chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented in ED with chief complaint of chest pain, a pressure-like left sided chest discomfort since 7AM with 7/10 intensity without radiation. Patient undergone urgent coronary angiogram which according to the Cardiologist report, it was predominantly normal.  He was given Morphine 2 mg IV on 8/23 0100H, metoprolol 12.5 mg PO on 8/23 0800H, Lisinopril 2.5 mg PO 8/23 0900H, Lasix 40 mg PO 8/23 0900H, Aspirin 325 mg PO 8/22 2100H.
Increased heart rate from 7:30pm to approximately 3:00 am. Reaching up to 130 beats per minute and this all occurred while resting on the couch. I stayed in constant contact with my family. I have a fitbit that alerted me and recorded the event
Please see details on previous page regarding itching and mild diarrhea.  I also had a slightly sore arm at the injection site, but not until 9 hours after the injection at 11 PM.  Itching may be due to my  occasional eczema--I still have it, or it may have been triggered by the gel used for my heart echocardiogram on 2/12/21 or possibly by the vaccine.  The mild diarrhea was only on 2/14/21 and resolved with OTC medication.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 as dose 4 (booster), single (Lot number: GJ6738) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE; ZOLMITRIPTAN. Past drug history included: Keflex, reaction(s): "Drug Allergy: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid taken from 16Jan2023 to 21Jan2023, lot number: GF4000).
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patients were inadvertently administered with improperly stored PEDIVAXHIB (Lot # L042258, expiry date: 18-AUG-2018; Lot# L051124, expiry date: 14-OCT-2018; Lot @ L033690, expiry date: 14-JUN-2018) (route of administration: intramuscular) (incorrect product storage). The vaccine was store at a temperature of 9.9 UC at an unknown time frame. Data logger was involved and there was no previous temperature excursion. No adverse effect reported. The outcome of the events was not reported. Additional information has been requested.
Information has been received from a physician concerning his 25 year old wife with no pertinent medical history or drug/allergies reactions, who on 24-JAN-2011 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) in one deltoid area and also was vaccinated subcutaneously with a 0.5 ml dose of MMR II (MSD), in the other deltoid area. There was no concomitant medication. Physician reported that "today" (On 25-JAN-2011) his wife experienced pain in the center of her upper back along the trapezius muscle. Physician mentioned that his wife is afebrile and she is not experiencing any injection site pain. He also mentioned that his wife did carry groceries "yesterday" (on 24-JAN-10) which may have contributed to this pain. Treatment therapy for the adverse event included TYLENOL. No lab diagnostic studies were performed. At the time of the report patient's pain in the center of her upper back along the trapezius muscle persisted. The patient sought for medical attention by speaking with the physician. Additional information has been requested.
FIVE HOURS AFTER RECEIVING VACCINE PT. REPORTED BY PHONE THAT ARM WAS RED, SWOLLEN AND PAINFUL
patient passed out while waiting in the observation area after the vaccine administration. He passed out briefly about 1 minute then regained consciousness. He then responded to pharmacist questions. 911 arrived and took him to the hospital
Mother noted approx 1-2 hrs after vaccine hives on legs / increased work of breathing and mild stridor. Local reaction persisted through clinic visit 4/19 - red/warm/swollen.
Muscle ache, headache, burning eyes sensitive to light, decreased appetite. Chills. Eventually hoarse voice over period of five days.
Our health department conducted a mass vaccination event on 4/13/21 where more than 1,000 people were vaccinated. Over the course of the 8 hr event there were 1 17 yo patient who received a first dose of Moderna vaccine. We have reported this to Moderna and they recommended we fill out a VAERS for each patient. We have spoken with the parents of each patient. There were no reported adverse effects and all of them are planning on getting their second shot of Moderna Vaccine.
1hr p/vax pt lt upper arm began to hurt;began swell & have inc pain;9OCT98 lt upper arm skin was sl taut & swollen over deltoid;sl red spotted area lower edge of muscle line;sl warm to touch;c/o pain w/any movement;
From telephone contact with reported, it was stated that a 4 year old (1 of 4) was vaccinated with Tripedia lot # UO356AA (date not specified). Some time after the vaccination, the patient developed a local reaction (date of onset not specified). Further information is requested. Link cases: U2001-00956, U20001-00957 & U2001-00958.
