chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LEGS FEEL WEAK; WEAKNESS; NAUSEA; FEELING DIZZY AND DIZZINESS GOT WORSE; MEDICINAL SMELL IN NOSE; BODY ACHE; CHILLS; STANDS AND WALKS AROUND FELT WINDED; LEGS FEELS HEAVY; This spontaneous report received from a parent concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 15:45 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stands and walks around felt winded. On APR-2021, the subject experienced legs feels heavy. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced feeling dizzy and dizziness got worse. On 12-APR-2021, the subject experienced medicinal smell in nose. On 13-APR-2021, the subject experienced legs feel weak. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 11-APR-2021, had not recovered from feeling dizzy and dizziness got worse, medicinal smell in nose, legs feel weak, nausea, body ache, and weakness, and the outcome of stands and walks around felt winded and legs feels heavy was not reported. This report was non-serious.
Put in hospital; This serious case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hospitalization (Verbatim: Put in hospital) (serious criteria hospitalization). The outcome of the hospitalization was not reported.   It was unknown if the reporter considered the hospitalization to be related to Shingles vaccine.     It was unknown if the company considered the hospitalization to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by the patient via interactive digital media. The patient reported that the Shingles vaccine put him or her in the hospital and reported that be very careful. Follow-up would not possible, as no contact details were available.
Heart palpitations, chest tightness, and pain. EKG and heart stress test with echocardiogram performed. Pericardial Effusion found. Colchicine 0.6 mg taken once a day with substantial meal started 02/18/2022. Palpitations and chest tightness lessening after 3+ weeks. Told to take medication for three months.
Pt stopped breathing and had a cardiac arrest. CPR required.  7/23/09 Hospital records received DOS 7/1/09 to 7/2/09. Assessment: Syncope vasovagal. Patient dizzy, passed out, loss of consciousness, not breathing spontaneously, CPR initiated. Bradycardia. Presented at ER lethargic and somnolent. Generalized aching severe in nature. Rash on arms. Anemia.
This spontaneous report was received from a health care worker regarding unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ (orally, dose was not reported, lot # L013192, expiration date 19-JAN-2017). There was no adverse event reported. This is one of several reports received from the same source. Additional information is not expected as there is no permission to contact the physician.
Information has been received from a physician concerning a 16 year old male who on 17-OCT-1994 and 20-JAN-2000 was vaccinated with the first and second dose of MMR II.  On 10-NOV-2009 the blood work was done and the results indicated IgM<1:10, IgG 9.29, and serum amylase 725.  On 10-NOV-2009 the patient was diagnosed.  On 11-NOV-2009 the patient experienced mumps.  The patient was afebrile and had a parotitis on the right side.  The outcome of mumps was unknown.  Follow-up information has been received from a physician concerning a 16 year old male who on 17-OCT-1994 and 20-JAN-2000 was vaccinated with the first and second dose of MMR II.  On 12-NOV-2009 the patient was diagnosed with mumps.  The patient was afebrile and had a parotitis on the right side.  On 12-NOV-2009 the patient did the first blood work and the results showed IgM negative, IgG 3.36, serum amylase 95.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Patient repports breaking out in hives the evening of her flu shot. She reports that her arms, legs and trunk were affected. She reports itching as if she was exposed to fiberglass. Patient took Benadryl that evening and on 11/20 reported that the hives had subsided.
Low grade fever, nausea, extreme pain in all joints, hands swollen and stiff, headache. diaherra for 2 days,, sleep on and off for 3 days.  Just starting to feel a little better.  It was hell.  10 days.
