chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This non-serious case was reported by a consumer via sales rep and described the occurrence of diarrhea in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced diarrhea (Verbatim: diarrhea). The patient was treated with loperamide hydrochloride (Imodium). Shingrix was discontinued. The outcome of the diarrhea was resolved (duration 5 days).   The reporter considered the diarrhea to be probably related to Shingrix.     The company considered the diarrhea to be probably related to Shingrix.   Additional Information: GSK Receipt Date: 10-FEB-2024 The reporter was working a conference and another vendor approached him/her to told him/her about a side effect he believed was retailed to Shingrix. It was reported that 3 days after received first Shingrix vaccination patient developed diarrhea that lasted 5 days.  He stated he went to an urgent care and determined his diarrhea was not bacterial and likely related to his Shingrix vaccination.  The patient stated he tried imodium to resolve symptoms and it did not work and stated after 5 days diarrhea was resolved.  The patient declined to receive his second vaccination. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dizziness postural, Labyrinthitis
Clinical narrative: severe dizziness /she felt dizzy and lightheaded every time she; labrynthitis; felt dizzy and lightheaded every time she rolled to her right side; This non-serious case was reported by a consumer via sales rep and described the occurrence of dizziness in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included syncope and dizziness. Previously administered products included Shingrix (Received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced dizziness (Verbatim: severe dizziness /she felt dizzy and lightheaded every time she), labyrinthitis (Verbatim: labrynthitis) and dizziness postural (Verbatim: felt dizzy and lightheaded every time she rolled to her right side). The patient was treated with prednisone and valaciclovir (Valacyclovir). The outcome of the dizziness, labyrinthitis and dizziness postural were resolved.   It was unknown if the reporter considered the dizziness, labyrinthitis and dizziness postural to be related to Shingrix.     It was unknown if the company considered the dizziness, labyrinthitis and dizziness postural to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-FEB-2024 The reporter self-reporter this case and was working a conference and another vendor. The reporter reported that 3 days after her second vaccination she experience severe dizziness and labyrinthitis. The reporter stated she felt dizzy and lightheaded every time she rolled to her right side. The reporter stated she saw her provider who prescribed prednisone and valacyclovir and that helped resolve her symptoms. The reporter stated these symptoms lasted on and off for 6 months. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: FLUX, RSV
Symptoms: Chills
Clinical narrative: Chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received Arexvy and Influenza vaccine. On an unknown date, an unknown time after receiving Arexvy and Influenza vaccine, the patient experienced chills (Verbatim: Chills). The outcome of the chills was not reported.   It was unknown if the reporter considered the chills to be related to Arexvy.     It was unknown if the company considered the chills to be related to Arexvy.   Additional Information: GSK Receipt Date: 10-FEB-2024 The case was received from the patient via interactive digital media. The patient received Arexvy and Flu vaccine at same time and experienced all of those (unspecified) and chills. It was unknown if the reporter considered the chills to be related to Influenza vaccine. The follow up not require per process.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: the next day and did not look good and did not feel good.; fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (the next day and did not look good and did not feel good.) and PYREXIA (fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced MALAISE (the next day and did not look good and did not feel good.) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) 20-Feb-2021 at a dose of 2 extra strength Tylenol and gave him 2 more extra strength Tylenol 6 hours later. On 20-Feb-2021, MALAISE (the next day and did not look good and did not feel good.) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: temperature was over 103..         It was unknown if any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Relevant medical history or conditions, allergy, concomitant diseases and risk factor was not reported.  Concomitant product use was not provided by the reporter.  It was reported that patient woke up the next day and did not look good and did not feel good. His temperature was over 103. Patient was treated with 2 extra strength Tylenol and gave him 2 more extra strength Tylenol 6 hours later. By that evening he felt better and his fever was gone.
