chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely sore arm; Pain up into neck; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 12Y230) via an unspecified route of administration in the left arm on 03Apr2021 at 11:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic pain from torn rotator cuffs and anxiety. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included atorvastatin calcium (LIPITOR), amlodipine besilate (NORVASC), oxycodone (MANUFACTURER UNKNOWN), amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL) and alprazolam (XANAX) all for unknown indication from an unknown date and unknown if ongoing. On 03Apr2021 at 18:00, the patient experienced extremely sore arm and pain up into neck. It was reported that the neck still hurts a month later before 2nd shot, and the patient felt like had slept on neck wrong every day. The patient did not have any neck pain before vaccine and never been treated for neck pain. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient had received any therapeutic measures for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extremely sore arm and pain up into neck were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient felt fine immediately after receiving shot and say it was painless but reported needing help while shopping right after in store since she experienced sharp back pain, inability to walk, and sweating and overall sudden unwell feeling
?COVID arm? or delayed cutaneous hypersensitivity Raised red bump, about 2? across, firm to the touch. Itches!
Seizure like activity, initially described by parents as "fits" with feeding.  Events occurred with more frequency over next month and occured at times other than feeding.  Patient was referred to a neurologist by this MD for evaluation of seizure activity.  Details of the subsequent course are unknown to me.
very sore arm; Swollen arm; Could not get out of bed; Flu like symptoms; Night sweats and was waking up soaking wet head to toe; She got really sick; Nausea; Chills; Fever of 103F; very tired; Arm red as a beet; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (She got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever of 103F), FATIGUE (very tired) and VACCINATION SITE ERYTHEMA (Arm red as a beet). At the time of the report, PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (She got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever of 103F), FATIGUE (very tired) and VACCINATION SITE ERYTHEMA (Arm red as a beet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: high (High) 103 F.         Patient had her first Moderns vaccine on 13 Jan2021 in her right arm with no side effects.  No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-294660 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) Positive, notes: On day 4; (2021) Positive, notes: On day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient was received vaccine and other medication with in 2 weeks reported as no. Adverse event: On day 4 after testing + on a rapid antigen test, and after taking 5 Paxlovid pills, I discontinued taking them. I had almost no Covid symptoms leading up to taking Paxlovid but was told to take it due to my age, 74. After 5 days quarantine and 5 days wearing a mask I resumed full activities. On day 12 I tested + on a rapid test. This is the adverse event. I had a very mild sore throat. I have quarantined an additional 5 days and am on day 9. No Known allergies.  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 provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Patient complained of tingling in lips and hives. Patient had already taken Zyrtec before reporting event. Patient was offered oral Benadryl and informed of availability of Epipens. Patient declined use. Patient declined shortness of breath, throat swelling, and difficulty breathing. Patient counseled to monitor for shortness of breath, throat swelling, and difficulty breathing and to seek medical attention should they occur. Patient was followed up with 3 times over the course of 4 hours and she said she was fine.
BODY FELT HOT ALL TIME; HOT BREATH; TROUBLE BREATHING; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced trouble breathing. On an unspecified date, the subject experienced body felt hot all time, and hot breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of body felt hot all time, hot breath and trouble breathing was not reported. This report was non-serious.
Sence the 2nd Madonna vaccination  I have been experiencing lightheadedness and dizziness And has affected slightly my day to day activities
Left Leg Hurting Badly; Has a little redness on the back of her leg and when she gets up it hurts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 79 years, in left arm for covid-19 immunisation, autoimmune disorder. The patient's relevant medical history included: "AFib" (ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure medication; "Heart medication" (unspecified if ongoing), notes: Heart medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Lot: EN6202), administration date: 27Feb2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (Dose: 02, Lot: EN8730), administration date: 27Mar2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (Dose: 03, Lot: FC3182), administration date: 20Aug2021, when the patient was 79-year-old, for Covid-19 immunization. The following information was reported: ERYTHEMA (non-serious) with onset 21Apr2022, outcome "not recovered", described as "Has a little redness on the back of her leg and when she gets up it hurts"; PAIN IN EXTREMITY (non-serious) with onset 21Apr2022, outcome "not recovered", described as "Left Leg Hurting Badly". Therapeutic measures were not taken as a result of pain in extremity, erythema.  Additional information: Caller states she had her Second Booster Shot on 09Apr2022, Caller states she is 79-Year-Old and all together she has gotten 4 shots and the last one was Booster 2. Caller states she is wondering has anyone reported any leg problems, Caller states she has never had any leg problems before. Caller states her Left leg is hurting badly. Caller states she was reading the paper she received about the Booster, and she was just wondering if it could be from that. Caller states she said if it is still hurting, she will go to the ER. Caller asks, has anyone reported any leg pain from the booster, Caller states she has a little redness on the back of her leg and when she gets up it hurts. Caller states she is wondering if she has a blood clot no treatment was taken, and she was just trying to walk around. No Additional Vaccines Administered on Same Date of the Pfizer Suspect, no prior vaccinations, no AE (s) following prior to vaccinations.