Hearing loss 5 days after vaccine, progressed to left sided facial paralysis, went to ER and was diagnosed with Ramsey Hunt and Bell's Palsy. Treatment consisted of 10 days Acyclovir and 5 days of high dose steroids. Condition progressed to include vestibular disturbance and ataxia. Referred to ophthalmologist but no eye involvement at this time.
patient who had first dose 10APR2020, second dose 17APR2020 and the dose due 01MAY2020 was not given, no AE; Initial information received on 14-May-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves patient of unknown demographics who had first dose of RABIES (HDC) VACCINE [IMOVAX RABIES] on 10-Apr-2020, second dose 17-Apr-2020 (lot number and other dosing details for all the regimens were not reported ,via unknown route in unknown administration site as prophylactic vaccination) and the dose due on 01-May-2020 that was not given and hence the dose was missed.   Medical history, medical treatment(s), vaccination(s) and family history were not provided.   This was potential medication error case due to missed dose.  It was not reported whether affected vaccine was administered to any one and experienced any adverse event.  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.  There will be no information on the batch number for this case.
Vaccine received roughly 1 month ago - 1-2 days onset of chest pain/ pleuritis.  improved with NSAIDS but still not resolved further work up pending
Associate reports Fever, headache, and sweating that began on 1/13/21, and fatigue, dizziness, "heavy head", tachycardia, and hypertension starting on 1/14/21. Advised to seek medical treatment.
Patient came in to  pharmacy on 03/03/2020 to report that the day (06/18/2019) after she received 2nd shingles vaccine she had pain in her left arm muscle and in her uterus. She reported that the pain stopped that evening.
Employee developed redness, swelling, warmth and discomfort within 24 hours of injection. This continued and areas of redness and swelling increased over the next 3 days maxing out at almost the entire upper arm. This remained stable for about 48 hours then slowly started to diminish.
Information has been received from a female from a physician's office concerning an 11-year-old male student who in 1996 was vaccinated with a dose of varicella virus vaccine live.  It was unknown if there was any illness at the time of vaccination.  On 10-DEC-2005 the patient developed multiple lesions in various stages, and had a lesion on his left eye.  The patient was seen in the physician's office, he was referred to an ophthalmologist and treated with routine calamine lotion and diphenhydramine hydrochloride.  Subsequently, the patient recovered on an unknown date.
blood clots on her lung; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (blood clots on her lung) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (blood clots on her lung) (seriousness criteria death and medically significant). The reported cause of death was blood clots on her lung. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.   It was reported that patient passed away in the summer after developing blood clots on her lungs.  Treatment information was not provided.   Reporter did not allow further contact; Reporter's Comments: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected, serious (medically significant) fatal event of pulmonary embolism (AESI) an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests, treatment provided, and autopsy report has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: blood clots on her lung
Needle of syringe was not capped tightly so most of the vaccine liquid leaked out instead of being injected inside patient's arm. Patient was injected another dose in the other arm.
Nausea, headache, severe dizziness, very tired, low grade fever ... lasted two days.
Patient received the Typhoid Vaccine 0.5ml IM Left Deltoid at Approximately 8:15am.  Left Health Center approx. 8:30am.  Health Center alerted at 9:30am that patient was experiencign itchy mouth.  Brought to health center.  In no distress. Mouth itchy.  No hive or oral lesion.  No swelling eveident. Lungs clear, no wheezing, no SOB, oxygen saturation 89% pulse 78.  Given Benadryl 50mg liquid PO.  Montiored for two hours post event.
Presumed possible reaction to imm given in Right arm. Persistent arm pain that started the day after the imm. that hasn't gone away and has variable locations in the right shoulder
Arm is swollen, hot, painful, red, and blotchy, lymphnodes in armpit are very swollen and painful. Been very sick with incrediable pain. everywhere. naucous and stomach pain. Terrible headache
A legal complaint was received from an attorney regarding an adult male plaintiff. The plaintiff's history includes exposure to asbestos and asbestos-containing products. According to the complaint, sometime between 1965 and 1967, plaintiff was administered OPV or IPV. On or about June 2001, at 43 years of age, the plaintiff was allegedly diagnosed with mesothelioma. The complaint alleges that the contaminated vaccine products were toxic and carcinogenic and that the plaintiff's exposure to asbestos, asbestos-containing products, and SV40 virus caused severe and permanent injury to the plaintiff, including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. The complaint alleges that the polio vaccine the plaintiff received was contaminated with the SV40 virus which was a substantial factor in plaintiff's contration of mesothelioma. No further information was available at the date of this report. Follow up received on 3/17/03 states the plaintiff was reportedly treated with unspecified chemotherapy treatments and medications.
