chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Start Date/Time: 8-MAR-2021 11:30 AM/15-JAN-2021 02:00 PM; Start Date/Time: 8-MAR-2021 11:30 AM/15-JAN-2021 02:00 PM; Fever; Arm Pain; Body Aches; Left Under Arm Lymph Node Swelling and Pain; Left Under Arm Lymph Node Swelling and Pain; This is a spontaneous report from a non-contactable consumer (patient). This 35-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9264) via an unspecified route of administration on 08Mar2021 at 11:30 (at the age of 35-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient previously received dose 1 of BNT162B2 (lot number EL9263) on 15Jan2021 at 14:00 (at the age of 34-years-old) as a single dose in the left arm for COVID-19 immunization. On 09Mar2021 after dose 2 of BNT162B2, the patient experienced fever, arm pain, body aches, and left underarm lymph node swelling and pain. The events were reported as non-serious. The patient was not hospitalized for the events. The patient was treated for the events with acetaminophen (TYLENOL) from an unspecified date. The outcomes of fever, arm pain, body aches, and left underarm lymph node swelling and pain were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient experienced headache, fever, and a "feeling of being out of sorts" the day after but the reason she came in was because around the injection site was red, swollen, hard, and painful to the touch.
Patient brought to ED by EMS after being found unresponsive. Patient reportedly was eating food, began to have trouble breathign, collapsed, and became unresponsive. Patient received 1 defibrillation prior to arrival for V-fib per EMS. King airway placed with bag-valve-mask and CPR in place upon arrival. Patient intubated upon arrival in ED. Received multiple medications including epinephrine, calcium, sodicum bicarbonate, magnesium, amiodarone. No return of spontaneous circulation Bedside u/s showed no cardiac activity. TIme of death 1712hrs on 9/23/2021. Post-mortem PCR COVID-19 test was postiive.
left arm swelling and redness, stiffness and tenderness at site within 4 hrs 6pm headache began, became severe i was unable to function and went to bed with out being able to rest/relax  Body aches and muscle stiffness throughout body 7/8pm fever of 101.2 around 11pm, with nausea and stomach cramping.   chills and shaking shortly after midnight through my entire body. continued through the night.  woke up this am with continued shaking and chills, pounding headache and redness and inflammation at left arm injection site.  will continue to monitor as symptoms are still present.
WITHIN SECONDS, PATIENT TOLD ME THAT SHE WAS NOT FEELING WELL. SHE COMPLAINED ABOUT A HEAVINESS IN HER CHEST, HER THROAT FELT "FUNNY" AND FELT LIKE IT WAS CLOSING AND SHE WAS TURNING A BRIGHT RED, SPLOTCHY COLOR ON HER FACE AND CHEST. I NOTICED SWELLING AROUND HER MOUTH AND SHE COMPLAINED ABOUT FEELING WORSE. I INJECTED HER WITH 0.3 MG EPINEPHRINE IN HER LEFT THIGH AND SHE IMMEDIATELY FELT BETTER AND REDNESS WENT AWAY AND BREATHING DIFFICULTY RESOLVED.
One day after vaccine got itching in neck and chin followed by red itchy papular (bumpy) rash on L arm (site of vaccine) 3 days later, then same rash on R inner thigh 2 days after that (6 days post vaccine) then L inner thigh one day later (7 days post vaccine). Didn't quite fit the "Covid Arm" reaction, also not sure if true allergy.
No additional AE; a dose of MMR II was inadvertently administered after it's expiration date; This spontaneous report has been received from a nurse concerning a 16-year-old male patient.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 07-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 milliliter (ml), once (lot# T018635, has been verified to be a valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [rHA] [M-M-R II], expiration date reported as 29-MAY-2022) dissolved in a sterile diluent (manufacturer unknown) for prophylaxis (Expired product administered).  The reporter stated that no adverse events were noted.
