chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt fine for the first 15 minutes after receiving a booster dose of the Moderna vaccine (my first vaccine was the J&J on 3/7/2021). About 30 minutes after the shot, and while driving, I felt my heart starting to race out of control. My watch captured my peak heart rate at 163 bpm (a typical heart rate for me is in the low 80s, resting rate is typically 74, walking is around 105-110). After about 15 minutes, and after being observed by a nurse and a physician, I felt better and went home. I had a subsequent "spike" another 20 minutes after the first incident where my heart rate peaked at 110. It has since leveled out and not recurred.
Pt developed a small rash 1-2 days post vax. Pt was immunized in the left arm. Rash on right hip with a small area of cellulitis at probable bug bite. MD doesn't think it is related to vaccine.
LMP 1/11/2022 FIRST TRIMESTER MISCARRIAGE CONFIRMED WITH ULTRASOUND ON 3/21/22 AND 4/11/22.
states that a staff administered a patient with expired fluzone qiv with no reported adverse event; Initial information was received on 27-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 62 years old male patient who states that a staff administered a patient with expired influenza quadrival a-b vaccine [Fluzone QIV] with no reported adverse  event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Oct-2023, the patient received a dose of 0.5 ml of suspect influenza quadrival a-b vaccine (Suspension for injection) (lot UT7751JA, Expiry date : 30-Jun-2023, strength was unknown) via intramuscular route in the left arm for Immunization and states that a staff administered a patient with expired fluzone qiv with no reported adverse event (expired product administered) (latency : same day).  Action taken with QUADRIVALENT influenza vaccine (Fluzone QIV) was not applicable.  At time of reporting, the outcome was Unknown for the event states that a staff administered a patient with expired fluzone qiv with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
trouble sleeping, didn't sleep very well; Aches pains in legs; where he got the vaccination, his arm was very, very sore; could hardly even lift his arm for a whole day; severe chills, couldn't get warm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 11:00 (Batch/Lot number: unknown) at the age of 72 years as dose 3, single for covid-19 immunisation. Relevant medical history included: "Knee replacement" (unspecified if ongoing), notes: Verbatim: Knee replacement. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 Immunization; Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 28Sep2021, outcome "recovered" (29Sep2021), described as "severe chills, couldn't get warm"; INSOMNIA (non-serious), outcome "recovered", described as "trouble sleeping, didn''t sleep very well"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Aches pains in legs"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "where he got the vaccination, his arm was very, very sore; could hardly even lift his arm for a whole day".  Additional information: The caller confirms he had the first two Pfizer vaccinations over 6 months ago and then had the booster shot the Tuesday before last. He states. He went in and got the vaccination and everything was fine. That evening he started to get really severe chills, he couldn't get warm. Also, that night he had trouble sleeping. He states he didn't sleep very well because he had aches and pains in both legs. Weight: his weight fluctuates between 165-170lbs. He mentions also where he got the vaccination, his arm was very, very sore. He could hardly even lift his arm for a whole day.  When probed for the outcome of his symptoms, the caller verifies everything is gone. He mentions he still has a little aches and pains. He clarifies further his chills went away the second day. The second night he still had aches and pains in his legs. Follow-up attempts completed. No further information is expected. lot/batch number is not available despite the follow-up attempts made.
Developed Shingles left side of face around eye. Pain along left side of head and face.
Patient reports that she broke out in a rash, three hours after receiving the flu vaccine.  Rash was on face, arms, and neck.  It appeared as small raised red bumps that did not itch or cause any other discomfort.  Vaccine administrator recommended that the patient see her primary care physician.  To date the patient has not seen a physician.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions and medical history was not reported. The healthcare worker reported that, on 19-FEB-2016, the patient was vaccinated with improperly stored GARDASIL 9 vaccine), lot # K011325 with expiration date 17-APR-2017, (dose number, dosage and route unspecified). The vaccine was exposed to the temperature of 15.3 degrees C for 240 hours. The vaccine had not undergone previous temperature excursion. No adverse symptoms were reported. No further information was provided. Product quality complaint was not involved. Additional information has been requested.
