chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Bruising at Injection Site-Mild, Additional Details: gave the COVID bivalent booster to patient. After taking out the needle, she did a normal and expected amount of bleeding. Once I stopped the bleeding after a few seconds, a bruise formed in the area. It got purple right around the injection site. Patient experienced no pain during and after the vaccination. She stated she bruises very easily. Bumping a table causes a bruise at home. Monitored patient for 15 minutes and followed up later, no adverse effects and she feels fine.
I started to experience itchiness of the skin 10 days after my vaccine. Scratching the skin would cause redness and hives. Since then I've gone on Zyrtec daily, which has greatly reduced the itching. However, the reddening of the skin, which was diagnosed as dermatographism, continues.
Within 1 hour of vaccine had "grapefruit" size swelling at vaccine site (did not observe), redness, heat, severe pain. 4 hours later severe chills & body aches, increased swelling. Used Ibuprofen. I saw patient 24 hours later - large, red, tender 10-15cm swelling. Treated with pain meds, cool compresses.
Don't think anything ( Moderna Vaccine) was in the syringe he used with patient; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Don't think anything ( Moderna Vaccine) was in the syringe he used with patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0167C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced UNDERDOSE (Don't think anything ( Moderna Vaccine) was in the syringe he used with patient). At the time of the report, UNDERDOSE (Don't think anything ( Moderna Vaccine) was in the syringe he used with patient) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with response to the events are not applicable.
REPORTED FAINTING BY WITNESSES, NURSE VISUALIZED DIAPHORESIS, DRY HEAVING, PT REPORTED WEAKNESS.
(I had a minimal reaction to my first vaccine. With the second vaccine, I had body aches and headaches, and fatigue.)  With my booster shot, I had an early onset of swelling in my mouth and itchiness/rash all over my body. My eyes became very red and irritated then crusty as if I had an eye infection.  I could barely open my eyes. I also had queasiness and headaches.  As of today, 1/17/2021 my body is still covered in redness/rash and I continue to itch and be very uncomfortable. My mouth is no longer swollen.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/2/2021 AMYLOIDOSIS, UNSPECIFIED
Information has been received from a physician concerning an "over 60" male with "a lot of problems" who "about a month ago" on approximately 05-Jun-2007, was vaccinated subsequently with 0.65 milliliter dose of ZOSTAVAX. It is reported that "recently", "about a month" after receiving the vaccination the patient developed shingles.  Unspecified medical treatment was sought.  The patient's outcome is unspecified. No product complaint was involved. No more information is expected.
Apprx. 6 inches below and forward of inject site is sore, swollen, hot , hard and discolored are apprx. 3 in long x 1 in wide. Afebrile. Hx Slint (rt coronary artery) 11/2/2000. Treated 10/09/2002 for abcessed tooth and subsequently 3 courses of antibiotics due to degree of infection.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 31-year-old male patient who received BOOSTRIX. On 27th May 2015 10:00, the patient received BOOSTRIX (injection) .5 ml. On 27th May 2015 18:00, 8 hrs after receiving BOOSTRIX, the patient experienced injection site swelling, injection site muscle reaction and chills. On an unknown date, the outcome of the injection site swelling, injection site muscle reaction and chills were unknown. The reporter considered the injection site swelling, injection site muscle reaction and chills to be related to BOOSTRIX. Additional information received: The subject experienced severe swelling, chills and muscle tightness. Most of the reactions were at the injection site. The pharmacist reported she adviced to take anti-inflammatory medication, use ice pack and referred to Emergency Room is condition worsened.
Patient had left to walk around the store. When patient returned she was not speaking.  Patient stumbled into the counter then into the wall.  We then caught patient before she could fall on the floor. We placed patient in a chair.  Tried to talk to patient but was not responding .  Called 911, and which point EMS said patient was having a seizure. EMS then transported patient to the hospital.
Pt recvd 1st dose of Engerix-B vax on 25OCT91 & 24 hrs post vax pt exp fever, hot sensation & had a faint rash on face including nose; tx none; pt was fine 48 hrs later;
pt recvd vax; devel joint pain, induration, erythema & itching; pain resolved p/ several days;
My husband initially tested positive for COVID-19 on 5/30/22. I took COVID-19 tests daily from 5/30/22-6/2/22 and they all came back negative. I woke up in the morning on 6/3/22 with nasal congestion. I thought it was allergies, so I started to gargle with salt water. The next day I woke up with a runny nose and I started to experience chest tightness, and my chest felt heavy as if someone was pushing on it. It was also hard to take in deep breaths. I took my oxygen level, and it was at 88. I took a COVID-19 test and it was positive. My husband called our primary care doctor and they prescribed me PAXLOVID. I took this medication from 6/5/22-6/10/22. My symptoms lasted for about 3 days.
This was my second shot. The same thing happened both times, except this was worse with body aches the next day. I had a fever of 99.1 by the night time both times, and throughout the night, even taking Tylenol.  I had muscle aches, chills, and woke up with a throbbing headache. The second was way worse in regards to inability to sleep, muscle aches, chills, headache, etc., even thought the fever stayed the same. The firs time lasted about 24 hours from onset. Second was over 48 hours. I couldn't work the second day or exercise the second time.
