chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild reaction to COVID-19 VACCINE; asthma consistently got worse in the springtime; asthma consistently got worse in the springtime despite of being on dupilumab; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Mild reaction to COVID-19 VACCINE), ASTHMA (asthma consistently got worse in the springtime) and THERAPEUTIC RESPONSE DECREASED (asthma consistently got worse in the springtime despite of being on dupilumab) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) injection for Asthma and Illness.    Concurrent medical conditions included Drug allergy, Drug allergy and Asthma.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Mild reaction to COVID-19 VACCINE), ASTHMA (asthma consistently got worse in the springtime) and THERAPEUTIC RESPONSE DECREASED (asthma consistently got worse in the springtime despite of being on dupilumab). The patient was treated with PREDNISONE for Asthma aggravated, at an unspecified dose and frequency. At the time of the report, ADVERSE DRUG REACTION (Mild reaction to COVID-19 VACCINE), ASTHMA (asthma consistently got worse in the springtime) and THERAPEUTIC RESPONSE DECREASED (asthma consistently got worse in the springtime despite of being on dupilumab) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Very limited information regarding these events has been provided at this time. No further information is expected. Company causality for adverse drug reaction and asthma aggravated is assessed as possible, while company causality for therapeutic response decreased  is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: TCR Follow-up information contains non-significant information. Upon TCR follow-up, the initial reporter/patient denied reporting reactions experienced after vaccine.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected. Company causality for adverse drug reaction and asthma aggravated is assessed as possible, while company causality for therapeutic response decreased  is not applicable.
Patient presented in clinic with erythema, swelling and minor bruising at injection site in the upper left arm. Area warm to the touch. Dr. was notified, he examined the patient and informed patient it is an allergic reaction to injection Tdap advised patient to apply heating pad and ice compress. Patient verbalized understanding.
pt says she immediately got a strange metallic taste in her mouth.  She said she could feel the medicine moving through her system (like having an IV contrast).  After about 24 hours she developed heightened pain with her CRPS.  The next day she became extremely nauseated, starting vomiting and had diarrhea.  Pt says these symptoms have lasted about a week before she started feeling better.
Nerve pain in foot, then moved to knee, followed by severe knee pain and swelling. Headache, neck pain, chills, upset stomach, flu-like symptoms, weakness, sore arm at site of injection, followed by a painful rash on my arm by the 3rd day. I am on day 4 and my knee is still painful and swollen. The arm rash is better w/less discomfort and itching. I still feel ill, and not back to normal.
Breakthrough case admission after 3 vaccines  2/27/21 Pfizer Lot# EL3248;  3/20/21 Pfizer Lot# EL9265;  Pfizer 12/3/21 Lot# FJ1620
Case number PHEH2015US020017, is an initial spontaneous report received from a healthcare professional on 05 OCT 2015. This report refers to a patient of unknown age and gender. Medical history and concomitant medication were not provided. The patient was vaccinated with FLUVIRIN 2015/2016 (batch number: unknown) intravenously through patient's hemodialysis machine on an unspecified date. Reporter was also calling it as  near miss, as the medicine was drawn out the machine. Outcome and seriousness of the event were unknown. Causality of the event was not reported. No further information was provided.
Patient presented with red, swollen, painful area on arm where vaccine was administered approximately 72 hours after shot was given. We told her to put ice on the area and take some acetaminophen for the pain. She then presented 8 days after the vaccination was administered - the area was still slightly pink in color and painful, but did no longer "feel like a knot". She stated the ice and pain pills had helped.
59 year old consumer received 3 dose series of GARDASIL 9; She had no side effects afer receiving GARDASIL 9; This spontaneous report was received from a 59-years-old female consumer, referring to herself. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On unspecified dates, the patient received three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis (product administered to patient of inappropriate age). The patient reported she had no side effects after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) doses.
fever x 3d;T104;inflammation @ inj site (thigh);rt thigh 11 1/2", lt thigh 11";
Patient was administered vaccine at approximately 3:10pm. By 3:20pm patient stated feeling anxious and exhausted. He was sweating a lot and felt cold to the touch. about 5-10 minutes later, EMS arrived to assess the patient.
the person named above sent a comment to the FDA stating that "my 3 year old daughter received her first flu shot on Thursday Nov 15th, 2001 around 10AM.  On monday Nov 19th, 2001 I noticed a change in her mood and she complained that her head hurt.  I took her temp anfter feeling her body and noticed she was very hot.  This fever lasted about 3 days and she was treated with Tylenol.  On Monday Dec 17th after 11am she received her second flu shot.  On Thursday Dec 20th she complained that her head hurt, her body was hot and i treated her with Tylenol for 3 days.  The temp that i recorded was on Sat 12/22/01 2:13AM, 101.9; 4:22am, 100.9; 11:28am, 100.7.  Prior to the vaccine, she was fine.  I feel that the vacc caused some type of reaction despite the fact that I did not notice and/or take her temp for 3-4 days after the vacc was given.  She could have very well had a fever prior to her temp being taken."
