chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling, redness and pain in addition to having the arm a little warm.  Patient reports pain. Patient noticed the next day after the vaccine administration. Patient put ice and has taken PANADOL and it has alleviated.
patient stated she would slit her wrist if we weren't able to assist her.; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient stated she would slit her wrist if we were not able to assist her. Patient stated she had COVID-19 shots. The outcome of the event was unknown.   Information about lot and batch number was requested.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Patient's medical history and concurrent condition was not reported. On 10-FEB-2015 the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD 0.5 ml, subcutaneously (lot # K008579, expiry date: 13-DEC-2015). No adverse effects reported. No product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning a 12 month old female with no pertinent medical history and no drug allergies, who on 08-JUN-2010 was vaccinated with a dose of MMR II (lot # 664800/0775Y, SC, 0.5ml). Concomitant therapy included nystatin and lactulose. On 19-JUN-2010 the patient developed rash on her trunk. There were no labs or diagnostic tests performed. The patient received unspecified medical attention. At the time of the reporting, the patient was recovering. Follow up information received from a licensed practical nurse concerning a 12 month old female with no known allergies, and a history of gastrooesophageal reflux, and diaper rash, constipation at time of vaccination, who on 08-JUN-2010 was vaccinated with a first dose of MMR II (lot # 664800/0775Y, SC). Suspect therapy given subcutaneously included a first dose of VARIVAX (lot # 666695/1706Y) on 08-JUN-2010. Concomitant vaccines on 08-JUN-2010 included a fourth dose of PREVNAR 13 (IM, lot # E49135) and the first dose of HAVRIX (IM, lot # AHAVB387BA). Rash was reported on 19-JUN-2010 after MMR II and VARIVAX (MSD) was given on 08-JUN-2010 per the patient's mother. It was reported to office on 22-JUN-2010 rash now was failing. No other signs & symptoms were reported. The patient was seen in ER on 20-JUN-2010 and the ER doctor thought the reaction to MMR vaccine. The patient recovered on 22-JUN-2010. No further information is available.
(Delayed Report) Pt. had fatigue, malaise, nausea, 3 days post vaccination.  Patient had low grade fever (100.4) with arm pain, swelling, malaise, mental "fogginess," 5-10 days post vaccination.  Pt had tender, "golf-ball" sized left axillary adenopathy which gradually decreased to 2 cm, about 2 months post vaccination ( also had posterior cervical adenopathy which also resolved).  Six to 7 months post vaccination, pt had recrudescence of the left axillary adenopathy during a URI, but the adenopathy gradually resolved.  Another recrudescence of the axillary adenopathy occurred about 10 months post vaccination.  Pt became pregnant 11 months post vaccination and after 1 month of pregnancy had recrudescence of left, tender, axillary adenopathy.
The vaccine was administered on Thursday of last week. 2 hours after the vaccine I had severe gas and digestive distress. 5 hours after the vaccine I had fever and chills which persisted until the following morning. Thereafter headache and periods of fever for the following 3 days. Today, Tuesday, 5 days after the vaccine I continue to have headaches and gastronomical distress including gas, diarhea and abdominal distress as well as headache. My wife had the same shot at the same date and time and similar distress.