Age: 16.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: tenivac is valid if it's given too early. according to her, adacel was given on 29dec2023 and tenivac was given on 20jan2024. since it's too early, medical assistant asked if it's a valid dose with no ae; Initial information received on 13-Feb-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who according to her, diphtheria-2/tetanus/5 AC pertussis vaccine [adacel] was given on 29dec2023 and diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac] was given on 20jan2024. since it's too early, medical assistant asked if it's a valid dose with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Prophylactic vaccination; MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On 29-Dec-2023, the patient received a dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot number, strength, dose and expiry date not reported) via unknown route in unknown administration site as Prophylactic vaccination. On 20-Jan-2024, the patient received a 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot U7920AA, Expiry: 25-OCT-2025 with unknown strength) via intramuscular route in the left deltoid as Prophylactic vaccination.  The diphtheria-2/tetanus/5 AC pertussis vaccine was given on 29-dec-2023 and diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult was given on 20-jan-2024. since it's too early, medical assistant asked if it's a valid dose with no adverse event (extra dose administered) (latency: same day) .   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; FBE reporting AE.  Caller reported expired dose of GARDASIL 9 was administered.; This spontaneous report was received from an office manager via company representative and refers to a 12-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 29-JAN-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, once, lot #1775811, expiration date: 07-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) by health professional (Expired product administered). The patient did not experience any adverse side effects or issues from the administration of the expired dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Contusion, Injection site erythema, Injection site rash, Swelling, Urticaria
Clinical narrative: Patient was seen in office on 2/16 @ 8:15 AM. Received 2 vaccines - MMRV and DTAP-IPV. Patient mother called on call physician on 2/17 at 7:48 PM to report that the small red bump was a rash that covered patient's leg about 12 hours later. Instructed to go to ER. Patient was treated for Urticaria in ER. Patient was given steroids - swelling has gone down, still some slight bruising. Overall much better.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Rash morbilliform
Clinical narrative: Child had vaccine on 01/31/24 and developed morbiliform rash on 02.15.24.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Langerhans' cell histiocytosis
Clinical narrative: I have developed LCH in my lungs. Just seeing if anyone else has developed this after taking pneumonia shot? Or after shot in Descovy ? seems to have all happened after taking the pneumonia shot though.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Hyperaesthesia, Pain, Scab, Skin discolouration
Clinical narrative: Received rsv shot. It was painful but I never have problems with vaccines. But week later still couldn't use my arm without hurting. Then it turned red and blue. About 4 in long and 3 in across. Couldn't even touch it when taking shower. Then the outline scabbed in several pieces. Went to my primary 2x. He took pics only answer was to lotion it. As of today 02/17/24 it's still red, hurts occasionally and still sensitive to touch
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, Concussion, Condition aggravated, Head injury, Hypotension
Clinical narrative: Two things happened: 1. unintentional weight loss. Began taking Ozempic 9-5-23, .25mg (introductory dosage) /week. By late September, nausea/unsettled stomach was becoming gradually more noticeable. Beginning 10-2-23 per Dr orders increased dose to .5mg (lowest therapeutic dose) / week. Nausea continued frequently enough to affect my appetite on an ongoing basis. Was weighing myself weekly and losing weight. On 11-20-23, reduced back to .25mg/week. By 11-26-23, had lost approx 6% of my body weight (~195 down to ~183). 2. On 11-26-23, I got a covid booster. That night, while returning from bathroom to bed, I blacked out - (became unresponsive while standing in doorway, according to my wife; began vomiting...); then collapsed, and hit my head on hardwood floor. Was out at least 20-25 seconds total. We called paramedics, I was taken to E.R. They ran multiple tests, diagnosed a mild concussion from having hit head on floor, but they were not able to identify any definitive cause of fainting. It was eventually decided FAINTING WAS PROBABLY DUE TO COMBINATION OF WEIGHT LOSS FROM OZEMPIC + reaction to covid booster* + low blood pressure** + possible dehydration. *Had had noticeable reaction to at least 1 previous covid booster - not as serious as above, but had generally felt flu-ey and nauseous for a couple days in spring of 2022. ** My blood pressure typically runs low - I frequently experience brief lightheadedness, especially when standing up too quickly from a seated position. This has been occurring for most of my adult life.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Loss of consciousness, Plasma cell myeloma, Syncope, Unresponsive to stimuli
