chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cannot taste anything; Tingling tongue; This spontaneous case was reported by a patient and describes the occurrence of AGEUSIA (Cannot taste anything) and PARAESTHESIA ORAL (Tingling tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced AGEUSIA (Cannot taste anything) and PARAESTHESIA ORAL (Tingling tongue). At the time of the report, AGEUSIA (Cannot taste anything) and PARAESTHESIA ORAL (Tingling tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-155168 (Linked Report).
reddening/itching @ site upon inj;became SOB/coughing;hx severe asthma;given med P104;cont coughing, P132;pt cough int, SOB, P104 d/c to home;exp dizziness/SOB;EKG nl w/mult PVC's;adm to hosp for probable allerg rxn;
Patient was unable to move arm within three to four hours after administration. She starting having pain radiating from fingers to neck. The emergency room doctor concluded that the immunization may have been given too far up on the arm, as he told the patient's family that it was 1.5 finger widths below the shoulder.
EPILEPSY, INTRACTABLE, W STATUS EPILEPTICUS 4/19/2023 RIGHT MULTIPLE RIBS FX, INIT
Gastrointestinol upset: Constipation, clenching of stomach in pain, excessive crying and pain when changing diapers, body jitters , stiff arms & legs and very uncomfortable Changed formula 3 times, supplemented breast milk when possible w/ formula  Added probiotic to formula 1x a day Massages to help baby relax and release toxins
pt rec'd vaccine, waited 15 min in recovery stood up ad became lightheaded, dizzy, pale, diaphoretic no LOC near syncope, + nausea, no vomit. Ice pack to head and back of neck. refused to lie down. Gave water for hydration provided reassurance. Pt stated no nourishment taken in prior to vaccine. VS taken 122/80, HR 88 reg strong, resps 16 reg non labored, 94% O2 sat. L arm vaccine site benign. Monitored 30 min. at 9:50 pt stated, " I feel great can I go" Paleness and diaphoresis subsided. OK'd to exit with friend.
Joints sore, BP 155/89 H 89, heavy feeling inside body, heavy head, felt as if brain was throbbing.
Large red welt/hive 4"x3" itching,lump,painful,hot to touch,headaches,chills,sweats,itching.
Information has been received from a registered nurse concerning a 27 year old black female who on 09SEP2003 at 5:25AM, on 22OCT2003 at 3:15Am, and on 31DEC2003 at 2:50Am was vaccinated with a first, second and third dose of varicella virus vaccine live subcutaneously in the left deltoid, respectively. There was no illness at the time of vaccination. Subsequently, the patient "did not seroconvert after two doses of vaccine." Follow up information reported that the patient "did not seroconvert after three doses of vaccine." On 19FEB2004 the patient tested negative for VZV antibody. There was no product quality complaint involved. No further information is available.
This spontaneous case reported by a consumer, describes the occurrence of dizziness (really dizzy) and fell out of bed (because she was so dizzy) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 14, 2021, patient experienced dizziness (really dizzy) and fell out of bed (because she was so dizzy). At the time of the report, dizziness (really dizzy) and fell out of bed (because she was so dizzy) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Treatment information included Benadryl. Reporter did not allow further contact.
Information has been received from a physician concerning an approximately 4-month-old patient who was vaccinated PO with the second dose of Rotateq. The physician reported that the patient subsequently developed Kawasaki's disease. The patient was seen by the physician and was subsequently hospitalized (duration unknown). The patient subsequently recovered. It was noted the third dose of Rotateq had not yet been given. Additional information has been requested. It has been determined that WAES #0709USA03450 is a duplicate of WAES #0710USA00261. Additional information is not expected.
Body flush, shortness of breathe, chest tightness, prolonged severe episodic anxiety and panic attacks without prior history
One week later he had a multiple sclerosis exacerbation/He had another MS exacerbation; This is a spontaneous report from a contactable consumer (Parent). This consumer reported for a male patient of unknown age (reporter's Son) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on Mar-2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. One week later after first dose, on an unspecified date, he had a multiple sclerosis exacerbation. He saw doctor who sent him for prednisone by IV for 5 days. He received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date a month later as dose 2, single for COVID-19 immunization and patient had another MS exacerbation and was treated again. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Per mom had amnesia for a few hours 4 days after vaccination (could not remember taking a test).  Patient now doing well.  No other neurologic symptoms or signs, no fever.
booster doses administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A.) for COVID-19 vaccination.     No medical history was provided.     On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. No treatment drug information was provided.