Inflammation throughout body; Iritis in left eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 12:00 (Lot number: FD0809) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INFLAMMATION (non-serious) with onset 19Sep2021 16:00, outcome "not recovered", described as "Inflammation throughout body"; IRITIS (non-serious) with onset 19Sep2021 16:00, outcome "not recovered", described as "Iritis in left eye". The events "inflammation throughout body" and "iritis in left eye" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of inflammation, iritis.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received by the patient within 2 weeks of vaccination. The treatment received for the adverse event was eye drops. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Constant headache since the day after 1st dose. Ear pain, pressure, periodically ringing. Vertigo. Eyes feel like the are crossing, blurred vision.
Swollen shoulder; Swollen upper arm; Arm hot; Arm itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen upper arm), FEELING HOT (Arm hot), PRURITUS (Arm itchy) and JOINT SWELLING (Swollen shoulder) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event (no medical history reported). Concomitant products included SPIRONOLACTONE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen upper arm), FEELING HOT (Arm hot) and PRURITUS (Arm itchy). On 07-Apr-2021, the patient experienced JOINT SWELLING (Swollen shoulder). At the time of the report, PERIPHERAL SWELLING (Swollen upper arm), FEELING HOT (Arm hot), PRURITUS (Arm itchy) and JOINT SWELLING (Swollen shoulder) had resolved.      Action taken with mRNA-1273 in response to the events was not Applicable.    This case was linked to MOD-2021-037412 (Patient Link).
12MN 7JUL95 grand mal sz w/duration approx 90seconds; 4 throughout noc last one 430AM; fever 102.4; called ER no orders; APAP for fever for 48 hr; ran low grade fever next 24 hr;
Patient gat 3 doses of Pfizer COVID vaccine and was hospitalized with respiratory failure and COVID pneumonia on 1/9/2022.  Patient remains hospitalized for this today 1/10/22.  The 3 doses of vaccine were administered on 9/2/21, 2/16/21, and 1/26/21.
Extremely sore arm , per patient. Cannot lift arm above head currently. Pain is going all the way down to wrist and even back toward shoulder
Rt shoulder area of 5cm diameter erythema with some induration and tenderness---over deltoid.
pain and soreness at injection site, chills, fever, muscle and joint pain, nausea, headache, fatigue "symptoms almost identical in type and order felt when I first experienced having COVID-19 in late November 2020, except of course; for the duration of each stage".
On March 28TH he started with a fever and runny nose and eye puss. He had a fever for 4 days and got sent to the hospital, and tested positive for human metapneumovirus. He was not speaking and tapping on his face with his fists.
Since receiving my flu vaccine two days ago i've had extremely vivid nightmares with three episodes of sleep paralysis. I also keep experiencing strong phosphene visual patterns  as if I have experienced pressure around my eyes during these sleep paralysis episodes and wake up feeling as if i'm struggling to get enough oxygen when I do. I have some of the more common symptoms going on. A very bad two day long migraine so far, aches, stiffness, and fatigue, as well. I do not know how serious a side effect one is supposed to report, but I cannot find much about repeat sleep paralysis episodes from the flu vaccine so I figured I would report it just to be on the safe side.
fever of unknown origin, severe myalgias/proximal muscle weakness, elevated muscle enzymes, rash
Inappropriate schedule of vaccine administration; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 61-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 10th October 2021).   On 10th September 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 10th September 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient has not received 3rd dose. The reporter did not consent to follow-up.
Information has been received from a physician concerning her 81 year old female friend having meningitis at age 2 years and hearing loss from the disease who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# and route not reported). Subsequently the patient developed pain in her neck and both shoulders and hearing loss. The neck and shoulder pain resulted in cervical spine surgery which requested hospitalization. The patient's hearing loss was worse since vaccination with ZOSTAVAX (Merck). At the time of reporting, the patient was not recovered. Upon internal review, worsening of hearing loss was determined to be an other important medical event. Additional information has been requested.
Within a couple minutes of receiving the vaccine, she reported that she could not hear, felt very tired, and was about to faint. She collapsed and was kneeling on the floor, holding my legs for support. She began to cough and vomited a small amount. She repeated that she felt like she was about to pass out. After about 15 min she recovered sufficiently to walk to the car and we drove home.
