chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; that patient received inappropriately stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 3-year-old (also reported as 4) male patient. The patient had 1 brother and 1 sister. There was no information about the patient's pertinent medical history or drug reactions and allergies provided. Concomitant therapies included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid(KINRIX).  On 15-MAY-2024, the patient was vaccinated with an inappropriately stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, single dose, lot #Y003143, expiration date: 27-JUL-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error).   Temperature excursion of 19.8 degrees Fahrenheit for 20 hours and 15 minutes was reported. No previous temperature excursion reported.  No adverse effects reported (No adverse event).  This is one of 36 reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA007588: US-009507513-2405USA007600: US-009507513-2405USA007488: US-009507513-2405USA007924:2405USA007454 US-009507513-2405USA007905: US-009507513-2405USA007617: US-009507513-2405USA007648: US-009507513-2405USA007667: US-009507513-2405USA007692: US-009507513-2405USA007713: US-009507513-2405USA007720: US-009507513-2405USA007722: US-009507513-2405USA007724: US-009507513-2405USA007727: US-009507513-2405USA007728: US-009507513-2405USA007731: US-009507513-2405USA007761: US-009507513-2405USA007763: US-009507513-2405USA007771: US-009507513-2405USA007833: US-009507513-2405USA007841: US-009507513-2405USA007911: US-009507513-2405USA007912: US-009507513-2405USA007935: US-009507513-2405USA007700: US-009507513-2405USA007916: US-009507513-2405USA007924:2405USA007454 US-009507513-2405USA007722: US-009507513-2405USA007912: US-009507513-2405USA007454:
Sex: U
Vaccine: FLU4, MMRV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No additional AE; Medical Assistant calling to report HCP accidentally reconstituting PROQUAD vaccines with a flu vaccine FLUZONE made by Sanofi as opposed to sterile diluent. Caller stated patient has not reported any symptoms. Permission to contact HCP was granted.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 27-SEP-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # X022920, expiration date 12-MAR-2025 (dose and route of administration not provided) for prophylaxis which was reconstituted with influenza vaccine inact split 4v(FLUZONE QUADRIVALENT) (dose, lot number and expiration date not reported) instead of sterile diluent (product preparation error). No adverse event was reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: no adverse event; a 4 month old patient is due for their ROTATEQ vaccination however cannot receive medications by mouth. Patient has a gastric tube; This spontaneous report was received from a licensed practical nurse referring to a 4 month old patient. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  It was mentioned that patient was due for their Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vaccination however cannot receive medications by mouth. On 01-OCT-2024, the patient received the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter (strength, dose number, lot number and expiration date were not provided) as prevention of rotavirus via gastric tube (incorrect route of product administration). No adverse event reported.  The lot# is being requested and will be submitted if received.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects were reported.; HCP called reporting a MMR II was administered after the expiration date. LOT/EXP   W029538  9/15/2024; Administered: 10/2/2024.; This spontaneous report was received from a nurse regarding to a 40-year-old female patient.  The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 02-OCT-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin)(M-M-R II) injection, lot #W029538 has been verified to be valid, expiration date reported and established as: 15-SEP-2024 (dose, strength, route of administration, and anatomical location were not provided); administered for prophylaxis after the expiration date (Expired product administered).  Product was supported and no adverse side effects were reported (No adverse event).
Age: 69.0
Sex: M
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: patient needed hepatitis b vaccination, as the patient had already completed a hepatitis a series in 2019; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included hepatitis a (completed a Hepatitis A series in 2019).   On 19-AUG-2024, the patient received Twinrix. On 19-AUG-2024, an unknown time after receiving Twinrix, the patient experienced extra dose administered (Verbatim: patient needed hepatitis b vaccination, as the patient had already completed a hepatitis a series in 2019). 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: 23-SEP-2024 The reporter reported that a patient was administered a dose of Twinrix. However, it turned out that the patient only needed Hepatitis B vaccination, as the patient had already completed a Hepatitis A series in 2019, which led to extra dose administered. The pharmacist did not have lot number information available at time of call.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 7.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Maladministration of an adult dose on a pediatric patient; Maladministration of an adult dose on a pediatric patient; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 7-year-old patient who received HAV (Havrix adult) (batch number 3S54K, expiry date 18-DEC-2025) for prophylaxis.   On 24-SEP-2024, the patient received Havrix adult. On 24-SEP-2024, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: Maladministration of an adult dose on a pediatric patient) and adult product administered to child (Verbatim: Maladministration of an adult dose on a pediatric patient). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-SEP-2024 The physician wanted advise about the maladministration of an adult dose on a pediatric patient, which led to overdose and adult product administered to child. No further information provided from the physician's end.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Resident received two doses of Influenza Vaccination in less than a week.
