chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain in left arm within 2 hours of having injection. Began having swelling, redness and warmth in arm. Entire upper arm edematous. Went to MD today and was prescribed cephalexin. Arm continues to be red and edematous but edema has settled in the elbow area also reports running a low grade temp.
approx 3hr p/vax pt broke out in hives;mom called MD office Tuesday AM 18AUG98 they recommended DPH as needed;Wednesday AM 19AUG98 pt stil had hives but not as raised red;
Less than 5 seconds after receiving MMR, pt's arms became stiff, back was arched, eyes were wide opening and staring, head was back. Diagnosed per doctors as opisthotonos.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-NOV-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N014759, expiration date 08-NOV-2017 (strength, dose and route of administration were not reported) for prophylaxis. It was reported that PROQUAD was reconstituted with properly stored sterile diluent (MERCK) lot number N011475, expiration date 08-AUG-2019. The temperature of excursion with PROQUAD was 15 to 46 Fahrenheit degrees during 11 hours and 30 minutes. Previous temperature of excursion was 15 to 46 Fahrenheit degrees for 12 hours and 45 minutes. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1711USA006109: US-009507513-1711USA006110.
LUMP AND RASH AROUND IMMUNIZATION SITE. RASH WAS 3"X3" WITH RAISED WHITE CIRCLES FORMING WITHIN PERIMETER.
Diarrhea and blood in stool started after the first dose. Symptoms got worse after dose 2. Diarrhea, blood in stool, stomach cramps. Saw PCP, blood tests came back with significant inflammation. Colonoscopy showed the development of proctosigmoiditis ulcerative colitis. No family history of the disease. There was no symptoms or colitis before taking the moderna vaccine.
I received #1 covid vaccine on 1/5/21. No reaction at the time. On 1/12/21 by the afternoon, my right arm started to itch and become sore. I then noticed the redness around the injection site. Injection site is sore, hot, and hard. The reddened area is continuing to spread.
He already had a cough because he has allergies. However, one of his teachers said his cough was worse. So, he tested negative on 05/04/2022. I took him to the doctor on 05/07/2022 and they upped him on allergy medicine because his lungs seemed clear and it seemed like his allergies were just worse. Then, I got a note from his school stating that he was exposed to COVID at school. I tested him on 05/08/2022 and it was almost instantaneously positive. Then, on 05/13/2022 he tested negative and he resumed his normal activities. As of 05/14/2022, he reported he was feeling about 75% normal and I remember by Wednesday 05/18/2022 he felt back to normal. He was doing Flovent and albuterol during the bad allergy and COVID event. However, since recovering he no longer needs those medicines.
pt recvd vax; large swelling of lymph nodes w/ redness of 2" at site
Child had fever and sore throat and bumps on abdomen and hands. Child diagnosed with varicella after vaccination.
Fever in breastfeeding infant, followed by congestion, cough and runny nose lasting over /week.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-JUL-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (Lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 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.
PATIENT FAINTED SHORTLY AFTER THE INJECTION, BUT THEN REGAINED CONSCIOUSNESS SHORTLY AFTER I ATTENDED TO HER BY SITTING HER UP AND CALLING 911. I WAS READY TO ADMINISTER CPR AND EPI.
Saturday Morning December 14th the patient woke up and said she couldn't roll over in bed and that it took her a few minutes to roll over, then it took her a few minutes to sit up. She said she wasn't in pain, her body "just wasn't working". Then she had trouble standing, and it took a few minutes before she could walk, and she had to walk with her walker. She also starting getting a prickly/burning sensation in her middle finger on both hands that went all the way to her wrists. (She has had carpal tunnels in the past). She reports that all of these issues resolved within about a half hour. She isn't sure if any of this was related to the vaccine, but we wanted to report still just in case.
On the 7th day after the reaction, I woke up with a slightly sore arm. When I looked in the mirror I also noticed my arm was red around the injection site - approximate size of 3x2 inches (tape measure all I had). It does itch somewhat as well as is a bit swollen in the area. Not warm to touch. No fever. This is a new, delayed-onset reaction as I experienced only a sore arm the day after the vaccination and no rash.  No medications are needed at this time as I am able to go about my ADLs.
10:30am slight headache and nausea. 5:30pm was uncontrollable chills, teeth chattering, whole body shaking and entire body hurt with aches. 6:30pm fever started and spiked to 102.9.   By 10:30pm fever had gone down to 100.7. By morning all fever was gone. Starting April 13th leg cramp in left calf.