Clinical narrative: Two things happened: 1. unintentional weight loss. Began taking Ozempic 9-5-23, .25mg (introductory dosage) /week. By late September, nausea/unsettled stomach was becoming gradually more noticeable. Beginning 10-2-23 per Dr orders increased dose to .5mg (lowest therapeutic dose) / week. Nausea continued frequently enough to affect my appetite on an ongoing basis. Was weighing myself weekly and losing weight. On 11-20-23, reduced back to .25mg/week. By 11-26-23, had lost approx 6% of my body weight (~195 down to ~183). 2. On 11-26-23, I got a covid booster. That night, while returning from bathroom to bed, I blacked out - (became unresponsive while standing in doorway, according to my wife; began vomiting...); then collapsed, and hit my head on hardwood floor. Was out at least 20-25 seconds total. We called paramedics, I was taken to E.R. They ran multiple tests, diagnosed a mild concussion from having hit head on floor, but they were not able to identify any definitive cause of fainting. It was eventually decided FAINTING WAS PROBABLY DUE TO COMBINATION OF WEIGHT LOSS FROM OZEMPIC + reaction to covid booster* + low blood pressure** + possible dehydration. *Had had noticeable reaction to at least 1 previous covid booster - not as serious as above, but had generally felt flu-ey and nauseous for a couple days in spring of 2022. ** My blood pressure typically runs low - I frequently experience brief lightheadedness, especially when standing up too quickly from a seated position. This has been occurring for most of my adult life.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Two things happened: 1. unintentional weight loss. Began taking Ozempic 9-5-23, .25mg (introductory dosage) /week. By late September, nausea/unsettled stomach was becoming gradually more noticeable. Beginning 10-2-23 per Dr orders increased dose to .5mg (lowest therapeutic dose) / week. Nausea continued frequently enough to affect my appetite on an ongoing basis. Was weighing myself weekly and losing weight. On 11-20-23, reduced back to .25mg/week. By 11-26-23, had lost approx 6% of my body weight (~195 down to ~183). 2. On 11-26-23, I got a covid booster. That night, while returning from bathroom to bed, I blacked out - (became unresponsive while standing in doorway, according to my wife; began vomiting...); then collapsed, and hit my head on hardwood floor. Was out at least 20-25 seconds total. We called paramedics, I was taken to E.R. They ran multiple tests, diagnosed a mild concussion from having hit head on floor, but they were not able to identify any definitive cause of fainting. It was eventually decided FAINTING WAS PROBABLY DUE TO COMBINATION OF WEIGHT LOSS FROM OZEMPIC + reaction to covid booster* + low blood pressure** + possible dehydration. *Had had noticeable reaction to at least 1 previous covid booster - not as serious as above, but had generally felt flu-ey and nauseous for a couple days in spring of 2022. ** My blood pressure typically runs low - I frequently experience brief lightheadedness, especially when standing up too quickly from a seated position. This has been occurring for most of my adult life.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient was inadvertently given 12+ dosing of 0.5ml instead of 6 months thru 11 years of 0.25 ml.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered with vaccine that has passed beyond use date.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Laboratory test, Pyrexia, Ultrasound abdomen, Viral test
Clinical narrative: Fever of 105, severe ab pain, vomitting
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Fever of 105, severe ab pain, vomitting
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Blood group O, Delivery, Exposure during pregnancy, Pregnancy
Clinical narrative: Uncomplicated pregnancy with due date 11/7/23. Delivered via uncomplicated vaginal birth. Infant developed acute jaundice and was treated with ~12 hours of light therapy in recovery ward on 11/13/23. Treatment was well-received. Infant bloodtype B+, maternal O+.  Birth weight 8lbs 11oz.
Age: 1.42
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Dose was deemed nonviable due to a temperature excursion but was administered to patient
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dizziness, Syncope
Clinical narrative: Convulsive syncope.  Stated she "felt like she was going to pass out", started to fall forward, pt was laid back, provider was called, vitals were taken throughout episode.  Episode lasted approximately 30 minutes
Age: 0.58
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: expired on 1-14-23
Age: 64.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 57.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to get PCV 20 but instead was given Pcv 13.
