chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per neurologist: "He was begining to take a couple of steps independantly after his first birthday. However, at around 15 to 16 months of age, in January od 2005, he became, "not the same person". This did not happen quickly. He seemed to lie down alot and was always trembling when he was upright. During this time he did have multiple ear infections. When he tried to sit, he would often fall over backwards, a skill that he had had previously. He also stopped crawling, something that he did quite a bit before. This persisted for a number of months, and in late June to mid July, he started to improve. He was more interested in trying to walk, though now he does so only with two-handed support. He always climbed, but stopped ascending stairs on his own. During this whole event, there has never been any concern about his muscle power, and he does not seem to be in any pain or have any fevers." MAJOR FINDINGS: "Weight is 26 pounds. Head circumference is 50 cms. This is a somewhat shaky and fussy 22 month-old infant boy who has an appropriate play interest for age. He is comfortable and variable cooperative. There are no unusual Physical features otherwise. Head is normocephalic. The hair is normal." "He has good tone, power, and bulk throughout. He is quite shaky, sometime with a mild myoclonic appearance. This involves the arms and legs, and is most evident playing with small toys or attempting standing, in which case there is also some truncal involvement.The stride length with walking is consistent and foot placement accurate. Most of his instability comes from support around the hips and to some extent the arms. Deep tendon reflexes are present and symmetrical and proportionate throughout. There are no pathologic reflexes." Dis Sum rec'd 10/26/2005; added ters - Respiratory distress, erythma, rhinorrhea, loss of developmental milestones, asthenia. Per followup report- Patient still has shakiness, inabilty to stand independently and still cannot walk.  Mother of patient believes the administering nurse said the office had no "acellular vaccine and gave patient the cellular" form. Discharge summary states status asthmaticus, cough, asthenia. msv
This case was reported by a healthcare professional and described the occurrence of metallic taste in mouth in a 40-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), ENGERIX B and typhoid vaccine (non-gsk). The subject's medical history included Crohn's disease. Concurrent medical conditions included allergy to horses and asthma. Previous and/or concurrent vaccination included TDAP; GlaxoSmithKline; unknown; unknown given on 22 July 2010. Concurrent medications included VENTOLIN and ADVAIR. On 4 May 2010 the subject received 1st dose of HAVRIX (1 ml, unknown route, left arm), and 1st dose of Typhoid vaccine (Non-GSK) (details unknown). On 4 May 2010, less than one day after vaccination with HAVRIX and Typhoid vaccine (Non-GSK), the subject experienced metallic taste in mouth. On 5 May 2010, the subject experienced injection arm pain (left arm) and unable to move arm. On 8 May 2010, the events were resolved. On 22 July 2010 at 11:45 the subject received unspecified dose of ENGERIX B (1 ml, unknown route and site). On 22 July 2010, immediately after vaccination with ENGERIX B, the subject experienced metallic taste in mouth, lasting for about 5 seconds. On 22 July 2010, the event was resolved. The healthcare professional considered the events were probably related to vaccination with HAVRIX, ENGERIX B and Typhoid vaccine (Non-GSK). Follow-up information received from the healthcare professional on 06 August 2010: Typhoid vaccine (0.5 cc) was administered in the left arm on 04 May 2010. The subject experienced injection arm pain on 04 May 2010, the same day after vaccination with HAVRIX and Typhoid vaccine. The subject received 1st dose of ENGERIX B in her left arm and BOOSTRIX (0.5 cc) in her right arm on 22 July 2010. The dose of BOOSTRIX administered on 22 July 2010 was also considered a suspect product for the event of metallic taste in mouth that occurred the same day.
This spontaneous report was received from a consumer refers to her 13 year old daughter. No pertinent medical history of the patient was reported. On 11-AUG-2014, the patient was administered with the first dose of GARDASIL intramuscularly (strength, lot number, expiry date and site of administration were not reported). On 06-OCT-2014, the patient received the second dose of GARDASIL. On 08-NOV-2014 the patient was vaccinated with the third dose GARDASIL, intramuscular. There was no concomitant medications reported. It was reported that on 08-NOV-2014, the third dose of GARDASIL was administered out of sequence, without waiting for the six months between the second and third doses. The vaccine was administered by an unspecified nurse at the practice. The patient did not experience any side effects from GARDASIL. The doctor suggested that the patient could get an additional dose of GARDASIL after the patient had reached the 6 months point. There was no product quality complaint involved. The outcome was unknown. Additional information has been requested.
w/in 24 hrs p/immun, pt exp fever of 103 & irritability; As of 4JUN91, pt had fever of 101.5; recvd DTP/OPV 4 wks prior w/no rxn;
I got the COVID-19 vaccine in October and had cold symptom 22NOV2022 and tested positive for the COVID-19 virus. About five days later I got a sore in the corner of my mouth and for the next three months I had a sore on one side or the other or both with maybe a day or of respite in between. This ere solved 14FEB2023. I did use nystatin ointment which heled as well as VASELINE. Clotrimazole was used as well. Angular Cheilitis is the condition and is different because it lasted so long.
