. On an unknown date, the patient received Menveo. On 21-OCT-2024, an unknown time after receiving Bexsero and not applicable after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Bexsero given in error instead of Menveo). The outcome of the wrong vaccine administered 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: 21-OCT-2024 Practice manager called to report Bexsero was administered to a patient in error, intended vaccine to be given was Menveo which led to wrong vaccine administered. Caller mentioned patient has no other Men B doses and on the same day received HPV Gardasil vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose over 1 year ago ).   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: 21-OCT-2024 The reporter questioned about the timing of the Shingrix vaccination for someone who took the first dose over 1 year ago and needed the second dose, did they have to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Muscle spasms, Pain in extremity, Pain in jaw
Clinical narrative: Chest pain; Cramps; Left hands pain; Jaws pain; Shortness of breath; Troponin level elevated to 63 on the day of ER; This serious initial Spontaneous safety report was received by Novavax on 26-Oct-2024 from a Consumer or other non health professional via Regulatory Authority (ref. no. US-1000000416-NVAX).   A 53-year-old Male was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) (LOT Number: 6024mf012) on 04-Oct-2024.  The following medical history was reported: FOOD ALLERGY. Past therapy included: Moderna (Elasomeran) on 23-Sep-2023.  The following concomitant medication was reported: TIROSINT (levothyroxine sodium).  On an unspecified date, a few days after vaccination the patient experienced chest pain (Chest pain)(Serious: Caused Hospitalization), cramps (Muscle spasms)(Serious: Caused Hospitalization), left hands pain (Pain in extremity)(Serious: Caused Hospitalization), jaws pain(Pain in jaw)(Serious: Caused Hospitalization), shortness of breath (Dyspnoea)(Serious: Caused Hospitalization) and troponin level elevated to 63 on the day of ER (Troponin increased)(Serious: Caused Hospitalization).  Relevant lab tests included: TROPONIN LEVEL (Result: 63, Test Date: 23-Oct-2024).  At the time of reporting, the event outcome of Chest pain was, Muscle spasms, Pain in extremity, Pain in jaw, Dyspnoea and Troponin increased was Unknown.; Sender's Comments: This 53-year-old Male experienced Chest pain, Muscle spasms, Pain in extremity, Pain in jaw, Dyspnoea and Troponin increased after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The event Chest pain was reported as serious.  The event Muscle spasms was reported as serious.  The event Pain in extremity was reported as serious.  The event Pain in jaw was reported as serious.  The event Dyspnoea was reported as serious.  The event Troponin increased was reported as serious.    Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Chest pain, Muscle spasms, Pain in extremity, Pain in jaw, Dyspnoea and Troponin increased is considered Possible.
Sex: M
Vaccine: COVID19
Symptoms: Troponin, Troponin increased
Clinical narrative: Chest pain; Cramps; Left hands pain; Jaws pain; Shortness of breath; Troponin level elevated to 63 on the day of ER; This serious initial Spontaneous safety report was received by Novavax on 26-Oct-2024 from a Consumer or other non health professional via Regulatory Authority (ref. no. US-1000000416-NVAX).   A 53-year-old Male was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) (LOT Number: 6024mf012) on 04-Oct-2024.  The following medical history was reported: FOOD ALLERGY. Past therapy included: Moderna (Elasomeran) on 23-Sep-2023.  The following concomitant medication was reported: TIROSINT (levothyroxine sodium).  On an unspecified date, a few days after vaccination the patient experienced chest pain (Chest pain)(Serious: Caused Hospitalization), cramps (Muscle spasms)(Serious: Caused Hospitalization), left hands pain (Pain in extremity)(Serious: Caused Hospitalization), jaws pain(Pain in jaw)(Serious: Caused Hospitalization), shortness of breath (Dyspnoea)(Serious: Caused Hospitalization) and troponin level elevated to 63 on the day of ER (Troponin increased)(Serious: Caused Hospitalization).  Relevant lab tests included: TROPONIN LEVEL (Result: 63, Test Date: 23-Oct-2024).  At the time of reporting, the event outcome of Chest pain was, Muscle spasms, Pain in extremity, Pain in jaw, Dyspnoea and Troponin increased was Unknown.; Sender's Comments: This 53-year-old Male experienced Chest pain, Muscle spasms, Pain in extremity, Pain in jaw, Dyspnoea and Troponin increased after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The event Chest pain was reported as serious.  The event Muscle spasms was reported as serious.  The event Pain in extremity was reported as serious.  The event Pain in jaw was reported as serious.  The event Dyspnoea was reported as serious.  The event Troponin increased was reported as serious.    Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Chest pain, Muscle spasms, Pain in extremity, Pain in jaw, Dyspnoea and Troponin increased is considered Possible.