Very bad allergic reaction with severe red rash all over body and swollen eyes. very itchy and scratching makes the rash worse. He is taking steroids,benadryl, zyrtec, applying TRIAM lotion on the rash to soothe itching.
localized (4 inch) redness, induration & swelling-resolved on its own by the time pt @ MD office;
Dose #1 Pfizer Covid 19 vaccine on 2Feb2021 Dose #2 Pfizer Covid 19 vaccine on 21Mar2021; Sick; Bed achy; Sweaty; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 21Mar2021 (Lot number: ER8727) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: he takes Metformin. States his sugar level goes up and down and he goes every 3-6 months. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing). Vaccination history included: Bnt162b2 (dose 1 single, lot number: EN6203, Anatomical Location: arm), administration date: 02Feb2021, when the patient was 61 years old, for COVID-19 immunization, reaction(s): "he's not positive but not late afternoon", "sore arm". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Mar2021, outcome "unknown", described as "Dose #1 Pfizer Covid 19 vaccine on 2Feb2021 Dose #2 Pfizer Covid 19 vaccine on 21Mar2021"; ILLNESS (non-serious) with onset 21Mar2021, outcome "recovered" (22Mar2021), described as "Sick"; PAIN (non-serious) with onset 21Mar2021, outcome "recovered" (22Mar2021), described as "Bed achy"; HYPERHIDROSIS (non-serious) with onset 21Mar2021, outcome "recovered" (22Mar2021), described as "Sweaty". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: The patient received Pfizer Covid 19 vaccine dose 2, on 21Mar2021 in his arm, does not recall which one, in the morning or early afternoon but not late afternoon. Stated  that was a hour and a half wait, that was a bitch, there was a computer glitch that happened. lot ER8727 Caller does not have NDC or expiry to provide.  Caller stated that, 2nd dose he was sick for about 24 hours in bed achy and sweaty. States his wife said suck it up it's only the vaccine and you will be better, there is nothing wrong with you you'll be ok. States he was better the next day, he was fine running around. No follow-up attempts are possible. No further information is expected.
Urticaria;Pruritis   On approximately 15 June 1998 pt developed intermittent erythematous pruritic hives on extremities,abdomen,chest & thighs, tx w/ prednisone & loratadine, urticaria,pruritis
pt reported macular papular rash started 24hr p/vax;urticaria as well;took DPH w/same relief;rash greatly dec by 6/15/99;rash on trunk & upper extremities;
Pt called and reports 5/28 right arm at injection site redness with swelling. Area the diameteer of a baseball. Also had upset stomach and diarrhea. Called PHN on 5/30 and area still red. Did not come in for PHN to see.
PATIENT REPORTED TINNITUS AND PARTIAL HEARING LOSS OCCURRING APPROXIMATELY ONE HOUR AFTER RECEIVING VACCINES. PATIENT RECEIVED FIRST DOSE ZOSTER (SHINGRIX)  WITHOUT ANY ADVERSE EFFECTS. PATIENT REPORTED "95%" SYMPTOM IMPROVEMENT APPROXIMATELY 6 HOURS LATER.
Covid Clinic scheduled for residents at Home on 10/4/2021. Facility Director of Nursing took Public Health Staff room to room to administer vaccine. Director of Nursing had already completed the needed paper forms prior to clinic. This resident inadvertently received a fourth dose of the pfizer covid 19 vaccine and it was not discovered until entering data into the immunization registry. No adverse effects at this time. Physician notified of the incident.
Pt was vaccinated for influenza on 9/27/2022 and was infected with Influenza A on 12/05/2022 and presented to the office ill with fever and systemic symptoms
No additional AE's; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 17-months-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-MAY-2021, the patient was vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T020652, expiration date: 16-JUN-2022 (formulation, strength, dose, frequency, route of administration were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S035352, expiration date: 05-NOV-2021 (formulation, strength, dose, frequency, route of administration were not reported), both for prophylaxis. On an unknown dates, the doses of the vaccines were exposed to temperature excursion at -14.03 Celsius degrees (C) for 1 hour 15 minutes, at -14.9 C for 9 minutes, at -10.3C for 1 hour and at -6.3C for 2 hours. There were previous temperature excursions at -14.03 for 1 hour 15 minutes and -14,9 C for 9 minutes.. The call was due to digital data logger. No additional adverse event was reported.
About 5 mins after admin, pt felt hot in face and ears. Feet started to feel numb. Resolved in approx. 10-15 mins.
After 48 hours of fever, chills, diarrhea, and heaviness all over, the diarrhea did not stop. And it hasn't stopped since. The second vaccine given on May 3rd, 2021 made it even worse. I couldn't eat. I was having inflammatory responses to everything I ate. I am around 3 months out from the first shot and 2 months out from the second dose, and I'm still experiencing chronic diarrhea and inflammation. I'm having reactions to chemicals and foods I've never had before. I'm experiencing hives and flushing under extreme duress and heat. I can't function at all.
