chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was seen on 10/5/21 for Pfizer Booster vaccine. Approximately 10 minutes into her post observation time she reported SOB and difficulty breathing. I was called into vaccine clinic where I assessed the patient and noted her labored breathing. Per WOG Emergency meds were pulled. 50 mg of Diphenhydramine was administered IM in upper right quadrant of gluteus. After 2 minutes patient was reassessed and declined needing further medication, no epinephrine was administered. Deep breathing practiced with the patient and within moments after the Benadryl injection patient reported feeling better. Her son was present, they denied needing further medical attention and opted to not take her in for further evaluation. I called to follow up with patient and her son today who reported she was doing well and only had mild discomfort at the injection site of her Covid vaccine.
On 4/29/2021 my left hand started twitching. Starting 4/30 left forearm,wrist,hand had weakness,pain which increases with use; Left leg below knee, ankle and foot have weakness, tingling, pain. It felt as if my limbs were asleep. Worsening everyday and with use.  A few weeks later my right arm was affected. A month later my right lower leg, ankle, foot.  I was unable to use my thumbs and then my arms.  My left leg felt like it was dragging.  I was diagnosed with CRPS now in all my limbs by Dr. I went to Physical Therapy for 2 months and then continued the exercises at home.  This has helped minimally with gaining strength back but when temperatures go below 75 my hands turn painful and very cold.  I'm not sure how I will get through the winter.  I cannot prepare dinner and in May I could barely use a knife and fork.  I still have difficulty cutting meat with a knife and fork.  I have difficulty in drying my hair which normally would take 15 minutes as my arms begin to feel very heavy and I have to put my arms down frequently to rest them.  My left leg  frequently feels like it is asleep.
PATIENT HAD GENERALIZED VACCINIA ONSET 11 DAYS AFTER VACCINATION.
When I woke up in the morning. I felt cold like symptoms. I felt tried, had a headache and I had a cough. My grandson was not feeling well. He tested positive so I decided to get tested. I went to urgent care and my COVID test came back negative. My symptoms started to get worse so I decided to go back to urgent care and get tested again. My test came back positive.
noticed inc hair loss/breakage since NOV93, approx 2 wks p/2nd vax & lasting about 2 months; perms hair every 2-3 months; last perm AUG93 & DEC93;
COVID arm starting day 11: swelling, redness, localized fever at injection site  Menstrual cycle change:  missing/erratic cycles since first shot
Patient received first dose of Moderna COVID-19 vaccine on 2/10/21 and had a large, red, inflamed area on her arm at the injection site for a few days, but otherwise tolerated vaccine well. She received the second dose of the Moderna COVID-19 vaccine on 3/10/21 and the next day (3/11/21) developed fatigue and lightheadedness while exercising, which continued for the next few days. She developed acute onset, sharp chest pain on 3/13/21 AM which did not resolve so she presented to an ED. Vitals were normal but labs notable for troponin I which peaked at 4.36, CK 758, d-dimer 640. CBC/CMP and EKG were unremarkable and initial TTE with EF ~45%. Repeat TTE obtained a few days later with normal LV and RV size/function without any wall motion abnormalities. Cardiac MRI obtained with normal LV function (EF 64%) but late gadolinium enhancement in a subepicardial distribution within the inferolateral wall of the left ventricle at the base most compatible with myocarditis. ESR and CRP were normal. Further workup to determine etiology of myocarditis was negative (ANA, ANCA, RF, hepatitis panel, HIV, full respiratory viral panel, COVID-19 PCR). She was placed on metoprolol succinate 12.5mg XL daily and will follow up with a cardiologist as an outpatient. Family concerned that COVID-19 vaccine was the trigger/underlying etiology of her myocarditis.
I started having shooting pains in lower back and hips, when I would turn a certain way it would be terrible terrible pain. I still have it it hasn't gone away. Went to the Dr on Monday, waited for 2 days and Wednesday I went back in and got a steroid shot trying to rule out Guillen barre, the steroid helped. I had ongoing back issues but it hasn't gone back to normal but not as bad as it was when it first started
COVID-19 symptoms started 06/23/22 at 8 Am with mild sore throat and a little congestion. I tested positive same day at 9 AM. Later in the day I felt achy and flu-like and I don't think I had a fever but I did feel achy and not good. Symptoms lasted that day but I had phoned clinic for COVID-19 hotline for virtual appointment and I got Paxlovid and started right away. After that I did have mild achiness and fatigue throughout the day and the next day I felt fine.
2 weeks after administration of vaccines developed skin rash on lower abdomen and scrotum along with significant scrotal swelling. Patient was discomfort and itching that required a evaluation in our clinic. Avoid contact with immunocompromised people, Tylenol and motrin for the discomfort, topical Benadryl for the itching, cold compresses and elevation of scrotum, and to call back if signs and symptoms of infection. Outcome to be determined
Pt vaccinated with DTP developed a fever of 105 within 24 hrs after immunization. Fever persisted for the next 48 hrs. Treated w/Tylenol. Wk after immunization, child was positive for Strep, treated w/Amoxicillin.