PATIENT CAME INTO PHARMACY TO GET A FLU SHOT, PRESENTED IMMUNIZING TECHNICIAN WITH HER COVID CARD AND TECHNICIAN GAVE HER A 3RD DOSE OF PFIZER (PATIENT HAD FIRST 2 DOSES OF MODERNA WITH LAST DOSE BEING 5/2021)
Pt was given pneumo vaccine-23 at office visit on 10/28/14 in left deltoid. Pt had had flu vaccine at work 6 days prior same arm. Pt called the office 10/30/14 in AM to state having reaction. Redness and some swelling with pain in left upper bicep to antecubital. Redness to upper forearm this afternoon when exam by PCP.
"mild cold symptoms" runny nose, sneezing, watery eyes, dry cough, headache, COVID test (+)
8 weeks since I had the 1st Moderna shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (8 weeks since I had the 1st Moderna shot) in a patient of an unknown age and gender 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 PRODUCT DOSE OMISSION ISSUE (8 weeks since I had the 1st Moderna shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (8 weeks since I had the 1st Moderna shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.
One day post vax the pt's left upper arm was red, hard, with quarter-sized lump and warm to the touch. Swelling, warmth and the hardness progressed. On 2/5/01 the left upper arm redness and swelling was the size of 3 silver dollars, still warm, hard. No fever was noted. On 2/7/01, mom noticed the child's hair was falling out in clumps.
nausea; patient felt like she was about to faint; headache; stomachache; patient felt very weak; patient felt like her blood pressure was low; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache), ASTHENIA (patient felt very weak), HYPOTENSION (patient felt like her blood pressure was low), NAUSEA (nausea) and DIZZINESS (patient felt like she was about to faint) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 032B21A and 030A22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo. Concurrent medical conditions included Blood pressure high (15 years ago) and Abdominal symptom NOS. Concomitant products included AMLODIPINE, LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for Blood pressure high, CYCLOBENZAPRINE for Muscle relaxation.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced ABDOMINAL PAIN UPPER (stomachache), ASTHENIA (patient felt very weak), HYPOTENSION (patient felt like her blood pressure was low), DIZZINESS (patient felt like she was about to faint) and HEADACHE (headache). On 08-Apr-2022, the patient experienced NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 08-Apr-2022, NAUSEA (nausea) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomachache), ASTHENIA (patient felt very weak), HYPOTENSION (patient felt like her blood pressure was low), DIZZINESS (patient felt like she was about to faint) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2022, Blood pressure measurement: low (Low) blood pressure was low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported no allergies, patient never had COVID  test or diagnosis and no Other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The recent status of blood pressure was reported as not known  how her blood pressure. patient fainted in the past, due to vertigo. Patient reported that the symptoms worsened.   This case was linked to MOD-2022-538656, MOD-2022-538649 (Patient Link).
Injection site became red, warm and painful the evening of the injection. The following morning the redness and swelling had increased in color and size. That evening the patient measured the length and width of the red, swollen area and it was 3 inches by 2 inches. The area was warm to the touch and still painful. The morning of the third day after the injection the area of redness and swelling had grown to 3 1/2 inches by 2 1/2 inches. The patient went to convenient care and was seen by a PA-C. Throughout this time period the site was treated with an ice pack and MOTRIN. The patient was told to continue the icing and MOTRIN and monitor the injection site for another 24 hours and report back to the PA-C as to any changes in size of redness and swelling.
This spontaneous case, initially received on 20-Sep-2018, reported by a pharmacist and concerning a 62-year-old, adult male patient. The patient's medical history and concomitant medications were not available. On 20-Sep-2018, the patient (under age of 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250786 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration). It was reported that the patient did not experience any adverse effect after the vaccination. The reporter assessed the case as non-serious.
