chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vertigo; Its swollen base of my left ear down to my jaw, mandible particular and when I open my mouth I can feel like pain; Its swollen base of my left ear down to my jaw, mandible particular and when I open my mouth I can feel like pain; Chills; Nauseated; This is a spontaneous report from a contactable physician (Patient).  A 74-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BOTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262; Expiration Date: 31May2021), via an unspecified route of administration, administered in Arm Right on 10Feb2021 (Age at vaccination: 74-years-old) as dose 1 single for covid-19 immunization. Medical history included Chronic Otitis Media from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ), lisinopril (LISINOPRIL) both taken for an unspecified indication from an unspecified start date and ongoing. It was reported that patient had his first Pfizer vaccine dosage yesterday although he did not have any immediate allergic reactions within the first 15min, after 15 minutes he started getting chills, he had vertigo and he was nauseated so he laid down rest of the day. This morning his symptoms were pretty much same and its swollen base of his left ear down to his jaw, mandible particular and when he open his mouth he can feel like pain. he suffer from Chronic Otitis Media. It was reported maxilla, mandible, his ear to there, its swollen, if he open his mouth wide, it hurts little bit on that side. Stated hard to say all he know was approximately 30 min after the injection, it was terrible the jaw swelling does not bother me that much than he stand up he feel vertigo. Patient did no received treatment for the events. The outcome for the events was reported as not resolved at the time of this report.  Follow-up attempts completed. No further information expected.
2nd vaccine yesterday morning at 7:30 am.  Around 6 pm started to have headache and fatigue.  This morning 6-7 am; started to feel congestion as well, h/o sinuses infection.  denies exposure. Last COVID test was last Thursday 01/14 - negative.
Patient presented to clinic for COVID 19 booster and was given a full-dose Moderna vaccine. Patient notified of dosing error via voicemail and advised to call with questions/concerns.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 07-APR-2016 the patient was vaccinated with an expired dose of MMR II (lot # K003822, expired date: 14-MAR-2016). No symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pt received Anthrax and typhoid vaccines in left deltoid on 5/12/17. pt presented to clinic on 5/15/17 with a red, rigid, hot to the touch swollen upper arm (deltoid and bicep.) Pt states she was sun burnt over the weekend. Anthrax normal rxn seen before. Pt instructed to take Benadryl and use ice packs on the area and to f/u with PCM if not better in a day or two.
Ringing in the ear. At least one episode per day. Mainly left ear, but occasionally right ear. Prior to vaccine, ear would seldomly ring - once per year or so.
Adverse event: Severe bilateral hip joint pain and inflammation that left me unable to walk and unable to conduct normal life functions without severe pain for approximately 38 hours.  Treatment: Over the counter pain relief, heating pad, ice packs, laying flat on my back.  Outcomes: At around 38 hours after the onset of the severe bilateral hip joint pain and inflammation that left me unable to walk and unable to conduct normal functions without severe pain the pain subsided.
Red spot; Non-severe allergic reactions to the vaccine; Little bit bump; Little itchy; Pain, a little bit red on the injection site; little bit red on the injection site; She had a little bit pain; This is a spontaneous report received from a contactable consumer (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0168) via an unspecified route of administration, on 26Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated, she had her 1st dose of the vaccine on Monday (26Jul2021) and yesterday she experienced some side effects which were not severe. According to caller, there was a little itchy, little bump, pain, a little bit red on the injection site, but today it was not much itchy, she wants to know if she should get the 2nd dose of the vaccine which was scheduled on 16Aug2021. States the 1st day she had a little bit pain on Jul2021, non-severe allergic reactions to the vaccine and red spot on unknown date. Caller was asking why it needed to get the 2nd dose of the vaccine, was the 1st dose of the Pfizer Covid19 vaccine not enough for her to be protected. Caller stated she has a question, she was a little concerned. States she got the 1st dose of the Pfizer 2 days before and the same day she did not had any problems. Caller stated that yesterday she was a little itchy, a had little bit bump and a little ride up. States in this situation can she still had the 2nd dose that was scheduled on 16Aug2021. States she wanted to make sure she can had the 2nd dose or see if she needs to go back to the place she took the shot and show them to see if she was ok for the 2nd dose. Caller declines to make a report. States this was not a severe problem. Caller relays that her son took the same shot and she did not see anything and he was a little itchy but like a bump up now the 2nd day he was a little itchy. Caller states she has lighter skin and he has darker skin. States she was not so much itchy and at night time she took off her clothes and was a little bit red, did not feel itchy and did not feel pain. States the 2nd day she had pain and itchy and the bump and today it was getting better, she has no pain, no itching and the red spot was still there. Caller states it was not a severe problem she just concerned about the 2nd dose, it was a little bit reaction on her arm at the spot and she was not sure for the 2nd shot or if she needs to go back to where she got it and show them. Caller states she does not had any information about the name of the shot, that she did not ask any questions. The outcome of the events itchy, vaccination site pain, vaccination site erythema, was reported as recovered in Jul2021 and pain, allergic reaction was unknown and event red spotty rash was not recovered and vaccination site mass was recovering.  Follow-up attempts are completed. No further information was expected.
