chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sinus infection; 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 73 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUSITIS (non-serious), outcome "unknown", described as "Sinus infection".  Additional information: Patient had the first dose of Pfizer COVID vaccine last week and now patient was getting a sinus infection. Is it okay for patient to take an antibiotic, amoxicillin/clav.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Subsequent to receiving first and second doses of varicella virus vaccine live on 8/14/97 and 10/8/98, the pt developed skin lesions consistent with varicella with diffuse lesions over the entire body, on 3/17/99. The pt was treated with Benadryl. The condition lasted for 6 days, then dried, scabbed, and cleared away.
Had pneumonia shot 9/20/12, then received another one 12/22/12. Reaction - left arm is red, hot, swollen (edematous).
Patient was given johnson and johnson vaccine and immediately felt lightheaded and faint. She laid down on the floor. I went to get cool wet papertowels and upon returning she was unresponsive. I immediately had staff call for an ambulance. Patient came to before needing to administer the epipen or diphenhydramine. Patient denied throat swelling or pain and was alert x3. EMS checked her out and determined it was just a fainting episode, which the patient admitted to having frequently in the healthcare setting. Patient was able to walk out of the pharmacy and is feeling fine now.
patient with rash on her face and neck which the physician diagnosed as chickenpox; This spontaneous report was received from a physician via a field employee referring to a 9 years old female patient.  Information about concomitant medication and drug reactions/allergies was unknown and the patient did not have any pertinent medical history.  On 28-JUN-2010, the patient was vaccinated with her fist dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose detail, route, lot # and expiration date were not reported) with sterile diluent for prophylaxis (was reported as prevention of varicella). On 08-JUN-2013, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose detail, route, lot # and expiration date were not reported) with sterile diluent for prophylaxis (was reported as prevention of varicella).   From 03-MAR-2019 to 10-MAR-2019, the patient went on a cruise. On 19-MAR-2019, the patient came into the office with a rash on her face and neck, which the physician diagnosed as chickenpox. Information about treatment given for the event, lab diagnostics/ studies performed was unknown. The patient was came to the physician's office for sought medical attention. The outcome of the event was reported as not recovered. The causality assessment between sterile diluent, varicella virus vaccine live (oka/merck) (VARIVAX) and the event was not reported.
Similar to the first shot, 12 hours after vaccine body aches and fever began.  This second time was actually worse than the first.  Like the first time, I have had to miss a day of work because of the intense flu-like symptoms.  This time, I had bit of rapid heartbeat as well, not sure if that was related to the fever, but I definitely noticed it.  I am still not 100% as of today, but can feel myself getting back to normal.
I received my second dose of the Pfizer vaccine for COVID-19 on 7/23/2021. On 7/6/2022, I began to get very weak and nauseous. I was tested for COVID-19, and the result was positive. They then gave me an experimental intravenous drug, bebtelovimab, I was then sent home. On 7/7/2022, my symptoms got progressively worse. I was so weak that I couldn't even stand up, and the nausea worsened to the point in which I had dry heaves. I was unable to eat at this time, so I had nothing to throw up. I spent most of the day sleeping. On 7/8/2022, my symptoms were so severe that my family insisted that I go to the hospital. I still felt weak and experienced nausea whenever I moved. I then went back to the ER, and I was admitted to the hospital. I was told that my heartrate was slightly irregular, and they wanted to keep me, so they could keep an eye on my situation and provide relief for my nausea. I slept most of the time while I was in the hospital. They experimented with different medication combinations to help me with my nausea, and I finally had relief from the nausea on about 7/12/2022. During this time, I was unable to eat, because the thought of eating just made me sick. I underwent various tests, and my heart function was normal. While I was in the hospital, it was also discovered that I had a urinary tract infection. I was finally released from the hospital on or about 7/13/2022. They prescribed me hydralazine to take at home and a scopolamine patch to wear behind the ear. When I got home, I slept most of the day. On 7/14/2022, I felt much better. I was no longer nauseous, and I had more strength. I was now also able to eat again.
