chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Metabolic function test, Mobility decreased
Clinical narrative: Within hours of receiving vaccination, experienced severe chills, fever, sweating, headache, nausea, and body aches to the point of not being able to move. This continued for the next 24 hours and mostly subsided by day 3. However, started developing SOB, what felt like chest palpitations, dizziness/vertigo, and bilateral numbness/tingling in upper extremities accompanied by tremors/shaking of arms. Would find myself out of breath simply walking up one flight of stairs in the house. Finally went to MD office 15 days later to undergo tests including CBCw/Diff, CMP, CK total and CKMB, chest x-ray, high sensitivity Troponin I, and D-Dimer. Results came back WNL with exception of elevated CO2 and was advised to follow up again if symptoms continued.  During this time we were moving so did not have new MD. Symptoms continued and at one point when staying at in-laws while looking for homes, fainted in driveway. To this day still experience intermittent bilateral tingling/numbness and shaking/tremors in upper extremities, SOB, and what feels like palpitations or best described as something "weighing" on the heart. Vertigo has also continued and been an ongoing issue.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Palpitations, Paraesthesia, Pyrexia
Clinical narrative: Within hours of receiving vaccination, experienced severe chills, fever, sweating, headache, nausea, and body aches to the point of not being able to move. This continued for the next 24 hours and mostly subsided by day 3. However, started developing SOB, what felt like chest palpitations, dizziness/vertigo, and bilateral numbness/tingling in upper extremities accompanied by tremors/shaking of arms. Would find myself out of breath simply walking up one flight of stairs in the house. Finally went to MD office 15 days later to undergo tests including CBCw/Diff, CMP, CK total and CKMB, chest x-ray, high sensitivity Troponin I, and D-Dimer. Results came back WNL with exception of elevated CO2 and was advised to follow up again if symptoms continued.  During this time we were moving so did not have new MD. Symptoms continued and at one point when staying at in-laws while looking for homes, fainted in driveway. To this day still experience intermittent bilateral tingling/numbness and shaking/tremors in upper extremities, SOB, and what feels like palpitations or best described as something "weighing" on the heart. Vertigo has also continued and been an ongoing issue.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Tremor, Troponin I normal, Vertigo
Clinical narrative: Within hours of receiving vaccination, experienced severe chills, fever, sweating, headache, nausea, and body aches to the point of not being able to move. This continued for the next 24 hours and mostly subsided by day 3. However, started developing SOB, what felt like chest palpitations, dizziness/vertigo, and bilateral numbness/tingling in upper extremities accompanied by tremors/shaking of arms. Would find myself out of breath simply walking up one flight of stairs in the house. Finally went to MD office 15 days later to undergo tests including CBCw/Diff, CMP, CK total and CKMB, chest x-ray, high sensitivity Troponin I, and D-Dimer. Results came back WNL with exception of elevated CO2 and was advised to follow up again if symptoms continued.  During this time we were moving so did not have new MD. Symptoms continued and at one point when staying at in-laws while looking for homes, fainted in driveway. To this day still experience intermittent bilateral tingling/numbness and shaking/tremors in upper extremities, SOB, and what feels like palpitations or best described as something "weighing" on the heart. Vertigo has also continued and been an ongoing issue.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Feeling abnormal, Influenza like illness, SARS-CoV-2 test positive
Clinical narrative: Started feeling flu symptoms on 01/05/2023; Took a home COVID-19 test and it was negative; Still felt bad a couple of days later so took another COVID-19 test and it was positive; Went to urgent care, tested for the Flu as well as COVID-19; Tested negative for the Flu, but COVID-19 was confirmed.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: A prepared vaccine syringe that was past the BUD was administered to the patient.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pericardial excision, Pleuropericarditis, Pyrexia, Thoracotomy
Clinical narrative: Patient developed fever and pleuropericarditis. He required hospitalization x several days and underwent thoracotomy and pericardial window
Sex: U
Vaccine: COVID19
Symptoms: Dysgraphia, Gait inability, Investigation, Pain
