chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received vaccine at 5:55 pm   At 6:00pm Pt had syncopal episode fell out of chair and hit head on concrete   Pt had abrasion to right head right wrist and right knee    Ot was able to answer questions A&Ox 4    No vomiting   No blurred vision    911 called and ot was transported to hospital via Ambulance
Fatigue. Aching and stiffness in joints throughout body. Treated with ibuprofen PRN  Lasted for approximately 3 days after onset.
COVID Vaccine Breakthrough Case Pfizer Dose 1 3/12/21 (EN6205) Pfizer Dose 2 4/2/21 (EP7533) COVID Positive 12/3/21  12/3/21: Patient is a 71-year-old female with a past medical history significant for hypertension, hyperlipidemia, OSA, type 2 diabetes, CAD s/p CABG, pacemaker, history of CVA, chronic back pain.  The patient presents to the ED today with complaints of significant weakness.  The patient states over the last few weeks she has been significantly weak, completely losing her ability to ambulate as of yesterday.  The patient's accompanying symptoms include fever, chills, flank pain.  She states her accompanying symptoms began yesterday.  The patient denies any nausea, vomiting, chest pain or shortness of breath. She rates her flank pain 10/10 and describes it as stabbing despite receiving IV pain medications for management.  The patient is vaccinated against COVID-19.  The patient does have known chronic back pain with sciatica to her right leg.  She states however her lower back/flank pain is different from her chronic pain.  The patient denies any tobacco use, illicit drug abuse or alcohol abuse.     Of note, the patient was admitted to the facility on 10/26/2021 discharged on 11/03/2021 the patient was admitted due to confusion and to rule out stroke.  The patient was discharged to a rehabilitation facility for deconditioning.  The patient was discharged from rehabilitation facility on 11/11/2021 with PT/OT in her home.  The patient states she has been progressively weakening ever since then.  The patient admits to having 1 fall since being discharged from the rehab facility.   Upon arrival to ED patient's heart rate 61, respirations 16, pulse ox 97% on room air, blood pressure 130/64. Lumbar spine x-ray reveals severe degenerative changes in the lumbar spine including degenerative disc disease and facet arthropathy; the appearance of the spinous process would be compatible with Bastrop syndrome, degenerative listhesis in the lumbar spine.  Pelvic x-ray reveals no acute fractures. Patient's laboratory findings are significant for glucose 134, BUN 31, hemoglobin 10.1, hematocrit 34.4.  The patient received 1 Lortab, 2 mg IV morphine, 4 mg IV morphine, 750 mg IV Levaquin in ED.  12/13/21: 71-year-old woman who presented worsening generalized weakness, inability to ambulate.  Labs were suggestive of urinary tract infection, COVID-19 PCR was positive and renal function shows signs of dehydration.  She was admitted to the hospitalist service, IV rehydration was initiated, empiric antibiotic therapy for treatment of urinary tract infection was started with urine cultures subsequently yielding Klebsiella pneumoniae.  She was also found to be significantly physically deconditioned and recommended for skilled placement on discharge.  She remained stable from a respiratory perspective anti diabetic criteria for treatment of COVID-19 pneumonia throughout hospital course.  She has been accepted to rehab and his been discharged today in stable medical condition to continue rehabilitation.
Patient seen for well child check and vaccines. After receiving vaccines including COVID Bivalent vaccine, mother called office informing triage nurse that patient did receive COVID Bivalent vaccine 11/9/2022 at pharmacy. This was not in our charting system. Patients primary physician notified of this.
Headache; This is a spontaneous report from the Pfizer-Sponsored program received by a contactable consumer (patient herself).  A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular, in Dec2020 (three days ago, as reported) at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient stated she took the COVID-19 shot three days ago and she started having headache.  The outcome of the event was unknown.  Information on the Lot/batch number has been requested.
