chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I recieved the first dose of Moderna vaccine on 1/5/21 and did not experience any adverse reactions in the days following. Then, on 1/13/21 (8 days post vaccine) I noticed hives covering most of my body. My face was tingling and my lips were swollen. I took an antihistamine that evening hoping it would go away. The day after 1/14/21 I woke up with the hives all over my body, especially on my face. They were very severe and itchy. I went to my dermatologist and they recommended a steroid cream and oral antihistamine to help reduce the itching. It is now 1/15/20, and the hives are still covering most of my body with severe hives on my face.
Td given right arm IM.  Patient was anxious about receiving injection, appeared to tolerate well after injection given.  When patient stood up to leave he stepped into hallway and apparently fainted.  Patient was lying prone on the floor bleeding from the nose.  Patient was unconscious for approx. 15-20 seconds.  Once patient was awake, assisted to chair and applied pressure to nose x 10 minutes.  V/S stable.  Patient transported to local ER by private car.
Headache around 3PM, took Excedrin Chills, stomach upset, headache, could not sleep 10:30PM. Took Excedrin and pantropozle, extra blankets and warmer pajamas
28 y/o M presents to VHC (walk-in) at 10 AM on 28JUN12. States he went to Clinic and they told him to come to VHC for eval of primary SPV site LUE. Patient receive primary SPV on 18JUN12, in addition to AVA#1 and Typhoid Vi. He also received Hep A #2 or # 3- documentation in record not clear on 23APR12. Denies viral or GI illness in weeks prior to receipt of above vaccines. Today is day # 10 s/p primary SPV, so he is typically in window for maximum cytokine activity of SPV (live virus). He reports that last evening he began to feel "flu-like" symptoms and took some Equate generic Flu Relief medication and an ALEVE this morning. He denies any CP, deep pressure in center of chest, but does endorse slight SOB (non-positional) last night. Actually felt better when he was in supine position. He endorses redness, warmth and a red streak going from deltoid toward left axilla (lymphangitis). He has also felt some tenderness in his left axilla. "Robust take" day #10 s/p SPV normal variant.
Per Hx and reviewed from ER records. Pt had fever and per gma she was told she had seizure rolling up her eyes, foaming of the mouth 24 hrs after shots per ER records immunization was not mentioned.
I had a severe cough and I was prescribed PAXLOVID because the doctors were concerned about my Asthma. I had to stop all other medications for 5 days until I completed the COVID medication.
P/2nd vax series of 3 HIB, mom noticed unusual head movements; Following 3rd dose HIB vax mom described movements as twitching & naughty movements; mom says pt is w/in normal limits; 2 mos later mom says unusual behavior is due to HIB vax;
Sweating; Dopey; Bogged down; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), SEDATION (Dopey), FEELING ABNORMAL (Bogged down) and CHILLS (Chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029LZOA) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma. Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced HYPERHIDROSIS (Sweating), SEDATION (Dopey) and FEELING ABNORMAL (Bogged down). At the time of the report, HYPERHIDROSIS (Sweating), SEDATION (Dopey), FEELING ABNORMAL (Bogged down) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication includes Cellselfazine 500 mg and 2 Drops for Glaucoma.  No treatment information was reported.   This case was linked to MOD-2021-254161 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: The significant follow up received in which Medical History is added. Concomitant drugs were added. Events were added.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23  (strength: 0.5ml, lot # k004281, expire date 22-MAR-2015; dose and route unknown). The total cumulative time was 1128 hours with the lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 01-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
By 5pm on 3/1/2021, a hard bump near injection site. Very itchy rash approximately 5" in diameter. Swelling on top side of arm. 3/2/2021 Swelling on underside of arm. Rash extended to underside of arm. All areas very tender and extremely itchy! Very tired. 3/5/2021 Chills and fever of 100.5. Still very tired and rash has not gone away. 3/6/2021 Rash beginning to diminish. Still itchy. Still tired.
