chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner regarding multiple unspecified number of patients of unknown age and gender. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored dose of MMR II lot L020189, expiry date 03-JUN-2017, Lot L024266, expiry date 01-JUL-2017 (dose number, route, anatomical location and dose units were not specified), (incorrect product storage). Concomitant medications were not reported. No adverse effects were reported. There was no Product Quality Concerns (PQC) involved. Temperature at which the product was stored was 48 degree Fahrenheit, for 5 minutes. There were no previous temperature excursion reported. Additional information has been requested.
Rash began on left arm (same arm Zostavax was administered).  Rash became widespread, was red and blotchy similar to a contact dermititis reaction (poison ivy).  Rash also caused itching.  Rash began to subside on 3/21/16 but itching remained.
Patient received Tdap and MCV in left thigh on 8/11/15.  The next day he awoke with left thigh pain.  Later in the day he developed increased redness around the area where the vaccine was given as well as increased pain.  Presented to clinic 08/12/2015 and noted to have pain with bearing weight on left leg, also with approximately 10 x 10 cm area of erythema and warmth surrounding area of vaccine administration of left thigh.  Vaccines appear to have been administered slightly medially of thigh muscles.  He had a previous similar reaction with IPV.  He was treated with Tylenol, hot/warm compresses, and rest.
Two days after injection patient began getting a red area at injection site.  It had a pea sized lump at that time.  The bump under the skin has gotten larger.  Now 25mmx25mm with redness of 20mm over lump.  Skin is warm to touch.
After giving the vaccination, it was found that vaccine was expired. The vaccine expired 01/01/2018. I contacted RN and Immunization Nurse with Health Dept to report this. Pts mother was made aware of the above and verbalized understanding.
Report 2001003514-1 describes joint pain in a 52 year old male who received Lyme disease vaccine (Lymerix). This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. Medical history included tick bite one week prior to receiving the first injection of Lymerix. The physician treated the patient with doxycycline. The patient received his first injection of Lymerix in April 2000. At some later, unspecified date, he developed "significant" joint pain, which made the patient feel as though he was "becoming like a cripple". The joint pain resolved after "a short time". The patient received his second injection of Lymerix on 05/04/00. At some later, unspecified date, the patient again experienced "significant" joint pain, which made him feel as though he was "becoming like a cripple". As of 02/01/01, the joint pain "had not totally resolved". The adverse experience of joint pain does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Patient received vaccine at 11:10,  Ten minutes later, at 11:20, patient presented to the First Aid Room.  She had the following symptoms: fatigue, headache, neck and shoulder pain. dizziness. Lips and tongue partially swollen, "having a hard time getting air down into my lungs."  Relates that she has had a headache, "migraine for the past 4 days.  Patient tells me there's a gun in his pants.
Redness approx. 3 inch across injection site area, pt. says feels warm to the touch. Now she admits that she gets same reaction with DPT inj.
Information has been received from a physician concerning a 4 year old male who on 13-MAR-2008 was vaccinated into the thigh with a second dose of  VARIVAX (Oka/Merck) (lot # 658566/1652U). The physician reported that on 15-MAR-2008, the patient developed a 8 x 10 centimeter swelling and tenderness at the injection site of the thigh. The patient was treated with SEPTRA. The patient recovered from the 8 x 10 centimeter swelling and tenderness at the injection site of the thigh. The patient sought medical attention, he was seen in the physician office. Additional information has been requested.
Information has been received from a physician concerning a 16 year old female with no known drug allergies, no pertinent medical history or concurrent conditions, who on 24-SEP-2009 was vaccinated with the 0.5 mL first dose of GARDASIL (lot # 663452/0671Y). No other vaccines or concomitant medications administered. The nurse administered the injection and the patient had immediate syncope with no warning and loss of consciousness for 15 seconds. The patient fell forward off the exam table, chip a tooth, scraped her knee, had a seizure and a concussion. The whole incident was 15 seconds. The physician stabilized her neck to open her airway, turned her on her back and patient came around. The patient was transported to emergency room and got a CT scan of head and neck performed (result not reported). Subsequently the patient recovered from the events. The physician's receptionist contacted during telephone follow-up, stated that the patient was not hospitalized and could not comment on disability or whether the event was life threatening, as there was no mention of this in the patient's chart. Seizure, syncope with no warning, fell forward off the exam table, chip a tooth, scraped her knee and concussion were determined to be an other important medical event by the physician. No further information is available. 12/30/09 PCP record received for DOS 09/28/07- 10/15/09. Patient had syncopal episode after receiving 1st dose of Gardasil on 09/24/09. Fell forward and hit head. Pt. was diaphoretic and unresponsive for 10-15 seconds with 3 second seizure. Transferred to ED.  On 09/25/09 Pt. presents for ER followup with neck pain. Tx. with Advil.  Phone call from mother on 9/28/09 reports pt. having dizziness, sleepiness and nausea.  Pt. went to school on 9/29/09 with headache and persistent sensitivity to left side of face. 01/04/10 ED records received DOS 02/21/06
Experienced left side tingling started from left shoulder down to her waist. Lasted for approximately 2 hrs.