Numbness in my finger on the hand I had shot on my left arm; I got in between my elbow and where I had shot; Tingling; Feels like kind of burning; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6199, NDC number and Expiry Date: Unknown), via an unspecified route of administration on 05Mar2021 (last Friday) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated I have been doing okay until this morning (on an unspecified date in 2021) I got up and I started to have numbness in my finger on the hand that I had shot on my left arm, I got in between my elbow and where I had shot, it felt like kind of tingling, burning, would that be any kind of side effect? When probed for vaccine expiration date, consumer stated, "Looks like, I had it 03May2021, I don't see, no (expiration date). The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Urinary problems; This case was reported by a consumer via interactive digital media and described the occurrence of micturition disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced micturition disorder. On an unknown date, the outcome of the micturition disorder was unknown.   It was unknown if the reporter considered the micturition disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced urinary problems.
2 weeks after vaccination - he developed a rash, not raised  on the right arm, opposite of the arm vaccine given in
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to (Patient Link).
Event-Severe itchy red rash and hives. Treatment-Prednisone (x3), Singulair, Zyrtec, Allegra, Triamcolone cream Outcome-Hives are gone. Red rash has turned pink. Itch remains.
Chills for a few hours, then very hot but never had a fever. Muscle aches and some joint pain, specifically in toes, shoulders and pain in my teeth. Lymph nodes were swollen in upper body (neck, arm pits). Easy to anger, slightly aggressive (I got angry easily at slow traffic) fatigue still even 2 days later. Arm pain at site of injection.
Systemic: Joint Pain-Severe, Additional Details: Pt experienced severe joint pain in whole body which sent her to ER and orthopedic specialist a month and half after the vaccine. Drs have nothing else to attribute severe joint pain to after tests and xrays. Pt missed several days of work and still is experiencing joint pain that drs are not sure what to do. Pt wrists and fingers were swollen and could not be contributed to carpel tunnel or other causes according to dr.
Developed soreness & redness of arm about 3-4 days after receiving. Present at HD with 2 areas of redness with small vesicle like lesions of (R) deltoid. Client states is better today than few days ago.
Tested positive for Covid and is fully vaccinated; Tested positive for Covid and is fully vaccinated; feeling really terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 9 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 14:00 (Lot number: FL0007) at the age of 8 years as dose 2 (tris), single and administered in arm left, administration date 01Dec2021 14:00 (Lot number: FL0007) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Feb2022, outcome "unknown" and all described as "Tested positive for Covid and is fully vaccinated"; FEELING ABNORMAL (non-serious) with onset Feb2022, outcome "unknown", described as "feeling really terrible". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Feb2022) positive, notes: A rapid test at home test was done, called doctor, took three tests; (07Feb2022) positive; (07Feb2022) positive.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts completed. No further information expected.
1. Local reaction on injection site 2. Facial redness 3. Lethargy
Temperature 102, chills, headache, muscle and bone pain.  Large cold sore.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 26 November 2013. A 47 year-old male subject with past medical history of high blood pressure, elevated cholesterol and cardiomyopathy was found to have other primary cardiomyopathy 7 days after the subject had received the following vaccines on 26 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM VI (lot number, route and site of administration not reported), FLUMIST (lot number not reported) and Anthrax vaccine (manufacturer, lot number, route and site of administration not reported). On 03 October 2013, the subject had an abnormal ECG. Echocardiogram results and MRI of the heart were not available. Troponin I, Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Moderate to severe pain in entire right arm. This pain is still persistent as of 2/2/2011.
Patient called in and reported that experienced symptoms about 10-12 hours after dose. She reported Temp=102 degree F, nausea, dizziness, migraine, and shaking.
On December 31st I woke up at 06:30. I went to use the restroom. I started to feel very lightheaded while in the bathroom, dizzy. I took my temperature  which was 98.0 degrees. I decide to return to bed to lay down. I had a syncopal episode, fell on the bedroom floor. My husband woke me up, I didn't know where I was or how I had gotten on the floor. He picked me up off the floor and returned me to bed. I had a cold sweat requiring me to change my clothing. I hit my posterior left head hard. I took 650mg of tylenol. Laid back down in bed and went to sleep. After waking in the morning, I have headache from the fall but otherwise feel fine.
