chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RINGING IN THE EARS, CANNOT LISTEN TO ANYTHING WITHOUT THE RINGING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The doctor said his ears were normal. The patient had no temporomandibular joint disorder (TMJ). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: 23-AUG-2021) dose was not reported, administered on 19-MAR-2021 11:23 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the patient experienced ringing in the ears, cannot listen to anything without the ringing. Laboratory data (dates unspecified) included: Blood test (NR: not provided) not reported, and Hearing test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in the ears, cannot listen to anything without the ringing. This report was non-serious.
Severe IBS symptoms; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (Severe IBS symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced IRRITABLE BOWEL SYNDROME (Severe IBS symptoms). At the time of the report, IRRITABLE BOWEL SYNDROME (Severe IBS symptoms) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.     Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: No new information reported.
Pt. called on 7/16/09 self reported event. Stated she thinks she had a reaction to the PNEUMOVAX vaccine. she had swelling under her arm, soreness at injection site - Small rash - States is better now - Took BENADRYL - Still has some itching - Denies any respiratory distress at any time with this.
Pt diagnosed with COVID-19 on 7/24/2021, succumbed to POST COVID INTERSTITIAL LUNG DISEASE
Reaction of difficult breathing, chest and throat pains, fever, fast heart beats.  Patient complained of symptoms on 4/16/08 @ approx 10:00 p.m., one day after shot was administered.
This spontaneous report as received from a mother via company representative refers to a female child patient of unknown age. The field representative states a Local TV news show on 28-MAY-2014 10 PM referenced GARDASIL safety concerns. The representative investigated the information on 29-MAY-2014 and found an article on the website. The article includes adverse event information from a mother, reporting her two children (related sibling case 1406USA000201). On an unknown date the patient was vaccinated with GARDASIL (lot number and dose not reported). No other concomitant medications were reported. On an unknown date the patient experienced grand mal seizure (medically significant) after administration of GARDASIL. No product quality issue involved. The outcome of grand mal seizure is unknown. The causality of grand mal seizure is not reported. Additional information has been requested.
Demyelinating disorder. Subsequent to vax, pt experienced changes on an MRI that may have been consistent with demyelinating disease. This was consider an important medical event.
warm to the touch; itching; rash on her arm; little hives at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), PRURITUS (itching), RASH (rash on her arm) and INJECTION SITE URTICARIA (little hives at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided. .  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and HYDROCORTISONE for an unknown indication.    On 12-Feb-2021 at 5:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRURITUS (itching), RASH (rash on her arm) and INJECTION SITE URTICARIA (little hives at the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), PRURITUS (itching), RASH (rash on her arm) and INJECTION SITE URTICARIA (little hives at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
This case was reported by a consumer and described the occurrence of allergic reaction in a 57-year-old female patient who received Influenza vaccine. Concurrent medical conditions included penicillin allergy, sulfonamide allergy, food allergy (milk, eggs, wheat, rice, yeast, spinach, mustard, soybeans, lettuce, appels, squash, mushrooms), allergy to animals (dogs, cats, horses), allergic reaction (various pollens, dust, dust mites, mold, some parfumes and other scents and other environmental allergies, both indoor and outdoor), asthma and chronic obstructive pulmonary disease. On an unknown date, the patient received influenza vaccine at an unknown dose. On an unknown date, Unknown after receiving Influenza vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine. Additional details: This report was received via Patient support program.
hallucinating; Delusional; Eyes are swollen; Night terrors; She was really really sick; her is red red; her body hurts; fever 102; A spontaneous report was received from an consumer concerning a 46 years old, female patient who experienced hallucination, delusional, swollen eyes, night terrors (sleep terror), was really sick (illness), her is red (erythema), body hurts (myalgia) and fever 102 (pyrexia)    The patient's medical history included COVID-19. Concomitant product use was not provided by the reporter.   On 05 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 036A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    The patient experienced the events she was really sick, fever 102, her body hurts, her is red, hallucinating, she was delusional, she had night terrors, like on drugs and her eyes are like swollen, like little bag under her eyes all since an unknown date in Mar 2021. The event hallucination was considered medically significant. Treatment for the event included Tylenol.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events hallucination, delusional, swollen eyes, night terrors, was really sick, her is red, body hurts and fever 102 were 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.