Clinical narrative: pain; can't even walk or write; can't even walk or write; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine ((DOSE 1, SINGLE), UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown"; GAIT INABILITY (non-serious), DYSGRAPHIA (non-serious), outcome "unknown" and all described as "can't even walk or write". The events "pain" and "can't even walk or write" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient has been in different doctors and different studies and all the results are fine (reported as find) and normal. The pain was awful. Now because of the pain, patient can't even walk or write. What the company is doing to help people like the patient with side effects. Patient can't even be with the daughter because of the pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Dyspnoea, Fatigue, Nasal congestion, Pyrexia
Clinical narrative: 12/22/2022 tested positive for Covid; prescribed PAXLOVID; mild symptoms low fever shortness of breath; 12/29/2022 tested negative 12/30/2022 started having nasal congestion with fever symptoms worsened through weekend. On Tuesday symptoms dropped off 01/03-01/05 home Covid test was positive. Shortness of breathe and fatigue. Tested 01/10/2022 for Covid result were negative.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 12/22/2022 tested positive for Covid; prescribed PAXLOVID; mild symptoms low fever shortness of breath; 12/29/2022 tested negative 12/30/2022 started having nasal congestion with fever symptoms worsened through weekend. On Tuesday symptoms dropped off 01/03-01/05 home Covid test was positive. Shortness of breathe and fatigue. Tested 01/10/2022 for Covid result were negative.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia, Pain
Clinical narrative: Muscle in arm still sore after 4 weeks.  She reported not sore all the time, but more so when she lays on that side or when using it.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 79.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This resident had already received a Pfizer Bivalent on 9/22/2022 but did not remember
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Vomiting
Clinical narrative: Employee developed a headache at 2:33pm. Donor stated she then had two episodes of emesis at 4:20pm after leaving the center. Employee stated she felt better after second episode of emesis and has tolerated oral fluids without any further nausea or vomiting. Employee also stated her headache has subsided as well.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Head injury, Injury, Loss of consciousness, Spinal fracture
Clinical narrative: about 12 hours after receiving shingrix pt fainted in her bathroom resulting in trauma to the patients head and a contusion fracture on patients back. patient states she blacked out and does not remember moments after she woke up and cannot recall how she got out of the bathroom. Patient subsequently went to the ER and spent 9 hours getting treated for her injuries
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: about 12 hours after receiving shingrix pt fainted in her bathroom resulting in trauma to the patients head and a contusion fracture on patients back. patient states she blacked out and does not remember moments after she woke up and cannot recall how she got out of the bathroom. Patient subsequently went to the ER and spent 9 hours getting treated for her injuries
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: His CDC shot card only indicated he received a Covid Booster, it did not have the words Bivalent on the Card.  When charting this information into patients Chart there was no indication he had received a Bivalent booster.  When he was researched in Immunization system again there was no indication he had received a Bivalent booster.  His CDC card had a date of 10/18/2022 and was given Pfizer and unsure who had delivered that vaccine. NO adverse reaction-no symptoms, no signs , no treatment, no reaction
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 39.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: COVID-19, Chills, Cough, Feeling cold, Influenza virus test negative
Clinical narrative: I had chills, and low-grade fever of 99. I started feeling better, so I went to work, and I started sneezing and coughing. When I got home on 12/12/2002 I took a COVID-19 test and it was positive. But for the rest of the week, I was fine. On 12/29/2022 I felt cold, fever of 102, and sore throat. I went to the doctor, and they tested me for COVID-19, Flu, and Strep. I was positive for strep.
Age: 39.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Malaise, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I had chills, and low-grade fever of 99. I started feeling better, so I went to work, and I started sneezing and coughing. When I got home on 12/12/2002 I took a COVID-19 test and it was positive. But for the rest of the week, I was fine. On 12/29/2022 I felt cold, fever of 102, and sore throat. I went to the doctor, and they tested me for COVID-19, Flu, and Strep. I was positive for strep.