Severe diarrhea and abdominal cramping. Lasted about 1.5 hours.  Sudden, unexpected start of menstrual period. Heavy blood flow.  Body aches and chills. 10+ hours
10 hours after receiving the second Pzifer COVID-19 vaccine, I experienced chills, fever, fatigue, and body aches. I also had a headache which lasted for 3 days following the vaccination, and when the headache subsided, I started experiencing vertical, monocular, bilateral double vision, glares, streaks, halos around light sources, and extremely dry eyes. I have never had eye dryness to this severity, and the visual disturbances that accompany the dryness have not subsided 5 months later.
Headache, Myalgia, Fever chillsand fatigue; LUQ abdominal pain x 2 weeks Narrative:
Stye; left eye hurts in the corner; This is a spontaneous report received from a non-contactable consumer, patient. A 22-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration in an unspecified arm on an unspecified date (at the age of 22-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has not been tested for COVID 19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain in left eye and stye on 16Mar2021. The patient did not receive any treatment for the events. The clinical outcome for events pain in left eye and stye was not recovered at the time of reporting.  Information about lot/batch number cannot be obtained. No further information is expected.
Swelling, redness, pain and warm to touch that started 6 days after injection. Patient was seen and given antibiotics and steroids.
Case number PHHY2011IN78597 is an initial spontaneous report received from a physician who received information from consumer (patient's husband) on 01 Sep 2011. This report refers to a 33-year-old female patient. She received first dose (day 0) of RABIPUR (batch number unknown) on 08 Apr 2011. She received another four doses of RABIPUR on day 3, 7, 14 and 28. On 05 Aug 2011, she started getting joint pains. Laboratory tests performed on an unknown date revealed erythrocyte sedimentation rate (ESR) of 135/hour; C-reactive protein of 2.4; IgM of 1.84 while IgG and IgA were negative. On an unknown date, she was diagnosed with reactive arthritis. It was also reported that the patient was given treatment for tuberculosis. However, it was unknown if the patient had tuberculosis before taking RABIPUR or not. The event outcome was unknown.
3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went to bed about 10:30. Got up about 4:30 am to use bathroom, felt lightheaded and blacked out and apparently hit my head on something.   Realized ears were closing up and had soreness in chest that made deep breath's difficult. Called 911 and nursing line and decided to go to Emergency Dept. Did CT scan for bumps on head and IV and gave me epinephrine and Pepcid.  Was discharged with prescription for Epi Pen, Zyrtec, and  Pepcid.  Still have rash and hives but not as extensive, comes and goes.
Puffiness at injection site (right thigh), high fever (103.8), pain at injection site, difficulty walking on leg where injection was given, welts around injection site, bruise at injection site...Tylenol, Motrin, and cortisone used to treat.
Patient received a partial dose as the vial lose some volume while it was being administered; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult female patient who received Herpes zoster (Shingrix) (batch number 7D73A, expiry date 18th May 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.       Additional Information: GSK receipt date: 1-June-2022 Reporter's comment: The pharmacist reported that a patient received a partial dose of shingrix as the vial lose some volume while it was being administered to the patient. The reporter consented to follow up.  Additional Supportive Information: The patient received partial dose of shingrix which led to accidental underdose.
Patient reports diarrhea, fever and chills this morning (7/30/2021), 1 day after vaccination. No other symptoms. Patient unable to give an exact temperature or severity of diarrhea.
Pt. received vaccine. Developed SOB and chest pain. Specific time of reaction unknown.