02/13 apx 4PM: headache bodyaches-tylenol started 2/13 apx 10PM: increased aches, tiredness, soreness and swelling at site 2/14 apx 7AM: fever, chills, teeth chattering, increase body aches and fatigue, more soreness at site 2/15 apx 4PM: no fever, aches and soreness reduced 2/15 apx 8PM: tylenol discontinued; 2/15 apx 10PM: painful dark red rash at site from shoulder to breast, overnight: soreness spreads to underarm and front and back of undearm area. 2/16 apx 6AM: rash is paler and has spread to elbow,pain increasedr under arm and on top of shoulder to shoulder blade, pain in elbow area  2/16 apx 4PM: rash unchanged, pain reduced in rash area, same in shoulder, underarm and elbow area. less painful movement, pa
baby was administered an expired vaccine; Initial information received on 15-May-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff) via phone.  This case involves a 4 months old male patient who was vaccinated with an 0.5 ml second expired dose of  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch number: C5455AA and expiry date: 18-Dec-2018) via intramuscular route on 14-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) on 14-May-2019.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
RED MARKS ON ANKLE, FEET AND CALVES OF LEGS; SWOLLEN WRIST; SWOLLEN  RIGHT FOREARM; SWELLING OF LEFT LEG CALF; PAIN; REACTION ON LEFT LEG WORSENED AND SPREAD TO RIGHT LEG AND INNER THIGHS; This spontaneous report received from a consumer concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, alcohol user (occasionally on weekend), and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage and no complaints of medical issues. The patient was previously treated with fexofenadine hydrochloride for seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swollen wrist. On APR-2021, the subject experienced swollen right forearm. On APR-2021, the subject experienced swelling of left leg calf. On APR-2021, the subject experienced pain. On APR-2021, the subject experienced reaction on left leg worsened and spread to right leg and inner thighs. On 20-APR-2021, the subject experienced red marks on ankle, feet and calves of legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen wrist, swollen right forearm, swelling of left leg calf, and pain on APR-2021, had not recovered from reaction on left leg worsened and spread to right leg and inner thighs, and the outcome of red marks on ankle, feet and calves of legs was not reported. This report was non-serious.
This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. No medical history or concurrent conditions reported. On 13-NOV-2013, the patient was vaccinated with the first dose of GARDASIL, intramuscular injection, dose: 0 .5 ml (Lot number and strength not provided). On 13-DEC-2013, patient was vaccinated with the second dose and on 15-JAN-2014 was vaccinated with the third dose. No adverse effects reported. Additional information has been requested.
Left axillary lymph node swelling  4 days after vaccination. As of 9/03 follow up appointment, swelling had improved (3 weeks after).
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: injection side was warm and erythematous 2 days after injection
Event: heart rate spikes (up to 175 bpm) upon standing, extreme dizziness, chest pain, intense full-body itching, vertigo, difficulty focusing eyes, extraordinary fatigue, muscle twitching / spasms, extreme cognitive issues, "flu-like" muscle and joint pain, fever and low-grade fever (99.5-102 degrees), swelling at injection site. Symptoms diminished after 12 weeks but remain.   Developed an extensive rash under clothing after being outside for 5-10 minutes. Happened every time I went outside. This has not resolved.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 26-Jul-2022).    No concomitant product use was reported. The patient received half dose. The vial had not undergone any temperature excursions. No treatment information was provided.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 14-Aug-2020 and the estimated date of delivery was 21-May-2021. On 06-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 06-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided Estimated date of conception was reported in Aug-2020.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2021: Additional information received as pregnancy form received with pregnancy details.
Full body rash. Numerous red, slightly raised areas. Diameter for 1/8" - 3/4". Majority approx 1/4" - 1/2". No apparent itching. No fever. MD diagnosed condition as hives, allergic reaction to MMR. Condition resolved by 6/18/05 in AM. Tx Benadryl 1/2 teas q 4-6 hrs. Needed only 2x.
Information has been received from a physician concerning an 18 year old female with no relevant medical history or allergies who on 28-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast). There was no concomitant medication. On 29-JUL-2008, also reported as "24 hours after vaccination" the patient developed fatigue and a rash on the palms of the hands and the soles of the feet. On 30-JUL-2008, the patient sought treatment with an urgent care provider rather than the provider who administered the vaccine. The rash was described as "little reddened spots that were almost raised and similar in look to that of a hands foot and mouth disease rash". The rash was painful and did not itch. The physician planed to prescribe unspecified anti-inflammatory pain medication for the symptoms. At the time of reporting, the patient's events persisted. Additional information has been requested.
pt called 3JUL96 had c/o aching in neck, arms, back, generalized & slept excessively for 3-4 days p/vax;6JUL96 c/o jaw aching states poss d/t 4 days singing engagement;no tx;pt denies any diff @ present;
Brachial Neuritis (self-diagnosis). Both arms and both wrists sore. Was unable to lift arms above head. Appeared within about 1 week. Mostly cleared up in next 2 weeks. Pain persists in left wrist for 2+ years, but could be due to pre-existing Reactive Arthritis
Patient reported a very sore arm and redness that extended from the vaccine administration site half way down his upper arm.