TWO DAYS OFTER INJECT REDNESS DEVELPD 2" DIAMETER, SWELLING AND HEAT
Red rash that is getting bigger everyday size of a softball it?s hot to the touch and my whole arm is twice the size of my other arm
requested medical records from a residential facility; the ones received were very limited; the pt had a positive COVID test on 7/26/21; pt passed away in a residential facility -  on 9/3/21; no other information
This report to VAERS provides the following narrative: A report has been received from VAERS (Health Authority) concerning a 31 year old, male patient. The patient's medical history included attention deficit disorder, epiglottis at age 3, tracheotomy, severe acne and vasectomy. Patient received FLUMIST (Intranasal) started on 31-Aug-2009. The patient experienced Guillain Barre syndrome which started on 12-Oct-2009. Patient had been having pain in legs requiring opioids, difficulty walking, leg weakness worse. Stands unsteady, drags right foot. Sensation and proprioception subjectively decreased in right leg. IVIG administered. Continued antalgic gait, pain in thighs. 18-Nov-2009 Physical Medicine Rehabilitation, additional hospital consults received service dates 29-Nov-2009 to 16-Nov-2009. Assessment: Relapse of Guillain-Barre Transferred from another hospital and admitted for rehabilitation for Guillain-Barre. Four weeks ago had weakness in upper and lower extremities, diagnosed with Guillain-Barre syndrome, treated with IVIG. Went to rehab and had seizure like episodes. on 04-Nov-2009 increased pain, increased weakness. Presumed diagnosis of relapse of Guillain-Barre with administration of IVIG. Possible seizure symptoms vs anxiety attack. Claustrophobia, Mild facial asymmetry. Deep tendon reflexes decreased. Pain inner thighs, legs hurt. Right-sided head pain diagnosed as migraine. Hands still painful. Numbness in feet persists. Complaints of vision problems and some difficulty urinating. Hyperventilation due to anxiety. Anxiety/Mood disorder. Patient complained of losing vision, dizziness, neuromuscular complaints. Eye exam was normal with exception of extraocular movements due to nystagmus. Neuro exam: normal. Patient presented to the hospital with extreme weakness, pain, trouble sleeping and anxious. Treatment: VICODIN, but no help. Patient saw a psychiatrist. Other treatment: XANAX, Klonopin, CYMBALTA. On examination, patient fatigued, anxiety, vision problems. Impression: Myopathy. Dr's opinion was that this was emotional related event. The outcome of the event of Guillain Barre syndrome was unknown. The reporter considered the event of Guillain Barre syndrome to be serious due to hospitalization. Laboratory values and diagnostic test details are available.
This spontaneous report as received from a certified medical assistant refers to a 4 year old male patient. On 27-MAY-2014, the patient was vaccinated with the second dose of PROQUAD (Merck) lot # H015639, expiration date 23-FEB-2014. On 27-MAY-2014, an expired dose of PROQUAD (Merck) was administered. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Running a fever of 103; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Running a fever of 103) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PYREXIA (Running a fever of 103). At the time of the report, PYREXIA (Running a fever of 103) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the onset date of the event of pyrexia, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of pyrexia, a causal relationship cannot be excluded.
This spontaneous report was received from a registered nurse refers to a 15 month old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016, the patient was vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # M027886, 03-JUN-2018 and (wistar ra 27-3) M-M-R II M002419 12-JAN-2018. No adverse effects were reported. Additional information has been requested.
Pt recvd vax on 15JUL92 & pt exp dizziness, vomiting & had glassy eyes; pt recovered the same day; No further details were provided;
Approximately 1 month and a few days after my 4th dose vaccination I contracted COVID-19 and experienced the following symptoms: Sneezing, Cold, Scratchy Throat, Headache, Congestion, Body Aches, Fatigue, Chills. I had Flonase and Tylenol for treatment. After testing positive for COVID-19 I had a Televisit my Doctor and was advised to just monitor my symptoms and let it run its course and if I started to feel worse I should contact him again. As of today 07/05/2022 I feel so much better; my appetite is back and my fatigue is almost gone. I'm starting to feel like my normal self again.
I woke up at 4 in the morning itching my hands and elbows.  I got up and put some cream on it, and continued to itch at different parts of my body.  I got up and tried different itch creams to no relief.   I also have a cough, feels like I have something in my throat.  I then took some benaryl and that helps relief the itch for about 6-7 hours, then I have to take another dose. I still have red patches on my body (hands, elbows, armpits, neck, and feet.)  These go away some when I take a benadryl.
Pain at injection site that resolves but started to have redness and swelling in the arm. No shortness of breath. Has intense itching.
Reports on 11-17-16 anterior portion of shoulder painful since few days after flu shot. No fall or bump or bang to arm. OTC MOTRIN helpful but deep persistent ache continues. No problem with range of motion. Concerned maybe related to vaccine or not. Pain worsens when lying down. No tenderness to palpation in A-C Junction 11/18/16.