Patient received his booster shot on 1/14/22.  On the evening of 1/14/22 he got a massive fever, loss of appetite, and inability to sleep.  On 1/15/22 he had a lingering headache and continued loss of appetite, but he forced himself to eat.  He started vomiting on 1/16/22 and said he was constantly vomiting from 12:00 a.m. - 5:00 p.m..  He estimated he vomited 8 times, until there was literally nothing left.  He said he didn't really eat anything or get good sleep on 1/16/22.  On 1/17/22 he reported he had shortness of breath and noted his heart was beating "quite fast."  He noted that when he cooled his head it helped the shortness of breath "a lot."  His last communication was at 8:40 p.m. on 1/17/22.  He was scheduled to teach a virtual class at the local College on 1/18/22, he did not attend.  He was found deceased in his apartment on 1/20/22 at 8:00 am.
Vaccines given and w/in 2 days blister at injection site and then eruption. Transverse line with vesicles and dryness/dry pink papules that was encouraged to be left alone and time to observe.
5/12/99 Pm 6x6cm raised red, warm area lt arm n/v, dizziness ? fever (at home);seen by MD 5/14/99;sx remained @ pt visit;
X 48 h. after vaccination "felt ill" and arm painful - then red and itchy at injection site -> ice, antihistamine.
on 11-1-07 pt. recevied flu vaccine and noted     3 X 1 1/4 redden, nodule, warm to touch, and painful to left arm.  No relief with Mobic or ice. On 11-2-07 reassessed area; now 4 X 2 cm.
had ringing in his ears; ear infection; clogged ears; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for 51-year-old patient.  A 51-year-old male patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 17Apr2021 (at the age of 51-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced ringing in his ears 4 days later that turned into clogged ears and asks if people have experienced this. Caller states that this has been going on since the end of April until now. Caller states her husband is on his fourth ear infection and went to his primary care and second ENT in (city name withheld) today and has a MRI on Thursday and they don't know. Caller asks if there is something set up to record data. The patient lab data includes MRI on an unspecified date with unknown results. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
On  Wednesday, August 25, 2021 I had the Shingrix shingles vaccine at 2:30pm.   At 10:30pm that evening, I had sudden severe eye pain that lasted through the night, only being slightly improved by Advil.   There was some light sensitivity as well as blurred vision.  The pain was a little better on Thursday August 26th but still very painful and light sensitivity increasing.     I saw the Eye doctor at 6:30pm on Thursday, August 26th who said I had an ulcer on my cornea (we are not 100% sure if it is a reaction to the shingles -which is listed as a rare side effect of Shingrix) or something else that caused it such as my contacts, , but because of the timing  and not having any eye problems before the vaccine,  we are reporting it anyway. My pharmacist and I also feel that it is probably a reaction from the vaccine as well  because of the timing.    Dr. placed me on strong antibiotic eye drops that I am to take 3x/day for 5 day.  Treatment started on 08/26/21.
Pt states he had generalized pruritis then developed dermatitis on bilateral shoulders and upper back. The pruritis resolved after 2 days and dermatitis is resolving.
Within one hour of receiving injection my arm became quite sore and started to itch and swell. Approx. 4 hours later arm was very swollen and slightly red and very tender. During the night while up to use the bathroom I became very diaphoretic and light headed. The next day the swelling extended nearly to my elbow, into my axilla and up under the clavicle and I continued to feel weak and fatigued. The swelling and redness continued through December 8 and then subsided gradually over the next several days.
Friday March 12 2:00PM onset of fatigue and chills and joint ache into the night. Saturday March 13th 3:00PM onset of stomach ache and bloated feeling. Pain increased through the night. Sunday March 14th 2:00AM pain extreme and severe, 911 called and taken by ambulence to Hospital where Acute Appendicitis was diagnosed by Dr. Sunday March 14th 8:00AM transfered by ambulence to Hospital, for surgery. Hospital Dr. Apendectomy Surgery performed at 12:00 Noon. Dr.
Diarrhea; feel off, strange / feeling not myself; Nausea; sore  arm,; fatigue; mild headache / dull headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MALAISE (feel off, strange / feeling not myself), MYALGIA (sore  arm,), FATIGUE (fatigue) and HEADACHE (mild headache / dull headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Multivitamin.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced MYALGIA (sore  arm,), FATIGUE (fatigue) and HEADACHE (mild headache / dull headache). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), MALAISE (feel off, strange / feeling not myself) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Aug-2021, MYALGIA (sore  arm,) and FATIGUE (fatigue) had resolved. At the time of the report, DIARRHOEA (Diarrhea), MALAISE (feel off, strange / feeling not myself) and NAUSEA (Nausea) outcome was unknown and HEADACHE (mild headache / dull headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that he  went  to his  doctor and  they advised him to take Ibuprofen and drink fluid. Patient took Tylenol but  it did not help that much, and  patient is  only  Multivitamin as  his regular medication.; 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.
