chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received IM Pfizer dose in Left arm at 4:10pm and moved to the waiting area.  About 5-10 min later she had developed a red, slightly raised blotch area around the injection site and down her left arm.  She said it did not itch, but felt warm and slight burning feeling.  Patient complained of being hot and nervous, but breathing was normal no chest tightness.  We had her get up and go outside (with 2 nursing staff members) to see if fresh air and no mask would help calm her.  On coming back in, the rash was still present and a small patch developed on her other arm.  WE gave her a cold compress and measured out 75mg of liquid diphenhydramine.  She took the diphenhydramine.  After about 5min, we saw the rash spread to her chest and connect the upper right and upper left arm area rashes.  We then called EMS to come assess the patient.  After assessment by the EMT and speaking with her PCP the patient decided not to go to the hospital for observation.  Rash was still present 1 hour later when patient left.  Breathing remained normal throughout the entire event and no swelling of face/tongue.
The patient works here in our store.  I administered both vaccines and the patient reported no issues at that time.  About 15 minutes later she came back over and reported terrible pain in the center of her back that radiated from her shoulder-blade area to the lower back.  I asked her if she was short of breath, if she felt her throat closing, was itchy, etc. and she reported no to all of those symptoms that would indicate anaphylaxis.  I had her sit down and took her blood pressure which was 141/81 and her HR was 78.  As she sat the pain subsided little by little and then she described it as feeling 'bruised.'  She described the pain as muscular not nerve-related. About another 15 minutes went by after sitting and she reported the pain was gone but just felt shaken up.  Later in the day she stopped by the pharmacy and only felt slight discomfort under her left shoulder blade.
Mom comes over in immense pain. Looks pale and states this is the worst pain she has ever felt.
Vomiting; Difficulty breathing; Diarrhea; Sore arm/Soreness of the arm and severe fatigues; Muscle aches and pain; GI upset; Nausea; Extreme tiredness; Aches; Fatigue; The initial case was missing the following minimum criteria: Unspecified adverse event. Upon receipt of follow-up information on 25Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 20Jan2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, in Jan2021, the patient experienced the following severe reactions: 14 hours after the 1st dose: vomiting, difficulty breathing, diarrhea, sore arm, muscle aches and pain, and GI upset. On 2nd day: nausea, extreme tiredness, and aches. On 3rd day: soreness of the arm and severe fatigues. On 5th day: moderate fatigue. Clinical outcome of the events was unknown at time of this report.  The information on the lot number has been requested.
Mom state son c/o of RA itching. Redness & rash noted to right arm and c/o of headache 01/06/2020. Benadryl po given, anti-itch cream applied. Requested mom to apply ice pack to area.
41-year-old male developed midsternal pressure clinching CP with point tenderness, and bilateral extremity edema (most pronounced on the injection arm side), with 4 hours onset, after receipt of Pfizer COVID-19 vaccine #1.
she received her COVID Booster; Fatigue; Chills; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose number Unknown), for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "she received her COVID Booster"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse, referring to a 15 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-MAR-2017 at a physician practice office, the patient was vaccinated with a dose of VARIVAX lot number reported as "M036293 with an expiration date on 17-AUG-2018 (strength, dose, administration route and anatomical location were not reported) for prophylaxis; and on the same date, the patient was also vaccinated with a dose of PROQUAD lot number M007963, with an expiration date on 05-AUG-2017 (strength, dose, administration route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected because there was no consent to contact for follow-up.
It was just a feeling of my arm from my elbow down to my wrist feeling constriction and spontaneously and I think it was right arm that did that but I don't know if it was in my left arm if I got the shot, it felt like pain and there was bruising and I went on line to see what happened because I thought it was a blood clot and I was getting migraines everyday for a month and for weeks I was having more headaches about everyday and it is possible some of the medication was causing it.
Patient states on last 2 anthrax shots muscular pain spread to back and neck and entire arm on that side. Previously, soreness had been limited to the upper arm where the vaccine had been administered (4 shots previous). This lasted for approximately 24 hours.
Diffuse, pruritic, erythematous, blanchable, macular rash. Sparing mucous membranes, palms and soles. +fevers (Tmax-101.4)
Within 24 hours of receiving the vaccine, fever and respiratory distress, and anxiety developed requiring oxygen, morphine and ativan. My Mom passed away on the evening of 12/26/2020.