Age: 80.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Fatigue, Full blood count, Headache, Lipase, Metabolic function test
Clinical narrative: Headache, nausea and vomiting, fatigue
Age: 80.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Nausea, Troponin, Vomiting
Clinical narrative: Headache, nausea and vomiting, fatigue
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Migraine, Nausea, Pain
Clinical narrative: Prolonged migraine with dizziness, nausea, pain, and light/smell sensitivity.  Beginning day after administration and ongoing as of 10/03/2024. Unusual presentation and longer time course than normal. Treated with ibuprofen/acetaminophen combo and zofran for nausea.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Photophobia
Clinical narrative: Prolonged migraine with dizziness, nausea, pain, and light/smell sensitivity.  Beginning day after administration and ongoing as of 10/03/2024. Unusual presentation and longer time course than normal. Treated with ibuprofen/acetaminophen combo and zofran for nausea.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Urticaria
Clinical narrative: Generalized urticaria beginning approximately 4 days post-vaccination and lasting approximately 3 days.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hive of 11 mm; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: hive of 11 mm). The outcome of the hives was not reported.   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-SEP-2024 The reporter reported that she is allergic to Prevnar 13 & amp; 20.  She is also allergic to the Shingrix vaccine.  She asked that, which were the ingredients that may be causing the allergic reaction. She states that, she had developed an anaphylactic reaction after getting Prevnar 13 and her doctor suggested her to get a test for it. So, she took up the Prevnar 20 and got it tested in the allergist office. She found that she had a severe reaction, as hive of 11 mm with the Shingrix. So, the patient was afraid to take Shingrix as she would have the same reaction. Patient was wondering about the ingredients of the Abrysvo and the other ones.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Patient's mother reports that vaccine was given subcutaneously rather than intramuscularly. Nurse gave vaccination using 23 G x 1 in needle inserted at 90 degree angle into tricep of right arm.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Diarrhoea, Fatigue, Feeling hot
Clinical narrative: An hour after shot, pt got weak, tired, hot and sweaty, vomitted, had diarrhea at the same time, and had loss of balance. Next day just tire and dizzy, no more diarrhea/vomitting. Pt takes in liquids to help. Two days later pt feels better and just tired.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Vomiting
Clinical narrative: An hour after shot, pt got weak, tired, hot and sweaty, vomitted, had diarrhea at the same time, and had loss of balance. Next day just tire and dizzy, no more diarrhea/vomitting. Pt takes in liquids to help. Two days later pt feels better and just tired.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Patient reports that vaccine was given subcutaneously rather than intramuscularly. Nurse gave vaccination using 23 G x 1 in needle inserted at 90 degree angle into tricep of left arm.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Patient's mother reports that vaccine was given subcutaneously rather than intramuscularly. Nurse gave vaccination using 23 G x 1 in needle inserted at 90 degree angle into tricep of right arm.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Patient's wife reports that vaccine was given subcutaneously rather than intramuscularly. Nurse gave vaccination 23 G x 1 in needle inserted at 90 degree angle into tricep of right arm.
