chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness on Arm; Difficulty Breathing; Vision Problems; Balance Problems; Headache; Tiredness; Low Oxygen Levels; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on Arm), DYSPNOEA (Difficulty Breathing), VISUAL IMPAIRMENT (Vision Problems), BALANCE DISORDER (Balance Problems) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Lung cancer (Small cell lung cancer) and Bell's palsy. Concomitant products included ACETAMINOPHEN, ALPRAZOLAM, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]), ERYTHROMYCIN, Corbideral, CLOPIDOGREL BISULFATE (PLAVIX), Gabastatin, HYDROCODONE, ALBUTEROL [SALBUTAMOL], LIOTHYRONINE SODIUM (CYTOMEL), MIRTAZAPINE (REMERON), MONTELUKAST SODIUM (SINGULAIR), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) and TRAMADOL for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (Redness on Arm), DYSPNOEA (Difficulty Breathing), VISUAL IMPAIRMENT (Vision Problems), BALANCE DISORDER (Balance Problems), HEADACHE (Headache), FATIGUE (Tiredness) and OXYGEN SATURATION DECREASED (Low Oxygen Levels). The patient was treated with OXYGEN for Oxygen saturation low, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness on Arm), DYSPNOEA (Difficulty Breathing), VISUAL IMPAIRMENT (Vision Problems), BALANCE DISORDER (Balance Problems), HEADACHE (Headache), FATIGUE (Tiredness) and OXYGEN SATURATION DECREASED (Low Oxygen Levels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I felt little intoxicated; Headache; Difficulty breathing; Tired; I was sensitive to light; It was little hard to hold my head up; Pain in my back between my shoulder blades like from muscle spasms; Severe pain in my lower back, in fact for most of the day I was unable to sit properly; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced felt little intoxicated, headache, difficulty breathing, tired, sensitive to light, it was little hard to hold my head up, pain in my back between my shoulder blades like from muscle spasms, severe pain in my lower back, in fact for most of the day was unable to sit properly. Patient stated, i just have couple of questions I got the Covid 19 injection on Monday the Pfizer medicine. So, I want to be talk to you for that there might be a reaction or not or I don't know. About an hour and half afterwards I had symptoms that I was almost expecting, little, tiny bit of difficulty breathing not that much. it was little hard to hold my head up, so I laid down but it only lasted two hours, after two hours I felt good. And that was on Monday and now on Tuesday I felt just fine all day long, I had been lying down his wife rubbed back few times. Here I have a question could it be some sort of reaction to my body due to vaccine in my body. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Dizziness, nausea, instability, headache, short term memory loss, loud tinnitus, hand tremor, vision focus problems, heart palpitations. Feeling of vibrating or "buzz" over the body.  Treatment: Benadryl 50-75 mg per day
Myalgias, Fever, Chills Day 2.  Chest Pain Day 3.
Hives that are itchy; Hives that are itchy; Red spot the size of a 50 cent piece on the area where the vaccine was administered; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 2B3P2, expiry date 10th May 2022) for prophylaxis.   On 12th August 2020, the patient received the 1st dose of Shingrix .5 ml. In August 2020, less than a week after receiving Shingrix, the patient experienced hives, itchy rash and injection site erythema. On an unknown date, the outcome of the hives, itchy rash and injection site erythema were unknown.   It was unknown if the reporter considered the hives, itchy rash and injection site erythema to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix in left arm and experienced hives that were itchy and a red spot the size of a 50 cent piece on the area where the vaccine was administered. The reporter consented to follow up.
Diarrhea, starting ~ 11 hrs after receiving vaccine.  Subsided about 12-13 hrs later.  Increased fluid intake at home.
Information has been received from a registered nurse concerning a 66 year old female with decreased kidney function and allergies to epinephrine, caffeine, iodine, sulfa and Macrodantin who on 05/09/2001 in the AM was vaccinated with the first dose of hep A vaccine in the left deltoid. Concomitant medication included "red yeast." There were no other concomitant medications or illness at the time of vaccination. That evening on 05/09/2001, the pt noticed an itching feeling over her body that lasted for 3-4 days and "felt like it was under the skin, "subdermal." However, the pt did not break out in a rash or hives. The pt stated that the symptoms wee "just enough to be irritating." She also reported taking Benadryl for three days and recovered from her symptoms. It was noted that a second dose was not given. It was reported that the pt recovered. No further info is expected.