Information has been received from the registered nurse on 02-JAN-2014. It was reproted that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 08-OCT-2013 (lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Medical assistant called RN's extension and asked for RN to open the vaccine fridge for two vaccines: MMR and Hepatitis B, she repeated this twice before hanging up the phone. RN went to the second floor and took out Hepatitis B and accidentally removed Varicella vial. Both were brought to MA who checked and verified both vaccines and expiration date. RN went back upstairs, MA called RN and stated she asked for MMR not Varicella and she already administered both vaccines to the patient. Patient's doctor Dr. made aware, RN went back downstairs and pulled MMR vial and verified the vaccine with MD and MA. MA informed patient that the doctor ordered another vaccine and administered it to patient's right arm. RN also wrote down all vaccines patient has received on an immunization card and gave it to the patient. Nurse manager made aware and an incident report was filed the same day.
Pt has pain in left arm and shoulder. Feels like arm is coming out of socket. Pt been taking Naprosyn OTC since 10-15-14. We call Dr to see if the dr. would prescribe a stronger NSAID for him. The Dr. said the pt. would need to be seen. .... on 11-11-14 the pt's representative (spouse (female voice) called and said patient never made it in for the MRI. She was following up on the NSAID. I called and left a message on their answering service on 11-5-14 about what the Dr. said.... needed to be seen. When I spoke with the pt. on 11-3-14. He said that because he was a tall person, so he hunched over to try to make it easier for me to give him the vaccine.
Patient called today to report swelling, redress and warmth at site of PNEUMOVAX, accompanied with a low grade fever. She took ibuprofen and then BENADRYL on recommendation. The patient after a few hours of initial phone call, reported that the reaction has not gotten worse and will continue to take BENADRYL until can speak to doctor.
Breakthrough bleeding with severe clotting and cramping. Went to ER and followed up with doctor. Undergoing increased birth control dosage to try and stop excess bleeding. Follow up appts every 4 weeks.
extreme headache/migraine next day/severe headache/migraine; foggy head; dizziness; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7534 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 01Apr2021 at 10:45 AM, as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history was reported as none. The patient did not have any known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 03Apr2021 at 06:00 AM, the patient experienced extreme headache/migraine next day, laster 2 days, ibuprofen did not help went to ER on day 3, got IV with migraine cocktail: Toradol, Reglan and Benadryl help with the severe headache/migraine 6 days after the dose of Pfizer vaccine, dizziness and foggy head (3 days already) on an unspecified date in Apr2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was recovered with sequel on an unspecified date in Apr2021.
Stroke; A spontaneous report was received on 09 FEB 2021 from a consumer concerning an 81-year-old, male patient who received Moderna's COVID-19 vaccine and experienced stroke.  The patient's medical history provided were, Alzheimer and Parkinson's disease. No relevant concomitant medications were reported. On 28 JAN 2021, patient received their first of two planned doses of mRNA-1273(Batch number 027L20A) injection for the prophylaxis of COVID-19 infection.  On 03 FEB 2021, within 7 days of receiving vaccine, patient experienced a stroke. On 03 FEB 2021, patient was admitted to hospital. Patient was due for his second shot of Moderna's COVID-19 vaccine on 26 Feb 2021. Patient's hospital can only provide Pfizer's vaccine and not Moderna's COVID-19 vaccine. But patient wanted to get Moderna's COVID-19 vaccine. Patient's wife wanted to know the way she could arrange the administration of the Moderna's COVID-19 vaccine in the hospital for her husband. Treatment for the event was not provided.   Action taken the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, stroke, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, patient's elderly age is considered a risk factor.
Symptoms for 4 days...Pt reported rashes that would come and go every 5 to 10 minutes, itching on hands and feet, itching/burning inside lungs, and swelling of jaw.
Broke out in rash on back, arms, & chest. Given one dose of BENADRYL & rash cleared up.
This spontaneous report was received from a physician concerning a 15 year old female patient. The patient's pertinent medical history, drug reactions/allergies were unknown. On an unknown dates, the patient received first, second, and third doses of RECOMBIVAX HB (also reported as manufacturer unknown) (dose, route, lot number and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. On an unknown date, it was reported that the patient had negative titers (titers lab test performed on an unspecified date). At the time of the report, the patient's outcome and relatedness between the event and suspect drug were not provided.  Additional information is not expected.
pt recv vax & approx 3-4hr p/vax then became limp & cyanotic;no apnea or convuls noted as described by mom;episode lasted only a few min;EMS arrived on scene shortly p/incident & taken to ER;
Body shivers chills, head ache,  dizziness, loss apatite.  Self medication and home rest at this time.