Age: 35.0
Sex: M
Vaccine: FLU3, PNC20, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Increasing pain at injections site & hot to touch  Redness around injection site - Reports 4 days after injection
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Was given Beyfortus on 9/16
Sex: M
Vaccine: VARCEL
Symptoms: Device connection issue, No adverse event
Clinical narrative: the needle came undone from the syringes when pulling out of the patient's skin following administration of the vaccine; the needle came undone from the syringes when pulling out of the patient's skin following administration of the vaccine; the needle came undone from the syringes when pulling out of the patient's skin following administration of the vaccine; No additional AE; This spontaneous report was received from a medical assistant referring to two patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown dates, the patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided); with sterile diluent (STERILE DILUENT) solution for injection/infusion, administered as medication dilution (strength, dose description, lot #, expiry date, and route of administration were not provided). The medical assistant reported that on two separate occasions, the needle came undone from the syringes when pulling out of the patient's skin following administration of the vaccine (Poor quality device used; Device connection issue). The medical assistant reported no issues with inserting the needle into the injection site; however, after administration, when removing the needle, it became detached from the syringe, leaving the needle in the patient's skin. The medical assistant reported to the field employee that the products have been discarded and she did not have lot numbers/expiration dates. There was no additional adverse event (AE) or product quality complaint (PQC) reported and no additional information was provided.   Follow-up information has been received from the medical assistant on 23-SEP-2024. The patient was male, around 4 or 5 years old. Varicella virus vaccine live (oka/merck) (VARIVAX) and sterile diluent was administered subcutaneously. It was reported that nurse was administering varicella virus vaccine live (oka/merck) (VARIVAX) with syringe sterile diluent. After the vaccine was administered, the needle detacted from syringe and stayed in child's leg (Complication of device removal, Needle issue).  This is one of several reports received from the same reporter.  Additional information is not expected. ; Sender's Comments:  US-009507513-2409USA009493:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: No other AE; an adult patient was inadvertently administered a pediatric dose of the RECOMBIVAX HB Vaccine.; This spontaneous report was received from a medical assistant and refers to an adult patient of unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was inadvertently administered a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #X011082, expiration date not reported but upon internal validation confirmed to be: 01-OCT-2025 (route of administration and vaccination site were not provided) administered for prophylaxis (accidental underdose). No symptoms were reported and no additional details were provided. No other adverse event (AE) and no product quality complaint (PQC) was reported (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Myocarditis
Clinical narrative: confirmed myocarditis diagnosis; crushing chest pain; This serious case was reported by a consumer via sales rep and described the occurrence of myocarditis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced myocarditis (Verbatim: confirmed myocarditis diagnosis) (serious criteria GSK medically significant) and chest pain (Verbatim: crushing chest pain). The outcome of the myocarditis was resolving and the outcome of the chest pain was not reported.   It was unknown if the reporter considered the myocarditis and chest pain to be related to Shingrix.     The company considered the myocarditis to be unrelated to Shingrix. It was unknown if the company considered the chest pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-SEP-2024 The consumer reported that the patient received a subsequent dose of Shingrix and experienced myocarditis. The patient also experienced crushing chest pain after the second dose of Shingrix (unknown how long after vaccination). The physician confirmed myocarditis diagnosis.; Sender's Comments: Myocarditis is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: COVID-19; suspected vaccination failure; had shingles 6 months before and have had shingles a total of 4 times; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In MAR-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles 6 months before and have had shingles a total of 4 times). On an unknown date, the patient experienced covid-19 (Verbatim: COVID-19). The outcome of the vaccination failure, shingles and covid-19 were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles and covid-19 to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 27-SEP-2024 The patient received both the doses of shingrix in 2021 and  had shingles 6 months before and had shingles a total of 4 times. The patient had covid about 5 days after the 2nd dose. The patient reported that each time was worse than the other. The patient had continue to got shingles even after the vaccine. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; It didn't work anymore; 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.   The patient's past medical history included herpes zoster (had them on and off since he/she was 51) and pain (definitely painful).   