chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a registered nurse concerning a 58 year old female social worker with hypertension and penicillin allergy who on 15-SEP-2004 was vaccinated with a first dose of hepatitis A virus vaccine inactivated (Lot # unknown). On 20-MAR-2005, the patient was vaccinated IM in the right deltoid with a second dose of hepatitis A virus vaccine inactivated (Lot # unknown). Subsequently, on 07-JUN-2005, a titer was drawn and did not show seroconversion (hepatitis A IgM antibody was negative). The nurse reported a "possible vaccine failure". The nurse also noted that the patient had a history of non-conversion with series # 1 of hepatitis B vaccine (WAES0605USA00044). After completing a second series, the patient's titer was positive for hepatitis B antibody. The nurse reported that a repeat of the hepatitis A vaccine was administered on 28-JUN-2005. It was also reported that the patient had nor symptoms. There was no product quality complaint involved. Additional information is not expected.
Hospitalized 1/13 COVID + that date collapsed 1-2 weeks post symptom onset, now with STEMI, COVID Pneumonia, treated with remdesivir and dexamethasone.
I had pain starting about 2 days after the 2nd shot and it never went away.  In the last 2 weeks it has become worse.  I was hoping it would run its course but it is still with me. Seems a little less today.  Pain is in the upper arm, shot area. sometimes down the arm and also in the shoulder. I had this shot on the 6th of April, still got the pain on the 7th of August.
her arm from shoulder to the elbow is so sore that she can't use it or lay on it/ pain immediately after receiving vaccine and if she forgets and use her left arm accidently she experiences that pain; Initial information received on 05-Mar-2021 regarding an unsolicited valid non-serious case from a consumer via Agency (under reference 00506632).  This case involves a 61 years old female patient whose arm from shoulder to the elbow was so sore, that she cannot use it or lay on it and it cause pain immediately if she forgets and use her left arm accidently, she experiences that pain (pain in extremity), after receiving DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   The patient's states that she cut herself pretty bad while cutting fabric and she went to the urgent care.  On 16-Feb-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6852AA and Expiration date:07-Oct-2022) via unknown route in the left arm for prophylactic vaccination.  On 16-Feb-2021, the patient developed a non-serious sore arm from shoulder to the elbow that she can't use it or lay on it (pain in extremity). Also reported that she experienced the pain immediately after receiving the vaccine and if she forgets and use her left arm accidently she experiences that pain. Patient also wanted to know if that was normal and she thinks they may have hit a bone when administering the shot.   No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.
I contracted COVID-19. My symptoms included congestion, sinus pressure, soreness of the throat, coughing, my eyes were burning & irritated, loss of taste, and complete lack of energy. I went to Urgent Care. My oxygen saturation was less than 90%. My temperature was slightly elevated and was at 99.2. My blood pressure was very high and it was 168 over 62.  I received Oral steroids. That same night after returning from Urgent Care, I was extremely sweaty. I still have a bit of congestion and sneezing. I'm still experiencing some loss of taste.
At 11:55 am this nurse summoned by another nurse as she was bringing client to treatment area as client feeling nauseated. Accompanied by three nurses in examination room. Client BP at arrival to treatment room 140/92 right arm in sitting position. Heart rate 68, SPO2 97% on room air. Respirations slight elevation at 23. No wheezing detected, no cyanosis. Noted with diminished breath sounds RLL, however client states,  "I have had allergies or a cold, but I've had this before the shot". Please note client remained alert throughout this event. Initial symptom nausea, no emesis. At 12:05pm client states, " I'm ok I feel better, I'm fine:". Reports is going to work (animal shelter), discourage, asked if anyone at home reports her mom is in hospital, client does have a husband. Reviewed anaphylactic symptoms/explained this is emergency 911 to be called IMMEDIATLY/verbalized understanding. States, " I will not be alone I have coworkers".  No respiratory symptoms. Left facility with no issues.
