chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient e-mailed provider on 3/1/21 - "I have pretty good inflammation in my mouth, lips, face, throat, shoulders, neck and knees.  Eyes fill a little weird too.  I also feel a bit fatigued and lack interest in normal Monday morning activities"; It was recommended pt tx s/s with Loratadine and diphenhdramine.  On 3/15/21, pt said swelling was better but he now had a rash on the front of both shins as well as a bruise on the top of his right foot and his left thigh.  CBC drawn 3/16/21 showing platelets of 40k.
Patient reported a rash to her physician at the site of the vaccine injection.  Physician diagnosed erythema multiforme and has advised patient not to receive second injection in the series.
first dose in the left arm and had underarm pain and swelling/left under arm pain; first dose in the left arm and had underarm pain and swelling/left under arm swelling; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL3247, expiration date was not reported) via an unspecified route of administration, in left arm, on 08Feb2021 (at the age of 42-years-old) at dose 1, single for covid-19 immunization. Medical history included spleen removed and other conditions (unspecified) at least before 13 years. Concomitant medication included botulinum toxin type a (BOTOX) taken as a facial paralyzer from Feb2021. The patient received the first dose of vaccination in the left arm and had underarm pain/left under arm pain and swelling/left under arm swelling on 10Feb2021. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6201) on 03Mar2021 for covid-19 immunization. The patient underwent lab tests and procedures which included covid-19 test: negative on 24Mar2021. The outcome of the events was recovered on 20Feb2021.     No follow-up attempts are possible. No further information is expected.
Bumpy rash on face, chest and back area. At site of immunization is red-size of dime-looks black and blue around area. Benadryl and warm compresses.
Immediately after the 2 vaccines admin., student said he was becoming faint.  He fainted sitting in chair supported by 2 staff and transfer to cot.  Student was pale, unrespon x 2-3 min - clenched R fist and mouth.  BP 122/58, P 65, R monitored.  Teleph - mom # d/c, dad reached - student awake, taking sips water.  Dad stated "this happens to everyone in the family".  Mother stated today 1/29/09 "I called my sister and she said Oh, he did this when he was 5 yrs old".  Health history from grade school "N/A" all new form.
Info has been received from a physician concerning a 19 year old female pt, who in approx. 1999 was vaccinated with the Hep-B series. In approx. 2002, the pt "tested positive core antibody". Unspecified medical attention was sought. Additional info has been requested.
On 4/15/01, post vax, pt developed ecchymosis at injection site with a very large area "whole upper arm" red, swollen and "hot to touch".
Pt had pain in her  right arm/shoulder.  She said she could not move her arm.
Axillary and supraclavicular adenopathy with mild pain.  Treated with Ibuprofen.
This was mostly already done.  Had a hard time sleeping last night, shift in schedule anyway but awoke with arm pain, chills, and a headache.  After one hour awake, mustered up energy to get up, take an extra 1/2 dose of my nightly 100 mg trazodone & 2 extra strength Tylenol, & get a second comforter and other bedding to help chills.  Today at work (working from home) I felt much more sluggish than usual, had a headache, mild muscle aches, didn't have energy to hop in the shower or even think to go get more Tylenol.  Just tried to manage to get through the day, do the minimum, while wanting to go back to sleep.  Chills reduced from this morning, got better over course of day but not fully subsided yet.  Along w/ chills, felt somewhat milder "something" -  "not quite" jumpy, trembly, twitchy or tingly...hard to describe, body today just felt a little "off,"  "unsettled,"  too vague or subtle to describe better; it's also improved I think over course of day some.
At first it got a very hard lump about the size of a nickel at the injection site. The lump lasted about a week, Then the area turned red and felt hot and itchy.  It is 8 inches by 5.5 inches in size.
