chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt subsequently had a colonoscopy and was found to have UC (pancolitis).; Pt reports severe reaction to the second dose and immediately reported worsening in stool frequency and bloody diarrhea.; Pt reports severe reaction to the second dose and immediately reported worsening in stool frequency and bloody diarrhea.; This is a spontaneous report received from a contactable physician. A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Medical history included eczema. Concomitant medication included ibuprofen prn (as needed). Patient had no known allergies. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for covid-19 since vaccination. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) received on an unspecified date for covid-19 immunization and two weeks after first dose patient developed diarrhea. On an unspecified date in Apr2021, the patient subsequently had a colonoscopy and was found to have uc (pancolitis), patient reported severe reaction to the second dose and immediately reported worsening in stool frequency and bloody diarrhea. It was reported that, two weeks after first dose patient developed diarrhea. Given symptom improvement, second dose was administered after 1 week delay. Patient reported severe reaction to the second dose and immediately reported worsening in stool frequency and bloody diarrhea. Patient subsequently had a colonoscopy and was found to have UC (pancolitis). The reporter seriousness was reported as serious (hospitalization). The patient visited Emergency room and Physician office due to adverse events. The patient underwent lab tests and procedures which included colonoscopy: uc (pancolitis), sars-cov-2 test (nasal swab): negative on 26May2021, sars-cov-2 test: negative on 01Jun2021. Steroids and Infliximab was received as a therapeutic measure to treat adverse events. The outcome of the events was unknown.   Information about lot/batch number is requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Frequent bowel movements ,Diarrhoea haemorrhagic and Colitis and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a 9 year old patient who on an unspecified date was vaccinated with VARIVAX (Oka/Merck). Subsequently, the patient developed herpes zoster. It was noted that the lesion was cultured and found by the CDC to be the vaccine strain that the patient received as a child. At the time of the report the patient's status was unknown. This is one of several reports from the same source. Additional information has been requested.
Upper left arm is covered with rash.  I first noticed itching and redness there on the morning of April 8th. It has gotten more itchy and sore and covers more area today, April 10th. I have put some hydrocortisone cream on it.
This case was reported by healthcare professional and described the occurrence of hives on head in a 29-year-old female subject who was vaccinated with ENGERIX B. The subject's medical history included allergy to seafood. Concurrent medications included inhaler. On 26 February 2008, the subject received the 1st dose of ENGERIX B. Approximately twenty minutes after vaccination with ENGERIX B, the subject experienced hives on her head, facial hives and hives behind her ears. The subject was treated with Benadryl and the events resolved on the same day. The ENGERIX B vaccination series was discontinued. The healthcare professional considered the events were possibly related to vaccination with ENGERIX B. follow-up information was received on 18 April 2008, via healthcare provider, who reported the hives appeared approximately 20 minutes after receiving the ENGERIX B on 26 February 2008. The hives resolved on 26 February 2008 after treatment with Benadryl. The immunization series with ENGERIX B was discontinued.
Arm swelled up; This spontaneous case  was received on 04-Mar-2021 from other non-health professional (consumer)(reference number: SEQW21-00896) and concerned a 74-year-old, female patient.  The patient's medical history included cancer surgery. The patient's concomitant medications were not reported.   On 01-Dec-2015, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, dose and anatomical location: not reported) as prevention of seasonal influenza. The batch number reported was 1413101.   On the same date, an unknown amount of time after receiving Fluad (TIV), the patient's arm swelled up.   On 11-Dec-2015, ten days after receiving Fluad (TIV) vaccine, the patient was vaccinated with non-company pneumonia vaccine (brand not specified; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.   The patient requested to know the ingredients of Fluad (TIV) vaccine as the patient was preparing to receive COVID vaccine.  The outcome of the event 'swelling arm' was not reported.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: A 74-year-old patient was vaccinated with Fluad (TIV). On the same date after receiving Fluad (TIV), the patient's arm swelled up. No alternative aetiology was provided. Causality is assessed as possibly related.; Sender's Comments: A 74-year-old patient was vaccinated with Fluad (TIV). On the same date after receiving Fluad (TIV), the patient's arm swelled up. No alternative aetiology was provided. Causality is assessed as possibly related.