Itchy red bumpy Rash (hives) on cheeks, ears, necks started 10 hours post vaccination, being treated with Benadryl (oral antihistamine), still present 7 days later but less intense, no signs of anaphylaxis    Also, Sore arm within an hour, lasted for 36 hours
patient said that her reaction started the morning after, on Wednesday, and escalated in the afternoon. Patient had chills, shaking , fever of 103, oxygen level dropped to 50, migraine, racing heart and blurred vision . went to the ER and they couldn't start an IV where it was needed because her vein blew up. patient said as of thursday she felt better but was still unable to go to work
Pt collapsed right after sitting down after receiving the vaccination. I went out and asked patient to stay on his back a nd raise his legs. He seemed confused and got up. As he appeared very unsteady and confused, I wrapped my arms around his torso so he would not fall. I asked him to lie down and he walked over to the chairs and sat down. I again asked that he lie down, but he stayed in the chair. He seemed lucid after a few minutes and asked for something cold water to drink. He was lucid at this point and took a small sip. He was sweating profusely and explained that he has  had this reaction before to  events and said it had happened when he witnessed a large gash on his brother's leg. I believe this was a situational reaction and not really related to the vaccination, as he had been vaccinated numerous times in the past. I had him wait 30 minutes and checked on him several times. He left on his own with a girl and another gentleman when the 30 minutes was over.
she got sick; She has been experiencing headaches ever since after the first dose of the vaccine (for 3 weeks); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021335060.  A 70-year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she got sick"; HEADACHE (non-serious), outcome "unknown", described as "She has been experiencing headaches ever since after the first dose of the vaccine (for 3 weeks)". Therapeutic measures were taken as a result of illness.  Additional information: The patient got sick and was prescribed azithromycin tablets. She wanted to know if it was okay if she takes the vaccine while on azithromycin. Her 2nd dose is on the 30 and it will be 1 day after stopping the medication. She would like to know if there will be any drug interactions.  Caller knew that it was very common to have a reaction (headaches) after the second dose of the vaccine; however, she would like to know if this has been reported also after the first dose and how long is this supposed to last (forever, 1 year). She read that when getting the Covid-19 vaccine you can take aspirin after the shot for headache but not before the injection. She is scheduled to receive the second shot dose of the vaccine and wanted to make sure she was doing everything right, she would like to know if she could take Aspirin. She would like to know if the percentage of participants who experienced headache in the clinical trials was higher after the second dose compared to the first dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a 90 year old male with PMH of BPH, Hypothyroidism, DM, Afib, MI and Osteoporosis present to the ED via ambulance from assisted living facility for evaluation after Fall. Patients reports he needed to get up and rang a call bell. After waiting, the aid did not come to assist him so he decided to get up on his own. The patient states he lost his balance, fell, and hit his head. Pt denies any LOC and unwitnessed. The patient states he hurts on the head where he hit his head. Pt also sustained laceration on the Left forhead and cut on the rt palm and right arm. In the ED, pt was given 1L NS and Aspirin. Dermabond and steches/ dressing were applied to the lacerations. Pt was also found to have urinary retention of 527ml. BUN/ Cr elevated. Rapid covid test was positive
4 cm area of redness with induration underneath and vesicles overlying skin > 2 weeks duration; treatment given - ibuprofen.
Information has been received from a registered pharmacist concerning a 72 year old female patient with a history of hypertension who on 25-JAN-2009 was vaccinated with ZOSTAVAX (Merck) SQ at the pharmacy. Concomitant therapy included Lisinopril (manufacturer unspecified), Hydrochlorothiazide (manufacturer unspecified), and atenolol (manufacturer unspecified). On 01-FEB-2009 the patient experienced intermittent episodes of widespread itchiness. The itchiness "all over her body" was not associated with a rash and responds to topical hydrocortisone cream. The patient went to the pharmacy for medical attention. The patient's intermittent episodes of widespread itchiness persisted. Follow-up information has been received from the registered pharmacist that on 12:00 PM 25-JAN-2009 the female patient with depression, high blood pressure and no allergies was vaccinated with her first dose of ZOSTAVAX (Merck) (lot # 662855/1623X) SQ at the pharmacy. On PM 25-JAN-2009 the patient called back to the pharmacy complaining about persistent widespread itchiness after receiving the vaccine. The registered pharmacist called the patient "today" and the patient said that itchiness was gone. The patient had never gone to the Emergency Room, hospital or the doctor's office to seek help for the itchiness. No further information is available.