Patient fainted briefly in lobby of store. Patient was conscious and allowed to rest until feeling okay after the observation period. Pharmacist followed up several hours later with patient's guardian and she reported filling completely well.
Information has been received from a Pharm. D concerning a female pt who on 10/31/00 was vaccinated. On approximately 11/02/00 the pt complained of redness, swelling and induration.
Information has been received from a registered nurse concerning a female with no known drug allergies who in 2000 was vaccinated with a dose of varicella virus vaccine live. On 02/18/2002 it was reported that a "recent" titer did not show seroconversion. The pt sought unspecified medical attention. Additional info has been requested.
Verbal aggresive; Memory problems; This spontaneous case was reported by a non-health professional and describes the occurrence of AGGRESSION (Verbal aggresive) and MEMORY IMPAIRMENT (Memory problems) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGGRESSION (Verbal aggresive) and MEMORY IMPAIRMENT (Memory problems). At the time of the report, AGGRESSION (Verbal aggresive) and MEMORY IMPAIRMENT (Memory problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Patient received vaccine. After about 5 minutes he slid off the chair onto the floor. He woke up after about 10 seconds, remained on the floor face up. Sat up with help and was given water and a granola bar, and a cold damp paper towel for his forehead. After 20 minutes he moved to a chair and sat upright for another 50 minutes. He was given more water and another granola bar. He was given the ok to leave about an hour after the incident, stating he felt good to go.
tooth ache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient medical history was not reported. The patient concomitant medications were not reported. The patient stated he was scheduled for his second dose of the vaccine in two days. The patient asked if he could take Clindamycin, 10-day course for a tooth ache before the vaccine. Patient questioned if any antibiotics interact with the vaccine. He stated that there was no adverse event at the time of reporting and confirmed he would call if there was any adverse event. The event outcome for tooth ache was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Child said her lips was tingling and mother noticed they was swollen and hands started swelling.  Parents took her to local ER room and they gave her breathing treatment and medicine.
This spontaneous report was received from a triage coordinator concerning 11 year old female patient with asthma, who on 09-JUL-2012 was vaccinated with dose 1 of GARDASIL (lot number 0459AE) and on 16-NOV-2012 was vaccinated with dose 2 of GARDASIL (lot # H013831). Concomitant therapies included ASMANEX and VERAMYST. It was reported that in approximately 15-DEC-2012 (reported as the middle of December) the patient developed extreme fatigue. On an unknown date, the patient was seen by the Rheumatologist and had a blood work; a Lyme work up, thyroid EB, mono evaluation and Epstein Barr work-up and this entire test had been negative. No treatment information was reported. At the time of the report, the patient had not recovered from the event. The reporting triage coordinator considered the event of extreme fatigue to be significant disability or incapacity as the patient felt tired after participating in sports. Additional information has been requested.
Patient was sick after COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Patient was sick after COVID-19 vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received J+J COVID vaccination in April of 2021 and received Pfizer COVID vaccination on 9/5/2021 as indicated in this report.
Vertigo four days after first shot and lasting 2 days. Repeated Vertigo after second shot and lasting 4 days. Continued Vertigo on and off up to the present.  Also sore arm, headache, fatigue after each shot.
