chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizzy; whole body soreness / soreness; shallow breathing; nausea/nauseated; Labored breathing; This case was reported by a physician via sales rep and described the occurrence of dizziness in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX797AA, expiry date unknown) for prophylaxis.   On 26th March 2019, the patient received the 1st dose of Bexsero. On 26th March 2019, 4 hrs after receiving Bexsero, the patient experienced dizziness, general body pain, shallow breathing, nausea and labored breathing. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the dizziness, general body pain, shallow breathing, nausea and labored breathing were recovering/resolving.   The reporter considered the dizziness, general body pain, shallow breathing, nausea and labored breathing to be probably related to Bexsero.  Additional details were reported as follows: The patient received  a dose of Bexsero on the left deltoid. Four to five hours (also discrepantly reported as within 4 to 5 hours) after vaccination, the patient experienced whole body soreness, dizzy, nauseated (did not throw up), labored breathing and shallow breathing. A clarification request had been raised to confirm time to onset for events. The patient did not experience cough and fever. The patient took Tylenol and then went to sleep.  Next day, the patient still had little sore, 1 to 2 hours later felt dizzy again.  The patient took Tylenol and 4 hours later, the patient felt better. The physician felt that, the patient's experience was most likely caused by the Bexsero and that she was hesitant to administer the 2nd dose. The reporter consented to follow up.
I started to get intermittent stomach pains in September with no change in bowl habits. There seemed to also be no known reason for the pain to come and go. Just pressure pain on my whole abdomen. Around December my bowel habits changed. I was not having a bowel movement every morning at 7am, it was now every few days.  I went to the doctor February 2022, they gave me medication for  an ulcer with no tests. I didnt take the meds since I didnt think it was an ulcer, and told them it didnt work and I was still in pain. They had me test my gall bladder in June  which came back fine.  Between May June and July Ive had to call out of work several times due to horrible stomach pain. On august 24, I had an EGD, saw I had no ulcer as I suspected, and they took a biopsy of my duodenum, and they saw I had short blunt villa. I went in for blood work on the 31st, and it became known  that I have celiacs disease.  I had no issues before my second vaccine on September 3rd.
I was supposed to give her the Bivalent Booster, but I gave her the Moderna Primary.
This spontaneous report as received from a Nurse Practitioner refers to a 60 year old male patient with no known pertinent medical history. In approximately 29-JUL-2013, within the last two weeks the patient was vaccinated with ZOSTAVAX (lot #, dose and route not provided) injection. In approximately 29-JUL-2013, within the last two weeks, the patient had developed a rash on the side of his face and around his eyes. On an unknown date, the patient visited the nurse practitioner, who said based on his clinical experienced that this was shingles. No laboratory tests were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
2 weeks ago his wife had developed shingles; 2 weeks ago his wife had developed shingles; This spontaneous report as received from a consumer via a company representative, referring to a 71-year-old female patient. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were reported as none. The patient's concurrent conditions were not reported. Laboratory diagnostics and studies performed were reported as none.  In approximately 2015 (also reported as over 5 years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection, 1 time injection, subcutaneously (strength, vaccination scheme and anatomical site of injection were not reported; lot number and expiration date were unknown by the reporter) as a routine vaccination (prophylaxis).  On 23-NOV-2020 (also reported as 2 weeks ago), the patient had developed shingles (herpes zoster), despite taking the vaccine over 5 years ago (vaccination failure). Gabapentin, at a dose of 100 milligram (mg) (taken at bed), was given as a treatment for the adverse event (AE).  The outcome of herpes zoster and vaccination failure was reported as not recovered. The causal relationship between the aforementioned events and the suspect therapy was not reported.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Vomiting-Medium
Pain at injection site, swelling lymph nodes, especially on side of vaccine administration, fatigue, brain fog, body aches, headaches, somnolence; post-vaccination symptoms experienced more than two months after administration. Diagnosis of fibromyalgia given following booster shot 11/14/2021
arm soreness around injection site of vaccination; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on an unspecified date at single dose in the arm for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient's arm soreness around injection site of vaccination. Event took place after use of product. Outcome of event was unknown.    Information on the lot/batch number has been requested.
