chrisvoncsefalvay/vaers-outcomes huggingface dataset:
abnormal heart on my left side (enlarge heart); This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: FN5318) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hermia ( stomach ) - fiber tissue on uterus" (unspecified if ongoing), notes: Hermia ( stomach ) - fiber tissue on, uterus. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number:1, dose product:COVID 19, Pfizer, administration time:16:00, Lot number: 30135BA, location: Left arm), when the patient was 58 years old, for Covid-19 Immunization; Bnt162b2 (dose number: 2, product: COVID 19, Pfizer, lot number: EN5318, location: Left arm), when the patient was 58 years old, for Covid-19 Immunization. The following information was reported: CARDIOMEGALY (non-serious) with onset 04Oct2021 14:30, outcome "not recovered", described as "abnormal heart on my left side (enlarge heart)". The event "abnormal heart on my left side (enlarge heart)" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cardiomegaly.  Additional information: Patient had no history of heart disease, nor high blood pressure and had no red meat in 17 years pretty much strike diet, he was concern if this condition is caused from the vaccine. Facility type vaccine: Pharmacy or Drug Store, No other vaccine and medication was taken in four weeks. Patient was not tested for covid prior and after vaccination. No known allergies.  Follow-up attempts are completed. No further information is expected.
The MenA lyophilized  was reconstituted with saline; The MenA lyophilized  was reconstituted with saline instead of the Men C,W,Y liquid.; This case was reported by a pharmacist via sales rep and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo (intramuscular). On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter reported the patient received Menveo as maladministration. The reporter stated that the only Men A component of the vaccine was administered intramuscularly. The Men A lyophilized powder was reconstituted with saline instead of the Men C, W, Y liquid. Therefore, the Men A vial was not reconstituted with the liquid Men C, W, Y vial, lot number was unknown.  The patient did not experience an adverse event as a result of the maladministration. The reporter did not consent to follow up. Additional supportive information: The patient received only the Men A portion only with saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
fast heartbeat; dizziness; vertigo; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jun-2021 and was forwarded to Moderna on 23-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (fast heartbeat), DIZZINESS (dizziness) and VERTIGO (vertigo) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced TACHYCARDIA (fast heartbeat), DIZZINESS (dizziness) and VERTIGO (vertigo). On 23-Jun-2021, TACHYCARDIA (fast heartbeat), DIZZINESS (dizziness) and VERTIGO (vertigo) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated that the patient sometimes feels pain when at work. No concomitant medication reported. No treatment medication was reported.   This case was linked to MOD-2021-236025, MOD-2021-236025 (Patient Link).
High fever for 5 days - 103.5, then low fever @ 100 for 5 + more... it hasn't ended yet, arm pain, chest pain, neck pain, stomach pain, vomiting, malaise, extreme fatigue. Treatment with acetaminophen and ibuprofen, cold pack on arm, heat pack on chest and neck.
MULTIPLE SCLEROSIS(BLURRY VISION IN EYES); CHILLS; NOT FEELING GOOD; FEVER; This spontaneous report received from a parent concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, non smoker, and patient had no known drug allergies and is healthy. Patient did not had a family history of multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 21-SEP-2021) dose was not reported, frequency 1 total, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, the patient experienced chills. not feeling good, fever and then he felt better after couple of days. On 16-JUN-2021, developed blurred vision in his eyes. Patient went to different doctors had different tests done and was diagnosed with multiple sclerosis in July. Patient was perfectly health before getting the vaccine and reporter stated that it might had been a poison or something wrong with the vaccine that patient received.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, not feeling good, and fever on MAY-2021, and had not recovered from multiple sclerosis(blurry vision in eyes). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210916940-Covid-19 vaccine ad26.cov2.s-Multiple sclerosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
PATIENT WAS GIVEN PFIZER BIVALENT ADULT DOSE ON ACCIDENT.  NO ADVERSE REACTIONS NOTED.
Rash & UrticariaPruritus Narrative: emp c/o raised itch rash at injection site. endorsed rash resolved with Hydrocortisone cream. denied pain at injection site. at encounter, pt denies any food/drug allergies.