Information has been received from a registered nurse concerning a 4 year old patient of unknown gender. Patient's medical history and concurrent condition were not reported. On 02-OCT-2014 the patient was vaccinated with the second dose of (Oka/Merck) VARIVAX, lot # J004157 expiration date 09-MAY-2014 (dose and route not reported), which was improperly stored and expired. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Death 3/25/2021 Causes of death listed on patient's death certificate: 1) COVID-19 Infection, 2) Acute Hypoxic Respiratory Failure, 3) Acute on Chronic Deconditioning
HCP administering the vaccine inadvertently pulled and gave the wrong formulation of vaccine to the patient. There were no known adverse effects from administration of vaccine.
Started 24 hr after vaccination, peak at 72 hr Arthrus type rxn at site of varicella dose #2 4" area warm, red, minimal induration initially puritic
Sterile Water for Injection as the diluent of ACT-HIB instead of the 0.4% Sodium Chloride with no adverse event; Initial information received on 07-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2-months-old male patient who had sterile water for injection as the diluent of HIB (PRP/T) vaccine [ACT-HIB] instead of the 0.4% sodium chloride with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine inact 3V (vero) (IPOL) for Immunisation.  On 29-Aug-2023, the patient received 0.5 mL dose 1 of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (Strength: Standard; Frequency: Once) (batch number: UJ837AA; expiry date: unknown) via intramuscular route in the left vastus lateralis for Immunization with sterile water for injection as the diluent instead of the 0.4% sodium chloride with no adverse event (product preparation error) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Trouble walking; back pain; stiffness; severe sore throat; inflammation; sores and swollen glands in mouth; swollen lymph nodes/swollen glands in mouth; white reaction in throat; fever x3 days 101.9 to 103.; Difficulty and pain swallowing; talking and opening mouth.; loss of appetite; decreased and dark urine output; decreased and dark urine output; constipation; nausea; vomiting; Light headedness/Dizziness; trembles; weakness; heart palpitations; fatigue; low blood pressure; Losing hearing; muscle twitches; jaw and sinus pain; jaw and sinus pain; chemical taste when eating/drinking; heightened sense of smell; Body aches; This is a spontaneous report from a contactable consumer. A 27-year-old non-pregnant female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0172) via an unspecified route of administration on 27Jul2021 at 12:15 PM (at 27-year-old) on right arm as dose 1, single for COVID-19 immunization. The medical history of the patient included mental illness and scoliosis. No other vaccines were received within 4 weeks prior to the COVID vaccine. The concomitant medications included venlafaxine taken for an unspecified indication, start and stop date were not reported and methylphenidate taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with COVID-19 prior to vaccination and was tested for covid-19 since the vaccination. The device date was 25Aug2021. The patient did not receive any past drug and had no allergies. On 27May2021 at 12:15 PM the patient experienced trouble walking, back pain and stiffness, severe sore throat, inflammation, sores and swollen glands in mouth, swollen lymph nodes, white reaction in throat, fever x3 days 101.9 to 103. Difficulty and pain swallowing, talking and opening mouth. Body aches, loss of appetite, decreased and dark urine output, constipation, nausea, vomiting. Light headedness, dizziness, trembles, weakness, fatigue. heart palpitations, low blood pressure. Losing hearing when dizzy upon standing. Left thigh muscle twitches. Jaw and sinus pain, chemical taste when eating/drinking, heightened sense of smell. No prolonged hospitalization was required. The patient went to emergency room, Walk-in, PCP-Decadron etc as treatment. On 27Jul2021 the patient underwent lab tests and procedures which included blood test for which results were unknown, blood and proteins in urine, body temperature was 101.9 to 103 fahrenheit, infectious mononucleosis were negative, pregnancy test was negative, protein urine was unknown. On 29Jul2021 blood and proteins in urine, sars-cov-2 test was negative, Nasal Swab, sars-cov-2 test: negative. On 01Aug2021 nasal Swab, sars-cov-2 test was negative. On 20Aug2021 Nasal Swab, streptococcus test was negative. The patient was recovering.  Follow-up attempts were completed. No further information was expected.
