chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has chronic autoimmune conditions of ITP and Evans syndrome. Her platelets and other blood counts  are monitored monthly by a Hematologist. Her platelets run low usually between 81-100. On her CBC taken 2/18/21, her platelets were 51. On 3/2 they were 47 and on 3/8 they were 34.  The first part of March a change in gate was noted in patient, sh fell on 3/8/21 and hit her head. On 3/8 a CT scan detected bilateral subdural hematoma. Certain internal bleeding was believed to be caused by the fall, other bleeding appeared to be present prior to the fall.
LEFT ARM RED AT INJECTION SITE APPROXIMATELY THE SIZE OF A HALF A DOLLAR. THE AREA FEELS HOT TO THE TOUCH, VERY TENDER, AND SLIGHTLY RAISED. NOT ITCHY.
About three months after receiving the vaccine I had a flare up of Vertigo that lasted for a month. I also experienced ringing in my ears that still exists.
Guillan Barre Syndrome; This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. A male patient of an unspecified age received pneumococcal 13 valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date at a single dose for immunisation and influenza vaccine (FLU), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took  atorvastatin (LIPITOR) in which his doctor overdosed him with, so he developed a liver problem. It was reported that the patient was planning on receiving the Pfizer-BioNTech Covid-19 Vaccine. However, he said he was concerned about getting it since he had a history of having a reaction with the flu and pneumonia shot. He said his doctor overdosed him with LIPITOR so he developed a liver problem. So when his doctor gave him the flu and pneumonia shot, he ended up getting Guillan Barre Syndrome on an unspecified date with unknown outcome. He wanted to know if it would still be safe for him to receive the vaccine considering this, and his weakened immune system.   Information on the lot/batch number has been requested.
oral temp 103.2 (3 day duration) given APAP; 13FEB93 stated legs hurt, would not roll over in bed-was carried; MD called rx children's advil no visit made; redness & edema noted on arm from near elbow to neck; vomited & made choking sounds;
had Covid  after receiving the covid vaccine; had Covid  after receiving the covid vaccine; hard time walking; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4223964-00.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single and intramuscular, administration date 09Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had Covid  after receiving the covid vaccine"; GAIT DISTURBANCE (medically significant), outcome "unknown", described as "hard time walking". The action taken for adalimumab was unknown. The reporter's assessment of the causal relationship of the events with the suspect product was not related. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events Drug ineffective, Suspected Covid-19, Gait disturbance and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Severe headache began 3am 11/21/06 and abdominal pain began 8am 11/21/06. Had Abd pain off and on throughout the day. Also ran fever 101.2 that day. Was fine by am 11/22/06.
No adverse effects reported. No Additional AE; HCP calling to report AE for supported TE for VARIVAX; This spontaneous report has been received from a medical assistant, concerning an 8-year-old female patient.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 05-SEP-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, dose frequency: single dose (lot number W018829 was verified to be valid, expiration date reported and confirmed as 14-JUN-2024), administered as prophylaxis (exact dose, route of administration, and anatomical location were not provided). The vaccine administered had been suffered temperature excursions (TE) in which a previous TE was of 5.7 degree Fahrenheit (F) for 1 Hour 30 Minutes, and the current TE was of 10.2F for 4 Hours 0 Minutes (Product storage error).  No adverse effects nor additional adverse events (AE) were reported.
Following second injection symptoms included: Headache for 10 days Pain in left side Thrombocytopenia  ** See "Item 19 for post emergency room, clinical post op and multiple lab work done with GP and hematologist.
I woke up early the morning of Sunday, February 21, 2021 with sudden idiopathic sensorineural hearing loss. in my right ear.  My hearing was severely impaired in that ear. I began 60 mg of prednisone daily by mouth for two weeks and then started weaning.  I also received a series of three intratympanic injections of steroids.  My hearing recovered to my baseline level.  I have had this happen to me once before approximately six years ago.
This spontaneous report as received from a pharmacist refers to a female patient in her 40's. On an unknown date the patient was vaccinated with MMR II injection as a baby in the early 1970's (lot #, expiry date, dose and route unknown). The pharmacist stated that she was unsure if the patient received "MMR" or MMR II. She stated that the patient recently had "titers" drawn and her titer for rubella was negative (date unknown). No treatment was given for the event. The patient did not seek medical attention. The patient was not recovered. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 17Apr2021 at 11:30 as dose 1, single (Lot number: EW0161), in left arm, on 08May2021 at 11:45 as dose 2, single (Lot number: EW0173), in left arm and on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: TRUVADA, start date: Aug2021; FINASTERIDE; WELLBUTRIN; PAXIL [PIROXICAM]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient received Paxlovid indicated for COVID-19 Treatment from 25Apr2022 till 30Apr2022. Patient's infection returned 6 days after completing the course of treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
"Covid arm";  redness (4 inch oblong) and itching starting 8 days after the vaccination, lasting 3 days.