DIZZINESS; VERTIGOS; NAUSEAS; LIGHT HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 02-OCT-2021 for covid-19 prophylaxis. No concomitant medications were reported. On FEB-2022, the patient experienced dizziness, vertigos, nauseas, and light headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, light headaches, nauseas, and vertigos. This report was non-serious.
Fever, headache, chills, fatigue, nausea, lose of appetite, right underarm soreness, left side rib soreness, numbness and tingling in righthand fingers.  Headache, fever, and underarm soreness on 3rd day; all others symptoms lasted 2 days.
PERSISTENT RANDOM QUICK SHARP PAIN IN CHEST; BLURRED VISION; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-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 persistent random quick sharp pain in chest, blurred vision, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent random quick sharp pain in chest, headache, and blurred vision. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Rash near injection site - hives, itching & along shoulder too, & inside of arm.  Red, itchy hives.
chilled, difficulty getting warm; shakiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 15:00 (Lot number: ER8727) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sleep apnea" (unspecified if ongoing); "depression" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Pine allergy" (unspecified if ongoing), notes: Known allergies: Pine allergy; "seafood sensitivity" (unspecified if ongoing), notes: Known allergies: Seafood sensitivity. Concomitant medication(s) included: WELLBUTRIN; CELEXA [CELECOXIB]; LEVOTHYROXINE; DIURETIC [HYDROCHLOROTHIAZIDE].  The following information was reported: CHILLS (non-serious) with onset 25Mar2021 23:00, outcome "recovered", described as "chilled, difficulty getting warm"; TREMOR (non-serious) with onset 25Mar2021 19:00, outcome "recovered", described as "shakiness". Therapeutic measures were not taken as a result of chills, tremor.  Additional information:No other vaccine in four weeks. Other medications (Wellbutrin, Celexa, levothyroxine, diuretic) had given in two weeks. No covid prior vaccination and covid tested post vaccination.The patient experienced shakiness after 4-5hours.  No follow-up attempts are possible. No further information is expected.
FLUBLOK QIV being administered to a patient under the age of 18. (8 year old patient) with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 8 years old male patient who experienced INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] being administered to a patient under the age of 18. (8-year-old patient) with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 23-Oct-2022, the patient received a 0.5ml once dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation, lot number and expiry date was unknown) via unknown route in the arm nos for Immunization.  On 23-Oct-2022 the patient developed a non-serious event of flublok qiv being administered to a patient under the age of 18. (8 year old patient) with no reported adverse event (Product administered to patient of inappropriate age )(Latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken: not applicable.  Outcome: Unknown  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 the 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.
Hives and rash began about 3 hours after getting the vaccine, skin felt hot. Two rounds of Benadryl needed to get symptoms under control.  Rash returned every time Benadryl wore off. Symptoms continued at same degree all through the night. By the following morning hives were not as itchy or prevalent. Symptoms decreased as time progressed. Only occasional hive outbreak by Sunday evening/ Monday.
Terrible migraine about an hour after my first injection lasting through the night. After 24 hours, no headache.
Patient felt hot, heart racing, dizziness and lightheadedness approximately 5 minutes after the receiving the vaccine. Patient drank some water and felt fine after 25 minutes.
Painful urination, urination urgency beginning in the evening one week after dose. Was seen by family physician next morning; urine test done; white blood cells seen; urine culture done; bacteria not found. Was given antibiotics while waiting for culture results (3 days;) some improvement, but not as expected.  Discontinued antibiotics when urine culture found negative.  Condition continued to improve, lasting about another 4 days.
After 1st shot my stomach began swelling and then I started getting diarrhea.  After the second shot a month later, the diarrhea worsened and has been like that since then. There was intense pain and burning in my intestines.  Couldn't really eat.  I went to the doctor 11/3 and was referred to a gastro doctor.  Then I got the booster shot and symptoms go worst.  Went to gastro doctor did a few tests 11/30th.  And they scheduled a surgery for April 2022 to cut out damaged part of my intestines and prescribed Budesonide.
Pt received DTaP, IPV, MMR. Next day had local reaction to DTaP-swelling and redness in arm.
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Medical history included a C-section, so it was assumed that the subject already gave birth previously. On 21 March 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, left deltoid). Her last menstrual period and estimated delivery date were not provided, but the subject was 32 weeks pregnant when she received the vaccine. At the time of reporting, no adverse event was reported and the pregnancy was still ongoing. Follow-up information received on 15 April 2014 by the healthcare provider of the subject: Vaccine was given via intramuscular route. The subject's last menstrual period was in August 2013 and estimated date of delivery was on 08 May 2014. The pregnancy was a normal conception. No adverse event was reported. The case has been also reported to the regulatory agency. 03 September 2014- No further information was provided; patient lost to follow-up. Follow-up information received on 15 September 2014: On an unspecified date, after a full term pregnancy (unspecified weeks gestation), the subject gave birth to a live infant of unspecified gender.
tenderness and a little swelling at injection site; tenderness and a little swelling at injection site; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 16:00 (Lot number: ER8730) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOPHEN. Past drug history included: Codeine, reaction(s): "Drug allergy", notes: known allergies: codeine. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "tenderness and a little swelling at injection site"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fatigue". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, fatigue.  Additional information: The patient received the first dose of BNT162b2 via an unspecified route of administration. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The adverse events did not result in doctor or other healthcare professional office, or clinic visit and emergency room or department or urgent care.  No follow-up attempts are possible. No further information is expected.