A spontaneous report has been received from a pharmacist concerning a 38 year old, female patient. No information regarding relevant medical history, concomitant disease or concomitant medication was provided. The patient was receiving Nasal FLUMIST (Intranasal) started on 10-Oct-2014. The reporter administered almost the full dose of FLUMIST into one nostril of the patient which started on 10-Oct-2014. The outcome of the event of patient received FLUMIST full dose in one nostril was unknown. The reporter considered the event patient received FLUMIST full dose in one nostril as non-serious.
On August 26th developed acute excruciating pain starting initially in left elbow which over 24 hours radiated up into axilla, left infrascapular area and down into hand with paresthesia and decrease motor function of 4th and 5th fingers.  Initially received methylprednisolone 24mg daily and 14 days with NSAIA with no improvement.  Saw Rheumatologist, Hand/Arm orthopod and eventually neurologist.   Diagnnosis of Parsanage-Turner Syndrome occurred and presently on course of high dose IV steroids 1 gram followed by 250mg Iv daily for 3 days along with intravenous immunoglobulins IV for 3 days 2mg/kg.
pt had (2) grand mal sz-1st sz 5-10mins p/vax; 2nd sz @ 7PM;
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 15:30 (Lot number: EN6205) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy issue" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity; FLONASE [FLUTICASONE PROPIONATE]; CHLOR-TRIMETON taken for hypersensitivity. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional information: The patient did not have any family medical history relevant to adverse event and did not additional vaccines on same date of the pfizer suspect. Patient was not having any prior vaccinations within 4 weeks. Clinical course: it was reported that with the first dose of the vaccine patient did not have any issues really and expected to have the sore arm. The patient received second dose of the Pfizer Vaccine on 30Mar2021 with lot ER8727, she had a lot of congestion, drainage and was coughing. Patient had contacted her HCP yesterday because she deals with a lot of allergies and kind of when she gets symptoms like this she sometimes gets what they call an allergy booster shot; states she has no name of the allergy booster shot, lot number or expiry date to provide and states she hasn't had an allergy booster shot in quite a while since Aug or Sept2020 and was trying to remember when her last one was and it was in 2020 when she had the last real big flare of allergies; her boss thought maybe her flare of allergies at that time was covid so she had to go test at that time and the covid test came back negative.  No follow-up attempts are possible. No further information is expected.
COVID Breakthrough Case  Pfizer Dose 1 1/12/21 Lot:unknown Pfizer Dose 2 2/2/21 Lot:unknown  CV+ 9/11/21  9/11/21 96-year-old male patient with  history of complete heart block and sick sinus syndrome status post permanent pacemaker, coronary artery disease status post PCIs, hypertension, atrial fibrillation and DVT anticoagulated on warfarin and  past history of traumatic subdural hematoma brought in due to hypoxia and shortness of breath.  Patient is currently is sleepy and unable to provide history, history is obtained from chart review.  Patient  recently diagnosed with COVID-19 ,found to have worsening shortness of breath with hypoxia in the 70s to 80s, EMS placed him on nasal cannula oxygen with improvement of his oxygen saturation.  At the time of my evaluation patient was 97% on 5 L of oxygen a febrile with stable vital signs otherwise.  ProBNP was elevated at 2035, troponin 0.05 repeat was 0.02, pH 7.41 with hypoxemia of 82. D-dimer was elevated at 1.09 with a CRP 0.7.  Chest CT showed no pulmonary embolism noted scattered bilateral atelectasis.  Head CT unremarkable for acute abnormalities. Patient received IV Decadron, ceftriaxone azithromycin and DuoNeb in the emergency room.
Hives, dizziness, itch, weakness. Went to ER. Received prednisone 60mg.
