chrisvoncsefalvay/vaers-outcomes huggingface dataset:
right side of my face was red with a rash; my eyes are very itchy; headache; felt Nausea; my right arm was itchy where i got the shot and sore/noticed from my shoulder to my elbow had rash, swollen and was very itchy; my right arm was itchy where i got the shot and sore; noticed from my shoulder to my elbow had rash, swollen and was very itchy; noticed from my shoulder to my elbow had rash, swollen and was very itchy; i am having allergic reaction; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old patient of an unspecified gender started to receive bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date), intramuscular right arm on 12Jan2021 11:15 at a single dose for covid-19 immunization. Medical history included allergies to latex and cillin family, and seasonal allergy. Concomitant medication included hydroxyzine pamoate (HYDROXYZINE PAMOATE), calcium carbonate, colecalciferol (VITAMIN D 2000), ketotifen fumarate (ZADITOR) for seasonal allergy, azelastine (AZELASTINE) and clarithromycin (CLARITIN). The patient did not receive other vaccines in four weeks and was not diagnosed with Covid prior to vaccination. The patient previously took but had allergies to amoxicillin, oxycodone hydrochloride; oxycodone terephthalate; paracetamol (PERCOCET), fusidate sodium (FUCIDIN) and morphine. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; unknown lot number and expiration date), via unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient reported that she the shot at her job 12Jan2021 11:15am, sat down for 15 minutes and she got up fine. She mentioned that around 04:00 pm, she had headache and felt nausea. Her right arm was itchy where she got the shot and sore, so she took off her sweater to check her right arm where she got vaccine and noticed from her shoulder to her elbow had rash, swollen and was very itchy. She took a Benadryl and put ice on her right arm. She waited an hour after she took the Benadryl. She noticed the rash was not itchy or as red as it was before but was still swollen. These adverse events started at 12Jan2021 15:45. She mentioned that she went to bed woke up at 5:30 am the next day (13Jan2021) and the right side of her face was red with a rash. She mentioned that when she checked her right arm, the rash was still there and was red again. She took her allergy medication and waited an hour and the rash still on her face and arm but not as red. It was mentioned that once her allergy medication wore off, the rash was red on her right arm and face, and her eyes are very itch. She took allergy medication again and waited 1 hour, the rash was not so itchy. She mentioned that she was having allergic reaction. The patient reported that she was COVID tested post vaccination (nasal swab) on 13Jan2021with pending results. The outcome of the events was not recovered.  The following information on the batch/lot number has been requested.
Leg pain started on 3/13/02; not bearing weight; warm to touch; not swollen; irritable; not red; and playful but cries occasionally.
Emergency Room PT is a 88 y.o. female who presents with chest pain.  Patient has a chronic intermittent chest pain due to coronary artery disease.  She was recently evaluated and catheter to cessation demonstrated coronary artery disease that was not amenable to stenting.  It was also felt that she was not a candidate for CABG due to her comorbid medical problems including renal insufficiency.  Patient has been managed medically.  She essentially has daily episodes of angina.  Patient denies associa or lightheadedness.  Patient had 1 sublingual nitroglycerin prior to arrival.  The pain had been present approximately 2 hr time prior to its resolution.  The pain had completely resolved prior to her arrival.  In addition, she had received 324 mg of aspirin orally.
Pt presented to UCC w/ c/o diarrhea on 4/17 that had been occurring since 1 hr after the SHINGRIX vaccine was given then progressed to 4-5 stools hourly. No bloody or dark stools. No nausea or vomiting but no appetite. Everything goes right through me. Denies eating any foods that tasted spoiled or bad. Small meals on wt loss diet. Pt was found to be dehydrated with hypokalemia, requiring IV fluids and repletion of potassium. Potassium chloride 20 MEQ once, sodium chloride ML once, Loperamide 4 mg once.
18 y/o male received J&J vaccine. Five minutes after being vaccinated, pt complained of nausea. Patient presented with pale skin, diaphoretic, and incontinence of bladder in the observation area. Pt lost consciousness for 15 seconds in the car. After 15 sec, pt regained consciousness and was able to walk and talk. EMT brought the patient into the observation tent to lay on the cot. EMT obtained 4 sets of vitals and completed orthostatic vitals. Last set of vitals are: 10:15am: BP 103/60, Pulse: 74, Respiration 18 and O2 98% on room air. Blood Glucose level was 106. Pt returned back to normal state after 15 minutes in observation. Pt was no longer diaphoretic, pale, or nauseous. Pt is stable, alert, and oriented x4. Pt is walking and talking independently. No EMS services needed. Pt was instructed to follow up with the nearest ER, if symptoms return or worsen. Pt left with his mother, who is the driver.
