chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 year old female patient with atypical seizure disorder (started following an episode of head trauma) characterized by lip smacking and dysarthria (not tonic clonic movements). She was on treatment for this. On 10-MAR-2009, the patient was vaccinated with the first dose of GARDASIL (Lot # 661841/0653X) in the right buttock and had only minor localized tenderness. Subsequently, in March 2009 the patient developed paralysis, dysarthria, pain in legs and "stroke-like symptoms". In follow-up, the physician reported that on 13-MAR-2009, 3 days after the dose, the patient developed a rash in the distribution of her quadriceps on both legs which lasted 3 days before resolving. ON 17-MAR-2009, 1 week after the dose, the patient developed dysarthria without other seizure symptoms. There were no new medications or change in medications. The patient was admitted to the hospital for evaluation: EEG, CT, CBC, blood chemistries all came back normal. She was discharged without any specific treatment. On 24-MAR-2009, the patient saw her neurologist for the dysarthria. An MRI with gadolinium was negative. That evening at home she stood up and lost consciousness. The patient complained of numbness in her right arm and leg. On 25-MAR-2009, the patient had been complaining of burning pain in the right leg (front and back) without focality. There were no objective physical findings. At the time of reporting, the patient's dysarthria persisted. Upon internal review, paralysis and stroke-like symptoms were considered to be other important medical events. Additional information has been requested.  4/17/09 Office notes received from PCP from 3/10/09 to 3/30/09. New pt visit 3/10/09.  Depoprovera and HPV#1 given.  OV 3/25/09- Pt developed injection site swelling and rash.  On 3/18/09 had a seizure with dysarthria seen in ER and admitted. Now with R arm pain and numbness.  PE (+) for slurred speech. Last night pt was dizzy, passed out, had dry heaves, leg numbness and R arm tingling. Tx with IM and po steroids. Seen 3/27/09 Still having severe,  shooting leg pain, speech improving. TX Toradol and Lyrica. Office note 3/30/09 reporting pt admitted with DX of GBS.    5/7/09 Hospital notes received from 3/18/09 to 3/19/09.   FINAL DIAGNOSIS: Seizure Disorder Unwitnessed seizure, mother states prolonged postictal phase, confused, slurred and repetitive speech.  Additional seizure in ED, shaking, eyes rolling, tongue moving, arms flexed. Returned to previous postictal state.  PE WNL other than dialated pupils. Consider possible conversion disorder.  6/4/09 DC and hospital records received DOS 3/28/09/ to 3/29/09. FINAL DIAGNOSIS: Persistant Right Leg Pain Post vaccination presents with severe right-sided leg pain. Vaccine was injected into right buttock. Depo-Provera into left leg. Seizure. Passed out, tingling and numbness on right side of body. Follow with psychiatry.
Pt given flu shot on 11/25/14. States her arm was red and swollen a few days later. Pt went to a local ER and was given antibiotics. Pt was then seen by a family doctor who diagnosed as staph infection.
pt recvd vax 21MAY93 & taken to ER 22MAY93 by mom w/rash; MD treated w/Epi & DPH per mom's report; MD advised mom to call clinic & report reaction;
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Severe, Systemic: Tinnitus-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: pt with syncopal episode following vaccine but initially unable to speak so epi pen was given.
Patient received vaccine with no issue. Within a minute or two, he felt as if his eyes were closing and began to faint.  HIs significant other was able to guide him to the bench.  I immediately went out and lifted his feet and began rubbing his chest and calling his name.  He responded and I proceeded to continue to talk to him and provide comfort until firemen arrived.  He was very "clamy", sweating, pale and complaining of stomach pain.
She says she had what felt like a band across her forehead, also her cheeks bulging out. This is what she felt like. She says she has vertigo that has not gone away and this started after the begining of 2022, she had her 3rd Moderna shot in December 2021. She is currently in the hospital for persistent weakness and she does complain of the continued vertigo. She says her doctor has told her she is "just getting old."