7/2/02 Telephone call.  Pt. c/o that aprox. 1Hour following injection on 7/1/02 that pt noticed knees turning blue and later noticed feet being swollen.  Today,7/02/02, notices that knees and elbows are blue and ankles are swollen.  Pt. c/o of headache at aprox. 3:00pm on 7/01/02 and was relieved after taking Ibuprofen. Encouraged to have pt seen by Dr. asap. The 60 day follow-up states that on 7/26/02 T.C. to father and was informed that they felt like the blue colored appearance of knees and elbows were from the dye of new sheets put on bed. Sitter also had blue coloring on body parts.
High Fever lasting two days, Dizziness, Swollen Lymph Nodes in Neck and lower cheek (Left side, now moving to right), Swollen Lymph Nodes in Back (left and right side, under armpit) back pain, Body aches, Chills, Insomnia, Restless Legs, Fatigue
Patient was very nervous about receiving a shot. After assuring her it was not painful, I administered a TDAP in left arm, After I applied bandage, she slumped in chair and had a mild clonic seizure. She regained consciousness within 1 minute. I telephoned Dr; he said she did not need EMS. She was to double her KEPPRA dose. He also talked to her father.
Dry heaves started about 12 hours after vaccine (approx. 11:15 p.m.) and lasted through the night.  I woke up with a headache on Day 2 which was resolved with Tylenol.  Tired and intermittent mild chills throughout Day 2 only.  Sore arm with redness around injection site that lasted for about 3-4 days.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 14-NOV-2014, the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-NOV-2016 the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Pfizer 4/3/21, 4/24/21, 8/30/21. Positive on 2/7/22
Covid arm, red swelling, itching and warm to the touch. Lasted 3 weeks and also breaking out in a rash mostly on my left side. Site where I had the injection  is dry and there?s a rash. Same rash on my left nipple.
Severe dizzy spell upon getting up from yoga stretches on floor;  Forehead pain above right eyebrow. Sinus Infection diagnosed. Treated Levaquin. Fluvanole Vaccine administered on 11/25/2014 at Dr. Office. Pink swollen welted RASH appeared within 5 hours, with 6 inch diameter. Very itchy.  Reported to school nurse next morning, for ice pack. Raised welt lasted for 5 days.  12/06/2014 cold achy symptoms, with pain radiating to right side of forehead 12/07/2014 Tingling pain on right side of forehead and scalp area only on right side of head.  12/09/2015 SHINGLES DIAGNOSED.
Site of injection swelling to size of egg by morning after (Tues), doubled by Tuesday evening and trippled by Wednesday: Tuesday experienced full body aches and headache. Injection site ached, itched, was red, warm and swollen. Sought medical attention and was given an antibiotic. Called pharmacy 11/7/14.
Overnight right arm began to be sl warm and this AM was swollen, tender and indurated. No particular abnml over actual injection site, but 5x8cm swath along right deltoid is red. Sl tactile temp and sl tired but not toxic appearing, playing with brother and went to school today.
Several hours after "flu" was given, mother noticed facial swelling, eyes nearly swollen shut, fever to 100.5, "rash" flat, speckled and red. No respiratory distress per mom. Mom administered ALLEGRA, BENADRYL swelling persisted. Improving for several days (mom called on 11/2/15).
Complete loss of hearing in left ear upon waking.  Called Dr's office and spoke with triage nurse.  She asked questions and took information and talked to Dr. who requested that we go immediately to the ER as the loss of hearing could be an "embolic stroke".  We went to the ER immediately and in the intake gave the information we gave to the Dr.'s office.  The ER did a blood test, EKG, monitored heart and oxygen, did a CT scan.  After all tests, they concluded that we should see an ENT the next day.  We went to the Clinic the next morning and they performed an urgent audiogram.  The audiogram was compared to one done one year ago and showed that the right ear was the same as previously and the left ear now had no usable function (and a year ago was normal).  A course of Prednisone was prescribed by Dr. and a return visit for a repeat audiogram was scheduled for Oct. 31st and a visit with Dr. on Nov. 1st. Currently, after 5 days of prednisone there has been no improvement in the left ear ability to hear.