Pfizer Covid-19 adult dose given in error. Peds dose was ordered but not given. Sore arm, no other symptoms
Delayed period with no pregnancy, 5/20 marks 46 days late for period, daily headaches
Date 04/07/2022 was administered on 04/19/2022.Pfizer could not verify stability data and recommended another booster administered 05/09/2022
Dev. 3 cm x 3 cm erythematous emacution indurated rash ( L ) upper arm in the area of where PVC 13 was given think was warm to touch.
Couldn't lift her arm for several days; Couldn't lift her arm for several days / still hurts 2 weeks later; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a 18-year-old female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   In March 2021, the patient received the 2nd dose of Meningococcal B vaccine. On an unknown date, less than 2 weeks after receiving Meningococcal B vaccine, the patient experienced mobility decreased and pain in arm. On an unknown date, the outcome of the mobility decreased and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the mobility decreased and pain in arm to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's parent. The patient got the second shot 2 weeks before the date of reporting and she could not lift her arm for several days and it still hurt 2 weeks later. It was reported that it had never happened to the patient with other vaccines, and she had an extremely high pain tolerance. The reporter commented that it was scary reading all the posts with adverse reactions to this vaccine.
Muscles spams along spine with pain radiating to all four extremities, pain 8 of 10. Spasms accompanied with cold chills and headache 7 of 10 pain. Mild back pain started around 5:30pm and climaxed to full spams at 9:30 pm. Spams lasted until 11:30 pm. Hot bath and ibuprofen used as treatment. No history of prior back spams. Headaches occurred evening prior (6 hours after dose) and day after, muscle spams only on 9/17.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) 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; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Feb2023, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (received Paxlovid for COVID 19 treatment on 24Feb2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortly after the vaccine, I started having dizzy spells.  One dizzy spell resulted in a fall where I received a six-inch cut in my scalp requiring stitches in a hospital emergency room.