10 minutes after the MMR vaccine injection I fell unconscious for a couple minutes. After I had ringing/buzzing in my ears for 30 minutes, then felt dizzy for the next 5-6 hours. The rest of the evening I felt fatigued and had a head ache. The next morning I felt fine. No other adverse reactions since.
Inconsolable. Clingy. Wouldn't let me put him down. Restless. Agitated.
Woke up with severe aches and pains all over. He said he was freezing, but he was very hot and feverish. He was shivering. He woke up several times throughout the night with the same symptoms. He felt better during the day, but still had the aches and pains, no more fever.
patient developed leukemia after vaccination wilh GARDASIL-9; This spontaneous report was received from a pharmacist via a company representative through an article referring to a female patient of unknown age. Information about concomitant medication, pertinent medical history and drug reactions/allergies was unknown.   On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage detail, strength, lot # and expiration date were not reported) intramuscularly for prophylaxis.  On an unknown date (reported as recently, not specified further), the patient developed leukemia after vaccination wilh hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The outcome of leukaemia was unknown.  It was unknown if patient sought medical attention or not and if any treatment or laboratory tests were performed for the event.  Causality assessment was not provided.  Upon internal review, leukemia was determined to be medically significant.
Pt reported scratchy throat, itchy lips, slight rash on chest approx. 10 min post vaccination. 25mg of Benadryl given PO. Transported to ER for continued observation.
Patient reports to clinic after receiving the COVID-19 Vaccine at today. Patient states that she was given the vaccine at 0915 today and about 5 mins after started to have symptoms of a hot sensation from head to toe, heart racing, ears burning, and chest tightness, no breathing difficulty. Patient notified staff and was given O2 and allowed to drink her water. Her symptoms did improve and she was sent to the waiting area again. After about 10 mins her chest tightness came back. Patient states she can feel her blood flowing, "kinda like when your limb is numb". Patient also had symptoms of chills, body shakes, loss of smell, and a metallic taste in mouth. Patient states that she was seen again by staff and laid on a cot for 20 mins, and was then cleared to head back to work around 1000. Patient was seen in the clinic at 1157, and her symptoms since it started have improved. Currently she has the following symptoms: can't taste/smell, (L) arm is sore, H/A, with constant ache, localized to back of neck up to behind the both eyes. Body feels worn out, everything feels heavy, takes a few second to focus when she looks around "like there is a delay". Patient was sent home to recover and to let medical staff know if her symptoms return.
Patient received Flumist vaccine, 11:30AM-Noon on 09/20/2005.  Work up at 01:00AM (12 hours later) 09/21/2005 with hives, joint pain, fever of 103-104, rash, achy joints, and lip swelling.  Treated with Benadryl and Motrin with noted improvement.
Right thigh redness and swelling at injection site approximately 3 1/2" x 4 1/2".
it was rpt fr MD ofc concerning pt who was vax & subsequently exp immediate localized react described as red & raised. treated w/benadryl
Neck pain, headaches, fatigue, shaking in the hands, anorexia, feeling cold all the time and pain on the right side of the head that feels like is an episode when he had shingles in the past.
sore at the shot site like they hit a nerve; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 27Sep2021, this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2, via an unspecified route of administration, administered in deltoid left (also reported as upper left arm) on 05May2021 14:20 (Batch/Lot Number: ER8734) at the age of 55 years old, as dose 2, single for COVID-19 immunisation. Medical history included degenerative disc from 1988 and ongoing, gall bladder from 1981 (taken out 1981), gastric bypass from 2008 and ongoing (lap band 2008), vasectomy from 1998 and ongoing, heart burn and heart health. Concomitant medication(s) included famotidine (PEPCID AC) taken for heart burn and acetylsalicylic acid (ASPIRIN BAYER) taken for heart health from an unspecified start date and ongoing. The patient previously received first dose of BNT162B2 (Batch/Lot Number: ER8730), intramuscular administered in upper left arm on 04Apr2021 14:20. No prior vaccination. The patient got his Pfizer vaccine first dose on 04Apr2021 (also reported as 21Apr2021) and the second dose on 05May2021. He got sore at the shot site like they hit a nerve on 10May2021, not very often. If he flexed his arm or rubbed it that it went away. It was starting to get worst. He was getting it every day or once every few days. It went away for a few days and came back like 25May2021 (as reported). Stated that that before he would go a week or so and nothing and wanted to know if it persists what should he do. A persistent site discomfort, like a ghost after shot feeling. Flex the muscle or rub the site and it goes away, but returns, maybe in a hour, maybe tomorrow. Always different. There was no treatment. Adverse event was still ongoing Relevant Test included COVID-19: Negative. Outcome of event was not recovered. Reporter assessed the event as serious with seriousness criteria of persistent/significant/disability/incapacity.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a doctor of pharmacy refers to a 52 years old male patient who on 21-AUG-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 22-AUG-2012, the patient developed an injection site reaction after receiving a dose of ZOSTAVAX. The patient had a red raised area in three inches in diameter. No treatment information was reported. At the time of the report, the patient had not recovered. It was unspecified if the patient sought medical attention. The relatedness for the patient had red raised are in 3 inches in diameter was unknown for ZOSTAVAX. Additional information has been requested.