Tightness in chest, throat, tingling in fingers,  racing heart- given IM epi - sx started resolving after approx 5 min
Severe body aches, chills and sweating. Dizziness, nausea, dehydration and stomach pain. Headache and passed out!
Moderate pain at injection site in right arm. Pain also began in non-injection left arm (site of the first injection) about the same time and worsened over about 8 hours. The pain subsided in the left arm, the first injection site, but continued for about 24 hours in current injection site - right arm.  Severe body aches, mild headache, chills, fever (101 F), fatigue, no appetite: began about 6 hours after injection and continued for about 30 hours. Temperature normal and symptoms subsided about 48 hours after injection.
Tested covid positive on 19Sep2022; Tested covid positive on 19Sep2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 at 11:30 as dose 1, single (Lot number: EN6201), in right arm, on 12Mar2021 at 14:00 as dose 2, single (Lot number: EN6202), in right arm, on 28Sep2021 at 15:00 as dose 3 (booster), single (Lot number: FE8841), in right arm and on 07Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: seasonal allergies" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Sep2022 at 15:00, outcome "recovered" (2022) and all described as "Tested covid positive on 19Sep2022". The event "tested covid positive on 19sep2022" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Facility type vaccine was Pharmacy or Drug Store. Other medications in two weeks included multi vitamins. No other vaccine in four weeks and no COVID prior vaccination. Adverse event treatment included PAXLOVID.
350PM dizziness-collapse-sweaty arms c/o h/a, pallor epi given; 355PM feels better (lying down); 4PM BP 110/50; DPH given; BP 110/50 sitting up sip of H20;
Presents to ED complaining of 2 days of progressively worsening shortness of breath. He denies having any fevers or cough but he does report a week ago he was exposed to somebody was positive for COVID-19.  Admitted for NSTEMI; developed COVID-19 during stay but asymptomatic.
THE DAY FOLLOWING VACCINATION, THE CHILD SCREAMED ALMOST INCONSOLABLY FOR NEARLY 14 HOURS.  11/7/06 Received medical records from PCP which included records from the hospital. PCP records reveal patient seen 9/26 for complaints of fussy since vax & not taking bottles.  Next visit is of 9/29 when patient had returned to normal.  Only finding on exam at that time was nasal congestion & runny nose. Hospital records reveal patient admitted to hospital overnight from 9/26-9/27/06.  Remained afebrile & improved.   D/C Dx: Fever, resolved; inconsolability, resolved; and URI./ss
Per patient: Felt hyper after receiving the vaccine then really tired later. Vaccine was painful when administered whereas the first dose didn't hurt at all.  Felt as if the vaccine was too high in the arm. Took nap after vaccine. When woke up (approx. 7hrs after vaccine), noticed face was very pale. Two hours later, was shaking with high fever (max was 103F). Began throwing up and couldn't keep anything down. Tried to take Tylenol for fever. Went to hospital approx. 1hr later. Area around the administration site became very red and inflamed. At hospital, she was treated for cellulits with clindamycin. Systolic blood pressure was 170mmHg. Also discovered during visit nasal colonization with MRSA, low magnesium, low potassium, low platelets, low white blood cells, and macrocytic anemia (although these were likely unrelated to vaccine). Hospital stay lasted 5 days.
temp to 105 on 29OCT91 w/brief 1 minute generalized seizure;
Case number PHEH2015US021783 is an initial spontaneous report received from a consumer on 19 OCT 2015. This report refers to a 70 year old male patient. Past medical history and concomitant medications were not reported. There was a bat in patient's house and hence the doctor recommended vaccination for protection in the event the patient was bitten. His vaccination history included administration of first dose of RABAVERT (batch number: 556011A) on 12 JUN 2015 for post exposure following which he was very sleep (see related case number: PHEH201US021782). He was vaccinated with second dose of RABAVERT (batch number: 556011A) on 15 JUN 2015. After vaccination he felt very sleepy. The events outcome, seriousness and causality were not reported. He further received third dose of RABAVERT (batch number: 559011A) on 19 JUN 2015, following which he was sleepy (see related case number: PHEH2015US021784). He further received fourth dose of RABAVERT (batch number: 559011A) on 26 JUN 2015 following which he experienced sleepiness and arthritis flare up (see related case number: PHEH2015US021396). No further information was provided.