It was a kidney infection which I have not had ever that i know of. i didn't have fever but had flank pain and my arm pain was horrible. and i had gastric pain and frequent urination but no burning. the labs showed some bacteria, a trace. i left a urine sample and the doctor called me back and gave me some antibiotics. i still have a lot of trouble with my arm, it's still very sore, the muscle. not sore to touch.
Chills and fatigue that started at 9:30 pm the night of the first shot and ended within 24 hours.
I had 3 shots of Pfizer Covid Vaccine on Mar 5, 2021, Mar 26, 2021, and Nov 3, 2021. After I got the Pfizer Covid vaccine, I felt persistent fatigue lasting several months. So I told my doctor about this, and he said it is OK to try Moderna for the 4th shot and maybe I will not have the same side effect, so I changed to Moderna for the 4th Covid vaccine on 8/4/20222. Then about 4 weeks later, when  I woke up on 8/30/2022 at 6:00am, and I felt that my chest area was trembling, and it lasted several hours, I felt very tired throughout the day. Symptoms persisted on 8/31, and worsened on 9/1 when I had 3 episodes of palpitation (beating very fast) and heart fluttering and it felt that my heart was struggling to beat, and each time it happened, I felt like I was passing out for 1 second. I also had piercing pain on both sides of my chest. I checked myself into the Emergency Room at 5:56pm on 9/1/2022. The symptoms were not present after I arrived at the emergency room. They ran ECG, Chest X-ray, and bloodwork, and the doctor said my heart and lungs look normal and I tested negative for Covid. They also had me take aspirin while in the ER. The doctor said he did not know the cause of the problem, then they discharged me at 1:30am on 9/2/2022 and advised me to follow up with a cardiologist.  I want to also note that I started a new medication on 8/29/2022 evening (this is after my Moderna shot) on Motelukast Sodium 10 mg, this is a medication to treat allergy and asthma. I do not have asthma, but there is swelling inside my nose, and my  ENT doctor said it looked like an allergy. please also note that the swelling inside my nose started slowly after my first shot of Pfizer vaccine. I took Montelukas Sodium on 8/29/2022 in the evening, 8/30 evening, and 8/31 evening and have not taken it again, and symptoms appeared to have improved. As of 9/6/2022, there is no palpitation, and no chest piercing pain, but there is still occasional hear fluttering.  I made an appointment with a cardiologist for 11/8/2022, that's the earliest appointment I could find in my area.
Information has been received from a 68 year old female lab technician at the doctor's office who reported that she was vaccinated with a dose of ZOSTAVAX (Oka/Merck), 0.65ml (lot number 654603/1405F) on 15-DEC-2006. Concomitant therapy included EVISTA. In JAN-2007, she experienced a whooshing warm sensation on the same side as the injection in upper left chest quadrant for 10 days to 2 weeks. That subsided. On 14-JUN-2007 she was taking a bath and could not get out of the tub without assistance. She was taken to the clinic where her blood pressure was 200/115. Her bloodwork showed a high C-reactive protein at 8.3, lactate dehydrogenase was 280, and a positive RA, full test name not identified. She had a negative doppler of all extremities and she was also negative for renal impairment. Seen by a rheumatologist who ruled out rheumatoid arthritis. She was seen by a cardiologist and heart conditions were ruled out. She was given 3 different medications to try to control the blood pressure but it was still elevated. In mid JUL-2007, everything returned to normal and she has had not had additional experiences. There was no product quality complaint. The patient sought medical assistance in the physician's office. Additional information has been requested.
Overall sick feeling flu like symptoms, hives (itching severe/left marks on face, arms shoulders, neck, hands. Stiffness, fatigue much worse than usual, worsened symptoms of current problems and nausea, aching, headaches, different type of sick feelings, eye drops used for dry eye completely blurred my vision couldn't see anything but blur. This eye reaction never happens with use of product for dry eye. I still however don't feel the same since I had the vaccine. I will never go back to this doctor. He ignored me and my suffering. Still having some itching, more frequent headaches, neck pain, nausea, worse than usual, I don't feel fully recovered from the symptomatic reactions. The Dr and his nurse rather blew me off, I don't know how else to explain how I was treated. It took a month or more for symptoms to go away.