Age: 63.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MMRV GIVEN TO ADULT PATIENT - NO REACTION NOTED
Age: 49.0
Sex: M
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient was given PCV -13 instead of PCV-20
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient was inadvertently given dose too early. Patient was given 1.0 mL (a double dose) of Recombivax Peds, a medically valid adult dose. Dose 1 and dose 3 were not 16 weeks apart which is the minimum interval required.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Pain, Peripheral swelling, Sleep disorder
Clinical narrative: Patient in for Well Child Visit  with PA  on 2/19/2024 @ 6pm. Patient was given 2nd dose of Bexero.  Vaccine given by staff MA in left upper arm.  Lot # 4M24Z, Expiration 7/31/26. It was reported by parent on 2/20 that patients entire arm is swollen and he could not move it..  Pain started the night of 2/19 and pt was unable to sleep from the pain.. It was noted the next morning the arm  and top of hand swollen   Provider advised and recommended that pt go to the ER ASAP.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Unevaluable event
Clinical narrative: None reported
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood thyroid stimulating hormone normal, Dry skin, Hypothyroidism, Memory impairment
Clinical narrative: Hypothyroidism. Hairloss, dry skin, memory issues
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Malaise, Myalgia, Nausea, Vomiting
Clinical narrative: Malaise, muscle pain, joint pain, nausea and vomiting x 1
Age: 7.0
Sex: F
Vaccine: PNC20
Symptoms: Unevaluable event
Clinical narrative: Child had never received a Pneumococcal vaccine in the past. Just moved to area. Misunderstanding/confusion with the verbiage when necessary to give P20 as a dose in child of her age. Dose inadvertently given when not needed.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Coagulation test normal, Deep vein thrombosis, Economic problem, Inability to afford medication, Pain in extremity
Clinical narrative: -Chronic DVTs noted on venous doppler and life long Eliquis needed, she is unable to afford the Greenfield filter or CTCP or additional work up she can't affordPt got Moderna  9/9/21 058E21A and 2nd dose 10/7/21 053E21A  She noticed leg achy and hurt from time to time but did not get checked out because she was not aware of the Vaccine?s adverse effects then she got into an ATV accident which incidentally saved her life. In the ED they discovered chronic clots in RLE and did not scan elsewhere. The US showed right popliteal and posterior tibial vein with chronic clots. I ran a coagulation study and she has no coagulation disorders at this time. Her only medical history was smoking. Now she is on Eliquis which she cannot afford, she needs Greenfield filter, CTCP and extensive work up but has no ability to afford this all due to the Covid Vaccine.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Road traffic accident, Ultrasound Doppler abnormal
Clinical narrative: -Chronic DVTs noted on venous doppler and life long Eliquis needed, she is unable to afford the Greenfield filter or CTCP or additional work up she can't affordPt got Moderna  9/9/21 058E21A and 2nd dose 10/7/21 053E21A  She noticed leg achy and hurt from time to time but did not get checked out because she was not aware of the Vaccine?s adverse effects then she got into an ATV accident which incidentally saved her life. In the ED they discovered chronic clots in RLE and did not scan elsewhere. The US showed right popliteal and posterior tibial vein with chronic clots. I ran a coagulation study and she has no coagulation disorders at this time. Her only medical history was smoking. Now she is on Eliquis which she cannot afford, she needs Greenfield filter, CTCP and extensive work up but has no ability to afford this all due to the Covid Vaccine.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Administered Arexvy vaccine subcutaneous instead of the manufacturer recommended intramuscular injection. The patient is not experiencing any side effects. I am creating a VAERS report to document the administration error.
Age: 1.83
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was here today 02/20/2024 to get caught up on vaccines and was given HPV instead of Prevnar 20  , Prevnar 20 is was they needed today
Age: 0.17
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was administered Hep A and Varicella vaccines too early in the vaccine schedule. Patient is only 2 months old. Both Hep A and Varicella vaccines are only to be administered when patient is 12 months old.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Breath holding, Condition aggravated
Clinical narrative: Child has been having "breath holding spells" since birth, mother states child usually has a couple a month, a couple days after immunizations child had increase in "episodes" up to a couple each day ongoing for a month+ until now he is back to his "normal" amount.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm sore - began approximately 1 day after immunization and has progressively gotten worse - unable to lift arm currently
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pruritus
Clinical narrative: Patient called and reported he has had intermittent left arm pain and mild itching since time of immunization (6 weeks). Pain comes and goes. Denies anaphylaxis, no hives, itching and pain is localized. Pt is able to proceed with work and other ADLs. Pt declined offer for f/u appt at this time.
Age: 24.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a children's Moderna dose instead of the adult dose on 2/12/24. Patient did not have any adverse events. The error was discovered by pharmacy staff member.