shivering; cold; Site of the injection was quite sore; Shakes that would give me a fever; got up to a 100.1; Shakes that would give me a fever; got up to a 100.1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown manufacturer.), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), single, Unknown manufacturer.), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), single, Unknown manufacturer.), for COVID-19 immunization. The following information was reported: TREMOR (non-serious) with onset 07Oct2023, outcome "unknown", PYREXIA (non-serious) with onset 07Oct2023, outcome "recovered" and all described as "Shakes that would give me a fever; got up to a 100.1"; VACCINATION SITE PAIN (non-serious) with onset 07Oct2023, outcome "unknown", described as "Site of the injection was quite sore"; NASOPHARYNGITIS (non-serious) with onset 07Oct2023, outcome "unknown", described as "cold"; CHILLS (non-serious) with onset 07Oct2023, outcome "unknown", described as "shivering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information: The patient was just calling to report a side effect because he had never had one and up and till now, he had 4 shots for COVID (suspect captured as Pfizer Covid Shot), the two initials and then two boosters last year and then he saw the commercials, he asked if he should be getting a new one for this year. They said yes, that is a good idea and what they gave was the Comirnaty and he was fine until yesterday (from the time of report), from the time he got it, so waving there. But at 3o'clock this morning, he was woken up and was shivering and cold he had to put blanket on. Beside the effect of these, site of the injection was quite sore and had that before but not as bad and never accompanied by the shakes that would give him a fever and that was what he had. He got up to a 100.1 and then in the morning it came back down. He took a non-Aspirin tablet and that did the trick because his fever came right down and disappeared. So, this is the first thing that he had ever had with any of them, in the first 4 of Pfizer shots.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Waste of 60 doses of Pfizer vaccine. 48 doses overdrawn, 12 doses splash back during drawing.
The vaccine that was provided was given at day 32 from fridge storage, rather than within the 30(+1) days after thawing.
Initial misuse report received from a healthcare professional on 14 February 2014. A patient had received a dose of PENTACEL on an unspecified date. It was reported that the product way was too long in transit and the MA's recorded and unpacked it. No adverse event was reported. List of documents held by sender: none.
Patient returned back to office within 20-30 minutes states "having a reaction to flu shot" complained of shortness of breath and internal itching.  Patient took 2 Benadryl while in car before arriving back to office.  No apparent shortness of breath noted.  No further treatment required.  Observed for 45 minutes.
Nausea; body aches; night sweats; headache; tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJI685), intramuscular on the arm (reported as location was in the left and right arm, pending clarification) on 21Dec2020 15:30 at a single dose for COVID-19 immunization. The patient's medical history included celiac disease and wheat, gluten, chicken, nightshades, yeast allergy. The patient was not pregnant. Concomitant medication included vortioxetine hydrobromide (TRINTELLIX). The patient previously took chlorhexidine (CHLORAPREP) and experienced allergies to chlorhexidine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 21Dec2020 17:00, the patient experienced nausea, body aches, night sweats, headache, and tired. Therapeutic measures were taken as a result of the events and included treatment with ondansetron (ZOFRAN) and paracetamol (TYLENOL). Outcome of the events was not recovered.
5-6 hrs p/vax stomach cramps, h/a, fever, pain in local arm area; 48 hrs p/arm still swollen <hard lump> hot, painful skin blotches noted on arm; t100; stomach cramps-nausea;
Received my first vaccine 1/6/2021. I was very nervous about the vaccine, so I brought 4 epi-pens with me. My PCP and allergist advised me to sit x30 minutes after the shot. 25 minutes after receiving the shot, I felt very warm.  I looked at my hands and they were fire-cracker red in color. I began doffing my sweatshirt and my arms/neck/stomach and back were had a spotty rash. There was no hives/areas of elevation.  Nurses took my BP.  40 minutes without medication, rash and warmth resolved. A few hours later, I had a terrible headache and then around 8pm, I started with bad aches, chills, fever of 101. I took tylenol and did not resolved. The next AM, symptoms continued. I took advil and this had a better effect with sx resolving. My second dose, I received on 2/5/2021. I had a similar response about 10 minutes after the shot but warmth/reddness did not last as long, ~5-10 minutes. Had my BP taken, which was elevated (probably from my own anxiety). a few hours after the shot, I began with the headache, chills and fever--- though all mild. fever was 99 degrees the next day. 2/8/2021, I felt very fatigued and weird for a few hours. this seem to pass and I have felt normal since; just very tired. *** additionally, I did have COVID-19, testing positive 11/11/2020. my sx were mild compared to others.
swollen lymph nodes on left underarm and right underarm pain in right breast lower abdominal cramping
A report was received from a health care professional on 11/14/03 concerning a 14 month old vaccinee of unknown sex, who inadvertently received Fluvirin on an unknown date. On an unknown date a child under 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Patient RECEIVED PFIZER BIVALENT COVID 19 VACCINE INSTEAD OF THE ORGINAL FORMULA OF THE PFIZER COVID 19 VACCINE. 11/2/22 11:18 patient STATED HE HAD NO ADVERSE EFFECTS.