Within 15-minutes of vaccination, the patient reported rapid palpitations. EMS evaluated the patient on-site. The patient was hypotensive (107/67) with a successful, unchanged vagal maneuver test. EKG demonstrated paroxysmal supraventricular tachycardia. EMS administered 0.5L IV normal saline and transported the patient to hospital Emergency Department. In the ED, EMS stated that the patient still had palpitations, but that their initial tachycardia (170bpm) had slightly improved (130bpm) after IV fluid. Physician administered an additional 1L normal saline. Second EKG did demonstrate SVT and physician was planning to administer Adenosine, but the patient's heart rate spontaneously improved. Upon re-evaluation, the patient remained in NSR and asymptomatic with an unremarkable work-up. After a negative D-Dimer, the physician ruled out a PE. The patient was discharged with diagnoses of SVT and palpitations with instructions to follow-up with a cardiologist.
I became dizzy and light and foggy headed after both shots a week later. 3 weeks ago I was mowing the lawn and became light headed and fell backwards on the grass but did not hurt myself
acute allergic rxn (beginning 19NOV through 23NOV) breathing problems cont currently hives over entire body, swelling of air passages, & tongue;general malaise, dehydration, pain in kidneys;
During the 15 minute monitoring time frame, patient stated she thought she might be having a reaction. She stated her heart rate was elevated over 100 bpm (approximately 125 fluctuating back and forth from 80 to over 100) She mentioned some shortness of breath and agreed to have me dial 911. The paramedics determined it was most likely a cardiac event because she did have a pacemaker that shows events. They took her to the hospital.
11APR92 MMR recvd 23-25APR92 stiff neck, sore joints, no fever, no rash, inject site-red & swollen; 28APR92 contacted clinic; 29APR92 pt taken to MD;
4/4/21 ER HPI: 70 y.o. female who presents with complaint of weakness, shortness of breath worse with exertion the started this morning.  Patient was said to be fine yesterday.  Patient denies chest pain, nausea vomiting or abdominal pain, no headache or dizziness.  Patient is also said to have pale conjunctiva.  No fever or chills and no cough.  triage note: Patient presents to er with daughter from home with complaints of increased weakness, increased shortness of breath.  States upon waking today daughter states "she was more confused and more difficulty with ambulation. States she was off balance today with stumbling more than normal. Daughter states she was "verbally exhausted today." Patient unable to answer questions.
Patient who received a dose from a vial that was punctured more than 24 hours ago; Swelling in right arm; Pain in right arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE PAIN (Pain in right arm) and EXPIRED PRODUCT ADMINISTERED (Patient who received a dose from a vial that was punctured more than 24 hours ago) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 004F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received a dose from a vial that was punctured more than 24 hours ago). In October 2021, the patient experienced VACCINATION SITE SWELLING (Swelling in right arm) and VACCINATION SITE PAIN (Pain in right arm). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient who received a dose from a vial that was punctured more than 24 hours ago) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling in right arm) and VACCINATION SITE PAIN (Pain in right arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter has stated that patient has administered her second dose on 14-Oct-2021 at 2.05 PM. No concomitant information was reported. No treatment information was reported. Reporter has stated that the Total amount of time the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F and From 2:05 13-Oct-2021 to 2:53 pm 14Oct2021
Called to make an appointment with healthcare provider correct. Started feeling new symptoms; arthritis in hands and feet 48 hours after the boosters develop arthritis of the joints in hands in the feet and was not able to bare weight, on day 4 had unusual lip swelling and a lump in throat. This condition lasted a week, and he took Aleve. The overall incident took a week.
I got a rash about 10 days after my 1st shot that was itchy and red. It was more on the inside of my arm not around the site of the shot. I used Benadryl cream during the day and Benadryl capsules at night. It cleared up in 7 days.
One site is red and swollen. It is hot to the touch. It does hurt. No fevers. He only complains that his arm is sore and itchy. No stomach ache or nausea. No throat itchy. No rash.
Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I was aching I had a fever 102.8 I had chills, body aches, my muscles where hurting, I also felt the pins & needles on my feet everything lasted about 36hrs. The headache lasted about 3 days.