1. Loss of Appetite 09-09-22, subsided 09-11-22 2. Severe headache during sex starting 09-09-22 3. Residual headache 09-10 through 09-12 4. Intracranial Pressure (started 09-13, subsided 09-14) - head felt like my skull was too small for my brain and my eyes were being pushed against. Very minor headache all day, no loss or blurring of vision. Called nurse hotline-planned to go to Emergency room if pressure got worse or caused vision blurring.
AST and ALT levels were extremely high. 337 and 139 respectively.; AST and ALT levels were extremely high. 337 and 139 respectively.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GJ6742) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Batch/lot number: EL3247, Anatomical Location: Arm Left, Dose Number: 1), for COVID-19 immunization; Bnt162b2 (Batch/lot number: EL3247, Anatomical Location: Arm Left, Dose Number: 2), for COVID-19 immunization; Bnt162b2 (Batch/lot number: FH8030, Anatomical Location: Arm Left, Dose Number: 3), for COVID-19 immunization; Bnt162b2 (Batch/lot number: FN2908, Anatomical Location: Arm Left, Dose Number: 4), for COVID-19 immunization. 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 and since the vaccination, the patient has not been tested for COVID-19. The following information was reported: ASPARTATE AMINOTRANSFERASE INCREASED (medically significant), ALANINE AMINOTRANSFERASE INCREASED (medically significant) all with onset Oct2022, outcome "recovering" and all described as "AST and ALT levels were extremely high. 337 and 139 respectively.". The events "ast and alt levels were extremely high. 337 and 139 respectively." required physician office visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: (21Apr2022) 14; (Oct2022) 139, notes: extremely high; Aspartate aminotransferase: (21Apr2022) 24; (Oct2022) 337, notes: extremely high; Blood test: (Oct2022) normal. Clinical course: Patient had a normal blood workup done on 06Oct2022 in prep for a physical and her AST and ALT levels were extremely high. 337 and 139 respectively. Prior levels done on 21Apr2022 were 24 and 14 (date of start of reaction/event was also reported as 01Oct2022). Events were reported as non-serious.
I received my Moderna Booster shot on 11/16/21.  Approximately two weeks later, I started experiencing light itching across different parts of my body: arms, legs, neck, shoulder, and primarily on the back / torso.  The areas of itchiness migrate to different areas every hour or so, and the skin is blotchy and raised - like a cat has scratched me.  Then for hours at a time, there is no itchiness.  It's never bothered me to the point where my sleep is disrupted.  I still notice the red spots today (12/6), although the itchiness has virtually disappeared and the red areas are smaller.   I have no food or medication allergies, and I have not changed my lotion, shampoo, detergent, or soap.  I also have not worn any new clothes.  I strongly think this reaction (it seems like an allergic reaction) was due to the booster shot.  I am an otherwise healthy adult female.  I have also never had COVID (fortunately).
3 hours after vaccination I experienced chills, fever, and severe fatigue which continued for 2. I took Advil and Tylenol for my symptoms. My arm was so sore I could barely move it for 2 days, and the pain lasted for 3 weeks. I was fatigued for a week. All symptoms have resolved.
This spontaneous report was received from a 80 year old patient of unknown gender. Information on medical history, concurrent condition, concomitant medication and drug allergies/reactions were not provided. On 23-FEB-2015, the patient was vaccinated with ZOSTAVAX subcutaneously of dose 0.85 ml (incorrect dose administered), lot # K020185 for prophylaxis. On 25-JAN-2017, the patient experienced shingles, which had effected his inner right thigh and upwards on to lower back. The patient reported that after taking the vaccine there was no side effects, like redness, pain or swelling. The pharmacist had no explanation and thought it to be very unusual. The patient stated that shingles was a serious disease and most painful and disabling than any other he had endured. Further, it also takes away weeks of productive time of the patient and close family, not to mention the physical and emotional discomfort. On an unknown date in January 2017, the patient was prescribed with VALTREX 1 gm 1X3 times for 7 days plus creams and OTC painkillers as treatment, and on 15-FEB-2017, was prescribed with Gabapentin 300mg 1 a day for prosthetic pain. The outcome of herpes zoster and incorrect dose administered were unknown. Causality assessment was not provided. The case was serious due to disability. Additional information has been requested.