Janssen Covid-19 EUA 3/22 started feeling ill. 4/4 went for nasal swab Covid test 4/9 results negative. 4/12 went to doctor with extreme abdominal pain, shortness of breath, blurred vision.  Ran bloodwork. Sent to ER for cat-scan.  Results were colitis.  Back to ER x3. Finally admitted and put on antibiotics, and fluids.  Released home to hospice after 4 days. Died on 4/30 with cause of death, colitis.
after her first dose she had swollen glands; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable female consumer (patient) reported for herself that, A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. After her first dose, she had swollen glands on an unspecified date. It was reported that, the patient already got her first dose. Her second dose was scheduled for tomorrow (date unspecified). The patient wanted to confirm if she could take Tylenol or Advil. Outcome of the event was unknown.  Information on the batch/lot number has been requested. Follow-up attempts completed. No further information expected.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  no concomitant drugs were reported no treatment drugs were reported. Patient date of birth was reported as
3/17 SHE BECAME VERY IRRITABLE AND CRANKY ALL DAY. 3/18 6:00 AM I NOTICED HER SIGHT OF SHOTS ONE WAS VERY PURPLE AND ANOTHER NEXT TO IT WAS VERY SWOLLEN AND RED SHE BEGAN THROWING UP AT 6 AM ON 3/18/ 2012 AND RUNNING A FEVER OF 101.7 SHE COULDN'T KEEP ANYTHING DOWN NOT EVEN PEDIALYTE. ITS NOW MONDAY 3/19/2012 SHE HAS NOT THROWN UP SINCE 03/18/2012 AT 10 PM. BUT IS STILL RUNNING A FEVER OF 101.9 AND DRINKS ABOUT 3 OUNCES OF PEDIALYTE. Still have not been contacted back by her Dr yet. It's 3/19/2012 9:42 am.
At 12 hrs post shot: Felt pain in muscles and joints; nauseous with dry heaves throughout the night and into the next day; could not keep any food or drink until next evening; elevated temp. (100), extreme fatigue and intense headache for at least 36 hours. Able to take a tylenol at 48 hrs post shot. At injection site bruising and a downward 4-5 inch teardrop shaped rash appeared on the inner upper arm. It slowly decreased in intensity after 4 days; most itching associated also decreased. 3 days post shot most symptoms had subsided with just a general malaise feeling; able to eat, but only small amounts; 4 days awoke to intense itching over entire upper torso, but no visible rash. 5 days most symptoms abated.
her eyes were small and puffy; felt very tired this morning; numbness on the right side of her face by the eye socket; pain on her TMJ, but on her right side of her face; She had a hard time to chew; usual pain in the arm after injection; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on the right side of her face by the eye socket), PAIN (pain on her TMJ, but on her right side of her face), MASTICATION DISORDER (She had a hard time to chew), PAIN IN EXTREMITY (usual pain in the arm after injection) and PERIORBITAL SWELLING (her eyes were small and puffy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic shock. Concurrent medical conditions included TMJ syndrome.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HYPOAESTHESIA (numbness on the right side of her face by the eye socket), PAIN (pain on her TMJ, but on her right side of her face), MASTICATION DISORDER (She had a hard time to chew) and PAIN IN EXTREMITY (usual pain in the arm after injection). On 14-Jan-2021, the patient experienced PERIORBITAL SWELLING (her eyes were small and puffy) and FATIGUE (felt very tired this morning). At the time of the report, HYPOAESTHESIA (numbness on the right side of her face by the eye socket), PAIN (pain on her TMJ, but on her right side of her face), MASTICATION DISORDER (She had a hard time to chew), PAIN IN EXTREMITY (usual pain in the arm after injection), PERIORBITAL SWELLING (her eyes were small and puffy) and FATIGUE (felt very tired this morning) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.