Janssen COVID-19 Vaccine EUA. Started feeling very tired two-three hours after the vaccination, got a mild fever approx 9 h after the vaccination and high fever (38.5 C) after 11 h. Strong dehydration feeling, nose numbness, chills, sensible skin feeling and dizziness. Fever and side effects approx 6-8 h and disappeared approx 17h after the vaccination
Mild case of painful to the touch feeling on buttocks and upper thigh of one leg. Lasted about 5 days, then went away. Caused me to wonder if I might come down with hives since I knew that was a symptom.
Shooting pain at time of injection.  Severe pain in shoulder started within an hour and within a few hours could not lift my arm at all.  Injection given at very top of my arm.  Felt like shoulder out of place or like severe tendinitis or frozen shoulder.  After about 3-4 days I started taking Prednisone and other prescription anti inflammatory to minimize pain and range of motion issues.  It helped but would come back as soon as I stopped taking it.
full anaphylaxis including tongue and throat swelling, elevated heart rate, elevated blood pressure, delirium, face slightly swollen, shortness of breath, dizziness
Day after shot, slight fever, chills, aches then ok the second day. Day  5 started getting tenderness/ache in left upper leg and trunk area on left side.  Day  9,  and since have had rash on left leg and has progressed to left butt area. Saw MD today and she confirmed Shingles. Now being treated for shingles.  I did have shingles vaccine 5 years ago.
Admin of 2 adjuvants only at the same time; 2 adjuvants only were administered.; 2 adjuvants only were administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number YZ9F7, expiry date 08-JUL-2024) and (batch number EC4CN) for prophylaxis.   On 29-SEP-2023, the patient received the 1st dose of Shingrix. On 29-SEP-2023, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: Admin of 2 adjuvants only at the same time), inappropriate preparation of medication (Verbatim: 2 adjuvants only were administered.) and inappropriate dose of vaccine administered (Verbatim: 2 adjuvants only were administered.). The outcome of the overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-OCT-2023 Pharmacist states they were administering the first dose of Shingrix to a patient and 2 adjuvants only were administered which led to overdose, inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility is the same as primary reporter. The lot numbers are the same for both the adjuvants. EC4CN is lot number from the adjuvant vial. Expiry date pulled from batch identifier.  The reporter consented to follow up via postal.
Vertigo:  room spinning, dizzy, eye movement, nausea, perspiration, unable to stand.
At 6 am the following morning after my vaccine, I had a slight fever, chills, body aches, nausea and extreme fatigue.  I am an active adult with a lot of energy but I stayed in bed all day only to get up for chicken noddle soup.  By evening I felt worse and was shivering so badly I bundled myself up put an extra cover on my bed to get warm, but the body aches were still ravaging my body.  The nausea symptoms had gone away mid afternoon.  I took tylenol around 1 pm and then again at 8 pm.  By 10:30 pm I woke up in a complete sweat and I felt fine.  All the body aches and uncontrollable shivering had vanished.  Today, which is day 2 after the vaccine, I am just a bit fatigued, The point of injection is still swollen and red and hard, but overall I'm  feeling much better.
Patient Medical Update January 19, 2022 from May 14, 2021  May 14 2021 Moderna first vaccination  Sore left arm for 3 days. No other issues.  June 7, 2021 Moderna second vaccination Low blood pressure, nausea, pain for 3 days requiring two I.V.?s.  Then 3 weeks sore arm.  October 22, 2021  Left arm swelling, week.  Severe pain, went to emergency room.    Letter to Emergency Department   ACUTE PROGRESSIVE SWELLING OF NONDOMINANT LEFT ARM  ONE WEEK HISTORY OF PROGRESSIVE SWELLING OF LEFT ARM. NO HISTORY OF STRENESOUS ACTIVTY, INFECTION, AFEBRILE, OR TRAUMA TO THE LEFT ARM. IBUPROFEN 400 MG Q8H FOR ONE WEEK HAS NOT RELEIVED PAIN OR SWELLING.  COLD COMPRESSES AND ELEVATION FOR ONE WEEK  ALSO NOT EFFECTIVE.   PAIN IS INCREASING OVER THE COURSE OF ONE WEEK. STARTED ASPIRIN Q4-6H OCT 22 LATE EVENING.  EMERGENCY ROOM VISIT ON OCTOBER 22 RESULTED IN NO DIAGNOSIS WITH ONLY IBUPROFEN THERAPY.   REGULAR PEDIATRIC CARE.  DOG BITE TO CRANIUM AT 6 YEARS OF AGE. TWO CONCUSSIONS IN ADOLESCENCE TREATED BY DOCTOR, CONCUSSION AND NEUROLOGIST SPECIALIST IMMUNIZATIONS UP TO DATE. MODERNA MAY THEN JUNE 2021.    1) PAGET SCHROETTER SYNDROME AXIAL SUBCLAVIAN VEIN THROMBOSIS REQUIRING IMMEDIATE DIAGNOSIS AND THROMBOLYTIC THERAPY.  MOST COMMON IN ACTIVE YOUNG MEN.  2) CARPELL TUNNEL SYNDROME 3) RHABDOMYOLYSIS 4) MALIGNANCY  November early Swelling went down, no pain. Still sore left hand & arm when in use.  December 24, 2021 Moderna 3rd vaccination Sick and sore arm for a week.  January early Left and right arm both hurt, circular wrist pain, severe pain on tip of right index finger, minor in left.  Pain in right arm started first time in right arm.   Exam by doctor. Consults with Doctor for irregular heartbeat, clotting,  and ordered an echocardiogram. Hand Surgeon, whom suspects either a rare vaccination reaction, compartment syndrome with arm/hand nerves, or plain over usage. Ordered bilateral MRI?s.   Jan 6 Labs .48 D-Dimer mg/L, normal .19 for age.  Normal 0-49.  Jan 19th No relief to date from rest.  Started two days ago 250mg Naproxen q6h & 1% Diclofenac Sodium Topical.
