chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Major hearing loss in left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Aug2021 (Lot number: FD8448) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history (no known allergies). There were no concomitant medications. The following information was reported: DEAFNESS (medically significant) with onset 30Aug2021, outcome "not recovered", described as "Major hearing loss in left ear". The event "major hearing loss in left ear" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (2021) unknown. Therapeutic measures were taken as a result of deafness (Amoxicillin and MRI prescribed). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19  No follow-up attempts are needed. No further information is expected
This spontaneous report as received from a Nurse refers to a patient of unknown age. The nurse reported that the patient received the 1st dose of RECOMBIVAX HB and VAQTA on 21-DEC-2012 and the second dose of RECOMBIVAX HB on 18-FEB-2013. The patient was in the office about to receive the 3rd dose of RECOMBIVAX HB and their dose of VAQTA on 17-JUN-2013.No adverse effect reported. This is one of two reports from the same source. Additional information has been requested.
A little while after the shot started getting a sharp pain in right foot, it is very sudden.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient did not receive any other medications within two weeks of vaccination. On 15Apr2021 at 15:45, a little while after the shot, the patient started getting a sharp pain in the right foot, it was very sudden and lasted for a few seconds then gone away for a while. It had occurred every 30 minutes or so since about 2 hours after the shot. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sharp pain in right foot was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
chest pains; sick; enlarged heart; it hurt for the patient to take a breath; heart rate was 105; back pain; fatigue/tired; This is a spontaneous report from a contactable consumer (patient's mother). A 25-year-old female patient (consumer's daughter) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 25Aug2021 at 15:00 (age at vaccination: 25 years), as dose 2, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Family history included cardiac history within the family. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 28Jul2021 (age at vaccination: 25 years), as a single dose for COVID-19 immunization and stated that it feels like pressure and tight in her chest, left arm pit pain, stated that her left armpit is swollen, and stated that it hurts through to her back. The reporter reported that the patient got her second dose of the vaccine and on 26Aug2021 at 02:00 AM, she got really sick. She had chest pains back and pains. She had to be seen at the doctor. Her heart rate was at 105, her oxygen was still good and her blood pressure wasn't too bad. It went on for 2 or 3 days. She was a little freaked out about it. She was scared to death and she was mad at mother because she encouraged her to get it. She had concerns about her heart being enlarged. It terrified her because it hurt her to take a breathe in because of the pain in her chest and back. We will be following up with the doctor and possibly having an echo done. The patient was so tired, the fatigue was terrible. The fatigue wasn't gone and so the patient went to the doctor. The patient saw the nurse practitioner. The way the patient was de-scribing the pain in her back, it was the same way the caller felt when her heart was enlarged. The patient felt really really sick. The patient was supposed to get the second dose on a Wednesday and didn't get it until the following Wednesday because she couldn't get off work. The patient got the vaccine at 3:00 in the afternoon on 25Aug2021 and then 2:00 am on Thursday morning is when everything started. The chest pain got better but the patient has the back pain. Maybe the back pain was body aches, but the caller doesn't know. The patient went into work on Friday and they sent her right back home because she looked so bad. Everything seems to have improved. The patient underwent lab test and procedure included Blood pressure with her blood pressure wasn't too bad, heart rate 105 and oxygen saturation was good on an unspecified date. Outcome of the events was recovering.  The lot number for the vaccine (BNT162B2) was not provided. No follow-up at-tempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bilateral upper arm erythema and edema began day after immunizations administered. Given BENADRYL in office.
Post vax, the pt had severe pain in upper left arm. The pt had swelling and erythema of entire upper arm spreading to neck and hand. Neck limited movement, tingling hand. Went to ER and received Ancef, Keflex, and Vicodin.
Gave vaccine and 2 days later pt had a normal reaction to vaccine (bumps around injection site).
Information has been received from a physician concerning a female with no pertinent medical history and no known drug allergies who on 21-JUL-2000 was vaccinated with a dose of VARIVAX (Merck) (dose, route, and lot# not reported). There was no concomitant medication. The patient experienced chickenpox a few days after the injection. "It was mild with some vesicles". On an unspecified date, the infection resolved. The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. Additional information has been requested.