A 67 year old female received RSV vaccine or placebo and Influenza vaccine on 10/18/02, and 115 days later was admitted to the hospital with exacerbation of COPD, exacerbation of CHF, and cholestasis/biliary colic on 2/10/03. Signs and symptoms included shortness of breath and chest discomfort. The patient was treated with Rocephin, Zithromax, Solumedrol, Lasix, and Aldactone. The patient recovered and was discharged on 2/14/03. The patient has a history of COPD and CHF. The investigator assessed the event as possibly related to the study products. Follow up information received on 3/25/03: Hospital discharge summary for 2/10/03 to 2/14/03. The patient was admitted with the above presumptive diagnosis with the possibility of pneumonia, but review of chest x-ray revealed no acute infiltrates, but pulmonary vascular congestion was present. Her therapy consisted of balance of intravascular volume and improvement of respiratory status while reducing preload and afterload, and she produced sputum well, diuresed well, and saturations improved to a level of 92 to 94 on room air by 2/14/03. Procedures done to evaluate her ongoing abdominal pain in the light of her acute presentation with dyspnea, revealed a normal ultrasound but a severely reduced gall bladder ejection fraction. She was however tolerating normal diet and ambulation, breathing without supplemental O2, normal bladder and bowel function were present, and she was requesting discharge on 2/14/03. This was granted with instructions to restart her usual medication with the following exceptions. She was to increase her Aldactone to 50mg PO BID, she was prescribed Humibid LA BID, she was to increase Lasix to 40mg BID, and she was to decrease Covera HS to 180mg q hs. She was prescribed doxycycline 100mg BID for 10 days and advised to maintain a low fat, low sodium, no sugar, low starch diet. She was to recheck in my office in one week and call if having any problems. Manufacturer Report number 200300028 was previously reported as 2003031078. 11/03: New version created in order to perform recoding of AE following data conversion project. Unblinding information received on 5/16/05. The subject received Placebo.
16 years old and was vaccinated with the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and was vaccinated with the 1st dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and was vaccinated with the 1st dose). On 31-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and was vaccinated with the 1st dose) had resolved.            Concomitant product information was not provided. Treatment information was not provided Patient stated that she was feeling well   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up information received on 11 Jun 2021 Dose 2 information was added; Sender's Comments: .
This report was received from GlaxoSmithKline and was assigned manufacturer report number A0769858A for KINRIX.  This case was originally reported by a physician via a sales representative and described the occurrence of itching in a 4-year-old male subject who was vaccinated with combined KINRIX, MMR II and VARIVAX (Oka/Merck).  Concurrent medical conditions included asthma.  On 19-FEB-2009 the subject received unspecified dose of KINRIX, unspecified dose of MMR II and unspecified dose of VARIVAX (Oka/Merck).  On 19-FEB-2009, approximately 5 minutes after vaccination with the 3 vaccines, the subject experienced itching, congestion (unknown) and wheezing.  The subject was treated with BENADRYL, SOLUMEDROL and EPINEPHRINE.  The subject was admitted to the hospital overnight for observation.  At the time of reporting the outcome of the events was unspecified.
While receiving the vaccine I felt pain and burning.  That subsided after waiting the 15 minutes for monitoring.  When I arrived home my arm was sore, tight, and felt swollen.  I wasn't able to sleep on that side, I wasn't able to lift normal everyday items and I felt shooting pains as if I was getting injected again.  I treated myself with Aleeve and iced my arm (20 mins about 3x a day) for 3 days.  Symptoms still persisted.  At my second dose my experience was very different from the first however, the pain from the first one still remained.  I inquired if I should still feel this pain and I was told to expect soreness.  At the urge of my family and coworkers I went to my doctor on 5/4 and he informed me that I have shoulder bursitis due to the poor administration of the vaccine.  The person who gave it to me either went in the wrong spot, or went too deep.  I am being treated with Methylprednisolone tablets (4mg 21 tabs) currently.  My doctor said that if this doesn't work I would have to see an ortho and possibly need to get cortisone injections.  There is no way to tell if this will heal or if I will have to live with this for the rest of my life.  Poorly skilled administration of this vaccine so far has changed my life...and not for the better.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 71-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (on 15th February 2018, the patient received 1st dose (refer case US2018130337)). On 2nd July 2018 16:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd July 2018, 1 days after receiving SHINGRIX, the patient experienced headache and fatigue. In July 2018, the patient experienced pain. On an unknown date, the outcome of the headache and fatigue were unknown and the outcome of the pain was recovering/resolving. It was unknown if the reporter considered the headache, fatigue and pain to be related to SHINGRIX. Additional information was reported as follows: On 3rd July 2018, the patient woke up with the events headache and fatigue after vaccination. The batch number for SHINGRIX was unknown. This case was linked with case US2018130337 (1st dose), reported by the same reporter for the same patient.