Age: 0.92
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: chicken pox appearing rash on trunk, face and proximal extremities.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis
Clinical narrative: Left leg developed cellulitis, iv antibiotic x 2 days and Keflex sent home with patient.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on arm and on back lasting 8 days
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Mastication disorder, Pain in jaw
Clinical narrative: pain on the right side of jaw and was very difficult to chew food
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Patient has had recurring lesions at the site of the injection, starting approximately 2 weeks after receiving vaccine
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea
Clinical narrative: diarrhea
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: patient states that rash occuried the day after vaccine admistration
Age: 91.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Arthralgia, Inflammation, Laboratory test
Clinical narrative: inflammatio and joint pain
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Localized severe rash
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy test negative, Allergy to vaccine, Anaphylactic reaction, Dizziness, Dysphonia
Clinical narrative: I had an anaphylactic response to the flu shot. I've had flu shots every year, but this time I was driving home and it was about 20 minutes later from getting the shot and I realized my throat was scratchy and swollen, my palms and face itched, my chest was blotchy and red, I got lightheaded and a sudden urge to go to the bathroom. I pulled over and called an ambulance. My vitals were fine, but my voice was very raspy (which is not my normal) so they took me to the ER where I was given a shot of epi and watched for 3 hours. This resolved my reaction, but I did have a rebound reaction 48 hours later as well, but was mild and epi was not needed at that time. I was prescribed an epi pen, but have not had to use it.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Micturition urgency, Pharyngeal swelling, Pruritus, Rash macular, Throat irritation
Clinical narrative: I had an anaphylactic response to the flu shot. I've had flu shots every year, but this time I was driving home and it was about 20 minutes later from getting the shot and I realized my throat was scratchy and swollen, my palms and face itched, my chest was blotchy and red, I got lightheaded and a sudden urge to go to the bathroom. I pulled over and called an ambulance. My vitals were fine, but my voice was very raspy (which is not my normal) so they took me to the ER where I was given a shot of epi and watched for 3 hours. This resolved my reaction, but I did have a rebound reaction 48 hours later as well, but was mild and epi was not needed at that time. I was prescribed an epi pen, but have not had to use it.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Pain in extremity, Periarthritis
Clinical narrative: Patient complained having frozen shoulder ever since getting Arexvy on 1/23/24.   She said her right arm was sored the night after getting the vaccine.  It got progressively worse that she cannot even pull her pants down.  She said it's frozen shoulder with very limited range of motion.  She is currently waiting for prior authorization to see her orthopedic for her left arm with rotator cuff pain, so she can ask the doctor about her right arm as well..
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Fatigue, Irritability, Lethargy, Rash
Clinical narrative: rash  on face, limbs, back.   Intermittent fever up to 100.1,   Tired lethargic and fussy
Age: 1.25
Sex: F
Vaccine: MMR, PNC20, VARCEL
Symptoms: Injection site reaction, Rash follicular
Clinical narrative: flesh colored follicular rash appeared on right thigh a few hours after vaccine. next day small amount on left too
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Death
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: NONE  - Reporting as Bivalent was no longer authorized for use effective 9/12/23
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling, numbness..all over body, pins and needles feeling in fingertips
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: tingling, numbness..all over body, pins and needles feeling in fingertips
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Impaired work ability, Pain, Sleep disorder
Clinical narrative: For first month after vaccination administration of Heplisav-B, patient experienced possible nerve pain starting at injection site and traveling down to hand. Pain did interfere with daily activities for this first month, with patient not being able to type on the computer at work for part of shift. As of 02/2024, pain is sometimes noticeable on left side during sleep (although patient typically sleeps on right side, opposite side of administration). Patient reports pain continues to improve and is not interfering with work at this time. Counseled patient to continue to monitor for improvement and will follow up with patient in 1 month to see if he would like referral to PCP for further evaluation.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 94.0
Sex: F
Vaccine: RSV
Symptoms: Disorientation, Malaise, Respiratory disorder
