chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling and moderate to severe pain in left armpit, partially radiating to the left shoulder blade.
Developed Hives on left thigh which extended down entire leg after 24 hours.  On the the Thursday, (1/14/21) devloped hives on the right thigh and leg.
Patient presented to pharmacy for the COVID19 adult bivalent booster vaccine. The pharmacist preparing the vaccination drew up an incorrect vaccine, the pediatric monovalent Moderna booster, and administered it to the patient. The error was discovered on 12/05/22 when pharmacy manager returned from weekend off and found the incorrect vial on the counter. The patient was contacted to discuss the incident. The patient stated that he had been experiencing weakness and fatigue since 12/04/22 that had been persisting to present, and a sore arm that resolved on 12/06/22. After discussing options with patient, the patient stated that he would return 2 months following the administration of the incorrect monovalent vaccine to receive the correct bivalent vaccine.
large hive on neck and skin itchy and tightness in the throat within one hour of receiving the vaccine.  Took a couple of Benadryl and 'eventually' subsided. No medical visit or treatment by physician, UR Or ED
Patient passed out in lobby after receiving vaccination. He was diaphoretic and hypotensive. Felt better lying down. BP after vaccine was 84/56, increased to 120/70 before leaving. Had abrasion on right temple due to fall. BACITRACIN applied. Was also dizzy but resolved after 1 cup of juice and 2 cups of water.
Uncontrollable, full body convulsions, almost daily. When not fully convulsing, constant tremors are present. Does not have full control of hands and legs, struggles with normal daily functions. Speech ability and cognitive capabilities have been challenged as well. Doctors have no idea what is happening, but all believe it is a reaction to the vaccine. Doctors have no idea what to do other than prescribe muscle relaxers, which do nothing. We have found that over the counter Benadryl helps to a degree. Josiah has been referred to a Neurologist, the neurologist also has no idea. Pt has lost his job and is facing having to quit school due to disability.
a lot of pain on my left arm; a lot of pain on my left leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a lot of pain on my left arm) and PAIN IN EXTREMITY (a lot of pain on my left leg) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was reported by reporter.     On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, the patient experienced PAIN IN EXTREMITY (a lot of pain on my left arm) and PAIN IN EXTREMITY (a lot of pain on my left leg). On 22-Jun-2021, PAIN IN EXTREMITY (a lot of pain on my left arm) and PAIN IN EXTREMITY (a lot of pain on my left leg) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs was reported. No  treatment medications were  reported.
Patient presented to the ED on 6/7/2021 and was subsequently hospitalized for Diverticulitis of large intestine without perforation or abscess with bleeding. Patient had second dose on 6/17/2021. On 6/22/2021 patient presented to the ED and was subsequently hospitalized for bright red rectal bleeding. These visits are within 6 weeks of receiving COVID vaccination.
My husband received the vaccine approximately 4:00 pm. He was told to wait at the site for 15 mins and he did. On his way home he called and said he had a very bad headache. Once home his shoulder swelled and he just didn't feel like himself. By the next morning he started running a fever that was between 100.1 and 102.1. I continue to take his temp and give him cold liquids and popsicles in an effort to control the temp. He has yet to start feeling better and it has been over 24 hours since the vaccine.
During HPV school based clinic held in the cafeteria, adolescent complained of feeling dizzy and feeling hot after looking at needle when HPV injection was given. Patient lowered to the floor. Cool wash cloth applied to forehead and vital signs taken: BP 105/72 and pulse 74. Skin color good. Patient did not have breakfast and was offered juice and crackers and a bottle of cold water. Patient was assisted to sitting position and parent notified by school nurse. Patient was able to stand after 30 minutes and ambulated to the school nurse's office.
patient is in office now and may receive 2nd dose ofHPV series today after received 1st dose ofGARDASIL 9 on 7/30/2019 as 11-year-old; patient is in office now and may receive 2nd dose ofHPV series today after received 1st dose ofGARDASIL 9 on 7/30/2019 as 11-year-old; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 30-JUL-2019, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 1 dosage form (concentration, frequency, administration route, anatomical location, lot number, and expiration date were not reported) as prophylaxis; as an 11-year-old patient.  On 29-JAN-2020, the patient possibly received a second dose (inappropriate schedule of product administration, circumstance or information capable of leading to medication error) of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 1 dosage form (concentration, frequency, administration route, anatomical location, lot number, and expiration date were not reported) as prophylaxis.