hot to the touch; he almost shot out of his skin; not been able to sleep on his left arm; upper arm with a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), VACCINATION COMPLICATION (he almost shot out of his skin), LIMB DISCOMFORT (not been able to sleep on his left arm) and RASH (upper arm with a rash) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 078C21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced VACCINATION SITE WARMTH (hot to the touch), VACCINATION COMPLICATION (he almost shot out of his skin), LIMB DISCOMFORT (not been able to sleep on his left arm) and RASH (upper arm with a rash). At the time of the report, VACCINATION SITE WARMTH (hot to the touch), VACCINATION COMPLICATION (he almost shot out of his skin), LIMB DISCOMFORT (not been able to sleep on his left arm) and RASH (upper arm with a rash) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.  The patient woke up with his upper arm with a rash, and hot to the touch. He had not been able to sleep on his left arm.   This case was linked to MOD-2021-315913 (Patient Link).
No adverse effects were reported.; patient (...) was administered a dose of improperly stored MMR II; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. On 01-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N014635, expiration date 11-MAY-2019 (dose and route of administration were not reported), albumin status rHA (recombinant Human albumin). Concomitant therapies included sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit (78 degrees Fahrenheit) for 5 hours. Data logger was not involved. There were no previous excursions reported.
Had vaccine on 10/02/2014 went to ER with SOB, whelps. Also, went to a urgent care clinic for hand swelling on 10/5/2014.
Initial information received on 23-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a two-years old male patient who was given ADACEL instead of DAPTACEL. This was actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration (2-year-old patient had been given ADACEL instead of DAPTACEL). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On 20-Apr-2016, the patient received a fourth dose of 0.5 ml of suspect ADACEL lot U5798AB, exp date: 15-November-2019, via unknown route in unknown administration site, instead of DAPTACEL. The patient had been kept at the office for 20 minutes afterwards for observation. It was not reported if the patient experienced any adverse event. Lab test and corrective treatment: not applicable. Outcome: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by sender: none.
40 mins after vaccine administration, family was out driving looking at houses and mother noticed that pt. appeared like she fell asleep in her carseat however she appeared like she was staring with eyes crossed, she was breathing, arms were stiff, no cyanosis. This episode lasted about 30 seconds and pt. gradually returned to baseline 2 minutes from the start of the episode. Parents immediately returned to clinic to be evaluated. She has history of breatholding spells, but this instance was different than her previous episodes and last time she had breathholding spells was 8/10 and none since. She didn't have fever, she received Ibuprofen prior to vaccines as she has done in the past.
Pfizer-BioNTech COVID-19 Vaccine I received the vaccine dose on May 4.  I experienced severe depressive symptoms (hopelessness, suicidal ideation) on May 5 and 6, along with body aches, fatigue, and an inability to concentrate.  On May 7, the only remaining symptom was a soreness at the injection site.
Information has been received from an 83 year old female consumer with no pertinent medical history and allergies to NEXIUM, ameprozol, DEMEROL, "statins and other unspecified medications" who on 19-FEB-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included "unspecified blood pressure medication." Subsequently, the patient experienced a burning sensation in her right armpit after receiving the vaccination. Unspecified medical attention was sought and there were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to reprt(s) previously submitted on 6/24/2008. Information has been received from an 83 year old female consumer with no pertinent medical history and allergies to NEXIUM and DEMEROL, "statima and other unspecified medications" who on 19-FEB-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included "unspecified blood pressure medication." Subsquently, the patient experienced a burning sensation in her right armpit receiving the vaccination. Unspecified medical attention was sought and there were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information was received on 07-JUL-2008 from a physician. The physician reported that the patient had "no ill effect." Additional information is not expected.
Reporter states several pt's devel SC nodules, size of a pea, following administration of HIB vax; Nodules were palpable two months following inject but later resolved;
Young lady reported to the Pharmacist with in 10 min of receiving the vaccine. She felt fatigue, headache, nausea and muscle pain in her legs.
