chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a licensed practice nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On an unspecified date in August 2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dosage form, lot # T000702 with expiration date 01-OCT-2021, route was not reported) for prophylaxis.       The vaccine experienced improperly stored and was stored at above 9 degree Celsius (13.4 degree Celsius) for 51 hours and 36 minutes. There was no previous temperature excursion. The call was because of a data logger involved.
bradycardia; fainting; Head and neck ache; Head and neck ache; first dose received on 09Mar2021; second dose received on 15Mar2021; first dose received on 09Mar2021; second dose received on 15Mar2021; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the right arm, on 15Mar2021 15:00, as single dose, for COVID-19 immunisation.  Medical history included psoriasis, high blood pressure, scoliosis and low thyroid. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline; sertraline hydrochloride (ZOLOFT); and levothyroxine sodium (LEVOTHYROXINE), all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported) received at age 67 years, via an unspecified route of administration in the right arm, on 09Mar2021 14:45, for COVID-19 immunisation. On 15Mar2021, the patient experienced bradycardia, was fainting, and had head and neck ache. One week after the second vaccine, in Mar2021, the patient was taken to the hospital due to the events. Treatment for the events included "had to have a pacemaker put in". The patient reported that she never had heart problems before, and she was curious if these could have ben side effects from the vaccine. The events resulted to physician office and emergency room visits, and hospitalization. The duration of the hospitalization was reported as 4 days. The events were reported as life-threatening illnesses. The patient was recovering from the events.  Information about Batch/Lot number has been requested.
Patient states he broke out in Hives from head to toe, felt dizzy and nauseous.  Took OTC Benadryl.  Hives gone,.  As of 3/8, still felt slightly Nauseous and dizzy, but improving.
Pt's arm is red, swollen & warm to the touch. Tx: ibu and ice.
After the vaccine I?ve been getting my period approximately every two weeks which is not normal for me. Before the vaccine I only got my period once a month than after the vaccine every two weeks they have been occurring. The period is the same length of time and flow as my normal period. There are no other factors that I can associate to this change. As a precaution I took two pregnancy tests, both were negative. I have not had a change in weight or exercise or stress level.
Less than 3 days after first dose I started to have blood in my stool. I started having episodes of blood and mucus which continued. I was diagnosed a month and a half later, now, with colitis or crohns via a colonoscopy. This does not run in my family and I have never had this happen before. Seems like since it is an autoimmune disease, and the timing, the Vaccine played a role in me developing it. Also, my doctor said it seems I have had it for probably a month or two, which also seems about right with the vaccine.
Patient reported she had fever and chills starting around 4:15 day after vaccine. Then she also stated her fibromyalgia flared so badly that all of her joints and muscles hurt for about 6 hours. She said after that 6 hours she felt better but her muscles were all very sore.
Entire upper arm around injection site red, swollen and painful.   Visibly obvious to others.  Sought care from clinic
This spontaneous case reported by a consumer, describes the occurrence of mouth ulceration (mouth ulcers) and oral pain (soreness in the mouth) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 036A21A) for COVID-19 immunization. Concurrent medical conditions included hypertension, cholesterosis and rheumatoid arthritis. On Mar 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 5, 2021, patient experienced mouth ulceration (mouth ulcers) and oral pain (soreness in the mouth). At the time of the report, mouth ulceration (mouth ulcers) and oral pain (soreness in the mouth) outcome: unknown. Treatment information included Magic mouth wash. Patient received the 2nd dose of Moderna vaccine, left arm, on Apr 2, 2021. (batch/lot# 037A21A).
Weakness, fatigue, fever and chills, headache and body ache, loss of taste and smell, labored breathing
Patient got sick the night of MMR administration. States just did not feel well, nonspecific. She had a fever, did not take temperature, states felt warm. She then developed a rash with swollen lymph nodes, some tenderness. No fever or chills or other problems. This is documented by physician on 05-21-08.
Nerve pain from neck to arm MD feels this is unrelated, pt feels it is related (has had a fusion in the discs of the neck).
Extremy left arm pain after Injection. Fever(lowgrade), migrane(extreme), heart and chest pain(went to er) difficulty breathing, numbness in lower right leg, difficulty waking, extreme anxiety/feeling of impending doom.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 at 13:00 as dose 1, single (Lot number: EW0150), in left arm and on 23Apr2021 at 14:00 as dose 2, single (Lot number: EW0172), in left arm for covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 22Nov2021 at 14:00 as dose 3 (booster), single (Lot number: BA7617333), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jul2022) Negative; (31Jul2022) Negative; (01Aug2022) Negative; (02Aug2022) Negative; (03Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient was treated with Paxlovid, treatment start date on 26Jul2022 and treatment stop date on 31Jul2022.
