chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax & the same day devel a fever; diffuse rash, measle-like, which crusted in the lt upper chest; & arm was hot to touch; exp chills, pain under lt ribs, difficulty breathing; pt presented to a MD tx DPH;
Babysitter called Mom around 11:00 AM on 4/30/03 to say left thigh was swollen. Mom brought pt to office 5/1/03 - left thigh swelling. No redness, warmth or pain. Able to bear weight. Injection site normal. Thigh measurement 32.25 cm. Swelling down to knee.
Moderna Vaccine Vial was removed directly from Freezer and thawed by Hand at room temperature for 15 minutes then drawn up in a syringe and later administered to patient.
12+ formulation was administered to child who was 11 years and 7 months old.
couldn't breath, gasping, inability to get up or get out of bed. lasted approximately 12 minutes then the gasping and labored breathing diminished and became easier to breath. after several more minutes, I was able to breath normally and could get up out of bed but couldn't walk without holding on to something. After a week my breathing is still shallow and my chest still feels "tight" at times.
After administering vaccine, patient complained about administration. Site soreness. Soreness did not subside. Pt went to PCP to get examined. X-ray was performed and according to doctor a nerve was hit by vaccine.
Pfizer-BioNTech COVID-19 Vaccine EUA: injection site soreness; joint pain (elbow); headache; nausea; muscle pain
Positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced COVID-19 (Positive for COVID). At the time of the report, COVID-19 (Positive for COVID) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On an unknown date, the patient experienced positive for COVID. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns an adult female of unknown age, with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event was resolving. Co suspect adalimumab could be a risk factor for the event. COVID-19 pandemia could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This spontaneous case concerns an adult female of unknown age, with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event was resolving. Co suspect adalimumab could be a risk factor for the event. COVID-19 pandemia could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report
broke out with chicken pox; 2. Vaccines in two days.They gave him vaccine again; off label use; This case was reported by a consumer and described the occurrence of chickenpox in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included Herpes zoster (Shingles vaccine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced chickenpox, drug dose administration interval too short and off label use. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the chickenpox was not recovered/not resolved and the outcome of the drug dose administration interval too short and off label use were unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingles vaccine and experienced chicken pox. For tolerance of 1st dose of Shingles vaccine, refer case US2021AMR178362. The physician gave two vaccines to the patient in two days and broke out with chicken pox. He got the Shingles vaccine, then he broke out.  The reporter took him back to physician, who gave him Shinles vaccine again, he broke out still. The patient received 2nd dose earlier than the recommended schedule, which led to shortening of vaccination schedule. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178362:Same reporter
pregnant; Pain at injection site; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) and VACCINATION SITE PAIN (Pain at injection site) in a 44-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage. Concurrent medical conditions included low thyroid.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 11-Dec-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) and VACCINATION SITE PAIN (Pain at injection site) had resolved.        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.   The patient is on thyroid medication, a t4 supplement due to low thyroid, over the counter fish oil and over the counter vitamin supplements.   No other medications for treatment are currently being taken.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Internal review conducted on 26jul2021 resulted in updates to pregnancy information
Client was leaving the parking lot post vaccination waiting period when he felt lightheaded. Wife indicates that client passed out twice in the car. Client reports feeling dizzy and hot and he looks pale and sweaty. His BP is 60/40. Client does not have any other medical history and is not taking any medications currently. He is allergic to sulfa. EMS on site evaluated client and was determined that 911 needed to be called. EMS responded and client was transported to the hospital.
Information has been received from a consumer concerning a "friend of the family", a male in his 50's with a history of shingles who on 30-JUN-2007 sat next to the reporter's parents who were vaccinated with Zostavax (Oka/Merck) on 25-JUN-2007.  On 01-JUL-2007 the patient broke out in a rash.  It was noted that he "may have developed shingles".  At the time of the report the patient had not recovered.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
No adverse event. MMRV administered when patient was only due for an MMR vaccine; Varicella was administered when patient was 3 years 5 months instead of at 4. Administration error.