Arm pain; Diarrhea; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), DIARRHOEA (Diarrhea), MYALGIA (Body aches) and CHILLS (Chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CHLORTHALIDONE, VITAMINS NOS, AMILORIDE, CABERGOLINE, PANTOPRAZOLE, POTASSIUM and ANASTROZOLE for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), DIARRHOEA (Diarrhea), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm pain), DIARRHOEA (Diarrhea), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also reported he receives injections for his kidneys. No treatment information was provided.
HIVES - ITCHING AND RASH  She had Entyvio infusion on 1/12/2021 She had dose # 1 on 1/21/2021 She had dose # 2 on 2/18/2021  Her itching began day after (I believe) of first dose.  Dr. contacted and we were prescribed Triamcinolone acetonide cream.  That gave little relief.  We went to see dermatologist on 2/5/2021 and were prescribed Clobetasol Propionate and itching began to subside. Immediately after second dose on 2/18/2021 the itching began once more.    She had a rash that began on her neck and slowly moved to her back, then her arms and now on her buttocks.  The itching is continual and rash moving
Infant experienced gastrointestinal distress and diarrhea within the first 24 hours of initial administration of Rotateq vaccine at 2 months of age.  I felt it was not necessary to not administer the second vaccine at 4 months of age; however after the second vaccine the infant again experienced gastrointestinal distress with a bloated stomach and diarrhea which lasted 48 hours.  In both instances the infant was fussy but no fever was noticed.  In the next section I have listed the vaccines administered at the 2 month visit but the same adverse event occurred with the 4 month immunizations.  Also, I am not really sure of the manufacturer other than Sanofi Pasteur and Wyeth
This spontaneous report as received from a medical assistant refers to unknown patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history or concomitant medications. On an unknown date, unknown patients were vaccinated with improperly stored GARDASIL 9 lot # M037770, expiration date of 01-JUN-2019, for prophylaxis (dose and route of administration were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 32.1 degrees Fahrenheit for 12 hours. There were no previous excursions or data logger involved. No further information provided. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001636:
Within 24 hours of receiving vaccine pt reported swelling & heat in (L) deltoid. Couldn't sleep at night - arm thumped - painful to touch - could barely lift it - hurt to push or pull. Pt also c/o severe headache. Pt took 800mg MOTRIN - no relief. As of 11/29 - pt still having difficulty lifting arm further than her shoulder.
Therapy non-responder. Poor quality drug administered. This case was reported by a nurse and described a 51 year old male who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. On 19 August 2004, the patient received the third dose of Engerix-B (lot ENG5389A4). The nurse stated the expiration date for this lot of Engerix-B was 21 June 2004. On 22 September 2004, a hepatitis B surface antibody titer was "less than 3.0".
Client came into the clinic for vaccinations on 6/8/22 with his guardian. This nurse reviewed the available record to determine what vaccines the child was to receive, per protocol. According to the only records available, after reviewing records multiple times, it was determined that that child needed Tdap, IPV, MMR, Varicella, Hep A, MenB, flu, and HPV. The client tolerated well the injections with no complications.   Once the client left the office, this nurse had a conversation with the clinic support supervisor and the immunization supervisor and it was communicated at that time that the child had multiple records prior to this appointment. The clinic support supervisor had called records, rather than fill out a petition  change form, to have the records merged and the result was an incorrect merge of the duplicate records. When the records were merged there were many vaccines that did not transfer over. Therefore, the "updated" record showed that he was incomplete with Tdap, IPV, MMR, Varicella, Hep A, MenB, flu, and HPV. With no documentation that this merge  had occurred in the chart, the only records this nurse had to evaluate to determine what the child was due for was the "updated"  record and the chart. Because of this, the child received Tdap, IPV, MMR, Varicella, Hep A, MenB, flu, and HPV.  Now that the records have been corrected, it shows that the child received additional doses of  MMR, Varicella, MenB, flu, and HPV that he did not need.  Child's guardian was notified. No adverse events were reported. Child tolerated well.