Dear,  Since i got my shot Covid19 (Janssen) I have muscle pain on my arm whre I received the vaccine. Please let me know what i have to do. Must i go to do a consultation and where. Thank you.  Sincerely
A few days after getting the vaccine, developed an itching/burning rash on top of both feet and discoloration on big toes. Currently treating with antistamine and itch relieving cream
had a flare following; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 52 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 52 years as dose number unknwon, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "had a flare following".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 75 year old female who in May 2008, was vaccinated with ZOSTAVAX (Merck) (lot no. route and site not reported). The physician reported that the patient had experienced persistent hives since vaccination. The patient was seeing by the physician. At the time of reporting the patient had not recovered. Additional information has been requested.
Dose1: Sore arm and a bit of fatigue Dose 2: sore arm, flu like symptoms, and I felt tightness in my intestines, felt like I was going to get diarrhea every time I ate and at times I did, and nausea/ pain in lower quadrants?this went on for 6 months (April 2021 to late September or early October 2021) Dose 3: once again flu like symptoms/messed up my gi tract but not for long this time, body felt more sore this time. Caused the bottom of my right foot to feel very sore like if I needed a good stretch. About a month and two weeks after getting the booster, I suddenly was unable to bear weight on my right foot while I was walking and I did not twist or injury my foot or ankle. My whole foot hurts and turns red. Some times, my toes burn like if someone rubbed chili on them and I feel needle like pain especially on my big toe which feels the most stiff out of all my toes. I feel numbing and tingling from my knee down to my toes. My foot swells up and gets very hot and red. Some times it feels very cold like if I have ice inside my lower leg/foot. Toes are very weak and the bottom of my foot, my heel and Achilles hurt when I stand or try to walk. I am going on 5 months with this weird and sudden foot pain. Before getting these vaccines I had no issues with my foot. I want to be able walk without limping, pain or getting tired again. This issue has also caused other body parts to hurt due to overuse (left foot/leg, hands and wrists). When my symptoms are very bad I crawl around the second story of my condominium  and when I?m downstairs or going to an appointment I use a wheelchair.  Blood work for possible autoimmune diseases came back normal. Recent foot MRI suggested ?questionable transient regional migratory osteoporosis? and ?nonspecific mild bone marrow edema on toes and first metatarsal neck?.   No treatment yet, but will be going to physical therapy soon.
Pt vaccinated with DTP/OPV developed temp 105(R) 4hrs after shots administered; High-pitched cry 1hr duration. Tylenol Given 2 hrs after shot given.
Interfere with her medicine; Anxiety; Panic attacks; Racing heart; Feeling of uneasiness; This is a spontaneous report from a contactable consumer (patient) reported herself. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration in left arm (left shoulder) on 15Mar2021 (at the age of 58-years-old) as dose 1, single for COVID-19 immunization; fluoxetine hydrochloride (Prozac, Formulation: tablet, Batch/Lot number: not reported), via oral route, once daily for anxiety. The patient's medical history included high cholesterol and blood pressure high; from an unknown date and unknown if ongoing. The patient's concomitant medications included losartan tablet taken orally once daily for blood pressure high; atorvastatin tablet taken orally once daily for high cholesterol; from an unknown date. The patient stated that after vaccination she did not have any reactions until ten days but later on an unspecified date in Mar2021 (22Mar2021 or 23Mar2021), the patient had experienced sudden anxiety, panic attacks, racing heart, general feeling of uneasiness. On an unknown date, Interfere with her medicine. The patient reported that she was on Prozac (her anxiety medication) from 21 years and queried if vaccine had interacted with the drug. The patient also was on other unspecified medications and asked if vaccine could have interacted with them. The patient stated that she was yet to receive second dose on 05Apr2021, but she was concerned about the interaction with her medicine and was very nervous. The patient underwent lab tests and procedures which included weight: 119 or 120 lbs. Therapeutic measures were taken as a result of anxiety, panic attacks, racing heart, feeling of uneasiness and included half of the Xanax when felt necessary. The outcome of the events anxiety, panic attacks, racing heart was recovering. The outcome of the event feeling of uneasiness was not recovered, while the outcome of the event interfere with her medicine was unknown.   No follow-up attempts are possible. No further information is expected.
Developed entire body rash with lesions, itching, elevated temp.  lasted for 8 days.  Parent states "looked like regular case of Chicken Pox".  Child adopted from China - has had vaccines in China without reactions. Treatment with Tylenol and fluids & rest.
