chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood pressure was high; The arm they gave me the shot in is sore; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (The arm they gave me the shot in is sore) and HYPERTENSION (blood pressure was high) in a 0-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Patient took blood pressure medicine.     On 16-May-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced VACCINATION SITE PAIN (The arm they gave me the shot in is sore). On an unknown date, the patient experienced HYPERTENSION (blood pressure was high). At the time of the report, VACCINATION SITE PAIN (The arm they gave me the shot in is sore) had not resolved and HYPERTENSION (blood pressure was high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: High  196/101.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Treatment medication not reported.
Patient developed black bumps in her genital area 2 days after (6/6) receiving second dose of the Pfizer COVID vaccine on 6/4, these ultimately developed into genital ulcers. Patient was initially seen and treated outpatient with Diflucan, prednisone, and topical clobetasol (although patient did not use any clobetasol). Patient experienced some improvement after dose of prednisone, but pain eventually became worse causing presentation to the emergency department. During admission patient received Valtrex (6/11 - 6/14), Ceftriaxone (6/11 - 6/14), Fluconazole x 1 dose (6/12), Solu-medrol (6/11 - 6/13, eventually changed to oral prednisone on 6/14), and PRN pain medications. Patient had a swab of the genital discharge on 6/11 that grew out pan-sensitive e coli and klebsiella pneumoniae (resistant to Ampicillin and Bactrim). Patient denies history of sexual activity and denies a history of sexual abuse.
Arm pain that influenced sleep (had to take sleeping pills), extended to neck. Ibuprofen and cold compresses helped pain. Pain has lasted 6 weeks from date of injection. Not influencing range of motion.
Pt received vaccine immediately complained of being light-headed became pale and diaphoretic.  Wheeled to recovery cot to lie down feet elevated, placed ice pack to back of neck. - LOC - SOB - N/V.   MD evaluated.  Vasovagal response to getting vaccine. VS taken  BP 124/80,  HR 64 reg strong, resps 14,  SpO2 98%.   Wife at side stated "this happens all the time after shots giving blood for labwork" Pt stated he didn't eat in morning.  After 10 min lying down with feet elevated,  sat pt up provided water for hydration,  pallor and diaphoresis subsided left deltoid site benign, pt stated "did OK with 1st vaccine". Provided reassurance encouraged to stay 30 min for observation  Pt refused to stay  for 30.  After 20 min.  pt left recovery with family.   Ok'd to exit, MD aware of pt exiting early OK'd.
VOMITING; DIARRHEA; TEMPERATURE OF 99.6 F FEVER; BODY ACHES; DIME-SIZE, PUFFY, SWOLLEN, PAINFUL BRUISE THAT STARTED ON RIGHT LEG, SHOWED UP BELOW KNEE ON SHIN, THAT GOT REAL BAD THE NEXT DAY, WAS SORE, KEPT GETTING BIGGER AND WENT BEING AND ACROSS THE KNEE; HEADACHE; TIRED; STOMACH ACHE AFTER FEW HOURS OF VACCINATION AND NEXT DAY THE STOMACH ACHE GOT PRETTY BAD; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, and shellfish allergy, and other pre-existing medical conditions included not allergic to iodine. The patient experienced drug allergy when treated with codeine, gabapentin, and morphine.  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 25-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced stomach ache after few hours of vaccination and next day the stomach ache got pretty bad. On 26-MAY-2021, the subject experienced body aches. On 26-MAY-2021, the subject experienced dime-size, puffy, swollen, painful bruise that started on right leg, showed up below knee on shin, that got real bad the next day, was sore, kept getting bigger and went being and across the knee. On 26-MAY-2021, the subject experienced headache. On 26-MAY-2021, the subject experienced tired. On 27-MAY-2021, the subject experienced vomiting. On 27-MAY-2021, the subject experienced diarrhea. On 27-MAY-2021, the subject experienced temperature of 99.6 f fever. Laboratory data included: Body temperature (NR: not provided) 99.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach ache after few hours of vaccination and next day the stomach ache got pretty bad, body aches, vomiting, diarrhea, headache, tired, and temperature of 99.6 f fever on 28-MAY-2021, and had not recovered from dime-size, puffy, swollen, painful bruise that started on right leg, showed up below knee on shin, that got real bad the next day, was sore, kept getting bigger and went being and across the knee. This report was non-serious.