A consumer report has been received concerning a 55 year old female patient. The patient's concurrent disease included Attention deficit/hyperactivity disorder, allergic to dust, pollen, and cat hair. The concomitant medications included Prednisone, cough medications, and antidepressants. The patient received nasal FLUMIST, a spray in each nostril on an unknown date for seasonal flu. The patient reported that she had shortness of breath, her body felt like it was on fire. She had breathing problems, her eyes swelled up, face swelled up, and she had a dry hacking cough on 11-Jan-2013. On 12-Jan and 13-Jan her airway closed for 35 sec. She also suffered from redness on her neck and upper chest. On 11-Feb, she went to a hospital emergency room. The doctor said it looked like Lupus and treated her with prednisone. She had hives all over her body. Doctor said she may have chlamydia. She had a chest X-ray. 30-Jan was the worst day for her red puffy face. She also had muscle weakness. She had a red infected pustule under her tongue. Her skin peeled like a sunburn from head to toe. She was taking cough medication, and green mucus was coming up on its own. She was treated for Attention deficit/hyperactivity disorder in Nov 2012. At the time of reporting, the events of shortness of breath / breathing problems, red puffy face / faced swelled up, hives all over body / red sunburned like skin, closed airway for 35 sec, infected pustule under tongue, and muscle weakness were continuing, and the outcome of body felt like was on fire, dry hacking cough, swollen eyes, green mucus coming up, and redness of neck chest was unknown.. Her skin peeled like a sunburn from head to toe. She was taking cough medication, and green mucus was coming up on its own. The company physician considered the events of closed airway for 35 sec, dry hacking cough, shortness of breath / breathing problems, red puffy face / face swellled up, body felt like it was on fire, swollen eyes, hives all over body / red sunburned like skin to be serious as Important medical events and the infected pustule under tongue, muscle weakness, green mucus coming up, and redness of neck & chest to be non serious. Laboratory values are available.
This literature marketed report was received from a physician concerning a 16 month old male patient. On an unknown date, the patient received PREVNAR 13 on an unknown date. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB (lot number, expiry date, dose and route unspecified). On an unknown date, the patient presented with symptoms of mild preseptal cellulitis (PC) of the right lower eyelid, purulent rhinorrhea, mild peri-oral facial rash, acute otitis media (AOM), purulent conjunctivitis for several days and upper respiratory infection (URI) for 2 weeks. The patient was treated with amoxicillin, twice daily for acute otitis media (AOM). Body temperature of the patient was 100 degrees Fahrenheit. The physical examination of the patient was unremarkable. Routine bacterial culture of the right eye discharge and complete blood count (CBC) showed a leukocyte count of 12550 cells per cubic millimeter. The patient was afebrile and non toxic, his leucocyte count was within normal range and he has an infection which highly suggest non typeable H. influenza. Patient received treatment with cefdinir and amoxicillin clavulanate twice daily. Three days later, his eye grew beta lactamase-negative H. influenzae. Upon follow up the next day, the preseptal cellulitis (PC) of the patient was much improved and his demeanor was much better. Additional information has been requested.
1:35 Pt complaints of dizziness, Pt put head on desk.  At 1:38 pt vomited small amt, color pale, clammy, alert oriented B/P 100/72 - Pt states she is hungry.  Juice + cereal offered & taken is problem.  Pt states she is good - color normal.  B/P 98/64 - Seen by MD & left with no acute distress.
Abrupt onset severe bilateral back and buttocks pain, facial flushing, anxiety, elevated blood pressure with no hypertension history.
ENLARGED SPLEEN (VERY PRONOUNCED); ACHES; FEVER; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease, and seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Concomitant medications included methotrexate for autoimmune disease. On 01-APR-2021, the patient experienced aches. On 01-APR-2021, the patient experienced fever. On 05-OCT-2021, the patient experienced enlarged spleen (very pronounced). Laboratory data included: CT scan (NR: not provided) enlarged spleen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and fever on 02-APR-2021, and the outcome of enlarged spleen (very pronounced) was not reported. This report was non-serious.
I had fatigue and shortness of breath. I had shortness of breath on exertion. I was concerned because I am a lung cancer survivor, and I am already missing half a lung. I also have Takayasu arteritis which can affect any artery. I had 7 MRI's done to make sure all my arteries are okay. I was referred to a pulmonologist and I will be seeing her on July 20th. I have had pulmonary embolism in the past and this shortness of breath is not as drastic as that. The fatigue is limiting and is now different that what it was initially. It was getting better and then reoccurred worse than before.
Numbness and tingling in left hand and arm which has not gone away. Dizziness lasted for 3 weeks.
Rash on left upper arm that formed 6 days following injection. Rash is itchy and did not go away with Benadryl. It has lasted 4 days already.
Left arm and bottom of hand numbing up/ legs, below the knees felt numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 (Lot number: EW0179) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset 03Aug2021, outcome "not recovered", described as "Left arm and bottom of hand numbing up/ legs, below the knees felt numb". Therapeutic measures were not taken as a result of hypoaesthesia. Additional information: The event numbness in toes was on 04Aug2021 not captured as a separate event because hypoaesthesia is already code and the outcome of event  was not recovered so retained in the narrative . The patient did not take any other vaccine within 4 weeks prior to Covid vaccine. No adverse events prior to vaccination. The patient has no illness at the time of vaccination. They did not visit any physician office or any emergency room. The patient did not administer any other vaccine on the same date.  No follow-up attempts are possible. No further information is expected.
