chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed hives on back of left arm.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the left arm on 12Apr2021 at 13:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The medical history included anemia and penicillin allergy. 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 vaccination. The patient did not receive any medication within two weeks of vaccination. On 18Apr2021 at 19:00, the patient developed hives on back of left arm. The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient not been tested for COVID-19. The clinical outcome of the event hives on back of left arm was recovered on an unknown date in Apr2021.    No follow-up attempts are needed. No further information is expected.
Erythema 10 cm x 10 cm, lump 2 1/2 cm x 3 cm. Patient c/o some discomfort. Swelling decreased from earlier. Low grade temp earlier today 98.9 oral temp. Augmentin x 7 days.
Evening after vaccination patient reports hives all over body. Treated with Benadryl. Day after patient reports injection site is slightly red and has a slight bump under skin. Took Zyrtec per her physicians orders.
NO ADVERSE EVENT.  PATIENT RECEIVED THE SECOND DOSE OF THE VACCINE AT 14 DAYS VERSE THE RECOMMENDED INTERVAL.
Medication/Administration Error- Patient given 0.2mL of Pfizer COVID-19 vaccine without diluting (6-10 times higher than recommended dose). Patient observed at home by parents. He was only noted to have a low-grade temp of 99ºF. Mother denied any localized reaction at the injection site or any other adverse effects.
2 hours after the Moderna vaccine, I began urinating blood!   It was not just pink tinted urine, it was a full stream of blood upon urination!!   The blood was actually collecting at the base of the toilet.  It slef checked my self to see if I        could tell where it was coming from. and it defnately was from my urethra,NOT my vagina.   I continued to bleed like this upon urination for the rest of the day.  When I woke up at night, the amount was much less, but still there.   For the next few  hours, the hematuria seemed to stop.   On Thursday  morning, it started up again!!   I was advised by the surgeon whom I work with, to go see my Dr.   As instructed, I went to the dr. after work.
On 12/19/20 Woke up at 4:30 , 3 hours after going to bed (9.5 hrs after receiving vaccination) with left arm throbbing. Was nauseated, whole body violently shaking, feverish (never took temperature).  States he could not control shaking. Lasted about 30 minutes, could barely walk. Afterwards felt achy and very weak.  Felt better on awakening, but whole body aching and weakness returned around 600PM and again at 1000PM.  Took Tylenol/Ibuprofen for relief. On 12/20 at 600PM also experienced whole body aching and felt generally poorly.  12/21/2020 Doing well today.
metastatic gallbladder cancer, sepsis, hypotension, altered mental status, acute on chronic renal insufficiency, colitis, lower GI bleed, and anemia
This spontaneous report as received from a currently 69 year old male consumer refers to himself. In December 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not provided) vial, single administration dose injection. Concomitant therapies included hydrocortisone cream. In 2012, a "few months" following administration, he began breaking out in a rash around the injection site. The rash grew in size and remained for nearly three months, also involving his hips and legs, beginning on the back of one leg, then "traveling to the other". The patient described the rash as "feeling like rough sandpaper, very itchy with small bumps that felt like they were bursting". Three months passed and the rash subsided. A physician confirmed the remarks on his skin as being evidence of the shingles virus. The patient added that "about two months ago, during 2013, he felt burning and heat on his left forearm. One day later, he began breaking out again in an intermittent rash which involved his arm, sides, hips and shoulders, in the form of small, burning and itchy patches. He experienced scarring of the skin and tiny pustules that burst. He noted that the rash often changed in size; it could range from "the size of a 50 cent piece to as long as 6-8 on his leg. The patient sought medical attention by an appointment with the physician. It was given over the counter ointment as treatment for the event. At the time of the report, the patient had not recovered. The therapy was not reintroduced. Additional information is not expected.
Itching, painful rash at the injection site. Almost entire bicep covered in bumps and welts. No adverse effects in the preceding week; rash appeared one week after injection.
Mother called about 11:30 am on 3/23/04 and child had recently developed hives. She called the doctor but hadn't heard back from them. Mother gave Benadryl through the night and child has no symptoms now. Mother never did talk to private medical doctor.
Pt states they have had arm pain since the shot.  Also, they state they are having a hard time closing their hand
After getting the first of 3 scheduled shots for HPV from her pediatrician, my daughter started to feel nauseus, lethargic, and have a severe lack of appetite. This happened gradually, and we didn't connect it to the shot at first. We followed up with the 2nd shot 2 months later as we still didn't make the connection to the shot. She went in for an unrelated doctor's visit 05/26/16 where they noted she had lost 7 pounds (from 123 to 116 lbs) since her February physical. The doctor wanted us to see some specialists and get blood work done. The blood work came back normal and the subsequent visits to Cardiology and Genetics found nothing wrong. We ended up at an Adolescent Specialist who has worked with her for the past 1 1/2 years. While waiting to get an appointment with the Specialist she had her 3rd shot of HPV vaccine, as we still had not made the connection. After many visits with the Specialist and subsequent blood, urine, feces tests and many medications, he diagnosed her with an autoimmune disorder, Dysautonomia, which he said may have been brought on by the HPV vaccination. There are no other events or diseases we could connect to the sudden start of extreme symptoms. He is the one who told us to make this report. One way he helped us connect it to the vaccine was because patient's younger sister, got the same shot and started to display slightly less severe syptoms that were the same as patient had just after her shot. We stopped after only 1 shot for her sister.  After I did a lot of research on vaccinations, and the HPV vaccine in particular, I discovered that there had been reports of over 700 girls who had recieved the HPV vaccine and then all had started to experience the same symptoms patient has. The agency had supplied the vaccine and has denied any connection, but the evidence is there. Certain genetic factors make the vaccine trigger this autoimmune response.  There are many other reports of similar findings in other places, including here. I have 2 other kids who also had 1 or 2 doses of the HPV vaccine before we made the discovery that it was the likely trigger for the problems, and they did not display any symptoms. They are very different, genetically, and are both being treated for other issues, unlike the patient and her sister, who were both very healthy prior to the vaccination.
Right arm is fine but pt is experiencing pain and swelling in the left arm, also warmth in area.
Went to bed early (about 7:30 pm) following 5:30 pm vaccination, feeling fatigued and "light" general malaise flu-like symptoms, not at all severe. Woke up at 10:30 pm with severe, almost spasmodic, full-body shakes... like tonic/clonic contractions in jaw, arms, core, legs. Tried to get out of bed, but afraid of falling as I could not stand up. Did not attempt taking my temperature at this time with oral thermometer because it's glass and I was afraid I would chomp on it and break it. Fever seemed to start at about 30 minutes of shaking. Shakes continued for one hour, tapering off last 15 minutes and subsiding at about the one hour mark, at which time I took my temperature and registered 102 F. The fever "broke" four hours later. After that, I slept well, and woke easily but felt very muscle sore all over (my descriptive: like I'd been worked over with a bat). General soreness and fatigue gradually went away over a three-day period. No other lingering effects noted. While shaking was severe enough I debated about going to the ER, in my rural setting this is not a simple 911 call: and the initial contractions did not worsen throughout the episode; so I "rode it out." My breathing was at all times normal. I have no idea what my blood pressure was.
Hives developed on arm, trunk, and buttocks. Felt short of breath and fatigued.
pt devel severe purplish, vasculitic & petechial rash 8 days p/vax; pt hosp last year;rash reappeared this year again 8 days p/flu vax;no hosp required this year;
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.  No treatment medications were reported.
Approximately two hours after the shot, I started feeling very dizzy, I felt off balance and felt as if I will fall while walking, had diarrhea, felt heavy at the back of my head and had neck pains. Had small bout of vertigo when I laid in the bed. Felt very tired and had some brain fog. S/S improved in 12 hours. Should I take the 2nd dose?
Left Arm became numb in elbow/ulnar nerve region for approximately 10 hours. Was possibly attributed to sleeping oddly at the time but is still exhibiting symptoms of inflammation and numbness 2 months later.
Moderna was administered to patient that was first punctured at 2pm on 12/21/21. Patient received vaccine at 8am on 12/22/21, no adverse reactions noted from patient. Patient was monitored for the 15 min post vaccination.
MIGRAINES 24/7-FROM TIME OF INJECTION TO CURRENT. -ON AIMOVIG 140MG AND MAXALT 10MG FOR IT. DVT BLOOD CLOTS IN LOWER LEFT LEG -FOUND SEPTEMBER 20TH, 2021. ON XARELTO FOR 3 MONTHS. HAD MRI'S, CT SCAN,EKG, AND ULTRASOUND.
Information has been received from a patient's mother concerning her 3 year old son, with no pertinent medical history and no drug allergies / drug reactions. The patient's mother reported that her son was vaccinated with a dose of VARIVAX (Oka/Merck) (lot# 656172/1498F) "one year ago". There were no concomitant medication. On 24-Nov-2008 the patient was diagnosed with shingles. The patient sought medical attention with the pediatrician. No laboratory diagnostic studies were performed. The patient had not recovered at the time of the report. Follow up information was received on 23-Dec-2008: the patient received the first dose VARIVAX (Oka/Merck) (lot# 656172/14987) on 16-May-2007 and in the same day received the first dose of HEP A (lot# 666993/000IU). It was reported that clustered vesicles on his left elbow clinically consisented with Zoster. The patient sought medical attention. Additional information has been requested.
acute subdural hemorrhage (presented as word finding difficulty and confusion for 2 days per son who convinced his mother to come in to ED)
Pt called on call physician and reported hives so pt was sent to ER and not seen in office for the complaint.
This case was reported by a healthcare professional and described the occurrence of lump at the injection site in a 21-year-old female subject who was vaccinated with influenza vaccine FLULAVAL, (GlaxoSmithKline).  There were no concurrent medications.  On 2 September 2008 at 10:00 the subject received unspecified dose of FLULAVAL at 0.5 ml, subcutaneously, in the left arm.  On 3 September 2008, 24 hours after vaccination with FLULAVAL, the subject experienced lump at the injection site, injection site warmth and injection site redness.  The drug was also administered via the incorrect route.  FLULAVAL should have been given intramuscularly.  At the time of reporting the events were unresolved.  This event occurred in three subjects.  Linked cases included A0746645A and A0746649A.
Child was brought in for routine well child care, and was inadvertently vaccinated with 0.5 ml Zostavax instead of the peds Varicella vaccine.
3 days p/vax pt devel bloody stools & dx w/intussusception required surgical repair & loss of 9cm of bowel;
Full blown flu.  Vomiting, 103.5 temperature, chills, body aches.  Administered ibuprofen and acetaminophen.  Fever only controlled with use of both.
Initial report received from a nurse, on 03 November 2006.  A 53 year old female patient, received Fluzone (lot number U2164AA) into the left deltoid, on 01 November 2006.  A few hours after immunization, on 01 November 2006, the patient experienced red and swollen area, at injection site.  24 hours (post vaccination) (on 02 November 2006), the injection site was warm to touch.  48 hours (post vaccination), on 03 November 2006, the injection site was itchy and there was a 9-19 cm red area at the left deltoid, of the injection site.  No corrective treatment was reported.  At the time of the report (03 November 2006), it was unknown if the patient had recovered.  The patient's medical history included unspecified allergies.  The patient did not have any illness at the time of vaccination.  The patient's concomitant medications included Zyrtec and "Singulair".  Prior exposure to Fluzone was not reported.  Follow-up information received on 04 December 2006.  Per the reporter, the patient recovered from these adverse events as reported by a friend of the patient on 01 December 2006.  No further information is expected.
Arm sore for 2 days, on 8th day the redness and rash appeared and its very minor. I'm scheduled for carpal tunnel surgery and had blood work done recently
No other AE; A dose was administered to a patient after a temperature excursion; This spontaneous report has been received from a nurse prescriber referring to a patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies were not reported.   On 27-JAN-2022, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose (route of administration, anatomical site of vaccination, and vaccine scheme were not reported; lot number U008315 has been verified to be valid, expiration date reported and established as 15-AUG-2023) for prophylaxis.  The vaccine was exposed to a temperature excursion of 0.5 degrees Celsius (C) during a time frame of 168 hours (product storage error). There was no previous temperature excursion, and no other adverse event was reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA003842: US-009507513-2202USA003879: US-009507513-2202USA003908: US-009507513-2202USA003856:
Patient received vaccine, waited in the pharmacy for approximately 15 minutes and left feeling well.  She then returned to the pharmacy approximately 20 minutes later with shortness of breath, cough, and malaise.  She was offered an Epi-Pen by the pharmacist, which she denied.  Pharmacist then called a provider (ARNP) who took vitals and administered IM diphenhydramine.  After several attempts to administer Epi-Pen, patient refused each time and an ambulance was called.  Spouse was present at all times.
At approximately 1:55pm LR received the covid-19 vaccination by Moderna. Around 2:00pm patient showed signs of allergic reaction during which she developed a rash on face. 911 was called and diphenhydramine 50mg IM was adminstered per protocol. Paramedics arrived on scene at 2:10pm where I ceded treatment.
Two sore arms; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received an unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, Batch/lot number, NDC number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The report was not related to a study or programme. On an unknown date the patient received the Pfizer shot, unspecified, and had two sore arms. The patient's investigation assessment was not provided. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever and restlessness for about two hours, followed by low-grade headache, and body ache, generally feeling tired.
Adverse reaction started to happen in the evening I went through body aches and then hot and cold flashes shivers the and sweats then shivers and sweats headache and general pain an d body aches with no relief took max dosage of Ibuprofen then called nurse for OTC recommendations I really only remember waiting the night out and it began to wane the next day. During the night could not walk I was shivering and weak.
Post injection x 11 days, I awoke to find a quarter-size dark pink circle on my left arm, at the injection site.  It was not painful, itchy or raised, but it did palpate feeling like a hard nodule below the surface. I contacted my primary physician, but she wasn't available.  On day 2 of the reaction, the size of the reddened area had increased in size. My physician suggested I contact a dermatologist. On day 3, a second adjacent area appeared, but larger in size than the first. I did not hear back from my dermatologist. I took a benadryl before bedtime, but awoke on morning 4 (today) to find the two areas and coalesced and have become itchy. I will contact a physician friend for advice.
Patient experiencing allergy symptoms, sneezing and body aches; is afraid to go to appointment for second vaccine tomorrow; Patient experiencing allergy symptoms, sneezing and body aches; is afraid to go to appointment for second vaccine tomorrow; Patient experiencing allergy symptoms, sneezing and body aches; is afraid to go to appointment for second vaccine tomorrow; This is a spontaneous report from a contactable consumer (Reporter is calling on behalf of her aunt). A unspecified age of female patient received BNT162B2 (Pfizer- BioNTech COVID 19, solution for injection, Batch/lot number: Not Provided) via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunization. The patients medical history and concmittant medications were not reported. On unspecified date, the patient experiencing allergy symptoms, sneezing and body aches; is afraid to go to appointment for second vaccine tomorrow. Reporter states she is going to tell the patient to just go next week for second vaccine. Reporter is calling on behalf of her aunt, who received the first dose of Covid-19 vaccine on 10Mar and had a scheduled appointment for a second dose due tomorrow, 31Mar. She mentioned that her aunt has an allergy and body ache yesterday so she cannot go tomorrow. Asked if she can cancel her appointment tomorrow and go next week. The oucome of events was unknown.  Follow-up (05Apr2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Query: Please see the attached source document with a medical inquiry. AER# 2021361419.Response: This is to confirm receipt of inquiry. Please see case in GRACE, INT-#  Follow-up (30Jun2021): Follow-up attempts completed. No further information expected.
doses were given after expiration date; expired vaccine is stored on 18-Oct-2021 and then administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored on 18-Oct-2021 and then administered) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (expired vaccine is stored on 18-Oct-2021 and then administered). On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored on 18-Oct-2021 and then administered) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient had not experienced any adverse event and No Temp excursion was happened to the suspect vaccine.  The vaccine was placed in refrigerator on 18 Oct 2021.   This case was linked to MOD-2022-491837 (Patient Link).
Patient complained of dizziness onsite EMS was called her sister translated spanish on the phone for us. Went home few 20 minutes later.