chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 10-AUG-2015 the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (0.5 ml, lot # L002310, expiration date 08-JUL-2016) intramuscularly. Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Immediately after receiving the vaccine had heart palpitations while sitting down for the 15 minute wait time.  She thought it would be temporary and go away, but did not.  She came home, and it was still happening, still having them.  She talked to her daughter and went to the ER.  They did an EKG and blood work for fear of having a heart attack, all was negative.  Didn't do anything more for her.  After 3 hours and moved to a chair and then it suddenly stopped.  She did have this reaction for about 5 hours.   Still feeling tired but not sure if it was from weather or stress itself.
Emergency room visit, COVID positive with symptoms. Fully vaccinated March 2021. Received Regeneron antibodies in ED.
Public Health Nurse RN gave MD wrong dose/type of H1N1. Patients should have received 0.25 ml preserv. and instead she gave MD 0.5 ml H1N1 with free preservative.
Caller returning call with patient information regarding improperly stored vaccine administration; This spontaneous report was received from an unspecified reporter, referring to a patient of 1 year old and unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) administered at a dose of 0.5 milliliters (ml) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number S038702, expiration date 01-DEC-2021) given as prophylaxis. The vaccine administered experienced a temperature excursion of -9.5 degrees Celsius (C) for 8 hours and 53 minutes; and -10.1C for 6 hours and 40 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event (AE) details were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA008397: US-009507513-2009USA008398: US-009507513-2009USA008475: US-009507513-2009USA008486: US-009507513-2009USA008520: US-009507513-2009USA008533: US-009507513-2009USA008555: US-009507513-2009USA008675: US-009507513-2009USA008746: US-009507513-2009USA008761: US-009507513-2009USA008780: US-009507513-2009USA008804:
sore arm; sore throat; dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat) and DRY MOUTH (dry mouth) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat) and DRY MOUTH (dry mouth). At the time of the report, PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (sore throat) and DRY MOUTH (dry mouth) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitants were not provided. Treatment was not provided.   This case was linked to MOD-2021-036265 (Patient Link).
1st shot-swelling and redness at site 2nd shot-unable to walk, all over pain, muscle weakness and chills.  When it started I thought it was my fibromyalgia.  The all over body ache, muscle weakness and unability to walk normal has continued to this day.  Doctor has given me more pain meds but nothing is helping.
I found that I had tiredness for about 8 days after. The second dose. I could function, but couldn?t get through exercises that I regularly do. Just tired a little achy.
Persistent cough, with no fever, won?t go away, lots of Mucus in the throat.  Much more frequent headaches, 3-4 days a week.
Pain & swelling on right deltoid area complains of pain and tenderness in bilateral axilla. 97.7 temp orally. Pt returning on 3-26-04 for follow-up visit.
This non-serious spontaneous case, was initially received from other health professional on 28-Sep-2017, concerning a 54-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered last year's expired FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported) The reporter assessed the report as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
After patient received SUB-Q injection, patient began to stiffen his body while collapsing to the floor. Skilled nurse assisted him to the floor with no incidence if head hitting the floor. While lying on the floor for a short moment patient was exhibiting jerky movements of facial muscles. Patient recovered shortly and acknowledged he was ok.
Information has been received from a physician concerning his 6 year old daughter with no known drug allergies who was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) a number of years ago. on 8/23/02 it was reported that recent lab work seems to show a Hepatitis B infection. The lab  data showed a positive core antibody and was negative for surface antigen. Additional information has been requested.
When pt came into the vaccine room she was accompanied with the sister and mother. Sister was making jokes and making fun of the patient regarding the vaccines. Pt was already sweating and nervous before and I while I was giving her the PPD and when I finish her giving her the HPV and the other shots the pt started feeling dizzy and fainted. I called the doctor we given her oxygen pt then woke up and we did her vitals. Then we placed her in a room where after 10 minutes more pt stated to be OK and left the location.
Rec'd Engerix-B 25JUL90; 2 wks p/therapy 8AUG90 experienced itching, bilateral rash on arms & shins, & "felting" of hair; Engerix-B discontinued & was treated w/Histamil (? Hismanal) & topical ointments for rash. Sx subsided.
