chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unspecified adverse event; This case was reported by a lawyer and described the occurrence of adverse event in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, 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.  Initial information was received on 04 August 2020 via medical records ( the case is medically confirmed). As per the records the patient underwent vaccination for herpes zoster 3 dose schedule. The patient was also receiving Vaccine zostervirus (shingles) recombinant, subunit adjuvanted no sooner than 07 September 2018 and no longer than 06 December 2018.
The adverse event included macular papular rash, shortness of breath and tongue swelling. Patient was treated with Claritin, Benadryl and steroids.
Client received a 2nd Tdap dose on 4-5-12. No adverse reaction. Follow up on 4-9-12. No problem.
The patient presented to our mobile vaccine clinic,  without her vaccination card, with her parent, requesting a "booster" for her. The patient's prior vaccination status was not verified and the patient received a third dose of Pfizer vaccine. Dates of vaccine for this patient  are as follows:  5/14/21,  6/3/21 and 12/1/21. The following morning (approx 14 hours later) the patient was  given ibuprofen by her father for fever. About 7 hours after the ibuprofen, she had fever to 101 degrees, some myalgia, fatigue, nausea and vomiting. She was reportedly given acetaminophen, and was advised to take oral rehydration and parents to continue monitoring. There was NO report of confusion, seizure, altered mental status, chest pain, rash, hives nor shortness of breath. ER warnings were given and the patient's father was referred to a local pediatric infectious disease specialist for an appointment for the patient.
Baby's mother called the clinic on 3/26/12 stating child had fever since receiving imms 3/22/12. Temp was 102 on 3-25-12 & 101.7 on 3-26-12. Also stated child was lethargic.
p/ pt recv vax the following day pt exp varicella-like rash, coryza & had fever greater than 100f.
Patient had more soreness and inflammation in the arm the vaccine was given. The redness spread all the way from her shoulder down to her bicep/elbow.
Left arm not able to move a lot; This spontaneous case was reported by an other health care professional and describes the occurrence of MOVEMENT DISORDER (Left arm not able to move a lot) 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.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (Left arm not able to move a lot). At the time of the report, MOVEMENT DISORDER (Left arm not able to move a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.
The patient explained that as soon as it was injected it hurt. It was bad enough pain that it limited range of motion in his right arm and the pain radiated back through his right side of his upper back to his spine. Redness developed 2 days post vaccination that spread down and around his arm that was warm to the touch. He had a bruise develop the day of and still had one today after reporting this to me. It appears that a vessel was nicked when he was vaccinated.
soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness). At the time of the report, MYALGIA (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Got vaccine as below at approximately 1130. Began with shortness of breath and skin red, like sunburn, all over and headache. Went to ER on 4/27/04 about 11.30. Had a racing pulse. ER. MD thought reaction to vaccine. Prescribed Benadryl. See attached report.
Fever 101.6 for 2 days, followed by 100 for one day.  Extreme fatigue,  Nausea,  Loss of taste,  Sore neck muscles, all lasting for one week.  Sore arm with red rash and bruising that lasted for 2 weeks
Patient went tanning at tanning booth, has tanned previous to vaccine. Did not use sun tanning lotion. 2 hrs post tanning after showering noticed hives on chest, breasts and armpits. C/O burning and itching, pt instructed no tanning until further notice per doctor. No other c/o symptoms. Hives lasted 8 hr then disappeared.
2 days after vaccine, patient experienced raised bump at injection site and facial rash. Has cleared since, but patient experiences occasional flare-ups that she treats with steroid cream.
