chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2009 til present day, I began feeling dizzy, and noticed a slight imbalance in my gait. I started to get headaches, and my wife told me that I would stop breathing for a few seconds at night then I started to get sinus infections once every 6 months. 2012- yearly failed my first physical fitness exam for the run part. I took the exam again and passed it within a 6 month training time. 2013. I failed the fitness exam again. This time seeking medical assistance from my family doctor. Whom referred me to a Neurologist. 2014 - Diagnosed with Spinocerebellar Ataxia. Causing me to medically separate from the military. Early retirement.
1.) WITHIN FIRST 2-3 HOURS POST INJECTION-HOT, SWOLLEN, INCREASED TENDERNESS (L) DETOID RASH 2.) @ 26 HOURS POST INJECTION - HIVES/RASH-BILATERAL UPPER EXTREMITY PROGRESSION TO CHEST, TORSO, BACK, POPLITEAL & NECK, FACE SCALP
Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003959 is a spontaneous case report initially received on 05-Oct-2022 from nurse via agency (reference number: USBAV22-1628) and concerns a patient of unknown demographics (fifth out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via agency (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003956, US-BN-2022-003958, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Chills, sweats, severe fatigue (unable to stand for about an hour), arm soreness, dizziness
Headache, Diarrhea & NauseaVomiting Narrative: experienced above symptoms within 48 hours of first dose
Patient came in for physical appointment, meningcoccal B was administered instead of MCV4.  Provider and mother were notified , child had no side effect with vaccine.  Medical assistant called parent to check on patient and he was doing  fine.
Patient received the vaccine on 7/28/2005. Has c/o flu-like symptoms approx 24 hours later: achiness and painful joints throughout her body.  On 8/3/05 c/o moderate to severe, frequent to constant neck pain bilaterally. She c/o increased pain on cervical flexion, extension and right and left lateral flexion. Soto Hall's test was positive. Her medical doctor's office was notified.
This case was reported by a physician via other and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the influenza-like symptoms to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by an attendee (physician) at Conference. The age at vaccination was not reported. The reporter did not specify when they received the dose. The patient had flu like symptoms for 3 to 4 days. The event did not cause the patient to be admitted to the hospital overnight or prolong an existing hospitalization. It was unknown if the reporting health care professional consider the events to be life threatening. It was unknown if the reporting health care professional consider the events to result in persistent or significant disability or incapacity. The patient did not die. It was unknown if the events require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events did not result in a congenital anomaly or birth defect. This case is 1 of 4 cases reported by the same reporter.
Information has been received from a registered nurse concerning a 9 year old female with no past medical history and no known drug allergies who was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 3/17/04 at 11:40 AM, also reported as 4/28/04 at 11:00 AM, the patient developed blister type lesions on her back and abdomen. Otherwise, there was no distress. The rash was reported as being itchy, and the vesicular rash also involved the face. It was also noted that there were no adverse reactions. Subsequently, the patient recovered. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the patient or her siblings. Follow up information received from a registered nurse indicated that the patient had an outbreak of a rash only. No other symptoms were noted. The outcome was reported as recovered approximately 3-4 days after onset. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations. No further information is expected.
Patient reports onset of edema in both arms. In right arm pt experienced swelling around shoulder down to wrist. Injection site was sore. No redness, are was "clammy". In left arm pt experienced swelling of shoulder down to elbow, injection site soreness. No redness or warmth.
gotten Covid at some point prior to this report; gotten Covid at some point prior to this report; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "gotten Covid at some point prior to this report"; COUGH (non-serious), outcome "recovering", described as "Had a rough sounding cough".  She stated was "recovering" in office (i am a contract worker), believe was referring to recovering from Covid. Had a rough sounding cough. Most people in the office are at least fully vaccinated, though I do not know which vaccine has received. Probably in late 30s or 40s for age. Do not know year but date is 30Jul I haven't gotten specific follow-up at this time, but [Name] from what I heard seems to have gotten Covid at some point prior to this report submission and was recovering. They were in the office space (as they were probably well enough to do so and past contagious point). Most people in the office are vaccianted, so I believe she is too.   The lot number for bnt162b2 was not provided and will be requested during follow up.