Clinical narrative: Patient waited 15 minutes following vaccine and left pharmacy with her caretaker and the assistance of a walker.  Patient and care taker were talking about lunch as they left the store.  At lunch, they left before ordering because the patient was disoriented and did not feel well.  Say she can not describe the feeling that she felt.  Once home the patient was still disoriented so the caretaker called EMS and the ambulance took the patient to the hospital where she was admitted for a day for observation.  She didn't recall feeling short of breath but was treated for her breathing at the hospital.  Patient reports no signs of a rash.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 32.0
Sex: M
Vaccine: TYP
Symptoms: Injection site pain
Clinical narrative: Pain to left shoulder
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: lost the use of the right arm, cannot raise arm without significant pain
Age: 28.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt requested to have both a Flu vaccine and a Covid vaccine.  After giving the flu vaccine it was found out that the patient had a previous Flu vaccine on 11/1/23.  Pt did not have any adverse symptoms.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discontinued product administered
Clinical narrative: NONE  - Reporting as Bivalent was no longer authorized for use effective 9/12/23
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 62.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site mass, Injection site pain, Ultrasound scan, X-ray
Clinical narrative: The patient had pain at site of injection, but no rash, shortness of breath, fever, chills, or other event. the site is still painful and has mass sensation, possible hematoma. the patient was sent for x-ray and ultrasound which are pending.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Bell's palsy, Compulsive lip biting, Computerised tomogram head abnormal, Conversion disorder, Cranial nerve disorder
Clinical narrative: Pain in my ear, jaw, blisters in my mouth on the left side, rash on the left side of my face, my eye was hurting like crazy. Everything on the left side. On the next day I developed Bell's palsy that is permanent. The left side of my face drooped. I did research on the Recombivax I took, and it stated that it could cause bell's palsy. I was diagnosed this year 2024 with Functional Neurological Disorder. I had surgery in my left eye due to the Bell's Palsy twice. My eye would not close. First surgery 2016 and second surgery in 2018. I lost my job. I was forced to get these Hep B vaccines by my job. I constantly bite my lip, it's now numb and I have to open my lips/mouth manually sometimes.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Dyskinesia, Ear pain, Eye operation, Eye pain, Eyelid function disorder
Clinical narrative: Pain in my ear, jaw, blisters in my mouth on the left side, rash on the left side of my face, my eye was hurting like crazy. Everything on the left side. On the next day I developed Bell's palsy that is permanent. The left side of my face drooped. I did research on the Recombivax I took, and it stated that it could cause bell's palsy. I was diagnosed this year 2024 with Functional Neurological Disorder. I had surgery in my left eye due to the Bell's Palsy twice. My eye would not close. First surgery 2016 and second surgery in 2018. I lost my job. I was forced to get these Hep B vaccines by my job. I constantly bite my lip, it's now numb and I have to open my lips/mouth manually sometimes.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Eyelid ptosis, Facial paralysis, Hypoaesthesia oral, Loss of employment, Magnetic resonance imaging head abnormal
Clinical narrative: Pain in my ear, jaw, blisters in my mouth on the left side, rash on the left side of my face, my eye was hurting like crazy. Everything on the left side. On the next day I developed Bell's palsy that is permanent. The left side of my face drooped. I did research on the Recombivax I took, and it stated that it could cause bell's palsy. I was diagnosed this year 2024 with Functional Neurological Disorder. I had surgery in my left eye due to the Bell's Palsy twice. My eye would not close. First surgery 2016 and second surgery in 2018. I lost my job. I was forced to get these Hep B vaccines by my job. I constantly bite my lip, it's now numb and I have to open my lips/mouth manually sometimes.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Oral mucosal blistering, Pain in jaw, Rash
Clinical narrative: Pain in my ear, jaw, blisters in my mouth on the left side, rash on the left side of my face, my eye was hurting like crazy. Everything on the left side. On the next day I developed Bell's palsy that is permanent. The left side of my face drooped. I did research on the Recombivax I took, and it stated that it could cause bell's palsy. I was diagnosed this year 2024 with Functional Neurological Disorder. I had surgery in my left eye due to the Bell's Palsy twice. My eye would not close. First surgery 2016 and second surgery in 2018. I lost my job. I was forced to get these Hep B vaccines by my job. I constantly bite my lip, it's now numb and I have to open my lips/mouth manually sometimes.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Involuntary chattering of teeth started in the evening, several hours after vaccine, was better by the time she woke the next morning. Did NOT feel cold, did NOT have chills