Age: 39.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Streptococcus test positive
Clinical narrative: I had chills, and low-grade fever of 99. I started feeling better, so I went to work, and I started sneezing and coughing. When I got home on 12/12/2002 I took a COVID-19 test and it was positive. But for the rest of the week, I was fine. On 12/29/2022 I felt cold, fever of 102, and sore throat. I went to the doctor, and they tested me for COVID-19, Flu, and Strep. I was positive for strep.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Headache, Influenza virus test, Pyrexia, Rhinorrhoea
Clinical narrative: My COVID-19 symptoms started on 12/22/2022 in the evening at 07:00PM. I had fever of 102.08, scratchy throat, runny nose, and chest congestions. It was mostly on my upper respiratory. I went to the urgent care on 12/23/2022 they did COVID-19 test and Flu. I was positive for COVID-19 infection. At the urgent care they prescribe me with PAXLOVID for 5 days. I self tested with a home COVID-19 test on 12/30/2022 which was negative. On 01/03/2023 I had a runny nose and a slight headache. On 01/05/2023 I tested positive for COVID-19 again. I am not taking any medication just trying to stay hydrated. I did not take any COVID-19 tests yet.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Throat irritation, Upper respiratory tract congestion
Clinical narrative: My COVID-19 symptoms started on 12/22/2022 in the evening at 07:00PM. I had fever of 102.08, scratchy throat, runny nose, and chest congestions. It was mostly on my upper respiratory. I went to the urgent care on 12/23/2022 they did COVID-19 test and Flu. I was positive for COVID-19 infection. At the urgent care they prescribe me with PAXLOVID for 5 days. I self tested with a home COVID-19 test on 12/30/2022 which was negative. On 01/03/2023 I had a runny nose and a slight headache. On 01/05/2023 I tested positive for COVID-19 again. I am not taking any medication just trying to stay hydrated. I did not take any COVID-19 tests yet.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Wrong product administered
Clinical narrative: Patient already received 1 dose of Jannsen in 2021. Received the Moderna Primary series vaccine when she likely wanted to have the bivalent booster.
Age: 52.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: i prepared the vaccine, got verified, then administered the vaccine. a couple hours later i went to document and it was expired.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Influenza like illness, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: Feeling fatigue 01/01/2023 flu like symptoms then fever followed next days body aches continued fever Mon/Tue; fever broke Wednesday morning. Felt sore for several days.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Feeling fatigue 01/01/2023 flu like symptoms then fever followed next days body aches continued fever Mon/Tue; fever broke Wednesday morning. Felt sore for several days.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: He is a health care worker.  He presented without his CDC card.  He filled out the paperwork for consent.  He did not remember exact date he received his last Covid injection but it had been more than 2 months. At time of injection prior to injection he was asked if he had received a Bivalent he stated no.  When charting this information into patients Chart there was no indication he had received a Bivalent booster.  However in immunization system, immunization system stated he received the Mod bivalent 10/29/2022 by pharmacy.  He was still waiting his 15 minutes and was informed he had in fact received the bivalent vaccine in OCT and did not required this injection he received today. NO adverse reaction-no symptoms, no signs , no treatment, no reaction
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Provider ordered Prevnar 20 from adult stock. Medical assistant gave Prevnar 13 from pediatric stock.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Second Bivalent booster dose given.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Headache, Syncope
Clinical narrative: Pt had a syncopal event. Vitals:123/82,92,16, O2 Sat 100% When sitting, pt denies dizziness. 14:05 108/68,78,18,100% no unusual symptoms or sensation. 14:10 c/o of having slight dizziness.  Pt remains sitting in bed 123/72,106,18,100% 14:17 122/74,99,18, 100%.  Claims HA is almost gone. Pt stable and released from vaccination site to home w/ husband
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided.; HCP states that PROQUAD was administered to a patient on 12/14/2022 after a supported temperature excursion that took place on 12/1/2022; This spontaneous report was received from Medical Assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status rHA (recombinant Human albumin), 0.5 milliliter, lot #W020552, expiration date: 26-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) after a supported temperature excursion (temperature 19.4 Degree Fahrenheit for 50 minutes) that took place on 01-DEC-2022 (product storage error). No additional adverse event information provided. There was no previous temperature excursion.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Nerve injury
Clinical narrative: hearing loss; nerve damage; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. In or around October 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, dose number, lot #, expiration date, site and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered from hearing loss and nerve damage. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event of hearing loss was determined to be medically significant. The events were considered as disabling by the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown gender and age. The patient's medical histories, concomitant medications, concurrent conditions and drug reaction/allergies were not reported.  On 26-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U015847, expiration date: 19-MAY-2023 administrated for prophylaxis (dose frequency reported as once, strength, route of administration and anatomical site of administration were not provided) after a temperature excursion. The temperature was reported as 8.42 degrees Fahrenheit (F) for 1 hour 2 minutes (product storage error). There was no previous temperature excursion. No additional adverse event  information was provided (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; Medical assistant reported that a patient received an expired MMR II vaccine on 01/05/2023.   No additional AEs were reported, no further information provided.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 05-JAN-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number t033814, expiration date 05-OCT-2022 (dose and route of administration not reported) for prophylaxis that was reconstituted with sterile diluent (expired product administered). No adverse event was reported.