Patient arrived for second dose and stated that ever since they got their first shot, they have experienced tinnitus. Stated they had never had tinnitus before and it's been severe enough to keep them awake at night.
58hr p/vax sibling noted difficulty breathing, loss of appetite & fever w/stiffness in neck d/t glands swelling;went to ER given a breathing tx;x-rays;
05/25/2005 Grandmother took child to ER for following symptoms:  right arm swollen and red from shoulder to fingers.  Eyes swollen also.  Child given medication.  Brought child to hospital on 05/26, arm swelling decreased but still present.  Child to see Pediatrician.
Administered on 8/3.  Red itchy rash appeared on 8/13.   No treatment plan due to no returned phone call from dr office. Received this report info from local pharmacy.
1-2wk a/Thanksgiving devel dec muscle strength & tingling in all extremities but most pronounced on the rt; couldn't raise either arm, balance became poor;had fallen w/no apparent injury 1NOV95;MRI, spinal all neg;dec strength, weakness
10/21/04: developed rash . 10/22/04: seen by clinic. Rash perisists.
Information has been received from a LVN concerning a 4 year old male with no medical history and no allergies who on 18-JUN-2003 was vaccinated with the first dose of Varivax (lot number reported as "1378L"). There was no concomitant medication. On 20-MAR-2005 the pt developed classic varicella characterized by 80-100 very itchy lesions scattered on his body, including his scalp. The nurse also reported that the pt developed conjunctivitis. Unspecified medical attention was sought. The pt was treated with tobramycin (Tobrex) ophthalmic drops and Benadryl. No laboratory or diagnostic tests were performed. The pt's present status was reported as unknown. No product quality complaint was involved. The nurse considered the adverse experiences to be other important medical events (OMIC). Additional information has been requested.
Approximatly  1 hour and 15 min tinnitus began and hasn't stoppen .  I have had occasssional tinnitus in the past that would cease.  The tinnitus has not stopped yet.  I also had  vomiting within 17 hours of the vaccine.
Mom called answering service (office closed) at 0810 am 11/17/16. Stated pt's fontanelle was enlarged, seemed full of fluid, pt. quieter than usual, afebrile, sent to ER. Results negative/WNL.
nurse gave 3 separate patient's an expired FLUZONE HD Quadrivalent vaccine, with no reported adverse event; Initial information received on 01-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/Non-Healthcare Professional and physician via Regulatory authority (under reference 00794848).  This case is linked to case 2021SA327336 (same reporter).  This case involves a 68 years old male patient who accidentally received an expired dose of QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) [expired product administered].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 01-Oct-2021, the patient received a 0.7 mL dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (Prefilled Syringe, TOTAL, lot UJ482AA, expiration date: 30-Jun-2021) via intramuscular route in the upper arm for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Practicing manager with provider's office is reporting they gave a patient an expired FLUZONE HD Quadrivalent vaccine. What shall we do from here? Caller repeated the above question. 2 HCP states that she saved back one box of FLUZONE HIGH DOSE because it had 1 month before it expired and the nurse accidentally pulled 3 prefilled syringes of FLUZONE HIGH DOSE from that box and gave them to 3 separate patients today 01-Oct-2021"  At time of reporting, no adverse event was reported.  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.
Rash, itchiness, hives, redness around the jab location.  Upper part,  left shoulder.  Consistent for 2 weeks after the shot. Size - oval or drop like shape, about 3x1.5 in. No treatment applied.
This spontaneous report as received from a physician refers to a 53 year old male patient with asthma and recurrent pneumonia with no drug reactions or allergies. The patient's medical history included pneumonia in April 2013 that was treated outpatient and recovered. Patient received a standard pneumonia vaccine in 2007 and did not experience any symptoms. On 20-MAY-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # and expiration date unspecified) 0.5 ml, intramuscular for recurrent pneumonia. Concomitant therapies included FORTESTA, BYSTOLIC, CIALIS, losartan potassium (manufacturer unknown), ZEGERID and ADVAIR. On 21-MAY-2013 "over the next 24 hours from receiving the vaccine" the patient developed induration at injection site, "20*22 cm"  erythema beginning at the deltoid all the way down to the triceps and significant pain including difficulty with range of motion after receiving PNEUMOVAX 23. The patient called the physician's office on 21-MAY-2013 and spoke with a nurse about the symptoms he developed and was instructed to use compresses and take unspecified anti-inflammatories. Physician reported that symptoms did not subside so the patient called and spoke with the physician on 22-MAY-2013 and was being seen at the time of the report. Laboratory tests were not performed. At the time of the report the outcome of induration at injection site, erythema, difficulty with range of motion and significant pain was reported as not recovered. Additional information has been requested.
Awakened approx 4AM c/o legs & stomach & arm pain (esp lt arm)- cried approx 3hrs even giving APAP has not been asleep since; now c/o severe abd pain, t98.8oral, eating very little;
Patient eyes and upper lip became swollen and face was tingly. Dr. gave pt. prednisone and clear after 2 days.
fever of 100.2F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.2F) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     no medical history was reported.     On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PYREXIA (fever of 100.2F). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PYREXIA (fever of 100.2F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (Inconclusive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication were reported
'beyond use date' was 7/19/2023. no known adverse outcome at this time
Headaches; Bad chills; Diarrhea; Extreme tiredness; Sleeping a lot; This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on unspecified date at a single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient's wife called in because her husband (the patient) was experiencing side effects like headaches, bad chills, diarrhea, extreme tiredness, and was sleeping a lot after the vaccine. She was asking how long the side effects last. The outcome of the events was not recovered.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Hard, tender lump under injection site. It is red and warm to the touch. Also, a sore lump in armpit on same side as injection. Started today after all other side effects had gone away.
Fatigue; This is a spontaneous report from a contactable 77-year-old male consumer reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL1283), via an unspecified route of administration on 10Jan2021 at 08:30 as single dose in right arm for covid-19 immunization. The patient's medical history included have 2 stents for heart condition inserted 15 years ago. Concomitant medications included rivaroxaban (XARELTO), atorvastatin 40 mg, acetylsalicylic acid (ASPIRIN 81), cyanocobalamin (B12) (dose description :500 unk). On 10Jan2021, the patient experienced fatigue. The patient did not take any treatment for the event. The outcome of the events was not recovered.
Started with sore throat progressed to runny nose had a telehealth visit. Took Covid at home test, used over the counter cough medication lasted for 4 days. Keep testing positive for 14 days.
Patient presented with redness at site of injection which was slightly warm to touch as well as small hardened lump. Symptoms had appeared approximately 24 hours after injection. Patient advised to seek medical care if lump and redness did not clear or if experiencing fever.