Injection site reaction-Injection given 7/8/05 with addition maculopapular lesions (4) at site, occurring one wk after injection 7/15/05 and persisting as of 7/20/05.
Information has been received from a RN concerning a pt who in 1999 was vaccinated with a dose of varicella virus vaccine live. The RN reported that in 2005 a titer found there was not effective seroconversion. Unspecified medical attention was sought. No further information is available.
DUPLICATE DOSAGE OF BIVALENT BOOSTER WAS ADMINISTERED ON 12/8/2022 AT 1300. RESIDENT HAD RECEIVED BIVALENT BOOSTER ON 10/28/2022 AS WELL. PATIENT HAS HAD NO ABNORMAL SIGNS OR SYMPTOMS DOCUMENTED AND CURRENT VITAL SIGNS ARE WITHIN NORMAL RANGES.
Patient called pharmacy to report swollen lip, itchy lips, and itching on body after receiving flu  vaccine today.
fever dec 103 ax; eyes rolled back in head; jerking movements x 5-10 seconds; talking out of his head
Patient had itching, redness on back. Gave Benadryl 25mg PO. Patient stable, released from vaccination site.
Burning sensation at injection site, felt itching in ears when administered. Felt sore since vaccine was administered. Today, 03/14, woke up feeling very sore and around 11:45am I began to feel chills, body aches, headache and fever.
pt vax w/2 doses of hepatitis B vax, p/each dose developed adenitis, arthalgia, fever & fatigue;
classic migraine-type headache 03/05-present  overall muscle ache 03/05-present  fatigue 03/05-present nausea 03/05-present  L foot & ankle swelling 03/06-present
12-12-11 - Middle of night - awoke with chest congestion, difficulty breathing, seizure-like episode lasting several minutes. To Emergency Rm. evaluated. Admitted on 12-13-11 for observation; discharged home on 12-14-11.
L arm infections x 2 on 8/6/02. 10cm x 7cm no redness/painful to touch.
This spontaneous report was received from a nurse practitioner refers to a 12-year-old male patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On 25-OCT-2017, the patient was vaccinated with doses of improperly stored GARDASIL 9 (dose, units and frequency were unknown) (lot # N007931 and expiration date 17-NOV-2019). The temperature excursion was at 9 C to 25 C (10 C) [C (degree centigrade)] for 1 hour. No adverse effects were reported. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter (1710USA002936, 1805USA004616, 1805USA004664, 1805USA004666 and 1805USA004667).
Pt has had sore arm since the day she got the vaccination. She stated it has been burning recently.
Information has been received from a registered nurse concerning a 19 year old female with no medical history and no known drug allergies who on 05-FEB-2009 was intramuscularly vaccinated with a 0.5 ml dose of GARDASIL (lot #660616/0570X). Concomitant therapy included vitamins (unspecified) (FLINTSTONES MULTIVITAMIN). The patient was pregnant while received GARDASIL. Her LMP was 25-JAN-2009. No adverse effect was reported. Lab diagnostic studies included prenatal screen. The patient had an office visit for medical attention. Follow up information was received from the registered nurse who reported that the 19 year old patient was a smoker with HPV infection. She had one previous pregnancy and pre-term delivery at 35.4 weeks by caesarean section in 2008. The patient was vaccinated with the first dose of GARDASIL on 05-FEB-2009. Concomitant therapy included vitamins (unspecified) (FLINTSTONES MULTIVITAMIN) for prenatal use. The patient experienced nausea during her pregnancy and was prescribed ZOFRAN 8mg every 12 hrs on 23-MAR-2009 for treatment. Her pregnancy was confirmed by sonogram at the first OB appointment on 26-MAR-2009. She was advised to quit smoking. There was no illness during the pregnancy. The patient was seen on 03-APR-2009 with known spotting. The patient also experienced heavy bleeding. She experienced spontaneous abortion complete in an emergency room while on vacation on 04-APR-2009, that was 8.2 weeks from her LMP. The patient was seen in the reporter's office on 08-APR-2009 and confirmed spontaneous abortion and by ultrasound. Upon internal review, spontaneous abortion was determined to be an other important medical event. Additional information is not expected.
