chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 6FEB96 & had onset of some pain & swelling in the area which had gotten progressively worse;pt saw MD yesterday;poss a type of allerg rxn & not a cellulitis;also myalgias w/nausea;erythematous 8" x 6" indurated region;tender
Within 3-5 seconds R ear felt blocked Within 5 minutes tongue felt itchy and swollen and difficulty swallowing - eased after 5 minutes  after 20 minutes - felt a constriction in throat and required effort to swallow
Information has been received from a physician who reported that he was contacted from another physician's office regarding a patient who on an unspecified date was vaccinated with the first dose of GARDASIL and experienced urticaria 48 hours after the first dose. The physician did not have additional details because he had not seen the patient. The outcome of the patient was not reported. It is unknown if the patient sought medical attention. Additional information has been requested.
2 1/2" area of warm, tender erythema over rt deltoid @ DT site; c/o generalized achiness;
He completed Covid Pfizer vaccines on 2/4/21. He noted cough, body aches, and nasal congestion, and he was tested covid antigen-positive at walkin clinic on 8/16/21. Despite receiving monoclonal antibody as an outpatient on 8/20/21, his symptoms of SOB and weakness were worse, so he came to Hospital on 8/26/21 and was admitted. He is now requiring 6L of oxygen and is currently on the 6th day of hospitalization.
Injection site reaction to Prevnar.  Patient has a dime size pinkish-red spot with a quarter size knot underneath at injection site.  Reaction started on 10/16/07 and still present on 10/18/07 in office.
I have pain to the left arm, it is not really pain, its more like an inability to lift my left arm; Then it began to progressively get worse,; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), 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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "I have pain to the left arm, it is not really pain, its more like an inability to lift my left arm"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "Then it began to progressively get worse,".  Additional information: He had pain to the left arm, it was not really pain, its more like an inability to lift his left arm. He took the shot with his mother who he cares for, and has not had any side effects. When he go the injection he did not feel anything at all, and had no soreness for a couple of days, then it began to progressively get worse, and now he was not able to lift it about my shoulders, while his right arm he can lift it over his head, and if he use his right hand to lift his left arm over his head, it does not hurt, its just that he cannot control lifting it without help. He had no body aches, no flu like symptoms, he had nothing except this. He went to see a pharmacist and asked him about this and he was no help other than to tell him to got the VAERS site. He was due to receive the second dose of the Pfizer Covid vaccine, but he still had this symptom.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions or concomitant medications were reported. On 30-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB 10/0.1 microgram/ml, lot # K019502, expiry 04-FEB-2016, dose 2, 0.5 ml intramuscularly. No adverse effects were reported. It was reported that the vaccines were exposed to a temperature of 0 C for 3 weeks or 12C for 3 weeks during November 2015. No previous temperature excursion was reported. There were no product quality complaints (PQC) involved. This is 2 of the 2 reports from the same reporter. Additional information has been requested.
This spontaneous report as received via a company representative from a pharmacist refers to unspecified number of patients. On an unknown date the patients was vaccinated with PNEUMOVAX23. Other suspect therapies included influenza vaccine (manufacturer unknown). On an unknown date the patients experienced aches and pains. The outcome of aches and pains was unknown. Additional information has been requested.
Urticaria; This is a spontaneous report from a contactable physician. A 21-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Concomitant medications were not reported. Patient had no past drug history.  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 an unknown date in 2021, the patient experienced urticaria. Therapeutic measures were taken as a result of the adverse event and included treatment with steroids. The clinical outcome of the event of urticaria was not recovered at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Aprox. 8 hours after receiving vaccine, mother noticed redness, itching and swelling at the injection site.  Pt was brought to clinic the next morning.  Both thigh and arm sites had aprox 3" - 3 1/2" dia. of swelling and redness.
p/inject pt exp SOB, audible wheezing, lightheadedness, tightness in throat;
Pt called and stated the day she received the flu shot, she vomited & had diarrhea about 2 hrs later.