Headache, Myalgia, Fever, CoughWheeze, UrticariaPruritus, NauseaVomiting, Fatigue Narrative:
Had a blood clot on the brain that caused a stroke, was in the hospital for 7 days then went to a rehab center.
patient's family member called after couple hours after receiving the vaccine,mentioning that the patient was feeling dizzy which might be also due to his upset stomach for which he had taken immidium. Pharmacist called  the patient in a few hours and patient was feeling ok.
A month after I received the vaccine, I started having symptoms of forgetfulness, became foggy, had severe exhaustion, intense headaches, loss of appetite, issues with balance, vivid dreams and apparent hallucinations. My PCP had me see a neurologist and a rheumatologist. I had blood work drawn, tested for COVID and x-rays done. I have a CT scan in the next three weeks. We are going to come up with a plan after my CT scan.
headache, sinus congestion, right ear plugged, body aches, diarrhea, chills. starting 10/6/2021. Lives with mother and grandmother who both recently tested positive (all vaccinated)
Awoke at 5:40 am seizure. Seizure lasted about 20 minutes. Was afebrile at the time but had a fever by the afternoon. Was evaluated in emergency room - postictal but otherwise fine.
The vaccine was given in left outer lower arm and it really hurt. That evening my arm at inj. site was red, itchy, hot and sore. Swollen red area was size of a fist and lasted 2 wks. Only Rx I did was put ice on it. I am a retired R.N.
93 y.o. Caucasian female w/ pmh significant for dementia, htn, schatzki's ring, ckd stage 3, CAD who presented w/ her son to the ED again w/ increased weakness and confusion.  Notably, she has been seen now 3 times since January 31, 2022 1st due to a fall in which she had noted bruising on her right upper extremity and had x-rays obtained which were negative, next on February 2nd due to dysphagia and globus sensation and 3rd today with increased weakness and confusion to the point that her son can no longer care for her.  No obvious infection from previous workup and/or recent medication changes per her son to have caused her increased weakness/confusion.  States that she is notably more lethargic in the morning, his increased garbled speech, is more agitated than normal and is having difficulty with mobility which she normally uses a walker.  Tested positive for COVID upon admission.
SUPERFICIAL BLOOD CLOTS IN BOTH LOWER EXTREMITIES; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient developed superficial blood clots in both lower extremities couple of weeks after receiving the vaccine. This was all documented as patient went to the emergency room for evaluation and it was confirmed by doppler. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of superficial blood clots in both lower extremities was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20220647590-covid-19 vaccine ad26.cov2.s- superficial blood clots in both lower extremities. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Pruritis and skin rash of superior aspect of bilateral pinna, face, upper torso/back
felt sore right after the vaccine and it got worse and has progressed; still sore fatigue generalized body aches starting about 7:00 pm on 2/4/20 throbbing headache and diahrrea about 8:00 woke with chills, aches, joint pain (everywhere); feels like flu
30 minutes after injection had lots of soreness. Later on developed hot red and itchy spot around injection site. Was recommended by doctor to put warm compresses, took Tylenol and Benadryl for 4days.
Three days after the 1st COVID shot, the patient developed a rash on the inner side of elbow on the left arm. The rash developed into blisters, serum/clear liquid bumps, and formed scars after bursting. The rash gradually increased in surface area as it progressed, and would itch after exercise. The patient took prednisone and amoxicillin, and as of today the affected area covers most of the upper arm, although it itches less than before.
Patient complained of sleeplessness, pressure in chest that subsided, fever of 101.3, aches, pulse 122
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Regulatory Authority, per guidance from Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
I have a severe rash on my neck after the COVID 19 vaccine shot my neck swelled during the night and lymph nodes in my neck swelled/but went to normal after the next day, but a rash occurred and it itches and burns and is still there two weeks later - I'm so scared to get the second dose on April 9th Any suggestions?
Diarrhea from approx 2 hours after vaccination to 5/16 Fatigue 5/12 to present (5/16) Headache from 5/12 to present (5/16) Intermittent Nausea/Abdominal pain from 5/12-5/16 Intermittent low grade fever (99.1-100.1) on 5/15 Injection site pain from 5/12-5/14
Case number PHEH2016US021840, is an initial spontaneous report received from a nurse on 25 Aug 2016. This report refers to a patient of unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) less than 0.1 ml intramuscularly on 25 Aug 2016 when the was prescribed with 0.5 ml. No adverse event was reported following this administration error.