Had to travel out of the country and missed getting his 2nd dose; A spontaneous report was received from a physician who received Moderna's COVID-19 vaccine (mRNA-1273) but missed the second vaccination dose (missed dose).  The patient's medication history was not provided. Concomitant product use was not reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, he was scheduled for second dose but missed the vaccination dose as he had to travel out of the country.  The treatment medications were not reported  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event was considered resolved on 27 Jan 2021.; Reporter's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Patient stated got sicker than a dog the day after receiving vaccine. Patient prescribed TESSALON PERLES and SKELAXIN.
No Sx immediately after. Joint and bone pain starting 12 hours later with increasing fatigue. Temp low -96.2° with chills (normal is 97°). Slight headache and ringing in ears started about 2pm.  I felt like temp was going up,  but I don't usually get a temp over 98.8° even when ill. Fever at 100° by 5pm Sat. No "CoVid symp" Eg cough, SOB, GI, loss of smell.   Increase fluids. Allergies to PEG in Acetaminophen otc, and NSAIDs. Non critical event at this time.
Shortly after injection my upper arm was very swollen and hot-the injection itself was not painful at all.  Then I developed a headache and didn't think anything of it.  I became tired and weak feeling and laid down, fell asleep which I never do in the day time.  I woke up with severe tachycardia and felt very dizzy.  I slowly stood up and felt very faint, then vomited.  I had not eaten anything in several hours and had not had anything my spouse had not eaten.  He had not taken the RSV vaccine and was fine.  All the next day I was very weak feeling and slept a lot, my blood pressure was very low.  I drank a lot of fluid, the headache persisted-actually became a pounding headache the evening of the 16th and is still there today but I feel I am almost back to normal otherwise today.
Crohn's disease/ acute Crohn's flare; got so bad and could hardly walk from bed to the living room; It was really bad, I wanted them to shoot me, I just wanted to die; Itching really bad all over; Severe muscle cramps in legs and back; Swelling; Fever; Chills; Tiredness; muscle pain; Joint pain; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number : 59267-1000-01), dose 2 via an unspecified route of administration, administered in arm left on 06Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (age: 66 years, as reported) for COVID-19 immunization. On 08Apr2021, the patient started to feel some of the side effect symptoms that were listed in the handout about the vaccine and also an autoimmune disease which is Crohn's disease; patient started to have acute Crohn's flare. Patient was also itching really bad all over, getting severe muscle cramps in legs and back, had swelling, fever, chills. The patient got so bad and could hardly walk from bed to the living room. Luckily it's only nine step to the bathroom so she could make it there. On the same day, the patient had to go to the emergency department due to the events. Upon arrival at the emergency room, patient required to do the COVID-19 test and was negative but was experiencing tiredness, muscle pain, joint pain, nausea, and feeling unwell. The patient started with the antibiotics and other unspecified medications for all the events and that's when the diarrhea started because of the strong antibiotic. Patient stated that the strong antibiotic gave her diarrhea. The patient was given a bunch of new medications. The patient stated, " It was really bad, I wanted them to shoot me, I just wanted to die." Right now, she was on 28 different medications as treatment for the events. The patient clarified that the events occurred on 08Apr2021. It was also reported that the patient was hospitalized for events Crohn's disease and could hardly walk from 03May2021 to 07May2021 and was treated with high doses of steroids. The final outcome of the events was unknown.  Information on the lot/batch number has been requested.
Around 11pm started having chills. Around 3:00am. fever, started shaking, had temperature 104 around 5: AM vomited and is having headache, had trouble breathing like someone was pushing on her chest last night. Now she is talking normal. Headache is bad and the light hurts her eyes.
SYMPTOMS STARTED AROUND 9 DAYS AFTER SHOT, BEGAN WITH INCREASED HEART RATE, TEMPERATURE FLUCTUATING FROM 101-95 WITH SWEATING COLD SPELLS, WITH TROUBLED BREATHING, WHEEZING AND COUGHING UP PHLEM, ALSO FROM CHECKING WITH FITBIT WHICH I KNOW IS NOT EXACT HEART RATE IS HIGHER THAN NORMAL. TO THIS DATE I'M STILL DEALING WITH ALL THE SAME ISSUES MINUS THE FEVER.  CURRENTLY GIVEN METHYLPREDNISOLONE AND AZITHROMYCIN
He states that his left arm swelled three times normal after receiving a flu shot. He states that it was so painful that he could not sleep that night. He saw PA the next day and was told it was an allergic reaction. His arm was warm to touch and swollen but not 3 times on 11/28/06
Syncope, Flushing/sweating. Post vaccination pt had a vaso vagal/syncopal episode in her seat in observation.  Pt did not fall.  Pt was wheeled back in supine position.  VS stable.  Patient recovered, drank juice.  When stable, patient was released from the vaccination site.
