chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PROQUAD (incorrect product storage) (lot # M015700, expiry date: 26-SEP-2017; lot # M017337, expiry date: 05-OCT-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of 9 degree Celsius (C) for 1 hour 1 minute. No previous temperature excursion was reported. It was also reported that this case was reported because of a data logger. No product quality complaint (PQC) was reported. This case is linked to case number 1611USA0048743 and 1611USA000386 via same reporter link. Additional information has been requested.
pt recvd vax;on 21nov95 broke out in rash;hlth dept felt it was chicken pox;head hurt and pt thought she had ear infect because unstable on feet;dx of mental status changes & post viral synd;27nov95 pt better but still lesion on pt's arm;
pt recv vax 12FEB96&22FEB96 devel little bitty bumps on upper back that were itchy but did not look red;in addtl chest was heavy when lying in bed;described sx as similar to rxn had to PCN;
2 days p/vax pt exp deep, aching pain in lt deltoid muscle;states pain in from lt shoulder to lt elbow;pt states has difficulty lifting w/lt arm now;
I did not have an adverse reaction to the vaccine. On 03/13/2023 I was sick with a stomach virus. I went to the emergency room, and they gave two IV's for dehydration and a prescription for Zofran and something for the pain. As of today, I am feeling better.
Patient said 6 hours later he experienced extreme nausea which led to multiple vomitting episodes. He also had a fever and chills, patient does not recall actual fever tempature. These symtoms lasted aproximately 12 hours.
pt recvd vax & awoke w/nausea, vomiting, lt arm was very sore & would not use it much; 18JUN94 around inject site on lt arm had redness the size of a tennis ball; entire arm was swollen;
NAUSEA; HEADACHE; PRESSURE IN THE EYE; VOMITING; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced nausea. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced pressure in the eye. On 06-MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, headache, pressure in the eye and vomiting was not reported. This report was non-serious.
Extreme soreness in left arm for 12 hours. Headache off and on for 3 days.
Mild tremors in muscle around sight of injection; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the arm left on 30Mar2021 at 18:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), aripiprazole (ABILIFY) and propranolol (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 2000 the patient experienced mild tremors in muscle around sight of injection. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of mild tremors in muscle around sight of injection was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient got seizure about 5 minutes after received injection. First seizure lasted less than a minute, and 2nd seizure happened about 5 minutes later lasted about 10 seconds. Paramedics arrived and take patient to local hospital.
Initial information received on 10-Aug-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves two patients (age and gender not reported) who was vaccinated with dose of ADACEL which was associated with exceeded shipping storage limits (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to exceeded shipping storage limits. It was reported that ADACEL was delivered late to facility. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
This spontaneous report was received from a 67-year-old female patient regarding herself. Current conditions included multiple sclerosis (MS). The patient was allergic to penicillin and sulfa drugs. The patient was vaccinated with ZOSTAVAX on 07-NOV-2012. Concomitant medications included COPAXONE. The patient reported that she developed a 2 inch by 1 inch varicella rash on the right side of her chest on 11-NOV-2012. The patient stated that the rash was slightly itchy. No treatment was given for the events. No lab studies were performed. The patient did not recover from the events. The patient sought medical attention the patient called her physician and was waiting for call back. Additional information has been requested.
arm is still sore; Initial information received on 23-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional (patient).  This case involves patient (age and gender not specified) who experienced arm is still sore (pain in extremity), while patient received INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arm is still sore (pain in extremity) from the last vaccine four days ago after the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  Just feel blessed to have had them though and praying things begin to ease up a bit.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
pt recvd 2nd dose of shot @ 7 months old; 1 hr later was in resp distress, constant crying, 1 day later convuls passing out, vomiting, couldnot catch breath; 1 wk hospitalization, steroids, preventol, auburetol;
Information has been received from a health professional concerning a 10 year old female patient with no allergies at time of vaccination and allergic reaction to Augmentin which caused hives, who on 07-SEP-1999 was vaccinated with the first dose of VARIVAX (Merck) SC. Subsequently, the patient experienced pink papular rash in head, legs and arms. On an unspecified date, the patient recovered. Additional information has been requested.
Iliac artery occlusion, right. Numbness in right leg beginning 11/18/2022.
Scratchy arms/body - denies swelling, SOB, rash (approximately 2 hr after vaccine). Scratchy throat/sore throat - denies swelling, SOB (approximately 3 hr after vaccine).