Age: 1.92
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HBP reported that VARIVAX was administered to a patient on 01/05/2023 after a temperature excursion. No further information was provided. Providers information was obtained and consent to contact was provided. No additional AEs/no PQCs.          ?; This spontaneous report was received from office manager and refers to a 23-month-old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not reported.  On 05-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), lot # W017551, expiration date 01-JUN-2024 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of suspect vaccine experienced temperature excursion from 6 degrees Fahrenheit (F) up to 14F for 10 minutes and from 14 F up to 46 F for 40 minutes (Product storage error). There was no previous temperature excursion. No additional adverse event.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; VARIVAX was administered to a patient on 01/03/2023 after a temperature excursion.; This spontaneous report was received from an office manager referring to a 6-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 03-JAN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), for prophylaxis (lot #W017551 had been verified to be a valid number; the expiration date was reported as 01-JUN-2024 and upon internal validation established as the same date) (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection date were not reported). The administered dose of the vaccine was stored at a temperature of 6 degrees Fahrenheit (F) up to 14°degrees Fahrenheit (F), during a time frame of 10 minutes, as recorded by a digital data logger, then 14°degrees Fahrenheit (F) up to 46 degrees Fahrenheit (F) during a time frame of 40 minutes, as recorded by a digital data logger.  There was no previous temperature excursion reported. There was no adverse effect reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE details were provided; AThe HCP also reported that both doses were administered intramuscularly instead of subcutaneously; The HCP reports that the patient was inadvertently administered both PROQUAD and VARIVAX at the same time; This spontaneous report has been received from a Medical Assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 04-NOV-2022, the patient was inadvertently vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection (lot number: U029323, which was determined to be valid with an expiration date on 19-MAR-2023) and varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (lot number: U039722, which was determined to be valid with an expiration date on 15-DEC-2023); both at a dose of 0.5 milliliters intramuscularly as prophylaxis at the same time (Accidental overdose, Inappropriate route of vaccination). No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No additional AE reported; Patient who was previously administered MMRII had missed MMRII Dose on 01/04/2023; This spontaneous report was received from a pharmacist referring to a patient of unknown gender and age. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (dose, strength, frequency, lot #, expiration date and route of administration were not provided) for prophylaxis.  On 04-JAN-2023, the patient missed dose of mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (product dose omission issue). The reporter was unable to further clarify these statements at current call time. No additional adverse event (AE) reported (no adverse event). No PQC reported.