I had pain the next day. It was about 5 or 6 inches of intense pain on my left arm between my elbow and mid arm. It wasn't stabbing or intermittent pain. It was just a burning pain. It hurt for clothes to touch it. March 22nd I went to a chiropractor and he adjusted it. That didn't help the pain at all. I then had 5 blisters that popped up. Tuesday March 30th I went in and saw a doctor. She told me it was shingles but it was too late for me to get the vaccine. I had the pain first and the then blisters came second. The blisters disappeared within 2 months in April. I didn't have other issues after that. On July 18th I was in my office and then all of a sudden my right leg below the knee had an electrical stabbing pain. My leg was jumping, and I was screaming. I looked and saw 2 inches of a varicose vein that popped out under my right knee. I could see my muscles jumping. It went on for about 10 or 15 minutes. The next day I had a second different vein pop out within a couple of inches away from the first one. It was just a little stabbing and achy pain. It was not as strong as the first one. I went to chiropractor on July 22nd. On July 23rd I saw doctor. He said he didn't think it was a problem. August 6th I went to see Dr. and she examined my leg. She said she think I have internal varicose veins. She said I should see a vascular doctor. September 7th I seen vascular surgeon and he said he never heard of internal varicose veins. He said I didn't have any symptoms of a person who has it. As a couple of weeks went by, I had pains in my legs still. They scheduled for an ultrasound on October 12. Nobody has never had signs of varicose veins ever in my family. I'm still having numbness and occasional tingling, but I don't know if it's from that or from my sciatic problem.
30AUG93 fever noted 31AUG93 fever now accompanied by rash; 2SEP93 pt seen in the office w/fever & rash; t104.6 R, skin multiple blanching wheals;
ACUTE DVT OF RIGHT ILIAC VEIN 2/1/2022 WEAKNESS  ACUTE DVT OF RIGHT ILIAC VEIN 2/1/2022 ANEMIA OF CHRONIC DISEASE  ACUTE DVT OF RIGHT ILIAC VEIN 2/1/2022 ANEMIA
Received shot in Dec 6th. On December 8th when I woke up, extreme pain in neck into shoulder arm and forearm with numbness in thumb. Also scapula was winged. Symptoms have persisted ever since.  Sometimes debilitating upon waking each day since. Weakness and loss of control in right arm where shot was administered.
I started feeling really sleepy and tired and the person who was with me stated that I began speaking more quietly and thought I seemed dazed. The next thing I remember is people standing over me and they called for an ambulance. I later was informed that I experienced a seizure. Even though I felt alright and didn't want to go the hospital, I was told that I had to due to a facial droop which I normally experience with migraines.
booster dose; Arm where the shot was, is warm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1/had her 2 Pfizer shots and that was over 6 months ago), for Covid-19 immunization; Bnt162b2 (Dose 2/had her 2 Pfizer shots and that was over 6 months ago), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "booster dose"; VACCINATION SITE WARMTH (non-serious) with onset 18Nov2021, outcome "unknown", described as "Arm where the shot was, is warm".  Additional information: clinical course: It was reported that patient got her booster shot, well she has had her 2 Pfizer shots and that was over 6 months ago and on Thursday she got her booster shot of Pfizer, her arm where the shot was, is warm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mom unable to control fever w/APAP; pt had febrile seizure 6PM 21APR91; Seen in ER by MD admitted to Hosp for observation until 27APR91;
Rapid heart rate of 160, blood pressure of 160/100, dizzy, faint, lightheaded, shortness of breath, tingling in fingers
VERY CHILLS; FEVER; This spontaneous report received from a patient concerned a 28 year old female. 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: 1808982, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced very chills. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and very chills was not reported. This report was non-serious.
red spots on feet that kept getting worse and traveled up lower extremities. He went to dermatology at UH and had biopsy completed which is being further evaluated with lab testing.  Final diagnosis biopsy results: interface dermatitis with a lymphocytic infiltrate and erythrocyte extravasation. These findings could be seen in pigmented purpuric dermatosis, a drug eruption,, viral exanthem or connective tissue disease such as a cute cutaneous  Lupus erythematosus, subacute cutaneous lupus erythematosus and dermatomyositis.