This prospective pregnancy case was reported by a pharmacist and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included delivery of a preterm baby, 6 year ago. The subject was not using contraception. On an unspecified date, the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown injection site). Her last menstrual period and estimated date of delivery were not provided. The subject was exposed to the vaccine during unspecified trimester. There was no evidence of a defect from prenatal testing. At the time of reporting, the subject was 33 weeks pregnant. The lot number was reported as AC528107BA from the reporter; however, based on a safety lot number review, the lot number was updated to AC52B107BA. Follow-up information received on 17 June 2014: The subject was vaccinated on 21 March 2014. The subject's last menstrual period was in August 2013 and estimated date of delivery was in May 2014. She was vaccinated when she was 33 weeks pregnant, so she was exposed to the vaccine during third trimester of pregnancy. No adverse event was reported after vaccination. 03 September 2014 - No further information was provided; patient lost to follow-up. Follow-up information received on 10 September 2014 from the pharmacist which received a follow-up form in the mail. The reporter had no further information available to add to the report.
Student received H1N1 FLUMIST on 12/10/09. That evening she broke out in a rash & itching all over her body. Prednisone & BENADRYL prescribed from ER-Hosp. No egg allergy. + Amoxicillin Allergy. No temp no blood work done. Still on BENADRYL.
Immediate edema @ inject site approx 1-1 1/2cm in diameter w/flat erythematous rash fr elbow to deltoid area of rt arm; no resp distress child remained alert & oriented; tx DPH;
Pt recvd 3 doses of Hep B vax & acquired antibodies; 2 months later, pt lost seropositiveness; No further details were provided;
Swelling of entire upper arm and into lower arm. Redness that spread to entire arm and continued to spread for 48 hours reaching a 4"x7" red patch and swelling that encompassed entire limb. After 48 hours the redness began to dissipate as did the swelling.
Patient was given the Fluzone High Dose vaccine instead of the approved Flublok or regular Fluzone quadrivalent. Pt notified. Pt reports he experience no adverse effects from the vaccine administration.
Information has been received from a 68 year old female with high cholesterol and allergy to Demerol and codeine and a history of bypass surgery who on 09-APR-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included TOPROL XL TABLETS, ezetimibe (MSD) and CRESTOR.  It was reported that the patient had 5 breakouts of shingles since vaccination.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Approximately 2 to 3 weeks after the vaccination I started to experience a tingling/numbness in my ring and pinky fingers on my left hand, along with a tenderness and strange feeling in my "funny bone" area of my left elbow.  Pressure on this elbow area would resulting in an uncomfortable (not pain) feeling down through to my two effected fingers.  The tingling in the fingers is mostly in the end of the finger, the last bone sections.  I did not originally suspect that the vaccine could be  linked to the tingling feeling; however, after speaking to a friend 2 months after the vaccine, he informed me that he has very similar tingling in his fingers.  After hearing this, and still experiencing the tingling to this day, I thought it would be a good idea to report the situation.
At 11 AM she was very irritable and wouldn't eat. I rectally took her temperature that was 103. I called her pediatrician, who recommended I alternate MOTRIN and TYLENOL. Her fever didn't really break until today. Today, when she woke up her temperature was 100. She breastfed fine and was just irritable and lethargic. She is getting her energy back because she trying to walk. She hasn't had a high temperature like this with other vaccines.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
Moderna COVID-19 Vaccine EAU 9 days after my vaccine I developed a hive the size of a lemon on my injection site. It was extremely hot, itchy, and burned. Had to go to a walk in clinic to get antihistamines. I was prescribed Hydroxyzine and had to stay home from work due to med causing extreme sleepiness. It has been 24 hours since my first dose of antihistamine and reaction has calmed down a bit
8-19-13 seen in clinic by ARNP. Lump that is read and warm on left inner upper arm (injection site) 2 cm of light erythema, 5 cm of induration. Rx'd cephalexin.
Hives and rash on injection site which spread to entire body. Lips and tongue swelling. Seen at urgent care and received injection of prednisone and follow up prescription
Headache, Myalgia, chills, tenderness at injection site Narrative: NA
Immediate experience of hot flushes and chills with severe nausea.  Chest felt tight, upper stomach in extreme discomfort,  Hard to see, lights hurting eyes, seeing spots in the air.  Sound became amplified and began to experience a migraine.  "People talking low to me felt like they were screaming into my ear drums." Extreme fatigue so could barely keep eyes open.  Standing was difficult; moved to wheelchair. Most symptoms lasted 2 to 3 days.  Fever of 102 on first day only.  Fatigue for one week.  Right upper arm, not at the injection site, had a "hive" about the size of a nickel that has not gone away (as of 2/23/21).   New migraines with light sensitivity that affect ability to work also have not gone away (as of 2/23/21).
Pt received 2 vaccines, ZOSTAVAX and FLUZONE HIGH DOSE. A short time later pt developed symptoms including cough, fever, chills and nausea. Pt reported to emergency room and was admitted to hospital.