chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme fatigue for two days. On the third day I began to have irregular heart palpitations leading to a cough. They were most prominent when I would lay down and particularly when laying on my left side. The would begin when I was totally relaxed. They would continue for several minutes up to half and hour. They began to occur while I was working. After I would sit down for my break and stand up and upon beginning to walk fast-which my job requires. They have continued off and on for the past three weeks. on Sunday, Oct 3, 2021, I experienced them for 2 hours. they seemed to be getting less frequent and less prominent until yesterday, when I contracted a cold virus and then they started happening and triggering a spasmatic cough.
In addition to side effects of myalgias, headache and malaise lasting about 48 hours, I developed right ear pain, which persisted for the next several weeks. On my exam of 12/13/2021, the pain was located more at the insertion of the right sternocleidomastoid muscle.
thromboembolic stroke; This is a spontaneous report from a contactable pharmacist. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at 1st dose, single for COVID-19 immunization. Medical history included hemophilia A. Concomitant medication included factor VII for hemophilia A. The patient with hemophilia A, usually gives herself activated factor VII before vaccines. So, she did, and a couple minutes later, she received the first dose of the Pfizer COVID vaccine. 48 minutes after, she suffered a thromboembolic stroke and was now hospitalized. The pharmacist was told by the patient as well as a biologist with Pfizer who has severe hemophilia that they read somewhere (unidentified source) that the Pfizer vaccine was contraindicated in people with bleeding disorders. The pharmacist would like to know, on behalf of a patient, whether the Pfizer COVID vaccine is contraindicated in persons with bleeding disorders such as hemophilia A. The outcome of the event was unknown.   Information on the lot/ batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event thromboembolic stroke  cannot be totally excluded.   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.
Patient's wife called complaining of improper immunization technique. Pharmacist had administered into shoulder instead of deltoid. Complains of radiatin pain, unable to move arm. Requesting pharmacist who discovered error to submit to VAERS and also internal incident reporting
Case number PHEH2011US01200 is an initial spontaneous report received from a physician on 10 Aug 2011. This report refers to a 12 years old male patient. He was vaccinated with MENVEO (batch number: M10053) intramuscularly at a dose of 0.5 ml on 01 Aug 2011. On 03 Aug 2011 he developed a tennis ball sized raised, red, tender area at the injection site. Outcome of the event was unknown.
Information has been received from a physician concerning a 12 year old female who was vaccinated IM with the first 0.5 ml dose of GARDASIL.  The patient developed pain, swelling, and edema at the injection site.  Unknown medical attention was sought in the office.  Patient outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
severe neck pain on left side/moved from the left, to the right and the middle; severe shoulder pain on left side/top of shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (severe neck pain on left side/moved from the left, to the right and the middle) and ARTHRALGIA (severe shoulder pain on left side/top of shoulder pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for ADHD, MONTELUKAST and OLOPATADINE HYDROCHLORIDE (PATADAY) for Allergy, ALBUTEROL [SALBUTAMOL] for Asthma, TESTOSTERONE for Hormone replacement therapy, THYROID (ARMOUR THYROID), VITAMIN D [VITAMIN D NOS], ESTRADIOL BENZOATE, PROGESTERONE (PROGESTERONE CO.), ACETYLSALICYLIC ACID (BABY ASPIRIN), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), MAGNESIUM and ZINC for an unknown indication.  On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced NECK PAIN (severe neck pain on left side/moved from the left, to the right and the middle) and ARTHRALGIA (severe shoulder pain on left side/top of shoulder pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. In March 2021, NECK PAIN (severe neck pain on left side/moved from the left, to the right and the middle) and ARTHRALGIA (severe shoulder pain on left side/top of shoulder pain) had resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Other concomitant medications include Pimlos which is given as injection for bone density improvement.  Patient reported that, had severe neck and shoulder pain on left side started about 3-4 days later and moved from the left, to the right and the middle and lasted about 6 days, cannot turn her neck, makes it difficult for her to drive. Patient tried ibuprofen, ice, heat, and it gave a little bit of relief and nothing that made it tolerable. Patient thought she may have parsonage Turner Syndrome which happens after vaccines and it seems similar to what she was experiencing.   This case was linked to MOD-2021-419391, MOD-2021-420207 (Patient Link).
Diarrhea, abdominal cramping, nausea, fatigue from 36 hours post vaccine to present time.
Patient had red raised area about 2 inches by 3 inches, area was hot. I told patient to ice area and when I called to follow up she said the area was better.
Patient had ringing in the ears. She reported she felt under water. She was congested and could not hear. Redness noticed around neck area. No shortness of breath, no immediate distress and no chest discomfort.  There were no visible sign of swelling or inflammation. Patient looks anxious and was wheeled to ER in a wheelchair for checkup.
