chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest flutter type feeling; irregular heart beat type feeling; dizzy; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on an unspecified date (Batch/Lot number was not reported) as 1 st dose, single then on an unspecified date (Batch/Lot Number: ER8732) (at the age of 35-years-old) as 2 nd dose, single; both via an unspecified route of administration for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. The patient had no medical history. The patient had no history of COVID or any health conditions. Concomitant medication was not reported. The patient reported that about 5 days after second dose (unspecified date), he developed a chest flutter type feeling/irregular heart beat type feeling. It was transient and went away after about 7 days. When he would get the weird heartbeat feeling he would feel dizzy. The patient had no treatment for the events. The outcome of the events was recovered on unspecified date.  No follow-up attempts are possible. No further information is expected.
Golf ball sized knot on right arm. Red & warm to touch. ER MD gave steriod dose pk. & Icc pack
Anaphylaxis. Patient experienced shortness of breath, tingling in hands and arms, cold chills, and feeling faint.
6 x 7cm erythematous warm area firm central area mildly tender to touch
discomfort at his jaw line from the bottom of left ear downward/tissue inside his jaw hurt when you pushed on it; left arm was sore (attempted to rise it); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Nov-2021 and was forwarded to Moderna on 01-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (discomfort at his jaw line from the bottom of left ear downward/tissue inside his jaw hurt when you pushed on it) and VACCINATION SITE PAIN (left arm was sore (attempted to rise it)) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011O21A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE (FLU SYRINGE) for an unknown indication.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN JAW (discomfort at his jaw line from the bottom of left ear downward/tissue inside his jaw hurt when you pushed on it) and VACCINATION SITE PAIN (left arm was sore (attempted to rise it)). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. In 2021, VACCINATION SITE PAIN (left arm was sore (attempted to rise it)) had resolved. At the time of the report, PAIN IN JAW (discomfort at his jaw line from the bottom of left ear downward/tissue inside his jaw hurt when you pushed on it) had not resolved.            Treatment details also included ICE for adverse event. Patient reported that there was discomfort at his jaw line from the bottom of left ear downward. He described it as the tissue inside his jaw hurt when you pushed on it. The pain is not overwhelming but it is there ~ 10 days later.   This case was linked to MOD-2021-370502 (Patient Link).
I was one week postpartum when I received the first Pfizer vaccine. Before that I was barely bleeding anymore and it was bright and light. Since the vaccine my bleeding has been heavy and dark for over a week now.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 27-OCT-2008 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-SEP-2013 the patient was treated by a physician for sever vesicular rash accompanied by weakened immune system which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
vertigo; neuropathy; vision loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around in July 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster)(lot#, expiration date, dose, and route not specified).  On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the pt. suffered vertigo, neuropathy (Neuropathy peripheral ), and vision loss. (Blindness)  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations did not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive,permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of the events were considered not recovered/not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling by the reporter.  Upon internal review blindness and neuropathy peripheral was considered to be medically significant.
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fainted while being given flu shot and was unconscious for ~5 seconds before coming to. Patient was lowered to ground level and had feet elevated above head. Patient waited at the pharmacy for ~20 minutes and was responsive and lucid at time of leaving.
caller confirmed that a dose of act-hib was administered in which the diluent has expired with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 1 years old male patient who was administered HIB (PRP/T) Vaccine [ACT-HIB] in which the diluent has expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP) for Prophylactic vaccination; and Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 10-Apr-2023, the patient received 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (DILUENT-Lot Number:U7261AA, Expiration Date :2023-04-07) (ACT-HIB-Lot Number:UJ679AA, Expiration Date :2023-05-28) (Frequency-ONCE) (Strength- Standard) via intramuscular route in the right thigh for prophylactic vaccination (Immunisation).  On 10-Apr-2023, the patient was administered HIB (PRP/T) Vaccine in which the diluent has expired with no reported adverse event (poor quality product administered) (Latency: same day).  Action taken: not applicable.  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.