Drowsiness (both first and second vaccine effects similar); Mild muscle soreness (both first and second vaccine effects similar); This is a spontaneous report received from a contactable consumer, the patient. A 72-Years-Old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route and on an unspecified anatomical sight on 19Mar2021, at 14:45 PM as an unknown single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. It was reported that, prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021, at 11:00 AM the patient experienced drowsiness and mild muscle soreness, the patient reported that both first and second vaccine effects similar. The patient did not receive any treatment for events. The clinical outcome of drowsiness and mild muscle soreness was recovering at the time of report. No follow-up attempts are possible. Information about lot number cannot be obtained.
I came down with covid; I came down with covid; Brain fog; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, via an unspecified route of administration on 18Feb2021 (Batch/Lot number and expiration date were not reported) as dose 2, single and dose 1 via an unspecified route of administration on 29Jan2021 (Batch/Lot number and expiration date were not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she came down with COVID (15Jul2021). What was really concerning about that was she did not know if she was super immune or was not as immune. She experienced Covid brain fog (on an unspecified date in 2021). Exactly 21 days apart she saw Health Care Professional when had COVID. The patient further stated that no one knew if you need another booster, she planned on getting the booster on 18Oct2021, eight months from my last vaccine, she did not know whether to continue to wear the mask, she did not want a cold, did not want anything, she believed the shots kept her out of the hospital, believed it could have been a lot worse. The patient questioned Where she stands on being immune, what should be done if a vaccinated person develops COVID-19? The patient stated that she didn't do a report of adverse reaction. The events I came down with covid were considered as serious (Medically Significant). The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I had a rash on stomach and back and it traveled up my neck into my hair. It was bumpy and red and hot to the touch.  I called my Dr. and was advised to take Benadryl.  The reaction didn?t cause any swelling in my throat and it did not impede my breathing. I took Benadryl for 2 days and then Zyrtec for a week. The rash was gone after 1 week.
I had a low grade fever that went up and down for about 6 days. I ended up in my doctor's office on 4/19. They did not test for Covid since I had already tested negative multiple times at home. They advised that it may be a reaction to the vaccine and that I should continue to monitor my symptoms. Within two days after that, my fever had gone away and I've been alright since then with the exception of some abnormal levels of fatigue that has remained since the vaccination.
The next day after the injection, my son woke up he had blurry vision in his left eye along with the usual sore arm and tiredness. It went away after five days.
UNEXPECTED THERAPEUTIC BENEFIT (NOT HAD AN EPISODE OF DIZZINESS  SINCE); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included positional vertigo. 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 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the subject experienced unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
ZOSTAVAX vaccination resulted in swollen, hot, red injection site for four days. Then an itchy rash along the right jaw line. A week later another itchy red rash on one side of the waist. Now 17 days later new itchy spots are still appearing. Only BENADRYL was used to prevent killing the vaccine.
PAIN IN BILATERAL GROINS AND HIPS AND IN RIGHT SHOULDER. PAIN INCREASING WORSE OVER DAYS AND WEEKS OF VACCINE. LOW GRADE FEVERS FLU-LIKE SX PERSISTING AS PAIN BECAME SO BAD HAD TO BE ADMITTED TO HOSPITAL THRU. BARELY ABLE TO WALK. ADMITTED ON 9/3/18 THRU 9/6/18, TREATED PAIN MEDS HIGH DOSES IV STEROIDS. STILL AS OF TODAY OUT OF WORK AND STILL ON PO STEROIDS, ALSO NOW NEEDING DIABETIC MEDICATIONS FROM STEROIDS.