After receiving the Pfizer booster shot,  I experienced fatigue and swelling in the injection site. The next day I started having fatigue and swelling in my lymph nodes in my under arm on the side where the injection was done. It is painful and is still swollen two days later.
Pt recv vax & devel inj site rxn of redness, swelling & warmth.
10:10 received 3 immunizations and PPD, at 10:15 child leaned over and fell out of the chair, hitting his head on the floor.  He then had what appeared to be a seizure lasting 5 seconds.  He was non responsive for about 30 seconds.  He then became alert to self and place.  Vitals within normal limits.  Referred to doctor.
Tired; Soreness in hand; 3rd dose administered to patient who is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), MYALGIA (Soreness in hand) and EXTRA DOSE ADMINISTERED (3rd dose administered to patient who is not immunocompromised) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired), MYALGIA (Soreness in hand) and EXTRA DOSE ADMINISTERED (3rd dose administered to patient who is not immunocompromised). At the time of the report, FATIGUE (Tired), MYALGIA (Soreness in hand) and EXTRA DOSE ADMINISTERED (3rd dose administered to patient who is not immunocompromised) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided. The 1st and 2nd dose 7 and a half months ago and 3rd dose administered 3 to 4 weeks ago
On the evening of, I had a bad headache. The next morning (sat), I woke up with aches ; by sat night, I had some chills. These all seemed normal according to what to expect. Sunday  morning I had a few red splotches a few inches below the injection site. By Sunday night, the splotches were much more noticeable, itchy, and hot. Monday morning the rash was about 4 inches wide by 2 inches tall and very itchy and red. By Tuesday, it had mostly subsided. Since then, it has been coming and going slightly.  After the first dose, I did have a small splotchy rash on left arm (which I had the first vaccine in L arm) that appeared 9 days after.
May 6th, I had a sore throat, ear ache, runny nose, fatigued, and has lasted 6 days. No prescriptions were giving by the physician and was told to treat it with over the counter medication.
pt recvd shot & then about a day p/ran a fever & had aches & pains; then about a wk & a half later had blood work @ clinic;
My symptoms started with bodyaches and fatigue. Quckly followed by a fever that reached 102.4.   Later that night I had congestion, cough and headache. Woke up the next mornign with moderate/sever bodyaches, chills, cough and headache. Moderate fatigue as well. Had to miss work.
First very sore upper arm and shoulder only got worse through the night- High fever all night and following day- Nausea-delirium.
Heart palpitations/dizziness/muscle spasms a couple weeks after. Then three weeks after menstrual period started and hasn't really stopped. Been bleeding almost daily since 3/30.
Fever of 102.4; Not feeling well last night; Felt sore, like he worked out; Arm hurt; Fatigue; Muscle pain; Joint pains; Swollen on injection site; Nauseas; Chills on and off; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well last night), PAIN (Felt sore, like he worked out), PAIN IN EXTREMITY (Arm hurt), FATIGUE (Fatigue) and MYALGIA (Muscle pain) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sleep apnea. Concurrent medical conditions included Penicillin allergy.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced MALAISE (Not feeling well last night), PAIN (Felt sore, like he worked out), PAIN IN EXTREMITY (Arm hurt), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pains), VACCINATION SITE SWELLING (Swollen on injection site) and CHILLS (Chills on and off). 10-Feb-2021, the patient experienced NAUSEA (Nauseas). On 11-Feb-2021, the patient experienced PYREXIA (Fever of 102.4). At the time of the report, MALAISE (Not feeling well last night), PAIN (Felt sore, like he worked out), PAIN IN EXTREMITY (Arm hurt), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pains), VACCINATION SITE SWELLING (Swollen on injection site), NAUSEA (Nauseas), CHILLS (Chills on and off) and PYREXIA (Fever of 102.4) outcome was unknown.            The patient's wife called and reported that the patient was not feeling well in the night, after he received his 2nd dose of COVID-19 vaccine shot. His body temperature was 102.4 degree F on the following day. The patient was not taking any concomitant medications. Details regarding treatment medications were not reported.
Patient received Flu/Pneumo vaccines on 10/25/05. Patient complained of redness, swelling, pain all the way around arm. Patient in to see doctor at clinic. Patient reports feeling much better at time of phone call 13:20 10/28/05.