Right after injection, felt flushed & heart racing. BENADRYL given 25mg.
2 menstrual periods in a space of less than 1 month:1st day pf period: June 20 Last day of period: June 271st day of period: July 12 Last day of period: ongoing; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW182) via an unspecified route of administration in the right arm on 28Apr2021(at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history and had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included paracetamol (ACETAMINOPHEN) and docusate sodium (STOOL SOFTENER). The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on an unknown date (age at vaccination unknown) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Jul2021 at 12:00, the patient experienced a shortened menstrual cycle. It was reported that the patient experienced two menstrual periods in a space of less than one month: first day pf period: 20Jun2021 Last day of period: 27Jun2021; first day of period: 12Jul2021 Last day of period: ongoing at the time of report. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event two menstrual periods in a space of less than one month: first day pf period: 20Jun2021 Last day of period: 27Jun2021; first day of period: 12Jul2021 Last day of period: ongoing at the time of report was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Upon rising from bed on the morning of Oct 9, 2014, exactly 20 days after receiving the influenza vaccine, I was overcome by extreme vertigo to the point that I was spinning so fast that I could not see.  I thought I was having a stroke.  It took about 5 minutes or so before I could get out of bed.  I began vomiting about an hour later and still 5 days later, I am unsteady on my feet.  I have had vertigo once before on Thanksgiving morning in 2012, exactly 28 days after receiving the flu vaccine on 9/30/2012. I also received the flu vaccination on 9/2/2013 with no adverse events following that vaccination.   I would also like to state that I had a shingles vaccination on Oct 3, 2014, 6 days before this adverse event occurred.
A week after vaccine, I vaccination site turned red and was warm to the touch. At 2 weeks after vaccination, the area has a red ring around it and has grown in size.
Rash below the injection site that ran from below the injection site to the end of the arm,rash also developed on the leg, back of the calf and knee, very itchy. Patient tried creams that he had at home and taking BENADRYL. BENADRYL helped for awhile, thought it may be from the injection and not a preexisting condition since his creams did not help. BENADRYL stopped working Friday. Tried hydrocortisone at home, got some relief. Came to pharmacy to get more. I encouraged him to call MD since he is leaving for trip tomorrow. Went to see MD, MD thinks from the shot gave him prednisone to take with him if it doses not continue to get better. Currently is getting better.
Patient received Tdap vaccine at approximately 11:50am without complications. Mother called office at 1:30pm stating child had rash on bilateral ankles/feet and in groin area. C/O itching. No difficulty with breathing. Rec take Benadryl and contact primary care MD for f/u ---> next day patient pc to patient ---> "did not go to PCP, rash gone"
Information has been received from a registered practical nurse concerning a 16 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. On an unspecified date the patient experienced headache, nausea and fever. The symptoms were resolved with TYLENOL. The patient sought medical attention by a phone call. Follow-up information was received from a physician's assistant who reported that on 14-JUL-2010, the 17 year old (also reported as 18 year old) female patient with no pertinent medical history and no known drug allergies, received the first dose of GARDASIL (lot # 663551/1495Y) intramuscularly into her left arm at 16:21 hours. It was reported that on 19-JUL-2010, the patient experienced headache and chills. The patient did not need any treatment. On an unspecified date, the patient recovered from headache and chills. There was no pre-existing illness at the time of vaccination. No further information is available.
Fatigue; felt hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 (Lot number: EW0171) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: None. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; FEELING HOT (non-serious), outcome "unknown", described as "felt hot".  Additional information: Patient told he was complete hermit. Patient told he experienced fatigue as well, but felt hot, not chills. Patient also told that he and his wife should get their second dose on 18May2021 but had not confirmed appointments then, stated he might go ahead and get his but was unsure if his wife should. Prior vaccinations (within 4 weeks) patient did not receive any other vaccinations. Patient medical history and family medical history was reported as none. Reporter seriousness for Fatigue and felt hot were reported as unspecified.  No follow-up attempts are possible. No further information is expected.
S&S: reduced white blood cell count, low neutrophils, increased fatigue, short on air. WBC have recovered. Increased Fatigue continues and fluctuates day to day without any correlation.