9/5/21  Received the third dose on Sunday morning, 8:30 am 9/6/21  Woke up early Monday morning with chills and sweats, 2:00 am for about two hours                   Fatigued Monday, sleepy, arm itching 9/7/21  Tuesday evening I noticed my arm itches, is warm and hot with a big red patch. 9/8/21   Wednesday go to Walk In - (not where I got the shot).  Diagnosed with Cellulitis, the patch is about 10 cm x 20 cm and had gotten bigger than the night before.  Prescribed Clindamycin (stopping Doxycycline), taking Zyrtec for itch and icing arm hourly.  We took pictures to compare over the next few days.
Myalgia all over the body, headache, nausea, vomiting x1, intermittent sheivering and feeling hot
FEVER AND BODY ACHE FOR 3 DAYS. THEN RASH BROKE OUT ON LIPS SPREADING TO FACE.  SIMILAR TO SHINGLES RASH THAT HAPPENED A FEW YEARS AGO.
Soft ball sized rash and lump at injection site in left arm; Soft ball sized rash and lump at injection site in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Soft ball sized rash and lump at injection site in left arm) and VACCINATION SITE RASH (Soft ball sized rash and lump at injection site in left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE MASS (Soft ball sized rash and lump at injection site in left arm) and VACCINATION SITE RASH (Soft ball sized rash and lump at injection site in left arm). At the time of the report, VACCINATION SITE MASS (Soft ball sized rash and lump at injection site in left arm) and VACCINATION SITE RASH (Soft ball sized rash and lump at injection site in left arm) outcome was unknown.            No concomitant medication was provided. Treatment included both a nerve medication and an anti-depressant.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-258036 (Patient Link).; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Exposed to herpes labialis 37 years ago. Never had an outbreak. One lesion diagnosed at physical one week prior to injection. Had outbreak of shingles within a few days of vaccine. On antivirals and pain patch. Lesion and shingles on back.
5/28: good at time of shot at 5PM. 5/29: Felt pretty good till 1pm, then started to feel fatigued and muscles begin to ache. could not stay awake and went to bed at 4pm and had cold chills. Slept till 7pm and was up for 2hr, then back to bed extremely fatigued and cold chills.  5/30: Woke up feeling better; not all the energy I usually have; slight headache; wore out early and in by by 7pm. 5/31: Much better and 95%+ back to normal From 4pm on 5/29 to 7am on 5/31, Slept a total of 25 or the 39hrs. (LOT for me, normal is 6hr of sleep for me, nightly)
Fever, chills, pain when breathing in, stomach cramps, body aches. No treatment yet, just fluids.
Started feeling ache that afternoon of Thursday 11-11-21 the day of my 3rd booster. Next day Friday 11-12-21 woke up and my arm pit on my left side down to my left breast was swollen and very painful my left arm hurt down to my wrist and hand joints hurt too. Ran a 100.2 fever around 6:00 Friday afternoon had chills and my arm pit was hot and painful had been taking ibuprofen at 6:00am 11:00am and 6:00pm on that Friday.
Patient received dose of Moderna COVID-19 vaccine, however, the dose was 0.3 mL instead of 0.5 mL.  After the patient received the incorrect dose, the vaccination team contacted the patient immediately to remediate the issue.  The patient received the supplemental dose of 0.2 mL within 1 hour of receiving the first dose.  The patient did not experience any adverse event symptoms.
COVID breakthrough. Patient presented to the emergency dept on 8/30/22 with shortness of breath, cough, wheezing, runny nose, and sore throat for several days. Tested positive for COVID on 8/30/22
dizziness; headache; tachycardia; chest pain; chills; fever; This is a spontaneous report from a contactable other healthcare professional (HCP). A 37-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982 and expiration date: unknown), intramuscular (right arm) on 24Jan2021 at 10:30 at a single dose for COVID-19 immunization. Medical history was not reported. Allergies to medications, food, or other products was unknown. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: unknown), on 03Jan2021 at 10:15AM, intramuscular (left arm) for COVID-19 immunization. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced dizziness, headache, tachycardia, chest pain, chills and fever on 25Jan2021. Treatment for the events included IV fluids, Benadryl, Antivert, Benadryl, Toradol and Reglan. The events required Emergency Room Visits and Physician Office Visit. The events were resolving at the time of the report.