Age: 22.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Systematic Rash covering face, neck, abdomen, back, chest
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Photopsia
Clinical narrative: Vision changes. Light flashes on periphery of vision.  Changes noted in both eyes but worse in the left eye. Condition gradually improved over the next 36 hours.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Vaccine in left arm. Significant upper arm pain (7) the next day in area of vaccine. The third day the pain eventually lessened to dull ache which has continued through today 24/7. Pain scale: 1 - 2. If my arm is leaning on a couch arm, or after sleeping on the arm, the pain becomes a 7 - 8+. It feels like my arm was hit with a baseball bat. Pain subsides to a 2 -3 within 5 - 10 minutes after changing position and, after taking Tylenol, subsides to a 1 - 2.  I've had every COVID shot and booster, all Moderna, since they were first available. I don't know how many there are in the series as they no longer fill out the vaccine card. This one has been the worst. I probably won't receive anymore after this one due to the ongoing pain.  I also received the Quad Flu Vaccine at the same time in my right arm with no adverse effects.
Age: 82.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Fatigue, Nausea, Pain, Poor quality sleep, Pyrexia
Clinical narrative: she felt fine after getting vaccinated then she started feeling tired so went to bed.  She took 2 tylenol but did not sleep well. When she woke up she was achy all over with 103 fever. She vomited after taking morning medication. She feels some better but not normal and her fever has come down to 99. She is still nauseated and sipping on water. She will contact her HCP if not feeling better.
Age: 82.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Vomiting
Clinical narrative: she felt fine after getting vaccinated then she started feeling tired so went to bed.  She took 2 tylenol but did not sleep well. When she woke up she was achy all over with 103 fever. She vomited after taking morning medication. She feels some better but not normal and her fever has come down to 99. She is still nauseated and sipping on water. She will contact her HCP if not feeling better.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Catheterisation cardiac abnormal, Coronary arterial stent insertion, Electrocardiogram abnormal, Myocardial infarction
Clinical narrative: I had an inferior myocardial infarction. This was diagnosed in the ED. I was sent to the Hospital cath lab and now have 2 Medtronic stents in my right coronary artery.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: I had an inferior myocardial infarction. This was diagnosed in the ED. I was sent to the Hospital cath lab and now have 2 Medtronic stents in my right coronary artery.
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: Wrong product administered
Clinical narrative: Dr. ordered Hep A vaccine for patient and a hiberix was administered by error instead.