There was no adverse event. Due to the scheduling edit being turned off, she was able to make an appointment. When I looked at her dob, I was thinking she was 18 years old due to her being born in 2003.
experiencing longer and more painful menstruation; experiencing longer and more painful menstruation; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 33 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization.  The following information was reported: DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown" and all described as "experiencing longer and more painful menstruation".  Additional information: Caller is just curious. His girlfriend got the Adult COVID vaccine. She got the two-shot series. Since, her menstrual cycle has been altered. She said she has talked to her friends who got the vaccine and experienced the same thing. Her periods are longer and more painful. It is concerning to him because she is in childbearing age, and this is her menstrual cycle. He is just curious. He doesn't know if she wants to do a report. He will tell her to report it online or call in if she wants to report. He is a doctor, but he isn't her doctor. She is 33 years old.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101883401 same reporter/drug/event, different patients
Hospitalized 12/25/2021; COVID-19 positive 12/25/2021; fully vaccinated  Discharge Provider:  MD Primary Care Provider: DO Admission Date: 12/25/2021 Discharge Date: Dec 29, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pulmonary edema cardiac cause  Acute on chronic congestive heart failure, unspecified heart failure type  Pneumonia due to COVID-19 virus    HOSPITAL COURSE: 85 year female with a history of chronic diastolic heart failure, aortic valve replacement, hypertension, who presented gradually increasing shortness of breath for a few days prior to admission. In the emergency department, Sodium was 130, hemoglobin was 9.5 and BNP was 1821. Chest x-ray shows finding concerning for pulmonary vascular congestion.  COVID-19 PCR was positive. Patient was not found to be hypoxic She was given a dose of 40 mg IV Lasix in the emergency department.  Echocardiogram was obtained and showed any was seen%, mild LVH, LV normal in size, no WMA, status post TAVR, mild-to-moderate mitral stenosis. She was seen by cardiology and they felt that patient had mild CHF exacerbation and also felt that COVID 19 pneumonia could also be playing a role in her symptoms. She was placed on Remdesivir and continued on IV lasix. She had improvement in her shortness of breath.  Cardiology recommended that IV diuretics were discontinued and she be placed back on her home dose of torsemide especially as she was found to have increasing creatinine. She was also found to have leukopenia of unclear etiology but was afebrile. Patient continued improvement that she has been weaned off oxygen.  Pulmonary rehab assess for home oxygen need and patient found to be not needing any.  PTOT evaluation completed and recommended home health with assist.  Patient then discharged to home stable.
Information has been received from a Licensed Visiting Nurse (LVN) concerning a 22 year old female patient with a history of toe surgery who on 22-MAY-2007 was vaccinated IM in deltoid with a dose of Gardasil, lot #657736/0389U.  Concomitant therapy included escitalopram oxalate (LEXAPRO) and a multivitamin.  On 22-MAY-2007 the patient developed bilateral hands and upper arms reddish-brown discoloration, swelling and pain.  She was examined in the office on 24-MAY-2007.  Azithromycin (Z-PAK) was prescribed, "not sure if started yet".  Her outcome was unknown.  It was noted that urine and CBC were taken on 22-MAY-2007, before vaccination, and that neutrophils, MCV (mean corpuscular volume) and MCH (mean corpuscular hemoglobin) were "a little high".  Additional information has been requested. Follow up information has been received from the LVN concering the 23 year old female patient with no known drug allergies who on 22-MAY-2007 at 2:00 p.m. was vaccinated IM in right deltoid witha first dose of GARDASIL, lot #657736/0389U. At 9:00 p.m. that evening her hands and feet were red and swollen, painful and itching. One week later, her hands and feet started peeling. The patient recovered on 22-JUN-2007. Additional information is not expected.
Severe vertigo starting on the morning of day 7 that took 10 days to fully resolve
I went to Urgent care to get the Influenza vaccination, after 10 to 15 minutes later I started to feel strange; my lips started to swell and I could taste the medication on my tongue. I felt as if I was on drugs, such as in a slow motion, non focus, blurry and my speech was slurred. I felt pain in the middle of stomach it made me feel nausea, that I needed to vomit. My mental state was non-focus. The weakness lasted about 3 to 4 hours. When I went home, I laid down and fell asleep, when I woke up at 8:30pm I was still drowsy. When I woke up this morning, I felt normal. (Note: I did not take anything nor went to the Emergency Department.)