Patient complain of slight headacke, dizziness, O2 sat 97, Pulse 76, Resp. 24, was assessed by nurse for10minutes, patient begins to cough with wheezing noted, states " I am feeling my throat funny, no respiratory distress noted, continued to be monitored for another 10 minutes, no changes noted, states,  I am feeling a bit tight in my chest,  O2 sat at 96-97%, BP 124/58 was taken to ER via EMS for evaluation at  14:35p
fever of 100.1°F; very fatigue; had chills; headache; I had a large knot under my injection site arm; large knot under my injection site arm, & it caused shooting pain across my chest; flu-like symptoms; My whole body was tender; soreness all over my body; joint pain; I couldn't sleep that night, because of soreness at the injection site; I couldn't sleep that night, because of soreness at the injection site; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (I couldn't sleep that night, because of soreness at the injection site), LIMB MASS (I had a large knot under my injection site arm), CHEST PAIN (large knot under my injection site arm, & it caused shooting pain across my chest), INFLUENZA LIKE ILLNESS (flu-like symptoms) and DIZZINESS (Dizziness) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Congestive heart failure. Concurrent medical conditions included COPD. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced DIZZINESS (Dizziness). On 27-Aug-2021, the patient experienced SLEEP DISORDER (I couldn't sleep that night, because of soreness at the injection site) and INJECTION SITE PAIN (I couldn't sleep that night, because of soreness at the injection site). On 28-Aug-2021, the patient experienced LIMB MASS (I had a large knot under my injection site arm), CHEST PAIN (large knot under my injection site arm, & it caused shooting pain across my chest), INFLUENZA LIKE ILLNESS (flu-like symptoms), TENDERNESS (My whole body was tender), MYALGIA (soreness all over my body), ARTHRALGIA (joint pain), FATIGUE (very fatigue), CHILLS (had chills) and HEADACHE (headache). On 29-Aug-2021, the patient experienced PYREXIA (fever of 100.1°F). At the time of the report, SLEEP DISORDER (I couldn't sleep that night, because of soreness at the injection site), LIMB MASS (I had a large knot under my injection site arm), CHEST PAIN (large knot under my injection site arm, & it caused shooting pain across my chest), INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (Dizziness), TENDERNESS (My whole body was tender), INJECTION SITE PAIN (I couldn't sleep that night, because of soreness at the injection site), MYALGIA (soreness all over my body), ARTHRALGIA (joint pain), PYREXIA (fever of 100.1°F), FATIGUE (very fatigue), CHILLS (had chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, Body temperature: 100.1 (High) fever of 100.1°F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Pt recvd MMR vax 15AUG90 & OCT90 devel OM, roseola, & a cough which lasted 2 wks; also noted rales; given med for resp infect; DEC90 devel bleeding gums; neutropenia;
Received 0.3 ml of not reconstituted vial. Vaccinator asuumed vial was reconstituted since vial was labeled with "RT" but was abbreviation for refrigeration time
Low risk pregnancy, due date 9/10/2021, complications caused an infection that resulted in termination of pregnancy.
24JUL91 8AM pt was given Engerix-B inject; Arm became red & warm @ inject site; Pt seen in ER-no treatment given; event abated;
kidney stones; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "he is diabetic" (ongoing), notes: Diagnosed maybe, she doesn't know 2000 or around 1996. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 3), for Covid-19 Immunization; Bnt162b2 (Dose: 2), for Covid-19 Immunization; Bnt162b2 (Dose: 1), for Covid-19 Immunization. The following information was reported: NEPHROLITHIASIS (medically significant) with onset 06Aug2023, outcome "not recovered", described as "kidney stones". The patient underwent the following laboratory tests and procedures: Body height: 5 foot 8 or 5 foot 9; Body temperature: fever around 99-101; Chest X-ray: he had viral pneumonia caused by Covid; X-ray: no pneumonia. Clinical course: She was reading all the information it can affect other conditions you have it can add to those conditions and one condition he hasn't had in a long time but is in pain and has had his share of kidney stones. When passing through it is very painful. They assume it's kidney stones. That started up with him being sick. Pain started like she would say 06Aug2023. Pain came maybe late Saturday. Pain is going from one to the other really hurting and then will be ok. Guess stones he has had over years but hasn't had in years. It's the stones going through bladder and tubes.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Headaches, nausea, fatigue, low grade fever, migraine all for 4 days. Migraine has not subsided. Naratriptan, nerve blockers inserted in head, three shots in arm (torodol, naratriptan, zoloft). Naratriptan four days after. Pregnazone taper for 12 days. Alanzapene for 13 days after taper. Dexamethazone for 12 days after Alanzapene. IV infusions (3 days in a row, scheduled for upcoming thursday, friday, and saturday).
Mother returned to flu clinic site and reported she noticed a rash on her son's back about 20 minutes prior. Dr. assessed patient, found macular rash to back, and order 25mg Benadryl IM.  Benadryl administered by RN.  Patient remained in observation for 30 mintutes and was released to care of mother with instructions to seek ER treatment if additonal symptoms occur/recur.