Pt devel stiffness in lt side of neck p/recvd Engerix-B;
Nausea post vaccination for 1 week. Ongoing moderate-to-severe dizziness post vaccination. The vertigo occurs in flashes. It usually happens at night, but has occurred during the day and while driving.  In some instances, the flashes were so severe that only the wall kept me steady.  I have not had a severe bout of dizziness in nearly 5 days, but I am still experiencing mild-to-moderate dizziness that has not resolved on the eve of my second vaccination. Needless to say, I am reluctant to proceed.   Be advised that I have never tested positive for SARs-2.
started a menstrual cycle a few days later than usual, had significant loss of blood on the 8th day, which turned out to be a spontaneous miscarriage and not a menstrual cycle, tested through blood test.
10/11/2007 L deltoid / inferior humerus subcutaneous soft tissue erythema approx 2 cm oval distribution, induration. nontender  recommended benadryl 50 mg po q 6 hours / warm compresses. reevaluated 24 hours later 10 cm induration nontender , recheck 10/15/2007 completely resolved
I had mild symptoms, a small cough. I did a home COVID-19 test, that came back positive. I called my PCP, we discussed my symptoms, she asked if I wanted to take the PAXLOVID, I told her no I wasn't interested in it. It took two weeks for the lethargy to go away but I feel great now. In March I had a runny nose, hacking cough. I went to urgent care; they tested me for strep throat and took chest x-rays. The test for strep came back positive, the chest x-rays came back negative. I was given an antibiotic; it took three weeks to get the strep out of my system.
Patient had flu like symptoms that developed the evening of vaccination including fever, headache, myalgias, nausea and vomiting. He had a syncopal episode on 7/18 (2 days after vaccination) and family found him on the ground.  Following this episode he complained of substernal pleuritic chest pain. Initial EKG demonstrated diffuse ST changes. He became hypotensive and developed respiratory distress with evidence of pulmonary edema on CXR. He was admitted to the PICU on 35L HFNC and received an epinephrine drip for blood pressure control. Respiratory status improved.
On 4/6/2023, I thought I had a cold, because I was sneezing a lot and had a runny nose. I also had a pretty bad cough. I took some pseudoephedrine that night before going to bed. On 4/7/2023, I took more pseudoephedrine and played golf with friends. I kept coughing and blowing my nose while on the course, so my friends suggested that I take a COVID-19 test, which I did that night. The result was positive. On 4/9/2023, I went to an urgent care clinic, and I was prescribed Molnupiravir. I asked the doctor if I could also take pseudoephedrine in conjunction with the Molnupiravir, and she said yes. She advised me to lay low and drink plenty of liquids. She also recommended that I stay home for at least six days, and as my symptoms improved, I could then resume my normal activities. She also recommended that I not test again, as it's possible to test positive for up to two months. I took the medication and still had the runny nose and congestion for a long time. It was about two and a half weeks before I felt really good again without postnasal drip. At the time of this writing, I feel great. I walked for two miles earlier this morning. I've also done yard work and played pickleball.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave a booster to a 5 year old) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave a booster to a 5 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave a booster to a 5 year old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
MALAISE; FEVER; This spontaneous report received from a patient concerned an 84 year old female. 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 and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On 06-APR-2021, Laboratory data included: Body temperature (NR: not provided) 96 F, 99.3 F. On an unspecified date, the patient experienced fever, and malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and malaise was not reported. This report was non-serious.