Pt felt wave come over body @ 1218 starting in head and going down. Bad taste in mouth, tingling in body ,  legs, back , across stomach, BP 150/100 P 120@ 1219, EMS activated. BP 120/80, P 80 Pt alert and oriented, Pt declined transport and Benadryl. Symptoms come and go, pt feels better but then bad taste in mouth starts, shaking of hands, tingling starts again in stomach and back. @ 1300 pt requests Benadryl, 25 mg administered. Pt notified family by phone of circumstances and family in transit.@1324 BP 120/80, P 84, tongue tingling and pt  reports smelling chemical smell. @1345 Pt complained of mouth itching, EMS activated and will transport to Medical Center.  Pt oriented and transported at @13
7x8cm inflammed localized reaction 8 hrs after injection in L lat. thigh c/o itching; minimal pain.
The patient called the pharmacy & reported having congestion, aches and pain all over, and that her skin was tinted orange all over including her hands, face, arms.
Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days; Admnistered Moderna vaccines beyond use date or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Admnistered Moderna vaccines beyond use date or expired) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Admnistered Moderna vaccines beyond use date or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Admnistered Moderna vaccines beyond use date or expired) and PRODUCT STORAGE ERROR (Vaccines are kept frozen until they were ready for administration, in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported.  Vaccines were kept frozen until they were ready for administration which meant they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated.  No Treatment information was reported.
may have given the child Pfizer instead of Moderna; may have given the child Pfizer instead of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (may have given the child Pfizer instead of Moderna) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (may have given the child Pfizer instead of Moderna) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (may have given the child Pfizer instead of Moderna) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (may have given the child Pfizer instead of Moderna). At the time of the report, WRONG PRODUCT ADMINISTERED (may have given the child Pfizer instead of Moderna) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (may have given the child Pfizer instead of Moderna) outcome was unknown.            No concomitant medication was reported. Reporter states that she already got the vaccine and everything online was a different color than the one she saw. Reporter thinks she saw the label was orange, reporter did not remember the cap color. Reporter saw online that the orange cap was Pfizer she thinks and they might had given the child Pfizer instead of Moderna. Reporter says she was 99 percent sure the vial was orange. Reporter was  wondering and wanted to double check. No treatment medication was reported.
The pt experienced a 7 1/2 cm circle of induration with extended region of erythema past that. The pt also experienced itching and pain to the right deltoid region.
In order of occurrence: Chills Face and neck hot and itchy, red rash on face Back itchy, red rash across back Head itchy, can't tell if a rash Bad arm pain to touch, not usual shot arm pain, couldn't lay on left side to sleep Cold all night, used 2 blankets instead of usual 1; fitful sleep As of this writing: arm pain better but minor arm redness/swelling; face and neck hot; neck/back/head itchy, rash on neck/back but not as red as yesterday.  Feel cold.
Starting 1 week after the vaccine (04/24/2021), I developed a flare-up of my Psoriatic Arthritis. My joints were swollen and red. It never really calmed down due to receiving my second dose shortly after.
refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351, 2020SA038352 and 2020SA038468.  This case involves a 13 years old male patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the right arm for Prophylactic vaccination on 15-Jan-2020.which was exposed to the temperature of 29.1F (Product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient inspite of being compromised.  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 compliance with the requirements set out in 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.
Shortly after Vaccination she had syncope and started vomiting in waiting area while sitting down since she wasn't feeling well. EMS was notified by an EMS walking by and seeing her in our waiting area. Ambulance arrived and vitals were checked and normal. She ate some crackers and had some water and walked out of the store on her own with parents.
Last night experienced itchiness on the back around 5:00 for a few hours. Chills, body aches and pain
"Member has been having pain in hands and knees for one week following recent COVID vaccination. Has history of gout and is still having this in his hands and knees. Feels this pain when he gets up in the morning. Indomethacin has helped a little bit, but not like normal. Noted some swelling hands and left knee. No shortness of breath or chest pain. Every other joint is fine.  PE: normal insight and thought content. Normal work of breathing and speaking in full sentences. No aphasia noted.