Had the 2 step shingles vx, now i have broken out/Suspected vaccination failure; Now i think that i have broken out; Trauma; Trauma to my left side from a fall; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injury and fall. On an unknown date, the outcome of the vaccination failure, shingles, injury and fall were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, injury and fall to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 09-APR-2022  Reporter's Comments: This case was received from the patient via interactive digital media. The patient had 2 step Shingle vaccine and now thought he/she had broken out across left chest and ribs after trauma to his/her left side from a fall. Additional Supportive Information:  This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Pfizer-BioNTech COVID-19 Vaccine EUA  After about 12 hours, I noticed welts on the same arm where I received the injection. There were about 4, some very small and some medium sized. I monitored them for the next 3 hrs and they did not get any bigger. They weren?t red or any sort of color really. The next morning they were completely gone.
Patient has redness, no pain/swelling, along the inside and front of her arm down to the elbow.
Shortness of breath without exerting myself; Minor chest pain in the center; This is a spontaneous report from a contactable consumer (patient himself). A 39-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, at age 39 years (as reported), administered in left arm on 02May2021 15:00 (Batch/Lot Number: ER8735) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was none. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. On 03May2021 at 11:00, patient experienced shortness of breath without exerting himself and minor chest pain in the center. No treatment for the adverse events. Facility where the most recent COVID-19 vaccine was administered at a pharmacy/drugstore. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The patient was vaccinated with BNT162B2 (lot number: ER8736) on the left arm on 23May2021 at 03:00 PM as DOSE 2, SINGLE, for COVID-19 immunisation.
Itchy red blotch approximately two inches in diameter around site of injection. Appeared eight days after injection.
This spontaneous report as received from a Medical Assistant (also reported healthcare worker) refers to a 49 year old female patient with allergic to AFRIN, lidocaine, lisinopril, hydralazine, type 1 diabetic and hypothyroidism. The patient's medical history included Temporo Mandibular Joint (TMJ). On 20-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date, dose not reported, subcutaneously). On 23-JAN-2014 the patient called the physician, stated that at the site of the injection her arm had swelled and the swelling was "from her elbow to under her arm pit", she also stated that it was painful and there was redness. Patient had been applying warm compresses to injection site and taking MOTRIN and the swelling was starting to go down. Patient was seen in the physician's office on 24-JAN-2014. It was documented by the physician that the inner posterior brachium had redness and swelling. The patient's arm was still stiff. Patient was prescribed ADVIL and TYLENOL to alleviate discomfort and to ice injection site for 30 minutes a day as well as range to motion for the stiffness in her arm for an unspecified amount of time. No lab work completed. The outcome of the event was reported as recovering. Additional information has been requested.
My left axillary lymph nodes are swollen, and the swelling is now as big as the size of an egg, starting at about 24h post-vaccine; painful depending on how I move my arm; having trouble sleeping; This is a spontaneous report from a contactable other health care professional. A 48-year-old non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265 and Expiration date was unknown), via an unknown route of administration in left arm, on 11Feb2021 at 17:15 (at the age of 48 year-old), as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had not had COVID prior vaccination and not tested COVID post vaccination. The patient had not received any other vaccine with in four weeks and no other medications were received within two weeks. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247 and Expiration date was unknown), via an unknown route of administration in left arm, (at the age of 48 years), on 19Jan2021 at 17:15, as single dose for covid-19 immunisation. On 12Feb2021, patient left axillary lymph nodes are swollen, and the swelling is now as big as the size of an egg, starting at about 24h post vaccine. The swelling underarm was uncomfortable and painful depending on how she moves her arm, she was also having trouble sleeping because of it and felt limited in her daily activities. Tonight, she called urgent care clinic and was told to go in to be checked out. The patient received no treatment for events, the events resulted in emergency room/department or urgent care. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Patient is a 33 y/o male c/o having dizziness and nausea while he is sitting after 5 minutes of getting vaccine.  vitals BP 100/60 HR 66 Oxygen sat 95 pain 0/10 resp. 18 Clamy to touch. Negative for shortness of breath, throat swelling, facial swelling, negative for rash. Negative for numbness or tingling of lips or throat.  Vasovagal synciope  Reasurrance given. Monitor. Patient standing walking around after 30 mintues. Refuses to call parents reports he feels much better.