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) and herpes zoster (Verbatim: It didn't work anymore). The outcome of the vaccination failure and herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and herpes zoster 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 herpes zoster to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-SEP-2024 This case was reported the patient via interactive digital media They were definitely painful.  The patient had them on and off since was 51.  The only medicine that worked was an antiviral. Shingles shot became available for people 60 and older.  By the time the patient got it at 60 it was too late and the vaccine didn't work anymore.  Antiviral was the best. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 Shingles vaccine.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; experienced a moderate outbreak of shingles on my upper left leg; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included excellent health.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In MAY-2024, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: experienced a moderate outbreak of shingles on my upper left leg). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. The company considered the shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 28-SEP-2024 The patient self-reported this case for himself. The patient with excellent health who had both series of Shingles vaccinations, the most recent being Shingrix.  However, in May of this year he had experienced a moderate outbreak of shingles on the upper left leg although he had never had a previous outbreak. The symptoms were relatively mild, which made the patient sure was due to the vaccine, so the patient definitely appreciated its effectiveness.  Even so, he was surprised that someone with his state of excellent health would be likely to have any outbreaks. The patient was an engineering manager and decided to keep a chronologic record of the symptoms as well as accompanying photos. If that information would be helpful in the research program and/or database of cases, the reporter would be glad to share it with GlaxoSmithKline. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix.  Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-SEP-2024 and 30-SEP-2024 This case was received from the patient via interactive digital media. The reporter reported that he/she had the Shingrix shots and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary 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 Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: only received one dose in 2023/ never got second dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2023).   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 received one dose in 2023/ never got second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-SEP-2024 This case was reported by a consumer via interactive digital media. The patient reported that she never got the second dose of Shingrix.  The reporter further stated that, all she wanted to know if she needs to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Elevated blood sugar over 180
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: AF with RVR within 24 hrs of vaccine
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial septal defect, Atrial septal defect repair, Blood test normal, Cerebral thrombosis, Cerebrovascular accident
Clinical narrative: I had a stroke. When it first happened I was having trouble pronouncing my words, especially the end of the words, but I managed, and then after 5-10 mins it stopped. The following day my left leg became heavy. I then went to the emergency room where they did multiple tests, CT scan, MRI and blood tests. The MRI showed 2 little spots on my brain. Ultrasound of heart found a small PFO, and since they couldn t find any clotting disorders or other reasons why I got a blood clot in the first place they concluded that the PFO led the clot to the brain, and they closed the PFO in a procedure 9/1/22
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Echocardiogram abnormal, Limb discomfort, Magnetic resonance imaging head abnormal, Speech disorder
Clinical narrative: I had a stroke. When it first happened I was having trouble pronouncing my words, especially the end of the words, but I managed, and then after 5-10 mins it stopped. The following day my left leg became heavy. I then went to the emergency room where they did multiple tests, CT scan, MRI and blood tests. The MRI showed 2 little spots on my brain. Ultrasound of heart found a small PFO, and since they couldn t find any clotting disorders or other reasons why I got a blood clot in the first place they concluded that the PFO led the clot to the brain, and they closed the PFO in a procedure 9/1/22
Age: 15.0
Sex: F
Vaccine: COVID19, FLU3, HEP
Symptoms: Dizziness, Fall
Clinical narrative: Patient was anxious about receiving  vaccines both prior to and during vaccinations. No immediate response was seen. Upon standing and walking out of the vaccination room door, patient became light-headed and fell. Patient was caught by their father and no injuries were sustained by the patient. Patient sat on floor until able to stand and walk safely, and requested water. Followed up with patient around 16 hours after the incident and no further adverse effects were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: I woke up at 11:30 pm the same day of injection shivering and every joint in my body hurt. My arm is red, swollen, and painful at injection site. On Tuesday 9/30/24 every time I would move my head the slightest I would get sharp, shorting pain towards my forehead. I have never experienced something like this before. This head issue lasted 2 days.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain
Clinical narrative: I woke up at 11:30 pm the same day of injection shivering and every joint in my body hurt. My arm is red, swollen, and painful at injection site. On Tuesday 9/30/24 every time I would move my head the slightest I would get sharp, shorting pain towards my forehead. I have never experienced something like this before. This head issue lasted 2 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cough, Erythema, Feeling hot, Induration, Oedema peripheral
Clinical narrative: It started with redness and then swelling. The swelling became hot, sore and the area became hard. After a few days an edema formed under the skin about the size of a half dollar and felt like a round ball was in the arm. This eventually led to a severe itch in the arm, sneezing and coughing.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Sneezing
Clinical narrative: It started with redness and then swelling. The swelling became hot, sore and the area became hard. After a few days an edema formed under the skin about the size of a half dollar and felt like a round ball was in the arm. This eventually led to a severe itch in the arm, sneezing and coughing.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Patient states that the following symptoms started on 9/12/24 at 8:00 AM: Blister was noted and was the size of the tip of a baby finger. Arm presented a red silver dollar sized area around the injection site.  The redness lasted 3 days and the soreness lasted about 10 days.  Patient is no longer having an issue once the former symptoms resolved.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Pain, Peripheral coldness
Clinical narrative: On 10/3/24 I woke up with a massive headache, fever and chills, ice cold feet, sore throat, aches and pains, and vomiting.  This continued throughout the day.  I spoke with my Doctor around 2:00 pm.  He informed me to take the covid test but felt I was having a reaction to the vaccine.  The test came back negative.  For the rest of the day all I could do was lay in bed.  I continued to vomit until about 8:00 pm when I went to sleep.  I got up in the morning on 10/4 and felt a little better.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Vomiting
Clinical narrative: On 10/3/24 I woke up with a massive headache, fever and chills, ice cold feet, sore throat, aches and pains, and vomiting.  This continued throughout the day.  I spoke with my Doctor around 2:00 pm.  He informed me to take the covid test but felt I was having a reaction to the vaccine.  The test came back negative.  For the rest of the day all I could do was lay in bed.  I continued to vomit until about 8:00 pm when I went to sleep.  I got up in the morning on 10/4 and felt a little better.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Cough, Nasal congestion
Clinical narrative: cough, weakness, chills, fever, ache, congestion
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: cough, weakness, chills, fever, ache, congestion
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Seizure like phenomena
Clinical narrative: Patient was given Menquadfi in office at 4:54 pm.  She left the office at 5:11pm.  Mom states she called EMS at 5:18 pm for seizure-like symptoms.  They were taken to Hospital and was diagnosed with a vaccine reaction.  Her first dose of this series was Menactra given in 2020 with no reactions.
Age: 37.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm swollen to almost twice the normal diameter of the left shoulder, redness and warmth over injection site, difficult to move arm, couldn't sleep on the area. Symptoms started getting better after 4-5 days and resolved after 7 days. Has chronic left shoulder pain that is similar after event.
Age: 37.0
Sex: M
Vaccine: PNC20
Symptoms: Sleep disorder
Clinical narrative: Left arm swollen to almost twice the normal diameter of the left shoulder, redness and warmth over injection site, difficult to move arm, couldn't sleep on the area. Symptoms started getting better after 4-5 days and resolved after 7 days. Has chronic left shoulder pain that is similar after event.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient had a low rubella titer and needed MMR vaccination. MMR vaccination discussed, varicella vaccine accidentally given.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: none
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PATIENT STATES THAT THERE IS A RED RING AROUND THE INJECTION SITE AND IT IS ITCHY.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: PATIENT WOKE UP NEXT MORNING WITH INJECTION SITE RED AND RAISED. LATER IN THE DAY THE INJECTION SITE WAS A WELT THAT TRAVELED DOWN HER ARM. OVER THE COURSE OF THE NEXT 2 DAYS SHE STARTED GETTING WELTS ON OTHER PARTS OF HER BODY, WHEN THEY APPEARED ON HER FACE SHE WENT TO THE ED.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given to patent out of the stated age range for vaccine.
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Incorrect dose administered, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Patient given Comirnaty 0.3 ml for 12 years and up.  Patient had a sore arm, no other complaints.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: hepatis B given instead of hepatitis A vaccine.  This is not harmful but he didn't need this vaccine. We will make up hep A at his next visit.
