chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has neurological and systemic problems; Caller states she has permanent tinnitus where she has a constant whistling tea kettle in her brain and ears 24/7.; her legs and arms went numb/numbness resides in toes and fingertips; her legs and arms went numb/she has permanent numbness in her fingertips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization. The following information was reported: NERVOUS SYSTEM DISORDER (medically significant), outcome "unknown", described as "has neurological and systemic problems"; TINNITUS (medically significant), outcome "unknown", described as "Caller states she has permanent tinnitus where she has a constant whistling tea kettle in her brain and ears 24/7."; HYPOAESTHESIA (medically significant), outcome "unknown", described as "her legs and arms went numb/numbness resides in toes and fingertips"; HYPOAESTHESIA (medically significant), outcome "unknown", described as "her legs and arms went numb/she has permanent numbness in her fingertips".  Clinical course: The patient stated she was looking at the Prescribing Information for RSV vaccine, Abrysvo. She can not find in the PI if this vaccine was composed of an attenuated virus, a live virus or an mRNA genetic modality. Caller stated the information was hidden. Caller stated she works in the pharmaceutical industry as a medical editor. Caller stated she was permanently damaged, has neurological and systemic problems as a result from the Pfizer BioNTech Covid shots, stated she received 2 doses. Caller stated for the Covid shots her body was loaded with spike proteins, where her body started making its own spike protein and cross the brain blood barrier and created problems for her because they were toxic. Caller stated she had permanent tinnitus where she had a constant whistling tea kettle in her brain and ears 24/7. Caller stated she had permanent numbness in her fingertips, numbness resides in toes and fingertips. Caller stated her legs and arms went numb and it stayed that way for weeks and weeks. Caller stated she was 70 years old, considered an at risk population and her doctor will recommend her an RSV vaccine for her and she was not interested in any mRNA modalities. Caller was gathering information to make an informed choice since they were not given an informed choice for the Covid shots, caller stated some 30% of the people where she lived received saline for the first series of injections as well as different strengths given to different people.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I woke up from sleep and developed tachycardia, tachypnea, feeling cannot breathe, excessive sweating, pain and numbness on the left arm where I received the vaccine, then I lost consciousness for unknown time.  When I woke up I felt my legs and arm were shaking not sure if it is seizure or not as there is no witness.  I walked a couple steps to the next room to wake up my husband and then I lost consciousness again after I heard ringing sound in my ears and black in front of my eyes.  My husband found me on the floor and I fell on my left hand with small injury on the dorsum of my left hand that I am not sure how it happened.  After drinking fluid I felt little bit better.  I received 600 mg of Motrin and continues to have headache and muscle ache but no other symptoms at this time.
Hospitalized 1/18/2022 COVID 19 infection presents with fatigue, weakness and cough,
Dose given greater than 12 hours post vial puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given greater than 12 hours post vial puncture) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Syncope. Concurrent medical conditions included Drug allergy (abilify), Drug allergy (Januvia), Hypertension, Type 2 diabetes mellitus, Chronic kidney disease and Depression. Concomitant products included AMLODIPINE, VALPROATE SEMISODIUM (DEPAKOTE), GLIPIZIDE and LABETALOL for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given greater than 12 hours post vial puncture). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose given greater than 12 hours post vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were provided concomitant medication included as AbN.   This case was linked to MOD-2021-416295 (Patient Link).
I had congestion, a slight sore throat that lasted 12 hours. I actually felt worse on the PAXLOVID, I started having muscle aches and a horrible taste in my mouth. I had a slight cough.