Ringing/buzzing/echoing in both ears, hearing loss, loss of balance, and dizziness. Symptoms have continued for 48 hours+
pt cried long x-reddened & swollen from thigh to knee;ER MD said nl rxn to immun & ordered nothing;has appt w/MD 1st wk of MAY;
Pt recvd 1st dose of Hep B vax on 18MAR91 & on 21MAY91 exp rt upper quad abd pain; MD dx liver pain; sx persisted x 2 days a/remitting; pt recovered & chose to have no further vax w/Hep B;
28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.
shingles/had "too much pain"; felt "super bad"/mind is going crazy right now; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL9261), via an unspecified route of administration on 05Feb2021 as 1 st dose, single for covid-19 immunisation. Medical history included psoriatic arthritis and osteoporosis. Concomitant medications included methotrexate for psoriatic arthritis and alendronate sodium (FOSAMAX) for osteoporosis and unspecified vitamins. On 09Feb2021, the patient developed shingles, she saw a doctor on Saturday because she had "too much pain", she was given a "very strong" treatment to fight the shingles with prednisone 20 mg, gabapentin 300 mg, acyclovir 800 mg. The patient did not know if this was a reaction from the vaccine or if what was happening to her, she never had shingles in her life. The rheumatologist recommended her to get the first COVID vaccine, but she didn't know about the second one. She was scheduled for the second vaccine on 26Feb, she didn't know what to do, if to get the second dose or not. The patient asked if the vaccine interfere with the meds she takes. Also asked if she could get the vaccine if she was on these meds. She felt "super bad" in Feb2021 and wondered if shingles were an allergic reaction to the vaccine or a disease. Patient stated, "My mind is going crazy right now". The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Patient presented to emergency department  on 8/16/2021 after falling at home. Patient presented with altered mental status associated with hyperventilation and diaphoresis. She was treated for metabolic encephalopathy related to COVID-19 infection. Her daughter had tested positive for COVID-19 prior to patient's admission. She did not requirement treatment of COVID-19 symptoms during admission with antivirals, steroids, or supplemental oxygen.
for the first 2 days after administration chills and fatigue. 1 week after vaccine bilateral lower extremities, buttock sensitive to touch skin, tingling and felt numbness to touch.  The s/s as of 03/17/21 starting to subside, however feet still feel cold.
Fever 101 F Chills Body aches  Nausea  Joint aches
Information has been received from a physician concerning an approximately 8 week old patient who was vaccinated PO with the first 2.0 mL dose of Rotateq. The physician reported that the patient subsequently developed diarrhea. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
COVID booster was administered first in left arm, then HPV administered in right arm.  Immediately after the HPV vaccine, looked pale and sweaty and said she felt like she was going to "pass out".  I laid her back and put ice pack on head and gave her a cup of water.    She rested for about 20 min, then was back to her usual self.  Ate a popsicle, was talking and smiling and walked out of clinic independently.
Moderna COVID-19 Vaccine EUA. Rash over chest, back, and neck.  Took Benadryl  50 mg
injection site soreness, foggy "loopy" "drunk" feeling first few hours, by hour 8 extreme joint aches body soreness headache ,  fever at hour 10 (99.9)  Increasing body aches and joint pain fatigue. Left arm (injection side) swelling and pain- unable to sleep on that side) persistent headache chills.  sensitivity to light. trouble sleeping. hour 20 sweats and aches. hour 24  finally woke. symptoms persisted but not as severely and was able to function... got better as time passed. every 6-8 hours a wave of either headache, fatigue or both passes through.   neck arm and elbow pain persist day 2 . time between pain/headache episodes increases by day 3
Pt recvd 1st dose Hep B vax 27FEB91 & on 01MAR91 awoke feeling achy w/chills; afternoon pt devel diarrhea until 3MAR91; also exp nausea & vomiting; 6MAR91 n,v,d & abd pain; hospitalized for gastroenteritis, dehydration; elevated NA;
3 hours post vaccine fever to 104 F and chills. Could not get warm for 18 to 24 hours. Hands and feet vasoconstricted and mottled.
Injection site Pain and swelling : started 6h post injection and is slightly resolving Fatigue, Headache, Chills, and Fever: started 10h post injection and resolved with 48h
Patient is asymptomatic, there is no fever and no hypoxia. Treatment is not indicated at this time. Patient is isolated per protocol.
Episode of Atrial fibrillation for 20 minutes and then 2 hours later episode of bradycardia of 32 beats per minute with loss of consciousness. The bradycardia resolved in 20 minutes. History of unexplained syncoty 2.5 years ago