18SEP97 inc fever 103;baseball size lump on lt thigh;redness & rash around lump;lethargic;diff walking;taken to MD 18SEP97;dx cellulitis;rx Augmentin & warm packs to area;19SEP97 size of lump reduced;temp dec, walking well;
The pt received an Influenza vaccination IM on 9/29/11 in the left upper arm (the pt is right hand dominant). The pt reported receiving the vaccination "high" on the left deltoid at 1-2cm from the acromion). The pt states that he had no pain at the time of the injection. The pt denied having localized swelling or redness after the injection. The pt was "fine" until Oct 5 when he noted "tightness" in his left shoulder with lifting a 5 gallon paint can. He also noted this tightness with cranking the window on his vehicle and steering. By 10/11/11 this "aggravating pain" was a 2-3/10 so the pt began to take ADVIL, TYLENOL (dose and frequency unknown) and use BENADRYL prn. The pt did not note that the oral medications improved the pain but he thought that using the BENGAY was helpful. The pt was seen on 11/3/11 at which time he reported left shoulder pain when raising his arm or rolling on to his shoulder while sleeping. The pt denied decreased ROM, strength or numbness/tingling in his left shoulder, arm or hand. The pt denied prior hx of trauma or issues with this left shoulder a review of ahita and consultation with the pt's PCM revealed a hx of left shoulder pain after a fall in 2007 which was evaluated with plain films--see below). Exam of the pt's left shoulder, arm and hand were normal. The pt was prescribed MOTRIN 600mg qid with food for 10 days and instructed to apply heat tid, avoid strenuous activity, perform ROM exercises and follow-up on 11/14/11 (per phone at the pt's request). At that time the pt's pain had decreased to a 1/10 and he was applying heat bid. The pt noted that he "aggravated" his shoulder at work (lifting). At that time the pt reported "having some tingling in his fingers of his left hand which he had been having intermittently before his immunization". He denied weakness or decreased ROM. The pt refused the request to come to the office for evaluation and possible low dose oral steroids or referral for possible nerve conduction studies/radiological studies and/or local steroid injection and/or physical therapy. On 11/21/11, pt was contacted and he reported that his symptoms were stable (pain 1/10 and intermittent numbness and tingling of fingers (left hand). Again the pt refused the office for further evaluation and treatment stating that he "would see his PCM in Jan for his routine appt".
Redness, swelling, warm to touch approx. 1/4 inch below the injection site. Patient was given antibiotic therapy, symptoms persisted antibiotic changed and then symptoms were relieved.
Vaccine given at 10:00 AM, patient requested assistance at 10:20AM. Stated that 10 minutes after vaccine her eyes began to itch and then at 10:20AM she felt flushed and her neck started itching. PC to regional medical director, 0.5ml of Epinephrine 1mg/ml administered to left thigh at 10:25AM. EMS called, patient declined transport. Patient waited and additional 30 minutes for monitoring. At 11:00 patient remained stable and stated she felt fine.
Extreme Fatigue Constant headache Lethargic  Brain fog Arm pain radiating to shoulder and Wrist Armpit pain swollen lymph nodes in armpit left side Swollen lymph nodes in neck left side Tinnitus Nausea Syncope
After receiving the vaccine I had issues breathing immediately and it last 30 to 62 minutes. It continued on for two weeks and and I wasn't feeling well and I was having a hard time getting up. The doctor checked my liver function and my blood sugars and diagnosed I have diabetes.
I tested positive for COVID.; This is a spontaneous report from a contactable consumer (Patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: E22613, Expiration date: Unknown), via an unspecified route of administration (at the age of 19-years-old) on 24Mar2021 as dose 1, single for COVID-19 immunization. No medical history and concomitant medications were reported. It was reported that the patient tested positive for COVID on 04Apr2021. The patient underwent lab test which included SARS-CoV-2 test: Positive (Covid test) on 04Apr2021. Patient was wondering how should go about the vaccine process now. When asked for NDC, UPC and Expiry date, the patient stated that this was all she had. Product Complaint was reported as Yes. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Patient had sever itching and hives all over arms and back and body. It started the day after the vaccine. She took benadryl to help and it upset her stomach. The rash calmed but was not gone. She continued with symptoms until her next appointment. She stopped by pharmacy on 9/2 to get vaccine. We advised against it. She began Allegra and that has controlled symptoms since.
Patent states that she had a headache, and flu like symptoms and her arm and back were sore for a few days. She was informed that these are normal side effect symptoms of a flu shot but she wanted the pharmacy to report it anyway.
Profusely sweating (clothes soaked), dizzy, clammy, nausea and fatigue
A spontaneous report was received on 08JUN2016 with additional information received on 27JUN2016. A 31 year old female employee reported experiencing injection site redness, swelling, and warmth, with feeling of numbness in left arm and shoulder area following immunization with BIOTHRAX. On 07JUN2016 she received a booster dose of BIOTHRAX (FAV602) intramuscularly in the left deltoid. Symptoms began in the evening of the day of vaccination. She was treated with ibuprofen and hydrocortisone cream and experienced some relief. Consumer reported that it took a week before the bump and redness was completely gone. She also reported that there remained a small scab at the injection site for 10 days after the injection. The adverse events were reported to be recovered on 14JUN2016. No additional information is expected.