1/20/21 vaccinated. 1/21 afternoon-itchy feeling on top of buttocks, tingling sensation consistent with herpes II/Zoster, nerve down right leg tingling, testing for all venereal diseases June 18,  2015, July 2015-Present married to wife no sexual activity outside of marriage, hyper sensitive to venereal disease. Wife is negative, PT is negative for IGA and IGE, PT received vacc and is now showing symptoms positive for herpes 2, PT is waiting for results as to if he is POSTIVE, blister on right side of penis-clear fluid filled, right sores/blisters crusty on buttocks, right inner thigh leg blister on scrotum with red dots in the middle, nothing on glands penis/urethra  or anus. Thursday night, pt had intimacy and it was dryer than normal, uncomfortable on the right side with penetration-skin is compromised. Saturday, PT was not feeling great, shaft not showing, in a rush to urinate, scrapped scrotum and now has lesions.  Sunday, fatigue, outbreak/whelp on legs, PT wore gauze/bandages to prevent chafing.  Monday, shaft not showing, patient went to urgent care. PT was told it presented as Zoster. Nothing on penis at this point in time.  Penis issues did not show until 1/26/2021. EX wife had herpes II. PT again was tested after in 2015 and was negative for IGE and IGA. Tuesday, patient started meds from urgent care. Wednesday morning, chest pain/pleurisy like-pain across chest.  Arm vaccination site sore, bruised to this day.   Herpes Zoster not typically going to end up on shaft, its unusual, PT is probable he has cross contaminated by itching his buttocks and then going to the restroom and touching right side of penis.
Maybe this is not an adverse event. The evening after the H1N1 nasal vaccine, the chil began to have fever and headache. She may coincidentally have another virus.
High fever started in about 12 hour after the second shot.  The fever and sore body lasted for 24 hours.
ringing in the ears started that night intermittent for a few days and now consistent for 10 days
I had symptoms the day after I got my shot, my left arm was sore. The next day I had other symptoms. I had low grade fever, difficulty breathing, lung congestion, headache. I had lab work performed and numerous tests. I went to the ER of the Hospital on 08-30-2021. I still have these symptoms today, but slowly recovering it. When they treated me in the hospital, treated me for the infection, thought I had pneumonia. The decided I had no pneumonia, and I still have to take oxygen at this time. The physicians do not know what caused this. The onset of symptoms were two days after my booster shot. The doctors are not sure what caused my symptoms, one doctor said I had a flare up of RA.
Erythema, warmth, mild discomfort of left medial arm.  Apparent cellulitis not located at reported injection site in deltoid but rather on inside of patients arm extending from axilla to elbow.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection (lot# L006546, expiration date 27-NOV-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
All muscles in body began to ache nose and eyes became watery throat became very sore and it hurt to talk. Extremely tired but unable to sleep.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 17May2021 (Lot number: EW0182) at the age of 60 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose: 22Apr2021 Lot: EW0172), administration date: 22Apr2021, when the patient was 60 years old, for Covid-19 immunization. The following information was reported: JOB DISSATISFACTION (disability), outcome "not recovered", described as "he is on Short Term Disability and can't work"; MUSCLE SPASMS (disability), BACK INJURY (disability), outcome "not recovered" and all described as "disabling muscle spasms and his back hurts all of the time"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "can't hardly walk". Clinical Course: Reporter stated that was on short term disability and can't work. He can't hardly walk and he has been doctoring the entire time and his neurologist was stumped at this point and time. He basically went from being a half marathon runner to being disabled with a long laundry list situation that keeps getting worse and worse. Reporter stated he had disabling muscle spasms and his back hurts all of the time.
Patient received FLUZONE and PNUEMOVAX at the same time in the same arm. The following day pt's arm swelled up and she had to go to MD where she got antibiotic.
Vaccines given 12/27/04 mom noted red, bumpy, rash on back and abdomen after vaccines (lasted 3 days) mom did not report until 1/27/05.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Systemic: Nausea-Mild, Additional Details: pt came to the pharmacy and complaint about the high fever for past 3 days 99F and above. the size of rash in the left arm was about the palm of the hand. looked red and tender, hot to touch. pt was very itchy at the site. suggested to take benadryl
"Bells Palsy"-6 hours after receiving (diagnosis MD).  Paralysis right side of face, right lip/right eye.  Affected speech - not clear.  Stays open (right eye) using gtts-ing over the counter.  History of Bells Palsy 25 years ago.  Telephone contact made 11/24/2003 by PHN: Patient first noticed the paralysis of the right side of his face in the morning of 11/21/2003.  He could not close his right eyelid and the right side of his mouth was paralyzed; his speech was "not clear".  He used over the counter eye drops until he could talk to his opthalmologist.  He was seen at the hospital ER on 11/21/2003 and was diagnosed as Bells Palsy.  Patient stated that he had Bells Palsy approximately 25 years ago.  He has had flu shots every year without any problems.  12/01/2003: Follow-up telephone call made by the Clinic Supervisor.  Patient stated he was seeing slight improvement in his speech and had no obvious signs of paralysis in his face.  His eyelid continued to not close.  He had received prescription eye drops that were helping him.  Patient was given the supervisor's name and phone number for future contact as needed.  He was instructed to discuss receiving future flu shots with his private MD.
