chrisvoncsefalvay/vaers-outcomes huggingface dataset:
death; dementia; potentially years of sleep deprivation (Chronic Insomnia); activation of stress hormones; This spontaneous report was received from medical consultant and refers to a 27-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced dementia, the patient experienced potentially years of sleep deprivation (Chronic Insomnia), the patient experienced activation of stress hormones. At the time of reporting, the outcome of the events was not reported.  The reporter considered activation of stress hormones to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The reporter considered potentially years of sleep deprivation (Chronic Insomnia) to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).   The causal relationship between other events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.    Upon internal review, the event of dementia was determined to be medically significant.
pain through entire left arm muscles. pain is close to having a cramp Sometimes the pain is at upper left arm and then travels down toward wrist
Headache, Myalgia, Fever, fatigue Narrative:  Fever 101.3, fatigue, headache, myalgia
Confusion, Headache, Arthralgia, Transient Aphasia Narrative:  Employee reports HA started w/in 30 min of COVID bivalent booster vaccine progressively got worse with transient aphasia morning of 01/07/2023 confused too major effort to say the words "Good morning" thoughts and words from mouth did not match was talking "nonsensical", reports one episode of transient aphasia, headache continued till approx 10am 01/08/2023. +Stiff neck onset several hours after vaccine on 01/05/2023 improved but still present as of 01/09/2023. +left arm sore/pain woke employee up at 1am on 01/06/2023 progressively got worse to the point unable to lift arm and resolved on 01/07/2023.
Anaphylactic Reaction within 1 minute of receiving vaccine.  Received Epipen injection & taken to ER by ambulance. Given IV steroids, anti-inflammatory.  Prescribed Prednisone 20mg for 4 days. T Instant weird feeling, dizzy, throat closing, trouble breathing & swallowing, fast heart rate, tongue & lips tingling and numbness
11FEB2023 in the evening I felt not normal, uncomfortable like I had something coming on also I had sort of chills. Saturday morning I woke up feeling worse feverish my wife administered a COVID-19 test, immediately it was positive with a solid red line. I tried to call my PCP but it was the weekend. I continued to feel poorly and my temperature reached 100.7. I continued to have flu like symptoms. I took ibuprofen for my temperature and Sunday morning made an appointment with the local urgent care clinic, I was attended to by the physicians there and was given a prescription for PAXLOVID. I took two days worth of doses and developed a very sore, hoarse throat and stopped the medicine the hoarseness subsided as well. I continued to get well on my own, the lingering event was my food taste was very salty.
This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 64, via an unspecified route of administration, right arm, on Apr 12, 2021, at 04:15, single dose, for COVID-19 immunisation. The patient did not have any reported medical history. The patient has no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications included Nexium (esomeprazole magnesium) from an unknown date for unspecified indication. The patient previously received the first dose (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, right arm, on Mar 22, 2021, at 00:15, single dose, for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On Apr 13, 2021, at 13:30, patient experienced headache, fever, chills and nausea. Since the vaccination, patient has not tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures taken as a result of the reported events. The clinical outcome of events headache, fever, chills and nausea resolved on an unknown date in Apr 2021. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Next morning I woke up with a migraine and stiff neck.  Following day I had multiple episodes of diarrhea and significant nausea.  I woke up with another migraine and stiff neck on 12/23/20.  I still had GI upset.  On 12/24/20 I had migraine again with body aches and GI upset.
Severe headache, muscle weakness, tingling sensation on left side, dizzy, feeling itchy but no rash, red and hot cheeks come and go, from day 1 until Day 8.  Today new swelling, itchy, redness and hard lump at injection site.
Sore throat, increased trouble breathing, whites of eyes turned bright red, felt sick. I had similar but less severe reaction to flu vaccine the prior year in 2009. I took Benadryl and breathing difficulty did not get worse.
Patient received the zoster vaccine on 9/28/15. He presented to his PCP on 10/6/15 with a rash on the left side of his face with pain, a headache, and hearing loss. Physical exam revealed swelling as well and a patch near the left ear. PCP notes patient reports sx started shortly after vaccine was administrated. Diagnosis of facial zoster was made. Patient was dispensed valacyclovir from office stock. Valacyclovir 1000 mg TID.
Information has been received from a registered nurse concerning a white female who on 08-APR-1996 was vaccinated with a dose of Varivax (Lot # 612226/1501B). Subsequently, the patient developed a generalized rash of 50-200 lesions. The patient was not hospitalized. Vaccine failure was noted. This was MD documented / evaluated. Follow up information indicated that no further information was available. No additional information is expected.
I have hade osteoarthritis for several years. But I have always been able to manage it. I know eventually I would need to have a hip replacement. 6 months ago I would have said I can go several more years before needing the replacement. Even since I had the first dose of the vaccine my condition worsened many fold. I have pain 24 hour a day even when lying in bed. It's becoming increasingly more difficult to get through the day. To day they don't have an expectation for the very sudden change in condition
Presented to ER that evening with malaise, general weakness, and dysuria. Work up in the ER showed Tropinins trending up and patient admitted with a NSTEMI.  Later patient was transferred to the ICU with significantly dyspnea and Mobitz type II second degree heart block with a heart rate in the 20's. He responded well to an epinephrine drip.  He was transferred to a higher acuity hospital via transport on 11/23/2022 where he received placement of a permanent pacemaker which resolved his issues. He was discharged the following day much improved.