Rashes on the right side of my neck on the 4th day after the first dose of vaccine. This rash has gone worse the next day, going down the right side of my neck and also on my face, and forehead.; Rash is raised, red and some had small yellow pinpoint in the center that was very itchy .; Rash is raised, red and some had small yellow pinpoint in the center that was very itchy .; This is a spontaneous report from a contactable Nurse. This 65-year-old female (non-pregnant) nurse reported for herself she received first dose of BNT162B2 (solution for injection, lot number: EL1283, Expiration date; unknown), in right arm on 10Feb2021,13:00 pm at single dose for COVID-19 immunization. Patient medical history included Left Stage 3 Breast Cancer in Feb2020, mild hypertension. Concomitant medications included Losartan and Amlodipine, Vitamin C and D3.Patient had no known allergies. The patient was not tested for COVID-19 since the vaccination.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19.On 14Feb2021 06:00 am, the patient experienced rashes on the right side of my neck on the fourth day after the first dose of vaccine. This rash has gone worse the next day, going down the right side of my neck and on my face, and forehead. Rash is raised, red and some had small yellow pinpoint in the centre that was very itchy. Patient not received treatment for the events. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the events was not recovered.
Chills  sleepiness. 100.4 fever. Head ache.  Took tylenol
The patient's current age is 17 and the Moderna COVID19 vaccination is currently only given to patients age 18 and over. There is no adverse event other than the age being incorrect - this is an administrative error.
I get monthly bloodwork for my RA and the eosinophils high for 700 times normal. I called my GP who got me in on the 16th. She referred me to a blood oncologist, immunologist, and a cardiologist. I also completed a sleep study. I got in with the oncologist and had a bone marrow biopsy and it showed no malignancies and normal bone marrow so it was not cancer. They also ran a full allergy profile and I was not allergic to anything. I began having vestibular issues and went to see otoneurologic who indicates that I have vertical nystagmus and its of unknown origin. Brain MRI with no contrast showed no lesions. They do not believe it is a brain issue. I have nystagmus vertical that when I stand up I get dizzy spells from a drop in my blood pressure. They do not believe its cardia related. I get my blood tested every month and the eosinophils count came back to where it should be. I am currently doing physical therapy which is not helping.
Patient is experiencing pain in (L) deltoid 2 weeks after receiving FLUVIRIN vaccine.
TACHYCARDIA, NASAL CONGESTION, MODERATE HEADACHE, FATIGUE
pt recv vax AUG95 & devel a severe case of shingles on half of face & head;also exp blurred vision;pt was seen in an ER 13AUG95;adm to hosp
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject completed the ENGERIX B primary series. It was found that the subject had not responded to therapy. No additional information was provided. It was noted that this event occurred in multiple vaccinated nursing students. No specifics were reported.
A mother reported that her 4 month old son received Prevnar, IPV, HIB and DPT vaccines on 8/8/00. On 8/10/00, he experienced an upper respiratory tract infection and "severe reflux". The pt was seen by an ENT physician, who surgically removed the child's adenoids and dx'd him with asthma. The child was also seen in the ER for both upper respiratory tract and an ear infection. He was treated with numerous antibiotics; however, "none of them have helped".
pt recv vax; 5 min later chest pain & wheezes noted which became worse 2-3 min; 50 mg Benadryl given w/ improvement;
10 minutes after injection experienced shortness of breath, chest pains,  heaviness in chest, constant headache and dizziness that continues to this day,  extreme fatigue, mental fog/confused state,  slurred speech, swelling and pain  in legs that escalated to extreme from 10 minutes after the injection to a week and 4 days later that affected my ability to walk.  Masses developed on both knees, also knee pain.  Large red lump where injection was given that was warm to the touch and increased in size and itchy. Went to ER to be seen but nothing was done.
After patient received her vaccination at about 11:25 am she sat down in the waiting room chair next to mom. About 3-5 minutes later she told her mom her arm felt heavy. Her mom reported patient's head then fell backwards and she made a grunting sound with her breathing and seemed tense. She was reported stiff with neck flexed and arms flexed. When Dr. arrived maybe 30 seconds later she was limp and relaxed and looked pale per Dr. I arrived maybe about 5 minutes after episode started. Patient was then conscious and talking and aware of surroundings. No incontinence. No post-ictal period. She was helped up and walked into an exam room to lay down on exam table. Glucose checked and was 98. Patient had banana only for breakfast around 8:30 amand nothing except dinner night before. Not much fluid intake. Patient then able to sit up. Did not feel dizzy. BP checked sitting and normal. She said she felt back to normal. This was around 12 noon now. Patient then walked downstairs with mom and brother and went to lab for lytes, CBC. Will phone f/u tomorrow.
pt recvd vax around 1045 never stopped crying w/inc crying p/arrived home; t99.6 & lt leg w/swelling;
died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were reported.  No treatment medications were reported.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious  (death and medically significant) event of Death (reported as Died) on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine.  Onset latency could not be determined as dates of vaccination and fatal event were not provided. Cause of death and autopsy result were undisclosed. No further information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-651049 (Linked Report).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious  (death and medically significant) event of Death (reported as Died) on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine.  Onset latency could not be determined as dates of vaccination and fatal event were not provided. Cause of death and autopsy result were undisclosed. No further information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-651049:same reporter; Reported Cause(s) of Death: Unknown cause of death
This spontaneous report as received from a registered nurse refers to a 68 years old female patient with no pertinent medical history and no drug reactions or allergies. The patient's medical history included shingles. The patient was vaccinated with a dose of ZOSTAVAX (Lot # H011049 expiration date 05-AUG-2013) SC on 10-SEP-2012. No other co-suspects were reported. Concomitant medications included: metoprolol. The nurse reported that on 15-SEP-2012, the patient developed a rash on her right torso that looks like shingles. The patient did not receive treatment for the adverse event. The outcome of rash on her right torso that looks like shingles was reported as not recovered/not resolved. Additional information has been requested.
