chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Excessive heart beating; Nausea; overall weakness; numbness of left arm; soreness of left arm; This is a spontaneous report from a contactable consumer, the patient. A 34-year old, male patient received his unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 15Mar2021 at 14:30 hours as single dose, for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to vaccination patient was not tested positive for COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient has no known Allergies to medications, food, or other products. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 14:30 the patient experienced events, Excessive heart beating, nausea after food consumption - haven't been able to hold food as of morning 3/19, overall weakness, numbness and soreness of left arm during first 2 days since the vaccination. The patient didn't receive any treatment for the events. The clinical outcome for the events Excessive heart beating, nausea, overall weakness, numbness and soreness of left arm was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
vestibular issues; vertigo; dizzy; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-healthcare professional via Medical Information (reference number-00557447 and 00558122) and transmitted to Sanofi on 12-Apr-2021.  This case involves a 54 year old female patient who had vestibular issues (vestibular disorder), vertigo and dizzy (dizziness) after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history included Vertigo.  Past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date in 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date 2019 the patient developed a non-serious vertigo and dizzy (dizziness) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date the patient developed a non-serious vestibular issue (vestibular disorder) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE..  The reporter stated that on an unknown date in 2019 (Oct-2019 or Nov-2019), the patient received the FLUZONE QUADRIVALENT vaccine and felt dizzy and experienced vertigo. Also, since an unknown date, the patient had continued to experience vestibular issues. The patient was currently having physical therapy for vestibular issues. The reporter had a concern regarding the patient receiving the COVID (coronavirus disease) vaccine and was asking which of the COVID vaccines was best for the patient based on her reaction to FLUZONE QUADRIVALENT.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment for the events dizziness and vestibular disorder.  At the time of reporting the events were not recovered.  There will be no information available on batch number for this case.
Severe chest pain around the heart. It would happen at random times, usually when resting (sitting or laying). the pain was so severe I could not move until it passed. It usually lasted a few seconds, sometimes up to one minute. I?ve never had a heart attack but it felt like what I imagine one feels like.
Info has been received from a physician concerning an 8 year old male who in approximately 1998, at 1 year of age, was vaccinated with dose of varicella virus vaccine live. On 3/31/05, the pt presented at the physician's office with 25 lesions scattered around his body. No further info was given at the time of this report. No product quality complaint was involved. Additional info has been requested.
Information has been received from a physician concerning an 11 year old male with Asthma, Gastro-esophagael Reflux, Pectus Excavatum, and seasonal allergy, who on 06/12/2005 was vaccinated with a dose of varicella virus vaccine live.  Concomitant therapy included ranitidine, fluticasone propionate, albuterol and fluticasone propionate.  On 06/02/2004 the patient experienced fever, and few itchy papules.  It was noted that over the course of the next 4 days he had a total body break out with vesicular lesions and oral mucosal ulcers.  No labs were done and no medications were prescribed.  The patient was treated with hydroxyzine hydrochloride, acetaminophen, calamine, camphor, pramoxine hydrochloride baths, and calamine lotion.  It was noted that the patient recovered by 06/11/2004 without incident.  Additional information is not expected.
Debilitating headache from 1030pm on night of vaccination  til about 48 hours later. Lower right back of head. Random muscle aches overnight. Night sweats on 2nd night.  Weak and tired 2nd day.
Patient reported having symptoms of chest and throat tightness that was worsening and mild labored breathing  Patient seen by medical team and blood pressure was 175/91 and heart rate was 83 and oxygen saturation was 99%; patient had clear lung sounds per paramedic  Patient refused medical transport and signed AMA form Patient reported symptoms improved
flu- like symptoms after 72 hrs lasted 2 weeks 1 st dose - red line going from finger tips up to the neck all previous injuries are felt after shot frozen shoulder  physical therapy
Left deltoid 2-3 + swelling, redness covering entire muscle area, area hot to touch.