The nurse that administered the vaccine at 4:00 pm and  states patient went limp and had vasovagal syncope immediately upon withdrawing needle from muscle and occurred immediately after vaccine administration. The nurse lowered the patient slowly to the groundf and put the pt's feet up. The pt has had prior episodes of vasovagal syncope in the past. Her pulse was noted to be in the 70s. Small eyelid and lip twitching noted. Pt had no injury as a result of the syncopal episode. Patient transported to the Emergency Room for evaluation at 4:09 pm. Blood pressure upon arrival in the EC was 143/74, pulse 57, Resp 14, pulse ox 99%. Patient able to open eyes to command and nod yes or no. Blood Glucose was 74 and ECG was unremarkable. Discharged to home at 1822.
No adverse event; Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose).    No concomitant medication information was reported.  The vaccination date was between 22-Jul-2022 and 28-Jul-2022.  It was unknown if the patient experienced any symptoms after getting the vaccine or not.  The reporter was told that adult patients who received a 25 microgram dose in the past 24 hours could come and get another 25 microgram dose and could be considered as getting a full 50 microgram dose to start with, but it was reported that the vast majority of patients had received this half dose more than 24 hours ago.  No treatment information was provided.
Patient reported to pharmacy experiencing  pain, redness and swelling  on the arm that she received the vaccinations. Reported to pharmacy 5 days after vaccine with unknown onset time. Patient reported going into clinic to be seen stating she was told to take benadryl and put an unknown cream on arm.
Information has been received from a physician concerning a 23 year old female with seizure disorder who on approximately 25-JUL-2008 was vaccinated intramuscularly with the first dose of GARDASIL.  After vaccination on approximately 25-JUL-2008 the patient experienced a seizure.  Medical attention was sought via calling ambulance.  Subsequently, the patient recovered from seizure.  No product quality complaint was involved.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested.
Pt. accompanied by her mother arrived at site around 0845 to be vaccinated with her second of the Pfizer vaccination. Pt. and parent confirmed no adverse reactions after first dose, no known medication or other allergies, no known past medical conditions and the pt. indicated she was not pregnant. The pt. was given her second vaccination and as the vaccinating nurse turned away from the patient to move her cart out of the way and shut the patient's car door the patient was slouched over and nearly falling out of the car. The vaccinating nurse caught the patient and lowered her down to the ground from her vehicle. Charge Nurse was in prep directly across from the incident. Site lead brought over the E-Kit  Charge Nurse utilized sternal rub to awaken patient which she was responsive to. Pt. was pale in color and stated she felt very lethargic. Pt. confirmed the last meal she had was over 13 hours ago. Upon initial evaluation of patient's vitals pt. was hypotensive 74/45 and bradycardic 45. EMS was called. Vitals reassessment BP increased to 81/54. Within two minutes of the syncopal episode the patient was able to talk and A&Ox4 after she was able to state full sentences she was given water, capri-sun and a sucker. After arrival by EMS the patient was reassessed. Vitals stabilized within normal limits. Parent informed the patient is stable and upon her choice she can be transferred to the hospital via ambulance for further evaluation. Parent decline. Pt. vitals and appearance within normal limits when driven from site by parent. Parent stated she will call the daughter's PCP to see if she can be further evaluated in her doctor's office today. Mother also stated pt. has an appointment 06/14/2021 for regular physical and follow-up.
red area 8mm in length;6mm width inc temp in area, erythema w/o induration;
Patient was given Pfizer Covid monovalent vaccine instead of Pfizer Covid bi-valent vaccine for booster dose
4 hours after getting vaccine patient began to have a headache and aching on her left side.  She had decreased movement on her left side due to pain.  Saw PCP 1-11-2021 and was referred to a neurologist.  Saw neurologist on the 1-19-2021 and was told it was due to vaccine.  Saw another Primary care doctor for second opinion on 1-26-2021 and had her antibodies tested and was positive for both past and present antibodies.  MD states that she was most likely unknowingly positive for Covid at the time of vaccination.
pt recvd Td 10SEP91 then FEB92 noticed lump size of dime lt deltoid; 24JUL92 excision was performed; inject granuloma; cystic structure; fibrosis & inflammation; necrosis; Lipoma;
Pt was given Kinrix, due for Dtap and IPV.  Pt tolerated well.