Pt recvd measles vax on 14DEC90 following vax swelling @ site of the inject & adenopathy on the side of the inject & on approx 23DEC90 exp nausea, h/a & a fever of approx 99; tx ASA; @ time of the report swelling persisted & was 5-6cm;
Headache, Myalgia, Fever, SkinRash, fatigue Narrative:  Other Relevant History:
Hives & generalized itching 4 days p/2nd dose lasted 2 wks;
Menstruation is VERY heavy and not typical for myself.  It?s like double or triple the amount of blood and duration of days.  It?s obviously not life threatening but I?ve heard other women say they too have had abnormally heavy periods so I wanted to report mine too just so you know how wide spread this may be and can look into why this might be for future.
No additional AE/PQC reported; HCP reported that an adult patient was administered the pediatric dose of the RECOMBIVAX HB vaccine.; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 28-SEP-2023, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (incorrect dose administered) (lot number W038864 has been determined to be valid for hepatitis b vaccine (recombinant) (RECOMBIVAX HB), with an expiration date established as 16-JUL-2025), administered for prophylaxis (strength, and anatomical site of administration were not provided). No adverse events were reported for this patient.
Patient reported that  within a "couple of minutes" of receiving 1st dose of Pfizer on 03/01/21 her face bilateral became numb in addition to her right arm and right hand. Patient stated after 5 minutes, she got feeling back in her face. As of 03/02/2021, patient states the numbness in her face and arm/hand is intermittent.   Patient stated she still has full ROM.
Noted onset of swelling underneath tongue at frenulum.  No rash, sob, chest tightness, swelling, wheezing, LAD or other symptoms.
had a Shingle shot and a bad case of shingles/ suspected vaccination failure; bad case of shingles; painful Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received Shingles shot and had a very bad case of painful Shingles. The reporter stated that guess what those vaccines did not stop Shingles. They did not tell that they could still get a mild case of Shingles. The reporter stated that the vaccines are not worth the risk. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
See report submitted on first shot in series #189158. After second shot - Urinary tract infection day after shot, put on nitrofurinan for five days, infection cleared up but recurred two weeks later, on Cipro now but getting switched to nitrofurinan again as that is supposed to clear it up
Extreme pain in injection site. Treated with ice and one Tylenol tablet.  Pain mostly gone by next morning.
Sharp chest pain that started in the right lower side of the chest 24 hours after vaccination. The next day sharp pain moved into the left lower side of the chest along with dizziness, nausea, and tightness of the whole chest. 72 hours after vaccine administered pain persist on both the left and right lower sides of the chest on a pain scale of 5 out of 10. Dizziness, nausea, and tightness of the whole chest also continue to persist.
Severe shoulder pain and pain in arm, hand, fingers. Left side. Tingling in fingers. Difficulty raising arm, pain is constant throb took ALEVE and MOTRIN helps slightly. Pain in shoulder and arm have continued for 5 weeks. Seeing doctor on 11/9/15.
Vaccine error. The patient received Dose 1 Moderna 2/24/2021 (lot 012A21A) and received the second dose of Pfizer  3/22/2021 (lot EN6206) in error. The dose should have been Moderna. The event occurred at a large vaccine site administered jointly. This event is being reported as a vaccine error to assist in data collection and process improvement. CDC recommendations are that no further action is needed at this time. Patient was counseled by a doctor .
0.5 ml fluvirin shot was given approximately at 9:30am.  Pt returned to clinic at 11:40am with complaints left side of jaw and face swollen.  Denied ss of SOB, itching or rash.  He stated at this time "a few weeks ago he had bells palsy".  He refused benadryl and siad that he was headed to the walkin clinic at Hospital.
