chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/16/2022 Felt itchy on the back of my scalp near neck, 1/17/2022 - [ ] Itchy all day, head, neck, skin - [ ] Hives disappeared or lessened in size  - [ ] This all happened around 11am - [ ] Took 2 25 mg banophen I got from pharmacy at 12 then again at 7, 1/18/2022 went to urgent care, prescribed - [ ] methyIPREDNISolone (MEDROL, PAK,) 4 MG tablet - [ ] cetirizine (ZYRTEC) 10 MG tablet, went to emergency room, felt line throat was closing. Not admitted. Went home.  1/19-23/2022 - [ ] Hands and feet hurt when pressure is put on them and red and swollen 1/24/2022 - [ ] Had more energy and hardly any itchiness. Skin still raised when scratched, Called allergist to make appt 1/25/2022 saw allergist and diagnosed with spontaneous urticaria and dermatographic urticaria.
Red, hot, itchy swelling directly under site of injection.  Blotchy redness down arm to below elbow.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium
Fever as high as 104, nausea, diarrhea, swollen lymph nodes- under my arm on injection site arm and on my neck- same side as injection site arm, massive headache, difficulty remaining awake, unable to eat due to nausea, dizzy, body aches and pains(internal organs hurt).
I woke up out of a dead sleep with a severe headache and my heart was pounding so hard that I thought it was going to explode out of my chest.  Lasted for several hours during the night long and did not feel  somewhat OK until approximately 4-5 PM on 10/08/2021.
Approx 1.5 weeks after 2nd dose, pain returned to injection arm and remained for a month.  Following this it transitioned into numbness with touch-sensitivity/pain.  This continued for 5 mos (and still continues as of this report date) with decreasing area.  Started with arm below injection site and over time the affected adverse event area shrunk distally.  Currently it is just affecting the distal areas of the left pointer and middle finger from the last joint to tips of fingers.
Seizures  I was found wandering naked outside the house at 5:40-6 AM.  I was let in the home and said I had to pee repeatedly, going to the bathroom 3-4 times in about 10 minutes.  My mother in law called my wife and and she brought me to the bedroom.  She saw I was confused and the room I was sleeping in was in disarray.  She was concerned but I thought I had probably been sleepwalking.  She is a night nurse so she went to sleep but stayed with me due to the strange occurrence. We typically sleep apart right now due to the covid surge.  Around 1245 PM my wife awoke to me seizing.  I had a tonic clonic seizure.  I was foaming into my CPAP mask and wet the bed with urine.  My wife pulled off my CPAP and ran into the house to alert her parents to call 911.  When she returned 20-30 sec later I had fallen onto the floor and knocked my bed to the side.  She held me to the side and I was still seizing when EMS arrived.  I did not respond to sternal rub.  EMS brought me to the hospital and I needed to be sedated and restrained as I was extremely confused and agitated after the event.  They tried versed x2 and finally ketamine IM to sedate me.    I received fluids, IV antibiotics, IV keppra, IV tylenol and IV muscle relaxers.    I know I had another unwitnessed seizure earlier that morning due to the pattern of disarray in the room after the second witnessed seizure.  I had fallen out of the bed both times.
lethargic; hot; slight fever, up by 1 degree; chilled; the arm started to itch like crazy; it was red; swollen; hard; A spontaneous report was received from a reporter concerning a 71-year-old, female patient, participating in the who received Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who and experienced  lethargy, chills, fever, vaccination site pruritus, vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site induration.   The patient's medical history, was not  provided by the reporter. There were no  Concomitant medications reported.   The patient received their first of two planned dose of mRNA-1273 on 09jan2021. On 09jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K2014)  in the right arm for prophylaxis of COVID-19 infection.     Initially after receiving mRNA-1273, the patient experienced lethargy, chills, fever up by 1 degree.        Action taken with mRNA-1273 in response to the events was not reported.     The events, lethargy, chills, fever   were considered resolved.   The reporter did not provide an assessment for the .events lethargy, chills, fever, vaccination site pruritus, vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site induration.