Information has been received from a nurse practitioner concerning a 26 year old female patient with gastrooesophageal reflux disease and no drug reactions/Allergies who on 03-APR-2012 was vaccinated IM with the first dose of GARDASIL. Concomitant therapy included omeprazole and MICROGESTIN. On 04-APR-2012 the patient found that it was very difficult to open her eyes in the morning. She also had nausea. These problems resolved as the day progressed. The patient recovered on 04-APR-2012 in the evening. The patient sought medical attention by going to the nurse practitioner's office. No treatment was given for the events. No lab diagnostics studies were performed. Follow up information has been received from nurse practitioner refers to 26 year old female patient with no illness at time of vaccination and none pre-existing allergies, birth defects and medical conditions. It was reported that patient presented for second dose of GARDASIL on 05-JUN-2012 (dose, route and Lot # not reported) and reported that on the morning following her first injection of GARDASIL on 03-APR-2012 on 14:19 (dose not reported, IM, right deltoid, Lot#668985/0690AA) it was very difficult to open her eyes. She believes she might have also nauseous. Patient stated she might have experienced similar symptoms in past after GARDASIL "but this was worse". The patient recovered on 04-APR-2012. Additional information is not expected.
patient fainted approx 5 minutes  after hpv given; sustained laceration to lower lip  was communicating within 1 minute of event, but was confused, with slurred speech
The patient fainted and struck head and face approx. 10-15 minutes after receiving vaccination. Pharmacist provided first aid care and she self transported home. Pharmacist called patient 5 hours later and she is doing much better.
Hoarseness, wheezing and trouble breathing. Called my doctor and was told to go to the emergency room. Treatment was an inhaler and Zyrtec over the next few days.
Case completed Covid vaccine in March 2021, then was hospitalized for Covid in October 2021 * Pneumonia due to COVID-19 virus Assessment & Plan Presents with cough, sob, weakness present 7-9 days. Covid + on admission. H/o pfizer vaccination in Feb 2020. Poor oral intake and too weak to care for at home. Due to advanced dementia, mostly comfort measures at home, but wife would like to see if he would improve with some treatment. He had modest hypoxia on arrival with 88% oxygen saturation on room air, required oxygen supplement of 1 to 2 L, and progressed to normal oxygenation on room air. He denied cough or shortness of breath and early in stay he was lethargic with poor mobility with progression to ambulating independently in the room, standby assist in transfers, able to get on the off the toilet independently. He was treated with dexamethasone 6 mg daily and remdesivir, both x5 days. His oral intake improved needed part of meal prior to discharge. He appears near his baseline is going to return home with care of family.
deathly sick; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves female patient who was deathly sick (illness), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient who was deathly sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Pt recvd 1st dose of vax w/no noted problems; Pt recvd 2nd dose of vax 18AUG92 & w/in an hr following vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further details were provided;
I had my vaccination on 09/27/2022.  On 10/25/2022 I woke up with coughing and runny nose. I took a at home COVID-19 test which was Negative. On 10/26/2022 I went to urgent care and tested COVID-19 Positive. I was given Mucinex and Robitussen. I am feeling better but not 100% on 11/01/2022.
a dose of Tdap was given instead a dose of GARDASIL 9.; This spontaneous report was received from an officer manager referring to a female patient of unspecified age. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.   On unspecified different dates, the patient received 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported) as prophylaxis.  On 31-AUG-2023, the patient was administered a dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (indication, dose, route of administration, lot# and expiration date were not reported) instead of a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (indication: prophylaxis) (wrong product administered). The reporter was requesting information regarding concomitant administration of the aforementioned vaccines; however, it was unknown if the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on that day.
Patient reported a persistent pain in upper arm ever since FLUZONE Hi Dose was administered on 10/30/17. Patient says dose may have been administered "too high" on arm and is concerned about possible damage to arm/joint.
Fever; Chills; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Soreness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Soreness). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Soreness) outcome was unknown.            This case was linked to MOD-2021-163710 (Patient Link).
Information has been received from a physician concerning a 37 day old male with no medical history or allergies who was vaccinated with a 0.5ml intramuscular first and second dose of RECOMBIVAX HB (652403/0040F) on 25-May-2006 and 24-Jun-2006, respectively. There were no concomitant medications. On 24-JUN-2006 the experienced "extreme lethergy". He slept all day after leaving the office, woke up for 1/2 hour and went back to sleep.
Patient experienced trouble swallowing. Was given 2 tablets of diphenhydramine 25 mg and improved after approximately 15 minutes.