"Did not go to the Dr."; swelling of the cheek and neck glands; strawberry, rash-like areas that were itchy over chest, arms, stomach and behind her ears(pt. kept calling the areas hives, though having 0 open areas); fever, body aches and pains; site reaction stated of the size of an orange, red, hot, slightly raised; missed work 11/12/08 due to c/o reaction; felt body aches for up to 1 week; no treatment was sought by pt.; nurse reviewed VIS information with pt. again;
Chills, fever, muscle aches, headache, very sore, red, swollen  arm at injection site, queasy stomach, swollen lymph nodes left armpit. Four days and counting. Symptoms slowly getting resolved.
Client reported to both nurses hx of multiple episodes of syncope with needles. Client was hydrated and offered to lay down prior to administration of vaccine severally. Client refused offer to lay down post vaccination prior to vaccine administration. Client experienced syncopal episode immediately after administration of vaccine. Client was eased to ground by staff. Legs were elevated on chair. Client displayed seizure like movements lasting 30 secs. Tonic-clonic, jerky movements observed. Eye rolled to back of head observed. LOC checked and client was AOx3. VS#1 BP: 122/82,O2: 100%; P: 84. VS#2 BP: 129/78, P: 94, O2: 100%. EKG: Sinus Tach, no blocks.
Patient began noticing increasing numbness in both lower extremities and was in the process of seeing a surgeon for lumbar spinal stenosis. She already had known DM neuropathy.  She received first covid vaccine on 3/4.  Lot # EN6199.  She received second vaccine 3/25 Lot # ER8732.  She reported five days later having bilateral leg spasms.  She presented to the ER with inability to walk or move her legs and numbness from her belly button down on 4/27/2021. Thoracic MRI shows demyelinating lesion at T1-T4.  Also noted to have epidural lipomatosis at T5-6 with mild to moderate spinal cord compression. Diagnosed with transverse myelitis. LP completed, Brain MRI and cervical mri completed.  No evidence of MS, no infectious or neoplastic process evident as a cause thus far. Anti mog and NMO negative.  It's not certain if the demyelinating lesion occurred because of the vaccine, but thus far, no other cause has been found.  Treated with 5 day course of IV steroids.   She remains unable to walk.
Tested positive for COVID.  subjective fever, muscle aches, runny nose, sore throat, loss of taste and smell, headache, fatigue, cough, wheezing, shortness of breath, chest pain, abdominal pain, diarrhea
Left arm/ left side and neck on left side all numb/ pins and needles. Switched snd got the shot in the RIGHT arm for the second shot but still had all numbness on the left side, neck, under left arm, numb hand ect.
Starting a week and a half after the injection, I started having pain in my shoulder, which would periodically migrate down into my left arm or up to my head.  When the pain progresses to my head it shows up as a sharp, intense stabbing pain that diminishes quickly, but then it followed up by another occurrence a few minutes later.  I have been treating the pain using OTC medications (naproxen and acetaminophen).  Also two weeks after the injection (11/09/2021), I started noticing the formation of a series of blotchy rashes appearing on my left arm.  On 11/11/2021, I visited the urgent care facility for my primary care provider and the attending physician diagnosed me with an outbreak of shingles, at which time I was prescribed a course of antivirals.  For the next two days, new rashes continued to appear, although starting today (11/14,2021) it appears that no new shingles rashes are forming.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Adverse reaction is still ongoing. Pt came to rx today concerned with reaction which started 2 days after vaccination. Arm is warm and red with some bruising. Adviced patient to apply cool compresses and monitor for next few days to see if there is an improvement.
injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site pain). On 19-Mar-2021, VACCINATION SITE PAIN (injection site pain) had resolved. Not Provided          No relevant concomitant medication was reported . Patient was wondering that whether should take Tylenol or any over the counter pain medication that would help relieve her symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2021-077831 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077831:Second dose
Rash appeared on both arms, vaccinated Left arm on deltoid muscle. Rash progressed to neck. No anaphylactic reaction. No known allergies.
