chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received a Tetanus vaccine and Influenza immunization on 1/16/2012. On 1/23/2012 I begin to develop numbness and pain in hands and feet by 1/29/12 I had extreme weakness in my legs and body and was unable to walk. I was admitted to the hospital and underwent a series of test that include complete blood work, MRI, Lumbar Punctures, X-rays and it was concluded and I was diagnosed with Guillain-Barre Syndrome due to vaccines as I was in normal active working individual prior to the vaccines. At the hospital I received two 5-day courses of IVIG. I was then transferred to a rehabilitation center where within a week my symptoms worsened and I developed puffiness in lips and tongue with a slurred speech and weakness in breath. I was sent back to the hospital and readmitted on 2/23/12 I had an EMG study and underwent additional lumbar puncture tests and blood work. I was intubated by 2/25/12 and by 3/12/12 I required a tracheostomy and feeding tube. I underwent plasmapheresis several times in the hospital. I was discharged back to the rehabilitation center where I continue to receive plasmapheresis twice a week and steroids and medication for pain management. Today 1/5/13 I am still in the rehabilitation center still receiving plasmapheresis 2x weekly and undergoing daily physical therapy I no longer require a vent or feeding tube and have improved movement but still unable to walk.
- Pain at injection site starting around 2 hours after injection - Fever: temperature taken approx. 12 hours after injection, 100.7 F - Chills accompanied by fever
COMA; COVID-19 RELATED PNEUMONIA; SEVERE SEPSIS; ACUTE RESPIRATORY SYNDROME; MULTIPLE ORGAN FAILURE; SUSPECTED COVID-19; ACUTE KIDNEY INJURY; THROMBOCYTOPENIA; SEVERELY DEHYDRATED; This spontaneous report received from a consumer concerned a 62 year old White, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, non-smoker, and non alcohol user. The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 26-MAY-2021 for prophylactic vaccination. Concomitant medications included etanercept for rheumatoid arthritis.  On 17-JUL-2021, the patient started feeling chills, fever and throwing up. The oximeter showed that his oxygen levels were low. On The patient was admitted to the hospital and on 18-JUL-2021 the patient was diagnosed with covid-19 related pneumonia. On an unspecified date in JUL-2021, it was reported that the patient was severely dehydrated and had an intravenous (IV), had thrombocytopenia and acute kidney injury. The reporter (spouse) stated that the patient was given 4 liters of oxygen but was not getting better, and hence was put on the ventilator. On JUL-2021, the patient experienced suspected covid-19, multiple organ failure. Laboratory data included: covid-19 antigen test (NR: not provided) positive to Covid-19. On an unspecified date, the patient experienced coma. On 25-JUL-2021, the patient died from covid-19 related pneumonia, severe sepsis, acute respiratory syndrome, suspected covid-19, and multiple organ failure. An autopsy was not performed. The duration of hospitalization was unspecified. The death certificate of the patient had severe sepsis, acute respiratory syndrome and covid-19 related pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from coma, thrombocytopenia, acute kidney injury, and severely dehydrated. This report was serious (Death and Hospitalization Caused / Prolonged). This case is associated with a Product Quality Complaint.; Sender's Comments: V0;20210834830; Covid-19 vaccine ad26.cov2. s, Suspected covid-19, Covid-19 related pneumonia, Acute respiratory syndrome, Severe sepsis, Coma, Thrombocytopenia, Multiple organ failure, Acute kidney injury and Severely dehydrated. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: COVID-19 RELATED PNEUMONIA; SEVERE SEPSIS; ACUTE RESPIRATORY SYNDROME; SUSPECTED COVID-19; MULTIPLE ORGAN FAILURE
Rash; Itching; Burning; selling of hands face and feet; High blood pressure; Shortness of breath; Change in voice; selling of hands face and feet; This is a spontaneous report from a contactable other hcp (patient). A 36-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration as dose 1, single on 19Mar2021 (at the age of 36-years-old) for covid-19 immunization at Public Health Clinic facility. Medical history included Hashimoto, asthma, linden factor 5 and patient was allergic to Latex, sulfa drugs, chicken, tree nuts, peanuts, insect bites, pumpkin, sunflower from an unknown date. Concomitant medications within 2 weeks included levothyroxine; colecalciferol (VITAMIN D 3); bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC); ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 19Mar2021, the patient experienced rash, burning, itching, swelling of hands face and feet (Selling of hands face and feet as reported), high blood pressure, shortness of breath and change in voice. The case was assessed as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for events included inhailer, left art shot of Benadryl mdl. Outcome of events was not recovered.   Information about lot/batch number is requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events burning sensation ,hypertension, dyspnoea, dysphonia, pruritus, rash cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Headache, Myalgia, Fever, body aches, chills, h/a, sunj fever Symptoms began 2/3 pm Narrative:
Mild headache; Mild pain in some of the muscles; Mild pain joints of the left hand; This is a spontaneous report from a non-contactable 31-year-old male consumer reported for himself that: A 31-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE;Solution for injection ;Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:45 as SINGLE DOSE for covid-19 immunisation.Medical history included food allergy from an unknown date and unknown if ongoing.The patient's concomitant medications were not reported.The patient previously took bactrim and experienced drug hypersensitivity.The patient experienced mild headache  on , mild pain in some of the muscles mild pain joints of the left hand on 31Jan2021  The events were assessed as serious Non serious by health authority on 31Jan 2021 outcome of events was recovered.   No follow up attempts are possible. No further information is expected.