Information has been received from a physician assistant concerning a 9 year old male patient with a history of chronic urticaria who on 03-JAN-2008 was vaccinated IM into left arm with 0.5 mL of pneumococcal 23v polysaccharide vaccine, lot # 658555/0964U. The reporter reported that the patient experienced an anaphylactic reaction which consisted of facial swelling, flushing, tightness of the throat, coughing and gastrointestinal upset within a few minutes of receiving the injection. He was administered epinephrine, intramuscular BENADRYL, ranitidine and oxygen at the physician's office. The patient also received three teaspoonsful of PRELONE prior to being transported to the emergency room. The patient was kept at the emergency room overnight so he could be monitored but was not admitted to the hospital. On 04-JAN-2008, the patient recovered. The reporter indicated that the patient's adverse event anaphylactic reaction, was disabling and life threatening. She also believed patient getting epinephrine, IM BENADRYL, ranitidine, oxygen and getting 3 teaspoonsful of PRELONE prior to being transported to the emergency room were interventions to prevent a serious criteria and the the event reported was an other medical event. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
34 hrs after vaccine i began having watery diarrhea.  So far it's been 4 times in one hour. Not sure how long it will last.
Injection site pruritus. Wrong drug administered. This case was reported by a healthcare professional and described the occurrence of injection site pruritus in female subject of unspecified age who was vaccinated with influenza vaccine trivalent (FLULAVAL, GalxoSmithKline) for prophylaxis. On 5 August 2009 at 16:00 the subject unspecified dose of FLULAVAL (unknown, left arm) instead of a TB test (wrong vaccine administered). On 5 August 2009, immediately after vaccination with FLULAVAL, the subject experienced injections site itching. At time of reporting the outcome of the injection site itching was unspecified.
Nurse reports that patient did not experience any symptoms.; patient was administered a dose of improperly stored VARIVAX that was reconstituted with Merck DILUENT that did not experience a temperature excursion.; Nurse reports route of administration to be "intramuscular" rather than subcutaneous.; This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. Information on pertinent medical history and drug reactions/allergies was not reported.   On 07-MAY-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX), intramuscularly (strength, dose, and vaccination scheme were not reported) (lot # R002057, expiration date: 22-JAN-2022), administered for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).   The vaccine underwent a temperature excursion of 15-degree Fahrenheit (° F) to 46° F (18.3 F) for a period of 1 hour and 15 minutes. The vaccine previously underwent a temperature excursion of 15° F to 46° F (34.5 F) for a period of 2 hours and 33 minutes. The excursion was called by a digital data logger. The nurse reported that the patient did not experience any symptoms (no adverse event).   This was one of three cases from the same reporter.; Sender's Comments:  US-009507513-2001USA000143: US-009507513-2001USA000179:
This medically confirmed spontaneous report (initial receipt 16-Jan-2013) concerns a 45 year old female patient with a medical history of chronic pain, low back pain, headache, fibromyalgia, and paresthesia. Concomitant medications included gabapentin, hydrocodone and sumatriptan. On 10-Jan-2013, the patient received AFLURIA (batch: 07849211A) in the right upper arm. On the same day, the patient developed a sore arm and afterwards experienced feeling of malaise and a migraine headache for 5 days. The patient was hypersensitive to the vaccine serum. The patient's upper and lower teeth were sensitive on one side only, which was her left side. The patient was treated with ketorolac. The event outcome was unknown. Reporter's comments: The reporter considered events serious due to significant disability or incapacity (bad headache).
Client reports he received 1st dose of COVID-19 vaccination early January, 2021, shortly after became SOB, continued for 3 weeks, worsening in the last week with increased weakness and lethargy, and received 2nd dose on 2/2/2021, and was seen by his PCP, PA Cerner  on 2/3/21, sent to to the ED of Hospital was admitted for 2 days
Breakthrough case admission after 4 vaccines Moderna 1/20/21 Lot# 032H20A;  Moderna 2/17/21 Lot# 026L20A;  Moderna 2/17/22 Lot# 028K21A;  Moderna 11/7/22 Lot# 061F22A
Noticed on 8/18/07 a rash with raised red bumps, rash was itchy and was diameter of 1/2 dollar at site of Varicella injection. On 8/20/07 it is flat and bruised per father.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling of feet in a 69-year-old male patient who received SHINGRIX (batch number ZX3YA, expiry date 28th April 2020). The patient's past medical history included heart disorder. On 28th March 2018, the patient received the 1st dose of SHINGRIX. On 11th April 2018, 14 days after receiving SHINGRIX, the patient experienced swelling of feet and eye floaters. On an unknown date, the outcome of the swelling of feet was recovering/resolving and the outcome of the eye floaters was not recovered/not resolved. It was unknown if the reporter considered the swelling of feet and eye floaters to be related to SHINGRIX. Additional details were provided as follows: The patient experienced toe swelling and feeling of 'lint' in eye. The pharmacist stated more in likely it was a floater. No additional information was provided.