Has experienced urinary bleeding; Has one kidney; Had tumors surgically removed from her bladder; Asthmatic; Now my lungs are starting to travel back downward; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization, reaction(s): "Elephant on my chest", "Double pneumonia", "Respiratory things/Breathing issues". The following information was reported: HAEMORRHAGE URINARY TRACT (medically significant), outcome "unknown", described as "Has experienced urinary bleeding"; SINGLE FUNCTIONAL KIDNEY (medically significant), outcome "unknown", described as "Has one kidney"; BLADDER NEOPLASM (medically significant), outcome "unknown", described as "Had tumors surgically removed from her bladder"; ASTHMA (non-serious), outcome "unknown", described as "Asthmatic"; LUNG DISORDER (non-serious), outcome "unknown", described as "Now my lungs are starting to travel back downward". Therapeutic measures were taken as a result of bladder neoplasm which included surgical removal. Per clinical course, patient stated she and her 18-year-old son got the two dose primary series of the Pfizer COVID-19 Vaccine about a year ago. The patient's second dose was okay. The CDC told her to get her second dose in the hospital, so she did. But it was okay. She didn't even know she got the thing. Patient stated she was "asthmatic, has one kidney, has experienced urinary bleeding, and had tumors surgically removed from her bladder, all after getting the COVID-19 Vaccine" (as reported). She stated, "now her lungs were starting to travel back downward" (as reported, pending clarification). Patient stated that people have died from these vaccines. She was querying if she and her son can get the old version of the booster instead of the new bivalent booster. Patient stated she was afraid she will have a severe reaction to the new formulation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201191499 same reporter/patient/vaccine, different dose/event;
Symptoms started Tuesday evening with aches and slight headache.  During the night the headache became excurciating, fever went up to 100.3, aches got worse, became nauseated.  Took Tylenol.  Arm was so sore I could not lay on it while sleeping. Could not sleep well, up every hour or so.  In morning still have symptoms, very fatigued.  Fever finally dissipated and symptoms lessened then found I had loss of taste.  About 6:00 fever started again.  By Thursday my symptoms were gone, but still have fatigue.
Member received anthrax#1 and smallpox vaccine on 11 July 2003 (first time vaccinee against smallpox).  On 20 July member noticed an itchy erythematous pustular rash on trunk and developed worsening myalgias/malaise/subjective fevers.  Saw doctor on 21 July 2003 and then presented yesterday to me with a worsening rash involving significant portions of his trunk/upper extremities/neck.  He has no facial involvement and has scattered lesions on his lower extremities.  There is no oropharyngeal or ocular involvement.  Photos were taken and transmitted via email.  They were shown to doctor who feels that this rash is consistent with "nonviral pustulosis" which tends to occur in healthy young males in their 20's.  Treatment is supportive and antihistamines are recommended for itching.  No bloodwork was recommended at this time.  Will continue to observe.  Pt is very well appearing and nontoxic.
Student had initial H1N1 dose given at school health clinic 11-20-09, then student went to primary care doctor and received another dose 11-29-09.
Feeling druggy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling druggy) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling druggy). At the time of the report, FEELING ABNORMAL (Feeling druggy) was resolving.            Treatment and concomitant medicines were not provided Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-110132 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Outcome of event updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-110132:
T101;h/a, chills on 29OCT97 for approx 24hr;felt fine 28OCT97;
I took a BENADRYL about an hour before. I first noticed heightened blood pressure about 20 minutes after the vaccine. About 25 minutes later, I started swelling above the clavicle on my neck. I was having a histamine reaction of some sort. About 4 hours later, I had extreme fatigue. I could not wait to lay down. I started feeling a heavy type of headache in my head. I had some brain fog. I couldn't think properly. The injection site was swollen. My shoulder continued to swell for a few hours. It stopped at a certain point and it took 2 weeks for it to go down. Around 2AM, I started experiencing fever. I just kind of left it alone hoping it would go away. In about 2 hours it was 99.1. It then went up to 102.9 around 3:30AM. I took an ADVIL and I was already having joint pain. I was having muscle discomfort as well. The joint pain, on a scale of 1 to 10, was about a 5. I had cold chills. My muscle aches was in my upper body joints. I don't think I was. I took another Advil about 3-4 hours later. My blood pressure was 166/99. The fever started coming down. The fever went away and my symptoms improved the next day. 24 hours later, the heaviness in my head went away. The brain fog stayed around for about 2 days. The fatigue stayed around for about 3 weeks. It really stuck around a while. The joint pain resolved around the same time that my fever came down. I talked with my PCP over the phone about what happened. It wasn't an official appointment. We just talked about what happened and how I was doing. She said that the swelling in my shoulder was the only thing that was not expected.