Employee reported itchy blisters on her hands and torso, stating they started to appear 3 days ago.  Was seen by the Occupational Medicine physician on 4/16/2020 and diagnosed with a Varicella reaction. She was started on Valtrex and will be seen again on 4/22/2020.
This case was reported by a consumer and described the occurrence of breast enlargement in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Approximately 13 or 14 November 2008, the subject received a dose of Influenza vaccine (unknown, unknown arm). In November 2008, 4 days after vaccination with Influenza vaccine, the subject experienced breast enlargement, pain and panicking. The subject stated "five days ago, I had a flu vaccine shot from your company. I had no adverse events until yesterday when one breast was very achy compared to the other one. Its the same side as my shot. I did not see my gynecologist yet." The subject stated she wanted to tell her gynecologist that and she was "getting panicky". The subject reported she received the flu vaccine 13 November 2008 in the left arm and four days after her left breast had enlarged. At the time of reporting the outcome of the events were unspecified. Follow-up information received on 19 November 2008. The subject provided conflicting information. The subject then reported she received an unknown Flu vaccine on 14 November 2008 in her right arm and four days later she notice enlargement of her right breast on the same side as her flu vaccine.
pt recv vax 12MAY97 &  17MAY97 pt devel rash;
pt recv vax; mom states pt had fever;unable to take T;had been fussy; gave apap then took pt to er;T 100 at er; had small red spots on back & stomach; seen by MD who stated rxn to shots; no tx done;
This is a spontaneous report from a non-contactable consumer (patient). A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 24Jul2021 11:00 (Batch/Lot Number: EW0181) age at vaccination of 38-years-old, as single dose, for covid-19 immunisation.  Medical history included was none. No known allergies. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in on an unspecified date (Batch/Lot Number: EW0181) age at vaccination of 38-years-old, as single dose, for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that her period did not come as usual on 11Aug2021, she period is always regular. She had intermittent spotting, but continued to be irregular for 2 months and ongoing. The patient confirmed that she is not pregnant (she has been checked); this is not emotional. Since she took vaccine her once regular period for 25 years is now spotty and gone. No treatments give for the event. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.  Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
presented for a well exam and was noted to have an irregular heart rate.  She was in atrial fibrillation with rapid ventricular response.  now on beta blocker, digoxin and eliquis.
Nausea, one episode of vomiting and headache. Arm has pain at the injection site.
Severe dizzy ness. It felt like if I was not deliberate in my steps I might fall. Balance was off. This lasted for 5 days off and on.; This is a spontaneous report received from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL92669), via an unspecified route of administration in the right arm on 09Mar2021 for COVID-19 immunisation. Medical history included rheumatoid arthritis, high blood pressure. Concomitant medications included metoprolol tartrate (MANUFACTURER UNKNOWN), triamterene (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and vitamin C (MANUFACTURER UNKNOWN) were reported. The patients past drug history included Amoxycillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient experienced severe dizziness on 09Mar2021. The therapeutic measures were taken for the dizziness, which included Meclizine. The adverse event resulted in emergency room visit. The clinical outcome of the severe dizziness was resolving.  No follow-up attempts are needed. No further information is expected.
About 16 hours after vaccine was administered, woke up with muscle aches and pains. Was able to get back to sleep after taking 2 Naproxen Sodium 220mg along with half a dose of Diphenhydramine Hcl. Aches continued the next day, along with soreness of left arm.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender, no pertinent medical history or drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with one dose of PNEUMOVAX 23 which had been improperly stored (lot # reported as: L003188, expiry date: 06-JUL-2016, route of administration and dosage were not provided). The product had been supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A couple of days after I received the 2nd dose, my ears started ringing and have never stopped. I wake up in the morning with them ringing. They are still ringing when I go to sleep in the evening.
Chills; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Patient developed red blotchy non hive like rash on his forehead and around his eyes and mouth.
worsened her depression; fatigue/ did not want to get out of bed; lowered by blood glucose readings related to her diabetes; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 27Mar2021, at 10:45 (Lot Number: ER8732, at the age of 67 years old) as dose 2, single for COVID-19 immunisation. The vaccine was administered in a pharmacy or drug store. Medical history included diabetes, high blood pressure, depression, and known allergies: Sulfa drugs. She was not pregnant at the time of report. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine but she received other medications within two weeks of vaccination. The patient previously received first dose of BNT162B2, administered in the left arm on 06Mar2021, at 10:00 (Lot Number: EN6199, at the age of 67 years old) for COVID-19 immunisation. On 29Mar2021, at 06:00, the patient experienced worsened her depression. The patient reported fatigue and did not want to get out of bed. She also had lowered by blood glucose readings related to her diabetes. The events were described as non-serious. She was not diagnosed with COVID-19 prior to vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 07Apr2021. No treatment was received for the events. The patient was recovering from the events at the time of report.  No follow-up attempts are needed. No further information is expected.