3/19/2021 horrible chest pains hard to breath Itching all over my body Right eye lid red and swollen   3/20 4-5:00 am up sitting in the side of the bed .  Very uncomfortable to lay down can?t breathe properly   Taking pantoprazole again 3/19- 9:00 pm 3/20- 9:05 am  3/20 - 9:04 blood pressure 130/87  9:15 am extreme itching and rash on both arms  Took a warm bath felt horrible.  Took temperature 100.5  Main concern is breathing
Hospitalization for acute on chronic heart failure and COVID-19 on dates 8/14/2023- 8/21/2023. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Constant Tinnitus began in left ear the night I received the Covid-19 Vaccine shot. After a couple of days more symptoms appeared, including: Left ear fullness/pressure/inflammation feeling, left ear numbness, left outer ear tightness, shooting nerve pain in into left ear (outside and inside ear), shooting nerve pain towards the scalp on left side, extreme cramping inside and outside left ear. The tinnitus alternates between loudness of 2-7, at worst its a high pitched ringing noise, at best its a hissing noise. Often also a whistling noise, crackling noise, sleigh bell noise, occasionally pulsatile.  Also have increased anxiety due to the tinnitus.   Audiologist confirmed unilateral hearing loss in left ear in the Ultra high frequency hearing range (35db at 10K Hz, 60 dB at 11.2K Hz, 50 dB at 12.5K Hz, 40 dB at 14K Hz, and 35 dB at 16K Hz). Audiologist recommended practicing Mindfulness and listening to classical music, so as to not be in quiet environment, where I might focus more on the ringing in my ear. Taking supplements including: Multi-Vitamin, Iron supplement, Vitamin D3, Vitamin B Complex, Alpha Lipoic Acid, Bio-Flavonoids, Systemic enzymes, Benfotiamine, Turmeric. Currently 3.5 weeks later, I still have tinnitus, but it is usually at a volume of 3 or 4. It more often is hissing noise with alternating high pitched ringing. The ear fullness, numbness and nerve pain is less, but still there. ENT PA prescribed Methylprednisolone 7 day tapered dose on 4/15/2021 to take if painful symptoms of nerve shooting continue or get worse. Nerve shooting pains improved slightly, so as of yet have not begun the methylprednisolone. Anxiety has improved with use of Classical Music and Mindfulness. Also found a Facebook Group of those suffering tinnitus after the Covid-19 vaccine, and have found support there to cope.
51 yo female with no significant headache history presented with new onset left sided parietal headache, severe 9/10 pain several days after receiving vaccine.  Headache lasted for over 2 weeks, was treated with Motrin and Tylenol around the clock and eventually subsided on it's own.  Headache intensity was significant enough and different enough to include awaking the patient at night, that an MRI was undertaken to rule out intracranial pathology.  No other neurological deficits, aura, or symptoms.
Pain at injection site; Fatigue; Joint pain; Low-grade fever; This is a spontaneous report from a contactable other healthcare professional. A 49-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the right arm on 22Mar2021 at 11:15, as a single dose for COVID-19 immunisation. Medical history included osteoarthritis, GERD, peripheral neuropathy and allergy to shellfish. Unspecified concomitant medications were taken by the patient. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 01Mar2021 at 11:15, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021, the patient experienced pain at injection site, fatigue, joint pain, and low-grade fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcomes of the events pain at injection site, fatigue, joint pain, and low-grade fever were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
During event day, Patient came and completed form attesting that it has been six months since 2nd dose was administered to receive booster dose. Booster dose was given. After returning from event to enter data and submission to insurance, claim was rejected for not covered since it has not been 6 months since last dose. After checking system, record shows last dose was April 26, 2021. Spoke to patient over the phone, and she stated that her cardiologist said her husband and her both have heart disease and need to get booster dose as soon as possible.
This spontaneous report as received from a pharmacist refers to an 81 year old female patient. No concurrent condition was reported. No historical medication was reported. Pharmacist reported that the patient was vaccinated with 2 doses of PNEUMOVAX 23 in her left arm within 48 hours. First dose was given on 17-JAN-2015 and second dose was given on 19-JAN-2015. No concomitant medication was reported. The patient experienced no adverse effect. No PQC was involved. The outcome of patient vaccinated 2 doses of PNEUMOVAX 23 in her left arm within 48 hours was unknown. No additional information was reported at time of call. Additional information has been requested.
pt recv vax 17DEC98 & devel pox rash 7JAN99 cont to get worse sent to MD 14JSn99;unusual presentation mult scabbed areas primarily arms & legs no fx;
Information has not been received from a nurse concerning a 24 month old female who on 15-OCT-2007 was vaccinated with VARIVAX (Oka/Merck) (lot # 658588/1273U). There was no concomitant medication. No medical history or drug allergy was reported. On approximately 15-OCT-2008 the patient experienced breakthrough varicella on lower back and arms and was seen in the office on 20-OCT-2008. No treatment was required. The patient's breakthrough varicella on her lower back and arms persisted. Additional information has been requested.
Patient had excessive injection site redness and swelling after injection of ADACEL in left arm.