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On unspecified dates, the unknown number of patients were vaccinated improperly stored doses of (Oka/Merck) VARIVAX lot # L001325, expiration date 13-JAN-2017, lot # L001335, expiration date 13-JAN-2017 and lot # reported as L024255, expiration date 01-JUL-2015 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports receive from the same source. Additional information has been requested.
sore shoulder; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced a sore shoulder on the first one. The outcome of the events was unknown. The second dose was scheduled for 16Feb2021 however was canceled due to weather.  Information on lot/ batch number has been requested
@09:35 pt reported with itchy/ numb mouth. BP 120/70 86 20 97% Started to feel very tired, pale in color, hands cold, difficulty finding words, pt speaking slowly. Placed into supine position. 0940 EMS notified 100/70 82 20 99% 0955 patient refused EMS transport to hospital. Remained in supine position and then sat in chair. 1026 color improved, denied numbness, c/o headache. Pt left @ 1045 color good, speaking clearly without difficulty. Denies complaints, amb. out of clinic.
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 was unknown and the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she had the Shingles vaccine and got the shingles terrible. They cleared, finally. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available. For second outbreak of shingles refer case US2021AMR260215, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR260215:same reporter.
Patient had raised red area around injection site that was warm to the touch. About the size of a half dollar.
Subject is enrolled in a clinical trial that is evaluating the HPV vaccine in cancer survivors. Pt received Dose 1 of the HPV vaccine on 8/17/2016. On 8/25/16 the patient's mother contacted the study nurse and reported that the patient had been evaluated by her OBGYN physician for a variety of medical issues including arthralgia and painful nodules on bilateral lower extremities. the mother states that the patient's medical issues may be related to HPV vaccine that she received in June, which has prompted this report. The mother also reported that the physician indicated that alternatively, the patient's medical issues may be due to a concomitant medication (birth control pills - Crysalta-28 tab, 0.3 mg/0.03 mg, initiated 6/18/18), which is being discontinued. We have requested medical records and will update this report when we have more information, but we are reporting what is known at this time. Additionally, the patient underwent medical evaluation for similar symptoms, including groin pain, arthralgia, and headache on 8/3/16; no diagnosis was made and no treatment was prescribed at that time. the patient was subsequently seen her oncologist on 8/9/16 for evaluation of continuing symptoms, and the oncologist had indicated at that time that he did not believe her symptoms were related to the HPV vaccine; he initiated an evaluation to determine the etiology of the patient's symptoms. the patient's symptoms did not improve, and the returned to the oncologist on 8/15/16 for further evaluation, including a work-up to rule out leukemia recurrence. Leukemia recurrence was ruled out; the final report of the additional evaluation are pending at this time.