5 mins after vaccination, began c/o feeling dizzy - I had her sit down and she began to lose consciousness. I laid her down in the floor and consciousness returned immediately. Color was pale, but returned immediately as well. The next day still c/o some dizziness, with pain in right arm and right leg. Also c/o weakness in right leg. Referred to a physician to check neurological status.
soreness at injection site by the end of day; This is a spontaneous report from a non-contactable other HCP (patient).  This 56 year-old female reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231 and Expiration date were not reported) on 05Jan2021 15:00 (at the age of 56-years) as single dose, unspecified route,  left arm  for COVID-19 immunisation.  Medical history included known allergy to latex, wheat intolerance, and seasonal allergies, and hypothyroidism. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications include levothyroxine (LEVOTHYROXINE), colecalciferol (VIT D3), ascorbic acid, copper, tocopheryl acetate, xantofyl, zinc (OCUVIT) and zinc (ZINC). Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 05Jan2021 at 21:00 AM the patient experienced soreness at injection site by the end of day.  The patient did not received treatment as a result of the event.  The outcome of soreness at injection site by the end of day was recovered with sequele.  No follow-up attempts are possible. No further information is expected.
Gillion bar syndrome, spinal tap confirmed on April  17, 2021 Pain started in her back in April 10th 36 hours after shot went down her back to but and legs. Friday April  16,2021 she could not walk. Hospital on the 16th by the 17th her arms and hands were affected. Still in the hospital to current date receiving IVIG to see if that will work for her.
Fever started a few hours after injection. 102-103 temps, extreme body aches, headache, nausea, migraine, joint pain. Lasted for 36 hours. Patient had NO reactions to 1st dose and only about 30 mins of feeling flushed 12 hours after 2nd dose.  Took 1000mg Tylenol 10pm on 11/17/21. Arm still very sore and mild headache now.
On April 29, patient developed marked eruption of pox-like lesions over torso, legs, arms, buttocks PO, then IV Acyclovir was started with slow resolution in symptoms over the next week.
I had an extremely irregular period following my second vaccine (August). Severe PMS cramping and excessive heavy bleeding for 3 days which has never happened before. This was the first month after receiving the second vaccine. This month (September) my period is back to normal and not heavy with very little PMS symptoms. I didn?t think anything of it but after reading that this could be a side effect I wanted to report it to help with the clinical research.
pt recvd vax; lethargy, pallor, vomited;seemed well after;
Initial and follow up information has been received from 2 registered nurse, concerning a 21 year old female patient, with no prior pregnancies, ovarian cysts and a drug hypersensitivity to VICODIN and a past history of anxiety (treated with EFFEXOR) and tobacco use, who on 27-FEB-2007 was vaccinated with the first dose of Gardasil (lot # not reported). On 16-APR-2007 the patient had her LMP, and on 27-APR-2007, was vaccinated with the second dose of Gardasil (Lot #656050/0245U). There was no concomitant medication. On an unspecified date, a pregnancy test confirmed the patient's pregnancy. The estimated date of delivery (EDC) was 20-JAN-2008. The nurse confirmed that the patient was not experiencing any known symptoms. Follow up information confirmed that on 07-JUN-2007, therapy with prenatal vitamins (PNV) was initiated for the pregnancy. On 27-JUN-2007, an ultrasound confirmed the EDC of 20-JAN-2008. On 23-OCT-2007, therapy with SLOW FE was initiated for treatment of anemia. A follow up ultrasound (date not reported) indicated that the fetus had short upper extremities, however this resolved at 35 weeks gestation. On 27-DEC-2007, therapy with ZOLOFT was initiated for treatment of anxiety and depression (onset of symptoms not specified). During labor (date not specified), there was an arrested descent, and the baby developed "multi variable decels." Due to these developments, on 12-JAN-2008, at 38 6/7 weeks gestation, a C-section was performed and a normal male infant (no congenital anomalies or abnormalities) was delivered, birth weight 7 lb 11.5 oz, APGAR 4/8. Upon internal review, arrested descent was multivaribable decels- C-section were considered to be serious as an other important medical event. Additional information is not expected.
Fever of 102.8; Sore arm; Cough; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Apr2021 at 13:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to egg. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient previously 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 07Apr2021 at 12:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 06:30, the patient experienced fever of 102.8, sore arm and cough on second shot. On 28Apr2021 at 06:30, the patient underwent body temperature and the result was 102.8 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not 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 of 102.8, sore arm and cough was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
A report has been received from a Health Professional concerning a 7 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 17-Jan-2014. It was reported that expired FLUMIST QUADRIVALENT was administered to forty two patients which started on 17-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
I have recently since October 2021 have had heart issues with A fib and now it is requiring a second hospital visit per my cardio doctor to resolve the A fib condition with another cardio version with in 45 days along with beta blockers
Rash; This is a spontaneous report from a contactable consumer(patient).  A patient of unspecified age and gender received BNT162B2(PFIZER BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 12Aug2021 (Batch/Lot Number: FC3180) as dose 1 single for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient stated, patient was not sure, how they can tell, if patient have a Covid rash from the Shot, patient mean not a Covid rash but a rash from the Covid-19 Vaccine and stated they know what the patient will just pass on all this and patient don't know what it is, it doesn't really matter, so never mind.It was reported that confirm if the rash was from the first dose or second dose vaccination, consumer stated experienced rash from the first shot.The patient experienced rash on an unspecified date in 2021. Outcome of the event was unknown.  No follow-up attempts are possible; No further information is expected.