Patient developed left arm and shoulder pain a few days after the vaccine, this progressively worsened over the next 2-3 weeks, over this time she developed left arm weakness and numbness and was admitted to the hospital on 1/17/2022. Her neurological exam at that time showed severe weakness of left arm abduction in all directions as well as weakness of external rotation and arm flexion, in addition to sensory loss. She had an extensive workup as below. The diagnosis was Parsonage-Turner syndrome, possibly related to the COVID vaccine. There was no trauma or injury. Patient significantly improved and her neurological exam today (2/17) was normal. She still has some pain in her arm, but full recovery is expected.
At 5 hours after immunization subject felt very tired. Over the next 6 hours, he vomited 5-6 times. Experienced body aches, chills, felt warm, small diarrheal stool and headache. By 03/15/04 subject still with symptoms of headache, also neck pain, photophobia and body aches. Subject seen in ER and a spinal tap was done. Doctor told him that he had an inflammation of the spinal cord related to the vaccine, but did not have meningitis due to infectious process.
This spontaneous prospective pregnancy report was received from a registered nurse referring to an 18 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies. On 28-APR-2011, on 21-MAY-2015 and on 28-SEP-2016, the patient was vaccinated with the first, second and third dose of GARDASIL 9 respectively (lot number and expiration date were unknown, except for the third dose given on 28-SEP-2016, which had the lot number of M011840, expiration date 01-FEB-2018), intramuscular route. The patient did not have concomitant medication. The patient became pregnant with last menstrual period (LMP) of 10-SEP-2016 and estimate date of delivery (EDD) of 17-JUN-2017. The initial exposure to GARDASIL 9 was at 2 weeks. The nurse reported that in approximately September 2026 (reported as "about a week ago"), the patient made an appointment to go into the office because she was experiencing "vaginal itching, urinary frequency and urinary urgency". The patient went to her scheduled appointment on 28-SEP-2016, and while the patient was in the office the health care professional performed an urinalysis, "Testing for Sexually Transmitted Diseases (STD) blood work testing" for Gonorrhea, human immunodeficiency virus (HIV), syphilis, and chlamydia, and a pregnancy test. She also receive the third dose of GARDASIL 9 to complete the series. After the GARDASIL 9 was administered the nurse reported that she discovered that the pregnancy test was positive. Additionally, it was also reported that when the patient went to the office, the urinary frequency and urinary urgency were recovered on an unknown date in September 2016. However, the patient was still experiencing vaginal itching and it was unknown if the patient recovered from the vaginal itching. The patient received treatment for the adverse events with Clotrimazole 1% cream. The pregnancy outcome was outcome pending. The causality assessment between the events and therapy with GARDASIL 9 was not provided. Additional information has been requested.
Dates for First Dose: Achy Arm/Second Dose: Achy Arm; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Mar2021 (Lot number: ER8730) at the age of 59 years as dose 1, single and administration date 20Apr2021 (Lot number: EP7533) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Mar2021, outcome "unknown", described as "Dates for First Dose: Achy Arm/Second Dose: Achy Arm". Therapeutic measures were taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200416195 similar report from same reporter
fever 100.3, exhaustion, headache, arm soreness - treated with tylenol, resolved within 36 hours redness and raised bump at injection site, resolved within 4 days
Received immunization at 1400, noticed nausea, vomiting, chills, headache at 1830 of 29Jan08.
Facial hives in three areas on my face. One hive about a nickel size and 2 others  less than a size of a dime, and slight itching occurring probably within 15 mins after shot, but did not discover until approx. 30 mins after shot (since I did not discover until I took my mask off).  Acute reaction lasted for approx. 2 hrs.
fever; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.            The patient's concomitant medications weren't reported Treatment information was not provided
Information has been received from a registered nurse concerning an 8-year-old patient with no known drug allergies who was vaccinated with a dose of Varivax (Oak/Merck). On 05-JUL-2006, the patient developed lesions on the chest, abdomen, and perineal area. there were <50 lesions. The outcome was recovered. There were no diagnostic test or laboratory data. Additional information has been requested.