Intoxication; high fever; This serious case was reported by a consumer via interactive digital media and described the occurrence of intoxication in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JUN-2023, the patient received Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced intoxication (Verbatim: Intoxication) (serious criteria death and GSK medically significant) and fever (Verbatim: high fever) (serious criteria death). The patient died in JUN-2023. The reported cause of death was intoxication and fever.   It was unknown if the reporter considered the intoxication and fever to be related to Shingles vaccine.     It was unknown if the company considered the intoxication and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUN-2023 This case was received from patient's friend via interactive digital media. This week (reporting week), the patient received Shingles vaccine and in some time she died of intoxication and the high fever. The reporter stated that it was enough and would not get it done.; Reported Cause(s) of Death: intoxication; high fever
pt recv vax a/noon;while pt was eating lunch had an 8min episode of dystonic posturing;no sz activity noted;
Havrix pediatric dose to an adult patient; Havrix pediatric dose to an adult; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 34-year-old male patient who received HAV (Havrix pediatric) (batch number YG7YJ, expiry date 3rd February 2023) for prophylaxis.   On 9th November 2021, the patient received the 1st dose of Havrix pediatric. On 9th November 2021, unknown after receiving Havrix pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   Additional details were reported as follows: The health care professional reported that an adult patient received Havrix pediatric dose by error, which led to accidental underdose and adult use of a child product . The health care professional did not want an account in GlaxoSmithKline database. Consent to follow up was granted. The reporter confirmed that she was a health professional without specifying.
woke up at 2 am with severe right arm pain, on examination by provider large hematoma noted with swelling, tenderness, pain with range of motion
This spontaneous report as received from a pharmacist refers to a 71 year old female patient. In April 2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J000432, expired date 10-APR-2014)(dosage and route information unspecified). The pharmacist reported that the patient experienced several sores, in her mouth, after received ZOSTAVAX. The patient had experienced several episodes of the mouth sores that "come and go." The patient had seen physician for medical attention. One unspecified physician correlated the sores in the mouth to ZOSTAVAX. The reported did not assess the relationship of the event and ZOSTAVAX. The outcome of the patient was unknown. Additional information has been requested.
He had Moderna vaccine #2 on 5/13/2021. The day after the vaccination he had fevers and chills.  Two days after his vaccination (5/15/2021) he developed mild midsternal chest pain. This worsened and on 5/16/2021 he felt like someone was sitting on his chest. This pain was worse with deep breaths and radiated to his shoulders. He sought care at an urgent care clinic where EKG unexpectedly showed diffuse ST elevations. He was referred to the ED where he had an elevated troponin and there was concern for myocarditis.    TTE done showed a normal ejection fraction and normal heart valves.    He denies recent illnesses. He denies recent sore throats or skin infections. He works in the hospitality industry but denies known recent COVID-19 infection.    Since admission he was seen by cardiology and was started on colchicine, indomethacin, and protonix. Telemetry has been reassuring. He reports feeling much better.
difficulty breathing, painful inspirations in throat and upper chest region. No wheezing, no nasal flaring or grunting or retractions. no cough. Upset and crying. No abd pain, nausea, vomiting or diarrhea. No rash. Stable VS, lungs clear to auscultation in all fields.  Referred to ER, mom transported her--CXR and EKG normal. No evidence of anaphylaxis. Improvement occurred ~24 hours later, burning in throat and chest improved throughout the day.
Left arm  where injection site pt arm swelled, went to urgent care and diagnosed with cellulitis.
Myalgia/arthralgia - (L) sided myalgia in arm. Shoulder, neck, and (L) sided knee and leg pain 9-5-18.