Sex: F
Vaccine: FLUX
Symptoms: Gastroenteritis viral, Influenza, Rhinorrhoea, Vaccination failure
Clinical narrative: Suspected vaccination failure/Got flu vaccine, got stomach virus and flu every winter; Flu/Had the shot but still got the stomach virus and flu every winter; Stomach virus; Runny nose; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, stomach virus and runny nose. On an unknown date, the outcome of the vaccination failure, influenza, stomach virus and runny nose were unknown.   The reporter considered the vaccination failure, influenza, stomach virus and runny nose to be possibly related to Flu vaccine.     Additional Information: GSK receipt date: 5-Jan-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that when she was getting the flu vaccine, got stomach virus and flu every winter in elementary and middle school. The patient stopped taking them in high school and had yet to be attacked by that virus. A runny nose did not equate to flu vaccine, there were natural ways to build her immune system and help her grow healthy and strong. The medicine was not the only way. The reporter think that the event might had been related to the Product/Device. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of flu were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per reported information, the gender was captured as female.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza, Vaccination failure
Clinical narrative: Suspected vaccination failure/Gave my children flu vaccine, let them deal with it; Gave my children flu vaccine, let them deal with it; Get sick and worse; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. The patient was treated with vitamins nos (Vitamins). On an unknown date, the outcome of the vaccination failure, influenza and sickness were unknown.   The reporter considered the vaccination failure, influenza and sickness to be possibly related to Flu vaccine.     Additional Information: GSK receipt date: 5-Jan-2023 Reporter's comment: The case was received from the patient's parent via interactive digital media. The reporter reported that he/she gave his/her female children flu vaccine before, but they still get sick and worse, so he/she stopped them. The reporter stated that let them deal with it but giving them healthy foods and plenty of water and giving vitamins. The reporter think that the event might have been related to the Product/Device. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of influenza were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick all year; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be possibly related to Flu vaccine.  Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment:  This case was reported by a consumer via interactive digital media. The reporter reported younger sister had the shot and was sick for a long period of time. Totally agree. Absolutely not. The patient got the flu vaccine and was sick all year. Not exaggerating either. The reporter reported what needs to be pushed is making these vaccine companies liable for vaccine injuries and see how fast they push their products on people.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: His CDC shot card only indicated he had received Covid vaccinations.  No indications he had received a shot dated 9/12/2022, which was a bivalent. When charting today?s vaccination it was noticed he had received a Covid vaccination 9/12/2022-bivalent, there was no other Covid vaccinations charted. NO adverse reaction-no symptoms, no signs , no treatment, no reaction
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Feeling hot
Clinical narrative: Two days after vaccination, patient experience shortness of breath, chest pain and a sensation of heat in the upper left arm area. The chest pains and shortness of breath occasionally still occurs.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt was given a de-authorized vaccination no adverse reaction was noted or reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Pt stated she got side effect:skin itching on neck area for 10 days, felt fast heart beat for 2 weeks, nausea for 2 weeks after Pfizer vaccination.  Pt did not seek medical care.  Pt received Novavax as alternative for 2nd dose on 8/24/22. No reaction noted for Novavax at the time of vaccination.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient was vaccinated as part of a mobile vaccination clinic at an assisted living facility. A copy of the COVID-19 Vaccine Card was provided to the pharmacist, showing the patient received her primary series and 2 monovalent boosters. The patient was given a Bivalent Moderna COVID-19 vaccination. Upon returning to the office, it was discovered upon entering into the system, the patient had actually received a Bivalent Booster on 10/14/2022 as well from another provider. The clinic coordinator at the facility was notified to keep an eye on the patient and to let us know of any side effects or concerns.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt received a bivalent vaccine instead of a monovalent no reaction was noted or reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Individual received a Moderna Bivalent Booster for ages 6 months-5 years as their first COVID vaccine.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt. was supposed to receive the Pfizer Bivalent Booster ages 5yrs-11yrs instead of a 3rd primary dose. Pt. did not report signs or symptoms of distress or adverse reactions. Mother of child notified of incident.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Heart rate increased, Laboratory test
Clinical narrative: Patient reports a chronic pain/ache in heart.   Also she had an increase in her heart rate while at rest that lasted for approximately 1 hour
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Pt didn't have an adverse reaction. He was given a de-authorized dose of medication.