62 yo female who recieved PPSV23 vaccine in R deltoid on 1/13. Pt also recieve influenza vaccine in L deltoid on 1/13. Per pt, she had received a pneumococcal vaccine in the past without any reactions. Initially, pt developed erythema, swelling, drainage, pain (took NSAIDs, used cold compresses, neosporin, witch hazel) on R arm. No reactions on L arm site. Saw clinic NP, "The injection reaction seems more infectious than allergic. Would probably be ok to get future pneumonia vaccines." Advised to keep area clean, was given antibiotics for sinus infection and infection at R arm injection site. One month later, induration still present, referral to surgery for second opinion about repair of area.
Tingling at vaccine injection site (left shoulder), followed by cold feeling. Feelings of cold and tingling spreading out from shoulder to rest of arm, left leg, and back of neck. Elevated heartrate and breathing, as well as mild chest pain; may or may not be from panic attack that happened after initial feelings of cold and tingling spreading along limbs. Doctor prescribed normal dose of OTC aspirin. Tingling returns intermittently, but much less severe and does not spread beyond shoulder of vaccine injection site.
Tested positive 04Jul2022; Tested positive 04Jul2022; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 74-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Batch/Lot number: unknown), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022, outcome "not recovered" and all described as "Tested positive 04Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) Positive; (09Jul2022) Negative; (14Jul2022) Positive; (Jul2022) Positive, notes: he tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: It was reported that the patient received vaccine. The patient did not receive any other medication in 2weeks. The patient received Paxlovid for COVID 19 Treatment. The patient had known no allergies. The treatment start date was reported as 04Jul2022 and stop date was 09Jul2022. It was reported that the patient's COVID symptoms started on 02Jul22. The patient completed 5 days of treatment. On 14Jul2022 symptoms of nasal drainage and cough returned and he tested positive again. Reporting this as a rebound case.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events Vaccination failure ,covid 19 cannot be completely excluded based on temporal association and known drug safety profile
1 day post vaccine injection, contract dermatitis around the droppage site where serum dripped from the needle site, after needle popped out.
Fevers up to 103, chills, fatigue, and loss of appetite. With Tylenol and ibuprofen, fevers stated 101-102 degrees.
pt had vax & approx 4 hrs later began crying w/a high pitched cry; temp 103.4; mom called ER & was told to use ice pack to leg; mom called MD & was told to give DPH; stopped crying about 930PM;
Fever 102 x approx 1 wk; sz pt limp & unresponsive x 3-5 minutes on 14FEB92;
Rash that began on trunk and spread to head, face, and extremities. Fever to 102 F axillary. Fussiness. Lack of appetite
Headache (3 days), sore injection site (4 days so far), numb fingers in injection arm (1 day), chills (1 day), exhaustion (2 days), and back ache (2 days)
pt c/o h/a p/2nd dose of vax; rxn over the counter medication resolved;prior to vax mild h/a;22NOV severe h/a dec;27NOV loss of vision to see neurologist & opthamologist
Sore throat, lightheaded, stuffy headed hours after receiving immunization went to ER, dx with reaction to vaccine. On 5/6/16 reports woke with low grade temp, nausea, diarrhea, generalized weakness, palms and feet sweaty.
Information has been received from two Licensed practical Nurses referring to unspecified number of patients (age and gender were unknown). Information regarding concurrent conditions and medical history was not provided. On 09-JUL-2014, LIQUID PEDVAXHIB was improperly exposed to 10.9C for 17 hours. On unspecified dates after this, unspecified number of patients were vaccinated with doses of the improperly stored LIQUID PEDVAXHIB, intramuscularly (strength, dose, dose number and lot # were not reported). Concomitant therapy was not reported. No known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
This was my booster shot (3rd dose). I was fine for the first 24 hours but for hours 24-48 I had (still have but I can feel it getting better) pretty strong muscle aches, cold chills, and general fatigue. I never spiked a fever. The muscle aches were strong enough that ibuprofen was not wholly helpful.
