chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little red acne-like bumps that are painful to touch; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 12:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's past drugs were unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 00:00, the patient experienced little red acne-like bumps that are painful to touch which lasted for 2 weeks. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event red acne-like bumps that are painful was resolved on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt states he was initially feeling fine s/p receiving his COVID vaccine. After 5-6 minutes he notes a syncopal episode that he describes as feeling like he randomly fell asleep. When this occurred, he fell back in his chair and hit his head. He notes blurry vision after this occurred but felt like he was slowly improving. While he was being brought to the ED in a wheelchair he began experiencing blurry vision again and his face became very pale. He was given some apple juice and reports that after 5-10 minutes he felt back to normal. While his vitals were being taken, his HR and BP were very low and he experienced another episode. Pt does not have a hx of passing out 2/2 needles and notes that he gets a flu shot every year and is totally fine. He does note that he became queasy when he tried to give blood in the past but that this does not normally happen. Of note, pt denies any leg swelling prior to these episodes. Pt endorses a low baseline HR in the 50s per his Fitbit but otherwise denies any known heart problems. He notes a fhx of heart problems and states that his dad had heart bypass surgery a couple years ago. Pt denies any daily medications other than vitamin gummies. Denies DVT risk factors or prior history of DVT.
Around 03/01/2021, I felt like I had a severe sinus headache, and all my teeth hurt, even the ones with root canals and crowns, and my joints hurt, I did not have a fever. I called the health nurse, on telehealth. She said your temperature is not high and you have not been around anyone and you cannot see a doctor here. And she said you need to go to the ER. I didn't not want to be exposed to COVID-19 at the ER.  At that time, if you did not have a written doctor's referral, you could not get a COVID Test. There were not enough C-19 test.   So I took Tylenol, Motrin, and Advil and drank a lot of fluids and laid around. A week and half later my doctor called me back and said it was probably a toothache or a sinus infection.  She said I could use a Netty Pot to wash  it if it was a sinus infection. My nasal passages were clear. but my sinus area was painful, my whole face was in pain. It lasted like a week or 10 days that I  felt like that.  Before I had the vaccine I was able to walk 3 miles in the morning. Now I can walk a block 1/2 before I am exhausted . The end of March I went to the dentist to get my teeth cleaned. I didn't have any cavities or dental problems. These symptoms are something I attribute to the shot.  Since March 2020, before the vaccine I live in a community were they are strict, we were on lockdown. I had no exposure to anyone. Everyone was very careful because it we live in a community of a lot of old people. I attribute my symptoms to the vaccine because my body just reacted to it some way. Other than this I have not been sick since 2014.  I have recovered from my symptoms, but I do not have stamina. I'm always exhausted.
INJECTION SITE IRRITATED; INJECTION SITE ITCHY; SORE ARM; INJECTION SITE RASH; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE IRRITATION (INJECTION SITE IRRITATED), INJECTION SITE PRURITUS (INJECTION SITE ITCHY), PAIN IN EXTREMITY (SORE ARM) and INJECTION SITE RASH (INJECTION SITE RASH) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE IRRITATION (INJECTION SITE IRRITATED), INJECTION SITE PRURITUS (INJECTION SITE ITCHY), PAIN IN EXTREMITY (SORE ARM) and INJECTION SITE RASH (INJECTION SITE RASH). At the time of the report, INJECTION SITE IRRITATION (INJECTION SITE IRRITATED), INJECTION SITE PRURITUS (INJECTION SITE ITCHY), PAIN IN EXTREMITY (SORE ARM) and INJECTION SITE RASH (INJECTION SITE RASH) had resolved.            No concomitant medications were reported.  The Causality as per reporter for HUMIRA was not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.
This is a spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerning a 35-year-old, adult, male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252227, expiry date: 31-May-2019, route of administration: intramuscular and anatomical location: left deltoid) which underwent temperature excursion The patient did not experience any adverse reactions. This case is linked to case 201805327 owing to same reporter. The reporter assessed this case as non-serious. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (35-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Information has been received from a certified medical assistant referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 04-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # K003413, expiry date: 06-MAR-2016) (dose, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 2/18/02, Hep-B #3 was given in the right deltoid, IM. On 2/19/02, report of right arm swollen, red and painful via telephone call. Pt seen in office again on 2/19/02. Treated for vaccine reaction vs cellulitis with Benadryl and Keflex 250mg.
pt devel severe local rxn p/vax;this is one of three pt's from this site who exp the above rxn;
pt recvd vax 14JUL95 & 19JUL95 presented w/paralysis of the lt side of face & muscular twitching around lt eye;pt had been evaluated by neurologist, who initiated a steroid, pain med for eye twitching & physical therapy;
Vaccine administered the day after the 30 day shelf life of being refrigerated. The patient reports no adverse reactions. Pt was Notified and offered a repeat dose and declined at this time.