Initial unsolicited report received from non-healthcare professional on 14 OCT 2014. A 71-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (lot number, dose, dose number, route and site of vaccination not reported) on 13 OCT 2014. The patient had a medical history of MRSA and atherosclerosis. It was reported that patient had used bandages, adhesive tape and stents. It was reported that on 14 OCT 2014, the night of vaccination, the patient developed chills and sweating. In the morning he experienced stomach pain like tightness. Lab investigation details and corrective treatments were not reported. The outcome of the event was reported as unknown. Documents held by sender: None. Follow-up information received from a non-healthcare professional on 05 JUNE 2015. No new information was provided. List of documents held by sender: None
Patient reported redness and some swelling starting a few hours after receiving ZOSTAVAX. Said she feels like there is a hard knot at the injection site. She has just been taking TYLENOL to relieve the swelling, and I counseled her around 6 pm on 1-8-18 and she showed me the redness on her arm. It is about the size of 1/2 of a dollar bill and wraps partway around her arm. I suggested she take 50 mg of BENADRYL every 4-6 hours for a couple days to see if that will help relieve the redness and also reduce the swelling some more. I also suggested she ice the area 3-4 times a day to see if that helps decrease the size of the knot and to call her dr and follow up with us again in a few days, or sooner if it gets worse.
BREAKTHROUGH COVID-19 INFECTION MILD SX REGEN-COV GIVEN 11/22/2021
she is having a problem with her bloodsugar that went up to 262 today.; This is a spontaneous report from a Pfizer-sponsored program. A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "she had Covid", start date: 2021 (unspecified if ongoing), notes: she had Covid a month ago. The patient's concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "she is having a problem with her blood sugar that went up to 262 today.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had Covid a month ago, and she was thinking about getting the vaccine. But since she had it, she is having a problem with her blood sugar that went up to 262 today. She is wondering if the vaccine is FDA approved because there was information that it is also EUA.   No follow-up attempts are possible. No further information is expected.
Pt broke out in rash, with in twenty mins of administration, rash was on upper torso, bilateral arms and neck.
Firm lump, redness and warmth to area surrounding injection site. Tx: with Keflex x 10 days.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 27-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient reported that at 7pm on the day of immunization Fever of 102, Severe Headache, Extreme Pain and Muscle Weakness and vomiting. At 48 hours, she reports loss of appetite , still feeling shaky/unstable and headache although less severe. Patient did not contact us until 2 days later but was not evaluated or treated at the time of incidence.
Chills after 6 hours, followed by dizziness and confusion and fever. overnight fever of 102 and headache. body aches.
Rash, hives, pain, shingles, per Dr unilateral left arm and neck.
The patient was given the Pneumococcal PCV 13 in error.  The patient was only supposed to get the Gardasil 9 vaccine.
Woke up with ankles and wrists hurting and over a month later still aching and muscles burn.  Legs and arms feel weird.  I'm tired and cold all the time and don't have an appetite.  I lost 10-20 lbs in that time period.  It hurst to pick things up.
Immediately following vaccine I experienced expected muscle soreness in affected arm.  Symptoms resolved by 12/31 (day 3). On 01/02/21 in the evening I began to experience tenderness in my underarm arm of my left arm.  about 24 hours later 01/03/21in the evening I continued to experience pain which began spreading to front and back shoulder. Pain extended down my left arm when reaching/extending arm.  Upon rising 01/04/21 swelling in underarm included lump approximately size of mandarin, swolling noted in left bicep. Aching in arm, pain continued to extend down arm.  Other symptoms included malaise, sore throat, nasal congestion, mild headache.  reported to employee health line, asked to receive COIVD test, informed to follow up with PCP regarding arm symptoms as "after 72 hours this is not considered side effects from the vaccine". PCP referred to respiratory clinic  to f/u to monitor swelling/pain.  Provider ordered ultrasound for underarm lump/swelling thought to be in response to COVID vaccine also to view veins in left arm due to my history of DVT.  currently awaiting ultrasound appointment for additional information.
This solicited report received from the patient's mother via Market Research Agency refers to a currently, an approximately 15 year-old male patient enrolled in a project. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported). The patient told the mother that the shot was painful. The outcome of the event was unknown. The relatedness between vaccination with GARDASIL and the event was not related. Additional information is not expected because the reporter did not agree for a contact with a doctor.
Allergic reaction itchy, swelling, with pain and area was red hot. Swelling spread down to the elbow left arm. Patient was icing the area and took BENADRYL when it started to itch. Localized reaction is subsided. Still feel light headed and feel jaw pain and difficulty in turning the head. MD recommended physical therapy CX thinking probably exacerbation of her MS.