Information has been received from a female nurse practitioner who "as a child" was vaccinated with doses of MMR. In 2001, the patient had a negative titer (she was not considered seroconverted for measles or rubella). She was given another dose of MMR in 2003, and then received an additional dose in 2006 because she "forgot about the 2003 dose". She has had no titer drawn since the titer in 2001. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
In the middle of the night he stood up to go to the bathroom, turned the light on, felt dizzy and light headed. Passed out and woke up confused unable to speak correctly and unstable when trying to stand up. Eyes were dilated. After he layed down for a few minutes he was ok, could walk and talk fine.  Migraine Chills Slightly warm
Pt received 2nd dose of primary series.  Almost immediately complained of abdominal pain and chest pain.  Pt turned bright red over entire body.  911 was called.  Pt did not have swelling of lips or mouth.  Pt was taken to hospital as a precaution.
A report was received from a health care professional on 10/28/2003 concerning a 44 year old female vaccinee who inadvertently received expired Fluvirin on 10/28/2003. The vaccinee had not experienced any adverse effects at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Client received the COVID vaccine (Pfizer dose 2, lot #ER8731, expiration date 07/2021) at 1050. Client reported feeling hot, seeing spots, and having a "pounding heart" right as she got vaccinated. EMT and RN responded at 1055. The client appeared flushed and diaphoretic. Vital signs were blood pressure 125/95, heart rate 120, O2 96%, respiratory rate 16. The client denied any shortness of breath or dizziness. The client has no allergies, her only medical condition is anxiety, and her only medications are her birth control and xanax as needed. The client stated they did not take any xanax previous to their appointment. The client stated that they did eat breakfast that day. The client was sitting in her chair comfortably in no distress. They refused benadryl at this time. At 1100, vital signs were as follows: heart rate 115, respiratory rate 14, and O2 95%. The client was alert and oriented, and denied needing any water. She stated that her symptoms were resolved and she was feeling "back to normal." At 1105, the vital signs were as follows: blood pressure 118/82, heart rate 97, respiratory rate 16, O2 99%. Education provided regarding emergency management and AMR activation, v-safe, and primary care follow up. At 1120, the client finished their 30 minute observation, and stated they had no remaining symptoms. Their color had returned to normal and they were no longer diaphoretic. They were able to stand and ambulate without any dizziness. Final vital signs were as follows: blood pressure 120/92, heart rate 92. The client was escorted to their car by the EMT, ambulated with a steady gait.
fell at Assisted Living apartment 8/27/2021. could not get up/walk thus ambulance called. Taken to hospital and found to be febrile and COVID (+). Son says that the delirium and weakness are the primary issues during hospitalization. Oxygenation is fine. NO ICU stay. Still admitted as of Sunday 9/05/2021 with no discharge date known.
2 wk history of shoulder s/p receiving Tdap vaccine.  Pain is worse with ROM and deep palplation.  Unable to sleep on shoulder at night.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 26-DEC-2014, the patient was vaccinated with improperly stored GARDASIL lot # J015378, expiry date 09-APR-2015 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report received from a contactable consumer. A 7-year old female received a dose of PREVNAR 7 intramuscularly for immunization on 10Mar2014. It was reported that the patient had completed therapy with PREVNAR. Relevant medical history was none. Relevant concomitant medications were unknown. In Feb2011 after the patient completed therapy with PREVNAR 7 vaccine, her blood work results revealed low titers. At the time of the report, outcome was unknown. Follow-up (30-AUG-2011): Follow-up attempts completed. No further information expected.
Vaccination failure; shingles; became ill; headache; myalgia; inappropriate schedule of vaccine; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received the Zostavax vaccine about seven years ago).   In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling unwell, headache, myalgia and drug dose administration interval too short. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles, feeling unwell, headache, myalgia and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the feeling unwell, headache and myalgia to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. Last summer before the date of reporting, the patient received Shingrix and 2nd dose 7 weeks later, earlier than recommended interval, led to the shortening of vaccination schedule between 1st and 2nd dose. A few hours later after the 2nd dose the patient became ill with headache, myalgia and other symptoms. The next day the patient felt better. Three days before the date of reporting the patient came up with shingles on my right side. Within six hours the patient started Valacyclovir.