Abnormal signal in Left temporal Lobe, Medial Temporal Lobe,  Subarachnoid Hemmorrage, Parenchmyal inflammation, Encephilitis FROM MRI 2/19/2021 H pylori infection carried in my body for three months from this hospital stay and overload of antibotics due to ignored possibility it could be an allergic reaction 04/20/2021 MRI BRAIN showed death had grown in my brain in my temporal lobes,Insular Cortex 06/01/2021 MRI BRAIN Showed change  07/16/2021 MRI BRAIN remained unchanged for the first time in 5 months
Shortly after the vaccine, I noticed a high pitched tone (sometimes described as ringing) in my head.  It seems in my head as it is non-directional and neither ear seems louder.  Plugging my ears does not change it.
chickenpox rash approx 40 pox chest, neck, ears, face, arms;
Approximately 8 hr after the second dose of vaccine, I started to have fever to 38.6 with chills, headache, fatigue and sweat. it lasted approximately 24 hours.
Pt recvd 3 doses of Engerix-B & determined to be a non-responder; given 1 booster dose;
Chicken Pox after 2nd Shingles Vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had as a child).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-JUL-2022 Reporter's Comments: This case reported by the patient via interactive digital media. The patient broke out with Chicken Pox after 2nd Shingles Vaccination.  The patient stated that what a ride down memory lane. Additional Supportive Information: Follow-up would not be possible as no contact details available.
Three hours after immunizations patient developed severe headache.  At bedtime patient's mouth was distorted to right and was numb and tingling.  Mouth continued to be drawn to the right through the weekend.  Went to clinic and was diagnosed with Bell's Palsy and treated with methylprednisolone dose pack.  Patient seen at health department on 6/9/09 and reported that the right side of his face still "felt a little weird".  No facial drooping, numbness noted at this time. Patient demonstrated normal facial movements.  Phone call to patient's mother on 6/17/09--mother reports full recovery of her son. Completed steroid dose pack. No complaints of pain, numbness, tingling.
painful  visibly puffy knees unable to crousch (resolved fully after 4 mos) pain in right shoulder when lifting above shoulder height frequent persistent excessive sweating in addition to typicel: pain at injection site, feverish, aches, fatigue, tingling in left head & head, nausea, bain fog (resolved within 72 hours)
About 15-20 minutes after receiving the vaccine, patient experienced burning and tingling on his tongue and hands. Patient took 2 Benadryl 25mg capsules and was monitored for 15 minutes. Stated he was feeling much better and it was going home. I followed up with him this evening at 8pm and he was stating he felt fine now and just drowsy from Benadryl.
Pt told mom she felt dizzy. On approach pale, dizzy, and nauseous. Escorted by wheelchair to bay #2. Assisted to lay on cot; ice pack to back of neck, legs elevated. mom with patient. Ate prior to vaccination.
Chills began at 11PM Eastern on May 6, 2021 followed by fever (100.4), muscle aches, and a throbbing headache. Taking Tylenol for the fever. Took 2 Excedrin Xtra Strength this morning at 9:15 AM Eastern for the headache. Okayed  by nurse to take both as long as the dose of acetaminophen doesn't exceed 4000 MG in 24 hours. The nurse said these symptoms should resolve themselves within 24-48 hours of getting the vaccine.
about 16 hrs after vaccine was given, pt began having dizziness, fatigue, moderate to severe frontal headache and fever to 101.6F.