I received the one dose Johnson & Johnson (Janssen) at 4pm on 24 December 2021 due to travel requirements. At 6am on the morning of 25 December 2021 I was woken by excruciating pain in my chest - heart region and a feeling of extreme weight on my chest. Since then I have experienced intermittent pain where it feels as though my heart is being stabbed by a hot poker. I have to stop what I'm doing and wait for the pain to subside, which takes from 20 to 30 minutes. This has impacted my life in all areas. I reported this to Janssen in January 2022 and am still waiting the answers to my questions - Will this pain continue for the rest of my life? Will I die of cardiac arrest?
ACUTE RESPIRATORY FAILURE  03/19/2022 -- RECURRENCE OF SAME SYMPTOMS
Patient requested and received 3 vaccines and immediately reported feeling short of breath and some chest tightness. EMS was called and patient received breathing treatment after which she stated that she felt much better.
Swelling, pain and hematoma in left breast; Swelling, pain and hematoma in left breast; Swelling, pain and hematoma in left breast; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Mar2021 at 18:00 (at the age of 55-years-old) in left arm as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine and no other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with covid-19. Since vaccination, the patient had not been tested for covid-19. Patient had no known allergies to medications, food, or other products. On 21Mar2021 at 19:00, the patient experienced swelling, pain, and hematoma in left breast. The events were reported as non-serious. The adverse events resulted in physician or other health professional office visit, urgency, or emergency room/department visit. Treatment medication included sedatives, anti-inflammatories, and antibiotics. The outcome of all the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with ROTATEQ orally (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA001256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011424, 1403USA011425, 1403USA011427 (same reporter link). Additional information has been requested.
Skin allergic reactions - itchy scalp, hands, feet, sides of torso + dermatographia
Two hours after the first shot I have been experienced adverse events an day by day are getting worst My flexible parts of my boy are getting drowsy and they burnt when friction is applied.
This case was reported by a healthcare professional and described the occurrence of fatigue in a 54-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergic reaction to msg and milk allergy. Concurrent medications included CARDIZEM, INSPRA, AVODART, CRESTOR, TRICOR, LOVAZA and NEXIUM. The subject had previously received influenza vaccinations and had experienced slight fatigue. Outcome of the slight fatigue was unspecified. On 17 November 2009 at 15:30, the subject received a dose of FLUARIX (.5 ml, unknown, left arm). In the morning on 18 November 2009, unspecified hours after vaccination with FLUARIX, the subject experienced fatigue, myalgia and arthralgia. At the time of reporting the events were improved. The healthcare professional considered fatigue and myalgia were probably related to vaccination with FLUARIX. The healthcare professional arthralgia was possibly related to vaccination with FLUARIX.
welps, hives & rashes. Treated with benadryl for 4 days. Advised to not get 2nd dose.
New COVID 2023-2024 vaccine given. Normal sore arm and body aches. Pt however stated she went to lay down at 12:15am and all of a sudden her whole body started to shake severely and teeth chattering and chills lasting 30minutes and it scared her, She did get her High dose flu vaccine same time.
This medically confirmed report (initial receipt 04-Sep-2012) concerns a female patient. In the past the patient received influenza vaccine (manufacturer and batch no. not provided) and experienced a severe reaction. No further information was available.
The next day I had headaches, my breathing was really heavy, I still don't have my taste and my smell back. I had body ache and my skin on my hands dried out. I contacted my doctor and she gave me an ointment to put on and it got better.
Started with low grade fever and rash on legs (upper right thigh, lower left shin) legs got infected. Everyday noticed new spots until eventually had it all over. Went to doctor 06/05/02 started on Prednisone 50 mg q da x 5 days, Augmentin 500/125 1 tab po twice day x 7 days. Aveno bath as needed fro itching. Improved today. Pt noted three different types of bmps, one looked like chicken pox, one looked like white head that wouldn't pop bright red very small compact deep blister looking no bump on top deep-clear in color.
Inflamed right Achilles tendon. I noticed a bump behind my right ankle sometime mid May. It didn't bother me until after the first weekend in June, when I was at the beach and walked a lot in ankle-deep loose sand. The bump got bigger, and I began favoring it. I went to my Primary Care doctor during the week of June 9. She prescribed meloxicam and ice to help with the inflammation. I also started using arnica gel on the inflamed area to help with pain and to try to reduce the inflammation.
For about 30 minutes I felt very jittery, as if I had had way too much caffeine.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, TELMISARTAN (MICARDIS HCT), DILTIAZEM (CARDIZEM [DILTIAZEM]), ZOLPIDEM, COLECALCIFEROL (VITAMIN D 3), FISH OIL, MULTIVITAMIN [VITAMINS NOS], CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, MANGANESE ASCORBATE (COSAMIN), VITAMIN B6, VITAMIN B3, VITAMIN B12 NOS and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 17-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included cinnamon and green tea.Treatment information not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-073751 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073751:2st dose events
Trouble getting needle into arm, unknown amount (seemingly a lot) of vaccine ran down the side of my arm. When I questioned if I received enough, I was brushed off and moved along the line. I am now trying to determine if I actually received enough of the 2nd dose. Can not get anyone to help me despite numerous calls to various agencies and helplines. Was told to file a report here.