Fluzone Quadrivalent was inadvertently administered to patient  instead of Fluzone HD, no adverse event; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA316261, 2019SA316263, 2019SA316255, 2019SA316259, 2019SA316260, 2019SA316286, 2019SA316288, 2019SA316289 and 2019SA316290 (same reporter).  This case involves a 80 years old female patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ305AA and Exp. Date 30-Jun-2020) instead of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] via intramuscular route in the left deltoid on 07-Nov-2019.  The patient's medical history not reported and patient did not received any concomitant medication.  It was an actual medication error case due to wrong vaccine administered.  No adverse symptoms reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
little arm soreness; pregnant woman (13 week of pregnancy) received ADACEL vaccine; Initial information was received on 14-May-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional.  This case involves a 38 years old pregnant female patient who experienced little arm soreness (pain in extremity) while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  Events occurred at 13 week of pregnancy.  The date of last menstrual period was reported as 08-Feb-2020.  The estimated due date was reported as 16-Nov-2020.  The patient's medical history included Limb injury (cut her finger).  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The Concomitant medications were not reported (no other vaccines given at the same visit)   On 13-May-2020, the patient received a standard dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via unknown route in the right deltoid for prophylactic vaccination.  On 14-May-2020, the patient developed a non-serious little arm soreness (pain in extremity) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also the case of vaccine exposure during pregnancy. The patient was 13 weeks pregnant while she received vaccine.  No laboratory data was reported.  Final diagnosis was pain in extremity.   It was not reported if the patient received a corrective treatment.  Pregnancy outcome was unknown at the time of report.  The outcome was unknown for the event of pain in extremity.  There will be no information available on the batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
About 1 1/2 hours, post vax, developed red rash around the site of MMR II with welts on lower legs. Disappeared with Benadryl then increased more in area distribution, 16 hours later. Should recover; did with initial Benadryl.
Patient states that even 3 weeks after administration her arm is sore, has limited mobility, and has difficulty raising arm.
injection site pain, light headedness, double vision,  trouble breathing , chest pain, coughing, vomiting
Headache, joint pain, fever, drowsiness, 2nd day, dizziness, loss of appetite, 3 day itchy rash in chest area. And waist with general discomfort. 4th day I have less rash, and loss of appetite.
The day after the shot I couldn't move my entire right side of my body for 2 days. Gradulately throughout the next two weeks my hip pain and walking got worse and worse where prior to the shot we had been treating my cronic hip pain condition that started 12/28/2020 to a point it was almost healed. The weekend of 5/22 the pain had become so extreme I could no longer walk and had to stop working. I continue to have excessive nausea and then on the weekend of 6/5 my neck cramped up and was so inflammed I couldn't move it. Laying down, standing and sitting were excruciating painful. I couldn't eat, stand or do anything without someone's assistance. Symptoms had not changed after being treated with a trigger injection, ondansetron, cyclobenzaprine and meloxican. My doctor also submitted referrals to pain management, orthopedic specialist. I have also continued to go to physical therapy.
visual loss permanantly in left eye Narrative: i am partially blind in left eye now permanently. Retinal branch occlusion was diagnosis. just completed mri with and without contrast, ct scan of neck and optical, and ultrasound and labs last week. all test returned with no findings..just blind
My prior vaccines was Pfizer. I started getting symptoms of a runny nose and I thought it was allergies. Then, I developed a scratchy throat, body aches, cough for 2 days. I took an at home COVID-19 test that was positive. I did a telehealth visit with my doctor and was prescribed Paxlovid. I took Paxlovid for 2 1/2 days due to making my stomach sick. I did also feel tiredness and fatigue. My symptoms lasted for a week. I still have a post nasal drip.
2 CM AREA OF ERYTHEMA, NO INDURATION, AROUND AND MOSTLY DISTAL TO SITE OF MMRV.  GIVE IBUPROFEN FOR DISCOMFORT.
Redness, swelling, warmth, tenderness. (R) 2 1/2 by 2/2, (L) 2 1/4 x 1 1/2.
Patient reports arm/shoulder soreness since receiving the vaccine.  She reports decreased range of motion, "I cannot reach up and pull the sun visor down on my car."  I referred the patient to her primary care doctor.
Initially began as redness and swelling along inside of left bicep along with itching. As swelling reduced in that area, it migrated toward elbow. As of Friday late afternoon, left elbow was swollen, hot and red to touch but itching had abated.
came down with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73-year-old male patient received pf-06928316 (ABRYSVO), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "came down with Covid". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Caller stated immediately after getting the vaccine, her husband came down with Covid and was now on Paxlovid. Caller stated she did not think getting Covid has anything to do with getting the vaccine, as they were at a racetrack.   The information on the batch/lot number for pf-06928316 has been requested and will be submitted if and when received.; Sender's Comments: COVID-19 represents an intercurrent viral infection caused by SARS COV-2 unrelated to ABRYSVO use.,Linked Report(s) : US-PFIZER INC-202300296329 same reporter/product/AE, different patient;
Patient developed myalgias in the neck and back within 24 hours of administration of Td booster.  Also had some nausea and some wheezing starting approx 36 hours after the Td booster. Treated with Xopenex inhaler, benadryl, and ibuprofen at home; given a prednisone oral burst 20mg/day x 5 days 2 days after Td was administered.