Pt recvd 3 doses of Engerix-B on 27APR90, 22MAY90, & 1OCT90 & was found to be a non-responder;
Entering details from my journal: Day 1 -- Received Jaansen vaccine on right arm. A few minutes later while waiting for vaccine card I felt very heavy arm as if I slept on it and a sharp pin-like pain in mid back to the left of spine near strap clip (not caused by clip).  Drank plenty of water afterwards when i arrived home; felt sleepy and a little sweaty.  Heaviness of arm mostly wore off a few hours later; perceived slight facial swelling by end of day; very sore injection site; Day 2 -- Drank usual coffee with milk after eating tangerine for breakfast.  A little while later, I felt little wriggly sensation around injection site similar to drying arm hairs lifting while wet skin is drying.  This lasted a few minutes.  It hurt to raise right arm due to muscle soreness; In the evening, I experienced mid-to-lower back discomfort and right hip joint discomfort (i never experienced hip joint discomfort in the past); Felt slightly achy and then drank more water; Day 3 -- Increased appetite, drank plenty of water, but was feeling blue for some reason; Noticed small, scattered raised small bumps similar to goosebumps on LEFT forearm -- didn't itch. Day 4 -- Felt actually good and energetic before having my morning coffee and throughout the rest of the day.  The scattered small bumps were still there but did not spread up my arm; there appears to be more bumps on the left forearm -- doesn't itch. Day 5 -- Soreness at injection site is not noticeable except when I lift my arm.  Noticed additional small goosebump-like bumps on my RIGHT forearm -- doesn't itch; Day 6 -- Felt wriggle sensation inside head or brain front left lobe for a few seconds -- very disconcerting but ignored it as another side effect of the Jaansen shot Day 7 -- Small bumps still of both forearms and very, very little spread to left bicep.  A very small dime-size patch on inner left forearm started to itch during the day so i ignored it by focusing on tv and the itch went away. In the late evening, while watching TV, both forearms felt AFIRE.  I tried to remain calm and ran cool water and applied medicated talc then i watched tv to force the focus away from the fiery flareup heat sensation.  It worked.  The fiery sensation peaked for a few minutes before it was gone; Day 8 -- Small bumps began to recede -- no itch. Felt wriggle sensation inside head again for a few seconds Day 9 -- Slight muscle acute ache near bra clip area again (not from bra clip); injection site no longer sore;  bump developed in middle of lower lip--applied iodine and it disappeared later; Day 10 -- small bumps on foreams nearly disappeared; felt wriggly discomfort in right armpit, scap, belly and left brow; Day 11 -- Skin on forearm is 97% clear; still feeling wriggly sensation for several days after but not the ones in my head. Thank you for the opportunity of documenting my symptoms.
Erythema to (L) upper arm down to just above elbow; hot to touch, painful 4/10 pain.
This spontaneous report was received from a nurse and refers to an unspecified number of adult patients. No information regarding the patients' pertinent medical history, concomitant medication and drug reaction or allergies was reported. On unknown dates, the patients were vaccinated with the complete three-dose series of RECOMBIVAX HB (strength, dose, route of administration, lot # and expiration date were not provided). On unknown dates (also reported as "over the years"), the patients were nonresponders (did not have detectable antibody levels). The outcome of the event was not reported. The relatedness between the events and RECOMBIVAX HB was not reported. This is one of several reports received from the same source. Additional information has been requested.
6 months since shot and I'm still experiencing fatigue, chest pains, shortness of breath, joint aches, headaches, tingly/numb sensations in various places, erectile disfunction, brain fog... previously active and would run for recreation regularly. Now can no longer run due to shortness of breath.
THE EMPLOYEE CONTACTED THE FACILITY AND STATED HER LEFT SIDE OF HER FACE IS SWOLLEN FROM THE EYE TO THE EAR. EMPLOYEE STATED SHE WAS ON HER WAY TO THE URGENT CARE AND WOULD GIVE US A CALL ABOUT WHAT THE DOCTOR STATED.
The next morning, patient developed a rash on his left arm that itched at first but did not last long.  He had not had any reactions to previous flu vaccines as far as he could recall.  He said he did not take any medications, like Benadryl, to resolve the issue as it is starting to get better on its own.  I informed patient if the rash started getting worse again, he should let a healthcare professional know.
The information was received from a pharmacist via Pfizer referring to three adult male patients under the age of 65. The reporter did not know of any concomitant medication, other medical conditions or if any tests were performed. On an unknown date, the patients received PNEUMOVAX 23 (lot number and dose unknown) and influenza virus vaccine (Flu vaccine) (manufacturer unknown) (lot number and dose unknown). All the three patients received the influenza virus vaccine (manufacturer unknown) at the same time. The indication for the influenza virus vaccine (manufacturer unknown) was assumed to be for protection against the flu and PNEUMOVAX 23 for protection against pneumococcal pneumonia. On an unspecified date and time, post administration of PNEUMOVAX 23 and influenza virus vaccine (manufacturer unknown), the patients experienced fatigue. The outcome of the event fatigue was unknown. The reporter considered the event was related to PNEUMOVAX 23 and the causality for influenza virus vaccine (manufacturer unknown) was unknown. Additional information has been requested.
Pt developed rash on arm, chest and back.  Pt also had severe itching and rhinorrhea.  Symptoms began = 1 hour after adminstation.  Pt was given some benedryl.  Symptoms are resolving.