Lt thigh red, hard, area size of golf ball on 22MAY91, fever 103.6ax on 24MAY91 was out of town; Called MD office adv to go to ER; ER states probable sterile abscess;dec T 010 on 25May, lump size of pea 6Jun91 per PC from mom
Presented with SOB, covid symptoms; +Covid 6 days PTA; Meds PTA included Vit C, Vit D, Zinc, antibiotics, ivermectin, and steroids; dx Covid PNA; treated with  previous meds and remdesivir; O2 including Bipap in hospital; discharged home on O2.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/18/21 (EN6205) Pfizer Dose 2 4/16/21 (Er8732) COVID Positive 11/5/21 Admitted to hospital 11/5/21-11/7/21  11/12/21: Patient is a 72-year-old female with a past medical history significant for type 2 diabetes, hypertension, GERD, hyperlipidemia, obesity, chronic ischemic heart disease.  The patient presents to the ED today with complaints of shortness of breath.  The patient tested positive for COVID-19 on 11/05/2021.  The patient was subsequently admitted to the hospital on Sunday evening 11/06/2021 and discharged on 11/07/2021 on 2 liters of home oxygen, she states she was not on any oxygen prior to admission to the hospital.  The patient states she received steroids while inpatient, did not receive any antivirals or convalescent plasma.  The patient states she did received convalescent plasma yesterday as an outpatient.  The patient states she woke up this morning was unable to catch her breath despite being on 2 L of oxygen via nasal cannula, her pulse ox symmetry was 87%. She denies any chest pain, fever, chills, loss of appetite, diarrhea.  Patient's accompanying symptoms include productive cough.   Upon arrival to ED patient's temperature is 97.3°, heart rate 62, respirations 22, pulse ox 90% on 2 L oxygen via nasal cannula, blood pressure 118/71.  The patient's oxygen was increased to 3 L and her oxygen saturation increased to 97%. Patient's chest x-ray reveals bilateral pulmonary infiltrates.  V/Q scan was completed in is normal. Patient's laboratory findings are significant for glucose 119, D-dimer 2.71.  Patient received 500 mg IV azithromycin, 2 g IV Rocephin, 6 mg IV Decadron in ED.   The patient was seen examined at the bedside in the ED. The patient states she continues to feel short of breath despite O2 saturations being 97% on 3 L oxygen.  The patient denies any previous history of lung conditions or shortness of breath.  Patient is vaccinated against COVID-19.  Patient denies any tobacco use, drug abuse or alcohol abuse.  11/16/21: A 72-year-old woman who had presented to the emergency room with worsening shortness of breath.  Patient recently diagnosed with COVID-19 after testing positive on 11/05/2021, she was admitted at Hospital on 11/06/2021 and discharged on 11/07/2021 on 2 L of oxygen.  Due to persistent symptoms, patient presented to the emergency room.  She was admitted for COVID-19 pneumonia and acute hypoxic respiratory failure.  Inflammatory markers where elevated.  Patient was started on IV remdesivir, empiric antibiotic therapy with ceftriaxone and azithromycin.  She is on IV dexamethasone.  She developed bradycardia remdesivir, this was discontinued.  She was continued on oxygen.  She had aggressive pulmonary toileting done.  Urine cultures returned positive for E coli sensitive to ceftriaxone.  Patient reports improvement in her symptoms, she is occasionally on room air, also requiring 2 L of oxygen.  She is stable and being discharged home in a stable condition.  For outpatient follow-up with PCP, can probably be weaned off oxygen in near future.
Fever to 104, 48 hours after vaccinations given, that continued till 4-5 days after vaccines.  Viral upper respiratory infection diagnosed 8/26.
kidney transplant; This spontaneous report was received from a pharmacist via company representative refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date in 2009, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot/ batch number and expiry date were not reported) for prophylaxis. On an unknown date in 2011, the patient had a kidney transplant (renal transplant) at unspecified location. The patient told to the pharmacist that he would need a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). No product quality complaint was reported. The outcome of renal transplant was unknown. Causality assessment was not provided.
Felt "bubble" in throat, sudden onset. mucus sensation in throat. 1600. Patient returned to stadium . Patient left with her daughter after wating 15 minutes in observation after her injection.  returned at 4pm complaining of "bubble " in throat. BP 184/149  HR92 o2 sat 95%  1601 blood pressure 177/94  1605  BP 176/103 HR93 o2 96%  1609 BP 176/98 HR 96 o2 94%, 911 called for EMS  1611 EMS arrived, patient care transferred to EMS, patient continues to complain of "bubble sensation". Transferred to Hospital
Red, Swollen, warm to touch from right upper arm to elbow (not at injection site).  Lower arm from elbow to wrist became swollen the next day.  Seen at emergency walk-in clinic.  Treated with warm compresses, Benadryl and Augmentin.
I woke up feeling like I had the flu. I had body aches, fever, chills and congestion. It was around the beginning of June. I took a COVID-19 test and it was positive. I did take PAXLOVID and my symptoms lasted about 7 days.
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 27-AUGP-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVIs 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of 72 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported. There was no product quality complained involved. This is one of several reports received from the same reporter. Additional information has been requested.