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Pfizer Bivalent as a 3rd dose instead of the Moderna Bivalent. No treatment neede and no signs or symptoms at this time.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer Monovalent dose administered instead of Bivalent dose.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dermatitis, Erythema, Fatigue, Full blood count normal
Clinical narrative: Day of vaccine: swelling and blister at injection site. 5 days following injection, she developed urticaria and swelling of posterior calves bilaterally. Rash limited to calf area only. Progressed to a symmetrical vertical linear erythematous dermatitis, consistent with phlebitis or lymphangitis. Remained very tender to touch. Also chest "heaviness", headaches, and fatigue.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site swelling, Injection site vesicles, Lymphangitis, Peripheral swelling
Clinical narrative: Day of vaccine: swelling and blister at injection site. 5 days following injection, she developed urticaria and swelling of posterior calves bilaterally. Rash limited to calf area only. Progressed to a symmetrical vertical linear erythematous dermatitis, consistent with phlebitis or lymphangitis. Remained very tender to touch. Also chest "heaviness", headaches, and fatigue.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Phlebitis, Rash, Tenderness, Ultrasound Doppler normal, Urticaria
Clinical narrative: Day of vaccine: swelling and blister at injection site. 5 days following injection, she developed urticaria and swelling of posterior calves bilaterally. Rash limited to calf area only. Progressed to a symmetrical vertical linear erythematous dermatitis, consistent with phlebitis or lymphangitis. Remained very tender to touch. Also chest "heaviness", headaches, and fatigue.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash pruritic, Urticaria
Clinical narrative: Pt reported  pruritic hives 9 days after vaccine.  A few days after receiving she got swelling, redness and heat at site. Also got hives at site and on cheek. Sx lasted a week or two after  No additional info available
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus right ear. No treatment
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient was erroneously given the wrong vaccine. Management, provider and patient was notified immediately. Provider consulted patient and then correct vaccine administered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Coma scale, Dizziness, Feeling hot, Palpitations
Clinical narrative: BIBA for possible reaction to covid vaccination. Pt received first covid vaccination today, reprts 5 min later developed sensation of throat closing up, heart racing, dizziness, and "heat inside chest and abdomen".  Denies facial swelling, rash, emesis, diarrhea, abdominal pain.  Sensation of throat closing resolved approximately after 10 minutes.  Currently only complains of feeling slightly dizzy and " heat inside chest and abdomen) No other new medications, environmental exposures, lotions/soaps, foods. NO meds given pta   No prior similar reaction to vaccinations No history of anaphylaxis  Allergies: Tuna (hives)  BP 129/61  | Pulse 84  | Temp 37.5 °C (99.5 °F) (Tympanic)  | Resp 18  | SpO2 96%  Physical Exam  Constitutional: She appears well-developed and well-nourished. No distress.  HENT:  Head: Normocephalic and atraumatic.  Right Ear: External ear normal.  Left Ear: External ear normal.  Nose: Nose normal.  Mouth/Throat: Uvula is midline, oropharynx is clear and moist and mucous membranes are normal. No uvula swelling. No posterior oropharyngeal edema.  No facial swelling, no oral lesions, oropharynx patent Nl phonation  Eyes: Conjunctivae and EOM are normal.  Neck: Trachea normal, normal range of motion, full passive range of motion without pain and phonation normal. Neck supple. No neck rigidity.  Cardiovascular: Normal rate and normal heart sounds.  Pulmonary/Chest: Effort normal and breath sounds normal. No respiratory distress. She has no wheezes.  Abdominal: Soft. There is no abdominal tenderness.  Musculoskeletal: Normal range of motion.  Lymphadenopathy:    She has no cervical adenopathy.  Neurological: She is alert. GCS eye subscore is 4. GCS verbal subscore is 5. GCS motor subscore is 6.  Skin: Skin is warm, dry and intact. Rash noted. She is not diaphoretic.  Psychiatric: She has a normal mood and affect. Her behavior is normal. Judgment and thought content normal.  Nursing note and vitals reviewed.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Throat tightness