COVID vaccine breakthrough case  dose 1 3/2/21  Moderna  025A21A dose 2 3/30/21  Moderna  028A21A dose 3 11/4/21  Moderna 939904
patient received vaccine on dec 18th.  on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics.  Pain radiated through her upper body and at times was shooting.  she was unable to perform ADLs.  She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes.  Covid test was negative, CRP was 3.6 and sed rate was 25.  all other labsl WNL,   symptoms resolved after 5 days
This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lip swollen), PRURITUS (Entire body was itchy), MASS (Lump size of an orange between legs, one on each) and URTICARIA (Hives all over the body) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025J20-2A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced LIP SWELLING (Lip swollen), PRURITUS (Entire body was itchy), MASS (Lump size of an orange between legs, one on each) and URTICARIA (Hives all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1-2 times, qd. At the time of the report, LIP SWELLING (Lip swollen), PRURITUS (Entire body was itchy), MASS (Lump size of an orange between legs, one on each) and URTICARIA (Hives all over the body) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood pressure measurement: 164/104 (Inconclusive) BP 164/104. Treatment include steroids, antihistamines. Concomitant medication information not provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-044626.
Shot in right arm 48/hrs lost all feeling in left arm. Jaw ache- neck pain- back pain- then to both legs and feet - Put on steroids to control swelling after 14 days - no feeling in hand, sore jaw;
An 18 year old female patient with no significant medical history and no current illnesses had received her first intramuscular injection of Menactra; lot number U1892AA, in the left deltoid on 27 June 2006. Within 24 hours, post-immunization, the patient complained of not feeling well (non-specific symptoms). Two days later, on 29 June 2006, she returned to the physician's office with a complaint of body aches, joint pains, vertigo-like dizziness, nausea, and vomiting. She was prescribed Antivert. Two days later, on 01 July 2006, the patient was generally feeling worse, still dizzy, passed out once, and had back pain (also described as low back pain) and headache. She was sent to the emergency room where a chest x-ray and routine blood work were normal. On 05 July 2006, the patient was seen in the physician's office with worsening back pain, neck pain, and headache. A CBC demonstrated a WBC 11.8 with "80P", ESR 25, and normal chemistry and renal/liver panels. Two days later on 07/ July 2006, the patient complained of worsening back pain, neck pain and headache. Upon examination, her neck was supple, but tender to palpation and she was complaining of neck pain with any movement. The patient's spine was tender to palpation along its entire length. There were no changes in vision, paraesthesia, numbness, muscle weakness, paralysis or other neurological symptoms. No fever was documented at home or in the physician's office but the patient was complaining of chills off and on and had been taking ibuprofen throughout the course of illnesses. Plan of care was to send the patient back to the emergency room for further evaluation. The recovery status of the patient was reported as not recovered. (OMIC)
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 27-month-old female. Neither the patient's past medical history nor the concomitant medications were reported. FLUMIST was given intranasally. The product expired on 04-Mar-2012. On 12-Mar-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 17-Apr-2012: Suspect drug information and the reporter stated that the patient did not experience any late occurring adverse events.
Rapid heart rate.  Beats per minute as high as 108-110 at highest point.  Noticed redness on both arms below elbows.  Primarily on arm where had injection.    Tried to take blood pressure with home bl; Blood pressure higher than normal with diastolic above 100; redness on both arms below elbows. Primarily on arm where had injection; redness on both arms below elbows. Primarily on arm where had injection; This is a spontaneous report from a contactable Consumer (patient reported for herself). A 65-year-old non-regnant female patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 12:30 (at the age of 65-year-old) as dose 1, single for covid-19 immunization. The patient Other medical history included PVCs (Premature ventricular contractions), high blood pressure, high cholesterol and migraines. The patient had no covid prior vaccination. The patient received unspecified concomitant medications. The patient previously took and had Known allergies to wheat, amoxicillin-pot Clavulanate, sulfamethoxazole-trimethoprim, Benzonatate and Nitrofurantoin Macro. The patient received no other vaccine in four weeks. The patient received unknown medications in two weeks of vaccination. The patient had not been covid tested post vaccination. On 03Mar2021 at 12:00 AM, the patient experienced Rapid heart rate. Beats per minute as high as 108-110 at highest point, noticed redness on both arms below elbows, primarily on arm where had injection. Tried to take blood pressure with home blood pressure cuff and blood pressure higher than normal with diastolic above 100. The patient Went to emergency room and symptoms had lessened by the time she arrived. The patient received no treatment for the events. The outcome of the events was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Severe pain in arm, hard to move, large hive and very hot to the touch, that night. Next morning pain and stiffness in arm continued and hive got larger and redder and bruising started to set in very tired and felt sick like flu onset. Today is 11/17/2011 and hive is gone, but bruising is still very visible. Patient has gotten flu shots every year for the last 6 years and have never had any issues ever. This shot was very different. The pain when it was administered was so excruciating, very different shot and outcome.
