chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The pt woke up on 10/16/01 and had redness and a hard knot to thigh. Mom called school nurse to look at it and the school nurse said there was a large red, hot area on thigh and painful to touch. The school nurse referred him to MD. Mom couldn't get child to MD so went to ER. He was dx'd with allergic reaction and given Benadryl and Augmentin. He never had a temperature. By 10/18/01, almost all of the redness and hardness was gone. On 10/23/01, mom states "no redness noted".
Case number PHEH2016US029332, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 37 years old male patient. Past medical history and concomitant medications were not reported. The nurse stated that, first temperature excursion of FLUCELVAX QUADRIVALENT at 52 Fahrenheit for 01 hour occurred on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 02 Nov 2016. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error.
Patient received vaccine and remained in pharmacy for 15 min. She had no adverse effects during that period. She then got in her car to drive home and within 5 min (20 min after the vaccine) she began having numbness in her face. She then drove back to the pharmacy to notify us of this.  She denied any chest tightness, swelling of lips/throat,  difficulty breathing. She was given 25 mg diphenhydramine and remained under our observation for another 15 minutes. Symptoms improved within 10 min after administration of diphenhydramine and drinking a bottle of water.
Headache, Myalgia, Arthralgia, Fever,  CoughWheeze & Syncope
PATIENT RECEIVED VACCINE ON 9/19/2017. PATIENT CALLED OFFICE ON 9/21 STATING HE HAD PAIN AT INJECTION SITE AS WELL AS REDNESS AND SWELLING FOR OVER A DAY. PATIENT INSTRUCTED TO TREAT WITH ICING/COLD COMPRESS, AND ACETAMINOPHEN AND IBUPROFEN.PATIENT RETURNED TO OFFICE 9/22. PAIN RESOLVED, BUT REDNESS/SWELLING HAD WORSENED. PATIENT COMPLAINED OF "MILD TINGLING" IN LEFT FIFTH AND ULNAR SIDE OF FOURTH FINGER, BUT NO WEAKNESS OR PAIN NOTED. PATIENT INSTRUCTED TO CONTINUE IBUPROFEN/ELEVATE ARM AND ICE ONLY 15MIN BID. PATIENT RETURNED TO OFFICE ON 9/23. REDNESS/ERYTHEMA DIMINISHED, FAINTER WITH MILD ITCHING. TINGLING/PAIN RESOLVED. CONTINUE TREATMENT.
Information has been received from a physician concerning a 2 month old male who 18-FEB-2008 was vaccinated orally with a first dose ROTATEQ (lot # 659685/1619U). Suspect therapy that same day included Hib conj vaccine (OMPC) (manufacturer unknown). Concomitant therapy included PEDIARIX, PREVNAR and ZANTAC. On 18-FEB-2008 the patient developed non stop vomiting 12 hrs post vaccination and was unable to keep anything down. The patient was taken to the hospital on 18 FEB 2008, at which time the patient was admitted, and treated with intravenous (unspecified). The patient was released from the hospital on 20 FEB 2008. At the time of reporting the patient was recovered (date unspecified). There was no product quality complaint. Additional information has been requested.
Patient got the IMZ high up and behind the arm. Immediately felt pain, and shortly after redness. Just took ibuprofen. Redness, but the pain moved down and felt her pinkie and pointer finger start to get tingly and numb. Been over a month and still feeling the numbness and tingling.
Immediately following the vaccination the nurse came to me stating that the injection did not "feel" right and that there had not been the typical resistance that she usually notices.  She wondered if the syringe was empty.  (The patient had already left the station.) We inspected the syringe and I then asked her to compare it to the next syringe that she used to vaccinate, making sure to look closely at the next syringe.  Upon comparing the two the one (of concern) was obviously "dry."  I will request ability to append a full report to this report.      I called the patient that evening and informed him of the situation and he returned today for his "replacement" vaccination.
Significant swelling, redness from upper arm to elbow & rash appearance, painful for 4 days after administration.
PERSISTING BODYACHE; PERSISTING FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 19-JUN-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: Body temperature (NR: not provided) 98.5F to 101F. On 20-JUN-2021, the subject experienced persisting bodyache. On 20-JUN-2021, the subject experienced persisting fever. On 20-JUN-2021, the subject experienced headache. On 24-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and had not recovered from persisting fever, and persisting bodyache. This report was non-serious.