Was post-menopausal, including blood test confirmation.  After vaccine have gotten periods: 4/10/21  5/6/21  5/30/21 6/21/21
ARM COULD FALL OFF; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced arm could fall off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm could fall off was not reported. This report was non-serious.
PATIENT WAS COUGHING AND WHEEZING. BY 2PM, HAD FEVER OF 102. GIVEN TAMIFLU AROUND 4PM WHICH SHE VOMITED. TEMP AT 4PM OF 103.2. WENT TO ER. PUT ON NEBULIZER TREATMENTS STARTED ON ZITHROMAX. THEN DISCHARGED HOME. PATIENT SHOULD HAVE RECEIVED H1N1 INJECTABLE, NOT INTRANASAL.
Low-grade fever, chills, body aches, headache, chest pains: these symptoms lasted about 21 hours.
Pt recvd 3 doses of Engerix-B vax & upon completion of series was determined to be a non-responder;
Pt was given a pediatric pfizer that was not reconstituted with diluent; no SE thus far
The young man the patient came in with came back to the pharmacy and said patient was feeling not feeling well. He said she was having difficulty breathing and feeling like she was going to pass out. She was sitting on a bench and conscious. I had my team call 911. Upon speaking with her, she said her throat was hurting. I checked the injection site for signs of swelling or a rash and there did not appear to be anything there. She was also leaning on the wall and her friend for support. I continued speaking with her and her friend. She appeared to have labored breathing. The paramedics arrived by 6:24 PM. The patient never lost consciousness that I saw. They ran some tests on her and she checked out okay according to them. They recommened she go to the emergency room, but she refused saying she was feeling better. About 10 minutes after they left and her friend was finished filling out some paperwork for pharmacy, they left. She was able to walk out on her own.
March 20th awoke with swollen tongue, burning throat, with blisters on both. Went to 1st ER visit, was given Benadryl and  Steroid injection. Was told allergic to vaccine cant get 2nd does. Follow up with primary care professional on March 22nd, was given another steroid injection and put on 50 mg Prednisone for 5 days. Was told cant get second vaccine dose. March 27th went back for sores on checks and burning in throat was put on Thrush medication. March 30th was having heart palpitations, confusion, dizziness, sudden severe headache, mild chest discomfort was given EKG, sent for labs. Then sent to 2nd ER visit to check for blood clots of lung and head. March 31st had to call 911 for elevated heartrate, chest pain and dizziness. Went to 3rd ER visit. ER DR gave TXA for the swollen tongue, did chest xray, gave another script for another round of steroids Methylprednisolone. April 1st, went for stress test. Went to Cardiologist April 8th was put on Heart Monitor for 30 days.
Information has been received from an other health professional concerning eight kids who were accidentally vaccinated with Zostavax (Oka/Merck) instead of Varivax (Oka/Merck).  The physician reported that the vaccine looked alike and were labeled almost identically.  No adverse events were reported.  Additional information is not expected.
Patient states onset of hives covering chest, back, inner thighs and buttocks within 2 hours of vaccination. Tolerates the seasonal flu vaccination without reaction.
This case was reported by a physician via call center representative and described the occurrence of diarrhea in a female infant exposed to FLULAVAL in utero. The parent received the product. The patient's medical history included hiccups. Concurrent medical conditions included food allergy (Allergy to dairy, soy, corn and egg diagnosed by an allergist but not considered as true allergies) and dietary control (strict diet due to food intolerance). On 24th October 2014, the mother received FLULAVAL. On 24th October 2014, the dose was an unknown dose. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The infant was diagnosed with diarrhea (serious criteria clinically significant/ intervention required). On an unknown date, the infant experienced vaccine exposure via breast milk. The infant was treated with medication unknown (Hydration (Unknown)). On an unknown date, the outcome of the diarrhea was not recovered/not resolved and the outcome of the vaccine exposure via breast milk was unknown. It was unknown if the reporter considered the diarrhea and vaccine exposure via breast milk to be related to FLULAVAL. Additional information: The patient was exposed to FLULAVAL via breast milk. Patient's mother (physician) received the vaccine at the hospital she works at on 24th October 2014 between 10 am and 1 pm because of standard work protocol. On 25 October 2014 in the evening, 1 day after patient's mother received the vaccine, the patient was fed with the milk her mother pumped and experienced diarrhea. She had to be changed twice. The patient received additional breast milk since she refused to take formula.