Received shot at 11:15 am and by 10pm I was freezing cold to the point shaking uncontrollably.  By 11pm I had a horrible headache and my body was aching. At midnight I still was feeling horrible and my chest was hurting and I was having difficulty breathing. Checked my heart rate with a pulse ox and it was in the 150?s. I realized had not taken my clonidine pill yet for the evening so I  took it and waited about an hour to hour an a half and my heart rate was still not coming down below 125. I ended up going to the emergency room and getting there by 3am. They immediately started running tests. My heart rate was in the 138 and my blood pressure was 148/100
31JAN97 9AM c/o sore arm TD inj site checked;sl swollen;no redness;no tenderness;5x5cm in size;sent to clinic given ATB for cellulitis;
Bad reaction; Contraindicated drug administered; Documented hypersensitivity to administered product; This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sucrose intolerance.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction, contraindicated drug administered and documented hypersensitivity to administered product. On an unknown date, the outcome of the adverse reaction, contraindicated drug administered and documented hypersensitivity to administered product were unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The student pharmacist reported that a patient with a sucrose allergy had a pretty bad reaction to Shingrix. The reporter was consented to follow up. The reporter had no further details. The patient identifiers or any further details regarding vaccine unknown where the event occured.
Starting in May I began to take a low dose of Lamictal, I had chapped lips that would crack for about 2 months steadily getting worse. In July over the period of 48 hours of being told to double the Lamictal, I got a chemical burn across my tongue, throat and urinary tract, I was then diagnosed to have SJS, Steven Johnson Syndrome by the hospital that I visited where they said that this is usually resulting in fatality. Taken off of Lamictal and became non critical and was discharged. I still have burning in my lips and urinary tract, however it is not incapacitating and my lips have returned to normal color. I have some eye problems that have developed that may or may not be associated. I began to develop a second autoimmune disease in October, it started out as pain in my legs and hard to move my leg, which then progressed across all of my joints and became extremely painful. I was given the diagnosis of polymyalgia rheumatica and was given prednisone for treatment option. and is pending full diagnosis. Prednisone has seems to help with about 75%. I am scheduled to see a rheumatologist in a week for check-up.
SORE THROAT, RUNNY NOSE, NON-PRODUCTIVE COUGH, EXTREME FATIQUE, NO FEVER,LASTING 5 DAYS
sick for five days; fast heartbeat; dizziness; read and bruised arm; muscle pain; chills; nausea; headache; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache) and DIZZINESS (dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache), DIZZINESS (dizziness), HEART RATE INCREASED (fast heartbeat), ILLNESS (sick for five days) and CONTUSION (read and bruised arm). At the time of the report, MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache), DIZZINESS (dizziness), HEART RATE INCREASED (fast heartbeat), ILLNESS (sick for five days) and CONTUSION (read and bruised arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided.
Persistent swelling L UE x6 months with continued tenderness & erythema.  No F/U, positive mild pruritis. 5/2/08-records received-1/10/08-seen for C/O left upper extremity arm swelling, tenderness since 8/8/07-pain persistent since that time and now has 1-2 months swelling. Received her 3rd Gardasil injection in right arm without complaints. Seen 1/29/08 for C/O joint pains. Each vaccination produced pain at the site of injection without any erythema or site reaction. By end of series in December experienced migratory arthralgias including hips, knees, feet, toes and hands. Daily pain. Impression:arthralgias and positive ANA titer.
I woke up this morning and after getting up within about 2 minutes became presyncopal and needed to lay flat for 20 min. If I sat up I would quickly become presyncopal again. This was roughly 15 hours after my vaccine. I had no issues up to that point. I have been much more sensitive to position changes since. I have also noted difficulty with exercise. I was regularly but today was unable to walk up a hill without becoming weak and feeling SOB.  I have checked and my resting HR is 70 and after standing 10 minutes it is greater than 100. My concern is autonomic dysfunction related to the vaccine. This is my 4th Pfizer vaccine.
local very tender swelling of biceps region @ inject site;  radiating pain to neck & chest wall
patient was 18 weeks and 6 days pregnant at the time of administration- with no reported adverse event; Initial information received on 21-Feb-2022 regarding an unsolicited valid non-serious case via Other Healthcare professional.  This case involves a 25 years old female patient who was exposed to Diphtheria-2/Tetanus/5 AC Pertusis Vaccine [Adacel] in context of patient was 18 weeks and 6 days pregnant at the time of administration- with no reported adverse event.   The date of last menstrual period was reported as 27-Sep-2021. The estimated due date is 12-Jul-2022.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported patient was exposed to Diphtheria-2/Tetanus/5 AC Pertusis Vaccine at 21 weeks of pregnancy, during second pregnancy trimester.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Feb-2022, the patient received 0.5 ml dose of Diphtheria-2/Tetanus/5 AC Pertusis Vaccine suspension for injection (lot number: U7271AA and expiry date: 12-Jan-2024) once via intramuscular route in an unknown administration site for immunization.  On 14-Feb-2022, patient was 18 weeks and 6 days pregnant at the time of administration- with no reported adverse event (exposure during pregnancy) (latency: same day) following the administration of Diphtheria-2/Tetanus/5 AC Pertusis Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event exposure during pregnancy.  Additionally, at time of reporting, the pregnancy is still ongoing.