"funny feeling in his face"; difficulties breathing; This is a spontaneous report received from a non-contactable other healthcare professional. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration on 24Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had experienced funny feeling in his face and difficulties in breathing during his 15 minutes waiting period after vaccination on 24Mar2021. The patient denied rash, difficulty swallowing, wheezing, throat tightness, dizziness and facial swelling. The patient received treatment with antihistamines and had taken water and snacks. The follow up response after treatment was good. The patient was stable to go home and follow up with primary care physician (PCP). The clinical outcome of the events funny feeling in his face and difficulties breathing was resolved on 24Mar2021.  No follow-up attempts are needed. No further information is expected.
Diarrhea; This is a spontaneous report received from a contactable patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on the left arm on 24Mar2021 at 1000 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Past medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Mar2021 at 1000, the patient experienced diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was taken for the event experienced. The clinical outcome of the event diarrhea was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Increase heart rate, hypertensive, throat feels full like there is "a tube in my throat".
A legal complaint was received from an attorney alleging that a child (birth date not specified) received a 3rd dose of Tetramune vaccine on 4/9/96. Previously the child had received Engerix B on 9/14/95 and haemophiluss B conjugate vaccine on 1/28/97. The child also received hep B vaccine on 9/25/96. According to the legal complaint, as a result of the vaccinations administered during the period September 1995 through July 1997, the child "was subjected to very high doses of the mercury contained in Thimerosal, a highly toxic preservative intentionally added to the vaccines he received." It is alleged that 'as a result of the mercury in the Thimerosal containing vaccinations that Minor child received, Minor child now suffers, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning." It is also alleged that the child has "sustained mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments." This case was serious since these events were considered medically important (OMIC) in this case. No additional info was available as of the date of this report.
This patient had a raised rash on back and abdomen, puffiness and redness around both eyes.
Intense swelling , redness, and soreness in the upper left  bicep area  slightly below the injection site, towards the front of the bicep, approx. 2.5-3in in diameter, starting overnight after my injection at approximately 3am ET, along with night sweats, body aches, slight headache, and fatigue, and then starting on 10/09/2023 at approximately 11am ET, intense itching at the 2.5-3in diameter red and swollen area, only moderately improved after taking Benadryl 25mg po and then briefly mostly improved after taking a second Benadryl 25mg po 30 min later, and now, as of 10/10/2023 at 9:10am, slightly decreased swelling and definition of the swollen and red area but still intense itching in that area on the bicep.
Can barely undress self, can't unhook things, pulling hands to back hurts; Sore Arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 10:15 (Lot number: EN6203) as dose 2, single and administered in arm left, administration date 24Feb2021 10:15 (Lot number: EL9808) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bladder Cancer" (unspecified if ongoing), notes: States was 5 years ago and has fully recovered.; "Oral Lichen Plantinus" (ongoing), notes: Spelling of condition as provided by caller. States that she was diagnosed several, maybe 5, years ago. States is autoimmune disorder causing sores in her mouth that do not heal. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Sore Arm"; PAIN (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Can barely undress self, can't unhook things, pulling hands to back hurts".  Additional information: The patient had both shots of the Pfizer BioNTech COVID 19 vaccine , both injected into left arm. After the first shot, patient left arm was hurting a lot and felt like a golf ball on the side, hard and round; second one was also hard but more like a square. The pain was still in her left arm when she got the second shot. The patient left arm still hurts and now it was 2 weeks after her second shot; she can barely move to unhook her bra and arm hurts when she reach for something. she can't lean down on left arm. Pain has gotten worse she can now barely undress herself, has issues unhooking things, pulling her arms behind her back is painful. This was persisting, she mentions not being able to undress herself. she have not contacted her doctor yet because she hopes it would be better. She got her second shot and her arm was still hurting at that time from the first shot three weeks earlier. States it continues hurting now, two weeks since her second shot. The patient told administrators of vaccine that her arm was still hurting from the first one when she went to get the second. She asked them about taking the second one in her right arm but they said not to do that because if both arms were hurting she wouldn't be able to use either arm. The patient stated that she usually does have arm pain after vaccines. Mentions she took a flu shot a few months ago. The patient had no additional Vaccines administered on Same Date of the Pfizer Suspect. The patient not visited Emergency Room or Physician Office. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient Sore Arm was reported as worsened. The patient took COVID Shot because she has a weak immune system.  No follow-up attempts are possible. No further information is expected.