Approx. 1 week after injection redness and hardness at the site of the injection with mild pain that lasted for 8 days post injection. Also began to notice joint pain I have not had before, in particular thumb joints and knees. Is now much milder but still exists.
Dry mouth.  Difficult to chew food.  Dry lips.  Loss of taste.  Low saliva.
Regular monthly allergy shots (1 yellowjacket, 1 dusts-molds-dander) administered left arm 6/9/03, 2 weeks after vaccina administered right arm.  Experienced arthritis flareup following am (pain & stiffness but no noticeable swelling or localized redness).
States woke up next am with small red patch to right arm. Then woke up this am (06/22/2012) with red ring around patch. Square red swollen are approximately 1 inch x 1 inch with red ring approximately 3 inch x 3 inch noted to right deltoid. To be seen by PMD today (06/22/2012).
03Jan90 pt vax; exp redness & swelling at inject site for 3 weeks.  18Feb90 devel pain in lt knee & rt heel & was unable to work for 2 days.  X-rays revealed degenerative joint disease in left knee & spur on rt heel.   See worm...
He reports notable erythema, warmth, edema, pruritus to his upper arm. He reports paresthesia?s and neuralgic pain to his left hand and fingers. He denies paresis or paralysis. He reports the vaccine site was very high on his shoulder, and had initial severe shoulder pain about an hour after receipt, which has resolved, and he reports normal ROM. He states he had flulike symptoms of fever, rhinitis, cough, malaise for 7 days starting prior to receipt, which his children had similar symptoms before his developed.  POC today: -Ibuprofen 800 mgs tid with food -Cetirazine 10 mgs daily, may repeat q12 severe pruritis -Topical lidex 0.05% AAA -Temporary medically reactive exemption. I would defer next dose until full 18 months have passed and recommend premedication with ibuprofen 800 mgs 1-4 hours prior to receipt. He reports he will be on duty and can contact or clinic to mange receipt at the time. -File VAERS report He also reports site placement of injection as ?too high?. He currently has normal ROM and denies significant pain. Paresthesia?s can be associated with Post immunization arthropathy, however we will assess further if they don?t clear with his local site reaction.
This initial non-serious spontaneous case, was received on 18-Sep-2017, reported by other health professional. Patient's medical history was not reported. On an unspecified date, a patient received FLUAD (TIV) (batch number: 178623, expiry date: Apr-2018, dose, route of administration and anatomical location was not reported), which reached 1.4 C F (as reported) for about 6 hours (reported as first time excursion and vaccine was not frozen) (explicitly coded as drug administration error). Outcome of the events were not reported.
Yellowing of eyes, Chest pain, rib pain, back pain, shortness of breath, nearly passing out
Got the shakes at 11PM on sat. night and at 2Am in the morning i am throwing up. I have a fever my head hurts and my neck. I am still  sick. I do not feel good.  I am not getting the 2 shot.
Lip vesicles (Cold sores) occurring on upper and lower lip. Started on 9/13/21 - noted to be painful. Of note, pt has had similar lesions in the past. Pt also has had fever Tmax 101.4 that started on 9/11/21 x 2 days, headache x 2 days, body aches x 2 days, fatigue x 2 days (all symptoms started approx 6h post 2nd vaccine according to mom).