felt so bad; flu-like symptoms; chills; sweats; runny nose; weakness/ no energy/ only wanted to rest; chest pain; tight muscles; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), RHINORRHOEA (runny nose), ASTHENIA (weakness/ no energy/ only wanted to rest), CHEST PAIN (chest pain) and MUSCLE TIGHTNESS (tight muscles) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, the patient experienced HYPERHIDROSIS (sweats), RHINORRHOEA (runny nose), ASTHENIA (weakness/ no energy/ only wanted to rest), CHEST PAIN (chest pain), MUSCLE TIGHTNESS (tight muscles) and CHILLS (chills). On 15-Jun-2021, the patient experienced FEELING ABNORMAL (felt so bad) and INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, HYPERHIDROSIS (sweats), RHINORRHOEA (runny nose), ASTHENIA (weakness/ no energy/ only wanted to rest), CHEST PAIN (chest pain), MUSCLE TIGHTNESS (tight muscles), FEELING ABNORMAL (felt so bad), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported .
allergy to the adjuvant in the shingrix vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of allergy to vaccine in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergy to vaccine. On an unknown date, the outcome of the allergy to vaccine was unknown.   It was unknown if the reporter considered the allergy to vaccine to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient experienced allergy to the adjuvant in the shingrix vaccine. The caller asked if the Covid vaccine has any adjuvants in it. Unable to contact reporter after corresponding phone attempts. The reporter did not consent to follow up.
An expired dose of Pediarix was given to six month old patient by a medical assistant working at our clinic who does not usually work at our facility, the medical assistant who gave the expired vaccine usually works at our sister office. The expired Pediarix had been left next to the unexpired vaccines by mistake and not isolated and marked like it should have been. The MA who gave the expired vaccine did not check the expiration date closely enough before giving the vaccine. I do the VFC reconciliations for our clinic, so I discovered this error while completing my January 2021 reconciliation. The patient who received the expired vaccine may need to repeat the vaccine if the patient is not immune. I will do a better job at identifying and isolating expired vaccines. The medical staff has been notified that they need to remember to check expiration dates on vaccines three times before administration, once when the vaccine is pulled from the fridge, second check while preparing the vaccine, and third check right before administration.
Overnight: low-grade fever, chills. 24 hours (or more?): stomach discomfort (mild), muscle aches (gluteals).
patient had onset of left sided numbness and tingling on march 12 and started to have facial dropping on march 14 patient was vaccinated with second dose on march the 9th
MMR given. Patient felt feverish had a headache over weekend and a rash at the injection site 2 inches in diameter
Initial misuse report received from a healthcare professional on 12 June 2013. One child received only a portion of DTaP-IPV from PENTACEL. No adverse event was reported. List of documents held by sender: none.