On day 10 post vaccination while relaxing at home, I experienced an intense episode of dizziness/vertigo. I proceeded to another room and felt the room spinning and began vomiting excessively.  Shortly after this incident,  I fell asleep due to exhaustion.    The following morning I woke up tired and weak,  upon getting out of bed noticed I still felt slightly dizzy and off balance.  This feeling continued the entire week and by the 8th day (Sept 20th) I contacted my doctor.  The recommendation was to try the epley maneuverer along with meclizine for two days.   No improvement, next step per the family practice was to scheduled an appointment with physical therapy to be treated for vertigo.
expired vaccine administered with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who administered expired vaccine with no reported adverse event, while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunization; and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunization.  On 08-Aug-2022, the patient received a dose of suspect HIB (PRP/T) VACCINE( lot UJ522AA and expiration date: 06-Aug-2022) at a dose of 0.50 ml via intramuscular route in the left thigh for immunization.  On 08-Aug-2022 (Latency: same day),the patient developed a non-serious event of expired vaccine administered with no reported adverse event (expired product administered) following the administration of HIB (PRP/T) VACCINE.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event.   Outcome: Unknown   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 the 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.
(L) post. forearm red, swollen, (approx 1 1/2 in diam.) and warm to touch. Rec. ice pack and TYLENOL.
Soreness, pain at site of injection, nausea and vomitting. patient come back to the pharmacy and was Feeling dizzy. patient started throwing up and after observation CALL 911 and EMS arrived and escort patient to ER
When I received the vaccine, I have a reaction with my nerves. My entire body starts itching. I also developed a Neurogenic Bladder. They prescribed Fluconazole for the yeast infection they found on 09/02/2022.
Initial report was received 26 October 2012 from a consumer, who is also the patient. A 52-year-old female patient with a history of asthma and who three days before vaccination had completed a course of CIPRO for an asthma flare-up, had received an intramuscular right deltoid injection of FLUZONE, lot number UM719AA (lot number invalid) "about three weeks ago on Thursday, maybe 04 October 2012" and an unspecified amount of time later, she experienced worsening of asthma with much coughing, wheezing, pain in chest, unable to talk and hives on her arm (which arm not specified). The patient had also received allergy testing on her left forearm on the day of vaccination. Over the next several days the hives on her arm changed to red, itchy round bumps and she continued to have trouble with her asthma. The patient was evaluated by her primary care physician and received steroids as corrective treatment. She continued to have red itchy round bumps on her arm and saw two different dermatologists. The second dermatologist performed a biopsy of the "bumps" on her arm. BENADRYL and steroid cream was prescribed for the bumps. At the time of the report, the bumps had changed to white patches that were dry, very itchy, and the itching was so bad the patient couldn't sleep. Outcome was not recovered. Documents held by sender: None.
Serum sickness syndrome; rash with pruritus and some swelling in hands. We identified this reaction through retro-spectrum chart review as part of the hospital's program. It may have already been reported to you. Also diagnosed with tinea pedis, Neutropenia, lymphocytopenia, Eosinophilia, anemia
forgetting things; my head is cloudy; I can't concentrate and unaware of what is real and what is not; my brain hurts; I feel dizzy a lot; I feel like I am dying; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tesla, start date: 1989, stop date: 1989, for Anger/ suicidal, notes: Name of product: Tesla/unknown, Reason for taking: Anger/ suicidal, Dosage and how often taken: Injection, Date started: 1989, Lot number: Unknown, Still Taking: No,, If no, Provide stop date: 1989., I remember when I was 9 yo I got a shot that said tesla on one side and Pfizer on the other.; Tesla, start date: 1989, stop date: 1989, for Anger/ suicidal, notes: Name of product: Tesla/unknown, Reason for taking: Anger/ suicidal, Dosage and how often taken: Injection, Date started: 1989, Lot number: Unknown, Still Taking: No,, If no, Provide stop date: 1989., I remember when I was 9 yo I got a shot that said tesla on one side and Pfizer on the other.  The following information was reported: AMNESIA (non-serious), outcome "unknown", described as "forgetting things"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "my head is cloudy"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "I can't concentrate and unaware of what is real and what is not"; HEADACHE (non-serious), outcome "unknown", described as "my brain hurts"; DIZZINESS (non-serious), outcome "unknown", described as "I feel dizzy a lot"; ILL-DEFINED DISORDER (non-serious), outcome "unknown", described as "I feel like I am dying". Additional information: After taking the 1st covid shot patient started forgetting things. he had a breakdown and was in facility and his head was cloudy. he can't concentrate and unaware of what is real and what is not. he feel like he was dying, his brain hurts and he feel dizzy a lot. He hardly ever had unclouded thoughts.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
