chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient vaccinated on 5/28/09, went to school on 5/29/09 and upon return home from school mother noticed swelling and redness on right arm.  Patient did not complain of any pain, no decreased range of motion, no fever and no other complaints.  Child was brought to the Emergency Department and admitted and treated for cellulitis; received IV antibiotics. 7/13/09-records received for ED visit 5/28/09-DX:Cellulitis of left arm. Labs WNL.
4/05/10 Cousin called and stated patient was having an "allergic reaction and that the patient had shots with us today. Caller described Rxn as a rash on both arms and on trunk of patient. Denies difficulty breathing. Referred immediately to PCP or ED for evaluation.
Extreme muscle pain; fatigue; headaches; loss of appetite; muscle weakness; body aches.
Patient had a syncopal episode while in shower a few hours after vaccine.  Patient then had seizure like activity and was transported to the hospital.  During transport patient's heart rate dropped to 20.  Patient was found to have iron deficiency anemia.
pt recv vax APR96 & 23OCT97 lab eval revealed lack of seroconversion;
This is a 77y.o. male with atrial fibrillation/flutter on Coumadin, COPD, stage 3 chronic kidney disease, CHF, and hypertension who presents from group home complaining of shortness of breath on exertion x 2 days. He also has chills, malaise, myalgias, cough, and chest tightness with coughing and admits to being in close contact with his roommate who is also ill. He reports he is fully vaccinated against COVID-19. He denies known fever, nausea, vomiting, abdominal pain, or diarrhea. He has chronic orthopnea, but denies lower extremity swelling or calf pain.   Upon arrival to the ED, BP was 163/110. He was afebrile, SpO2 92% on room air and 1 liter of supplemental oxygen applied, which was then escalated to 3 liters. COVID-19 detected. No acute process seen on chest x-ray. Labs notable for D-dimer 500, CRP 128, troponin negative, ferritin 201, LDH 237, CK 109. Creatinine 1.84, near baseline. Procalcitonin 0.11. The patient was admitted on IV dexamethasone. ID consulted.
Upon awakening at 07:00 began an uncomfortable feeding in chest. Over the next few hours, the feeling became painful. The pain was radiating from the center of my middle chest  outward. It became more painful to breath deeply. At about Noon I began feeling worse all over my body. Joint aches, sensitive skin and just feeling  not well. It is now 1:48 and I feel no better, but no worse. A nurse from the facility, is going to give me and my wife a Covid-19 test momentarily.
itchy blister; watery blister; blister broke open; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingles Vaccine (received 1 year ago).   On 21st June 2019, the patient received the 1st dose of Shingrix. On 24th June 2019, 3 days after receiving Shingrix, the patient experienced pruritus, blister and blister rupture. On an unknown date, the outcome of the pruritus was not recovered/not resolved and the outcome of the blister and blister rupture were unknown.   It was unknown if the reporter considered the pruritus, blister and blister rupture to be related to Shingrix.  Additional details were provided as follows:  The patient had the previous shingles shot years ago and she has a history of shingles. On 21st June 2019, the patient received the 1st dose of Shingrix in left arm. On 24th June 2019, she noticed two blisters approximately 6 inches below the injection site on her left arm. The blisters were itchy and watery. The blisters were worse and bigger and one has broke open.  The reporter consented to follow up.
5-10 minutes after receiving the Janssen COVID-19 vaccine the patient fainted.
After about an hour I had extreme stomach upset and sudden, uncontrollable diarrhea (similar to food poisoning, but without the intestinal pain or vomiting). I had flu like symptoms following this for about 24 hours
Starting at about 3 AM the next morning after my 2nd vaccine, I woke up sweating, hurting all over, and running fever. Symptoms continued for over 24 hours. I woke up the second morning after symptoms started and was sweating so much that my clothes & bedsheets were soaking wet.  As that day progressed, I began feeling better. By that evening & the next day, I was more or less back to feeling normal, except for continuing to feel very fatigued. The fatigue lasted for a few weeks.
Headache, fatigue, nausea, weakness and fever. I am writing this letter in regards to my patient. Patient was administered a GARDASIL immunization at the County Health Department on August 12, 2014. On August 13, 2014, patient came into the office showing symptoms of a reaction to the immunization. In my opinion, I do not feel that he needs to be administered this immunization again, due to the high risk of another reaction. If you have any questions, feel free to contact my office.