Age: 0.67
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: incorrect vaccine administered according to child's age
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node swelling right clavicle
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Brain fog, Hypoaesthesia, Malaise, Myalgia, Palpitations
Clinical narrative: Malaise, Myalgia, Numbness/Tingling to Fingers and Face, Palpitations, Dizziness, Head Feeling Foggy.   The patient was taken to the Emergency Room due to reactions progressing.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Malaise, Myalgia, Numbness/Tingling to Fingers and Face, Palpitations, Dizziness, Head Feeling Foggy.   The patient was taken to the Emergency Room due to reactions progressing.
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was administered.  Patient was given a MMR vaccine on 10/03/2024 that had expired on 09/27/2024.  No adverse reactions. Patient will be revaccinated in 4 weeks.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache
Clinical narrative: Patient was dizzy and reported headache 5 minutes post vaccination
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric Dose instead of adult dose administered
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given both doses in error, was only supposed to receive the high dose fluad. No actual adverse reaction, just reporting that the patient had both doses.
Age: 78.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Balance disorder, Blood glucose decreased, Dizziness, Lethargy, Wheelchair user
Clinical narrative: pt came in for appt with pcp. Pt taken in by this writer at 9:58am for 10am  appt. Prior to visit pt recevied influenza and covid vaccine in flu clinic in  right arm. As pt was being weigh started to feel lethargic. Wheelchair obtained  to help with balance and dizziness. BS checked and level was 136. BP dropped to  56/41. PCP made aware of finding and a came to assess pt. Rapid response was  called to address issues and transport patient to ER. For further evaluation.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Elevated heart rate of 150 bpm at rest throughout the night
Age: 34.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Condition aggravated, Genital herpes simplex
Clinical narrative: Outbreak of genital HSV 3 days after immunizations. Only 1 previous outbreak 12 years prior. Patient sought antiviral tx after 5 days.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Left arm is bright red, very swollen, itchy and hurts.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient was to receive blue cap 5yr to 11 yr Covid vaccine. Received yellow cap 6m to 4yr Covid vaccine. Parent to be called to administer correct dose of blue cap 5yr to 11yr Covid vaccine
Age: 34.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Hyperhidrosis, Myoclonus, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Patient has a history of syncope with lab draws.  Hepatitis A was administered first, tolerated well, administered Typhoid vaccine within 1-2 minutes his head dropped forward, he was unresponsive, diaphoretic with myoclonic jerks. Applied an ice pack to posterior neck, patient was alert and responsive within 5min. Paramedics from our building came to room and talked with patient for a few minutes. Patient sat in clinic room for another 15-20min, then left with his spouse who was present during incident.
Age: 55.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient came into pharmacy requesting Shingrix vaccine based on physician recommendation. Vaccine was administered and upon recording administration into database, I realized that the patient had already received the recommended 2 Shingrix doses prior to encounter. Patient was informed that they had just received a third Shingrix vaccine when only 2 doses are recommended by the CDC and manufacturer. I let them know to monitor closely for any side effects and let me know if they experience anything more than the expected Shringrix vaccine side effects. Also printed off his vaccine list from database and gave it to him for his reference and to show the physician. I plan to call the patient 5 days after incident to see how he is feeling if I do not hear anything from him before then.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: shoulder pain and limited mobility started one day after injection
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Breath holding, Chest X-ray, Cyanosis, Feeling hot, Influenza virus test negative
Clinical narrative: Seen in ER on 9/27 for possible seizure-like activity Patient was lying in bed, he began to stare off to the side and became non-interactive Father sat him on the counter but he continued to stare off; he was tremulous but did not have tonic-clonic moements He then vomited twice and became drowsy No measured fever but had felt intermittently hot since getting vaccines earlier in the day (Pediarix, Havrix) Parents denied any seizure history in child or family, no injury, no cough / cold symptoms, diarrhea, or decreased UOP Wheezing vs upper airway noise on exam CXR with possible viral respiratory process COVID, flu, and RSV swabs negative Here today for follow up Mother reports that prior to the event he was running / jumping / playing without signs of any problems Issue occurred when he was put down in bed Small tremors and staring off until arrived at hospital, about 30 minutes or so He was turning a little blue / holding breath but mouth was open Fell asleep after arriving in the ER No issues since that time.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Somnolence, Staring, Tremor