fever 101.8 (resolved within 24 hours) lymphadenopathy (ongoing - submandibular, anterior/posterior/deep cervical) edema of soft tissues i throat on right side making it difficult to swallow  SOB n/v/d
Wednesday evening lt arm was swollen, red & hot, blisters noted; taken to hos Thursday AM; dx allergic rxn; rx DPH, ice;
Initial misuse report received from healthcare professional on 29 October 2013. A 9-month-old patient received 0.5 ml dose of FLUZONE. (No  other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Site on right deltoid following DTaP injection noted redness, warmth, edema, and hardness about 3 cm below injection site. On 6/11/14 area improving, redness 5 x 3 cm, no warmth, slight edema.
Swollen glands on both sides under my chin & down the front & back of my neck.Fever 101-102,night sweats,headache,body aches,& redness on legs up to my knees.Took ibuprofen w/o relief.Went to ER & tx w/ antibiotics.
One day following vaccination, patient became presyncopal and tachycardic. She presented to local ER, where she was found to have multiple pulmonary emboli. She is being treated with heparin. We are seeking to obtain medical records now.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
On immediate injection I felt very sick but it passed. I went home. My arm became swollen and hot and painful. Arm was about 3x as big-very hard. Arm stayed like this 5 or 6 days. Took BENADRY.
I told the NP on site that I was nervous to get the vaccine as I have had an allergic reaction before the the meningitis vaccine, and when I described my previous reaction she brushed it off as coincidental. When I was 18, prior to leaving for college, I received the meningitis vaccine, administered by my pediatrician and within 30 minutes had a full body rash, fever, swollen lymph nodes and extreme brain fog. After I had stepped on a screw in my garage in 2016, I saw NP and asked if I needed to receive this vaccine or if I should consult a doctor. She mocked me, said that I was being dramatic and stated, 'we give this to 7 year olds' and stuck me in my left arm. I can still feel the pain to this day and there is an indent in my arm. I was out of commission for about two years, suffering from weight gain of 60 pounds within the two weeks following my vaccine, my thyroid began to fail, I suffered from peripheral neuropathy, extreme fatigue, difficulty concentrating, depression, dizziness, chest pain, rash, feeling of ants under my skin and so, so many more. Since then I have suffered a miscarriage and still don't feel 100% - even after being gluten, soy, dairy, egg and alcohol free for over a year now. I felt in my gut I shouldn't have gotten that shot and NP robbed me of my options by injecting me without a real discussion and disbelief that I had a true reaction to a prior vaccine. My life will never be the same.
I had a sore arm for about 24 hours after receiving the vaccine. I tested positive for COVID-19 in 06/2022. I had symptoms for about 24 hours prior to testing positive.  On day five I contacted my doctor, and it was decided that I do not take Paxlovid. I didn't take anything for my symptoms and just dealt with it.
both of my legs went numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (both of my legs went numb) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to aspirin). Concomitant products included PRAMIPEXOLE from 10-Jan-2008 to an unknown date for Restless leg syndrome.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 25-Feb-2021, the patient experienced HYPOAESTHESIA (both of my legs went numb). On 25-Feb-2021, HYPOAESTHESIA (both of my legs went numb) had resolved.            No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up information received on 05 May 2021, No new significant information On 06-May-2021: Follow up information received on 06 May 2021, contains No New Information. On 16-Jul-2021: Follow up information received on 16 Jul 2021, Patient demographics updated and first dose information, concomitant  were added, outcome was updated.
Left arm SQ redness, bruise. Posterior neck and arm papules. (<20)