Upper left arm, swollen, 4" long red stripe going around arm, about 2" in height. Very sore to the touch, red stripe is much = hotter than rest of arm. Approx. 18 hours before any symptoms. Slight temp.
Initial summary report received from a healthcare professional on 03 October 2013. A female patient (age unknown) whose medical history and concomitant medications were not reported received first dose of FLUZONE ID batch no 3, on left deltoid (route, dose, from, frequency not reported) on 03 October 2013. The female patient received vaccine during pregnancy. Mother did not experience any adverse event. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
swelling, redness at injection site, within an hour, nausea and headache 24 hrs later, 48 hrs later headache , nausea and all over body pain, 72 hrs still had headache.  Took ibuprofen 800 mg kept headache and body pain at bay till it wore off, bendaryl to calm mast cells,  Dramamine-n for nausea seemed to control it.  Arm is still red, bruised looking and itchy 9 days out just dealing with it at this point
I was up all night with chills, fever (101+) and severe headache.  The headache is what kept me from being able to sleep.  I wasn't sure if it was ok to take otc pain meds so I waited until morning (9:30 am) to call my doc. Fever had subsided, but still had intense headache.  Doc told me to take 2 extra strength Tylenol which I did. Headache was relieved within 45 minutes.  I was able to sleep.  Felt much better afterwards although still struggled with fatigue and mild headache for approx 80 hours following vaccine.
Patient stated her left arm was warm and swollen. I noticed that it was swollen from her bicep down to her elbow. She stated she had difficult raising her arm.
PATIENT WAS UNDER THE AGE OF 18 AT THE TIME OF ADMINISTRATION. NO ADVERSE EVENTS REPORTED BY PATIENT.
Information has been received from a physician concerning a 20 year old female patient who on 20-MAR-2007 was vaccinated with her first dose of Gardasil.  Three days after the vaccination the patient passed out and was taken to the ER.  It was not known if she was admitted to the hospital.  Subsequently, the patient recovered.  Additional information has been requested.
Moderna was received from deep freezer on 8/6/21. Was placed in Student Health refrigerator on 8/6/21. 30 day expiration date was 9/5/21. Moderna was left in Student Health refrigerator and used until 9/13/21. On 9/14/21 we realized we were beyond the 30 days and immediately notified the Pharmacy for direction. The Pharmacists are in communication with Moderna to see if the doses are considered valid or invalid. Risk Management is involved to decide on the best course of action and if we notify the patient before we hear back from Moderna.
acute pancreatitis; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19, Lot Number: EK5730), via an unspecified route of administration, administered in arm right on 18Dec2020 (at the age of 41-years-old) as dose 1, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included acute pancreatitis from an unknown date. There were no concomitant medications. The patient previously took Reglan [metoclopramide hydrochloride], and experienced drug allergy. Within a week and a half from getting the 1st of 2 Pfizer vaccines, the patient had acute pancreatitis on 04Jan2021. The acute pancreatitis would resolve for a short time and then come back within days for several reoccurrences. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 5 days within the month of Jan/Feb of 2021. The patient received IV fluids, pain/nausea meds, CT scans, blood work as treatment. The outcome of the event was recovered.; Sender's Comments: Based on the currently available information the  causal association between the event acute pancreatitis and the suspect drug BNT162B2  is assessed unrelated and more likely due to underlying medical condition of acute pancreatitis.
The next day in the evening I experienced fever of 102 and I had chills, achiness in my body.  I couldn't sleep, my thinking patterns were little confused, I was confused. I was also having adverse dreams.  By Monday the fever went down, and the body aches and tiredness went down some. On Monday I went and got a COVID test and got a positive. Up to time of vaccination I have tested negative. The place that gave me the COVID test said it could be a false positive due to recently being vaccinated. The person from the COVID test said it was safe to get the 2nd dose. I feel okay right now and I am out and about.