Patient was administered dose 2 of Moderna vaccine on 2/22/2021 and on evening of 2/23/2021 patient experienced a witnessed cardiac arrest, was transported to the ED and expired
pt recvd flu vax & devel cellulitis @ the site of inject; pt was hosptialized 4 day & treated w/ATB;
10min post vax pt devel rash on torso neck & upper arm-persisting 20min;pt stated felt hot & ears burned most of evening;also stated felt woozy;
Unwell feeling; Heart palpitation; numbness on toes, fingers; Numbness on lips; Burning sensation on hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 11:00 (Lot number: EN6207) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies: All fruits except bananas" (unspecified if ongoing), notes: known allergies: All fruits except bananas; "Allergies: Dust" (unspecified if ongoing), notes: known allergies: Dust; "Allergies: Pollen" (unspecified if ongoing), notes: known allergies:pollen; "Allergies: Grass" (unspecified if ongoing), notes: known allergies: grass; "Allergies: Ragweed" (unspecified if ongoing), notes: known allergies: ragweed. Concomitant medication(s) included: ALLEGRA; AZELASTINE; TRIAMTERENE. The following information was reported: MALAISE (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "Unwell feeling"; PALPITATIONS (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "Heart palpitation"; HYPOAESTHESIA (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "numbness on toes, fingers"; HYPOAESTHESIA ORAL (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "Numbness on lips"; BURNING SENSATION (non-serious) with onset 31Mar2021 03:00, outcome "not recovered", described as "Burning sensation on hands and feet". The events "unwell feeling", "heart palpitation", "numbness on toes, fingers", "numbness on lips" and "burning sensation on hands and feet" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise, palpitations, hypoaesthesia, hypoaesthesia oral, burning sensation.  Additional information: The patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
pt devel weakness (total body) 9OCT96 AM;pain localized to upper rt arm (?deltoid muscle);felt like tightness-nerve pain that radiated to back (rt scapula area over the next few days);pain went up into face;saw MD-sinus infect/teeth p
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Pt reports swelling, a "hard knot" at injection site that causes intense itching
non tender, 1-2 inch node supraclavicular, non-tender node above his clavicle after his second dose; This is a spontaneous report from contactable physician from a Pfizer sponsored program.  A 16-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown) via unspecified route of administration in left arm on 26May2021 as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medication were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown) via unspecified route of administration on an unspecified date, as 1st dose, single for COVID-19 immunization. On an unspecified date in 2021, the patient developed a non-tender, 1-2 inch node supraclavicular, not painful, non-tender node above his clavicle after his second dose. Reporter wanted to know if it's a common occurrence. Caller stated if this was a common side effect then this information should be publicly provided when getting injection. Caller enquired if this situation was a common occurrence with his age. The outcome of event was unknown.  Information on Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021641345 same reporter, product and AE, different patient
Arm soreness, I had dinner and maybe it was the food I ate, my stomach really hurted and lots of pain. I laid down and rested and next morning my stomach pains were gone. My arm was still hurting a lot the next day, not anymore.
Nausea for about a week,then felt good for about 3 week, then had burning sensation back of head and felt light headed and that lasted for about a week, then once again disappeared and then I got sick to my stomach, bad stomach pains that lasted about 6 weeks, then that went away then I had bad headaches with sharp shooting pains, burning sensations at the back and the front of the head, and had teethache even took trips to the dentist to find out everything was ok the duration of the headaches lasted about 3 1/2 months.  Then had leg/muscle pains for about 3 weeks, joint pain, andchest pain, sensation of not able to get enough air that take place on in off over the past 8 months, and tireness.  7/15/08 Reviewed vax & PCP medical records. Received HPV #1, lot# 0525U, RA on 8/28/07.  Records indicate patient tolerated HPV #1 well.    9/9/08 Reviewed additional PCP medical records. FINAL DX: none provided Records reveal patient experienced general good health on 8/28/07 but with bilateral ear discomfort & wisdom teeth coming in.  RTC 7/15/08 & seen by Rheum c/o feeling unwell since 10/2007 w/multiple complaints of lightheadedness, nausea, HA, abdominal pain, sensitive teeth, burning ears, arthralgias, paresthesias, chest discomfort, difficulty breathing, feelings of impending doom, .   Had been seen by GI & dx w/IBS.  Seen by Neuro & exam was WNL.  RTC 7/21/08 c/o nausea, tooth pain & increased heart rate, no diagnosis provided.  RTC 8/12/08 for intermittent dizziness x several months, achy & joint pain
Had DTAP on 4/7 and developed redness and swelling the same evening and it spread to side was over 5" diameter. Better in 4 days.