(L) arm - very minimal erythema an edema, non tender moves arm without pain.
Pt. had swelling - warmth, redness at injection site - upper (R) deltoid area.
6 hrs after shot, went into uncontrollable full body rigid tremors for about  30 minutes.  Only relieved by weight of heavy, confining blankets and a Tylenol.  No chills or fever, just horrific tremors.
Chronic choleycystitis, Cholelithiasis  diagnosed in ER 05/30/2021  Choleycystectomy 07/15/2021  Hospital
At 2 am woke with pounding headache. Advil generic taken by 2:30.  Symptoms worsened until 3:30 to migraine levels.   Nausea and vomiting from 3:30 till 6AM. Headache persists into next day
Patient was administered both the influenza and pneumococcal vaccinations and approximately 5 min later he felt heat rising up his throat (similar to heartburn) and short of breath. He was administered diphenydramine 50 mg IV-push x1 dose, then another 50 mg dose by mouth about 1.5 hours later. No angioedema was noted on exam.
Patient was approached in observation area while slumped in wheelchair and pale in appearance. Medical personnel asked patient's spouse if this was patient's "norm," to which he responded "yes." Pulse was non-palpable and compressions were started. EMS was activated and arrived on scene. Patient was in asystole and was transported to ER via EMS.
Went to ED on 1/11 and diagnosed with Bell's Palsy.  Ordered eye drops and an eye patch to sleep
In the morning of Thursday February 25 at around 6:5 AM, as I was brushing my teeth, the water was leaking out when swishing from side to side. As the day progress, the right side of my mouth was getting number.  The next morning Friday February 26, the right side of my face was numb, my speech was swirl, eating and drinking became  challenging. I went to the emergency rom at Hospital where the team of doctors diagnosed me with Bell's Palsy.  I was given Prednisone and Valtrex for a period of 7 days. Physical therapy as also being advised.  The hospital advise me to follow up with my Primary Care Doctor (schedule for Monday March 1st), and to see a neurologist (waiting for an appt). As of today, the right side of my face has lost mobility.
Red, raised "boil" like, fluid filled at injection sight. Pt going to see doctor. Pt received antibiotics. Infection now improving.
This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 15-month-old male patient who received INFANRIX for prophylaxis. On 12th January 2019, the patient received INFANRIX. In January 2019, less than a week after receiving INFANRIX, the patient experienced injection site swelling, rash, injection site lump and injection site warmth. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved and the outcome of the rash, injection site lump and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site swelling, rash, injection site lump and injection site warmth to be related to INFANRIX. Additional details were reported as follows: The age at vaccination was not reported but it could be 14 or 15 months old. After vaccination, the patient experienced rash covered front of thigh with quarter size knot at injection site, hot to touch and swelling at the injection site. On 16th January 2019, the events were mostly resolved with just a bit of swelling at the injection site. The reporter agreed to be contacted for follow up.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 81 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 15-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 15-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
4 x 6 red, warm swollen area on LD. Symptoms of pt. resolved in 48 hrs.
after 2 days in the evening was hit with a severe stomach pain, after 1 hour started getting heat flashes and chills, lasted untill I woke up on Sunday the next day. Feeling weak, but better so far.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 11-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case: 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004377: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261 US-009507513-1808USA004401: Original Case : 1808USA001261.
Left deltoid 10 cm x 10 cm induration, 7.5 cm x 8 cm erythematous (2-13-06 11 AM). 2-12-06 started feeling itching, this morning notice edema. 2-11-06 felt pain, applied ice pain - ineffective; applied hot patch to area (used 2 patches 20 minutes each)  - mild decrease in pain has used hot patch before on back without problems. 2-15-03 BP 110/66 (takes HTN meds), P 70 reg, T 98.0F (ear). 2-15-06 F/u with DR, improving.
