chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adacel at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes. with no reported ae; ADACEL (8 doses) were administrated post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 38 years old male patient and it was reported DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] exposed at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes with no reported adverse event(AE) and adacel (8 doses) were administrated post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 29-Aug-2022, the patient received suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 0.5 ml once (lot U7461AA, expiry date: 12-Jul-2024) via intramuscular route in the right arm for immunisation.  On an unknown date the patient adacel was at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes. with no reported ae (product storage error). On 29-Aug-2022 the patient developed a non-serious adacel (8 doses) were administrated post excursion with no reported adverse event (poor quality product administered) same day latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: Not applicable.  Outcome was Unknown for the event adacel at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes. with no reported ae and was Unknown for the event adacel (8 doses) were administrated post excursion with no reported adverse event.   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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01266768: 01266921: 01266924: US-SA-2022SA372080:
Fever for 36 hours, left armpit swollen lymph node (same arm as injection site), which lasted 5 days. Shortness of breath and chest pain for 2 weeks.
Information has been received from a health professional concerning a 15 to 18 month old male who in April 2001, was vaccinated with one dose of varicella virus vaccine live. On 13 JUL 2000 the patient experienced greater than 20 crusted and dry lesions. The lesion looked like varicella. Medical attention was sought. It was noted that his two siblings were not immunized and had varicella in the past few weeks prior to the patient's experience. In follow up, the reporter stated that there was in fact no true diagnosis of varicella in these children--the had an allergic reaction to detergent. No further information is available.
Headache, fatigue,  injection site pain/soreness, photosensitivity. All ongoing
A 17 year old person received 1st dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021.    This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old person received 1st dose) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old person received 1st dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old person received 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
larger rash; it was not quite as itchy; covid arm came earlier; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (covid arm came earlier), VACCINATION SITE RASH (larger rash) and VACCINATION SITE PRURITUS (it was not quite as itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE REACTION (covid arm came earlier). On an unknown date, the patient experienced VACCINATION SITE RASH (larger rash) and VACCINATION SITE PRURITUS (it was not quite as itchy). On 04-Mar-2021, VACCINATION SITE REACTION (covid arm came earlier), VACCINATION SITE RASH (larger rash) and VACCINATION SITE PRURITUS (it was not quite as itchy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not reported.    This case was linked to MOD-2021-012002 (Patient Link).
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 11:19 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 11:19 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 30.60.  Concomitant medication was not provided.  On 17-Feb-2021, Excursion time was 9 AM with temperature as 22. Total doses given for the day was not provided. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 11-Feb-2021. Vial was moved to clinic on 17-Feb-2021. 5 vials were sent to clinic. Vaccine BUD date was 13-Mar-2021. On 17-Feb-2021, no hourly temperature recordings available.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The  explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when temperature data logger registered 34 or 35 degree F.  Treatment information was not reported.
redness of the shoulder / redness is about 5 inches by 3 inches; shoulder that is hot to the touch; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 4BA4A, expiry date 29th January 2022) for prophylaxis.   On 21st December 2020 09:00, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In December 2020, less than a week after receiving Shingrix, the patient experienced localized erythema and feeling hot. On an unknown date, the outcome of the localized erythema and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the localized erythema and feeling hot to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right deltoid and experienced redness of shoulder 5 inches by 3 inches and shoulder was hot to touch. The reporter mentioned that, events were still not resolved at the time of reporting. The reporter stated that the primary care physician had been seeing had retired, and that he currently has not had a primary care physician. The reporter consented to follow up.
The patient received her 2nd Moderna COVID vaccine on 3/25/21 at 1:00. At 3:00 she began to feel shaky and tired. She is still feeling shaky and tired but has taken any medication or gone to the doctor.
I began itching in random places all over my body at approximately 3:00pm, My skin was splotchy but no raised rash, by 3:30PM my bottom lip went completely numb and I noticed I felt like I had phlegm in my throat and was having trouble clearing. By 5:00PM the itching had became worse and my face began to itch and tingle, by 5:30pm the whole left side of my face was numb as well as my top lip. By 5:45PM my tongue was tingling and itching and when I looked at it, it was doubled in size and the back of my throat began to itch and I felt I was having difficulty breathing. I realized the itching was not normal like I had thought, when I noticed my face, tongue, and throat. I took 2 Benadryl immediately. I continued taking Benadryl every time I felt the reaction coming back as the pharmacist had instructed. I did this around the clock Friday evening and Saturday until around 9:00PM. When I realized the reaction time was getting closer together and the dose of Benadryl I had taken was no longer seeming to stop the reaction. The pharmacist had recommended going to the hospital if the last statement began happening and they would have to give me something to stop it. I went to the ER, arriving around 9:45PM and was given 60mgs of Prednisone orally shortly after. I was sent home with a prednisone prescription for 10mg tablet taper 5, 4, 3, 2, 1 to start on Sunday April 7th, 2013. The diagnoses was allergic reaction.