Chills; Sweats; Exhaustion; Weakness; This is a spontaneous report from a contactable consumer, the patient. A 92-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 22Feb2021 at 19:30 (at the age of 92-years-old) as a single dose for COVID-19 immunisation. Medical history included unable to urinate, urethra and kidney issue. The patient also reported that prior to vaccination he had bladder and kidney issues and on 25Feb2021 after the vaccination, he was hospitalized. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) and statin (MANUFACTURER UNKNOWN); all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el9263) via an unspecified route of administration on 27Jan2021 at 19:00 (at the age of 92-years-old) as a single dose for COVID-19 immunisation. On 22Feb2021 at 21:00, the patient experienced chills, sweats, exhaustion and weakness. Therapeutic measures were taken as a result of the events which included unknown treatment. On 28Feb2021, the patient underwent nasal swab and the result was unknown results. The clinical outcome of the events chills, sweats, exhaustion and weakness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
15hrs after the covid vaccine felt the chills,slight temp 99.1, body aches, sore on the site,  following day felt better BUT my injection site still sore all the way to my armpit forward & swollen, today 2/2/21@8pm swollen decreased but still tender.
sinus infection; Tingling; Feeling that something was draining down the side of my face and arm; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 64 years old, dose 1 via an unspecified route of administration on 29Jul2021 (Batch/Lot Number: FA9780) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included breast cancer from 2010 (she had breast cancer (stage) w/ radiation), lumpectomy in 2010, and hysterectomy from 1997 (She had a full hysterectomy in 1997). The patient's concomitant medications were not reported. Patient had for anything was a Tetanus shot for Immunization in 2015 and had no reactions to it. 10 days after patient took her first shot (Aug2021), she thought she had a sinus infection for which she kept Cephalexin around her house. Patient took no drugs of any kind, and that night she took 500MG of Cephalexin, and for the rest of the night and into the next day, she had "tingling" and a feeling that something was draining down the side of her face and arm. It disappeared, for the most part after about 10 hours. The outcome of event sinus infection was unknown and outcome of event tingling was not recovered while other event was recovered on Aug2021.   Follow-up attempts are completed. No further information is expected.
Cough; Sore throat; Sneezing; Runny nose; Sore Arm; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via unspecified route of administration on 05May2021 as dose 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 14Apr2021 as Dose1, SINGLE for covid-19 immunization and had no adverse events. The patient experienced cough, sore throat, sneezing, runny nose and sore arm on an unspecified date after vaccination. The patient stated that, I had after my shot, I had the first shot on 14Apr and second one on 05May. I had no problem at all, all I had was a sore arm but now it started like, I got this little cough but I don't have it right now but I have the cough and now I got the runny nose and this cough a little bit sneezing. I mean but what I am trying to talk about its try to find out, I mean I do not feel sick and all like that but like probably having the shot and somebody said you probably got a back again and I thought I rather call you all to find out, What is going on. I mean it probably goes away but I would like to feel more sure, If I am sick and all and you all could tell me you know, Is it ok right. The outcome of the events cough, sneezing and runny nose was not recovered and the outcome of the rest of the events was unknown.  Information on the lot/batch number has been requested.
Pt states 1 week after she got the PREVNAR 13, she got sick (fever, sweating, nausea). She believes it was related to her sulfa allergy.
SIRVA - severe pain in  right shoulder night and day  since vaccination.  Dr prescribed Nabumetone 750 MG 2 x daily and Tylenol 1300 MG 3 x daily for 3 to 4 weeks
Dizziness, fainting, difficulty breathing, pressure on chest, heart palpitations, high blood pressure, elevated heart rate, body temperature increasing.
Red and itchy at sight of injection.  Initially felt like slump but the lump subsided.  On day 8 are is very itchy and red.  Also looks bruised.