Immediately following the first shot I experienced pain shooting from the injection site up to my left ear, down to my shoulder blade, and across my upper left chest area.  The pain is mild at times, but if I turn my head to the left, as to see on-coming traffic, I experience a sharper pain.  I have had massage therapy, as well as chiropractic care. These have lessened the pain for a short period of time, but it never goes away.  My family doctor administered two trigger point injections in the left trapezius yesterday (5/17/2021) She advised Ice last night and heat after to make comfortable.
Mild nausea and loss of appetite approximately 26 hours post-vaccination that resolved within 5 hours . No treatment
Reports shortness of breath, chest pain, headache, and neck pain immediately after receiving vaccine. However she did not report it to the vaccinator. States she experienced the same symptoms after receiving first injection.  After first injection she went to PCP lab work done and per employee hgb 7.6  As a result we directed her to local ER. ER did EKG only and per employee was normal. Next day at employee clinic labs and chest xray were obtained.
Diarrhea (up to 7 loose/watery non-bloody BMs without mucus)x ~ 1 week, as of 5/17 improving. Loss of appetite ongoing since onset. Fever (up to ~103) & chills and head congestion started on 5/14/2017 and then sore throat.
Patient presented 8 days after receiving the vaccine with an open, dime-sized, crusty scabbed lesion over injection site. Area was draining clear yellow fluid.
Edema, erythema and lump at vaccine site noticed 1 day post vax. Treatment warm compresses. Observed by PCP on 5/24/00.
Burning reported immediately injection administration. 4 Nov 2005. Burning continued through day with warmth, reported at the site. Late that night itching/scaling  noted on today.
Patient had low grade fever, pale skin, rash/ hives, not feel well within 5 days of 2nd shot of Gardasil. Patient mother informed to use Benadryl for hives. Recommend no more HPV shots.
Patient stated she had localized swelling in left upper arm (injection site) within 24 hours.  Been on 5/15/09 no redness.  C/o pain from left shoulder to elbow.
After the second dose of the Moderna Vaccine, inside my left ear canal. This was shortly thereafter diagnosed as squamous cell carcinoma inside the left ear canal in stage T3N0. The was not due to sun exposure, since the area is not exposed to sunlight, nor this this run in my family. I am also a man of dark skin color.  The cancerous tumor was surgically removed on 10/27/2021. In the operation, it was necessary to permanently remove my ear drum, which left me with conductive hearing loss and tinnitus in my left ear.
Woke up Friday morning with a headache, super dizzy, light headed, heart racing. Took Patient to ER. ER told me his body immune system is fighting the virus. 3 shots in one day. Don't give me Tylenol. The headache was an 8 when we were admitted and it was a 6 and slowly going down by the time we were done with the Dr. His heart stopped racing at the hospital. His dizziness went away afterwards in the afternoon. He was tired though. Saturday afternoon 3PM headache came back. No Tylenol. Redness and warm to the touch right arm started Friday evening. Told him to put an ice pack on it. urgant care Dr. said give him Tylenol so she did. If the redness gets worse take him in. He is doing better now as of Sunday night.
Pfizer-Biontech Covid-19 Vaccine EUA  Diarrhea Chills Stomach pain & cramps Lightheadedness Dizziness
CRAPPY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 10-MAR-2021, the patient experienced crappy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of crappy was not reported. This report was non-serious.
Pt. showed me L upper arm on 11-18-07, Sunday.  L upper arm had splotchy red area about the size of a nickel scattered over upper portion of arm.  States she went to ER the night she got the shots with fever and shaking.  Temp. was 100.2.  No fever on 11-18-07.
Decreased stamina starting in months following vaccine. Retired 11/30/21 due to being unable to maintain work routine and stay on HIV medications. This had not ever been a problem before.  Decreased stamina listed as diagnosis 1/11/23 after ongoing complaints. Tinnitus both ears 3/1/21. ptosis of eyelid 7/1/21. Cortisol deficiency 5/22/23. Cortisone levels were normal when last tested in 2012 at Clinic. Sleep apnea 6/30/23. Currently taking cortisol 10mg PO BID and using CPAP machine. OTC eye gtts QD for dry eyes. Decreased stamina with extreme fatigue in morning hours and tinnitus continue to be problem.