Received vaccination at    am. At 2:30 I begain to feel nauseaous and lightheaded. By 4:30 I was shivering and experiencing muscle aches which progressed to fatigue, fever and general influenza like illness. I took an OTC flue remedy that night. I missed one day of work. Most of symptoms resolved by noon the next day, except for the fatigue which continued for the rest of the day. I am a nurse and have had numerous influenza vaccines (10+) with no previous reported effects.
Syncope 30 min after injection. Severe right arm pain radiating to fingertips 1 hour after injection.
Information has been received as part of a pregnancy registry from a mother concerning her 18 year old daughter with a drug hypersensitivity to acetaminophen (+) hydrocodone bitartrate (VICODIN) that makes her sick to her stomach and "ovarian problems" that prevent her from menstruating with a history of ovarian cysts and ovarian endometriosis who on 03-AUG-2007 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  In approximately September 2007, the patient became pregnant.  On 05-OCT-2007 the patient received her second dose of GARDASIL.  No adverse event was reported.  No laboratory studies were performed.  As of 25-OCT-2007 the patient was 7 weeks pregnant and her estimated date of delivery is 12-JUN-2008.  As of 25-OCT-2007, the patient had not sought medical attention.  Follow-up information was received.  On an unspecified date the patient had an abortion; elective termination.  Upon internal review abortion; elective termination is considered to be an other medical event.  Additional information is not expected.
FELT LIGHTHEADED AND DIZZY; BODY TINGLES; FELT LIKE HE WAS GOING TO PASS OUT; This spontaneous report received from a consumer concerned a 20 year old male. 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 not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 12:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced felt lightheaded and dizzy. On 06-APR-2021, the subject experienced body tingles. On 06-APR-2021, the subject experienced felt like he was going to pass out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt lightheaded and dizzy, body tingles and felt like he was going to pass out was not reported. This report was non-serious.
OBSTRUCTIVE SLEEP APNEA 3/15/2023 UTERINE FIBROIDS
Meniere's disease; not able to do anything; throwing up; Dizzy/ Light headed; sick; Cannot drive; Ear stuffed up; Ringing in Ear; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (Meniere's disease) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History reported.  Concomitant products included LISINOPRIL, LEVOTHYROXINE and SIMVASTATIN for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced TINNITUS (Ringing in Ear). On 11-Mar-2021, the patient experienced EAR DISCOMFORT (Ear stuffed up). On 14-Mar-2021, the patient experienced DIZZINESS (Dizzy/ Light headed), ILLNESS (sick), IMPAIRED DRIVING ABILITY (Cannot drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to do anything) and VOMITING (throwing up). On 21-Apr-2021, the patient experienced MENIERE'S DISEASE (Meniere's disease) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Ear discomfort, at an unspecified dose and frequency. At the time of the report, MENIERE'S DISEASE (Meniere's disease), EAR DISCOMFORT (Ear stuffed up), DIZZINESS (Dizzy/ Light headed), ILLNESS (sick), IMPAIRED DRIVING ABILITY (Cannot drive), TINNITUS (Ringing in Ear), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to do anything) and VOMITING (throwing up) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was also provided treatment with a low salt diet and an unspecified diuretic.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
given dosing for 5-11 year old but patient is 14 years old - no adverse effects
Prolonged fever (approx 13 days), congestion, watering eyes, rash, seizure.
36 y/o male referred to VHC (15MAR13, 1300 EST) for evaluation of primary SPV site (LUE) on day #10 following immunization. Patient received primary SPV (LUE) and AVA #8 (RUE) on 05MAR13 in preparation for travel in early APR 2013 (2 weeks). Also received rabies booster on 27FEB13. Patient denies viral or GI illness within 30 days prior to receipt of vaccines. Patient c/o not being able to sleep last night due to throbbing and pain LUE. Rates pain last night as "8"/10 and now is about "7"/10. Endorses itching, warmth, throbbing and redness about the size of an orange at SPV site (LUE) with red streaking (lymphangitis) going toward downward toward left axilla. Tenderness under left axilla. Reports having a HA and feeling lightheaded and very fatigued / SOB since Wednesday 13MAR13 (day #8 s/p SPV). Did warm-up exercises during PT on Wednesday and had to quit due to fatigue and SOB. Denies CP or deep pressure in center of chest. No diaphoresis, pallor, N or V. No radiation of pain to jaw, back of throat or to left arm, but his left arm feels kind of numb today from the localized swelling and redness at SPV site. Denies flu-like sx or chills. Denies positional or pleuritic SOB, made worse when supine. Not able to raise left arm higher than shoulder level. Pain (LUE) is impeding his ability to perform duties carrying boxes at work.
caused me to be immunocompromised; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number, unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "caused me to be immunocompromised".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 12.75 hours. On 20-DEC-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.