I was short of breath. I felt different. I couldn't walk without running out of breath. My heart was beating really fast. In September is when everything really started to go wacko. September 22, 2022 that is usually high was very low. I just didn't feel good. I got on heart monitors and going to the doctor. They referred me to a cardiologist. I'm doing at home EKG monitoring at home. I have to check my weight, EKG daily. Went back into doctor in December.
Extreme head and chest pain resulting in a visit to the emergency room.  It should be noted that i had covid in December and recovered, then in March post-covid I had a similar experience that resulted in a visit to the emergency room
felt a bit tired the next day; she had a little bit of soreness at the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she had a little bit of soreness at the area of the injection) and FATIGUE (felt a bit tired the next day) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M201A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (she had a little bit of soreness at the area of the injection). On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (felt a bit tired the next day). At the time of the report, VACCINATION SITE PAIN (she had a little bit of soreness at the area of the injection) and FATIGUE (felt a bit tired the next day) outcome was unknown.            Concomitant product details was not reported.  Treatment details was not reported .     This case was linked to MOD-2021-338431 (Patient Link).
Previously frozen Flublok Quad 22-23 PFS vaccine was inadvertently administered to the patient.   No reaction has been reported.
Uncontrolled coughing, hoarseness, tongue started swelling, fever & chills, short of breath, red eyes; was seen in emergency dept at Rutland Regional Med Ctr & treated for allergic reaction.
Patient had severe vaso response and fainted at check out window approximately 8 minutes after receiving vaccine.  She fell hard and hit the floor with her head.  An ambulance was called due to the magnitude that she hit her head and it took her quite a long time (roughly 10 minutes) to completely come to and know her surroundings.  She had a very large knot on her forehead/temple area and we felt the need for the ER to evaluate the head for any trauma associated with the fall.
Fussy, inconsolable, non-stop crying, low grade fever, legs seemed to hurt to move.
2/17/21:  later in the afternoon had a bit of swelling and itchiness at the injection site.  Later that evening it turned red.  A couple days later, that subsided.  2/24/21:  Itchiness at site reoccurred as well as swelling and redness and heat.  Applied ice that evening and decided to send an email to my primary physician on 2/25/21.  The Physician suggested I report this adverse event and sent me this link!   2/25/21:  Arm is still red, itchy and swollen but has subsided a bit.  I have not taken any form of analgesic or allergy medicine.   Thus, the answer to  Item 20 is still no as it has not yet fully subsided.
Headache, Myalgia, Arthralgia, INJECTION SITE PAIN, SWOLLEN GLANDS Narrative:
Swelling & itching around tetanus toxid inject site (size of a baseball); general malaise;
initially severe fatigue  after about 5 days started to feel flu like pain symptoms through out body then the symptoms became horrible pain that kept be bed ridden for 3 days.  the body pain finally dissipated but feeling of fatigue continued
Uponi receiving 2nd shot for COVID 19 vaccination protocol, the shot in the arm hurt much more than the prior shot.  The next morning my entire arm area was in extreme pain with loss of range of motion and pain throughout up to shoulder.  It last for three days.  Within three weeks, the pain got worse, my range of motion gone, extreme pain I could not move my arm.  I had been going to a chiropractor every once in a while and paid a visit.  He said it was not my neck area and need to see my dr.  I made an appt by Sept to see my dr as my shoulder and arm were extremely painful and I could not move it.  My dr ordered an MRI, recommended an orthopedic shoulder expert which I made an apptment for November 2021.  The MRI showed I had a Frozen Shoulder of the Left arm.  I asked my dr if I could go to physical therapy as I had a month before the orthho.  Approved, I started with one pt site, and switched to PT and still going.  My range of motion has improved from what it was like in July, but not to full functioning so I can resume exercise, yoga, and doing daily activities using the arm.  I have spent $$$$$$ on rehab, drs, foam rolls, massage tools, massages, and more to help me imiprove.
Pain in the site of injection X 1 month Generalized rashes Streaks of subcutaneous bleed Generalized skin hyphae and blots  Severe generalized itching
body rash, intense itching on hands, under arms & groin-MD tx w/cortisone;resolved over several days;