Alt is at 148; my INR level went from 2.9 to 4.3; This is a spontaneous report from a contactable consumer, the patient. This 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose  1, single dose via an unspecified route of administration in the left arm on 15Feb2021 at 12:00 PM (at the age of 65-years-old ) for COVID-19 vaccination. Relevant medical history included asthma and chronic blood clot in heart. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included amiodarone and warfarin. On 16Feb2021 at 15:00 the patient experienced alanine aminotransferase (ALT) at 148 and international normalized ratio (INR) went from 2.9 to 4.3. The events were reported as non-serious and required a doctor or other healthcare professional office/clinic visit. Treatment received for events alanine aminotransferase (ALT) at 148 and international normalized ratio (INR) went from 2.9 to 4.3 included reducing dosage of warfarin still working on the liver. The clinical outcome of alanine aminotransferase (ALT) at 148 and international normalized ratio (INR) went from 2.9 to 4.3 was unknown. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
patient who never received Twinrix third dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 8th October 2019) and Twinrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by pharmacist technician. The age at vaccination was not applicable for this report. The reporter asked safety information about the patient. The patient never received Twinrix third dose from standard dosing schedule, which led to incomplete course of vaccination. No information was reported about lot numbers from 1st and 2nd dose. The reporter consented to follow up.
2 days after receiving intranasal FluMist vaccine developed pain in hand/feet, general myalgias, itching of skin with rash, mild swelling of the real symptom with erythema.
Client reports when she woke up the day after shots were given, she was unable to move her (L) arm. Client came to our office, Dr. evaluated her, prescribed Tramadol, 50mg, 1 PO, Q 6 hrs PRN. Advised her to contact us as needed.
I received MMR vaccine ,Merck no 1381L 0.5SC left upper arm on 08/30/02, On the evening of Sunday, 09/22/02, I began to experience and myalgias which progressed to polymyalgia during the night. I was profoundly incapacitated, to be extent that i could barely talk walk or lift my arm. These symptoms responded to NSAIDS. Another individual who received MMR at Rhode Island Hospital apparently had a similar problem.
I started feeling very tired on June 2nd, 2022. I felt chills, fatigue, sniffles and cough.
approximately 24h after receiving the COVID-19 Pfizer vaccine booster, i presented with swollen and painful lymph nodes on the injection arm. These lymph nodes were located on the proximal side of the upper arm.
p/recv vax pt exp generalized itching sensation, 15min later itching @ waist, under breast, under arms, 15min later tight chest, hives at waist, @ mmr infect site & arm, hives bilaterally in axillae & behind knees, spots before eyes
Headache, Myalgia, Fever, chills Narrative:  patient also reported having chills day of vaccination. endorsed symptoms completely resolved
Hives, Rash, Swelling of eyes, redness, itching. Received oral prednisone, benadryl at the ER. Has had two doses of treatment and condition is improving but still present.
Patient experienced numbness and tingling down her arm into her fingers. Still continuing 2 days after injection. Arm is also sore allover, not at injection site.
Rapid heart rate with a feeling of fluttering and shortness of breath. Dizziness along with nausea and vomiting approximately 24 hours after the injection.
This spontaneous case was initially received on 14-Oct-2015. The case report was received from a Non Health Professional and concerns a female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 12-Oct-2015 - 12-Oct-2015, Batch no: 11049211A (thiomersal containing), Route of administration; Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 12-Oct-2015, after starting treatment with AFLURIA the patient experienced administration of vaccine from multidose vial of 9 doses/able to got 9 doses out of instead of 10 (AFLURIA MDV). On 13-Oct-2015, after starting treatment with AFLURIA the patient experienced joints ached, and felt like a "Mac" truck hit her. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: Non-serious. The patient was not concerned as this was an expected side effect.
This case was reported by a physician and described the occurrence of lethargy in a 2-month-old subject of unspecified gender who vaccinated with PEDIARIX. On an unspecified date, the subject received an unspecified dose PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced lethargy. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 06 October 2008 indicated that the subject was a 3 month old. Events of lethargy and adverse reactions (not specified otherwise) were reported to have begun on 10 July 2008 with a resolution date of 11 July 2008. The reporter considered the events to be probably related to the DTap component of the PEDIARIX vaccine. The 0.5 ml dose of PEDIARIX received by the subject was the 1st dose administered.