I had the Flu shot on 10/29/2009 and a week later 11/4/09 I started to itch all over my body. I went to the doctor after trying all kinds of creams with no results. I even tried a bleach bath using a 1/2 cup of bleach. On Nov. 9th I turned to hives after itching my skin. I called my skin doctor. He had me come in and gave me a antihistime to take at night and that has solved my problem so far. I have been getting the flu shot for at least 10 years and never had a problem.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: As of time Mother called itchy rash with hives had not resolved.  Being followed by pediatrician
Got the chills, especially my feet.  Had blanket over my feet but still freezing.  The injection site was red, swollen, and quite sore.  I felt really nauseated and did not sleep more than 2 hours.  The first vaccine was nowhere this bad.  This all started approximately 13 hours after receiving the second dose.
Patient was inadvertently administered vaccination by intravenous route.  Patient was monitored for any adverse reactions for 2 hours, including vital signs. He was given a correct dose by intramuscular injection prior to discharge from the emergency department.
Within 5 minutes of receiving the Pfizer COVID-19 vaccine, I had terrible hot flashes and was unable to focus. This subsided within 15 minutes. Within an hour of the vaccine, my tongue went numb and mildly swelled, my face grew hot, and my throat swelled. It was difficult to swallow saliva and water. Within two hours, I grew progressively weaker, light-headed/dizzy, and experienced mild confusion (unable to understand what folks were saying on the onset). I also had quite low blood pressure when observed by the EMTs. My swelling subsided within 5 hours, both through time and the eventually emergency room treatment of Benadryl, Prednisone, and saline.
Case number PHEH2014US025095, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 64-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication.
Noticed today-red, hot, swollen injection site. Approximately 3 X 3-right thigh . Will give Tylenol and Benadryl
FEVER 102.5F FOR 48 HOURS, CRYING, RESTLESSNESS, CRANKINESS, RED EYES, STUFFED NOSE, RUNNING NOSE, COUGHING - GENERAL FLU/COLD SYMPTOMS LASTING 7 DAYS. FEVER WAS MANAGEABLE WITH INFANT MOTRIN.
Received 2nd COVID vaccine around 3pm and then about 3 hours later my heart began thumping so hard it felt as if it were coming out of my chest.   The thumping continued into the next day and I ended up going to the Emergency Room for treatment where they ran an EKG, full blood work up, chest xrays and went home wearing a portable halter heart monitor for 48 hours.  Follow-up with a cardiologist for results.  The thumping has continued almost 2 weeks later.
She lost consciousness with the jerky movement. BP- 120/81, HR- 82, O2sat-99%. After couple of seconds she woke up alert and oriented like nothing happened. Advised to go to PCP after declining to go to ED.
Approximately 15+ minutes after receiving the vaccine, the patient stood up from the chair and felt dizzy and faint.  She was escorted to a bed to lay down.  Ice packs were placed on her neck.  Patient said she felt tachycardic.  Pulse was 86.  She denied SOB, had appropriate mentation.  No rash was visualized on face, neck, abdomen, or legs.  She drank apple juice.  At 4:26, patient tried to sit but again felt dizzy and faint.  She was transferred to the ED via wheelchair.
Information has been received from a male physician who was vaccinated with a subcutaneous dose of Zostavax. There was no concomitant therapy. Subsequently the physician experienced a fever, GI upset and fever blister on his lip. Unspecified medical attention was sought. No product quality complaint. Subsequently, the physician recovered. No further information is available.
Weakness, headache & nausea & after my 2nd shot my effects were 90% milder but have a light-medium non itchy rash on upper torso unrelated to any other health issues atm feels like blah. 1st shot I was sick 2 weeks afterwards.
Patient reports localized redness, warmth, swelling and a large hard lump. States her arm was so sore she couldn't lift it above her head. Reports it lasted for 3 days.