Patient is a 35 y.o. female with history of primary mediastinal large B-cell lymphoma (s/p chemotherapy 12/2020, in complete remission), suspected dysautonomia with inappropriate sinus tachycardia, who presents with 8 days left-sided chest pain and shortness of breath, found to have pericarditis on cardiac MRI and small pericardial effusion on bedside ultrasound.    Per outpatient cardiology notes, the patient has had tachycardia and DOE which began during chemotherapy, which persisted continued after completing treatment. On 2/17/21, she had a BWH ED evaluation after snowshoeing for dyspnea and tachycardia, workup notable for CTA without evidence of PE or pleural effusion and stable appearing mediastinal mass. She went on to have MRI brain 2/18, which did not show evidence of lymphoma involvement of the brain or other anomaly. She had Zio patch monitoring from 2/24-3/10, HR 45-176 bpm, avg 85, sinus; rare PACs and PVCs. On 3/5, fainted in setting of THC gummy then going to get water, no arrhythmia noted. On 3/19, she underwent TTE with normal biventricular size and function, trace TR with RVSP estimated 20+ RAP with a normal IVC, trivial anterior pericardial effusion. On 4/12, she had stress cardiac MRI demonstrating active pericarditis without evidence of inducible ischemia or constrictive physiology. She was started on ibuprofen and colchicine (4 days thus far).
Muscle aches primarily in lower and upper back and shoulders; fever; headache; fatigue.  Symptoms cleared around 10:00 AM on 09/25/2013.
BLOOD CLOT IN HEAD; BLOOD CLOT IN SINUS VEIN; BLOOD CLOT IN NECK; BLOOD CLOT IN LEFT AND RIGHT LUNGS; MINI STROKES; LOW PLATELETS; This spontaneous report received from a parent via a social media platform and concerned a female patient of unspecified age, race and ethnicity. 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, and batch number were not reported) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 16-APR-2021,10 days after the vaccination, the patient experienced a first blood clot in her head, then a second blood clot in the head, then several more in the left and right lungs, another in the neck and developed a blood clot in the sinus vein leading to the brain, and on unspecified dates in APR-2021, the patient also experienced mini strokes and low platelets.  The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The patient had not recovered from blood clot in head, mini strokes, blood clot in left and right lungs, blood clot in neck, low platelets and blood clot in sinus vein. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received via social media concerns a female age, unspecified age, unknown ethnicity, who was noted to have multiple blood clots, clot in the sinus vein, mini strokes and low platelet 10 days after receiving the Janssen Covid-19 vaccine.  The patient experienced multiple clots - head, both lungs, neck, and in the sinus vein leading to the brain. She also experienced mini strokes and low platelets. Patient's height and weight were not reported. Patient's past medical/surgical history, concurrent conditions and concomitant medications were not reported. Information regarding past smoking history, illicit drug use and alcohol abuse were not provided. Information is limited in this case. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate. Additional information has been requested.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced very red swollen arm with a raised area size of grapefruit on an unspecified date with outcome of unknown.
Subsequent to receiving vax the pt developed about 20 wheals on her torso. She was treated with Benadryl and the wheals went away. A few days later she broke out with 30 wheals which left bruises when they went away. At one point the child had 50 wheals including some on her eyelids. The pt was seen by a physician and a dermatologist, both of whom felt her adverse reaction was related to therapy with varicella virus vaccine live. The pt was treated with Atarax. The pt currently has bruising on her back and abdomen with no lesions. Follow up information indicated that the pt has a history of pneumonia with one associated case of asthma at the age of six months. Pt was treated with albuterol at this time but never received steroid therapy. Pt never had a reoccurrence of asthma. The pt has had several colds and ear infections, but no other significant medical history. There was no other concurrent medication and no known exposure to varicella or a tan center. None of the lesions vesiculated or scabbed over. These first 20 lesions resolved after treatment with Benadryl, however bruising developed and remained at the site of the wheals. Several days later the pt again broke out with approximately 30 wheals, which also resolved and left bruises. At one point the pt has 50 wheals and each time they resolve she is left with bruising. There are no other signs or symptoms. The pt was seen by a physician who diagnosed the lesions as mosquito bites. She was seen by two other physicians who felt that they were a hypersensitivity reaction to varicella virus vaccine live. Pt began treatment with Atarax The pts experiences persisted. No further information is available.