Usual symptom began about 12 hours following the vaccine--sore arm More usual symptoms began about 24 hours following the vaccine-- felt feverish, muscle aches, fatigue Unusual symptoms began approximately 30-32 hours following the vaccine--MS exacerbation with left leg pain, severe muscle spasms and inability to  ambulate.
Arm swelling, chills, fever, aches and headache.  On 11/11/2020, the shot area raised up and became red... approximately 1.5 inch diameter. This was my second shot.  My first shot I experienced a large swelling at the shot site, but nothing else.
After waiting the 15 minutes in observation, patient started to leave.  She felt some swelling of her lower lip and returned for evaluation.  Denies shortness of breath, no trouble swallowing, no swelling of tongue.  BP 161/81, p 107, O2 sat- 98% Took own OTC Benadryl 25 mg tab at 09:40 am .  Noted decrease in swelling within 5 minutes.   Continues to deny swelling of tongue, throat, or difficulty swallowing.   Discharged home with relative. She will notify her PCP prior to next injection to make sure she is okay to have the second shot.
Inflammation of the ganglios close to the clavicle, pain in the arm and affected right eye vision (flies around)
Patient was given the first Moderna COVID-19 vaccine on 25/JAN/2021 and 0n 22/FEB/2021, the patient got her second COVID-19 vaccine.; Patient was given the first Moderna COVID-19 vaccine on 25/JAN/2021 and 0n 22/FEB/2021, the patient got her second COVID-19 vaccine.; had no reaction to the COVID-19 vaccine injections except for a little soreness in the arm; This is a spontaneous report based on information received from a non-Pfizer sponsored program (marketing program name not available) by Pfizer (manufacturer control number: US-AMGEN-USASL2019000533), license party for etanercept (ENBREL). A contactable consumer reported a 76-years-old female patient received bnt162b2 (PFIZE-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 22Feb2021 as dose 2 (initial Pfizer dose), single for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took gold and prednisone for unknown indication and also took moderna covid-19 vaccine on 25Jan2021 for covid-19 immunisation and experienced a little bruise and soreness. The patient was given the first Moderna COVID-19 vaccine on 25Jan2021 and on 22Feb2021, she got her second COVID-19 vaccine. She had completed two COVID-19 vaccine injections. On unknown date in feb2021, she had no reaction to the COVID-19 vaccine injections except for a little soreness in the arm. Patient had no fever and no headache with the COVID-19 vaccine either. Subsequently, the patient took Tylenol (paracetamol) as a treatment right after she got the COVID-19 vaccine, and she did. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
within 1 hr of vax pt developed inject site react. felt as though her arm was ``falling off''. pt applied hot & cold compresses & took MOTRIN w/little relief. Follow-up information received from the physician on 04-MAY-1999 indicate that within 24 hours following receipt of TETANUS and DIPHTHERIA TOXOIDS Adsorbed, Purogenerated, the patient developed an injection site reaction characterized by swelling and redness. She was treated with antibiotics which were "moderately effective" at reducing symptoms, and antihistamines. The symptoms resolved over time with antihistamine therapy. The physician noted the symptoms  to be a "probable" localized allergic reaction. She recovered."
Almost immediate dizziness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Almost immediate dizziness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SULFA [SULFADIAZINE] (Allergy). Concurrent medical conditions included Hyperlipidemia, Hypertension and Penicillin allergy. Concomitant products included ATORVASTATIN, HCTZ and LOSARTAN POTASSIUM (COZAAR) for an unknown indication.    On 22-Jan-2021 at 10:21 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021 at 11:00 AM, the patient experienced DIZZINESS (Almost immediate dizziness). At the time of the report, DIZZINESS (Almost immediate dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I have had 5 shots and experienced severe localized reactions on shot number 3 and 4. on shot number three, I had joint pain in the right arm that lasted for 7 days and a grapefruit size welt on the bicep/deltoid. It was difficult to work or hold a pen. Since my fifth shot, I have had memory loss and joint pain. I also have a mild rash on both arms. I refuse to take any more shots. It is not worth the risk.
Patient had a stroke two days after vaccine.  Recevied TPA for treatment of stroke due to acute onset of altered mental status.  Had a history of afib, not on anticoagulation, which is likely cause of stroke. Family opted for comfort measures given poor neurologic status. Passed awaiting hospice placement
Sudden onset of bilateral aural fullness, tinnitus and hearing loss several hours after receiving her first injection.