Tired, headache, lethargic feelings.  Then after starting to feel better had cold/flu-like symptoms for 5 days
severe stomach aches, severe period cramps and symptoms much worse related to PMS and period pain. two weeks after second shot, I had blurry vision for a day where I saw lots of white spots. for two weeks I had headaches as well.
2 days after vaccine she woke up with a big painful lump under her armpit. She stated that she cannot put her arm down. She will be going to the urgent care facility today because the pain has become unbearable.
alot of muscle jerking can barely hold on to anything always dropping things, glitching in eyes
Havrix adult dose administered to a child; Overdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a patient who received HAV (Havrix adult) (batch number 772YT) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Havrix adult dose administered to a child) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK receipt date: 27-OCT-2023 The pharmacist called MI to see which formulation was the following Havrix.  HCP requested information about how to proceed with Havrix second dose if a kid patient receive Havrix adult first dose. Health care professional (HCP) was in doubt about if there was a patient involved in this possible scenario. The child patient received adult Havrix dose, which led to overdose and adult product used by the child. The HCP accepted follow up by Safety Team to his personal  email.
This case was reported by a consumer via call center representative and described the occurrence of herpetiform lesion in a 75-year-old male patient who received SHINGRIX. The patient's past medical history included herpes virus infection. Previously administered products included shingles vaccine with an associated reaction of herpes zoster (1st dose received over 4 to 5 years before the date of reporting and experienced shingles a couple of years before the date of reporting). On 16th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, 7 days after receiving SHINGRIX, the patient experienced herpetiform lesion. On an unknown date, the outcome of the herpetiform lesion was recovered/resolved. The reporter considered the herpetiform lesion to be related to SHINGRIX. Additional details were provided as follows: The patient had not had a herpes lesion on his lip for over one year prior to the SHINGRIX vaccine. The patient's concomitant medication included, blood pressure medication and vitamins. The patient received the vaccine at approximately 2:00 to 3:00 PM and he experienced the worst case of herpes on his lips in two different spots. The lesions took about three weeks to resolve and the reporter described the lesions as one that was big and then on a separate area of his lip, the other lesion was smaller. The lesions were bigger than the patient ever had. The reporter was supposed to be getting the SHINGRIX vaccine but she kind of was hesitating she would even go for it.
patient was given an expired dose of Menactra, no adverse event; Initial information was received on 29-Jul-2020 regarding an unsolicited valid non-serious case from a other health care professional.  This case involves a 16 year old patient (gender was not reported) who was vaccinated with a 0.5 ml second dose (booster) once of an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (single-dose vial, lot U6208AD and expiration date 08-Jul-2020) via an intramuscular route in the right arm for prophylactic vaccination on 20-Jul-2020.  The patient received first dose of Menactra vaccine in the past on an unknown date.  The patient's medical history, past medical treatment and family history were not provided.  The patient was concomitantly vaccinated with a dose of MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for prophylactic vaccination (batch number and other dosing details were not reported).  It was an actual medication error case due to expired vaccine used (expired product administered).  No adverse event reported at the time of reporting.  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 Directive and Module VI of the 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.
Thirty five minutes following administration, patient became nauseous, dizzy, headache occipital area of head, and blurred vision. A fever developed at about 7:30pm with chills that lasted until about 4:30am the next morning.
9DEC91 MD recvd call from pt mom 6DEC91 state pt had high pitched screaming for 30-45 min; t100 ax, fussy, pt screamed from 8PM-1130PM; slept all night, fussy 07DEC91;
Patient did not disclaim that she had a previous reaction to the pneumococcal vaccine and answered no on the questionnaire and told the vaccinator that she had no prior reactions. She was instructed by the vaccinator to wait 15 minutes. Client stayed in observation room for 20 minutes and had no symptoms. She then left the building and went to her car. She was in her car for 10 minutes on the phone. She stated that at this time her lower lip started to feel heavy and numb, and her left arm started to feel itchy. She came back into the building and reported her symptoms. Vital signs were taken at 1325 (blood pressure 120/50 and pulse 70). Client given 50mg liquid oral solution of Diphenhydramine (Benadryl) at 1325. Vitals signs retaken at 1330 (Blood pressure 110/50 and pulse 70). Patient stated at this time that ?the itching is feeling better,? but also complained of a headache. Patient offered water. Continued to monitor. Patient sated that her headache was gone at 1337 and that her ?arm was only slightly itchy now,? and her ?lip feels better.? Vital signs taken at 1340 (Blood pressure 110/60, pulse 68, and SPO2 99%. Patient advised to follow up with primary care provider within 24 hours, or call 911 if symptoms return more severe. Patient walked out of facility unassisted with steady gait.