Case number PHEH2015US002315, is an initial spontaneous report received from physician on 29 Jan 2015. This report received 16 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENOMUNE (batch number: UH532AA) instead of MENVEO (batch number: not reported) on 28 Jan 2015. The reporter was intended to administer MENVEO. No adverse events reported after the maladministration.
Information has been received from a medical assistant concerning an 87 year old male hypothyroid patient with allergy to sulfur, hypertension, high cholesterol, chronic obstructive pulmonary disease, and a history of coronary artery bypass graft, QUAD bypass and cataract surgery who on 13-JAN-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665708/0651Z, expire date 15-JUN-2011), 0.5 ml, subcutaneously. Concomitant therapy included PLAVIX, BYSTOLIC, LIPITOR, AVALIDE, NIFEDICAL, levothyroxine NA, aspirin and fish oil. Medical assistant stated that the next Friday (on 14-JAN-2011) after vaccination with PNEUMOVAX 23, patient called the office to report he did not sleep well the whole night after receiving PNEUMOVAX 23 due to the pain and discomfort he felt in his arm. Medical assistant indicated that patient did not report any swelling, redness or fever in the first 24 hours following receipt PNEUMOVAX 23. Patient was instructed to apply cold compress (ice) for 10 minute intervals every couple of hours and call back if there was no improvement. Medical assistant mentioned that on Saturday 15-JAN-2011, the patient called the on-call physician to report he was still losing sleep and he had begun to have redness down the arm. Medical assistant mentioned that on Sunday 16-JAN-2011, patient reported that his arm began to swell and the redness increased all the way down the arm. Medical assistant also said that by Monday morning 17-JAN-2011, when the patient was seen by the doctor, the redness and swelling had began to subside (about 50% as reported by the patient) but for precautionary measures, the physician placed the patient on cephalexin and ordered a multitude of tests: comprehensive metabolic panel, sed rate, CBC, C-reactive protein, ANA (results not provided) to be certain the symptoms the patient was experiencing were not due to an underlying condition, that may have coincidently appeared at the time of the vaccination. At the time of the report, the patient was recovering. Follow-up information has been received from the medical assistant, who reported that the retired patient with no acute illness at the time of vaccination, who was vaccinated with a second dose of PNEUMOVAX 23 (Lot # 665708/0651Z), SQ, left arm on 13-JAN-2011 at 11:30. The medical assistant stated that on 14-JAN-2011 the patient experienced redness with itching, swelling of left elbow. The medical assistant also reported that the left upper arm had only a small bruise no indurations tenderness, or pain. The pain swelling, redness extended from left elbow to left middle upper arm and left forearm upper (2 inches) above left wrist that worse 2 days later, no fever, ice, elevation, KEFLEX initially and later oral prednisone was given as a treatment. The medical assistant also stated that the patient never had any shortness of breath or chest pain. At the time of the report the patient's outcome was unknown. The events required medical/surgical   [Due to memory limitations, the remainder of this text could not be compared.]  surgical intervention for several visit follow-up. Additional information has been requested.
Dizziness, Tachycardia, tingling in upper and lower extremities Narrative:
This spontaneous report as received from a nurse via a representative refers to a 14 year old male patient. On an unknown date the patient was vaccinated with a dose of GARDASIL injection, 0.5 ml, intramuscular (lot # and expiry date unknown). The patient developed weakness in the knees after standing up "shortly" after receiving GARDASIL. The nurse reported that the patient was instructed to lay back on the table and the patient was monitored for an unspecified amount of time and then sent home the same day after he was better. The patient was recovered. No treatment was given for the event. Lab diagnostics studies were not performed. Additional information is not expected.
Patient fainted after receiving the vaccine. He was standing in line w/his mom post the vaccine & passed out on the floor for a second.