Shortly after receiving Hepatitis vaccine, Pt walked out of the office about 4-5 blocks and fell.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date unspecified number of patients were vaccinated with improperly stored GARDASIL (Lot #, dosage regimen were not reported). No adverse effects were noted. This is one of the several reports received from same reporter. Additional information has been requested.
Patient called on 10/19/09 with unusual pain. Patient was seen by Dr. on 10/19/09. Dr. just told patient to keep them informed if pain persist. Dr has not heard back from patient since last seen on 10/19/09.
Patient came back to pharmacy on 11/23/15 and spoke to pharmacist on duty.  She stated that since the immunization was given she had been having extreme arm pain. She went to the emergency room where there was an x-ray done to make sure there wasn't a needle in her arm.  Patient was prescribed Ambien, Etodolac and Norco for the pain.
At the time of event pt was taking Claritin, Diazide. Prilosec and vit C. On Feb 25, 2000 the patient received a booster dose of Engerix B  because her titer was negative for anti hep B antibody. She did not sero convert after the series. Within 12-24 after the booster shot she experienced perioral swelling and hives. She was treated with antihistamines and steroids. The information received on March 9, 2000 reports the symptoms resolved.
Parsonage-Turner syndrome -- brachial plexopathy, resulting in R phrenic nerve palsy, paralysis of R hemidiaphragm, impaired R lung ventilation
Pt recvd vax on 15SEP92 (less than 1 wk p/the 2nd dose) pt was checked for antigen & found to be pos; test was performed again 8 days later & remained pos;
Husband of client received IIV4 Flulaval at 2:25 pm on 1/6/16 during a clinic visit with wife and 4 week old infant. This client is a 36 year old male with no history of illness and no history of chronic illness. Client was asked all required and necessary questions regarding past experience with vaccinations, allergies to eggs and/or vaccine components. Client stated no negative events occurred from vaccinations, the last vaccination being a TD. This was his first flu shot he was receiving to protect his 4 week old daughter. Flulaval  (Lot: AT3CC, NCD 19515-898-11), 0.5ml, was administered IM to right deltoid at 2:25pm. Fifteen minutes following vaccination with Flulaval client reports going into bathroom, feeling lightheaded, lowering himself to the floor and then vomited. He returned to office and then reported to another nurse that he had nearly passed out when he had a vaccination in the past. Vital signs were taken, 108/76, Pulse regular 80. Client appeared pale and was sat at table, provided a drink, and asked to remain in place for monitoring. At 3:30pm this client desired to leave with wife/baby reporting he felt better. His pulse was 80 regular. At time of event the Nursing Supervisor was informed and present for entire follow up monitoring. Client was advised at time of department from office to seek medical attention for further symptoms. A follow up telephone call was made to client at 4 pm, he was attempting to eat, but reports vomiting what he had eaten. This RN instructed patient to have wife drive him home, and to lay down.
Narrative: Patient received two doses of covid vaccine. Patient died some time after at outside hospital. Admitted for PNA. PMHx significant for CAD hx of stent x 3 (2000 & 2012), Hyperlipidemia, HTN, end stage/severe COPD on continues home oxygen dependent, Hyperthyroidism, macular degeneration. No further details of death.
Developed skin bump at site of HPV injection on right lower deltoid a couple weeks after vaccination. Lesion grow over time. On 5/31/17 there was a 1.5 cm x 2 cm dermal nodule on right upper arm. Lesion excised 9/27/17. Path showed cellular benign fibrous histiocytoma. Now has wide scar and possible recurrence of the benign tumor of this site.
pt recv vax 14OCT98 & 15OCT devel significant red, warm, indurated area of upper arm (10x7cm);
cyst; leg pain; pain in arm; fever; pain ankle; chills; This spontaneous case was reported by an other and describes the occurrence of CYST (cyst), PAIN IN EXTREMITY (leg pain), PAIN IN EXTREMITY (pain in arm), PYREXIA (fever) and ARTHRALGIA (pain ankle) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 UNK. On an unknown date, the patient experienced CYST (cyst), PAIN IN EXTREMITY (leg pain), PAIN IN EXTREMITY (pain in arm), PYREXIA (fever), ARTHRALGIA (pain ankle) and CHILLS (chills). At the time of the report, CYST (cyst), PAIN IN EXTREMITY (leg pain) and ARTHRALGIA (pain ankle) had not resolved and PAIN IN EXTREMITY (pain in arm), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       An ultrasound was done on an unknown date. Treatment was not reported.
27JUL95 vomited twice; 28JUL95 was crying, had a jerking movement & body was stiff; gasped for air & then collapsed laid on the floor & mom called 911 while mom was on phone pt came to; paramedics found pt in no distress;31JUL95 saw MD