chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Palpitations; Generalized Itching/start to each different part of my body find it self too burning in itch; A rash all over her body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Generalized Itching/start to each different part of my body find it self too burning in itch), RASH (A rash all over her body) and PALPITATIONS (Palpitations) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043b21a and 028a21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Cefdinir allergy), Mosquito bite (Itchy), Hashimoto's disease since 2010 and Psoriatic arthritis since 1987. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE for Thyroid disorder NOS, MULTIVITAMIN [VITAMINS NOS] and CIPROFLOXACIN;DEXAMETHASONE from 01-Apr-2021 to 01-May-2021 for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PRURITUS (Generalized Itching/start to each different part of my body find it self too burning in itch). 23-Apr-2021, the patient experienced RASH (A rash all over her body). On an unknown date, the patient experienced PALPITATIONS (Palpitations). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (CETRIZINE) (oral) ongoing from 2016 for Adverse event, at a dose of 1 dosage form. On 27-Apr-2021, PRURITUS (Generalized Itching/start to each different part of my body find it self too burning in itch) had resolved. At the time of the report, RASH (A rash all over her body) outcome was unknown and PALPITATIONS (Palpitations) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 109 (High) 109.         The patient took cetirizine for the itching without relief ,and had to go to the emergency room  after a few days. She was prescribed steroids, Benadryl and other medicine. She was initially told to withhold the steroids because of an upcoming surgery, but because she experienced  palpitations after taking Benadryl, she went back to the emergency and was given the steroids, and felt relief after two hours.   This case was linked to MOD-2021-091047.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Significant Follow-up received on 28-MAY-2021 and contains updated information on patient history, allergies and events. On 28-May-2021: Initial Additional-1 : Merged from duplicate case MOD-2021-187596 On 28-May-2021: Translated document : Merged from Duplicate case MOD-2021-187596
Vomiting, Dizziness, Sweating (possible anxiety sweating per mom), BP 91/64, HR 53 RR 16, 99% RA (1425) -- > BP 110/76, HR 72, RR 16, 99% RA (1429)
Numbness and tingling in my left arm.  Begins near the shoulder and extends into fingers.  It is not happening all the time, but happens multiple times in an hour.  Did not have this problem before vaccine.
Inflamed lymph nodes under arms to breast,  fever, nausea, diarrhea, extreme muscle pain
Sudden onset: Sore arm - really sore. Whole body aches. Headache and neckache. I did not have a fever. 24 hours later they all disappeared. I found out I was pregnant on the 8th. I had  a normal ultrasound and a heartbeat at the end of January (the 29th) and February 8, there was no heartbeat anymore. I miscarried.  This was my fifth pregnancy. I had one other  miscarriage. I had a pregnancy where I had twins and one of the twins miscarried. So I have miscarried three babies. The expected date of delivery for this pregnancy was September 13, 2021.
PATIENT HAD COVID-19 VACCINE ON Dose 1 date: 03/23/2021, Dose 2 date: 04/13/2021, AND TESTED POSITIVE TO COVID.
Developed large welt sized hives that were very itchy, all over my face, neck, fingers, hands, arms, legs, and torso front and back, fever, difficulty breathing, severe weakness, severe fatigue, body aches and a general feeling of being weighed down, chest caving in and chest pain when breathing, rapid heartbeat, migraines, diarrhea. I was given topical steroid cream for itching, a 6 day dose of Prednisone, and a daily dose of Claritin. Hives would subside and scar, then a day later new large hives with severe itching would recur. I have been experiencing this since the vaccination and still experiencing it today with worsening symptoms, even after the regimen of Steroids.
Pt presented to the ER 3 days after vaccine with redness, pain, and swelling that had gotten progressively worse since the time of the vaccination. Pt was found to have cellulitis and was given antibiotic treatment. 10/5/09 Hospital records, DC summary, received service dates 8/9/09 to 8/10/09. Assessment: Anemia, renal insufficiency, hypertension, congestive heart failure, diabetes mellitus. Patient presents with painful swollen (R) arm and elbow x 2 days. Feverish and unable to sleep. Discharged against medical advice. ICD-9 Codes: 999.39 Infection Following Oth Infus Inject Trans or Vac, 682.3 Cellulitis/Abcess of Upper arm/Forearm, E879.8 Abnormal Reaction In Procedure NEC, 593.9 Disorder of Kidney/Ureter NOS, Diabetes Uncomp. Type II Controlled, 428.0 Congestive Heart Failure Unspecified, 285.21 Anemia in Chronic Kidney Disease, 403.90 Hypertensive Kidney Dis NOS w/Chronic Kidney Dis I-IV, 585.9 Chronic Kidney Disease Unspecified.
Dizzy, all day  Brain fog, all day  Hands tingled, for about hour after shot.  Muscle spasms/sore. Sporadically all over the body but last 1-30 minutes at a time. About a week.  Headache everyday since the first dose.  Rash and eye problems came back after the first dose.  On going.