COVID breakthrough- Symptoms began 12/18/21. He came to the ED on 12/23/21 and was discharged home. He came back to the ED on 1/2/22  for cough, congestion, and shortness of breath.
Vaccine given 3/17/06. Child returned to office 3/19/06 with 3-4 inch area of redness surrounding injection site. Area warm to touch per triage RN report.
Headache, SkinRash, CHILLS, FATIGUE, SOB, Narrative: INHALER FOR SOB  Other Relevant History:
I had a flare of my arthritis symptoms. My right thumb was swollen and still is swollen, pain in both knees, both elbows, both wrists and both feet.
Vaccine was administered after the 30 day BUD date of December 1, 2022
The patient was seen in the ED on 9/17/23 for evaluation of syncope. That morning (on 9/17), the patient reports he felt dizzy and experienced a syncopal episode, causing him to fall. In the ED, he reported rib pain, back pain, nausea, vomiting, and urinary incontinence. Overall, he has been feeling sick and very weak. A COVID PCR test done in the ED resulted positive. The patient felt too weak to go home, so was admitted to the hospital. The patient was admitted 9/17/23 - 9/18/23, with discharged diagnoses including COVID-19. Of note, the patient has received the primary COVID vaccine series and three boosters.
Same day post vax, the pt's right upper arm "blew up", with redness and intense pain to the touch. She sought unspecified medical attention.
He was administered Moderna Infant vaccine, which has an expiration date today 07/22/2022 at 7:53 am.
Shot arm swelling and throbbing to fingertips. Stiff neck and back of head hurt. Extreme diarrhea and violent vomiting. Started bedtime on 24th to the 26th. Felt bad for a week afterwards. Husband starting feeling same few days later. Last year I had a shot and it didn't react the same. Shot arm throbbed though, for days.
face looked droopy on the left side;; itchy; felt like my face had been punched on the left side; A spontaneous report was received from a consumer concerning a 60-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pruritis, facial pain and facial paralysis.   The patient's medical history, as provided by the reporter, included bell's palsy 20 years ago. Concomitant medications were not reported. On 03 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Jan 2021, prior to receiving mRNA-1273, the patient felt itchy and like her face had been punched on the left side. On 06 Jan 2021 she felt her face looked droopy on the left side. Her dimple came back in her face. On 21 Jan 2021 her eyes was droopy and can see a line on one side, and other side doesn't have a line. It's gotten better with acupuncture. She gets acupuncture and electrostimulation; she had a horrible reaction to steroids. Her eye was stuck open for 3 months, she had a patch. Treatment for the events include 3 sessions of acupuncture. Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, pruritis, facial pain and facial paralysis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Transaminitis; This is a spontaneous report from a contactable healthcare professional received from a Pfizer-sponsored program . A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced transaminitis. It was reported that, the healthcare professional called and reported that they had a patient that after taking the Covid-19 Vaccine, was tested to have transaminitis now. The reporter had no information about the patient and was asked whether there are any reports regarding this. As the caller wanted to know more information. On an unspecified date, the patient underwent lab tests and procedures which included transaminitis. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
CDC reports: 4 mo infant developed fever to 102, local rxn, rash, allergic event consisting of swelling & hives following DTP/OPV immunization.
Pt recv vax on 11/25/98; on 11/27/98 pt exp decreased appetite, non-active, bad smelling bowel movement, loose bowels, made grunting noises, fever; pt imp 11/28/98
Narrative:  76yo male patient died at home in home hospice care on 10/25/2021.Pt had history of paroxysmal atrial fibrillation, obesity, dyslipidemia, kidney cancer and followed in this neurology clinic for Parkinson's disease, which he has had for about 20 years. Pt had received covid vaccines on 1/22/21 & 2/22/21. Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
Anaphylactic reaction with facial erythema, edema, lip swelling, wheezing, SOB.