36 year old female presented to ER with c/o vomiting blood- says she has been binge drinking and her last drink was 3 days- says had fight with her boyfriend- denies abd pain/nausea- denies sob,cp,palpitations in ER her HR was high- she was initiated on CIWA/given lopressor and fluids
Information has been received from a physician's assistant (PA), via a company representative, regarding a 17 year old female patient, who "months ago" was vaccinated with the first dose of Gardasil (Lot # not provided). The day following the vaccination, she developed appendicitis and was hospitalized (dates and duration not reported). At the time of this report, the patient was recovering from the event. Additional information has been requested.
Delayed local reaction with large area of erythema and edema at injection site, enlarged left axillary lymph node, joint aches, fatigue starting on 3/19/21, 7 days after vaccine.  First the left arm rash and node appeared, them joint pains, then fatigue.
At 1:30am on 4/2/21, my mother had fallen at home and was transported to the hospital. She was not injured from the fall however by 4/4/21, she was showing signs of end stage dementia.  Her symptoms literally came on as if switching on a light.  Through testing ruled out stroke, cancer, seizure as well as a lumbar puncture was negative for infection. She remains hospitalized and is transitioning to a specialized care facility that will provide 24/7 care.
Itchy and rash on neck, arms, hands, and cold sore below the nose above the lip from February 18 till now.  I put on Ointment, it relieves the itchy and rash.
He did not have an adverse reaction to the vaccine. He started having congestion about one day prior to testing. He tested positive for COVID-19 in 02/2023. Several days into the infection, he had a deeper cough, so we got him to the doctor to check for other illnesses and he was fine.
15 min after injection, pt reports dizziness. She was closely monitored and then she threw up as well
Developed a moveable lump in my neck on the left side. Doctor said that it is due to the injections.
NO ADVERSE REACTION TO FIRST MODERNA SHOT, WHEN PATIENT CAME FOR 2ND MODERNA SHOT IS WAS DISCOVERED HE HAD GOTTEN A JOHNSON AND JOHNSON SHOT ABOUT A MONTH BEFORE THE MODERNA SHOT. PATIENT DID NOT PROVIDE THIS INFORMATION. NO ADVERSE REACTIONS
23JAN98  pt recv vax & 5JUN98 pt broke out w/ 8 varicella lesions, on 9JUN98 pt was eval for 3 lesions on nape of neck;infected;
Patient states that approximately 2 days following vaccine, she developed pain in joints and muscles. Was diagnosed with polymyalgia rheumatica, and has been treated with prednisone since.
Client was inadvertently given an unneeded/additional dose of Hep A.  2 dose series was already complete, and he received a 3rd dose.  Client also received Kinrix (DTaP-IPV) over age range.  Client's mother reported no symptoms following vaccination other than sore arm the following day.
Patient c/o itching on left upper arm. Pt. recieved TB skin test along with a varicella vaccine...no induration was noted on LUA, but slight reddness was seen.
This spontaneous report as received from a nurse refers to a female patient of unknown age. On 14-MAR-2014 the patient was vaccinated with first dose GARDASIL (lot # not reported) 0.5 ml, intramuscular. Other doses of GARDASIL were given respectively (both intramuscularly and 0.5 ml) on 16-MAY-2014 (Second dose), 29-JUL-2014 (Third dose). No adverse effect reported. The outcome of the event was unknown. Additional information has been requested.
At first my right arm became red, swollen and sore. The area measured about 3"X 3". That was on March 16th. I called my primary doctor on Wednesday, and he recommended ice for 20 min on and off followed by heat. It remained that way until the 18th when the swelling went down and an itchy rash appeared and I called the doctor again and he recommended cortisone cream. The rash went away and then a 3"X 3" row of dots encircled the area disappearing about two days ago.
This spontaneous report as received from a female patient of unknown age and refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneously. On an unknown date, the following day, patient experienced redness on her skin, where the vaccine was administered. The outcome of the event was reported as not recovered/not resolved. No product quality complaint was involved. Additional information has been requested.
Itching and mild swelling which continued to spread over the course of 24 hours. At largest involvement patient states it covered her entire upper arm from elbow to shoulder and around entire circumference of arm. Patient had redness, swelling, and area was very warm to the touch. Patient also reported mild soreness at injection site. Symptoms lessened with oral diphenhydramine.