Flush, dizzy. NIBP 182/114 @ 1028. 223/112 @ 1031.  HR 91 initially, shot up to 114. No c/o SOB, sats 100% on RA. Pt taken to ED immediately.
injection site reaction of pain, swelling and itching; injection site reaction of pain, swelling and itching; injection site reaction of pain, swelling and itching; site where she got vaccine is red; painful on the inside of her arm; This is a spontaneous report received from contactable reporter (Other HCP) from medical information team.  A 49-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 11Aug2023 as dose number unknown, 0.5ml single (Lot number: GN1898, Expiration Date: 30Sep2024) at the age of 49 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Diabetes", start date: Jun2022 (unspecified if ongoing); "Hypothyroidism", start date: Jun2022 (unspecified if ongoing); "hypertensive disorder", start date: 11Aug2023 (unspecified if ongoing); "Anemic", start date: Jul2022 (unspecified if ongoing). Concomitant medication(s) included: TDAP intramuscular taken for immunisation, on 11Aug2023 as dose number unknown, 0.5ml single. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "unknown" and all described as "injection site reaction of pain, swelling and itching"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "site where she got vaccine is red"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "painful on the inside of her arm". The events "injection site reaction of pain, swelling and itching", "site where she got vaccine is red" and "painful on the inside of her arm" required physician office visit.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Patient said the area became very painful and had trouble with mobility of the arm. As time went by more pain that went down the arm and up the arm to neck and shoulder area. Patient stated that back side of the arm became hot to the touch with swelling to the area and redness.The reaction occurred on the left arm where Pneumovax was administered.
Patient had complaint of left thigh feeling sore (immunization given in left deltoid) then mother looked at thigh and noted U shaped rash 10 cm x 6-8 cm, states with touch like pin prickling and now 30 hours later sharp pain. Will be seeing provider today.
The day after I recieved the vaccine, my arm was red and swollen and hurt to the touch.  Around noon, I felt achy and had a headache.  At around 3 PM, I felt feverish and had a fever of 100.4.  I felt general malaise and achy all evening.  This morning, I still have a bit of a headache, but feel much better than yesterday.
The nurse is reporting that the patient received improperly stored vaccine; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.   On 30-SEP-2019, the patient was vaccinated with one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) in the right thigh for prophylaxis (lot number: S007770, expiration date: 24-JUL-2020) (exact dose and route of administration was not reported) and with one dose of influenza virus whole virion 3v vaccine inactivated (FLUZONE) in the left thigh with lot number: 06653BD (exact dose, route of administration, indication and expiration date were not reported). It was reported that the patient received previously 1 dose of hepatitis a vaccine, inactivated (VAQTA) and 1 dose of influenza virus whole virion 3v vaccine inactivated (FLUZONE) on an unknown dates.  The hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion of 1.4 degree Celsius for 20 minutes. Previous temperature excursion was 10.5 degree Celsius for 56 minutes. The digital data logger was involved.
large lump/swelling, red, itching & burning around injection site; started about 9-10 days p/inject; Neosporin on site-DPH capsules for itch; lasted for aprox 2 1/2 wks; little red dots all over both arms;
Mom states child's left arm became very swollen and red. Taken to emergency Dept on 08/18/2001. Immunization given on 08/16/2001.
Body aches; chest pain; left armpit/axillary lymph node swelling; brain fog
I had headache and allergy type symptoms with fever for a day or so. (03/12/2021) When I visited my doctor, I was given a COVID test which turned out negative. No medical test or labs otherwise and was told it should subside. Was told if any new trouble to come in. No other issues occurred.
Got a flu shot. The next two days patient had chills; tired; headache; sweats; a 100 temperature; Initial information was received on 24-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who got a flu shot. The next two days patient had chills (chills), tired (fatigue), headache, sweats (hyperhidrosis) and a 100 temperature (body temperature increased), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient got a flu shot. The next two days patient had chills (chills), tired (fatigue), headache, sweats (hyperhidrosis) and a 100 temperature (body temperature increased).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
vomiting; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration from 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 Vaccine on 05Jan2021 and she experienced vomiting the next day 06Jan2021, multiple times during the day. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Myalgia, Fever, CHILLS Narrative:  SYMPTOMS KEPT FROM GOING TO  WORK
Redness surrounding injection site, with raised swollen area - error was - patient received 3rd dose of Hep A.
I've been having involuntary muscle jerks in my extremities. They are noticeable. Muscle shaking in my inner thighs, unsteady walking and pointer finger shaking. Convulsive-like jerking that wakes me up. Horrible cognitive problems, word recall, spelling and forgetfulness. The most terrible and shocking thing is not remembering how to pronounce simple words like 'smooth.' I eventually pronounce it, but it is so scary when it happens. This started off as annoyances I thought would go away, but they are getting worse. The muscle shaking is daily now, mostly when I'm lying down. The cognitive spelling and word recall issues also every day.
Headache for two days straight, very bad. Front and back of the head. Blurry vision. Tiredness and throat pain. Headache doesn't go away. No treatment, waiting for the headache to stop but it only gets worse.
Pt seen in ER on 11/19 with 4" diameter redness (reaction) to immunization given on 11/17/04. R arm where Dtap was given
Massive headache, chills and shivering for hours, body in pain for for a full day and night.   Very sore arm  Developed large red rash at injection site. Slightly itchy, hot.
pt recvd vax & AUG89 exp arthritis, diarrhea, nausea, hot, warm arm & devel scarring on arm @ inject site;