Rash x 3 days. Rash evaluated in office, consistent with a reactive rash to the MMR.
Patient was getting 1st Covid-Moderna shot for .5 ml but pharmacy only gave booster dose of .25 ml
12:15 Patient advised feeling short of breath and dizzy after receiving vaccine. Asked patient to lower her mask and take deep breaths. Patient denies chest pain, N/V or other symptoms. Patient given drink and windows opened. Patient declines to go to ER at this time. Contacted nursing supervisor for assistance. Will continue to monitor. 12:20 Patient still c/o SOB. 12:25 Patient transported to ER for further evaluation. Report called to ER by RN.
Extreme upset stomach and nausea, could not eat. Symptoms got worse so I went to PCP after 5 days. He prescribed Zofran. Started getting abdominal pain, returned to PCP on day 6.  He ordered bloodwork and abdominal CAT scan. Indicated acute Pancreatitis. Hospitalized for 3 days. They did abdominal ultrasound. Still felt bad until July. Put me on Omeprazole, still taking it, which helps. If I stop, symptoms return.
The morning after the employee received the second dose vaccine, she felt a sore lump under her armpit, right side of the breast. The same side when she received the first dose. The side of the breast looks swollen and fells tender and sore to touch x 2 days. She took Ibuprofen
10/26/19- developed chills, fever, muscle aches, lasted 3 days. 11/05/19 - thumbs swollen and painful 11/06/19 - hands swollen, stiff, painful, 11/07/19- hands and arms painful, especially at night, 11/08/19 - hands stiff and numb 11/10/19 - wrists and hands just achy, slightly numb As of this date, 2/1/2020, fingers on right hand , from mid joint to tips still numb
40 y.o. male with PMHx including asthma and HLD presenting to the ED today with c/f allergic reaction. Pt is coming in after about 35 minutes ago he had some extreme flushing he describes it as "feeling like he put his head in an oven and some skin itchiness on his arms. He notes he started taking niacin today. He also got his second dose of his Covid vaccine last night. He has no throat swelling or difficult breathing. He has not had any nausea or vomiting. He denies any recent fevers or chills. He did switch his asthma medications to Trelegy last week. He otherwise has no other allergies. The patient had just started taking Niacin which is more likely the etiology of the case in question and symptoms rather than the vaccine-pfizer. Most likely this was related to the niacin and not the pfizer vaccine.
Site: Pain at Injection Site-Mild, Systemic: Patient reports painful blisters breaking out on face-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Almost exactly 12 hours after receiving the second dose of COVID vaccine, I woke up from sleep curled into a ball, covered in sweat, absolutely freezing, teeth chattering, and all my muscles were shaking violently. I tried to roll over in bed and all of my muscles locked up and I began to convulse even stronger. This made me feel extremely nauseous and then I began to vomit. I know I had a high fever but I was unable to keep down any medications as I kept vomiting. I felt ill like this for the next 24 hours, with a 100.1 fever even after rounds of ibuprofen and tylenol, and severe muscle soreness and achiness, and headache. I also have intermittent nausea and will occasionally vomit bile. I finally woke up on 1/10/2020 and don?t have a fever, but my body feels very beat up and sore.
Felt bad after their 2nd Covid 19 Pfizer vaccine; This is a spontaneous report from a non-contactable nurse via Pfizer sales representative. A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient felt bad after their second Pfizer vaccine. It was not unexpected. Outcome of the event was unknown.  No follow up attempts are possible. Information about lot and batch number could not be obtained. No further information is expected.
Became nauseous "stomach hurt" immediately & she fainted. Placed from sitting position on pt. table to lying flat. Layed, & was dizzy - remained laying down for approx 10 minutes then sitting then went home ambulatory.