- 15 minutes after vaccine administration, patient's arm began to swell all the way down to her fingertips. Jewelry had to be quickly removed due to swelling.  -1-3 hours post vaccine- extreme arm soreness, unable to lift arm, fever of 99.9, nausea, course throat/mild cough (resolved with albuterol inhaler) - 1 day post vaccine- symptoms continued into the following day and a mild fever was maintained. Difficulty breathing occurred occasionally throughout the following day, resolved with albuterol inhaler. Arm swelling slowly started to go away over 24 hours after the dose was given.
blindness in left eye; stroke in back of the eye; blood clot; A spontaneous report was received from a consumer concerning an 83-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced blindness in left eye, blood clot, and stroke in back of the eye.  The patient's medical history was not provided. Concomitant medications reported included comerdol, losartan, hydrocortisone, meloxicam, and unspecified stomach pills.  On 14 Jan 2021 at 10:15 am, approximately 3 hours and 45 minutes prior to the onset of the events, the patient received a dose of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021 around 2:00 pm, the patient lost sight in her left eye as a result of a blood clot and stroke in the back of her eye. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, blindness in left eye, blood clot, and stroke in back of eye, was unknown.; Reporter's Comments: This case concerns an 83-years-old female patient, who experienced a serious unexpected event of blindness unilateral, retinal artery occlusion, and thrombosis. The event of blindness unilateral and retinal artery occlusion occurred 3 hrs. after first dose of mRNA-1273, lot # 013L20A.  The event of thrombosis occurred on an unspecified date after first dose of mRNA-1273, lot # 013L20A. Treatment included details were not provided. Concomitant medications included Comerdol, Losartan for blood pressure, Hydrocortisone, Meloxicam and stomach pills. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Initial report received from a nurse on 20 November 2009. A 48-year-old female patient received an intramuscular left deltoid injection of FLUZONE (lot number UT3251AA) and an intramuscular right deltoid injection of H1N1 (lot number UP001AA). Two hours post-vaccination, she noticed pain in the left upper deltoid with decreased range of motion. The patient had a history of penicillin allergy, and was taking CLIMARA concomitantly. Outcome was not reported.
Red bruise like area around the right wrist. Nothing by injection site itself. Patient said it was a little warm, but didn't hurt. Recommended to get checked out by a doctor to determine if related to the injection and appropriate treatment. Patient saw doctor and they said it was a right hand hematoma due to a shot being given too low on the upper arm. Patient was instructed to rest the arm and ice as directed by the doctor. Patient also was told by doctor to apply BIOFREEZE to the area as directed by the doctor.
This medically confirmed spontaneous report (initial receipt 08-Oct-2013) concerns a male patient. On an unspecified date, the patient was administered AFLURIA (batch number not specified). On an unspecified date, after vaccination, the patient developed an injection site reaction. He developed an abscess at the injection site. On an unspecified date, the patient was hospitalised to undergo surgery to drain the abscess from the injection site. The reporter was not sure about the length of time the patient had to remain in the hospital after the abscess drainage surgery. Outcome was not reported.
Systemic inflammation.  Painful joints. Skin irritation  Abdominal swelling and discomfort.  Gastrointestinal difficulties and discomfort.  Weakness and muscle aches. Headache.
Sever burning and shocking (electric shock) pain in right leg extending to all over the body. Called his Nero doctor. He prescribed oxycodone-acetaminophen 5-325 to take 1 or 2 every 6 hrs for severe pain. He took 2 and had some relief within 20 minutes.
I was prescribed an anti-viral that I took for 5 days I don't recall the name. When I was sick, I had fever and no appetite and heavy cough that lasted for some time even to this day.
Patient had an uncomplicated  vaginal delivery of a viable male infant weighing 7 # 15.9 oz. Hospital admission within 6 weeks of receiving the COVID vaccine.
Pt. reported feeling lightheaded and dizzy, Headache and blurry vision when trying to text within 10 minutes of getting dose of vaccine.  Patient was transported to ED.  HA and blurred vision resolved.  Given toradol and zofran. Discharged stable.
My son started having raised bumps on his skin. Some appeared pimple like others just raised. No redness.
Vaccine stored in refrigerator for 3 days after the beyond-use-date. Had been refrigerated for 10 weeks +3 days at the time of administration. There were never any temperature excursions during this time, but given beyond the 10-week recommended storage in refrigerated conditions time period.