ACUTE RESPIRATORY FAILURE 7/29/2021 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART    RUPTURED ANEURYSM OF COMMON ILIAC ARTERY  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/29/2021 ABDOMINAL AORTIC ANEURYSM, UNSPECIFIED PART    RUPTURED ANEURYSM OF COMMON ILIAC ARTERY
Hx Asthma Hx anxiety with injections Albuterol inhaler Felt dizzie, lightheaded after covid vaccine
Hospitalization for COVID PENUMONIA, hypoxic respiratory distress. Treated with baricitinib, Remdesivir, dexamethasone, zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
generalized flushing of face, neck & arms;husband noted redness when pt got home about 515PM;co-workers did not notice anything while pt was @ work;took DPH;
Pt reported to EMS in post-vaccination waiting area stating that she did not feel well. EMS  stated patient hypertensive and having irregular heartbeat. Pt reported to EMS that her blood pressure had been high for a few days prior to receiving vaccine. Pt reported to EMS that she had not addressed the issue due to being the caretaker of her spouse.
Fever 100.4-103, myalgia, fatigue (extreme), cough intermittently for 30 days after vaccination.
Came into office 5/23/16 at 4:30 p.m. Received BEXSERO Meningococcal Group B vaccine 1 single dose (0.5 ml). This was his second in the series. # 1 was given on 4/22/16. About 6:30 p.m. he started felling light headed and dizzy. Ran a temp of < 101, arm was warm and red where vaccine given. The following day 5/24/16 he still "felt off" per mom. Did also report some double vision. Seen later in our office on 5/24/16 and states arm was less painful temp 99.5 pulse 68, BP 118/64. Still little "motion sickness". No fevers since Tue. Per mother 5/26/16 (back to school).
Imm given on 6/21 - no complaints. 6/22 - arm not observed by parents. 6/23 - Felt nauseous - eye pain - arm site "popping out" - warm - went to ER 7:30 pm.
Throat hurt, felt dizzy, heart rate 110, bp normal, clammy; occurred about 20 minutes after administration and was ok 40 minutes after administration
my left "shoulder and everything" was stiff; the lymph node was / painful / I can still feel the soreness; my lymph nodes under my (left) armpit were swollen out of proportion / big time swollen; This case was reported by a consumer via call center representative and described the occurrence of stiffness shoulder in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 1st February 2021). Concomitant products included COVID 19 VACCINE and COVID 19 VACCINE.   On 4th May 2021, the patient received the 2nd dose of Shingrix (intramuscular). In May 2021, less than a week after receiving Shingrix, the patient experienced stiffness shoulder, lymph node pain and axillary lymph nodes enlarged. On an unknown date, the outcome of the stiffness shoulder and axillary lymph nodes enlarged were recovered/resolved and the outcome of the lymph node pain was not recovered/not resolved.   It was unknown if the reporter considered the stiffness shoulder, lymph node pain and axillary lymph nodes enlarged to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient wanted to know if it was normal for Shingrix to cause lymph nodes to swell.  The patient did not want to provide her date of birth but did provide her age. She also did not want to provide her MD contact information. The patient stated that, she had received the second Shingrix shot intramuscularly a few days ago in her left shoulder deltoid and her left shoulder and everything was stiff. The patient did not had the paperwork from the pharmacy to check for the lot/expiry date. She was concerned because her lymph nodes under her left armpit were swollen out of proportion. At the time of reporting, the shoulder was no longer stiff, she was worried about the armpit, underneath the armpit, the lymph node was swollen big time and painful the whole time and it just calmed down but she could still feel the soreness. The patient did not consent to follow up.
pt recvd vax & exp redness & swelling described as a rash in the arm of inject from the shoulder down;
Prior to administration of Prevnar 13 vaccination, noticed particulate matter floating in solution of pre-filled syringe that did not dissolve with vigorous shaking. Disposed vaccine in appropriate manner. Administered another dosage from same lot without noticeable particulate.