Felt fine for 2  1/2 or 3 days.  Then2-3 days...extreme fatigue...total loss of appetite......some fairly severe muscle aches.....no fever (possibly less than 1degree one night)....
armpit is sore and swollen was reported as worsened; sore and swollen arm pit the same side/arm as the injection; sore and swollen arm pit the same side/arm as the injection; armpit is sore and swollen; armpit is sore and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 20:00 (Lot number: FF2588) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing), notes: she has mild asthma since she was a baby. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 01Sep2021, outcome "not recovered" and all described as "sore and swollen arm pit the same side/arm as the injection"; AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 01Sep2021, outcome "not recovered" and all described as "armpit is sore and swollen"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "armpit is sore and swollen was reported as worsened". Therapeutic measures were not taken as a result of axillary pain.  Additional information: The swelling and soreness is under her left arm which is the same arm she got the vaccine in. Her daughter first noticed the soreness and swelling yesterday 01Sep2021. The daughter just told the mother today. When she moves her arm around it was sore feeling. A girl at her schools armpit did the same thing, but hers already went away. She had not received treatment.  She did not required emergency room and physician office. No prior Vaccinations (within 4 weeks). No list other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI).   No follow-up attempts are possible. No further information is expected.
Pt vaccinated MMR Revacc 6JUL90 on 16AUG90 Titer test result came back marked no immunity.
Shingles; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Oct2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clonidine (CATAPRESS) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Oct2021 at 09:00, the patient experienced shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with unspecified medicine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was not resolved at the time of report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient presents to the ED on 4/23 with complaints of dizziness described as presyncopal episodes happening twice that day.   Felt lightheaded early in the day.  Patient noticed his stool was dark black colored the last 2 days, no prior history of GI bleed.  Patient is not on anticoagulation therapy currently, is taking fish oil and acetaminophen.  INR is at 1.2 upon admission.  Patient diagnosed with severe diverticulitis, patient was operated on to remove polyps, no source located for GI bleed. Patient was treated for anemia and discharged after 6 days.
Patient reports Bell's Palsy in face following vaccination. Has continued for days since vaccine and was still unresolved as of Thursday 4/1/2021. Unsure at this point if resolved. Reports facial weakness and drooping.
A nurse reported that on 10/30/01, an 84 year old male was vaccinated with expired Pnu-Imune (expired 8/01). It was also discovered that the pt was previously immunized with Pnu-Imune in 1/01. The pt experienced a local reaction of redness, swelling and pain. He was unable to sleep all night due to the pain.
felt crappy; extreme achiness, it was hard for him to keep his eyes open; described the fever as if his "brain was not attached inside; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt crappy), MYALGIA (extreme achiness, it was hard for him to keep his eyes open) and PYREXIA (described the fever as if his "brain was not attached inside) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 10-Mar-2021, the patient experienced MALAISE (felt crappy), MYALGIA (extreme achiness, it was hard for him to keep his eyes open) and PYREXIA (described the fever as if his "brain was not attached inside). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE (felt crappy), MYALGIA (extreme achiness, it was hard for him to keep his eyes open) and PYREXIA (described the fever as if his "brain was not attached inside) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
really achy/flu-like aches; a really bad headache; joint soreness; am still nauseous; I had the chills; sweats; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation and experienced extreme fatigue and headache. The patient reported experiencing really achy flu-like aches, a really bad headache, and joint soreness, described as painful to walk down the steps, for the first 36 hours. The patient further reported still feeling nauseous, stating she got "it" on Friday afternoon; she had chills and "now" she had the sweats and fatigue, further described as extreme fatigue that she fell asleep at her son's baseball game. She stated she was "never ever" warm and she was sweating "right now." The clinical outcomes of nauseous, sweats and extreme fatigue were not recovered; the outcomes of really achy/flu-like aches, headache, joint soreness, and chills were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
3/30-Adverse events experienced and are they still occurring now:  C/o heat, redness and swelling in arm at injection site & extreme fatigue after 1st shot; 11 days after 1st shot developed large lump on at injections site. Today developed red hives/lumps on chest area & trunk area. Using benadryl cream as needed, not taking any other medications. Advised tylenol or ibuprofen as well as PO benadryl, advised to f/u with PCP or urgent care due to worsening symptoms.
This spontaneous report was received from a nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients received unknown number of doses of ROTATEQ lot# M029252 with expiry date: 04-MAR-2018 and lot# M018957 with expiry date: 22-NOV-2017 following temperature excursions to -1 C for 30 minutes and 9C for 13 minutes for prophylaxis (dosing details not reported). There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported in any patients. No product quality complaint was involved. This is one of the several reports due to the same reporter. Additional information has been requested.