24 hrs after receiving shot, I had same symptoms as I did with getting Covid-19 back in June 2020. Fever, Chills, Muscle/body ache, headache. This started on Friday and lasted through Sunday early evening, then went away as quickly as they came about. Only lasting affect now is redness and soreness approx 3" below injection site
Patient fainted right after shot it lasted like X 4 - 5 seconds then came back pale but alert.  We keep her waiting till completely well.  Then mom came to inform about 1 vomit episode out in parking lot.  I went out check on her she was alert, smiley, wanted to go eat because she was hungry.  We check on patient next day, she's doing well, mom instructed to call if any concerns.
Pt admit to hospital 6/15/22 with COVID s/p 3 doses Pfizer on 2/4/21, 2/25/21, and 10/22/21. At this time, his O2 sats haven't fallen below 90%
6/26/99 hands began to hurt 4 days & p/feet began hurting;p/1st & before 2nd inj pt c/o tightness in both hands & both wrists, rt being worse & throughout the day & toes;
They gave me the vaccine, I sit down, and I got dizzy and nauseated, they laid me on a stretcher with my feet up, I couldn't drive. At night I had chills, the next day my arm was red, pain in the joints, two days I had a fever. On the third day I felt better, only my arm was red for a week.
At wellcheck visit, influenza 0.5ml IM administered in pt's left arm and a pneumococcal vaccine 0.5ml IM high in her right arm on 1/15/13 -12N. No complaints until -1600 when she began having pain in right arm. At 2000, pt called MD to report symptoms and MD referred pt to urgent care or ED. Pt declined and self-medicated with unknown dose of ibuprofen at 2015 and again at 0145 1/16 and again at breakfast 1/16. Presented to clinic 1/16 and was found to have severe pain -10/10- when moving arm. Right shoulder diffusely tender with very limited ROM. Significant guarding. Cannot externally rotate arm. Appeared to have normal strength of elbow, fingers, wrist. Pulses: 2+ and symmetric. Pt was seen and evaluated and referred to orthopedics to evaluate.
Change in residents condition, decrease in responsiviness, would not speak or follow commands, expiratory wheezing, Pulse ox 91% RA
Within about 2 days a round red sore appeared on my left arm just below my elbow.  Each day it became more sore and inflamed.  Within one week it became filled with puss, erupted, bled and now seems to be filling with puss again.  Now, within the last 2-3 days the injection site has suddenly developed a large red patch of mildly itchy irritation surrounding the site, with one or two other small patches starting to appear nearby.  During the last few days I have also notice a dull pain coming and going in my left arm.  Using my cell phone, I have taken photos of the sore in 3 stages and of the red injection area.  Those photos could be submitted to my doctor or this office, via text, if helpful.
My 1 day old daughter was administered the first HepB Vaccine 1 day after her birth.  Immediately (within a day) thereafter, she began experiencing acid reflux.  She had to be put on Axid for reflux at the age of 3 weeks and has been on the medication ever since.  After researching, we have reason to believe that the Hep B vaccine is what has contributed to her acid reflux.
Asthma; This is a spontaneous report from a contactable consumer (mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 14Jul2021 (also reported as in this morning) as dose number unknown, single for COVID-19 immunisation. Medical history included asthma. Concomitant medication included salbutamol (SALBUTAMOL) taken for asthma. The patient experienced asthma on 14Jul2021. The reporter was asking if the patient can use her Ventolin inhaler as she experienced asthma. The outcome for the event was unknown.  Information on lot/batch number has been requested.
pt recvd vax & Lt leg was swelling all way to the ankle & up across belly; states vaginal area turned blue; R leg showed hives, red real splotchy; to er; all this disappeared in 1 hr;
In mid afternoon day of vaccination I was feeling flushed; My neck and face and scalp turned red; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration in left arm on 15Feb2021 10:00 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/Veterans Administration facility. Medical history included asthma, drug allergy (Allergies to combo glucomate). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took [amoxicillin sodium;clavulanate potassium] (AUGMENTIN) and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  In mid afternoon day of vaccination on 15Feb2021 15:00 patient as feeling flushed. Patient's neck and face and scalp turned red on 15Feb2021 15:00. This went away later that evening in Feb2021. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. Case was non-serious. The outcome of the events was recovered in Feb2021.  Information on the lot/batch number has been requested.
10cm x 12cm area of erythema right arm circumference 21.0 cm left arm circumference 18.5 cm. Given Benadryl prn.
Cough Headache Fever 99 this morning Tired Patient stated feeling terrible Viral upper respiratory tract infection  Fever of unknown origin  Tachycardia
Running nose started at 12 noon 8/6/03.  Fever 102 x2 days, 8/7/03, flat red marks developed over total body x4-5 days, 8/8/03 no appetite x4 days.  Went to Hospital on 8/8/03, diagnosis viral rash.  No treatment required.
Pt reported swelling in injected arm. Pt experienced pain in arm and an injection of the skin that required antibiotic therapy.