Active case of shingles; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (Active case of shingles) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Active case of shingles). At the time of the report, HERPES ZOSTER (Active case of shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: No specific follow-up information recorded. On 13-May-2021: No specific follow-up information recorded.
Moderate fever, sweating, unusual fussiness, unusual crying, refusal to eat. Fever lasted 4 days, fussinesss lasted 8. Child fully recovered by 11/22/2014.
Redness, swelling, soreness, rash. Taken TYLENOL for symptom, - 1000 mg.
Information has been received from a registered nurse concerning a 21 year old female patient with autoimmune hepatitis, who on 15 Feb 2005 was vaccinated with a dose, 0.5ml, IM, of Gardasil. Concomitant suspect therapy included Adacel, and other concomitant medication included birth control pills, prednisone, vitamins (unspecified) and calcium (unspecified). The nurse reported that on 15 Feb 2007, "20 hours later," the patient "felt lightheaded and passed out. She came to and when she got up she passed out and fell to the floor." The nurse further stated that "both episodes were very brief." On approximately 16 Feb 2007 ("later") the patient "had one episode of diarrhea." On the morning of 16 Feb 2007, the nurse stated that the patient was seen by the doctor and "blood pressure was normal and injection site looked fine. No treatment required." At the time of this report, the patient had recovered. Additional information has been requested. Information received 04/03/2009. The nurse confirmed that the patient actually experienced "two concurrent bried syncopal episodes." Additional information has been requested.
A report has been received from a Health Professional concerning a 3 year old, female patient. The patient's medical history, concurrent diseases and concomitant medications were not reported. On 22-Jan-2014 the patient received nasal FLUMIST (intranasal), but the vaccine was expired on 20-Jan-2014. At the time of reporting, the outcome of the event of inadvertently administered expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Around 11pm, i started experiencing leg cramps in my right lower leg. I applied a heating pad to ease the pain. I am still experiencing leg cramps but not as bad now.
No adverse effect; patient was administered a expired dose; This spontaneous report was received from a medical assistant referring to a 30-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 09-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, route, frequency, indication were not provided). Lot No. N017395 has been verified to be a valid lot number for [varicella virus vaccine live (oka/merck)], expiration date reported as 07-JUN-2019, and upon internal validation established as the same. The patient was administered an expired dose of properly stored varicella virus vaccine live (oka/merck) (VARIVAX). The vaccine was reconstituted with properly stored sterile diluent (lot # R001089 and with an expiration 18-SEP-2020). No adverse effects reported.
Day after vaccine was given, patient quit talking, waving, eating majority of foods, and developed "odd" behavior.  He no longer said "bye bye", "daddy", "good boy", etc.
arm soreness; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (Pfizer COVID-19 booster; Solution for injection), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 3, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 2, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Apr2022, outcome "unknown", described as "arm soreness"; NAUSEA (non-serious) with onset 19Apr2022, outcome "unknown". Additional information: Description of Event: 56 yo  female experienced arm soreness and nausea following second Pfizer COVID-19 booster. Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
19APR93 temp 103 ax, redness swelling @ site of inject L&T leg;
Monday morning, May 16th, I woke and I had a terrible headache. I was congested. I called the doctor because I thought I had a sinus infection. I also had a raspy voice. They prescribed Amoxicillin 3 times a day and Mucinex. Consequently, 24 hours later I began to feel better as if I would if I had a sinus infection. On Friday the 20th I had to be tested for Covid for an endoscopy (sleep) and I tested positive for Covid19. I haven't recovered completely, but still have congestion and enough of a headache to annoy me.
Within a couple of minutes of giving vaccines pt developed swelling and redness around injection site.  There was also visible swelling and redness developing around knee's.  Epiniphrine was ready to give to pt but we did not give since after about ten minutes reaction was diminishing.  Mom says this also happened @ 4 mo.