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Rash over trunk and face, mildly erythematous. Fever 100.7. Symptoms started today. Recommended office visit for patient to be assessed by provider. Per office note today- Vaccine induced varicella, initial encounter- Assessment & Plan: No intervention required Mother counseled Risks and benefits discussed Anticipatory guidance provided
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Death, Electrocardiogram, Impaired driving ability, Mobility decreased
Clinical narrative: Terrible back pain, could not drive, crumpled up on the floor in physical pain, 3 massive heart attacks, DEAD within weeks of the shot
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Pain
Clinical narrative: Terrible back pain, could not drive, crumpled up on the floor in physical pain, 3 massive heart attacks, DEAD within weeks of the shot
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 69.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Eye swelling, Pruritus, Swelling, Swelling face, Urticaria
Clinical narrative: on 12/11/23 patient had itching, swelling and welts in vaginal area which then spread to her legs, face, and arms.  She visited ER on 12/17/23.  On 12/21/23 she woke up with both eyes swollen shut and a swollen face.  She visited another ER.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea exertional, Electrocardiogram, Exercise tolerance decreased, Palpitations
Clinical narrative: Endurance capacity is lower than before. Shortness of breath at high intensity workouts.  Heart palpitations, chest pain (sometimes)
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Chest pain, Eye swelling, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Mom reported by phone on 02/13/24 that on the morning after receiving his vaccines, 02/08/24, Patient had redness, a knot at the injection site, and pain that moved toward his chest on the left side where he received his MenQuadfi vaccine.  He was given a benadryl and his symptoms completely improved per mom. She did not seek any medical attention. On 02/12/24, mom stated that Patient complained of his face, throat, neck and eye being swollen and also his throat feeling itchy on the left side. She stated that he had no difficulty breathing and no fever. Mom did not take him to a doctor or the ER. She stated that she gave him another benadryl. On 02/13/24, the day the report was made, mom stated that when Patient woke up, he still had some swelling on and around his left eye and his neck on the left side was achy.  She gave him another Benadryl before sending him to school.  He has a doctors appointment scheduled for 02/21/24 with Dr.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Pain, Pharyngeal swelling, Swelling, Swelling face, Throat irritation
Clinical narrative: Mom reported by phone on 02/13/24 that on the morning after receiving his vaccines, 02/08/24, Patient had redness, a knot at the injection site, and pain that moved toward his chest on the left side where he received his MenQuadfi vaccine.  He was given a benadryl and his symptoms completely improved per mom. She did not seek any medical attention. On 02/12/24, mom stated that Patient complained of his face, throat, neck and eye being swollen and also his throat feeling itchy on the left side. She stated that he had no difficulty breathing and no fever. Mom did not take him to a doctor or the ER. She stated that she gave him another benadryl. On 02/13/24, the day the report was made, mom stated that when Patient woke up, he still had some swelling on and around his left eye and his neck on the left side was achy.  She gave him another Benadryl before sending him to school.  He has a doctors appointment scheduled for 02/21/24 with Dr.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Nausea, Pallor, Syncope
Clinical narrative: Patient was nauseous, pale, and sweaty. Mother stated she collapsed twice. I took the patient to the ED. Her vitals were good, she was given zofran for her nausea and discharged home.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Injected limb mobility decreased, Mobility decreased, Pain
Clinical narrative: Extreme, swelling, extreme pain,  redness, burning  feeling, unable to move left arm and shoulder, unable to move neck
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling, X-ray limb
Clinical narrative: Extreme, swelling, extreme pain,  redness, burning  feeling, unable to move left arm and shoulder, unable to move neck
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site pain, Muscular weakness
Clinical narrative: Severe injection site pain lasting 4 days, flu like symptoms, fatigue, shivering, muscle weakness - all lasting approximately 48 hours,
Age: 49.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Back pain, Bowel movement irregularity, Burning sensation, Computerised tomogram, Gait inability
Clinical narrative: Acute attack to my spinal cord causing lower back pain, numbness and weakness in my legs and feet I loss the ability to walk. Abnormal fellings in my legs like tingling, burning and tightness. Unpredictable bowel control.  Very heightened sensitivity in my legs and feet.
Age: 49.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Guillain-Barre syndrome, Hyperaesthesia, Hypoaesthesia, Laboratory test, Lumbar puncture
Clinical narrative: Acute attack to my spinal cord causing lower back pain, numbness and weakness in my legs and feet I loss the ability to walk. Abnormal fellings in my legs like tingling, burning and tightness. Unpredictable bowel control.  Very heightened sensitivity in my legs and feet.