Age: 11.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Glossitis, Oral disorder, Oral papule, Pyrexia, Tongue eruption
Clinical narrative: Got Moderna COVID and flu vaccines 10/26/24 afternoon  Sunday, started to have low grade fever, mom reports 99.6 degrees taken with IR thermometer, 2 degrees higher than normal  Complained of mouth pain Sunday through time of appointment (10/30/24), pt indicated that 10/30/24 is slightly better than 10/29/24. Dad said pt is talking more 10/30/24 . Pt is drinking, but not eating  Papules under tongue and on tongue, lesions on the sides, noticed 10/29/24  Diagnosis was glossitis
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Pruritus, Urticaria
Clinical narrative: SHE EXPERIENCED ITCHING, SWELLING TO ARM OF INJECTION AND HIVES,
Age: 40.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Pain
Clinical narrative: Between 8-10 hours after receiving the vaccines I had body aches,  felt feverish, left arm became sore. Trouble going back to sleep. Next morning fell worse. Took my meds. Also took 600mg Ibuprofen which made me feel a bit better but symptoms returned around 8pm on Wednesday. Fell asleep. Had the shivering feeling all night. Woke up at 1am with stomach pain. Also had a few loose bowel movements during the two day period. Within 12 hours of vaccination I had other symptoms that were similar to acute Covid infection?  Myalgia/Arthralgia which migrated all over the body. Sometimes the left knee would hurt, other times a sharp pain would persist in the right arm, also right sided pain  at the back of the cranium (right mastoid process of temporal bone). I also felt my temporal veins ?throbbing?? a symptom that was new as I have never experienced it before.
Age: 40.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity, Pyrexia, Sleep disorder, Vein disorder
Clinical narrative: Between 8-10 hours after receiving the vaccines I had body aches,  felt feverish, left arm became sore. Trouble going back to sleep. Next morning fell worse. Took my meds. Also took 600mg Ibuprofen which made me feel a bit better but symptoms returned around 8pm on Wednesday. Fell asleep. Had the shivering feeling all night. Woke up at 1am with stomach pain. Also had a few loose bowel movements during the two day period. Within 12 hours of vaccination I had other symptoms that were similar to acute Covid infection?  Myalgia/Arthralgia which migrated all over the body. Sometimes the left knee would hurt, other times a sharp pain would persist in the right arm, also right sided pain  at the back of the cranium (right mastoid process of temporal bone). I also felt my temporal veins ?throbbing?? a symptom that was new as I have never experienced it before.
Age: 74.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Syncope
Clinical narrative: Patient received pneumonia vaccine in her left arm first. She then received a flu vaccine and Covid vaccine in right arm. After immunization of the last vaccine patient fainted. She regained alertness shortly after. Patient stated that she has fainted before.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Patient was given 2 doses of flu vaccines same vaccine same lot number both times. First dose was administered on 10/04/2024 and 2nd dose was administered on 10/24/2024. Patient was contacted stated that symptoms that were present were soreness at the injection site. No other symptoms reported at this time.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Sleep disorder
Clinical narrative: Felt electrical shock like sensation all over body that woke me from my sleep
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Throat tightness
Clinical narrative: Adverse reaction: throat closing, SOB, stomach redness treatment Benadryl, solumedrol, and steroids.  resolved with medication
Age: 1.5
Sex: M
Vaccine: FLU3
Symptoms: Erythema multiforme
Clinical narrative: erythemia multiforme minor  rash started 10/30/24  in the afternoon, after receiving vaccines in the morning and spreading 11/1/24  acting well
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Abnormal behaviour, Aggression, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Foster mother called 10/31/24 to report that a few hours after TDAP vaccine on 10/21/24 child developed rash on abdomen between belly button and underwear line.  Rash was itchy,  hive-like with a lot o f tiny red dots per caller.  No rash or concerns at injection site on R deltoid.  She is unaware of any other possible cause for rash (change in soap, personal care products, no new foods tried).  Lavendar lotion applied to sooth itch.  Child also had behavior change for a few days after shot, having violent temper tantrums more extreme  than his norm.  In one instance he was so upset he flipped over backwards and was very still for a few seconds, she is unsure if he passed out, etc.  Symptoms resolved at time PHD was notified.  She did contact pediatrician Dr. about possible reaction.  No evaluation recommended and he instructed her to update PHD.  PCP did not make any recommendations about future vaccinations.