Clinical narrative: BIBA for possible reaction to covid vaccination. Pt received first covid vaccination today, reprts 5 min later developed sensation of throat closing up, heart racing, dizziness, and "heat inside chest and abdomen".  Denies facial swelling, rash, emesis, diarrhea, abdominal pain.  Sensation of throat closing resolved approximately after 10 minutes.  Currently only complains of feeling slightly dizzy and " heat inside chest and abdomen) No other new medications, environmental exposures, lotions/soaps, foods. NO meds given pta   No prior similar reaction to vaccinations No history of anaphylaxis  Allergies: Tuna (hives)  BP 129/61  | Pulse 84  | Temp 37.5 °C (99.5 °F) (Tympanic)  | Resp 18  | SpO2 96%  Physical Exam  Constitutional: She appears well-developed and well-nourished. No distress.  HENT:  Head: Normocephalic and atraumatic.  Right Ear: External ear normal.  Left Ear: External ear normal.  Nose: Nose normal.  Mouth/Throat: Uvula is midline, oropharynx is clear and moist and mucous membranes are normal. No uvula swelling. No posterior oropharyngeal edema.  No facial swelling, no oral lesions, oropharynx patent Nl phonation  Eyes: Conjunctivae and EOM are normal.  Neck: Trachea normal, normal range of motion, full passive range of motion without pain and phonation normal. Neck supple. No neck rigidity.  Cardiovascular: Normal rate and normal heart sounds.  Pulmonary/Chest: Effort normal and breath sounds normal. No respiratory distress. She has no wheezes.  Abdominal: Soft. There is no abdominal tenderness.  Musculoskeletal: Normal range of motion.  Lymphadenopathy:    She has no cervical adenopathy.  Neurological: She is alert. GCS eye subscore is 4. GCS verbal subscore is 5. GCS motor subscore is 6.  Skin: Skin is warm, dry and intact. Rash noted. She is not diaphoretic.  Psychiatric: She has a normal mood and affect. Her behavior is normal. Judgment and thought content normal.  Nursing note and vitals reviewed.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Tinnitus, Vertigo
Clinical narrative: Vertigo lasting 5 weeks, Tinnitus persistent , and worsening, Brain Fog, lasting 4 weeks
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was at the pharmacy to receive the Bivalent Moderna Booster for Peds however received the primary series of the Moderna Covid Peds vaccine. Parents did not report any adverse events from the vaccine.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Disturbance in attention, Fatigue, Feeling abnormal, Loss of personal independence in daily activities
Clinical narrative: Fatigue that interfered with daily activities; "brain fog" (unusual difficulty focusing and concentrating); nausea and loss of appetite
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Fatigue that interfered with daily activities; "brain fog" (unusual difficulty focusing and concentrating); nausea and loss of appetite
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: redness on arm , itching , rash
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Fatigue, Headache
Clinical narrative: Tested positive for covid no 12/31/22, the symptoms I had were fe ver/ chills, body aches, headache, cough, sneezing, fatigue
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive, Sneezing
Clinical narrative: Tested positive for covid no 12/31/22, the symptoms I had were fe ver/ chills, body aches, headache, cough, sneezing, fatigue
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Laboratory test, Seizure
Clinical narrative: Seizure
Age: 12.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received incorrect vaccine. Original formula was administered instead of the bivalent booster.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given original formulation of vaccine rather than the bivalent booster.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received original formulation of vaccine rather than bivalent booster
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received original formulation rather than bivalent booster
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus, mild but still happening. Never before.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Blister, Dermatitis, Skin discolouration
Clinical narrative: Developed purple blisters biopsied as nutriphilic dermatitis Recurred with second booster from pfizer
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient was advised to wait 15 min after vaccine. Patient fainted twice and EMS was called
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd Dose give 10 days to early No adverse events.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: 2nd Dose give 10 days to early No adverse events.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Second dose given 10 days too early. No adverse events.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd Dose give 10 days to early No adverse events
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd Dose give 10 days to early No adverse events.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2nd Dose give 10 days to early No adverse events
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2 vaccines were given 8 days too early. Not found until 2 months later during billing.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: After vax was given patient experienced VasoVagal syncope. Pt was monitored, given fluid & crackers observed for 30min before released.