Developed amphnus stomatitis 2ds post. AVA #2. 15-20 mins after shot became nauseous. Symptoms relieved in 2 hrs. On 1/27/03 developed multiple ulcerations on the tongue, hard and soft palate and throat. Her throat had 4+ erythema and was very painful. She developed lesions on the corners of her mouth. Her cough worsened. She went to her PCP on 1/30/03 who did a throat culture and gave her mycelex. She reports that she had a swollen left tonsilar node and a very sore throat.
dizziness; fall; Swelling in arm; pain in arm; felt sleepy; weakness in the right eye; balance issues (falling into her right side); This is a spontaneous report from a contactable consumer, the patient.  A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263; Expiration Date: May2021), via an unspecified route of administration in the right arm on 02Feb2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization.   Medical history included cancer survivor, type 2 diabetes mellitus, and surgery of the left hand in 2020.  Concomitant medications included the second dose of varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on 12Jan2021 for immunization. The patient previously received the first dose of the varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on an unknown date for immunization.  On 02Feb2021, the patient experienced swelling and pain in arm and felt sleepy. On 03Feb2021, the patient fell on the table due to dizziness. The patient had to use her cane more to get around.  On an unknown date in Feb2021, the patient had weakness in the right eye and balance issues (falling into her right side). The clinical outcomes of the dizziness, swelling in the arm, and weakness in the right eye were recovering; while that of the pain in the arm was not recovered. The clinical outcomes of the sleepiness, fall, and balance issues (falling into her right side), were unknown.
pt recvd vax;crying & holding lt arm,consolable as long as held;no redness,no swelling;warm to touch;apap given;MD ordered advil,fussy thru noc 8mar & sl redness noted at site 9mar95;more irritable than usual x 4 days;MD said ped DT in futu
I received my vaccine on Wednesday, Dec. 8, 2021 at 3:45 P.M. in my left arm. I felt fine that evening. I woke up Thursday morning with pain throughout my body. It was a deep pain, as if in my bones. My joints hurt, especially  my hips and left shoulder. By the afternoon of December 9, I noticed pain and swelling in my lymph nodes under my left arm. I was extremely tired. These symptoms increased throughout the day. By 6:15 P.M. I was exhausted. I took two Tylenol 325mg and went to bed. I slept for 11 hours. The next morning, December 10, the pain throughout my body was better, but the pain in my lymph nodes had gotten worse. I could not lower my arm by my side without feeling the swelling in my lymph nodes. The swelling was easily visible. the swelling continued Dec. 9, 10 ,11. On Dec. 12, I noticed visible bruising under my left arm due to the swelling. I still have pain, but the swelling has appeared to deceased slightly
Patient came in requesting a flublok vaccine. Questions were asked if she had any allergies. She stated she's had flu shots in the past without any issues, however, last year, after her flu shot she realized she was experiencing increase in heart rate but didn't think anything of it so she went home and used her albuterol inhaler. She then later realized some slight swelling in the throat, but nothing too severe to go to the emergency room and felt better in a couple of days. She also stated that lately, she has noticed that she cannot tolerate eggs. Even though she can have eggs when mixed in foods like cake, she just cannot eat eggs alone. Every time she had eggs by itself, she would experience increase in heart, slight swelling of throat. She also added that after careful review with her PCP, her doctor thinks she may have an egg allergy.  The choice was then made to give flublok instead because of the egg intolerance she had been experiencing. Patient was educated to wait in the pharmacy at least 30minutes and report any issues such as increase in rate, dizziness or etc. A couple of minutes after vaccine administration, patient stated feeling an increase in rate. Due to similar characteristics patient had described with her pervious flu shot, Permission was seeked on her behalf to call the ambulance and patient agreed. Ambulance arrived in less than 5 minutes after call was placed. Patient was alert and responded well to every question until paramedics arrived. Epinephrine was set in place in the place in the course should patient require it. Epinephrine was however never administered at any point throughout this incident. Paramedics transported patient to hospital upon request and monitored for a few and discharged the same day. Patient reported that she was given Benadryl and steroids  whiles at the hospital and upon discharge.  Patient husband stated, patient resumed work two days following this incident.
Developed Temp 104 about 24 hours after receiving vaccinations. Behavior okay. No rash or c/o pain.
RN pulled Tdap from refrigerator erroneously, meaning to pull Hepatitis B vaccine. Wrong med was given, pediatrician was informed within 30 minutes, and parents were as well, once error was caught. There was no adverse reaction (as of now, baby is 32 hours old, erroneous vaccine was given at 2 hours of age. Vital signs and assessment have been WDL (normal). MD to be following up with CDC tomorrow, Monday.
Pruritis and Headache.  Treatment Benadryl 50 mg IM.  Provider recommended hydration and tylenol.
arm sore at injection site; head felt warm; face was ice cold; slight nausea; no appetite; This is a spontaneous report based on information received by Pfizer. A contactable consumer reported for herself that an 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced arm sore at injection site, head felt warm, after waking up face was ice cold, slight nausea and no appetite on unspecified dates. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I developed severe and long lasting gastrointestinal problems including but not limited too severe abdominal pain, lack of appetite resulting in a weight loss of over 10 pounds in 2 months, constant nausea, diarrhea, constant urination lasting for months, constant high heart rate, lightheadedness and dizziness, itching, feeling flush, chills, foggyness and confusion, severe back pain and acid indigestion, issues with blood sugar, gastritis, easily brusied, development of anxiety and depression, stomach feeling inflamed bloated and irritated, heart palpitations and chest pain
Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on 15-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    Concomitant medications of the patient were not reported.  The vial was initially stored in the refrigerator on 14-Mar-2023. The vial did not undergo any temperature excursions.  HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-Mar-2023. There was potentially a second lot number that was expired and was administered to patients on 03-Mar-2023, but HCP did not have any details on this event at the time of reporting.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case