This spontaneous report as received from a medical assistant refers to three patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with a dose of PEDVAXHIB injection (dose, route of administration, indication, lot# and expiry date unspecified), that were improperly stored on an unspecified date. No concomitant medications were reported. The doses were administered according to the prescribing information. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
administered Fluzone High Dose to a patient who is 58 years old, with no reported adverse event; administered Fluzone High Dose to a patient who is 58 years old, with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from pharmacist and consumer or non-health professional via Information (Reference number: 00789359) and transmitted to Sanofi on 28-Sep-2021.  This case involved a 58-year-old patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported. [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test, strength: 0.5 mL, lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  This was actual medication error case due to Inappropriate age at vaccine administration and vaccine overdose.  It was reporter ''pharmacist states that the patient administered FLUZONE HIGH DOSE to a patient who was 58 years old. Pharmacist asks if this was okay and if it would cause any problems. Pharmacist states the patient did not have time to complete an adverse event or safety report at time of call. Pharmacist was given case reference number; stated the patient would try to call back to complete adverse event or safety report at a better time.''  no other vaccines.  At the time of this report the patient was fine and had no adverse events after the vaccination.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Initial unsolicited report received from physician via other company (Pfizer) on 14 November 2016. (Manufacturer report number: 2016494864). This case involves a male patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS TOXOID) (dose, batch number, expiration date site and route of administration was not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following vaccination patient had allergy to vaccine. Lab data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
This serious spontaneous case, initially received on 06-Feb-2018, reported by consumer, concerning a 50-year-old, adult, male patient. The patient had pneumonia (reported as during childhood). The patient's current condition included multiple sclerosis (since an unspecified date). Since an unspecified date in 2008, the patient started treatment of GILENYA (dose: 0.5 mg, route of administration: oral, frequency: once daily, batch number, expiry date: not reported) for multiple sclerosis. On an unspecified date (4 to 5 weeks ago), the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date (reported as 4 to 5 weeks later vaccination), the patient developed cold, sore throat and flu symptoms. It was reported that the patient had cold a week prior. On an unknown date, the patient also experienced respiratory infection. The patient was referred to a physician. On an unspecified date, the patient recovered from cold, while the outcome of the events, sore throat, flu symptoms and respiratory infection was not reported.
I got the vaccine on the 10/22/2014. I only want to take the flu shot every other year. This time the news of ebola, made feel I have to take it. About 45 min to 1 hour my arm's were itching bad I was shopping. Got home looked at my body at that time I didn't know what it was. My doc said it was hives.
Local reaction left deltoid; swelling and redness 8cmx11cm. Rx Benadryl and Ibuprofen PRN
first episode was 11AM had no appetite, & had apnea; that day followed w/2 more apneas both in which had to stimulate viguorously; color was nl but seemed a little lethargic;
pt recvd vax; upper arm swelled & a rash formed on upper arm & chest area;
CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was unknown if the patient had drug abuse or illicit drug usage, consume alcohol and smoke. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 14-AUG-2021, the patient experienced chills. On 14-AUG-2021, the patient experienced fever. On 14-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, chills, and nausea. This report was non-serious.
Arm progressively sore; Pains in the right arm/Pains in the right leg; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm progressively sore) and PAIN IN EXTREMITY (Pains in the right arm/Pains in the right leg) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 012M29A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (Arm progressively sore) and PAIN IN EXTREMITY (Pains in the right arm/Pains in the right leg). At the time of the report, MYALGIA (Arm progressively sore) and PAIN IN EXTREMITY (Pains in the right arm/Pains in the right leg) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
On March 14th, 2011 a 15 years old male received 7 vaccines at about 2pm at Health Department. When he returned home, he felt dizzy and discomfort to his body so his parents took him to hospital for check up at night time. He stayed in hospital for three days and was discharged on March 16th, 2011. He returned to his school on March 17th, 2011 and still complained same symptoms in school. That was the time this clinic received the phone call from school on March 17th, 2011 at about 4pm reported by his school nurse.
Chills x 3 days Shaking, tremor x 1 day Fatigue x 3 days Brain fog  x 3 days