Enlarged lymph nodes on left and right side of armpits and both breasts.  The left side enlargement was very visible to the naked eye and looked to be as large as a tennis ball.  Both breasts where swollen and tender/sore.  Right side enlargement of armpit as not as large (maybe the size of a golf ball).
First dose / 13-December-2020 / planning / second dose this weekend; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose (0.5 ml) received intramuscularly on 13th December 2020 at the pharmacy).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by patient's spouse. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, but was planning to receive 2nd dose this weekend, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose. The reporter consented to follow up. This case had been linked with US2021166467, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021166467:Same reporter. Spouse's case.
6 hrs p/recvd immun, pt exp an allergic rxn & had projectile vomiting;
VACCINE WAS RECEIVED AT THE PHARMACY IN EARLY AFTERNOON AT THE PHARMACY.  APPROXIMATELY 9PM SHE STARTED TO EXPERIENCE LIPS SWELLING AND ITCHING SKIN.  TREATED WITH BENADRYL 50MG [2 X 25MG CAPSULES] AND REPEATED AT 2AM.  REACTION SUBSIDED BY 3AM.  PATIENT REFUSED TO USE EPI PEN [WHICH SHE HAS A PRESCRIPTION] AND REFUSED TO GO TO EMERGENCY ROOM.
This spontaneous report was received from a pharmacist and refers to a 61 years old female patient. No medical history, concurrent conditions or concomitant therapies were reported. On 11-SEP-2015, the patient was vaccinated with ZOSTAVAX (lot # and dose were not reported), subcutaneously in the gluteal region. The patient had not reported an adverse effect. Additional information has been requested.
Cellulitis with blistering on both thighs anteriorly - lasting over 1 week.
Participant stated that he tested positive for COVID-19 on 05/07/2022. It started off very mild but my ears popping, fever, chills, fatigue, body aches and congestions. I went to the local pharmacy and that gave me Paxlovid to take for 5 days. I am still feeling really bad. I took a at home COVID-19 test and the pharmacist said that test was ok.
fever for 14 days, around 100;cramps in neck & upper back;lethargic several wk;
Child presented to ER on 1/23/2020 with left arm erythema, swelling and warmth since immunizations day prior. Patient complained of pain, Motrin was given for pain/swelling. Warm compress applied. Ultrasound showed no fluid collection but concerns for cellulitis. Treated with Keflex TID x7 days. Patient is scheduled to come into office for a follow up on 1/31. Patient was followed up on after ER report, parent reported no issues at that time.
A year later I had a red circle Skin rash that is at the site where I had the injection for shingles. Now that same spot has been removed and was basil cell carcinoma.
Pt came in to pharmacy with her mom for her 1st dose Pfizer vaccine appointment at 2pm on 5/26/21. We checked her in and (pharmacist ) gave her shot with her mom present at 2 10pm and she was fine with no issues. Within 2 minutes in of her observation period, she started fainting and having seizure like for about 10 seconds, and regained conscious and said she felt dizzy and then blacked out. She was pale and sweating and asked for water. Our shift lead happened to be closed by her chair where she was sitting so she prevented pt from falling down from the chair and called pharmacist for help from inside the pharmacy. Pharmacist rushed to the patient and asked shift lead to call 911. Pt was consious, but lethargic, she could breath normally, no sign of obtruction airway. Pharmacist lift her legs up to opposite chair and started to take BP. Paramedic arrived within minutes and took her vitals which was normal. Mom agreed for paramedic took her out in stretcher to hospital for check up.