No additional AE details available; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a medical assistant referring to a 13-month-old patient of unknown gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.      On 20-SEP-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not reported; lot # T032317, expiration date: 22-SEP-2022) for prophylaxis (product storage error).         The vaccine underwent temperature excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (8.5 Fahrenheit) for 18 minutes and 6 degrees Fahrenheit to 14 degrees Fahrenheit (11.9 Fahrenheit) for 1 hour. Cumulative timeframe: 1 hour and 18 minutes. There was no previous temperature excursion. No additional adverse event details was available (no adverse event).
pt had a positive COVID test on 10/10/21 at Facility; pt also received the antibody infusion; pt to hospital with increasing SOB, fever, chills, non-productive cough; given IV steroids and ABX; required intubation; pneumothorax that required chest tube; pt on high ventilator settings; poor prognosis; status changed to DNR; pt showed no improvement; family chose to remove life support and focus on comfort; extubated and pt passed away in the hospital
1/12  "Yesterday afternoon I was nauseous and cold.  today I have been tired with a headache  no appetite.  It cannot compare to the severe symptoms of COVID"
Received first COVID-19 vaccine dose. About 25 minutes after administration, patient started to complain of throat itching, upper chest/throat tightness. Was able to swallow, speak, and breathe. Sats remained stable. Epinephrine and diphenhydramine administered in clinic. Emergency was called and patient was transferred to emergency department.. No additional concerns found in the ED. Discharged home with EpiPen.
Mother states pt has red, swollen, itchy area where shot was given. Left arm, 1/2 dollar size.
MT, MA and Dr. initially present at the time of vasovagal reaction after Pneumococcal 23 vaccine administration. No reaction noted after Influenza vaccine received at beginning of appt. Assumed care of pt at 1145. Pt sitting on bed with head elevated and legs extended. Vitals obtained x1. Allergies verified. Pt given bottle of water. Pt reported immediately feeling chest tightness and abdominal pain after administration of vaccine. Pt denies nausea, dizziness, lightheadedness, and vision changes. Pt reports H/O COPD and inhaler use PRN. Pt's last meal was last night-only had coffee this morning. Dr. at bedside at 1153. Report given. Continued to monitor patient per Dr.'s request. Repeat vitals obtained x5. Pt reported all symptoms resolved. Dr back at bedside to reassess pt at 1214. Vitals reviewed by MD. MD discussed precautions with pt. Pt released home in stable condition.
Moderna Arm.  Rash and redness at site of shot. Itch.  Active 3 days.  Still  a little red but no itch a week later.
pt recv vax & fainted, became pale & semiconscious, cold clammy, BP 60/0 given adrenalin;
Patient is a 57-year-old female with history as detailed below presents to the emergency department for further evaluation of an allergic reaction.  She received her 1st dose of the Pfizer COVID vaccine at app 4:20 this afternoon. She states that approximately 15-20 minutes after receiving the vaccine she developed acute onset of hives and itching of her arms, neck and face.  She denies shortness of breath or chest tightness with the symptoms.  She was given 25 mg of Benadryl p.o. at the clinic prior to being brought into the ED.  Medication Orders Placed: diphenhydrAMINE (Benadryl) cap 25 mg (25 mg Oral Given 4/24/21 1918) Famotidine (Pepcid) tab 20 mg (20 mg Oral Given 4/24/21 1919) predniSONE (Deltasone) tab 60 mg (60 mg Oral Given 4/24/21 1918)  A history was obtained and a physical exam was completed upon the patient's arrival to the emergency department. History and exam were concerning for anaphylaxis versus allergic reaction. Initial vital signs as above are unremarkable the patient is hemodynamically stable.  Physical exam as above is benign no signs/ symptoms of anaphylaxis.     The patient's constellation of clinical and laboratory findings was most consistent with allergic reaction. The patient was re-evaluated after the above treatment/therapies and her condition/symptoms improved. Based on the patient's age, coexisting illnesses, labs, imaging, and exam findings, the decision to treat as an outpatient was made. I discussed my findings with the patient and she understand(s) and agree(s) with the treatment plan. All of the questions and concerns of the patient were addressed. The patient was comfortable with and in agreement with the established plan of care.
Abscess; Aches and pain in legs; Low grade fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABSCESS (Abscess), PAIN IN EXTREMITY (Aches and pain in legs) and PYREXIA (Low grade fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Acute myeloid leukaemia (5 YEARS REMISSION) on 15-Sep-2015, Perfume sensitivity and Allergy to plants (Hayweed). Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), VALSARTAN for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 10-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABSCESS (Abscess), PAIN IN EXTREMITY (Aches and pain in legs) and PYREXIA (Low grade fever). At the time of the report, ABSCESS (Abscess), PAIN IN EXTREMITY (Aches and pain in legs) and PYREXIA (Low grade fever) outcome was unknown.            Treatment for the event included antibiotics.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.   This case was linked to MOD-2021-033331 (Patient Link).