The swollen part on my arm keeps getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (The swollen part on my arm keeps getting bigger) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (The swollen part on my arm keeps getting bigger). At the time of the report, VACCINATION SITE SWELLING (The swollen part on my arm keeps getting bigger) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications and No Treatment medications were reported.
the vaccine went down the arm  not in the arm  with no adverse event; the vaccine went down the arm  not in the arm  with no adverse event; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious case from  a Medical Assistant.  This case involves a 4 year-old-female patient for whom it was reported when she moved influenza quadrival a-b vaccine [Fluzone QIV] went down the arm  not in the arm (Exposure via skin contact and Underdose) on 05-Nov-2020 (lot: UT7049LA, expiry date 30-Jun-2021) at a dose of 0.5 ml of unknown frequency via unknownroute in right arm  for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was none.  The patient was not using the vaccine first time.  This was an actual medication error case due to the event Exposure via skin contact and Underdose (latency: same day).  No laboratory data was reported.  Disclaimer: 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 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.
Episode of vomiting x1 followed by sleepiness, difficult to arose, irritiablilty, seemed "out of it" for 10-15 minutes.
This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The nurse reported that, on 07-MAR-2017, the patient received an improperly stored dose of VARIVAX subcutaneously, lot number: M037643, expiration date: 01-SEP-2018 (strength, dose, frequency, and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature of 10 Fahrenheit (F) (between 6F to 14F), for 40 minutes due to a data logger issue. There was no previous temperature excursion. No adverse effects reported. There was no product quality complaint involved. Additional information has been requested.
antineutrophilic cytoplasmic antibody vasculitis; This literature-non-study case was reported in a literature article and describes the occurrence of ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (antineutrophilic cytoplasmic antibody vasculitis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (antineutrophilic cytoplasmic antibody vasculitis) (seriousness criterion medically significant). The patient was treated with Immunotherapy for Anti-neutrophil cytoplasmic antibody positive vasculitis. At the time of the report, ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (antineutrophilic cytoplasmic antibody vasculitis) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (antineutrophilic cytoplasmic antibody vasculitis) to be related.    No concomitant was reported.  The patient developed the event one day after the first dose of the mRNA-1273 vaccine. Patient improved with supportive care and immunosuppressive therapies.  Company comment: This case concerns a 60-year-old female patient with no medical history provided, who experienced serious unexpected event of Anti-neutrophilic cytoplasmic antibody positive vasculitis which presented as granulomatous pulmonary nodules. As per currently available information, the event occurred the day after the patient had received the first dose of the mRNA-1273 vaccine. The patient was treated with supportive care and immunosuppressive therapies and her condition improved. No further details were available at the moment. The reporter assessed the event as related to the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 60-year-old female patient with no medical history provided, who experienced serious unexpected event of Anti-neutrophilic cytoplasmic antibody positive vasculitis which presented as granulomatous pulmonary nodules. As per currently available information, the event occurred the day after the patient had received the first dose of the mRNA-1273 vaccine. The patient was treated with supportive care and immunosuppressive therapies and her condition improved. No further details were available at the moment. The reporter assessed the event as related to the mRNA-1273 vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Lost control and feeling of my right leg and right arm for approximately three minutes. Started with tingling and then no feeling or control of them. I had blurry vision and was disoriented.
This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 30-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Information has been received from a health professional concerning a 6 month old female, with no medical history and no allergies, who was vaccinated with a first and second 2 ml oral dose of Rotateq on 19-OCT-2006 and 17-JAN-2007 (Lot# 655866/1110F), respectively. Concomitant vaccinee administered on 17-JAN-2007 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of IPOL, a dose of PedvaxHIB (manufacturer unknown) and a dose of Prevnar. It was reported that, according to the hospital discharge summary, 24 hours prior to presentation at the hospital, on 07-MAR-2007, the patient began with nausea, vomiting, abdominal pain and constipation. The patient was admitted to the hospital on 08-MAR-2007 and had episodes of vomiting, diarrhea, and bloody stools. The patient was diagnosed with ileocolic intussusception, which was initially encountered in the distal transverse colon. It was also noted by the physician on the discharge summary that the patient had rotavirus. The patient did not have surgery and the intussusception was reduced by an air contrast enema. The patient was discharged on 10-MAR-2007 and had recovered. The patient's intussusception and rotavirus were considered to be other important medical events by the reporter. A lot check has been requested. Additional information has been requested.  04/12/07-records received from facility for DOS 03/08-03/10/2007. DC DX: Ileocolic intussusception. Diagnosed and treated with air contrast enema. Developed abdominal pain 24 hours prior to presentation with decreased PO intake, several episode of vomiting and an episode of diarrhea but no further bowel movements over 24 hours. Febrile to 38.3. PE bowel sounds present soft non distended tender to palpation no masses palpable. Rectal grossly bloody stool in rectal vault.