Age: 49.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Magnetic resonance imaging, Muscle tightness, Muscular weakness, Myelitis transverse, Paraesthesia
Clinical narrative: Acute attack to my spinal cord causing lower back pain, numbness and weakness in my legs and feet I loss the ability to walk. Abnormal fellings in my legs like tingling, burning and tightness. Unpredictable bowel control.  Very heightened sensitivity in my legs and feet.
Age: 49.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Spinal cord disorder
Clinical narrative: Acute attack to my spinal cord causing lower back pain, numbness and weakness in my legs and feet I loss the ability to walk. Abnormal fellings in my legs like tingling, burning and tightness. Unpredictable bowel control.  Very heightened sensitivity in my legs and feet.
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Maternal exposure before pregnancy, Pregnancy test negative, Pregnancy test positive
Clinical narrative: Patient presented for her Refugee 1 appointment 01/11/2024 and was not pregnant and had a negative pregnancy test 01/11/2024. Varicella vaccine administered for immigration requirements. Patient tested positive for pregnancy on 02/05/2024 which is with in the 30 day period of vaccine administration. This was reported to Merck, case #02554754
Age: 26.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Maternal exposure before pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Patient presented for her Refugee 1 appointment 01/11/2024 and was not pregnant and had a negative pregnancy test 01/11/2024. Varicella vaccine administered for immigration requirements. Patient tested positive for pregnancy on 02/05/2024 which is with in the 30 day period of vaccine administration. This was reported to Merck, case #02554754
Age: 72.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Concussion, Head injury, Loss of consciousness
Clinical narrative: Patient received her vaccines on 11/15/2023. She came to the pharmacy on 2/20/2024 and reported that when she went home after she received her vaccine she was black out and hit her head. She had to stay at the hospital for 1 month because of the concussion which she thinks its from the vaccines that cause her black out.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLU4, HEP, HEPA, IPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 6 year old patient came in to the clinic with no prior vaccines or vaccine record. Patient needed Hepatitis B, Dtap, Polio, MMR, Varicella, Hepatitis A, and Influenza. Nurse proceeded to dispense all vaccines from the accuvax. Vaccines administered with no concerns. Afterwards upon documentation, nurse realized the DTAP vaccine syringe was in fact DTAP-IPV (KINRIX) administered intramuscularly. The patient also received a single dose IPV (IPOL) subcutaneously. Nurse then proceeded to notify management of vaccine error. Nurse called patient's guardian to notify that an additional dose of polio was given. As per guardian; patient has not developed any symptoms or issues currently. Nurse educated on possible adverse reactions and to contact emergency services if needed. Nurse also educated on reporting any symptoms promptly. Patient?s guardian given the opportunity to ask questions and acknowledged. No further questions asked and reassured that follow up contact would be made within 2 days to assess the patient?s status.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient reported no adverse events. Filling out form to report that vaccine administered was expired. Vaccine expired 06/30/23 and was administered 12/09/23
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Feeling hot, Induration, Swelling
Clinical narrative: 11 x 11.5 cm redness and warmth, was swollen and hard.  Was getting better.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient reported no adverse events. Filling out report because on 2/10/24, it was discovered that the vaccine administered on 12/09/23 had expired 06/30/23.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Biopsy skin, Blood test, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: 2/12/24 Developed low grade fever, sore throat, on 2/16/24 developed rash. 2/17/24 Seen at urgent care and given Kenalog shot, seen 2/18/24 seen at same urgent care and given Rx for 40 mg prednisone. 2/19/24 Dad spoke to Dr on the phone and increased prednisone to 80 mg.  2/20/24 Seen Dr in clinic and Rx of 0.1% triamcinolone given.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Urine analysis
Clinical narrative: 2/12/24 Developed low grade fever, sore throat, on 2/16/24 developed rash. 2/17/24 Seen at urgent care and given Kenalog shot, seen 2/18/24 seen at same urgent care and given Rx for 40 mg prednisone. 2/19/24 Dad spoke to Dr on the phone and increased prednisone to 80 mg.  2/20/24 Seen Dr in clinic and Rx of 0.1% triamcinolone given.