This case was reported by a pharmacist via call center representative and described the occurrence of death nos in a 61-year-old male patient who received SHINGRIX (batch number 23JK5, expiry date 13th April 2020) for prophylaxis. On 4th May 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2019, 4 hrs after receiving SHINGRIX, the patient experienced death nos (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death nos was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death nos to be related to SHINGRIX. Additional details were provided as follows: The patient tolerated the SHINGRIX dose at the pharmacy with no noted issues. The reporter had no specific details on cause of death. Follow up information received on 9th May 2019: Following a review of the inventory status for batch number 23JK5 the entire batch has been distributed as of on 12th April 2019. With regards to the complaint history for this batch number to date there were two complaints neither of which were related to the nature of the reported adverse event. There was no product quality issue noted by the pharmacist upon vaccination and the cause of death for the patient was currently unknown. The pharmacist did not have reason to believe that the vaccine was compromised, but she would like further guidance to be certain. Reported Cause(s) of Death: Death NOS.
Severe migraines Imitrex and Zofran to treat regular migraines multiple times per month that were not persisting before vaccine. Fatigue, fever, vomiting, soreness.
No additional adverse events reported.; The nurse called to determine the stability of an expired dose of MMR II that was administered to a patient. No additional Ae's and no PQc's were reported.; This spontaneous report was received from a administrator referring to a 6-year-old patient of an unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 27-APR-2022, the patient was vaccinated with an expired vaccine (Expired product administered) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin - rHA) (M-M-R II) subcutaneous injection, lot number T001214, expiration date: reported as 17-JAN-2022 but internally confirmed as 12-JAN-2022, (strength, dose, anatomical location, and route of administration were not provided).   No additional adverse events reported.
On Monday April 12 I had terrible chest pain and it was very hard for me to catch my breath. I tried to get up and walk and became very dizzy. I was then taken to the hospital and my mom stated that while in the car I had a loss of consciousness. Doctors at the hospital came to the conclusion that it was a heart attack but after following up with the cardiologist then he thought I may have myocarditis. Unfortunately I have a pectus excavatum that is being repaired and the mri couldn?t confirm the myocarditis due to the metal in my chest.
PT via chiropractor with massage to improve range of motion.    Alot of pain in upper arm.  Using ibuprofen and ALleve
PT HAD VACCINES GIVEN @ 1400 ON 11/18/11 AND WOKE UP VOMITING @ 2300. PT WAS SHAKING AND RECTAL TEMP REGISTERED @ 105. PT TAKEN TO ER - GIVEN TYLENOL, IBUPROFEN, IV FLUIDS, AND NAUSEA MED. PT CONTINUED WITH TEMP OF 103 X 2-3 MORE DAYS. PT IS DOING BETTER NOW ON 11/22/11.
A half hour after the shot, I felt numbness from my neck to my ear on right side and it spread across my face in about an hour.  An hour after that, my right arm and leg were numb.  within 5 hours, all symptoms were gone.
Within weeks of vaccine,  progressive whole body weakness began.  Medical work ups continued from October. Finally myasthenia gravis was diagnosed with multiple antibody tests
Headache, Myalgia, fatigue, chills, pain at injection site Narrative:
REDNESS, SWELLING, WARMTH AT INJECTION SITE.  PAIN TO EXTREMITY. HEADACHE
Swollen bottom lip with blisters. Started feeling discomfort around 48 hours after the shot. The swelling has worsened since then. It is currently 64 hours since vaccination.
Incorrect booster dose given. Patient received 0.5 ml of Moderna rather that the 0.25ml booster dose
This is a spontaneous report from a non-contactable pharmacist.  A female elderly patient (age unspecified but more than 65-year-old) of an unspecified race and ethnicity received PREVNAR 13 single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced sore on one side (at injection site) after the injection and had also pain on different parts of body. The patient did not recover from the event pain (is ongoing at 28 days post dose), while clinical outcome of the other adverse event was unknown at time of this report. No follow-up attempts possible. No further information expected.
Patient's mother called today and stated that he had a seizure this afternoon at 1:35 PM.  She stated that she and her husband are both nurses.  She happened to be off today and was home with her son.  She stated that the seizure was like a Grand Mal seizure that lasted approximately 5 minutes. She stated that he has had a diabetic seizure before when his blood glucose levels were low.  She stated his blood glucose was 71.  She said this was different, he had no residual after effects. He was not incontinent of bowel or bladder and he woke up quickly afterwards.  About an hour after the seizure he ate and only complained of a headache.  She gave him ibuprofen 600 mg and he put an ice pack on his head.  She said he is better. She stated that she is a nurse and this really scared her, since it was so different than any other seizure he has ever had.  She was thankful she was home.  She call his primary healthcare provider and she did  not feel he needed to be seen.