A physician reported that a female child (age unspecified) received HIB, MMR and Varivax vaccines on 6/5/96. Two days later, the child developed a fever of 104F. The pt's sister experienced injection site reaction on 11/28/00 following Prevnar, Hib-Titer and MMR vaccination; see HQ6902606FEB2001.
Narrative:  this appears to have been contributed to more by the patients age and potentially the combination diuretic/ace inhibitor and other co-morbitities rather than the administration of the COVID vaccine Symptoms:  HYPOtension & Syncope Treatment:
Eight hours after the vaccine, I awoke with moderate chills and tremors.  Eleven hours after the vaccine, i awoke with all-over body aches and a mild headache.  I slept 3 more hours and woke up with all of the previous symptoms at once.  I felt moderate malaise and these symptoms  for 24 hours.  I had a sore arm for 4 days.
Pt called to have VV when she noticed a blistering rash on her L thigh.  Not classic but rash looks most c/w shingles.
8-12-14 ROTATEQ given, that evening child developed fever and diarrhea per mom. 8-13-14 childs diarrhea continued, blood in stools developed, called office, given temp 102.8, bloody diarrhea
shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. No information about concomitant medication, current condition or historical condition was provided. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, batch/lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions by a health care provider (HCP) in a medical group. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a HCP in the same medical group for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Extremely swollen and very painful lymph node under left arm pit.   Lasted for 3-4 days after vaccine.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Patient was feeling extremely flush and dizzy after receiving her vaccine. She was monitored for 45 minutes post vaccine, had orange juice and was feeling much better when she left.
Gave him another Tylenol but he is still shivering because his temperature is still 106.6; Little bit chills; Little bit temperature and he had 99.7; Checked the temperature now and it was a 102; Started shaking; Little bit chest pain; This is a spontaneous report from a contactable consumer. This contactable consumer reported for male patient (reporter's son). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 immunization. The patient experienced gave him another tylenol but he is still shivering because his temperature is still 106.6, little bit chills, little bit temperature and he had 99.7; checked the temperature now and it was a 102, started shaking, and little bit chest pain on an unspecified. Reporter stated, this is for his son. He received the second dose which was the Pfizer Vaccine yesterday and what happened was around maybe 7 or 8 o'clock, he was feeling a little bit chills and a little bit temperature and he had 99.7. So, reporter said take a Tylenol and so, he was due for maybe another dose at about 3:15. as he took at 8:15 but reporter checked the temperature now and it was a 102. So, he started shaking and he had a little bit chest pain, so, reporter gave him another Tylenol, but he is still shivering because his temperature is still 106.6. It was reported that should reporter be concerned about that, with his chest pain especially. Reporter was informed about the role of Pfizer Drug Safety and advised to contact the nearest emergency room if required. Reporter further stated, "So, I should just take him to the ER. In response to further probing for safety report, reporter stated, "It would be absolutely no because reporter concerned about his son first and then reporter can get through this later. Further probing could not initiate as reporter was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call. The patient underwent lab tests and procedures which included body temperature: 99.7, a little bit temperature and he had 99.7, body temperature: 102, reporter checked the temperature now and it was a 102, body temperature: 106.6 he is still shivering because his temperature is still 106.6. The outcome of events was unknown.
I had diarrhea for almost 4 months. I went on for a while and stopped. It was the same thing that happened when I caught COVID. It would go in a 10 to 20 day cycle for a about 4 months and 2 days ago it just stopped. It just stopped yesterday. I had a weird tingling in my mouth like I had COVID.
Large patch of raised redness (about 5in X 3 in) at injection site.  Itchy rash. Arm hot to touch.  Began night of 2nd day after 2nd shot. (Feb 20th)   All symptoms decreased gradually over following 4 days.  Remaining redness, bumps, and itchiness disappeared by morning of Feb 25th.
Localized swelling of left arm 8 hours after injection. Given DEPO MEDROL 80mg injection on 6/19/15.
Case number PHEH2014US016995, is an initial spontaneous report received from a healthcare professional on 21 Aug 2014. This report refers to an unknown age and gender patient. The reporter stated that, the patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M14044), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component and then administered a correct dose of Men A reconstituted with the Men C, Y, W-135 at dose of 0.5 ml on an unknown date (months ago). No adverse event was reported following this administration error.
arm hurt; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the reporter for his sister. The age at vaccination was not reported. Post vaccination the patient's arm hurt which was a known side effect. This case was linked to another case US2019AMR225799 reported by the same reporter.
Approximately 10:00 am on 5/18/05 patient's teacher noticed a large area of swelling with red splotches, a fever around the swelling, and patient complaining of itching. She also noticed the site was bleeding. I was called to pick her up at 11:00 am. Patient was also running a fever of 101.9 degrees and the swelling began to resemble the size and shape of a tennis ball in the shoulder area.