Pt states about 3 days after receiving vaccines on 12/28/12, she noted "wavy" mark on (R) upper outer extremity that was not painful, palpable or pruritic but is constant has recovered. About 1 wk later felt "pins/needles" RUE btw shoulder/elbow & then at wrist. Now 5d h/o pain 7.5/10 RUE limiting function at work but not of ADL's. No swelling. Not affecting hand/fingers.
Vaccines administered at approx 1100. Mom brought patient back to the clinic at approx 1445 noting that at 1300 - pt started with temp and shaking. TYLENOL given at home at 1430. Dr. saw the patient and documented this note: Patient return to clinic with fever up to 102.8 recorded here as well as shaking and shivering. He was monitored here for roughly about 2-2.5 hours and given TYLENOL and MOTRIN 600 milligrams. His fever remained high but that should bring stopped.  During this entire time neurologically he remained intact. There was no evidence of airway compromise such as wheezing, shortness of breath or tongue fullness. No swallowing issues. Ultimately was sent home with instructions to continue use of TYLENOL and ibuprofen to keep the fever down and to monitor and if worsening symptoms seek medical attention over the weekend. Parent was here who voiced understanding and agreement.
I received a booster on 1/10/2022 and a day or so after I had urination frequency and would wake up throughout the night. Went to an urologist and they did all sort of tests which came back negative.  I received another booster yesterday, 9/14/2022 and these same symptoms came back, yet milder. I was waking up to urinate, which does not usually happen to me. May it be related to a side effect?
Arm pain the following morning, followed by 3 days of fevers ranging from 99-103 chills, body aches, skin was painful to touch. Responded somewhat to rotating Tylenol and ibuprofen
This spontaneous report was received from a consumer referring to her granddaughter, a 19 year old female patient. Concurrent conditions or pertinent medical history were not reported. On an unknown date in 2006, the patient was vaccinated with a dose of GARDASIL (lot#, dose, frequency, route of administration and anatomical location were not specified). The patient had none concomitant medications. The reporter stated that it was unknown when the first symptom occurred (adverse event), but the patient has been hospitalized ("several hospitals but no names were revealed"), that throughout the years, the patient had menstrual bleeding issues (unspecified) and cyst in her ovaries that have busted and then new ones have formed. At the time of the report, the outcome of adverse event, ovarian cyst ruptured, ovarian cyst and menstrual disorder was unknown. The relatedness of GARDASIL with the adverse events was not reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no drug reactions or allergies. On 26-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 0.5 ml in the right arm (lot # K004487 and expiry date: 21-AUG-2015) (route not reported). On 27-AUG-2014 the patient developed a large area of erythema and tenderness at the injection site of the right arm. The patient sought medical attention and was prescribed KEFLEX and unspecified antihistamines as a treatment. The outcome a large area of erythema and tenderness at the injection site of the right arm was unknown. Relatedness between the events and PNEUMOVAX 23 was not specified. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist referring a 64 year old female patient. The patient's medical history included diabetes mellitus and unspecified cholesterol problem. On 15-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (Lot # K016320 Expiration Date: 24-DEC-2015) subcutaneously in left deltoid. The concomitant therapies included fish oil, aspirin (manufacturer unknown) 81 mg, metoprolol (manufacturer unknown), vitamin D3 and unspecified "diabetes and cholesterol" medications. On 15-MAY-2015, the patient reported she "felt fine". The following day, on 16-MAY-2015, the patient noticed that her injection site was red (injection site erythema), sore to the touch (injection site pain), and swollen in a 1 inch by 1 inch round area (injection site swelling). The patient also stated that her injection site was "black and blue" to indicate bruising (injection site bruising). At the time of this report, the patient stated she "felt fine' and that she did not see any evidence of a rash at her injection site. Additionally, it was stated that the patient did not receive any treatment for the adverse events. The outcome of injection site haemorrhage, injection site  pain, injection site erythema and injection site swelling was unknown. Additional information has been requested.
hypotonic, hyporesponsive episode w/pallor & ?apnea-lasting several minutes, about 34 hrs p/DTP/OPV/HIB; adm for 2 days, no recurrance, EEG & Pneumogram nl;
Patient developed hives 24 hours after being given GARDASIL HPV and HepA vaccines. Hives are on her arm and legs not at the injection site. Gone after rx with hydrocortisone, cetirizine and BENADRYL.