Age: 79.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Feeling abnormal, Gastric ulcer haemorrhage, Mass, Skin warm
Clinical narrative: Patient states a knot appear behind left ear on 10/16/24 and by 10/18/24, had increased and size and became hot. She called her doctor who said she could take Tylenol or Ibuprofen and use compresses and make an appointment after a month if not resolved. She went to the ER on 10/23/24 because she "felt so bad" and was diagnosed with a bleeding stomach ulcer and was put on pantoprazole. She says as of today 11/1/24, the knot has decreased and she is feeling better.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: ONSET OF SEVERE FLU LIKE SYMPTOMS FOR NEARLY A WEEK. COUGH, FEVER, FATIUGE, SHORTNESS OF BREATH
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient was given total of two flu shots (FLuad Trival 2024-2025) for the season on 08/12/2024  (Lot 388459) and 10/30/2024  (Lot388477).  Patient was informed of the incident and is ok / no complaint.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong patient received product, Wrong product administered
Clinical narrative: Pharmacy Technician called a patient into the room, but another patient entered instead. Technician did not verify name and DOB in the room and administered a Flu shot meant for another patient to this patient. The patient had actually come in asking for a Covid vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Limb discomfort
Clinical narrative: Fever & chills lasting until next morning. Considerable fatigue, muscle & joint ache throughout body lasting the entire next day. Severe pain at injection site making use of that arm VERY uncomfortable for at least 36 hours.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever & chills lasting until next morning. Considerable fatigue, muscle & joint ache throughout body lasting the entire next day. Severe pain at injection site making use of that arm VERY uncomfortable for at least 36 hours.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: I received latest COVID-19 vaccine on 9/xx/24 ( my birthday) at Pharmacy in my right arm. My initial side effects were redness, slight swelling and muscle soreness at the site.  For the past six weeks, I have experienced sharp pain in the bicep muscle when I bend my right arm towards the mid line and/or lift it up. In the last week the pain was exacerbated when the arm was struck by an opening door at work.  An example of the motion- when lifting a container to pour liquid in a glass or the pull motion required to remove a cork from a wine bottle.  I'm not able to do bent arm pull ups to the chin with a 5 lb weight for my twice a week strength training sessions. This is the only movement where I experience this. Other motions with a straight arm  with a weight-- pushing up, arm curls are all pain free.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Urticaria
Clinical narrative: Hives after given flu shot on arm and a headache everyday since then. Taking motrin is not helping. It was flu shot but not sure of the type
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient reporting lingering sore muscle in right arm.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Extra dose administered
Clinical narrative: gave at school flu clinic. When entered in record next day, inactivated flu vaccine  shown to have been given 1 day prior at Pediatrician clinic
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Rash pruritic
Clinical narrative: The patient's mother reported that the client woke up on 11/1/2024 and verbalized that he had "small bumps" on his feet and that is has a slight itch. No other symptoms reported, and parent denies that the patient has difficulty breathing, swallowing, chest tightness, or skin reaction where the vaccine was administered.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE IS RED, SWALLEN,FIRM-TIGHT AND WARM
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Balance disorder, Bradyphrenia, Coordination abnormal, Dizziness, Dysuria
Clinical narrative: She became very nauseated and her thinking became cloudy. She was off balance and dizzy. She had neck pain and body aches. Her hands and feet were having spasms and curling up, it was crippling. Her cooridination was off and symptoms getting worse so she took advil, flexeral, melantonin and laid down. She would get up to urinate and it was painful. By next morning she is some better but not well. She takes the flu vaccine every year and has never had a reaction before. She will contact her HCP for treatment if needed.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms, Nausea, Neck pain, Pain
Clinical narrative: She became very nauseated and her thinking became cloudy. She was off balance and dizzy. She had neck pain and body aches. Her hands and feet were having spasms and curling up, it was crippling. Her cooridination was off and symptoms getting worse so she took advil, flexeral, melantonin and laid down. She would get up to urinate and it was painful. By next morning she is some better but not well. She takes the flu vaccine every year and has never had a reaction before. She will contact her HCP for treatment if needed.