chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Constant chronic headache, head feels like I am floating at times, like I am almost going to have a dizzy spell but I don't (so far),  much more pain that had been under control until the first shot on April 26,, 2021.  Pain in places I have never had pain before including my jaw, my shoulders, my hands are flaring in places I haven't felt pain.  I have a spot in my left calf that has been hurting since first shot.. buzzing in my brain that has not stopped since the first shot.  Almost didn't get the second shot because of these side effects but some of these were starting to ease up and with Delta I am afraid not to get the second shot.  I have some shortness of breath too that is new.  Terrible fatigue more so than before and not able to sleep well.  Getting most nights only 4 to 5 hours sleep where as before the first shot I was sleeping 8 hours and it was more refreshing.  My most worry is what is going on in my brain what is this vaccine doing to my brain?
Covered upper half of left arm and didn't hurt or itch. Sought PCP to identify and was advised to leave it alone unless it got worse. Rash went away in 2 weeks with no treatment. No other issues to report.
Redness, wheezing, syncope, emesis. Pt given 2 doses of IM epinephrine, BENADRYL, PEPCID and DECADRON. Required hospital admission.
breast fibroids hemorrhagic cysts; breast fibroids hemorrhagic cysts; menstrual cycle changes; tenderness in abd and breast; tenderness in abd and breast; This is a spontaneous report from a contactable nurse (patient). A 27-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in left arm on 17Feb2021 as dose 2, single (age at vaccination: 27 years) for COVID-19 immunisation. The patient medical history was not reported, and concomitant medications was none. Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in left arm on 22Jan2021 as dose 2, single (age at vaccination: 27 years) for COVID-19 immunisation. No other vaccine in four weeks. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. COVID prior vaccination and tested COVID post vaccination. On 17Feb2021, the patient experienced breast fibroids hemorrhagic cysts, menstrual cycle changes, tenderness in abdomen and breast. The adverse event resulted in doctor or other healthcare professional office clinic visit/emergency room department or urgent care, hospitalization. The patient was hospitalized for the events for 3 days. The patient underwent lab tests and procedures which included binax resulted as negative on 02Aug2021 nasal swab. Treatment received was surgery and was recovered with lasting effects. The clinical outcome of the events was resolved with sequel as of unspecified date of 2021.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Based on strong temporal relationship the role of the vaccine BNT162B2 in triggering/contributing to the events breast fibroadenosis, hemorrhagic cysts, menstrual cycle changes, tenderness in abdomen and breast cannot be completely excluded. The case will be reassessed once additional information is available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Joint pain began in left elbow in May and continues; then in June it started in right wrist but has subsided for the most part; and in July it startedin the knuckles of my right hand and continues.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 25Apr2021 at 14:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included GERD (gastroesophageal reflux disease). The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other concomitant medications within two weeks of the vaccination which are unspecified. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 04Apr2021 at 13:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. On 02May2021 at 09:00 the patient experienced joint pain which began in left elbow in May2021 and continues, then in June2021 it started in right wrist but subsided for the most part and in July2021 it started in the knuckles of the right hand and continues. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event joint pain was not resolved at the time of this report.
This case was reported by a physician via call center representative and described the occurrence of sepsis in a 64-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included SHINGRIX, methotrexate and etanercept (Enbrel). On 28th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In February 2019, 14 days after receiving SHINGRIX, the patient experienced sepsis (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), seizure (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required), transaminitis (serious criteria hospitalization and clinically significant/intervention required) and metabolic encephalopathy (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required). The patient was treated with sulphamethoxazole, trimethoprim (Bactrim), levetiracetam (Keppra) and methylprednisolone sodium succinate (Solumedrol). On an unknown date, the outcome of the sepsis, seizure and metabolic encephalopathy were recovered/resolved and the outcome of the transaminitis was unknown.  It was unknown if the reporter considered the sepsis, transaminitis and metabolic encephalopathy to be related to SHINGRIX. The reporter considered the seizure to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 63 or 64 years. On 27th November 2018, the patient received 1st dose of SHINGRIX. The patient received both doses of SHINGRIX in the left deltoid. The batch number was not available at the time of reporting. Two weeks after the 2nd dose, the patient had an unexplained seizure. He was hospitalized from 13th February 2019 through 16th February 2019 where he received intravenous (IV) solumedrol and Bactrim, and was sent home on Keppra. The patient also had elevated transaminases and acute metabolic encephalopathy. At the hospital, the patient was informed the seizure was related to SHINGRIX. The primary diagnosis on paperwork notes was severe sepsis. The patient's physician attempted to determine causality or relation to SHINGRIX.
My Symptoms began Oct 20th 2017, the day after I received my flu shot Oct 19th 2017. Whole body started getting hot like burning sensation in head through all body, couldn't walk need assistance, severe headache, numbness and tingling starting from feet increased to whole body, trouble breathing, dizziness, extreme exhaustion, trouble moving my body, uncontrollable shaking, blurry, double vision, tightness and pain in/over heart. As well as unable to sleep at night. I've been drinking tons of water since then and rest, I am unable to work and function at normal quality of life. Take one melatonin 5 mg before sleep. Been in hospital 2 times since then from these symptoms.