I have mild headaches daily due to seasonal allergies, but I was told to report even if I wasn?t sure if it was a reaction.  Early Monday, 4/12/21, I woke up with a severe sinus headache. I took some sinus medicine by 7 am but it remained fairly strong for 2-3 hours. It eased up some so I went to work and by 11 am took another dose of sinus medicine. I felt nauseated so I ate a couple of Tums through the afternoon. I assumed it was related to the sinus medicine.  After work, I went home and was very tired. I went to bed earlier than normal but woke up this morning feeling normal. (With a mild - as usual - headache)
face broke out at about 4 pm on Thursday, has cleared up by Friday; This is a spontaneous report from a contactable Consumer (reporting herself). A 36-Year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 28Jan2021 at 10:00 as a single dose for COVID-19 immunization. The patient did not receive other vaccination in four weeks. The patient was on birth control. The patient's concomitant medication included Prozac and trazadone. The patient was not diagnosed with COVID prior vaccination. The patient did not underwent COVID test post vaccination. On an unknown date, the patient's face broke out at about 4 pm on Thursday and had cleared up by Friday. The patient did not receive any treatment medication for the event. The outcome of the event was recovered.  Information on Lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Soreness and itching beginning in evening, followed by redness, swelling of approx 3 in diam. Hot to touch, also c/o tingling in fingers of l/hand.
The morning after the shot I woke up with fever and about a 21/2 inch ring, violently red, around the shot area. Since then I?ve been dizzy, put on blood pressure meds and diuretic
Significant eyelid swelling and urticaria on her back day 6 post vaccination around 8 pm. Nothing prior. Day 7 more fulminant urticaria involving chest, eyelids and back, again around 8-9 pm; Significant eyelid swelling and urticaria on her back day 6 post vaccination around 8 pm. Nothing prior. Day 7 more fulminant urticaria involving chest, eyelids and back, again around 8-9 pm; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the parent.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Nov2021 15:30 (Batch/Lot number: unknown) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: CONCERTA 27mg; Oral METHYLPHENIDATE 27 mg taken for attention deficit hyperactivity disorder (ongoing). The following information was reported: URTICARIA (non-serious), SWELLING OF EYELID (non-serious) all with onset 17Nov2021 20:00, outcome "recovered" (2021) and all described as "Significant eyelid swelling and urticaria on her back day 6 post vaccination around 8 pm. Nothing prior. Day 7 more fulminant urticaria involving chest, eyelids and back, again around 8-9 pm". Therapeutic measures were taken as a result of urticaria, swelling of eyelid.  Additional information: adverse event; Significant eyelid swelling and urticaria on her back day 6 post vaccination around 8 pm. Nothing prior. Day 7 more fulminant urticaria involving chest, eyelids and back,again around 8-9 pm. Both resolved with antihistamine and prednisone. Today is day 8 now with urticaria of posterior right knee. Patient received treatment as antihistamine and prednisone for event. Upon Follow-up it was reported that Day 6 Post 1st Covid vaccine shot she developed bilateral eyelid swelling, Day 7-9 She had uitcaria of her torso arms and focally on her Right leg Benadryl, zyzal and prednisone 10 mg given each day, days 6-9 spentaneously resolved. Specific Relevant Test for thromboembolic event with Thrombocytopenia:  None. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 20-FEB-2018, the patient was vaccinated with an improperly stored Oka-Merck PROQUAD for prophylaxis (dose, strength, frequency, lot#, expiration date and route of administration were not reported). The temperature excursion was reported from 6°F to 14°F, and the time frame was reported as 1 hour and 30 minutes. Previous temperature excursion was reported from -9°C to 8°C (-6.4°C) for a time frame of 3 hours. Data logger was reported. Merck sterile diluent was used to reconstitute the vaccine. No product quality complain was present. This is one of several reports received from the same reporter.
Developed what appears to be Shingles on right torso side 9 days after second dose of Pfizer vaccine.  Visited doctor after 5 days of symptoms and was prescribed Acyclovir tablets.
Sudden and severe vertigo when getting out of bed. Improved throughout day except when bending over.  Continues at a mild level 2 days later
Pt had syncopal episode approximately 5 minutes following vaccination. LOC was less than 1 min. He was treated with crackers and juice and returned to baseline within 10 minutes and was discharged.