Immediately after the injection my left upper arm hurt very badly and did not subside after several days. Eventually, the pain spread to the shoulder and down my arm into my left thumb which is now partially numb. I have limited range of motion. Some days are not as bad as others, but the pain is constant.
10-17-07Father called and said baby has screamed since she was given her shots. They were unable to console her and he reported an axillary temp of 99.2. They had alternated tylenol and motrin all night. Urged them to take her in to health care provider for evaluation.AS
tenderness; slightly raised; itchy; fever; muscle and joint pain; muscle and joint pain; chills; big red splotchy area an inch below injection site; fatigue; sore by armpit; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), RASH PAPULAR (slightly raised), VACCINATION SITE PRURITUS (itchy), ERYTHEMA (big red splotchy area an inch below injection site) and FATIGUE (fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney cancer in 2017. Concomitant products included DOXYCYCLINE for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced FATIGUE (fatigue). On 25-Feb-2021, the patient experienced TENDERNESS (tenderness), RASH PAPULAR (slightly raised), VACCINATION SITE PRURITUS (itchy), ERYTHEMA (big red splotchy area an inch below injection site), PYREXIA (fever), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain) and CHILLS (chills). At the time of the report, TENDERNESS (tenderness), RASH PAPULAR (slightly raised), VACCINATION SITE PRURITUS (itchy), ERYTHEMA (big red splotchy area an inch below injection site), FATIGUE (fatigue), PYREXIA (fever), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
pt recvd vax;noted swelling & stiffness of rt jaw;low grade fever; body aches & some difficulty talking & chewing;began 8pm same day as vax;
Staff ARNP here received flu shot and had anaphylactic reaction. 2 other staff members had allergic reaction (itching).
A couple of hours after receiving the Pfizer-BioNTech Covid-19 Vaccine EUA in my upper left arm muscle, that muscle starting aching and the pain increased so that I chose to take Tylenol ExStrength for the next 24 hours (every 6 hours). I also used an ice pack and heating pad alternately several times. My overnight sleep was interrupted because of the pain. On a scale of 1 to 10, with 10 being the worst pain ever, I would rate this pain a 7.5. It lasted for 2 and 1/2 days then subsided.  The more disconcerting side effect is the brain-zapping episodes. This sensation began 3 days after the Vaccine shot: 7/10/2021. I sensed a vertigo-like sensation while standing still and erect and simply looking from one thing to another- not fast; just moving my eyes. It is a combination of visual vertigo and an electric pulse sensation in my brain only lasting for 1 to 2 seconds. That's why I describe it as a brain zap. This happens 3 - 4 times a day. It has lessened and only happens every few days now. Then I did get positional vertigo for 2 weeks. It's finally going away. It is mild and didn't need doctor attention.
Fever (not lowered by Tylenol), chills, headache, tired, sore, etc.  Injection site is red, firm, tender, raised up
Pt received 1st dose of moderna covid vaccine at 0942. At 0953, pt reported feeling hot and eyes feeling funny. Moved to exam room. BP185/82, pulse 70, o2 94% on 4l/nc (pt on home o2 at same flowrate). Reported "spots" in eyes. Spots and hot feeling resolved by 1008. Pt reported jaw stiffness at 1008, states feels similar to when she sits for a long time. Dr notified and benadryl given per order. Continued to monitor patient. At 1047, pt reported that jaw felt "tired", no other c/o. 1101-Dr updated on pt condition, Dr stated that patient may be discharged to home with husband and may receive 2nd dose of vaccine, but should take benadryl prior to appointment. Vital signs remained stable, bp 173/73, pulse 71, SpO2 91% on 4l/nc at discharge.
palpitation, 1-2 times a day, started after the 2nd dose.
racing heart, ringing in ears, shaky, convulsions, head and face pressure, left side of body