Case number PHEH2014US020963, is an initial spontaneous report received from a pharmacist on 15 OCT 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411201) intramuscular on 14 OCT 2014. She experienced dizziness immediately post vaccination which progressively got worse. She was unable to work on 15 OCT 2014. Pharmacist reported that she had the most severe reactions among reported reactions. Seriousness, causality and outcome of the event were not reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dose unknown). No concomitant medications were reported. The pharmacist reproted that the GARDASIL was exposed to a temperature of 27F for 216 hours. The pharmacist stated that he would call back once he knew for sure if GARDASIL was administered or not. No adverse effect was reported. Additional information has been requested.
Chills, fever, pain in back and both legs, headache, loss of balance, it lasted 24 hrs.
Information has been received from a doctor of pharmacy concerning a female (age not given) who was vaccinated on an unknown date with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 0128-invalid).  Subsequently the patient developed a unilateral pruritis that was determined to be mumps.  The patient sough unspecified medical attention.  No intervention data was provided.  Additional information has been requested.
Atrial Fibrilation - Hospitalized 2 days now on Cartia XR and Eliquis
I got my covid vaccine on sept 28. I already had a mild headache so it was no surprise when it turned into a migraine.  29th migraine (took a maxalt around 12pm) 30th migraine (took a maxalt at 2am)- gone by mid afternoon  October 1st- no headache but tired/ foggy brained (common after long migraine) 2nd- woke up ok! Mid afternoon I got a sharp stabbing pain in the left side of my neck, all the way down my arm and down my back. Lasted the rest of the day, made it hard to sleep 3rd- stiff neck, shoulder, arm, back. No longer stabbing but still really hurt  4th- stiff painful neck and headache on left side of head 5th- headache on left side of head  6th-  headache on left side of head  7th-  headache on left side of head  8th-  headache on left side of head allergy type symptoms  9th-headache on left side of head allergy type symptoms  10th- lots of sinus pressure.  11th- runny nose but no headache 12th- sinus issues are gone. But headache is back. On the RIGHT side of my head.  13th- woke up with a migraine- took a maxalt at 7pm for some relief. Cold sore on bottom lip started this afternoon (noticed it around lunch) 14th- jaw feels stiff. Mild headache. Coldsore 15th - Mild headache and coldsore 16th- FINALLY Woke up feeling Good! For the first time since September 28th.
Red, itchy macular rash developed over torso, bilateral arms and legs the day after vaccine administered. No other symptoms.
heart rate goes up and down; 12 hours after she got it her heart rate ran high for 12 hours straight.; heart rate goes up and down; 12 hours after she got it her heart rate ran high for 12 hours straight.; This is a spontaneous report from a contactable consumer (patient) reported that a 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration on an unspecified date as a single dose (at the age of 49-years-old) for covid-19 immunization. The patient had ongoing covid-19 from Nov2020 and has been having post Covid symptoms. The patient also had ongoing heart issues and heart rate issues right now. The patient's concomitant medication included beta blocker (unspecified). It was reported that the patient was calling about the vaccine. She got the first vaccine almost 3 weeks ago and she was due for her second one tomorrow (23Mar2021). She had Covid 3 months ago (reported as Nov2020) and she has been having post Covid symptoms, she have gotten diagnosed with post Covid symptoms. The patient's heart rate goes up and down anyway when she got the first vaccine, about 12 hours after she got it her heart rate ran high for 12 hours straight, that's was the only thing that have ever done that so she was guessing a very usual effect from the vaccine, so she was concerned about getting the second dose. The patient did not received any treatment for the events. The outcome of the events was unknown.
I had extreme chills beginning at 5:00 pm, then fever and vomiting for six hours the day of the vaccine.  The day following I was tired and had a headache. Now on April 13, I feel better but still tired and my breathing feels heavy but I am giving it some time for improvement.
Very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired) 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 FATIGUE (Very tired). At the time of the report, FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
syncope; This case was reported by a physician via call center representative and described the occurrence of syncope in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABX751AA, expiry date 29th February 2020) for prophylaxis.   On 5th June 2019, the patient received Bexsero. On an unknown date, less than a week after receiving Bexsero, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Bexsero.  The additional details were provided as follows: In June 2019,the patient experienced an episode of syncope. This case is one of 4 cases, reported by same reporter. The vaccination date for Bexsero was discrepantly reported as 23rd June 2019 which was future date and it was updated to 5th June 2019 as per the adverse event description
Client's mother reports that the child had a rash on head, shoulders, torso, arms and legs. Also reports that she got an area on her hear that had yellow drainage and became "crusted". Client's mother reports that the rash lasted for 3 and a half weeks. She reports that she took the child to her doctor and they gave her an antibiotic.
3/26/21- unexplained vaginal bleeding after 1st dose of vaccine. Not related to normal mentration.  4/16/21- unexplained appearances of bruises all over arms and legs  4/10/21- fell off bike and had a large bruise appear on right glute. Doesn't appear to be healing well. Still reddish in the middle and black/blue/purple