Headache, Diarrhea, NauseaVomiting, lethargy, fever
fever/Temperature taken 100 degrees Fahrenheit; chills; overall fatigue; headache; This is a spontaneous report from two contactable physicians. A 41-year-old male patient received second dose of bnt162b2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After taking his 2nd dose of the vaccine on 09Jan2021, the patient experienced a headache on 09Jan2021, then on 10Jan2021, also included a fever and chills and overall fatigue throughout the day on 10Jan2021. Although these were consistent with the educational pamphlet on the vaccine, we still wanted to report it. Patient was taking ibuprofen and paracetamol (TYLENOL) as needed. Temperature taken 100 degrees Fahrenheit. Event took place after use of product. The outcome of all the events was unknown.   Information about the lot/batch number has been requested.
This spontaneous report as received from a 25-year-old female patient refers to herself. The patient's concurrent conditions included Human papilloma virus infection diagnosed two years ago. Medical history and concomitant therapies were not reported. On 17-DEC-2015, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot# were not reported), intramuscular. Immediately after the vaccination, the patient experienced chronic injection site and muscular pain. Lab diagnostic studies were not performed and the patient did not seek medical attention. At the time of the report, the patient was still experiencing the pain. The causality between the events and GARDASIL 9 was not reported. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of VARIVAX (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. It was reported that there was no lot numbers, expiration dates and patient data readily available. Nurse reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from a licensed practical nurse on 23-JAN-2015. The nurse stated that 9 doses of VARIVAX (Merck) with lot number K006137 were administered since fridge incident (since 09-DEC-2014). Follow up information has been received from a licensed practical nurse on 18-MAR-2015. On 02-SEP-2013, the patient of unknown age and gender was vaccinated with a dose of VARIVAX (Merck) that underwent a temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected, all available information has been received.
Suspected vaccination failure; had it twice; had it twice/2nd time was mild; This case was reported by a consumer via interactive digital media and described the occurrence of suspeted vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immunosuppression.   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), shingles and shingles. On an unknown date, the outcome of the vaccination failure, shingles and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported The patient stated he/she had shingles twice and was immunosuppressive. The patient had the shots and took the medicine and still caught shingles twice. The patient further stated, however, the 2nd time was not as bad. The patient strongly suggested people to get immunized. The patient's medical history was why it appeared again and he/she did stress that the 2nd time was milder and immunizations do work. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were not provided. The follow-up would not be possible as no contact details were available.
I developed intense soreness, which developed over 3-5 days into black and blue bruising in my arm pit and on the side of my breast only for the arm that had the injection. I also developed intense headaches in the middle of the night. For the first 48 hours, I have suffered fever and chills, but that did go away. I am 6 days from the day of injection and still struggling with the headaches and the significant bruising (it looks like I got beat up on my left breast).
PATIENT RECIEVED VACCINATION ON 12/1/07 AND PRESENTED WITH SX OF LOCAL REDNESS AND SWELLING AT INJECTION SITE AND A RASH ON RIGHT REAR TRUNK AT DRS OFFICE ON 12/4/07. SHE COMPLAINED OF SOME ITCHING OF THE RASH ON HER BACK.SHE STATES HER DR SAYS SHE HAS A SHINGLES OUTBREAK AND WAS  GIVEN AN RX FOR ACYCLOVIR.
experienced pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received HAV (Havrix) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   On 27th February 2020, the patient received Havrix. In February 2020, immediately after receiving Havrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Havrix.  Additional details were provided as follows: The patient received Havrix and experienced pain at the injection site since receiving the vaccine. There is discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
2-3 days after shot developed fatigue, muscle aches, metallic taste in mouth, diarrhea: fever, "bumps" on tongue lasting 6 days after immunization.  Refer to PICH/PCP
Side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included belimumab (Benlysta).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting Benlysta, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if 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 age group was not reported but was selected as adult as per vaccine indication. The patient asked how long do side effects from Shingrix shot last.   Following the action item reply, the following corrections were performed: The concomitant products belimumab (Benlysta) was deleted.
sore arm, pain down lt back & armpit;gen body aches & t101, no appetite, nausea swelling arm & throbbins arm @ noc;sl sore throat;
T105, P130, R24 in ER fever began day of vax 19NOV91; skin warm, dry no rash; tympanic membranes normal, lungs clear, neck supple;
Post vax, the pt developed erythema, edema, warmth, and tenderness at injection site. Pt started on Keflex and warm compresses.
Rash developed, blisters on bilateral legs.  Rash very itchy.  Diagnosed as Varicella rash
Welt on neck, and stiffness. I received the flu vaccine on Monday (10-1-18). Received steroid shot for bites last week.
Chills Narrative:  Patient called triage line 10/1/2020 after receiving flu shot on 9/23/20 to report chills, shaking, cough, nausea, headache, and right ear pain over the past 2 weeks.
Fever; body aches; chills; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 09Jul2021 at 18:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jul2021 at 06:00, the patient experienced fever, body aches and chills. Fever was continuing on day 2. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, body aches and chills were not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Several hours after patient received vaccine, rash developed on both of the patient's lower extremities. Patient reported to the ED the next day (26 June)  where he was referred to the dermatology clinic. Clinic obtained biopsy of the rash sight and prescribed triamcinolone topical. Rash continued to spread rapidly over his entire body, bringing the patient back to the ED on 28 June. Patient also complained of N/V, subjective chills, itching, and pain in his feet. Patient diagnoses with erythema multiforme as a possible reaction to the anthrax vaccine.
pt recv vax 23APR98;swelling, heat & redness devel 27APR approx 8-10cm as per mom;seen in ER but I have no records tx w/reflex;
My symptoms started on December 17, 2022 I experienced a Cerebellar Stroke.