Information has been received from an approximately 60 year old female registered pharmacist with no pertinent medical history and no drug reactions or allergies, who in approximately 2007, "about three and a half years ago", was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # not reported) SQ. Concomitant therapy included losartan potassium-HCTZ, FLOVENT, albuterol, levothyroxine sodium and CLARITIN-D. The pharmacist reported that in approximately 2007, since she was vaccinated she had experienced 5 or 6 episodes where she developed pruritic, fluid filled lesions around her mouth. These lesions formed a crusty surface and then healed. The pharmacist mentioned that the lesions around her mouth caused a tingling sensation. The pharmacist also developed two deep pink spots on either side of her neck just below her chin that had not resolved. On approximately 05-JAN-2011, "two weeks ago", the patient experienced an episode where she developed the mouth lesions, and she also developed flat, pruritic, non fluid filled lesions on the back of her knee, her arm and the palm of her hand. The pharmacist stated that she knew this was called erythema multiforme. She stated that VALTREX 1 gram twice daily for two days had helped to improve the healing time, especially during the most recent episode when she started the VALTREX immediately. She was also treated with hydrocortisone 2.5% cream. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. The patient sought medical attention by seeing the physician. Follow up information has been received from a physician indicating that the patient was vaccinated in 2009 and on 09-MAR-2010 developed herpes stomatitis. At the time of the report, the patient had recovered. This is one of two reports received from the same source. No further information is available.
This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a health professional concerning a 14 year old  male child with no known medical history or allergies who on 19FEB2003 at 13:00  was vaccinated SC in the deltoid  with a first dose of varicella virus vaccine live (lot # 642994/0566M). The patient's three siblings were vaccinated the same day. He presented on 01NOV2003 completely covered with chickenpox. It was reported that two of his siblings (WAES #0311USA01047 and 0401USA00639) also developed chickenpox. The reported expressed a concern with the lot. Unspecified medical attention was sought. There was no product quality complaint involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Follow-up information indicated that the on 02-Nov-2003 (previously reported on 01-Nov-2003) the patient broke out into a rash which had now spread. No fever, cough or vomiting were noted. He denied headache or abdominal pain. The patient's sister (0401USA00639) had chickenpox for a few weeks and his littler brother (0311USA01047) also had chickenpox. No mouth lesions were noted. Small vesicular lesions in various stages were noted, classic appearing pox. The patient was given hydroxyzine hydrochloride (Atarax) (10mg/5cc) 2 teaspoons every 6 hours prn. Subsequently the patient recovered. The patient received additional vaccinations on 22-Jan-2003 at 13:17 which included a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live which was given SC in the thigh, a first dose of diphtheria toxoid (+) tetanus toxoid given IM in the thigh, a first dose of poliovirus vaccine inactivated (unspecified) which was given SC in the deltoid and a first dose of hepatitis virus vaccine (unspecified) given IM in the thigh. No further information is expected.
Began running a temperature of 103 the evening of the vaccine 3/4/2021
Swelling of edema in forehand. Patient indicated that his right hand is getting numb and he is not able to use his hand grab things and do his normal activities.
Approx 26hrs after dose administered in L deltoid, pt developed red, itchy swollen area medial aspect of L elbow.  Pt developed angioedema of lips 30hrs after dose os vaccine.  Pt treated with diphenhydramine and hydroxyzine after E.R. visit.
Body aches; Chills; Fever; Dizziness; Migraine; Headache; Nausea; Vomiting; Sick for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 10Apr2021 at 09:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included Hashimoto's, an allergy to penicillin and sulfa (sulfonamide). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), quinidine sulfate, dextromethorphan hydrobromide (NUEDEXTA), topiramate (MANUFACTURER UNKNOWN), tizanidine (MANUFACTURER UNKNOWN) and "S"; all from an unknown date for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207) via an unspecified route of administration in the left arm on 20Mar2021 at 13:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10Apr2021 at 22:00, about 12 hours after the injection, the patient experienced body aches, chills, fever, dizziness, migraine headache, nausea and vomiting and the patient reported that she had "been in bed sick for 3 days" and had finally started to feel better. The patient reported that she had to miss work. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events body aches, chills, fever, dizziness, migraine headache, nausea, vomiting and "been in bed sick for 3 days" was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fever of 101 Hot, red lump on thigh 1? to the right of the injection site.  Injection site is also warm, red, and swollen  Gave dose of ibuprofen for fever and pain at 9 AM on 12/12/19