Developed red itchy smooth feverish rash on legs and arms starting after 7 days and still have rash to this date .  Joints ached. Took antihistamine tablet and also acetaminophen but that  did not help so quit taking anything.
Swelling, erythema and tenderness at injection site which peaked on second day after administration of vaccine. One dose diphenhydramine was given.
Participant experienced a severe Headache and extreme facial pain upon waking but no other symptoms her pain level 10/10 She told her school principal she would get tested for COVID and  left work at 3pm to get tested She was  tested and given Amoxicillin which helped reduce the pain within 24 hours and after she continued to take the antibiotics for 10 days and was fine after that. The doctor diagnosed her with Acute Upper raspatory infection
Employee says she started feeling pain on right side muscle area under armpit down to rib cage. The began as stiffness then it felt very sore.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 66 years old female patient who was given an expired FLUZONE HIGH DOSE vaccine, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Oct-2018, the patient received a 0.5 ml dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine lot UI884AA, expiry date- 24-May-2018 via intramuscular route in the right deltoid. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for was given an expired FLUZONE HIGH DOSE vaccine. 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.
3-4 days after vaccine subjective fever, migrating arthralgias, pains above and below joints that are intermitant.
Pt stood up and began to walk after injection and became light headed. Pt sat down on the floor. Pt was assisted to a  chair. VS were stable, pt felt recovered after a few minutes. Pt was monitored for 30 minutes.
Swelling, bruising, and pain on the inner bicep/elbow region. No reaction around the site of injection.
Narrative: Patient is a 66 year old M with PMH significant for hyperlipidemia, neurogenic bladder (self caths), OA, and osteoporosis who presents for chills. Patient notes chills developed last night and have not resolved. He has not had any other symptoms (no fever, night sweats, headache, myalgias, cough, dyspnea, chest pain, abdominal pain, nausea, vomiting, diarrhea, urinary changes). His son and daughter-in-law have had flu-like symptoms for the past few days. No one has been tested for COVID. He had his first dose of Pfizer 2/2021 and the second dose 6/2021. In the ED the patient was found to have a fever of 104.4, HR 120s, systolic BP was quite low in the 80s, labs significant for elevated WBCs, lactic. Cr, procal, and with positive COVID-19 test. HOSPITAL COURSE: Sepsis protocol initiated, has completed ceftriaxone 2 g IV, will transition for 5 day course of outpatient keflex. slow improvement in status, originally downgraded from MICU to Covid Ward. Slow but sure increase in movement / activity, as he is able to do at home. Reinforcing importance of continued med, Practitioner compliance. Elevated LE due to ongoing dependent edema, self reliance on ADL needs as able to include ongoing self catheterization due to neurogenic bladder. CONDITION AT DISCHARGE: stable in care of self to home
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates in April 2017 (reported as from 20-APR-2017 to 25-APR-2017), the patients were vaccinated with improperly stored doses of ROTATEQ (lot number M029251 with expiration date of 14-MAR-2018, lot number M042172 with expiration date of 08-JUN-2018, lot number reported as M034495 with expiration date of 31-MAY-2018 and lot number M039067 with expiration date of 18-APR-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour 17 minutes at a temperature between 9 degrees Celsius and 25 degrees Celsius on unspecified dates. No previous temperature excursion was reported. A data logger issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001801: US-009507513-1705USA001802:
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note: "67-year-old female past medical history tobacco use hypertension drainage presented for chief complaint of weakness/pre syncope and altered mental status.  She is noted have some difficulty with speaking very full code stroke was called.  CT was performed negative.  CTA was performed showing bilateral carotid stenosis.  She was seen by vascular surgery for her carotid stenosis with plans for right ICA.  Patient required washout of Plavix prior to procedure.  She was seen by a PT and OT services deemed appropriate for outpatient therapy.  Patient received right CEA underwent normal postoperative course and was discharged."
Extremely painful and heavier periods starting with the first period after full vaccination. After 4 months of symtomps getting worse with each period I was treated by changing the NuvaRing every 3 weeks without a break so I do not get a period. This has resulted in some relief but not complete relief.
at around 2am I woke up shaking and extremely cold. Got up and felt severe body aches and rigors. Throughout the day I had persistent fever of up to 101.8F which improved with alternating IBU 800mg and Tylenol 1g, but did not resolve. The severe body pains and headache also lasted all day. Improved but not resolved with medication. My right arm was also severely painful. Could not raise it.  All symptoms resolved by the next morning except for  the arm pain which is much milder, like a 1/10 dull pain but still persistent.
got really sick (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick (1st dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick (1st dose)). At the time of the report, ILLNESS (got really sick (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.   No concomitant medication reported.  No treatment information was provided.   This case was linked to MOD-2021-402846 (Patient Link).