Mother states that one hour after shots given her son began crying high-pitched cry. No fever. Called doctor who told her to increase dose of Tylenol. Crying persisted for 8 hrs then baby fell asleep. Next day patient was "cranky" but ate and sleep normally. Injection site LT red, warm to touch X24 hrs then subsided. Denies fever, limpness, paleness, convulsion. Only other complaint was constipation for which he is on lactose. Mother does not give it as prescribed.
Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 70 years old male patient who experienced high blood pressure, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitants were reported. On an unknown date (reported as 09-Nov-201), the patient received a dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine lot number not reported via unknown route in the left arm. On an unknown date, the patient developed a non-serious high blood pressure (hypertension) (Unknown latency) following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. The patient went to a cardiologist a couple days ago and they performed EKG and advised him to keep monitoring readings. It was reported that his blood pressure increased in three days "from 120/70 to 150/100." Final diagnosis was high blood pressure. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for high blood pressure. List of documents held by sender: none.
9/13 Myocarditis started 1 hour after moderate and lasted a week but contacted Primary Physician on Friday 9/17 of symptoms .  He said it was normal so no need for any tests per the office.  On 9/26 eye developed  eye floaters and went to Ophthalmologist.  After examination he said I had Posterier Vitreous Detachment.  I went to another specialist and he said I had some retinal bleeding and said maybe retinal tear or detachment soon.
This spontaneous report as received from the patient's mother refers to a female patient of unknown age. It was reported that the patient was just vaccinated with the second dose of GARDASIL on 19-JUL-2013, (lot number and expiration date unknown), (dose, route and anatomical location unspecified) for prophylaxis. The patient had received her first dose on an unspecified date in 2008 and has not yet received her third dose. Additional information has been requested.
red, inflamed, left deltoid with pain. pt applied cold compress and swelling went down. Used tylenol.
Vitreous hemorrhage right eye.  Acute and not related to trauma or previous eye pathology.  Impairment of visual acuity due to spontaneous bleeding.  Resolved over 6 weeks with conservative treatment.
Immunization site warm to touch. Area is red, swollen and uncomfortable when moving arm. Afebrile.     .
10/19 Noted bump on vaccinated arm. 10/20 9 pm Noted 3" reddened area where vaccinated. After showering noted area hot to the touch, remains red & swollen has diarrhea, nauseated & felt like vomiting.
No Symptoms. On 3/5/2022, Patient transported via ambulance after fall in home, fractured hip, COVID tested as part of pre-op. Follow up on 3/25, confirmed never developed COVID symptoms.
I have hives on my legs and I haven't ever had that before until I took the shot.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0185), dose 1 via an unspecified route of administration on 21Jun2021, as single dose for COVID-19 immunisation. Medical history included heart problems, thyroid problems and asthma. The patient's concomitant medications were not reported. After took first COVID shot on 22Jun2021, the patient noticed had hives on legs and she had not ever had that before until she took the shot and went to her doctor in few minutes. Patient stated this must be a side effect. The last night (22Jun2021) and took a very cold shower and iced the area with a bunch of ice and she called her doctor, doctor told to go and get over the counter medicine at any pharmacy and got Benadryl 25 mg. Therapeutic measures were taken as a result of event and treatment with Benadryl 25 mg. Outcome of the event was unknown.  Follow-up attempts are needed;further information is expected.; Sender's Comments: Linked Report(s):PFIZER INC-2021770789 Same reporter/product/event, different patients
patient reprorted having a sore arm but then after 2 days a red patch began to develope. The red patch was located below the injection site. Pt was referred to her physician to verify there is no form of infection that may be causing the redness.
pt recv vax 16MAR96 & 26MAR96 pt exp a measles/rubella-like rash;no further details were provided;
Injection site soreness, pain with lifting the arm. Pt reports pain started the morning after the vaccination and the pain has remained since 11/3/22. He has tried a warm compress and Tylenol and has not found relief.   Denies swollen, inflammation or any hard spot or nodules.
My blood pressure went up very high, pain in my chest, shortness of breath, rash on my face, swollen arm and redness at injection site.  Went to the hospital. Monday, March 15th at hospital from 2:00 p.m. until 7:00 p.m.
Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: pt is diabetic, was very nervous prior to vaccine administration. states she has not eaten in several hours. pt given water and piece of candy in case blood sugar low. pt fine at time of leaving
the night i got the first vaccine , Pfizer-Lot EH9899 i started having tightness in my legs and problems breathing 12/23/2020, after the vaccine , it seemed as i was maybe having a panic attack, or a seizure,  i was sweating and i could get my son to understand to call the emergency number. I calmed down and fell asleep , exhaling. I woke up just fine with a sore arm. chalked it up to listening to the news to much, then the other symptoms came after the 2nd shot on jan 13, and i never got to go back to work. i kept having tightness in my legs, i had tremors i never had before, i was a (Privacy) and had to take care of patients and walk the hals, i could do my job pretty much just fine. the symptoms kept going back and forth, now i have a hard time walking in spirts. its like the vaccine boosted my auto immune forward 40 years ahead of my age, now i walk and look like im 90 years old instead of a fun spunky 45 yr old, all within a year of that vaccine. i was PRO , i got it to help protect my patients at the nursing home , now i can hardly use my left arm, its like i had a stroke, i need help doing alot of things now i didnt before , more of my teeth broke out, decay, i have constant pain all over and i have not been able to work since jan 10th 2021, my memory and dates are off, and it took me until now to figure out how to report this but i originally wrote a letter since my doctors and ER docs all think im crazy and i was on the 1 year date , and i still hadnt gottenany better. i need someone to help me bathe, some days, i cant drive either and im on some srious meds to, my feet started having nerological problems even more and i stay in bed most of the time, im on methotrexate to try and slow the lupus down, its working a little maybe. but im still not able to function like i could before these shots .
Patient's mother called on 1/23/22 to let us know that the patient had been admitted to the hospital on 1/19/22 around 10 AM due to an allergic reaction (swollen eyes) from the COVID vaccine. The mother stated that the patient had begun complaining about her eyes hurting the of the vaccine, 1/15/22, and had continued to complain about her eyes until they started swelling the morning of 1/18/22. Patient was taken to her pediatrician which recommended the patient go to the hospital . The mother stated that the patient was given antibiotics that the patient did not respond to, but when given steroids the patient showed improvement in symptoms. Patient was released from the hospital on 1/22/22
swollen lymph node under armpits on both sides; sensitive skin under armpits on both sides; Initial information was received on 29-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or other non-professional.  This case involves a 38-year-old male patient who experienced swollen lymph node and sensitive skin under armpits on both sides (lymphadenopathy and sensitive skin), while he received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 28-Sep-2020 around 11:00 am, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an intramuscular route at the right deltoid for prophylactic vaccination.  On 29-Sep-2020, the patient developed a non- swollen lymph node and sensitive skin under armpits on both sides (lymphadenopathy and sensitive skin), 1 day following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown for all reported events.   There will be no information available on the batch number for this case.
no adverse event; the temperate excuration occurred, vaccines have been administered; This spontaneous report was received from a medical assistant and referred to 1-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-MAR-2022, the temperate excursion occurred to varicella virus vaccine live (oka/merck) (VARIVAX). The vaccines underwent temperature excursion of -14 degrees Celsius up to -10 degrees Celsius during a time frame of 3 hours; -10 degrees Celsius up to 8 degrees Celsius during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion.  On 25-APR-2022, at a private doctor's officer/hospital, the patient was vaccinated by a healthcare professional with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (valid lot # U025790 with expiration date: 19-AUG-2023; dose not provided) administered subcutaneously for prophylaxis (product storage error). This initially used vaccine was not available for return/evaluation due to being given to the patient. There was no prescription drug treatment for the experience required. No adverse event was reported (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2204USA009330:
CHIEF COMPLAINT/REASON FOR VISIT Weakness - Generalized   HISTORY OF PRESENT ILLNESS  Patient is a 74 y.o. female presents with generalized weakness.  Patient describes that she has been feeling generally weak for the past week which is been associated with COVID.  Patient also describes that for the past 3 weeks she has been having intermittent black stools.  Last 1 that was abnormal was last night.  She describes that today her stools were almost back to normal.  Chronic back and neck pain which are unchanged.  No abdominal or chest pain.  No difficulty breathing.  No pain with urination.  No fevers or chills.  No nausea or vomiting.  EGD 07/17/2019 showed grade 1 varices in the lower 3rd of the  Additional information for Item 18:  CHIEF COMPLAINT/REASON FOR VISIT Weakness - Generalized     HISTORY OF PRESENT ILLNESS  Patient is a 74 y.o. female presents with generalized weakness.  Patient describes that she has been feeling generally weak for the past week which is been associated with COVID.  Patient also describes that for the past 3 weeks she has been having intermittent black stools.  Last 1 that was abnormal was last night.  She describes that today her stools were almost back to normal.  Chronic back and neck pain which are unchanged.  No abdominal or chest pain.  No difficulty breathing.  No pain with urination.  No fevers or chills.  No nausea or vomiting.  EGD 07/17/2019 showed grade 1 varices in the lower 3rd of the esophagus.  PMH includes insulin-dependent diabetes, general weakness, CHF, portal hypertension, malnutrition, heart failure, pancreatic cancer with Whipple procedure, cerebral hemorrhage, ascites, cirrhosis, bacteremia, colitis, AFib, PE on Eliquis, gastric ulcer, AFib, IVC filter, soft feel varices, COVID.