Headache; fatigue; rash on injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (fatigue) and INJECTION SITE RASH (rash on injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included cholestrol since an unknown date. Concurrent medical conditions included Diabetes and Hypertension.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE RASH (rash on injection site). On 04-Mar-2021, the patient experienced HEADACHE (Headache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Fatigue and Injection site rash, at an unspecified dose and frequency. On 04-Mar-2021, INJECTION SITE RASH (rash on injection site) had resolved. On 07-Mar-2021, FATIGUE (fatigue) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is taking medications for Cholesterol, diabetic and high blood pressure.
20FEB97 exp swelling @ inj site;cult done;seen again 25FEB97;(warmth-swelling @ site);to clinic for I&D lt upper arm, t99;hx painful fluid filled induration lt upper arm @ site 1mo ago;pus @ site & 4cm palpable fluid-filled mass;eryth
left side of his face is paralyzed and his left eye will not blink/ he thought he had a stroke/diagnosed with Bell's Palsy/had Bell's Palsy in the past several years ago; left side of his face is paralyzed and his left eye will not blink/ he thought he had a stroke/diagnosed with Bell's Palsy/had Bell's Palsy in the past several years ago; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included that he had Bell's Palsy in the past several years ago. The patient's concomitant medications were not reported. The patient experienced Bell's Palsy after receiving the first dose of the Pfizer Covid 19 vaccine. He stated that the left side of his face is paralyzed and his left eye will not blink. He received the first dose of the vaccine on a Thursday and the following Wednesday he went to the ER because he thought he had a stroke. He was diagnosed with Bell's Palsy, was given medication, and its been a week and his eye still is not blinking. His doctor is uncertain if he should receive the second dose of the vaccine or not. He was asking if he should he get the second dose and how many people were in the study. He also asked if he gets the second dose, if it will make the Bell's palsy worse. Therapeutic measures were taken as a result of event. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, and on a positive drug-event temporal association,  the Company  assessed that a reasonable possibility could not be excluded that the suspect product BNT162B2 contributed to the occurrence of the reported events Bell's palsy and Disease recurrence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Beginning the 2nd day after this dose, I had severe, watery diarrhea. This continued for weeks, and I lost ten pounds in the first two weeks. On April 13, I went to an urgent care clinic as I was unable to get in to see my primary care dr. The urgent care took a stool sample and checked for a multitude of bacteria (norovirus, salmonella, giardia, etc) but found nothing positive. My PC ordered a CT scan on April 27 and found inflammation in my colon. A colonoscopy was ordered and it was performed on May 14. I was diagnosed with lymphocytic colitis. I do not take NSAIDs or any other medications known for causing this disorder.
the patient received VARIVAX after temperature excursion; This spontaneous report was received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration and anatomical site of vaccination were not reported; lot number reported as R018933, expiration date 02-JUL-2020) as prophylaxis (product storage error). The vaccine had a temperature excursion from 15 degrees Fahrenheit (°F) to 46 °F (34.1 °F) for 4 hours; which was call because of a data logger. As concomitant medication, sterile diluent was used to reconstitute the vaccine, which did not suffer any temperature excursion.   This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1910USA013438:
mom states pt began running fever the same day recvd shots, n&v, t104-105 spent 26MAY93 in ER AM-PM; mom states MD wasn't sure if it was a shot rxn;
Dermatographia began two weeks after receiving shot. Extreme itchiness across entire body that results in redness and hives. Only controllable via daily allergy medication.
On the AM of 3/27/06, the child was given 4 vaccines by injections. Mother called 3-4 hours later to report that he had been crying despite receiving Tylenol. The crying stopped after about 5 hours. Mother did not he would be seen. No other signs or symptoms.
51yo F rec'd Pfizer Covid-19 vaccine 2nd dose on 1/19/21. Two days later, patient reported numbness/tingling at injection site, left thumb and left facial cheek area without muscle weakness, facial drooping, drooling, slur speech, headaches, nausea, fever, or rash.