Developed redness and mild swelling in right deltoid region at about 1330 on 5/25/05 with no fever, but with mild itching. She was seen in clinic at 1630 that same day with area measuring 4.5 by 3.5cm with on tenderness, warmth, or flucture. Prescribed Benadryl and Ibuprofen; felt to be local reaction and not cellulitis. Area marked with instruction to call if progressing.
Red, hot, swollen around injection site.  Major migraine causing multiple black outs, unable to walk without getting dizzy and light headed.
Initial information received on 01-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an eight-year-old male patient who was vaccinated with 1.0 ml of FLUZONE lot number not reported via intramuscular route in the left deltoid on 01-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to overdose. It was unknown that any adverse event was occurred or not. 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. List of documents held by sender: none.
Left arm went completely numb. Left side of neck was completely numb and left side of face was completely numb. Duration was for about 3 hours.
Pt was given a repeat series of Hep-B vaccine in preparation for a liver transplant. This ADR (adverse drug reaction) occurred following the 2nd injection of the repeat series. Symptoms included: fever to 102.7F, polyarthritis, warm and red knee and ankle joints, myalgias and lethargy.
I awoke during the night I received my vaccine with some mild itching of my extremities, but no rashes. This disappeared by the morning. On 3/11/21, I discovered an enlarged lymph node near my left collar bone. As of today, 3/18/21, the lymph node is still palpable and hasn't changed.
Fluviran given on 10/13/2009.  Patient visted me on 10/15/2009.  Stated Dizziness. Also, had bright field of vision in middle of visual field.  Vitalsigns stable/normal
Child started with a fever and then developed vomiting. Highest fever was 102.5. Mother called our office on 6/14/17 and was instructed to call her family doctor for advice. Dr. thought vomiting was either a virus or was caused by the fever. No treatment other than antipyretic/analgesic. Child is doing better.
Rash began on front of neck upon waking and slightly itchy. The rash has progressed over entire neck (looked more like hives) I took Benadryl twice today.
After the shot I went Back to work and experienced no other side effects except just a slight sore arm in injection site. I got home later that night and did school work and felt a tad more tired than usual, went to bed and woke up aT 1:45 a.m.  with intense body chills, body aches and soreness that it felt like I got Got By a bus , I also felt nauseous. Took a Tylenol and finally fell back asleep and woke Up feeling just tired. Tried to work but had to go home because I had no energy and feeling nauseous while working. I have been home and have not left my Bed since 10 a.m. and I still feel super awful.
Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Specific product reported? Yes, specific product known from information provided.     On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable).    No concomitant medications were reported. It was reported a temperature excursion that occurred several days ago in the Freezer. It was found that vaccines were viable. The patient received the booster dose. No treatment medications were reported.
PATIENT RECEIVED THE VACCINE AND WITHIN APPOX 15 MINUTES CAME BACK TO THE PHARMACY WITH SWOLLEN LIPS AND ITCHY HANDS AND WAS FLUSHED. WE ADMINISTERED 10ML OF ORAL BENEDRYL , PATIENTS BLOOD PRESSURE WAS FINE. CONTACTED 911 AND EMS RESPONDED AND TOOK PATIENT TO HOSPITAL.. BEFORE TRANSPORT PATIENT  WAS PRESENTING SIGNS OF FEELING BETTER.
Awoke in the early morning hours of 1/23/21 with severe vertigo, almost fell over twice while walking to the bathroom. Vertigo caused severe nausea and vomiting, with inability to drink or eat for 36 hours. I became dehydrated. Went to the ED and was admitted overnight for vertigo, orthostatic hypotension, dehydration.
2-3 days p/shot c/o muscle weakness on 9JUL92 t100-100.2; also had swollen lt lymph nodes in neck w/fever;
Case number PHEH2013US020253 is an initial spontaneous report received from a consumer on 26 Sep 2013. This report refers to an 18-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) in the upper arm on 23 Sep 2013. It was reported that the injection was given under the skin, underneath the fatty part instead of intramuscular administration. On 23 Sep 2013, she experienced swelling, redness and pain in site immediately after vaccination. She went to the physician on 25 Sep 2013 and the physician confirmed that MENVEO was adminsitered in the wrong place. The physician did not do anything to treat the symptoms and stated that the symptoms would eventually go away. The patient was instructed that she could put ice on the area or take ibuprofen. The outcome of the event was unknown. No further information was provided.