Problems with Sleep; can't sleep the required hours; Horrible Extreme Fatigue; had 2 blood tests done and both were abnormal with no answers from the doctors; poisoned by the vaccine; developed a tick in her right eye; neurological problems; last February or March but she could not remember the date; This is a spontaneous report from a Pfizer- COVAX. A contactable 82-year-old female consumer(patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, Expiry Date, NDC number: not reported), via an unspecified route of administration, administered in Arm Left on 05Feb2021 at 14:00-15:00 (did not exactly remember) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. It was reported that it had been many years since she had taken vaccines. She stated that she got her first dose last February or March but she could not remember the date. She stated that she experienced side effects from the vaccine, and she had problems with sleep, she could not sleep the required hours. Her blood tests, 2 of them, were abnormal. The doctors said that they did not know whether they were abnormal. She had horrible extreme fatigue. She reported that she wasn't going to take the vaccine but every doctor pushed her to take the vaccine and so she took it, and now this company had destroyed her health. She reported that she was 82 and she was in good health. She just heard about the extreme fatigue, she didn't know that was from the vaccine also. She assumed that the vaccine caused her neurological problems. She developed, about month and a half ago, she developed a tick in her right eye and she didn't know what it was from. Her side effects started in the early Spring, probably March. She knew something was different but she didn't put it together with the shot and she didn't think about it. She did not visit emergency room as wasn't smart enough to go to the ER, she never thought it was from the vaccine. She went to doctor with the extreme fatigue and that was how found out about abnormal bloodwork and then she had more blood work done and it was abnormal too. These were things she had never had before. She was not sure if she went to the doctor in March or April. She knew that she had 2 blood tests done and both were abnormal with no answers from the doctors. She had not received her second vaccine. Also, stated that she was poisoned by the vaccine. No treatment taken as nobody knew what to do. She stated that like an idiot, she took it. The outcome of all events were not recovered except the outcome of event short-term memory impairment was unknown.  Follow-up attempts were needed. Further information was expected.
Urticaria 15 cm X 7 cm around injection site.  Treating with oral BENADRYL.
MD's office called nurse-stated "L arm from shoulder to elbow is swollen, red, warm." DTaP #5 give L deltoid, varicella #1 L SC given on 7/22/02.
3/23: hands & feet felt puffy and swollen, but not actually puffy. All day.  3/24: hands &  progressively more puffy (feeling) with tingles in hands/feet. -2:30- Mild chest pain  -3:30- rash with itching/hives -5:00- full body red rash/hives with chest pain that went across the whole front of chest and wrapped around ribs on both sides. NO difficulty breathing.  -6:00 took Benadryll capsules
Fuzzy brain and dizziness and tinnitus. This was reported on a separate vaers number  1578337. However that only indicated severe tinnitus after the second vaccine. However upon reviewing my v-safe entries thirds side effects were also reported after my initial vaccine on 1/9/21
Pt brought to ER with a fever of 104.3 at home. TYLENOL given temp down to 102.5 rectal. Discharged with possible viral syndrome vs. reaction to vaccine.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Mild, Systemic: Fever-Medium, Systemic: Headache-Severe, Additional Details: severe sinus congetion and pressure
Patient arrived to clinic for appointment and update on vaccines. Patient stated he was due for Typhoid and when it was being verified the date was misread  for another vaccine the patient  had due. Patient was given one extra typhoid dose too early. Patient did not have any symptoms and was stable after the vaccine was given.
Soreness and weakness until first seizure exactly 1 year later.  Has had 3 since and is currently on Keppra, which make her a tired and non-functioning.  All MRIs, blood test, EEG's normal.  Nurtritionalist believe the vaccine damaged her nervous system which is going completely wacky during puberty.    Question #21 below does not  work properly.  The vaccine is Gardasil, my daughter had all three shots, last one on July 13th, 2007.
Upon receiving 2nd injection (flu vaccine), Pt had a syncopal event that lasted approximately 5 seconds.  Pt was A/ox4 post event, pt placed in right lateral recovery position, ice packs placed on head and neck with vs stable (see documentation).  Pt denies any palpitations, chest pain, dizziness, shortness of breath, headache, nausea or other discomfort.  Pt discharged home with mother after 10 minutes of rest on his own recognizance and without any complaints.  Pt given instructions to go to the immediate care or emergency department if he has further symptoms or has a syncopal episode again. Pt verbalized understanding.
Received the J&J vaccine and 7 hours later broke out in hives , itchy throat swollen lips . Had anaphylactic reaction to tetanus in the past ...psoriasis break out as a infant and childhood after every vaccine received
Awoke w/terrible thirst - lasted approx 4 hrs developed chills w/temp 102 - aches and pains in legs and back. Very weak and disoriented - treatment Aspirin - lasted 24 hrs.