Intense pain upon initial vaccination. Subsequent pain and discomfort for approx 10 weeks following vaccination. All pain in shoulder area (deltoid).
This spontaneous report was received from a physician and a medical assistant, referring to a 50 year old male patient with tick-borne meat allergy and no drug reactions/allergies. The patient's medical history and concomitant medications were not reported. It was informed that the patient had facial swelling and hives at the time of vaccination. On 03-MAR-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # M043987, expiration date 30-JUN-2018) as a routine vaccine (dose and route of administration were not reported). On 03-MAR-2017 as well, 6 hrs after the vaccination, the patient's facial swelling and hives worsened. Medical assistant reported that the patient self treated with unspecified antihistamines and that, as of the evening of 05-MAR-2017, her symptoms began to subside. The patient was fully recovered as of the morning of 06-MAR-2017. No laboratory diagnostic studies were performed. Causality relationship between the events and PNEUMOVAX 23 was not reported. No product quality complaint was involved. Additional information has been requested.
Information has been received from a nurse concerning a female who on an unknown date was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657449/0567U). Subsequently, the patient experienced "cellulitis" after getting second dose. The physician was concerned that there might be a problem with the lot number. The patient sought unspecified medical attention. A lot check has been requested. Subsequently, the patient recovered. Follow-up information was received via telephone call from a licensed practical nurse (LPN) who reported that the female patient was between the age of 7-11 years old. She developed "softball sized bumps on her arms" following varicella virus vaccine live (Oka/Merck) (Lot # 657449/0597U). The patient returned to the office. The physicians office had since switched to using another lot of vaccine and have had no problems. The records of testing prior to release of lot #657449/0597U have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. No additional information is available.
IPOL as Tubersol skin test in error/no AE; IPOL as Tubersol skin test in error via intradermal route/no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 23 years old female patient received vaccine IPV (VERO) [IPOL] instead of TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  . On 07-OCT-2019, the patient received a 0.5 ml dose of suspect IPV (VERO) lot P1A242M via intradermal route in the left arm.  It was of actual medication error case due to Inappropriate route of vaccination and Wrong vaccine administered.  It was unknown whether adverse event was noticed or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient used to have 20/20 vision. A little after one week of her vaccination, patient reported a grey blob blocking her central vision along with distortion that continued to get worst. We thought it was anxiety at first but took her to the eye doctor on February 5. They found posterior uveitis and macular edema and her vision had reduced to 300/20. They immediately sent us to retina specialists. Since then, we have seen multiple specialists to try to figure out what was going on. She has been diagnosed with ampiginous choroiditis. She is on prednison and Cellcept to try to stop the inflammation and restore vision. Her vision has improved but is around 125/20. We are still trying to restore vision.
Patient came in on the morning of 3/3/2021, stating the arm she was injected into started turning red and swollen (about 8 days later). She's been feeling uncomfortable. She said no pain and able to move her arm around. After the shot, she said it hurt, but pain went away. But 8 days later, redness occurred. I advised patient to go see a doctor. She followed up and said, MD said it was infected, and prescribed her prednisone and cefuroxime, which she filled at a different pharmacy.
Patient received his second dose of the MODERNA vaccine on Thursday, 4/29.  He started experiencing flu-like symptoms with fever on 4/30.  He stated that he felt fine on 5/1 and went out and had two mojitos.  Awoke at ~3 am on 5/2 with subxiphoid/epigstric pain, associated with L elbow pain. His father had an MI in his 30's. Patient is also going through a divorce.  Treated in ED with lovenox, Pepcid, morphine, and nitro. Transferred for further management of NSTEMI.
Pt father states the "lump" was visible on the left thigh on the day of the injection. It has stayed the same size per pt. father from 5/13/14 to today 8/14/14. The site is hard to the touch and approximately the size of a quarter. It is not red, irritated or warm to the touch. This is the first time the pt has returned to the clinic since the immunizations were given on 5/13/14 and the first time the site has been observed by medical personnel.