Information has been received from a Registered Nurse, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female with 36 weeks pregnancy and with allergies to aspirin who on 07-JUL-2010 was vaccinated subcutaneously with 1.0 ml of GARDASIL (lot# not reported) in place of tuberculin purified protein derivative ("PPD") due to human error, not product confusion. Concomitant therapy included vitamins (unspecified). Office stated that 1 ml GARDASIL was given subcutaneous, not standard PPD dose of 0.1 ml. Unspecified medical attention was sought. The patient's last menstrual period was approximately 29-OCT-2010 and estimate delivery date will be 05-AUG-2010. Follow-up information has been received from the Registered Nurse. She reported that the prenatal patient was given 0.1 ml of GARDASIL subcutaneously. She stated that event though the dose of GARDASIL was much less than the normal dose they were still given GARDASIL. The patient was given GARDASIL in place of PPD due to human error. Follow-up information has been received from the registered nurse. The nurse reported that the female patient was a non-smoker and she had no significant past medical history and no family history. The patient had 5 previous pregnancies: twice full term deliveries and twice elective terminations. There was no birth defect in previous pregnancies. On 14-JUL-2010, ultrasound was performed and it showed the patient was 37 weeks and 3 days, the result was normal. On the same the patient started ferrous sulfate 325 mg daily for Fe decreased. On 05-AUG-2010, 40.2 weeks from LMP, the patient delivered a female baby. Weighed 7lbs 13oz, Apgar scored 8/9. The baby was normal and there were no congenital anomalies. There were no complications during pregnancy or labor. There were no infections or illness during pregnancy. This is one of several reports received from the same source. Additional information is not expected.
Redness, heat, swelling and discomfort within 24 hrs.  Severe local reaction.
Chest pain, fullness in throat increased in saliva 1/2 hour after vaccine, pt went to movies, ate lunch and then came back to office - exam begin vss pulse cx normal - EKG normal. Spoke to father 10/1/10 pt recovered.
Onset March 2, 2000 with swollen glands, muscle aches, sinus pain, slight cough, sore throat and sore glands. Had first Anthrax vaccination on March 1, 2000.  Follow up 06/05/2000: "Patient partially recovered from adverse event.  Flu symptoms lasted from 03/02/2000 to 03/18/2000 after first shot on 03/01/2000.  Declined second shot scheduled for 03/17/2000 until URI symptoms cleared up.  Accepted second shot.  After 2nd shot, continuous symptoms listed above."
got the booster last week but now has started a high dose steroid after being diagnosed with an autoimmune disease; This spontaneous case was reported by a pharmacist and describes the occurrence of AUTOIMMUNE DISORDER (got the booster last week but now has started a high dose steroid after being diagnosed with an autoimmune disease) 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.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced AUTOIMMUNE DISORDER (got the booster last week but now has started a high dose steroid after being diagnosed with an autoimmune disease) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (got the booster last week but now has started a high dose steroid after being diagnosed with an autoimmune disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details provided.  Patient started a high dose steroid after diagnosed with autoimmune disease.  Company comment: This case concerns a  female patient (age not provided) with no relevant medical history, who experienced the unexpected event of Autoimmune Disorder. The event occurred approximately 1 week after the third dose  (booster) of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 Vaccine)  is not affected by this report.; Sender's Comments: This case concerns a  female patient (age not provided) with no relevant medical history, who experienced the unexpected event of Autoimmune Disorder. The event occurred approximately 1 week after the third dose  (booster) of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 Vaccine)  is not affected by this report.
Extreme fatigue, shortness of breath, flushing - 2/21 went back to Dr. saw physician assistant - not sure if I am having a reaction to the 3 vaccines administered on 2/19 (pneumonia, pertussis, tetanus) or the flu.
The patient experienced severe hives all over her body beginning on 10/19/2001. The patient took various anti-histamines and was given a shot in the Dr's office. The patient is now taking Zyrtec, which so far reduces the hives.
Patient developed red, swollen shoulder and upper arm. Edema three times normal size. Warm but nontender. Also a few blisters where band-aid adhesive was. Occurred 24 hrs after vaccine. See ER report. Fever to 101.
Covid vaccine- not documented which one  Fatigue, significant- prevents daily activity Dizziness, headache- significant use of prescription pain reliver or prevents daily activity  Myalgia, nausea
Patient started developing a rash on the right side of his head the day after receiving the immunization. Patient said he went to the clinic and was treated for shingles. He did not mention the specific treated that he was on and it was not filled at our pharmacy.
Redness on Rt leg with warm to touch swelling. Instructed mom Tyl, warm compress to area. If redness or swelling increases to RTC or ER.
Patient received vaccine 12/3 in the evening. Noticed some are soreness but 12/4 had arm pain and limited range of motion with pain radiating to back of arm and upper back.
Patient given Flumist.  Immediately after administering in each nostril, child started crying and nose began to bleed.  Pressure applied to nose by mom, bleeding lasted approx 2 min.