I was administered the Pfizer Booster approximately at 15:20 on my left arm, I was given a timer with 30 min. Sometime during that period I felt a slight numbness on the injection site that radiated all the way down to the wrist (top portion of the arm only), but I disregarded it due to be though to be related to the needle size since they used the drawing needle for administration. I left the clinic with no other symptoms and walked to my car where I took (2) 500mg Tylenol since I did experience fever, flu like symptom and headaches with the second dose (symptoms lasted 3 days and the headache about 10 days post 2nd shot -I did not report these at that time). I left the parking structure and within 5 minutes I began to feel a pulsating sensation on the outer-upper-left side of my left calf (2.5-3inches below the back of the knee), increasing numbing sensation on the arm and mild lightheadedness. At 15:55, I pulled over and ate a mini kind bar, drank some water and walked around for a few minutes in case symptoms were to be r/t hypoglycemia and cramping. I resumed driving at 16:00 but symptoms got progressively worse with severe left calf pulsation on the same area, calf tightness with now a new burning sensation on the outer side of the left heel (below the ankle bone) and moderate dizziness. At 16:05 my arm and legs became extremely heavy, I could feel my heart pounding out of chest and a systemic burning sensation of blood rushing down my lower extremities (the burning can be described as similar to that of medication being injected into the injection site however this was felt like my blood was burning through my veins as it traveled down), I became overwhelmingly dizzy and nauseous, my vision became hazy and finally my arms and legs went completely limp. I managed to stop the vehicle; my coordination was poor (I took approx. 3 minutes to unlock my phone to call for assistant). It took 9 min for help to arrive, I was given oral fluids in the form of water and sugary drinks and applied cold compress to back of my head and forehead. At 16:47 I was finally feeling well enough to leave however still moderately dizzy. The dizziness remained for 3 days, as of today (1/14/2022) I am still experiencing orthostatic hypotension and tachycardia. My reaction has later been diagnosed as a Near Syncope. For the 2 days following the booster administration I experienced moderate to severe headaches and fever ranging between 102.7-103.1 that would not go lower than 102 with medication. The third day my temperature remained around 100.9-101.1 and the headache from mild to moderate.  Footnote: Vaccine Administration time is reported based on appointment time; actual administration time might have range between 2-5 minutes after. All other times have been abstracted from my own cell records so accuracy of times can be considered extremely accurate.  I have not been able to schedule a primary physician appointment due to the high volume of patients however I did speak with 2 providers that I personally know following the event and they both agree on the near syncope diagnosis. My primary physician appointment at pcp is scheduled for 01/28/2022.
nose bleed from one nostril; This is a spontaneous report from a contactable consumer (patient) received via the Medical Information Team. A female patient of an unspecified age (reported as patient age: 78; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 04Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a nose bleed from one nostril (non-serious) on 04Mar2021. The patient would like to know if this is a possible side effect of the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous prospective pregnancy report was received from a healthcare worker refers to a 38 year old female patient. On an unknown date, when the patient was pregnant she was vaccinated with a dose of GARDASIL (lot # H021346, expiry: 01-OCT-2015) 0.5 ml, intramuscularly. The LMP and EDD was not known. The pregnancy outcome was pending. There was no adverse effects to the patient. Patient sought medical attention was reported as no. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
PATIENT'S LEFT ARM BLISTERED AND SCABBED OVER THE NIGHT OF THE VACCINE (12/1). TODAY (12/23) SHE PRESENTED WITH SCABS  WITHIN A CIRCLE OF HER VACCINATION SITE. HER ARM WAS STILL A LITTLE SWOLLEN AND HARD TO THE TOUCH. PATIENT PRESENTED WITH NO PAIN OR TENDERNESS, BUT SAID THE BLISTERS ITCHED THE NIGHT THEY APPEARED. THEY DO NOT ITCH NOW. NO TREATMENT WAS GIVEN.
a week after the 1st dose, i start having a migraine behind my left ear for a while and then it moves at the back of my head and after on the right side. I also have body ache at night and lower back pain. it comes and goes until the time come for the second dose. at first, I simply take tylenol and green tea. After the second dose, the next day, i discover a swollen lymph nod between my neck and my shoulder but closer to my neck area. The following day, I went to my doctor who prescribes a steroid and  an antibiotic. However the med is over and i am still having the migraine from time to time and when have it, i also have lower back pain.  This week i also feel pain in my ears
pallor-10 mins; nausea 5min; sweating few mins; scared prior to inject; fatigue end of visit started unk length of time;
Patient reports that the evening he received the vaccinations, he became very ill (fever, chills, red and swollen arm, fatigue). He reports presenting to the local ER that same evening, but medical records from local clinic document patient being seen on 10-6-11 (2 days later) with reports of 2 day history of fever, chills, fatigue. His WBC was 20.3. Blood cultures were run and were negative. Patient was administered 1 gram of ceftriaxone and discharged home. He was seen again on 10-7-11, where diagnosis listed as cellulitis and patient received another 1 gram of ceftriaxone and given cephalexin 500mg four times daily.