Information has been received from a physician concerning a 32 year old white female, with allergies to amoxicillin and sulfa, who "two weeks ago" on 21 Apr 2006, was vaccinated (route unknown) with a first dose of Varivax. There was no illness at the time of vaccination. The physician reported that the patient was vaccinated at another practice two weeks ago and on 08 May 2006 she developed a vesiculopapular rash with about 10-15 lesions on her trunk and arms. It was noted that the patient had no fever. The patient's status was reported as not recovered. Unspecified medical attention was sought, but no treatment was required at this time. Additional information has been requested.
still have pain in left arm; This is a spontaneous report from a contactable consumer (reported for herself). A 44-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 02Feb2021 at 10:00 (at the age of 44-years-old) as dose 1, single for covid-19 immunisation at workplace clinic. Medical history included ongoing hypersensitivity (Known allergies: Yes). Concomitant medication included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021, the patient experienced still have pain in left arm. The reporter stated the event result in Doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The outcome of the event was resolving.  Follow-up attempts completed. No further information expected.
Lightheaded BP: 113/49 ( Reports hx of hypotensive, states her BP is always low) HR: 71 Sp02: 96% No acute distress, Seen and cleared by EMS
"screamed high pitched shrill scream @ top of lungs" began PM of date of vax lasted more than 1 wk; Pt seen by MD 13NOV91; nl-PE MD stated crying was due to vax; fever 101;
Vaccine was adminstered post expiration. A letter was sent to the patient's address on 2/17/2023 stating manufacturer's vaccine activity at the time of administration. Manufacturer Statement: Moderna reviewed the stability of the vaccine you received and determined that it maintained the activity necessary to protect against COVID-19 at time of administration. Moderna cannot guarantee the protection you have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you. However, if you wish to undergo revaccination, we will provide you access as outlined below. The patient returned on 2/27/23 to be revaccinated; he received Moderna  Lot# 066H22A Exp: 3/8/23.
Initially, it started with some odd headaches exclusive to the right side of my face - near my sinus cavity extending to my right temple and around my right ear.  On day 10, March 20, 2021, at approximately 5:00 pm, I lost all hearing in my right ear.  I was turned away as a possible ear infection, but due to the complete loss of hearing, I followed up on Tuesday, March 23, 2021.  After being seen by an ENT, I was diagnosed with Sudden Sensorineural Hearing Loss in my Right ear.  I have started treatment with my first injection into the eardrum and am currently on day 3 of oral steroids (predniSONE - 20mg Tablets, 3x first 7 days, 2x days 8-9, 1x day 10).  No improvement or recovery as of yet, if at all.
Starting the night of the day I got the shot, my left arm was very sore. In the following days, it progressively got worse. I was sent for an MRI that showed a rotator cuff tear and a lot of inflammation. I saw an orthopedist in May who diagnosed me with adhesive capsulitis (frozen shoulder). I could barely use my left arm. My range of motion was about 40%. The pain has been considerable, especially at night. I am going for physical therapy which has helped minimally to this point.
Headache almost immediately, chest tightness starting maybe 2 hours later and persisting until present time, roughly 30 hours post-vaccine.
Patient became a little bit dizzy.   Patient also had blood drawn.  Patient was given juice and crackers and with in 15 minutes felt better.
I got the moderna bivalent  5wy1749 booster shot. My adverse event happened 3 days later at 7PM. I was at the computer and when I got up I couldn't move my left leg. My right leg was fine.It really was scary. It took 2 days until I could walk normally.