8FEB PM high temp 104, nausea, chills, pain in head, IV fluids, ATB no vomiting;hosp;pt was sent consent to sign for release of med records 3OCT97 but have not recv as of 23OCT97. The hospital discharge summary state dehydration, fever, sinusitis and HTN.
weakness; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced weakness. On an unknown date, the outcome of the weakness was recovered/resolved.   It was unknown if the reporter considered the weakness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's sister. It was reported that the patient received her first dose of Shingrix about one month before the date of reporting and the morning following her vaccine, she was weak for 4 to 5 days. The reporter did not have all the information for her sister's adverse event. The case has been linked with the case US2019100967, reported by same reporter.
Experiencing muscle soreness in his arms and legs; Headache; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th March 2022, the patient received the 2nd dose of Shingrix. On 25th March 2022, 1 days after receiving Shingrix, the patient experienced muscle soreness and headache. On an unknown date, the outcome of the muscle soreness and headache were unknown.   It was unknown if the reporter considered the muscle soreness and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-MAR-2022 Reporter's Comment:  This case was reported by the patient's wife. The patient received dose of Shingrix, a day before reporting and was now experiencing muscle soreness in his arms and legs and a headache. The reporter did not consent to follow-up. Additional supportive information:  This case has been linked to the case US2022054958 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022054958:Same Reporter
Day after vaccination fatigue, swollen lymph nodes.  All swollen lymph nodes are on left side of body, same as shot. Nodes in armpit were swollen to about the size of half a tennis ball and very painful.  Armpits were sore and swollen for approximately 4 days. After that swelling and pain were less intense. Nodes on neck and head painfully enlarged. They remain painfully swollen 1 week after shot.
I received the injection around 11:30am on Saturday, 8/21. Beginning about 7pm that evening, I started feeling very fatigued and soon after began having chills. I went to bed around 9pm and woke up several times during the night with intense nausea. I also experienced waves of chills and sweating all night and very vivid, realistic dreams. The dreams were so real and mundane that I?m not entirely certain still if they were dreams or me sleep walking/hallucinating. The next day I had extreme fatigue and both head and body aches - I felt as though I had been in a car accident. No additional nausea or chills/sweats all day Sunday, but just very intense fatigue and all over body aches. I took my temperature under my arm with my baby?s thermometer (it was all I had) and it read 104. I?m not certain of the accuracy though. I took extra strength Tylenol as frequently as the directions allowed and slept for most of the day and all night Sunday. Once I woke up Monday morning around 9am, I felt completely normal again.
Sore arm,headache,dysphagia. 2 hrs later arm red, hot, baseball size knot, swollen from shoulder to elbowTightness of throat, muscle spasms of legs and shoulders. Nausea. Tx for 5 hrs in ER with Benadryl and steroids
A few hours after the injection, he developed redness, swelling and mild discomfort. No fever or significant tenderness. Seen 10/31 and found to have 6x8 cm area of mild erythema, induration, in the general shape of the deltoid muscle.
This spontaneous report was received from an unspecified source, concerning unknown female patients from unmentioned ages, posted in an online article. The patients' concurrent conditions, pertinent medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL (dose number, anatomical location, lot # and expiration date were not known) for prophylaxis. Furthermore it was reported, that within a few years of vaccination the patients experienced ovarian dysfunction manifested by amenorrhea and premature ovarian dysfunction. The outcome of the events was not known. The relatedness between event and vaccination with GARDASIL was not provided. This is one of several reports received from the same source. Additional information is not expected as no contact details were given. Sender's Comments:  US-009507513-1705USA002407: US-009507513-1705USA002409: US-009507513-1705USA002408: US-009507513-1705USA002410: US-009507513-1705USA002411: US-009507513-1705USA002413: US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416: US-009507513-1705USA002393: ZA-009507513-1507ZAF012830:  US-009507513-1705USA003214: