chrisvoncsefalvay/vaers-outcomes huggingface dataset:
broke out in hives; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: EN6204) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 06Mar2021, outcome "recovered" (2021), described as "broke out in hives". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria.  Additional information: AE treatment was reported as topical ointment. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks and other medications in two weeks. At the time of report, no known allergies and other medical history reported, and device date reported as 19Nov2021.  No follow-up attempts are possible. No further information is expected.
Chicken pox blister appeared on my forehead and lasted for a week, a week later another blister formed at the injection site and lasted for a week. Yesterday, 2 months after the vaccine was administered, another blister formed on my neck. All three itched and became very red, then scabbed over the next day.
My daughter started to have her period at 9. I feel it?s the vaccine as she has been exam before by her doctor. I was told that this wouldn?t start until 2 more years. After vaccine she complained about pain and cramping in stomach.
had shingles and the shot/ Suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot and shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Patient in for red pimple like lesions on his abdomen and back noticed since 4 days now.  Parents state the older papular rashes are drying up but new ones are noted on the face, left shoulder, left axilla, right arm, 3 on the right thigh and one on the right leg. Rashes start as red papules which become crusted. He had his Varicella Vaccine #1 given on July 12, 2021.  No new soap, lotion used. No new food eaten. They have dogs outside the house. Nobody else has it at home.  He also has a runny nose with clear nasal discharges but is getting better.   No fever or cough. No fast or labored breathing.  He is active and eating well.  No sick contacts at home but goes day care.   DIAGNOSIS: Parents were advised since he was noted with new red papules over the weekend  and had old ones which are drying up now with history of Varicella vaccine on 7/12/2021, rashes likely from the Varicella vaccine. he has no exposure to active Tuberculosis, none reproted from daycare and nobody at home has it. Parents were advised not to bring him back to daycare until all the lesions are dried up. Advised he is contagious too though it is from the vaccine.  Will report to VAERS.
Initial unsolicited report received from a healthcare professional on 08-Nov-2017. This case involves an 86-year-old male patient who was vaccinated with 0.5 ml dose of FLUZONE HD (batch number: UI887AA, expiry date, dose, site of administration was not reported), intramuscularly on 07-Nov-2017 and also was vaccinated with PNEUMOVAX in left deltoid on an unknown date. The patient's medical history included hypertension, heart issues. The patient had no known drug allergies (NKDA) and was not sick at the time of vaccination. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient couldn't sleep last night due to left arm pain, developed swelling and pain of the upper left arm, and can't lift the arm, this morning had nausea and diarrhea. No other symptoms reported. Lab data and corrective treatment was not reported. The patient had not recovered from the events. List of documents held by sender: none.
Local skin swelling and itching with large red rash on left arm.   Went to Urgent Care Facility:  (Date of visit:  February 09, 2021 Treatment:  Doxycycline 100 MG Capsule
A very very fast heart beat; Difficulty breathing; Severe headache; This is a spontaneous report from a contactable consumer and a physician. This 32-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0172) via an unspecified route of administration on 22May2021 between 08:30-09:00am in left arm as 1st dose, single dose for COVID-19 immunization. The patient's medical history included enbomecriosia, she was diagnosed with this condition for a long time and does not remember but has had it for 20 years or more. The patient's concomitant medications were not reported. It was mentioned that the patient had vaccine early in the morning and went home to sleep a little bit and woke up and had an unbearable headache on the same day (22May2021). On 23May2021 she mentioned that she could not go to church and was very very sick and had difficulty breathing and very fast heartbeat, which were not continuous but were intermittent and it takes like 30 minutes before they go away and then happen the next minute again; she stated that the difficulty breathing comes with wearing a mask and she could not breath and has a sharp pain in her head. She had not had the second dose yet and was concerned about getting the second dose because of her reaction to the first dose. She was asking for recommendations. and wanted to know how long to expect these symptoms. Therapeutic measures were taken with Tylenol 500mg with lot 9LE00071, expiry date Sep2021 and UPC 4099100107333 for the events very very fast heart beat, severe headache and difficulty breathing. The outcome of all the events was not recovered.
Fever of 103.5. Disoriented. Slept 20 hours. Heart palpitations lasting several days. Extreme thirst lasting several weeks.
Fever of 101, shaking, chills, headache, joints hurt, sbody stiff, achy all over, fatigue, general not feeling well which all lasted 24 hours and began 12 hours exactly after shot, dizzy (vertigo) and nausea, fatigue, and headache, began 2 days after shot and is still on going
Redness and swelling at injection site which took in the left arm from upper arm to left wrist aread.  Almost cellulitis appearance with itching and red streaks.  Resolved in 5 days.
Weird taste in the throat, chills, headache. Almost felt like I was anxious for the first two hours then it went away. The night i felt chills, fever, slight cough and then it went away by sunday.
I began vomitting in the middle of the night. This continued every 15 minutes for 13 hours straight. I was seen in the ED and was treated with IV fluids and nausea medication.
blood pressure was very high; This is a spontaneous report from a contactable consumer reporting for herself. A 65-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203, Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 28Feb2021 15:00 as single dose (at age of 65-years old) for covid-19 immunization. Medical history included High Blood Pressure, diabetes mellitus, cardiac pacemaker insertion from an unknown date and unknown if ongoing, penicillin allergy, COVID-19 from an unknown date and unknown if ongoing (if covid prior vaccination: Yes). The patient received other medications within 2 weeks of vaccination (unspecified). 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. The patient experienced blood pressure was very high on 11Mar2021. Patient stated, sent her to the Emergency Room. She had to switch medicines and still trying to get it under control. Patient received treatment of IV, Tests and monitoring. The patient underwent lab tests and procedures which included Blood pressure measurement: very high on 11Mar2021, SARS-COV-2 test: positive on unknown date. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
was given MENACTRA today and had prior dose on 21SEP2021 with no adverse event; Initial information received on 08-Jul-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. GMI Inquiry Number: 01182535  This case involves a 12-year-old female patient who experienced was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] today and had prior dose on 21sep2021 with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Sep-2021, patient received dose of Menectra at unknown (formulation, strength, dose, frequency, route, lot, administration site) for prophylactic vaccination.  On 08-Jul-2022, the 12-year-old patient received another dose of suspect Menectra vaccine at dose 0.5ml once (lot U7190AA, expiry date: 16-JAN-2023) via intramuscular route in the left deltoid for prophylactic vaccination (extra dose administered, latency same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 guidelines. 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.
No additional AE reported.; dose of VARIVAX was administered after a temperature excursion.; This spontaneous report was received from office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W020540, expiration date: reported as 29-JUN-2024, however upon internal validation it was established as 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error).  Administered doses of vaccines experienced the temperature excursion of 41.4 degrees Fahrenheit (F) for 1 hour 58 minutes. There was no adverse event reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA008267:Same Reporter US-009507513-2301USA008103:Same Reporter
Deceased on  2/28/22   Per notes in she was admitted thru ER where she presented with dyspnea and had AFIB RVR.  She had flu B prior to admission.  Admitted 1-30-22 .  Covid pneumonia.  was to be given Rem D decadron, rocephin azithromycin.  Converted to NSR .
Metallic taste in their mouth; This case was reported by a pharmacist via call center representative and described the occurrence of taste metallic in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced taste metallic. On an unknown date, the outcome of the taste metallic was unknown.   It was unknown if the reporter considered the taste metallic to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  As the patient received Shingrix, they experienced a metallic taste in their mouth. The reporter had no further information and at the time of reporting was not at work.
Muscle weakness, dizziness, nausea and vomiting beginning 7 hours after administration and continuing to occur 36 hours later at the time this form is completed.
I begin to notice hives developing about a week after my "booster" shot. I had no real adverse reactions after my first two shots and didn't really think anything of it until the hives were all over my body. They itched so much I had trouble sleeping. After a couple of days of trying Benadryl off and on, I went to the web and found other people had the same reaction. It was suggested by someone that Zyrtec was better than Benadryl and I tried that which works! Now I still get blotchy spots on my skin and if I miss a dose, the hives come back. It just sucks that I now have to take medication once a day to keep it at bay with no idea of how long I am going to have to do this...
dizziness, loss of consciousness, several minutes unable to regain consciousness, blood pressure remained low, after trip to ER required two bags of liquids to bring blood pressure up to a safe level for discharge
10 cm red, raised with bulls eye in center left mid arm at site of varicella vaccine. Occurred 24 hours after vaccination itches and burns with some pain. Given Benadryl, ice pack and Tylenol for pain.
1/6/21: Received Moderna COVID vaccine. Just wanted to let you know that I am experience some ?flu? like symptoms after my vaccination which sounds like are normal for some folks. Temp 99.6 just now was 99.1 when I came in this morning. Freezing/chills, cough, pain and redness at site, joint aches.  1/7/21 at noon temp 101.2.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. The reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter while reporting her own adverse event, mentioned she had a friend who also had a reaction to the SHINGRIX vaccine. No further detail was provided. This case has been linked with case US2018086788, reported by the same reporter.
Persistent rash (usually over upper half of body). Hives come and go throughout the day.
Approx 12 hr after receiving the 1st dose of Moderna, she states she woke at 3am due to a strong perfume scent.  She feels the smell comes from her nose.  She has not lost her sense of smell.  The perfume smell is always there, but she can smell other odors as well (eg- toothpaste, peanut butter)   The odors are just combined.    The perfume scent is less prominent at times, but always there.
temperature is 96.7 C; chills; soreness on the injection site; A spontaneous report was received from a consumer concerning a 80-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain (soreness on the injection site), chills and pyrexia (temperature is 96.7 °c).  The patient's medical history was not provided. Concomitant medications reported were Thyroid medication for drug use of unknown indication.  On 28 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Not provided) via unknown route for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced soreness on the injection site and chills few times for about 10 days. On an unknown date, the patient experienced drainage and On 25 Feb 2021, the patient stated she had temperature of 96.7 â°c.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
147/67 BP 67 HR 18 RR 99% Pso2 on Room Air    After receiving the first first doze of Pfizer vaccine. Patient started developing pruritus around her face. Patient was taken to the assessment area where she now admits to a generalized itchiness. MD  was informed. There is no rash, hives on the patient skin. Patient denies  Shortness of breath at this time. Decision to give patient 25 milligrams of benadryl PO was consulted with MD and given to the patient.    11:20 patient states she feels much better at this time and her pruritus is gone.  We will continue to assess and monitor patient.    11:30  patient was D/C per MD. Patient walked with a steady gait. No distress noted. Patient denies any dizziness, SOB,  Patient will follow up with PCP
sitting in chair, became pale, started shaking lasted approx 15sec; pt states fainted; no apparent injury or hx of sz disorder
Redness and soreness around the injection site, redness on the right cheek and right ear with some swelling. Flu like symptoms like aching, dizziness and headache.
Pt recvd vax & exp joint stiffness & severe arthralgia pain not relieved by Motrin;
Information has been received from a consumer concerning her 6 year old son with a history of fever, diarrhea, lost appetite and "lost eye contact" after getting first dose of MMR (WAES #0903USA02669) on an unknown date, who "a month later" was vaccinated with ROTATEQ (manufacturer unknown). It was reported that the patient's antibody response negative. No further information is available.
pericardial effusion; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, who was an echocardiographer had recently noticed more healthy patients coming in with small non-hemodynamically significant pericardial effusions (PE) on those who were vaccinated with the Pfizer vaccine. The patient scanned self before getting the first vaccine and had no effusion, but 7 days later, the patient did have one on an unspecified date. That was why he started asking patients which vaccine they got. The patient had not seen any PE's with the other vaccines and patient don't believe this was a coincidence and it deserves further investigation. Outcome of event was unknown.
14 hours of Fever 100.4 degrees, pain in  back, neck,  arm, chills. The   fatigue and brain fog continued for 4 days.  All reactions resolved.
28 yo F who had SOB and wheezing and itchy throat that occurred about 10 hours after receiving her vaccine.  Symptoms resolved after 2 days and now feels fine.
First dose / Dec. 2020 / has not yet taken her second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in December 2020 intramuscularly).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up. No other information was provided.
Patient was in for initial visit and came back in a few weeks later for an IUD placement when routine IUD found that patient was pregnant.
INJECTION SITE PAIN; BODY ACHES; HEADACHE; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 14:00 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced injection site pain. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and dizziness on 10-MAR-2021, and had not recovered from body aches, headache, and injection site pain. This report was non-serious.
DIFFICULTY WALKING DUE TO THE PAIN; TINGLING IN LEG THAT GOES UP AND DOWN SOMETIMES INVOLVES TOES; DULL ACHE/PAIN IN LEFT LEG; HEAVINESS IN LEFT LEG; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 23-AUG-2021) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient experienced heaviness in left leg. On 17-MAR-2021, the patient experienced dull ache/pain in left leg. On 20-JUN-2021, the patient experienced difficulty walking due to the pain. On 20-JUN-2021, the patient experienced tingling in leg that goes up and down sometimes involves toes. Treatment medications (dates unspecified) included: diclofenac sodium, and meloxicam. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dull ache/pain in left leg, and the outcome of tingling in leg that goes up and down sometimes involves toes, heaviness in left leg and difficulty walking due to the pain was not reported. This report was non-serious.
Heart palpitations, prolonged QT interval. Last baseline and check up  was recorded August 2020 with no  cardiac related issues. Slightly elevated BP of 140/92