Violent shivering, then fever to 101F, weakness, nausea, dizziness, hypertonic bladder.  All symptoms passed in 10 hours except for weakness which persisted 24 hours.
Received dose from a vial that was punctured for more than 12hs; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs) had resolved. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  it was reported that Moderna COVID-19 vaccine was given outside the recommended time frame, more than 12 hours post vial puncture. vial was kept at recommended temperature of 2-8 C before administration.  No treatment medication reported by the reporter.   This case was linked to MOD-2021-295452, MOD-2021-331621 (Patient Link).
12 x 10 erythematous region including approximately 80% of (L) upper arm. Influenza immunization administered in (L) deltoid area. Area of erythematous/tenderness resolved 01/12/16.
Pain at injection site starting 6 hours after injection Fever, chills, myalgia, malaise starting 18 hours after injection Ibuprofen 400 mg as needed Resolution of symptoms after 48 hours from injection
No adverse effects have been reported; a patient received one dose of MMR II that expired on 11-MAY-2019; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 22-MAY-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N014635, expiration date 11-MAY-2019, 1 dosage form, intramuscular (strength and anatomical location were not provided) for prophylaxis. The vaccine and the sterile diluent had not any temperature excursions and no adverse effects were reported.
I keep having pain in my upper left chest, my left arm would go numb and tingling. This started about a week after the vaccine. Doctor prescribe omepravole.
The next day after having the vaccine my arm was sore at the injection site and I felt a little achy. Like flu symptoms but they were very slight. My arm was sore after a week. On 10/02/2021 I started getting a sore throat. I thought it was allergies because of the weather. It did not go away. I started getting a runny nose, cough, headache, flu like symptoms, diarrhea, low grade fever. It went down to my chest. I never lost my sense of smell or taste. It felt like the normal flu. On Monday I called the doctor to make sure I did not have COVID-19. I took an antigen test that I got from Walgreens and the doctor ordered a PCR test and both were negative. She prescribed a steroid and an inhaler. I also took some over the counter medication.
Continuous Shoulder pain, burning, dull throbbing  pain from left shoulder down to elbow. Shoulder pain is so bad it wakes me out of my sleep, cannot move left arm at times, pain gets worse while at work, constantly in pain whether I amusing it or or, hurts to lift arm Began 3/14/2021 to present,
Arm soreness, redness, swelling. Arm pain with swollen lymph node , increased swelling going down to elbow
Patient gotten a 2nd shingles shot on 08/02/2021. She informed us that when she had gotten the 1st shot, she had a pretty bad reaction to it. She developed rash all over her upper arm, swelling and nausea in addition to not feeling good at all. She let her MD know at that time. The day after she got the 2nd shot, she called to let us know that her arm is swollen and very sore. I recommended her to take Ibuprofen after finding out that she doesn't have any blood pressure issues or does not take any blood thinners. I offered to call her MD and did get in touch with the office. I was told by the MD's office that the patient need to call MD's office. I conveyed that message to the patient and she said she will call her MD.
administered with vaccine that experienced more than 1 temperature excursion; administered with vaccine that experienced more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 8:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 8:47 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine that experienced more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (administered with vaccine that experienced more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 62.54.  Concomitant medication of the patient was not reported.  Batch number 025C21A underwent temperature excursion on 24-May-2021 with temperature of 35 degrees Fahrenheit at 08:00 AM and 09:00 AM. These vials were moved to fridge on 03-May-2021 and 18-May-2021 and beyond use date for the vials was reported as 02-Jun-2021 and 17-Jun-2021. The vaccines moved to clinic on 24-May-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
7pm- rash to buttocks. 8pm- red spot on cheek. 4/24/2015- woke up with hives from head to toes, congestion and runny nose; Mom gave Benadryl.
Cough, shortness of breath, sinus congestion, headache, generalized body aches, fever, nausea and vomiting.
This spontaneous report as received from a nurse practitioner, via a company representative, refers to several (also reported as multiple) patients of unknown age. Recently (dates unspecified) the patients were vaccinated with ZOSTAVAX, by intramuscular route instead of by subcutaneous route. Dosing information and lot numbers were not provided. On unknown dates the patients experienced a higher than normal level of significant injection site reactions (unspecified). The patients had received the vaccine at the same pharmacy. The outcome of the injection site reactions and causality assessment were not provided. Additional information has been requested.
Pt called office today, described pain in LT arm sore can't raised arm at this time - denies redness - swelling - fever at this time - Pain just developed on 6/27/07 in AM