Clinical narrative: Seen in ER on 9/27 for possible seizure-like activity Patient was lying in bed, he began to stare off to the side and became non-interactive Father sat him on the counter but he continued to stare off; he was tremulous but did not have tonic-clonic moements He then vomited twice and became drowsy No measured fever but had felt intermittently hot since getting vaccines earlier in the day (Pediarix, Havrix) Parents denied any seizure history in child or family, no injury, no cough / cold symptoms, diarrhea, or decreased UOP Wheezing vs upper airway noise on exam CXR with possible viral respiratory process COVID, flu, and RSV swabs negative Here today for follow up Mother reports that prior to the event he was running / jumping / playing without signs of any problems Issue occurred when he was put down in bed Small tremors and staring off until arrived at hospital, about 30 minutes or so He was turning a little blue / holding breath but mouth was open Fell asleep after arriving in the ER No issues since that time.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Vomiting
Clinical narrative: Seen in ER on 9/27 for possible seizure-like activity Patient was lying in bed, he began to stare off to the side and became non-interactive Father sat him on the counter but he continued to stare off; he was tremulous but did not have tonic-clonic moements He then vomited twice and became drowsy No measured fever but had felt intermittently hot since getting vaccines earlier in the day (Pediarix, Havrix) Parents denied any seizure history in child or family, no injury, no cough / cold symptoms, diarrhea, or decreased UOP Wheezing vs upper airway noise on exam CXR with possible viral respiratory process COVID, flu, and RSV swabs negative Here today for follow up Mother reports that prior to the event he was running / jumping / playing without signs of any problems Issue occurred when he was put down in bed Small tremors and staring off until arrived at hospital, about 30 minutes or so He was turning a little blue / holding breath but mouth was open Fell asleep after arriving in the ER No issues since that time.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Gave pt kinrix 3 mo too early. No symptoms, called cdc for recommendations.
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product prescribing error
Clinical narrative: Incorrect dose ordered and administered
Age: 71.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: The COVID19 and influenza vaccines were administered in the right gluteal muscle per patient's request. Patient was not harmed. Wrong administration site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fall, Fatigue, Headache, Injection site erythema
Clinical narrative: pt states she developed a large lump on right arm at the injection site. It became itchy, red and very warm. She went to bed on Friday and woke up Saturday morning with a severe headache and vomiting. The worst headache she ever had. She vomited 5 or 6 times. She laid down and rested but could not get rid of the headache. She was unable to eat for about 4 days. She continues to have a severe headache. She develops a sensation in her legs which causes her to fall.  She has fell twice. Still has some nausea and is totally exhausted. She has reached out to her doctor and was precribed predinsone 20 mg per day and allegra. She will contact her doctor if she does not recover.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus, Injection site warmth, Nausea, Sensory disturbance
Clinical narrative: pt states she developed a large lump on right arm at the injection site. It became itchy, red and very warm. She went to bed on Friday and woke up Saturday morning with a severe headache and vomiting. The worst headache she ever had. She vomited 5 or 6 times. She laid down and rested but could not get rid of the headache. She was unable to eat for about 4 days. She continues to have a severe headache. She develops a sensation in her legs which causes her to fall.  She has fell twice. Still has some nausea and is totally exhausted. She has reached out to her doctor and was precribed predinsone 20 mg per day and allegra. She will contact her doctor if she does not recover.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: pt states she developed a large lump on right arm at the injection site. It became itchy, red and very warm. She went to bed on Friday and woke up Saturday morning with a severe headache and vomiting. The worst headache she ever had. She vomited 5 or 6 times. She laid down and rested but could not get rid of the headache. She was unable to eat for about 4 days. She continues to have a severe headache. She develops a sensation in her legs which causes her to fall.  She has fell twice. Still has some nausea and is totally exhausted. She has reached out to her doctor and was precribed predinsone 20 mg per day and allegra. She will contact her doctor if she does not recover.
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Injection site swelling
Clinical narrative: left thigh swelling
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: took inhaler Levalbuterol, Zyrtec 20 mg, tums