I woke up from a nap on 2/10/22 with sudden onset binocular horizontal diplopia accompanied by headache. On 2/12/2022 pain in RIGHT eye with left upward gaze, left side gaze, and left downward gaze began. Eye pain located specifically at left side of right eye only. I assumed everything would disappear as they had appeared, so waited a few days. When waking Monday morning, I called my PCP who advised me to go immediately to the ER. I instead contacted an Ophthalmologist who was able to see me ASAP. After through exam, they sent me directly to ER for MRI and blood work. Following the hospital, I have been followed by Ophthalmologist, and then consequently referred and treated by a Neuro-Ophthalmologist. I was treated with a 15 day round of corticosteroids, which was extended by 10 days, for a total of 25 days. There was improvement while on high dose of steroids (40mg daily), yet when tapering, all symptoms returned. When completely off medication, all symptoms fully returned. I was diagnosed last week with a rare autoimmune: Idiopathic Orbital (Ocular) Myositis and have been told to see a Rheumatologist for steroid sparing treatment.
patient received the flublok vaccine by accident, he only wanted a covid vaccine and his partner wanted the flu shot. He was informed multiple times that he was getting the flu shot but did object until after it was already given. There was a miscommunication.
I received the 2nd dose of the vaccine at 5pm on 4/26 and around 10:30pm on 4/26 I lost my sense of smell
Cellulitis or Arthus reaction from Tdap vaccine--Patient reported her arm was fine on 6/28 and 6/29/17, however after that date she began experiencing increased swelling, burning, bruising and flu-like symptoms. Pt. sought care through Hospital ER on 7/2/17 where she stated the ER doctor informed her the site was not cleaned properly at the time of vaccination. She stated she was taking ibuprofen every 8 hours after receiving vaccination and was prescribed Ibuprofen 600 mg every 6 hours time 3 days and Clindamycin 300 mg, 1 capsule by mouth every 6 hours x 10 days. Also stated she used cold and warm compresses, in which the cold compress helped to relieve the itching and burning.
congested, coughing; wheezing a little; Warmness; A wet forehead; achy all over; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 85-years-old female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st DOSE SINGLE DOSE for covid-19 immunization. Patient medical history included asthma from an unknown date and unknown if ongoing, pneumonia from an unknown date and unknown if ongoing, cough from an unknown date and unknown if ongoing , nasopharyngitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced congested, coughing wheezing, warmness, a wet forehead, achy all over on 08Mar2021 with outcome of unknown.  No follow-up attempts are possible. No further information is expected.
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt passed out several minutes after recieving vaccine. BP was measured at 144/82 and the patients father stated she had passed out in the past when giving blood or seeing needles after a vaccine. no allergic response or history of allergy reported prior to administration outside of mild shellfish allergy. pt was monitored for 30 minutes before being allowed to leave with her father
Bleeding of eyes; Bruising of leg; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient daughter) reported that a 81-year-old (same age at vaccination) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on Feb2021 as single dose for COVID-19 immunization. Caller stated that her mother received the first Pfizer covid vaccine in February and had large bruising that showed up on one leg, then she received the second dose and large bruising showed up on her other leg. while her mother was at her eye appointment, she started bleeding from her eye. Caller stated her mother was now being seen by a haematologist for a bleeding disorder. Caller stated her mother was very active and doesn't take medication for anything, no blood thinners, no heart medications. Outcome of both the events was unknown.  Information on the lot/batch number has been requested.
IPOL given to 1 yr old at well child visit inadvertantly (instead of Prevnar)  Follow-up - None! No adverse events occurred!
Soreness in left arm around injection area the following morning (3/30).    No treatment.   Soreness mostly gone by the next morning (3/31).
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Lot #, expire date and route not reported) (Merck). Physician stated that on an unspecified date, the patient experienced a severe case of shingles. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Information has been received from a physician concerning his sister who on an unspecified date was vaccinated with Gardasil (Lot # not provided).  Subsequently, she developed a rash that was itchy and swelling.  Unspecified medical attention was sought.  At the time of this report it was unknown if she had recovered from the event.  Additional information has been requested.
Injection site swelling, itching. Swelling starts in tricep area at injection site and spreads toward deltoid and elbow. Some discoloration (pink/red). Chlorpheniramine 4mg every 4 to 6 hours started. Patient returned 9/19/14 and swelling had increased. Patient noted warmth. States that adult varicella vaccine resulted in similar reaction. At this time a change to diphenhydramine was recommended. Also advised a visit to the prescribing provider to recommend any additional treatment.