pt recv vax 10DEC97 & devel itchy tongue immed & while in class a heavy jaw;mom was called & pt went home;9PM pt started to vomit for 1/2hr;
blood pressure was going up and down; Wobbly; Dizzy; Slight headache; Muscle Aches; Inability to grip well; staggering walk; Extremely tired; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included liver transplantation. Concomitant products included Immunosuppressant Drug (Nos).   On 12th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2019, less than a day after receiving Shingrix, the patient experienced tiredness. On 13th August 2019, the patient experienced unsteadiness, dizziness, headache, muscle pain, muscle weakness and staggering gait. On 15th August 2019, the patient experienced blood pressure fluctuation. On 14th August 2019, the outcome of the headache and muscle weakness were recovered/resolved. On 16th August 2019, the outcome of the unsteadiness, dizziness and staggering gait were recovered/resolved. On an unknown date, the outcome of the tiredness, muscle pain and blood pressure fluctuation were unknown.   It was unknown if the reporter considered the tiredness, unsteadiness, dizziness, headache, muscle pain, muscle weakness, staggering gait and blood pressure fluctuation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The caller saw her transplant coordinator a week before Shingrix vaccination and reported all was well with her body and no sickness. The caller reported the day of vaccination she was tired due to a hard week but nothing wrong or no illness at time of vaccination. After receiving vaccine, caller reported going home doing some things but had to end up driving roughly 100 miles as usual for a business trip. When she arrived at the hotel she reported being extremely tired and going to bed early due to exhaustion. The next morning after vaccination, she felt wobbly and dizzy on her feet. The caller reported having a slight headache, muscle aches all over her body, inability to grip well, and having a staggering walk due to wobbly legs. She stayed in bed as much as possible but did not get better all day long. The following morning caller reports feeling a little better and driving home although still very dizzy. When she got home she called the coordinator from liver transplant and they consulted whether to receive 2nd dose of Shingrix. Caller also consulted with her primary care physician, and both practices had same conclusion of not receiving 2nd dose. Caller also reported her blood pressure was going up and down, blood pressure would be high at night but low in the mornings. The caller reported on the day of reporting she was not dizzy anymore and has pretty good strength in her legs. The reporter consented to follow up. Caller reported no fever or nausea, but all muscular. Caller also mentions liver transplant office reported adverse event elsewhere but recommended her to contact GlaxoSmithKline as well.
17y / male presents  8/29/2021 with 4 days of symptoms: fever, tachycardia, vomiting, congestion, and red eyes diagnosed with MIS-C
Rash and neck stiffiness, 4/15/2021 1200a,
facial flushing; nausea; vomiting; felt faint; This case was reported by a physician via sales rep and described the occurrence of facial flushing in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number GD44Z, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced facial flushing, nausea, vomiting and felt faint. On an unknown date, the outcome of the facial flushing, nausea, vomiting and felt faint were unknown.   It was unknown if the reporter considered the facial flushing, nausea, vomiting and felt faint to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. GlaxoSmithKline sales professional called in and stated her colleague had already reported this adverse event but the GlaxoSmithKline staff who is the reporter today got to speak to the physician on 4th October 2019 morning and obtained clarifications.  The patient identifiers were not available. Around 1st October 2019, the patient received Flulaval vaccine 2019-2020. The patient had facial flushing, they felt faint and also had nausea and vomiting. There were no hospitalization required.  Additional information was not provided.  The reporter consented to follow up. This is 1 of 5 cases reported by the same reporter.
By Day 2 I noticed new tinnitus sounds, louder and hauntingly disturbing. Roaring in ears different than before and scary. My blood pressure dropped when I stood up and although I did not faint, I had difficulty standing up and moving about. My chest burned and I coughed a lot, shortness of breath worse than usual, and my O2sat went down to 94 when it usually was no lower than 96. These mild but disturbing symptoms persisted, and then on Day 6 I had a sudden onset of dizziness and cognitive dysfunction that made me a "bobble head" that put me to bed for 3 days. I had a headache and chest pains and dizziness that wanted to become vertigo if I moved my head. I am afraid to get the 2nd dose because I'm concerned that these symptoms will be triggered again and become permanent.
Severe fatigue, dizzy, nausea, vomiting, muscle cramps on right side stomach thigh calf & foot,  difficulty breathing, headache, chills, fever, swelling & red hot feeling of arm and no appetite.
he couldn't eat; he couldn't eat or walk to open the door for his mother; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (he couldn't eat) and GAIT INABILITY (he couldn't eat or walk to open the door for his mother) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEEDING DISORDER (he couldn't eat) and GAIT INABILITY (he couldn't eat or walk to open the door for his mother). At the time of the report, FEEDING DISORDER (he couldn't eat) and GAIT INABILITY (he couldn't eat or walk to open the door for his mother) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2022-540133, MOD-2022-540288, MOD-2022-540353 (Patient Link).