Received moderna vaccine on 2/11/21. Unsure of lot number. COVID positive 2/25/22 and presented to ER on 2/25/22.  admitted on 2/25/2022 presented to PCP with not feeling well and upper respiratory symptoms.  Screening COVID tested positive. was vaccinated against COVID.  Maintaining saturation room air. Discharged on 3/4/22
01/17/22 presents to ED for "worsening SOB and LE edema". PMHx of "GIB and acute HFrEF, HTN, Afib on Xarelto, CKDIII"
I got my covid booster on Friday and this morning (10/9) I was bending over to clean my cats' litterbox and got the first nosebleed of my life. It was a decently heavy bleed from my right nostril only and saturated my moustache in about 20-30 seconds. The bleeding stopped relatively quickly after being upright again, and there was some blood in my postnasal drip so it seems like it may have originated a bit further back. I haven't had any notable dryness, but I did have a bit of sinus pressure after the vaccine.
Within 2 days of the second shot I had significant leg weakness. Within 2 weeks of second shot, I started having right lower quadrant pain. A CT scan showed that my previously stable ovarian cyst was growing rapidly. The cyst measured 14 cm on Friday January 29th and measured 17cm on February 3rd when I had to have an open abdominal hysterectomy. I was out of work for 10 weeks for surgery and the first day  I returned back to work my leg weakness returned with great severity. I was unable to continue working full time at the job I was at for 18 years. I had to go PRN and lost my insurance.I am now under the care of neurologist and starting infusions for multiple sclerosis. He has written me out work for 6 months due to my weakness and the infusions.
Woke up the morning after my 2nd dose of the vaccine with extreme nausea, dry-heaving, fever, body aches, and headache.
mom noted pt groggy the day p/shots was taking a nap day p/shots, grandma noted child quit breathing & in a deep sleep;responded to stimulus;came out of it;Md wanted hosp observation only;no other sx was fine after that;
I received the first shingles vaccine on 9/23/2021;  I received the second shot on 12/28/1021.  Six days after each shot, I developed short term memory loss and was hospitalized.  I lost all memories for approx. 48 hours.  I was taken to the ER both times by ambulance; I don't remember any of it.  I lost pain sensation; I have bad arthritis in both knees, but my husband tells me I was sitting cross legged on the kitchen floor.  I haven't been able to sit on the floor in years.  I'm told I was constantly touching things around the house, as if I was trying to figure out what they were.  While hospitalized I was asked my name and birth-date constantly; I had no idea what the answers were. After my first episode, my neurologist thought the problem could have been a steroid shot in my knee followed by the Pfizer Covid booster 2 weeks later.  That doesn't explain why the shingles vaccine was involved in both occurrences.
Multiple seizures, blackouts, near fainting episodes, frequent heart palpitations, multiple miscarriages, ectopic pregnancy and high risk pregnancies, chronic fatigue, muscle and joint pain, susceptible to illnesses (possible immune system problems), depression and anxiety resulting from illness and pregnancy loss. All of these presented after two rounds of the vaccine. I was afraid of taking the third dose because of the adverse reactions. My health has been poor since, and my fertility has been permanently affected. Many tests were done to determine the cause of my miscarriages, with no findings as to the cause. But I was very healthy and fertile until injection of the Gardasil Vaccine. I strongly suspect it is to blame.
7 yo girl, obese, presented with/4 day hx of fever nonresponsive to Tylenol (though significantly underdosed for weight), severe abdominal pain, vomiting, rash and conjunctivitis. 1/24 Admitted medical center, Differential included MISC vs vs septic shock secondary UTI. CRP 159, Procalcitonin 3.47, Ddimer3,618, Pro-BNP 2,376, PT 14.4. Tachypnic, hypotensive, elevated inflammatory markers, neg COVID and flu PCRs and pos COVID Abs. Urinalysis with +LE, bacteria, WBC. Blood & culture pending. Zosyn, vancomycin administered pending clinical course/culture results.  Increased tachypnea/fatigue 1/26 received IVIG overnight for possible MIS-C, echo with decrease in function, some PVCs noted overnight, concern for patient being at risk for need of escalation in cardiac support, iv linezolid and meropenem, decision to transfer to center with ECMO capabilities. Arterial line placed, pulse dose of Solumedrol given, turned over to transport team. Urine culture-probable contamination, blood culture-no growth at 4 days.
Information has been received from an advanced registered nurse practitioner concerning a patient who was vaccinated with GARDASIL.  Subsequently the patient experienced joint pain that lasted for a week after the vaccination with GARDASIL.  This was one of 3 reports from the same resource.  Additional information has been requested.
Pt to ED 9/23 for AMS and hypoglycemia. Pt COVID+ 9/23, on high flow non rebreather. 9/24 Pt denies any shortness of breath, on decadron. 9/25 pt alert & oriented x3, on 6L NC with continuous pulse ox on, VSS, denies any pain, no NVD. 9/26 sepsis BPA firing. Patient vitals are stable. 9/27 pt denies any complications with her breathing. 9/29 pt discharged.