Had typical flu like symptoms beginning 12 hours post vaccine (ie body aches, chills, fever fatigue). About 36 hours after receiving the vaccine I developed a  rash on palms of hands and wrists that burned and itched. By 48 hours after I had the same rash covering my feet.
I had 4-5 inches of  red hive, raised, hot, sore and itchy, lasted about 10 days.
This spontaneous report was received from a healthcare worker refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous (strength and lot # were not reported) which had been exposed to temperatures outside of recommended condition. No adverse events were reported. Additional information has been requested.
I had a severe sore throat for 3 days. I made an appointment to see my doctor on March 3rd, 2023. The diagnosis was thru a throat swab. I was prescribed 10 days of Amoxicillin. My symptoms improved in less than 24 hours.
pt recv vax 25MAR97 & was found to be pregnant (LMP 27FEB97); estimated delivery date 28DEC97);diagnostic testing (test unspecified) @ 6wk from LMP indicated collapsing sac & no cardiac activity;same wk pt exp spontaneous abortion;
pediatric dose was given to an adult; pediatric dose was given to an adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 41-year-old female patient who received HBV (Engerix B pediatric) (batch number unknown, expiry date 7th December 2023) for prophylaxis.   On 10th January 2023, the patient received Engerix B pediatric. On 10th January 2023, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.      Additional Information: GSK receipt date: 10-Jan-2023 Reporter's comment: A nurse reported that an adult patient was given a pediatric dose of Engerix B. No symptoms were reported. The reporter consented to follow-up. Additional supportive information: The adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
severe hives, called on Dr, throat was feeling tight ,went to emergency room was given oral cortisone
Patient received the Fluzone High Dose immunization on 10/11/2021 at Pharmacy . She informed me of the adverse event on 10/20/2021. She states that she had a severe injection site reaction in the arm that received the vaccine. She states that her bicep area (not deltoid where the immunization was administered), was red, swollen, painful, and itchy for approximately 3 days. The size of the reaction was approximately 4-5 inches wide and long, covering her bicep, according to the photo the patient showed me. The immunization was administered on Monday 10/11/2021, and she went to the doctor on Wednesday 10/13/2021. The doctor administered a steroid shot and the swelling, redness, etc. resolved by the next day.
Mother describes severe nightmares on night of receiving vaccine with violent episodes. Patient has a history of mental illness with nightmares but mother states this event was much more severe than any previous. Saw on VIS behavior changes as a possible reaction to vaccine.
Moderna Dose 1 1/7/21 (025L20A) Moderna Dose 2 2/4/21 (057G20A) COVID Positive 1/5/22 COVID Negative 1/30/22 COVID Negative 2/4/21 COVID Positive 2/5/22  1/30/22: 57-year-old male with a past medical history significant for heart failure with reduced ejection fraction, CKD stage 4, history of dilated cardiomyopathy, hypertension, hepatic encephalopathy and alcoholic liver disease comes in for increased swelling of lower extremities abdomen and arms.  Patient is a very poor historian history is primarily obtained from ED provider sign-out and chart review.  Reportedly patient was recently admitted to medical service for similar complaints was to discharge, reportedly has not taken his Lasix as outpatient now is coming back in for increased swelling. Blood work demonstrates mildly elevated troponin, mild AKI on CKD,, leukocytosis, chest x-ray reportedly negative.  Patient received Lasix was not requiring any supplemental oxygen request was made to admit to medical service for further treatment evaluation.  Bedside patient is sitting comfortably in bed currently denies any lightheadedness, dizziness, chills, fever, nausea, vomiting, diarrhea, chest pain, palpitations, abdominal pain or discomfort.  As noted has swelling in all extremities abdomen feels tightness. Endorses tobacco use, alcohol consumption though very evasive on how much she consumes and when his last intake was, unclear on marijuana/recreational drugs.  Unclear on sick contacts, recent travel outside the area or family history even though inquired.  Reportedly has gotten COVID-19 vaccination per chart unclear on booster.  2/15/22: Patient is a 58-year-old male history of nonischemic dilated cardiomyopathy due to alcohol admitted to the hospital for acute decompensated systolic CHF and acute kidney injury on CKD.  Under the guidance of Nephrology patient was treated with IV diuretic, as time progressed patient clinically improved.  Patient's hospitalization was complicated by MSSA bacteremia of unclear source, Infectious Disease was consulted patient was treated with IV antibiotics, patient completed transthoracic echocardiogram which was negative, transesophageal echocardiogram which is negative, repeat blood cultures were negative, ID recommended p.o. Keflex on discharge for completion.  Incidentally patient was also noted to be positive for COVID-19 without respiratory symptoms.  Patient was evaluated by therapy prior to discharge recommended home VNA.  Patient will be discharged home with VNA recommended follow-up with PCP within 1 week.