A mother reported that her 15 month old son received his 3rd dose of Prevnar on 9/23/00. He developed a runny nose and was empirically treated with amoxicillin. On 12/20/00, he returned a positive throat culture for a strain of Streptococcus pneumonia that was "resistant to antibiotics". The serotype was not specified. He recovered.
30 hrs p/vax site was noted to be inflammed & reddish & warm x2" x 2 1/2 ' & uncomfortable;
This spontaneous report as received from a health professional refers to a 12 month of patient. On 13-JUN-2014 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # J012818, 10-OCT-2015) dose and route not reported which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Worst headache imaginable where I felt as if Atlas were pressing the world against my forehead Extreme nausea and vomiting Passing out Extreme sensitivity to light Called emergency services emergency services came and sat me up, checked all my vital signs,  I signed a form because I refused to go to the hospital Day # 8: eating causes nausea and bad headache still
shingles occurred on 6/17. Treated with 7 day course of Valtrex with good effect.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. In 2010 the patient was vaccinated with a first (only one) dose of M-M-R II (lot #, strength and dose were not reported). ON an unspecified date, the patient has serologic testing completed which was negative for two (unspecified) of the three components of the M-M-R II. The outcome of the patient's event was not reported. The relatedness between vaccination and M-M-R II and the patient's event was not reported. Additional information has been requested.
Shortly after receiving her flu shot (~within 5 minutes of receiving it), a patient came back and reported that she was feeling flushed and asked if she appeared red.  She seemed normal in appearance, but then she started complaining of severe lower back pain.  At this point, I asked her if she would like us to call an ambulance to which she responded, "yes."  I asked my technician to call 911, while I continued to assess the patient. I went out of the pharmacy to see if I could aid the patient to a chair in the nearby waiting area (5 steps away), but she complained her back was in too much pain, and she remained hunched over a shopping cart for support. Patient did not report difficulty breathing, dizziness, or nausea. I grabbed a chair and put it directly behind the patient so that she could sit down.  After sitting, patient reported the pain in her back moved to her legs.  And after a few more minutes of waiting, patient began to report she was experiencing chest pain.  Shortly after this, the paramedics arrived and took the patient to the hospital.
tested positive for COVID-19 and has been fully vaccinated for approximately 5 months/experiencing mild 'head cold' symptoms; tested positive for COVID-19 and has been fully vaccinated for approximately 5 months/experiencing mild 'head cold' symptoms; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID-19 and has been fully vaccinated for approximately 5 months/experiencing mild 'head cold' symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Event took place after the use of the product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dec started with abdominal pain, to the point she had to leave school.  On 12/4 abd pain and nausea continued.  12/5 started with diffuse hives.  Improves temporarily with benadryl
ADULT OBSTRUCTIVE SLEEP APNEA ACUTE ON CHRONIC RESPIRATORY FAILURE HYPOVOLEMIC SHOCK
Symptoms started 3 minutes after IM injection.  Heart beat bounding, then severe heat flash to skin on face chest and neck. Tongue and lips tingly. Lasted a minute or two then faded away. Symptoms came back 7 minutes later but less sever then faded. This was the second dose of the Moderna vaccine. And the symptoms were worse the second time when compared to the first dose.
Patient experienced chills, fever, fatigue, and lightheadedness the same day that he received his Johnson and Johnson vaccine.
Cough and shortness of breath with fever, began day after vaccination. COVID PCR negative. Required brief hospitalization for evaluation.
Information has been received from a physician concerning a 17 year old female with no known allergies who in the first week of March 2008, was vaccinated intramuscularly with the first dose of GARDASIL vaccine (yeast). Two hours after dose given the patient developed cough, shortness of breath and wheezing. The patient went to emergency room and was given steroids and antibiotic. The patient felt better the next morning (within 24 hours). Subsequently, the patient recovered from cough, shortness of breath and wheezing. It was reported that the patient will most likely not be getting second dose of GARDASIL vaccine (yeast) (also reported as discontinued). It was unknown if the symptoms were related to GARDASIL vaccine (yeast) or not. No product quality complaint was involved. Additional information has been requested.
Having flu like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Having flu like symptoms) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Having flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Having flu like symptoms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Cold Chills , Real weak, Loss of appetite, Headache, Vomiting (once)
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information regarding the patient's pertinent medial history, concomitant medications, drug reactions, or allergies was provided. On 16-SEP-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided). On an unknown date in September 2017, the patient experienced numbness and tingling on the right side of her face. The pharmacist did not know if the dose of ZOSTAVAX had any previous temperature excursions prior to administration. The outcome of numbness and tingling on the right side of her face was not reported. The relatedness between the adverse events and ZOSTAVAX was not provided.