COAGULOPATHY, UNSPECIFIED TYPE PERICARDIAL CALCIFICATION ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
c/o difficulty swallowing, hyper salivation, loss of appetite (decreased # 20). Symptoms started last week of Sept. 2019 - ER visit, 4 clinic visits  -feeling better now; still c/o salivation
This is to inform you of my reaction to the immunizations administered. SHINGRIX reaction: Flu and SHINGRIX shots administered Oct. 2 -- left arm very sore by evening and by 10pm fever and chills. Had to change pajamas because sweating so much. Aches like the flu. Slept badly and napped the next day. Felt a bit better by Thursday evening, Friday prepared for trip to cabin at state park. Very tired -- toast for supper. Oatmeal breakfast, then stomach started hurting. Acid, not able to burp, constipated. By night stomach felt like it was going to bust -- pain 8 level. Walked, tried yoga poses, couldn't sleep or eat, drank a lot of water and tried TUMS. Started puking about 3:00 am. Did not feel any better. Then diarrhea. Packed up and came home a day early. Monday exhausted. Tuesday headache but pain pills helped and ZANTAC started helping stomach but still sore stomach through the week. Fever back on Sunday. Sunday night rash on forehead and around left eye. Monday visited Dr. at clinic -  she said it didn't look like a zoster rash to her and to call if pustules formed. Called today and the clinic will see me. My rash is spreading and pustules visible. Itchy. I don't want the rash to invade my eye. Looking at shot record I had the ZOSTAVAX in 2014 so I should not have had the SHINGRIX until 2019 or 2020. The CDC said that the vaccine was only tested for people 5 years or more after ZOSTAVAX vaccination so could not guarantee safety of the vaccine given before that time frame. Perhaps why my reaction was so strong.
tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020, Clot blood (in left arm since the pacemaker implantation) and Pacemaker insertion (cardiac) (pacemaker/defibrillator). Concurrent medical conditions included COPD and Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), UMECLIDINIUM BROMIDE (INCRUSE), SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), APIXABAN (ELIQUIS) and LEVOTHYROXINE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FATIGUE (tired). On 07-Mar-2021, FATIGUE (tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient reported no known allergies. No treatment information was provided by the reporter.   This case was linked to MOD-2021-211604, MOD-2021-211687 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non-significant followup
Pt states came in on Sun 10/27/19 for Flu and Pneumonia shot.  About 3 hours later, she stated she started to see swelling in the her arm, pain, and hot to the touch in her right arm only.  She said her left arm only felt sore, no other complaints.  She states she could not get out of bed until today 10/29/19 and came to the pharmacy to inquired about it.  She said the pain and swelling has reduced greatly but is still visible.
This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 22-JAN-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccines improperly stored as follows: On 13-JAN-2014, oral, ROTATEQ was stored outside of recommended temperatures for 2 hours (2pm-4pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, oral, ROTATEQ was stored outside of recommended temperatures for 2 hours (2pm-4pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, oral, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm- 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, oral, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm- 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, oral, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm- 6 pm) the temperatures recorded was 52.7 degrees F. On 09-MAR-2014, oral, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm- 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, oral, ROTATEQ was stored outside of recommended temperature for 6 hours (8 am- 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, oral, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am-10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, oral, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.