The COVID vaccine was given first and the Flu vaccine was given second. When the vaccines were administered, and the patient attempted to stand. She   exhibited signs of weakness, dizziness, muscle jerks, clamminess and she fainted. She was placed on the floor and her blood pressure was checked.  The value was 106/68 HR68.  She passed out for approximately 2 minutes and then she began to urinate. She woke up and said she was fine. Her Mother stated that this happens all the time and did not want EMS Called. The patient was given some water and she stated that she felt better. She waited in the Pharmacy Lobby 45 minutes after being in the immunization room 25 minutes.
Husband stated that the pt had noticed swelling around the inside of her left elbow, swelling of her lower left arm, and possibly swelling of her hand. Stated that there was no reaction around the site of injection, but the symptoms were in the same arm. When asked if the patient had hives, rash, itching, swelling of the face or throat or anywhere above the neck or difficulty breathing, he said "no". He was speaking with the patient in the background while I was on the phone with him.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (no adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A and 001J21-2A) for COVID-19 prophylaxis. It was unknown if patient had acute illnesses at the time of vaccination and up to one month before. It was unknown if patient had chronic or long-standing health conditions. Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose number: 1, Batch/lot number- EW0186, 0.3 milliliter, Route of administration- intramuscular, left arm.) on 24-May-2021, Pfizer / BioNTech (Dose number- 2, Batch/lot number- EW0180, 0.3 milliliter, Route of administration- intramuscular and left arm.) on 14-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-May-2022 at 9:24 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:24 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) to have an unknown relationship. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. No treatment medications was provided by the reporter. The used vials were placed in the refrigerator on the same day of administration 26-May-2022.
Two weeks to the day of my second injection (Fe. 25) I went to an ER for atrial fibrillation, the first time in my life. After I converted, I was was sent home with prescriptions for Eliquis and Metoprolol. On Sunday March 21 I went to another ER with A-Fib and was hospitalized until Tuesday. They changed the Metoprolol from succinate to tartate and did an echocardiogram.  Upon release I saw a cardiologist and began a series of tests. I don't know whether the A-Fib could be related to the vaccine but I was encouraged to report this to the CDC. Thanks.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of an unknown age and gender. On an unknown date, an unspecified number of patients were administered with improperly stored doses of (Oka/Merck) PROQUAD (dose, route of administration, lot# and expiration date were not provided). No adverse effects were reported. All telephone attempts to obtain follow up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
1 day after mild headache that became more severe through the afternoon.  Ibuprofen was given where it was relieved later in the evening. The next morning on the 05/03/2022 she woke with pain in the armpit on the left side as well as swelling.   Again ibuprofen was given.   With some relief.
injection given at 9:30am 10/09/21. Adverse reaction started at 4pm same day. Chills alternating with sweats, low grade fever,  extreme pain in joints and muscles all over body, extreme fatigue. Symptoms subsided next day Sunday 9pm. Symptoms returned Monday approx 10am as well as extreme swelling and redness at injection site and down my arm approx 6inches. Saw my general physician. He decided to treat as an infection. Medication prescribed:Cephalexin 500mg. At this time, only 2 doses of medication have been taken. No change yet.
Respiratory problems; shortness of breath; Arm was sore; Coughing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COUGH (Coughing), DYSPNOEA (Respiratory problems; shortness of breath) and PAIN IN EXTREMITY (Arm was sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L0A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Brulenta. Past adverse reactions to the above products included Cough with Brulenta.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced COUGH (Coughing) and PAIN IN EXTREMITY (Arm was sore). On an unknown date, the patient experienced DYSPNOEA (Respiratory problems; shortness of breath). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (CORICIDIN HBP CHEST CONGESTION & COUGH) for Coughing, at a dose of UNK dosage form and OXYGEN for Shortness of breath, at a dose of UNK dosage form. On 23-Jan-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. At the time of the report, COUGH (Coughing) and DYSPNOEA (Respiratory problems; shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Right after the vaccination, about 15 minutes later the patient started coughing, then drank some water and kind of stopped; but ever since then she had been coughing periodically and last night (night prior to report) could not sleep or slept a few hours and woke up coughing.  Adding to a previous message, it was reported that it could be a side effect, because she had this kind of reaction before, and it was Brulenta that was given to her, the minute they took them off she stopped coughing. The arm was sore but went away the same day.
Pt. called c/o redness and bruising at the injection site lasting a week.  No swelling, drainage or heat reported.  Provider advised warm moist packs may help.
two migraine headaches - atrial fibrillation; two migraine headaches - atrial fibrillation; This is a spontaneous report from a contactable consumer, the patient.   A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810), via an unspecified route of administration in the left arm on 07Mar2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation.  Medical history included stroke and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.  Concomitant medications included warfarin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); both taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 at 10:00, the patient experienced two migraine headaches and atrial fibrillation. It was unknown if the patient received any treatment for the events. The clinical outcomes of the two migraine headaches and atrial fibrillation were recovered in Mar2021.
Notable generalized swelling of entire LUE and LLE (from knee down through foot), as reported by patient, at about 1 hour from vaccine administration. By the time of evaluation in clinic 3.5 hours later, these symptoms were no longer evident on physical exam