Injection site was painful, red, hot, and swollen after vaccination until 1/5/20, resolved and then all symptoms returned 1/7/20.
Sudden vaginal bleeding. I had a very strong reaction to the second dose - 103F fever, chills, sweating, aches. My period ended several days before vaccination, so this bleeding is sudden and worrisome.
still a part of her forehead that feels like a live nerve; upper back started hurting/back was very tender and sensitive around the spine area; arm was a little sore; pharmacist had some left over in the vial and gave her that; has post traumatic neuralgia" related to her shingles; Shingles; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 29Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from two contactable consumers via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. Medical history included dental work/specifying a tooth being pulled and an implant (an antibiotic (Amoxicillin)) was used and shingles (7 years ago). The patient's concomitant medications were not reported. It was reported that Pharmacist had some left over in the vial and gave the patient on 28Jan2021. Patient wanted to make sure it was ok. Patient stated "she got shingles on her face, 7 years ago, and had recent dental work done," specifying a tooth being pulled and an implant. She stated she received the first dose of the COVID-19 vaccine last Thursday evening (28Jan2021). On 29Jan2021 and 30Jan2021 (friday and saturday), she mentioned, her "arm was a little sore". On 30Jan2021 and 31Jan2021 (saturday evening and sunday morning) she said her "upper back started hurting" and thought "maybe [she] sat on the couch for too long". On 31Jan2021 (Sunday evening), she added her "back was very tender and sensitive around the spine area" therefore, she "took some tylenol and used a heating pad thinking [she] pulled a muscle". On 01Feb2021 (By Monday) she said her "the back and front were very sensitive" to the point where: when she "touched [her] skin it felt like [she] was touching some live nerves". She explained seeing a physician assistant who "couldn't figure out what was going on" and since it seemed to be getting worst, she thought she could possibly have Shingles. She continued saying she then "went to see an orthopedic doctor who took x-rays and said he doesn't see anything, and it may be the beginning phases of Shingles". She mentioned she has an appointment with her internist today at 4:20. She later mentioned her "brother, who is a doctor, thinks [she] has post traumatic neuralgia" related to her shingles on an unspecified date in Jan2021. She then added there is "still a part of her forehead that feels like a live nerve" to touch, since having Shingles, on 01Feb2021. The outcome of the events was unknown. The outcome of the events was unknown.  The information on the Batch/Lot number has been requested.
Swelling on injection site to the size of baseball/softball with sensation of mass inside the injection site. Rash with fever on face, stomach. Approximately 15 places with bumps.
systemic hives, treated for 7 days with benadryl with no longterm improvement, hives keep returning.
My are is painful where she put it; Aches; Also have a slight flavor; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (only 1 pox on cheek as a kid.).   On 24-MAR-2023, the patient received Shingles vaccine (intramuscular). In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: My are is painful where she put it), pain (Verbatim: Aches) and taste altered (Verbatim: Also have a slight flavor). The outcome of the injection site pain was not resolved and the outcome of the pain and taste altered were not reported.   It was unknown if the reporter considered the injection site pain, pain and taste altered to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, pain and taste altered to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient wife has shingles now. she was in an anti viral med and calamine lotion.  The patient had chicken pox but only 1 pox on his cheek as a kid.  The patient had one shingles shot on Friday.his are was painful where she put it intramuscular also have a slight flavor and aches. The follow-up could not be possible as no contact details were available.
New symptom of sharp pain in sternum area worse on any movement (side to side in bed, lifting, reaching.) Lingered, finally went to Medical  urgent care on  April 11,  seen by Dr., given medrol pack, and muscle relaxant-, EKG-normal. After 1 week, pain no better.  Pain continued to linger, present every day, sharp, especially on movement.  Seen by my new  primary (Dr.) on 6/17 because pain had not abated, sometimes severe-took naproxen as needed.  Dr. diagnosed me with costochondritis, drew blood work, checked for inflammation, clotting time, etc., ekg and chest xray done- all results were normal.  Suggested I take NSAIDs.  To date pain continues limiting my activities
Ongoing dull headaches, never had an issue with headaches in life; have a dull pressure on the back of the head; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via unspecified route of administration in the right arm on 02Apr2021 at 15:00 (at the age of 53-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via unspecified route of administration in the right arm on 23Apr2021 at 13:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included alfuzosin (MANUFACTURER UNKNOWN) for an unknown indication from unknown date and unknown if ongoing. On an unknown date in Apr2021 at 12:00, the patient experienced ongoing dull headaches, patient never had an issue with headaches in his life, but now he had them pretty much all day and patient also had a dull pressure on the back of his head. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of reported events. The clinical outcome of the event dull headaches and dull pressure on the back of the head was not recovered at the time of this report.
Parents notice the pink and redness 4 hours after the vaccine given. Parents gave TYLENOL and few hours after the TYLENOL the pink and redness gone. No more symptoms.