Patient received flu vaccine in right upper arm and immediately reports an "electric shock" sensation that traveled the length of her arm into the hand. Patient continued to experience throbbing pain in the upper arm/shoulder for the next month, although the electric shock sensation was only felt at the time of injection. In December, the patient went to her family doctor as symptoms continued and reports increasing weakness to the arm. Dr. reports that the nurse administering likely hit/irritated the axillary nerve during administration. He has ordered an EMG for the patient scheduled for 1/18/18.
Information has been received from a licensed practical nurse concerning a 9 year old male patient who on 05-AUG-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number665527/0696Z, exp 21-APR-2011) instead of the second dose of VARIVAX (Merck). The staff reached for the wrong vial. This was no a PQC but human error. No adverse symptoms noted. The patient sought unspecified medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
Approx. 10 mins after receiving her vaccine, the patient stated that she was having an allergic reaction. The patient stated that her eyes were closing and that it was her allergic reaction. Patient was alert and oriented and able to converse with medical professionals as this was happening. Patient took one Benadryl tablet (her own medication). Patient was assessed as she took the medication and had no signs or complaints of respiratory distress. Patient then expressed that the Benadryl tablet was not working and requested to be given IM Benadryl.  Benadryl 25mg  IM administered by an RN (not myself). Vital Signs were taken (BP: 144/90 HR: 90 SpO2: 99%  on room air). Patient monitored closely for additional 15 mins. Patient stated that she was feeling better after 15 minute observation.
Patient was given a dose from a vial that was open for 22 hours/12 hours past stability.  Per guidance from CDC and Health Dept, patient will return asap for repeat dose in opposite arm and then will come back 28 days after that dose for final dose.
Rash developed at injection site. Swelling, redness, and warmth at site persisting 3 days after injection.
Guillain-Barre/ Miller Fisher Variant.  Eyes not working together, could not swallow or open mouth much or speak correctly, could not breathe well, could not hold body up straight, could not lift head when lying down, legs weak, could not lift hands to top of head , could barely hold arms in front of me, overall weakness.  Was hospitalized for 8 days.
Cerebral Venus Sinus Thrombosis; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 33 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8736), administration date: 24Jul2021, when the patient was 33-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8733), administration date: 31Mar2021, when the patient was 32-year-old, for COVID-19 immunization. The following information was reported: THROMBOSIS (hospitalization, life threatening) with onset 20Jun2022, outcome "recovering", described as "Cerebral Venus Sinus Thrombosis"; HEADACHE (hospitalization, life threatening) with onset 20Jun2022, outcome "recovering". The patient was hospitalized for thrombosis, headache (start date: 19Jun2022, discharge date: 22Jun2022, hospitalization duration: 4 day(s)). The events "cerebral venus sinus thrombosis" and "headache" required emergency room visit. Therapeutic measures were taken as a result of thrombosis, headache.
Upset stomach; Dizzy; Weak; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizzy) and ASTHENIA (Weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizzy) and ASTHENIA (Weak).   At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizzy) and ASTHENIA (Weak) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
The day following receiving her COVID vaccine she developed itchiness, fussiness, and a rash behind her knees
Admitted with intractable back pain (known compression fracture).  Per ED note, patient found to have cough and labored breathing.  New onset A fib
weird sensation,feeling like funny; left lower leg started like having an electric shock; numbness on the back of the neck, near the ear; This spontaneous case was reported by a consumer and describes the occurrence of ELECTRIC SHOCK SENSATION (left lower leg started like having an electric shock), HYPOAESTHESIA (numbness on the back of the neck, near the ear) and FEELING ABNORMAL (weird sensation,feeling like funny) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 011C211A and 032E211A) for COVID-19 vaccination.     Concurrent medical conditions included Back disorder NOS.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced ELECTRIC SHOCK SENSATION (left lower leg started like having an electric shock) and HYPOAESTHESIA (numbness on the back of the neck, near the ear). On an unknown date, the patient experienced FEELING ABNORMAL (weird sensation,feeling like funny). At the time of the report, ELECTRIC SHOCK SENSATION (left lower leg started like having an electric shock), HYPOAESTHESIA (numbness on the back of the neck, near the ear) and FEELING ABNORMAL (weird sensation,feeling like funny) outcome was unknown.            Concomitant medications include Medication for thyroid and depression. No treatment information was provided. The patient is in her 60s.
2 or 3 days prior to developing iritis; pressure spiked; This is a spontaneous report from Pfizer sponsored safety call center case report form. A Physician reported for a female patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation; bimatoprost (DURYSTA) 10 mcg route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced 2 or 3 days prior to developing iritis, pressure spiked. The patient received the treatment as Durezol, Lotemax. The clinical outcome of the events was unknown at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. No pertinent medical history or drug reactions/allergies were provided. The medical assistant reported that a patient received her first dose of GARDASIL on 20-AUG-2007, her second dose on 03-APR-2008, and her third dose on 03-JUN-2008 (dose, route and lot numbers were not specified). No adverse effect were reported. Additional information is not expected because there was no consent to follow-up.