Patient had arm soreness and headache the afternoon of injection. The next morning she had severe headache, diarrhea, nausea and vomiting. She was fatigued for the next 2 days. Saturday morning, October 31, she noticed her vision was not right. She had previous eye surgery, so she contacted her ophthalmologist.  He told her to come in Monday to be checked. When she went in for checkup, her retina was detached and she had to have surgery to repair it the next Monday
pt states that her menstrual period ended on 4/18/21 but after getting the vaccine she started having  severe back pain and then on 4/24/21 started an abnormal heavy menstrual period again.  Pt went to ER on 4/27/21 due to these symptoms.   She had blood work and was given Provera and was told to FU w/ OB-GYN.  She had to find a new OB-GYN doctor and finally found one that she saw 3 weeks ago where she had more blood work.  She has an US scheduled on 8/3/21.  Her menstrual periods are back to a normal schedule but has a much heavier flow now.  She has a strange sensation in her private area now that comes and goes and she doesnt know how to explain it.
On 6/14/21 This patient came in for her scheduled 4 month well child check and was due for vaccinations including Pediarix, HIB, rotateq and PCV13.  The vaccinations were administered to the patient with her mother present in the room at approximately 1135 by this RN.  After which the patient and her mother left the clinic. At approximately 1151, this RN went to document the vaccinations into the pts chart and discovered a medication error had occurred. Instead of the ordered vaccine of PCV13, Fluzone was pulled from the omnicell and administered to the pt as an IM injection to the right thigh. After this discovery, this RN informed the provider at approximately 1155. Dr. called and informed the patients mother who reports no adverse effects and stated the pt was just a little fussy and tired. Dr. will continue to monitor the pt and see her in the officer for a follow up visit.
Entered observation @ 1501.  Pt c/o itching to throat and face @ 1523.  Patient walked over to stretcher in the clinic.  Benadryl 25mg was given po.  V/S @ 1526 139/53, P-100, R-18. O2-93%.  V/S @ 1530 BP-137/77, P-103, R-18, O2-98%.  1537 pt talking, alert, and oriented.  BP-125/75, R-18, P-101, O2-99%.  Remained in observation.  Alert and responsive.  V/S @ 1544 BP-131/77, P-85, O2-100% R-18.  Continued to voice no s/s of itching to throat nor face.  V/S checked again @ 1553, BP-101/81, P-81, R-18, O2-100%.  Pt states that she feels fine.  Walked short distance in clinic after sitting up and on side of the bed for a couple of minutes.  Left observation @ 1605.
Felt unwell; Coudn't walk; Couldn't talk; A spontaneous report (United States) was received from a consumer concerning a 87 year old male patient, who experienced feeling unwell (malaise), couldn't walk (gait disturbance), and couldn't talk (speech disorder).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received the first dose of  mRNA-1273 (lot number 029L201A) on 14 Jan 2021.   On 11 Feb 2021, the  patient received their second of two planned doses of mRNA-1273 (Lot number 030M20A) intramuscularly in the right arm for COVID-19 infection prophylaxis.  On 14 Feb 2021, the patient felt unwell for a few days, and couldn't walk or talk.  On 16 Feb 2021, the patient was admitted to the ICU for 7 days. Then, moved to rehabilitation and remains there. Wife stated that she wants Moderna to reach out to them with regards to compensation or whatever can be done. She is OK for safety follow-up.   The patient received both scheduled doses of mRNA-1273 prior to the events. Therefore, action taken with the drug in response to the events is not applicable.   The outcome for the events of feeling unwell (malaise), couldn't walk (gait disturbance), and couldn't talk (speech disorder) was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.
The next day there were sharp pains in my chest area. I felt like a heart attack.  The pan lasted about a hour. I took a baby aspirin, Gas-ex and Pepcid. This has happened after every shot of the Moderna vaccine.  The pain went away after applying the medications each time .
Broke out in Hives all over my body , received Perscriptions for lotions and Rx for itching.  First visit was to ER (3/16/21) 2 days after shot administered.  2nd visit was to urgent care (3/18 /21)  Third visit was to Primary Care Dr. on 3/21/21.  The hives would settle down and then aggressively flare up again.
Heart attack walking into the ER on the way in. I had a heart catheterization performed in the hospital at which time, there was no signs of any blockages and issues. Nothing visual at all when they did this procedure. They were looking to see if the stents had moved or if there were any blockages. That's when the doctors became suspicious. They noted that there were heart attacks after vaccines. Neither condition I think can be connected to the vaccine at this time. Non-contagious rash, uncommon in men, after I got the 2nd dose of the vaccine, I got a 2nd rash on top of the original rash. They said it was an HPV disease called squamous cell carcinoma, pre-condition to cancer. Dormant until I got the vaccine. When they put me on the acitretin, put me into a condition called Rhabdomyolysis, takes protein out of muscles. Gave me an irregular heartbeat and pulse rate. Changes in medication since the health event.