Initially admitted with extreme shortness of breath/pneumonitis and pleural effusions noted after 2-3 week history of illness. Admit 3/27/03. On 4/6/03 Patient had mental status changes, partial complex seizure. Shortly thereafter decreased BP, required ventilation. Transferred to another hospital; later expired. Information received from transfer summary states fever, pain in chest, cough increased, supraventricular tachycardia.   Discharge final summary states accident injury, collegen disorder, sepsis, nausea, vomiting and back pain. msv
Pt with redness, warmth on (L) arm surrounding injection site. Area is very tender. WBC was elevated. Dxed with early cellulitis & txed with antibiotics.
patient complained of severe joint aches, whole body hurt, believed he had a fever, malaise for several days
received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number GF2DK, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 13th September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The patient received fluarix vaccine after its expiry date which led to the event expired vaccine used. The reporter did not consent to follow up. This is 1 of the 8 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232194:Same reporter US-GLAXOSMITHKLINE-US2021232193:Same reporter US-GLAXOSMITHKLINE-US2021232202:Same reporter US-GLAXOSMITHKLINE-US2021232201:Same reporter US-GLAXOSMITHKLINE-US2021232197:Same reporter US-GLAXOSMITHKLINE-US2021232200:Same reporter US-GLAXOSMITHKLINE-US2021232198:Same reporter
2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Tongue numbness then throat tingling  She had premedicated with Benadryl oral 25 mg.   Additional dose of Benadryl 50mg IM given   observed one hour and began to have reappearance of symptoms.  Epi 0.3 mg given.
90y.o. male with PMH as below who presented on 8/4/22 with coffee ground emesis found to have gallstone illeus requiring ex lap on 8/5/22. His post-operative course has been complicated by afib with RVR, initiation of TPN, COVID+ on 8/17 with worsening respiratory distress requiring ICU admission. He underwent CT non-contrast abd/pelvis today after hgb this am returned at 6.7, down from 9.0. Imaging demonstrated new bilateral retroperitoneal hematomas, greater on the right. IR is consulted for possible embolization. 8/24: The patient has been hypotensive during the day with BP 80s/40s. He has received 1 uPRBCs. Current HR in the 60's on amiodarone drip. He is on HFNC. He is on a heparin gtt for treatment of his Afib. The patient reports right flank pain. He otherwise states that he is doing well. He denies fever, chills, chest pain, n/v/d, or headaches.   8/25:  Hgb downtrending during the day despite 3 uPRBCs. CTA abd/pelvis obtained demonstrating small contrast blush along the proximal right inferior epigastric artery. CTA demonstrating possible extrav near R inferior epigastric. IR angiogram with no evidence of bleeding, no intervention done .  Intubated and ventilated.
Allergic reaction: Hives all over body Patient was seen at Urgent Care by MD on Thursday 1/19/2023 @ 6:25pm for the allergic reaction. She was administered PR/TX/PROPHY/DX INJ SQ/IM for allergic reaction.  She was prescribed triamcinolone acetonide (KENALOG  40)
neuropathy in each arm and both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "neuropathy in each arm and both hands". Clinical course: After receiving a Pfizer vaccine in each arm patient now had neuropathy in each arm and both hands and don't have diabetes or any other issues. Patient thought the need to be compensated for this horrible heath issue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300201418 same patient, same vaccine, different doses, same events;
R jaw pain maxillary/mandibular with mouth symptoms in neuropathic pattern similar to V2/V3 trigeminal distribution, low concern for CNS event, saw urgent care, dentist, periodontist, PCP x 2, scheduled to see ENT; symptoms improving somewhat, supportive care with viscous lidocaine, ice/heat, APAP/NSAIDs
Pt. reported redness, arm and back pain. Explained normal adverse effects of shot. Pt. wanted to go to Dr. She iced it and took TYLENOL. Redness was inside of arm opposite injection site.
pt recvd vax SEP92 & exp pain in lt bicep & @ both inject sites; persisted for 3 to 4 days; pt exp tingling in lt hand;
Normal reactions but no out of ordinary reaction; Went to get a stress test the other day, and they gave her contrast with dye in it. The patient ended up being allergic to the lipids component; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Normal reactions but no out of ordinary reaction) and CONTRAST MEDIA ALLERGY (Went to get a stress test the other day, and they gave her contrast with dye in it. The patient ended up being allergic to the lipids component) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Normal reactions but no out of ordinary reaction) and CONTRAST MEDIA ALLERGY (Went to get a stress test the other day, and they gave her contrast with dye in it. The patient ended up being allergic to the lipids component). At the time of the report, VACCINATION COMPLICATION (Normal reactions but no out of ordinary reaction) and CONTRAST MEDIA ALLERGY (Went to get a stress test the other day, and they gave her contrast with dye in it. The patient ended up being allergic to the lipids component) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: results not reported Results not reported.         No concomitant medications were reported.  It was reported that the patient was now worried if she should continue to get her booster shot if it had lipids.  No treatment medications were reported.   This case was linked to MOD-2022-488522 (Patient Link).   Reporter did not allow further contact
fine papular eruption enter aspects for arms-pruritic, began 5hr p/inj;no other sx;
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 20-APR-2011, the patient was vaccinated with the first dose of GARDASIL (lot #, route and site of administration was not provided). On 07-FEB-2013 the patient was vaccinated with the second dose of GARDASIL (lot #, route and site of administration was not provided). No adverse symptoms was reported. Additional information has been requested.
Admission on 10/06//2021 with pleuritic chest pain secondary to pericarditis after receiving third dose of COVID-19 vaccine (booster), which resolved with colchicine and ibuprofen. He was found in fluid overload on exam which was corrected by additional HD treatment and Lasix IVP. Seen by cardiology, pulmonology and nephrology. Condition improved during hospital stay. Denied any chest pain or shortness of breath. Converted to NSR and remained in sinus. No further pleuritic left chest discomfort with inspiration. Patient was discharged 10/08/2021.
SYNCOPE, LIGHTHEADEDNESS, NAUSEA, PALE SKIN, AND FAINTING.  MEMBER ACTUALLY FELL OUT OF CHAIR SHE WAS SITTING IN AND HIT HER HEAD, MEMBER WAS SEEN BY A STAFF PA.
Pt. began to experience a little shortness of breath, then had chills and sweating.  Also had headache and muscle aches. Fell asleep and woke up feeling fine next morning.  Experienced same symptoms with last influenza immunization.
9 days post initial injection a bulls-eye, hot, non-pruritic rash appeared. The rash coalesced and became slightly itchy and remained warm for several days. Nothing was done to abate symptoms.  Photo was sent to healthcare provider.
2 days after injection, noticed red rash between and under breasts and on back. No pain, no itching. I feel absolutely fine,
Worsening paresthesias & numbness, tingling anterior chest, left face, arm, leg, top of hand, and left eye twitching. MRI & CT of head, referral to Neurology.
Monday, Feb 15- Mild Headache, Feb 16 - mild body ache, Feb 17 - symptoms resolved
Patient contacted office today reporting  "headache started somewhere between 11 and 1 yesterday. No it has not stopped it did ease up a little bit but then right back bad. I vomited at about 7 o'clock this morning but that was actually more dry heaving. I did vomit At 7:30 this morning and it was bile. I got probably between 5 and 6 hours of sleep last night and only woke up 2 times in that period of sleep. I felt like I had gotten up sleep but I'm just tired I do have a little bit of diarrhea it's not bad but But it hits me here and there and I have to run to the restroom. I felt fine yesterday morning when I was there to get the shot". She then added "also vomited at like 10 this morning.  I haven't been able to eat my stomach is queasy.  I haven't had as much to drink as usual"
In case of starting the vaccination at 11:45am it went fine and once again I have have no medicine allergies.  My adverse effects were the following throwing up, pain in the upper Portion of my neck and slight pain in my chest , and fever with chills  grandually getting worse throughout the day.  By 9:00pm - midnight I couldn?t even sleep or close my eyes to sleep because the pain was unbarring that I had to call my family for mental support.  I eventually fell asleep because of exhaustion, and Sunday I couldn?t even get out of bed my body was so worn out from the shot and the night. I stayed home all day and slept . I still  have pains in my neck and coughing becomes my issue.
The pt experienced chicken pox spots approximately 300 all over body. They appeared but did not break completely out and scab.
Chills,; fever; sweating; headache; loss of appetite; joint pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 06Apr2021 at 15:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no allergies to food, medications or other products. The patient did not receive any other medications  within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. On 09Apr2021 at 03:00 the patient experienced chills, fever, sweating, headache, loss of appetite and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chills, fever, sweating, headache, loss of appetite & joint pain was recovered, on unknown date in Apr2021  No follow-up attempts are needed. No further information is expected.
Infant became lethargic within 6 hours, post vax of DPT #2. He was speech impaired until the age of 10. He has a history of febrile seizures since DPT #2. Child has transient asthma and is working on overcoming dyslexia.