chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a lot of soreness and tenderness at the site of my breast cancer surgery (right side of my body); a lot of soreness and tenderness at the site of my breast cancer surgery (right side of my body); felt a tender lump at that site; feel lingering tightness; tenderness I felt after my shot seemed to be centered between the two scars (lymph nodes and one for the tumor); This is a spontaneous report from a contactable consumer (patient).  A 68-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via unknown route of administration at left arm on 08Mar2021 at 12:45 pm (age at vaccination 68-year-old) as dose 1, single for COVID-19 immunisation at Public Health Clinic/Military Administration facility. The patient known allergy included nickel allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient medical history included recovered from breast cancer, 3 lymph nodes under this arm were surgically removed 3 years ago/breast cancer and breast cancer surgery on an unknown date. The patient concomitant medications (other medication) included Letrozole 2.5 mg in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Mar2021 at 11:00 pm, the patient woke up and had a lot of soreness and tenderness at the site of my breast cancer surgery (right side of my body). This is unusual. I might only experience such a sensation similar to this if I touched the scar tissue continuously and with a lot of pressure. The tenderness I felt after my shot seemed to be centered between the two scars (lymph nodes and one for the tumor) and was constant. The sensation was similar to what I felt when my incisions were just starting to heal. I also felt a tender lump at that site. The "lump", tenderness and soreness have since gone away. It lasted a bit more than 12 hours. I still feel lingering tightness. The patient was informed that swelling of lymph nodes in the arm of injection is common after vaccination but, this was the opposite side. The patient did not received treatment for the events. The outcome of the event feel lingering tightness was not recovered, and other events was recovered with sequel on Mar2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Client received Fluzone flu shot IMLD on 10/19/2004 at 8:20pm. Client phoned me on Saturday 10/23/04 and advised me of the following: on Thursday 10/21/04 around noon he noticed rash to arms, legs and groin area, worse to groin. Itchy. Rash began as scattered , pink, non-raised to slightly raised, then developed a dark red dot in centers and elevated more and spread, with blotches connecting. Rash became dark red/ purplish. He was without wheezing or breathing difficulties. He did have some occasional dizziness without passing out. Positive for malaise. He is up and moving about with periods of rest. He states that he feels like he had been running a fever, temperature not taken. Denies any new foods, medicines, detergents or sea food consumption. On Friday 10/22/04 around 3AM he went to hospital ER where he was told that the rash was not likely caused by the flu shot, but was more likely a virus. Blood was drawn and was okay. No other diagnostic tests were performed. Prednisone 150 mg or 175 mg was given IM injection and Prednisone 50 mg i p.o. q. am was ordered. On Saturday 10/23/04 around 4 am he returned to the ER for rash and itch not improving. He saw a different doctor than the previous day who said that the rash may be related to something he ate. Prednisone 20 mg prescription given. I advised client that rash client that rash/itch may or may not be related to the flu shot and to call his PCP. He did  so and an appointment was set up for Sunday 10/24/04 at the hospital. Over the phone, doctor advised client to change Prednisone to 25 mg am and 25 mg pm, by cutting 50 mg tablets in half and use up supply. Client called me back after Sunday's visit with doctor and told me that doctor said his rash/itch is related to the flu vaccine and that his body's antibodies are working extra hard to fight off the vaccine. After Prednisone 50 mg's are gone, use Prednisone 10 mg am and 10 mg pm by cutting the 20 mg in half until gone. I spoke to client by phone on Monday 10/25/04. Rash/ itch is improving, but same malaise . Has appointment with doctor today at 3:45 pm at office. 1.5 Prednisone 50 mg tablets left and 10 Prednisone 20 mg tablets left. On Monday 10/25/04 at 11 am. I left a message on client's answering machine to advise doctor if he has been out in the woods lately. Client has a history of heart fibrillation and HTN which he takes medication for. He states that he did not have a reaction to last years flu shot, but that he did have a bad flu, without rash, several times after receiving the flu shot form the railroad.
Received Varivax 8/22/06 developed severe headache 9/7 and 9/8 followed by blister rash 9/9 15 days after vaccine. Mom stated rash was generalized with possibly up to 55 lesions. Still new crops. Extremely itchy saw PCP who confirmed rash as chickenpox. Question vaccine induced, possibly incubating disease when immunized or adverse event. Discussed with supervisor, chief of 10 9 state. Enter into NEPPS as chickenpox. re immunize.
Started with severe swelling between shoulder and elbow along with a deep reddish bluish discoloration that lasted 10 days. Then my joints began to become very painful to the point that I could not climb stairs unless I crawled on my hands and knees. Walking became painful. I had a low grade temperature since May 5th. On May 19th, I could not sleep from the pain and aches in my legs and an increasingly higher temperature. I also had a faint sense of nausea. On May 20th my temp got to 100 (normal is 97.4) and I thought it might be diverticulitis flare so there was a CAT scan done to rule that out. Negative scan. Blood showed elevated WBC. This continued through to May 23rd when I completely had a shutdown and became listless and my temp went up to 101.6, May 24th I now have diarrhea along with a lowered temperature but still severe muscle and joint pain.
Shingles Heart problems While sitting at rest Heart rate goes to 160 BPM down to 30BPM
had a bug bite or shingles; bug bite; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. In July 2020, less than 9 months after receiving Shingrix, the patient experienced shingles and bug bite. On an unknown date, the outcome of the shingles and bug bite were unknown.   It was unknown if the reporter considered the shingles and bug bite to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a bug bite or shingles.  The reporter consented to follow up. No more information was provided.  The pharmacist agrees to FUP via email or postal. For tolerance after 2nd dose refer case US2020123366.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020123366:same reporter
developed shingles; felt like she had the flu after injection; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (developed shingles) and INFLUENZA (felt like she had the flu after injection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (developed shingles) and INFLUENZA (felt like she had the flu after injection). At the time of the report, HERPES ZOSTER (developed shingles) and INFLUENZA (felt like she had the flu after injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 09-MAY-2018, the patient was vaccinated with an expired dose of VAQTA (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis.
PATIENT WAS TO RECEIVE 1 DOSE OF BIVALENT PFIZER COVID AND 1 DOSE OF HD FLU VACCINE. PATIENT WAS GIVEN 2 DOSES OF THE COVID VACCINE AND DIDN'T RECEIVE THE FLU VACCINE.
head ache, sore arm, dizziness, nausea, numbness down right hand and leg, fever
Sore right arm; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK 9231, via an unspecified route of administration in the right arm on 31Dec2020 at 14:30 (at the age of 63-years-old) as a single dose for COVID-19 vaccination. Medical history included hypothyroidism, hypertension, high cholesterol, penicillin allergy; all from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan, levothyroxine/liothyronine (NP THYROID), simvastatin, vitamin B, vitamin c [ascorbic acid], colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 01Jan2021 at 12:00, the patient experienced a sore right arm. Treatment was not received for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the sore right arm was resolved on Jan2021.
headache started approx 12hrs after injection lasting approx 24hrs, severe headache and chills started approx 24hrs after injection lasting approx 1 hour, rash at injection site appeared approx 36hrs after injection.
Mild soreness in the right arm; no treatment was given; it was still slightly noticeable the next day.
I had what I diagnosed as hives for 3 days but only in the evening.  During the day my itching went away and the skin was clear
they also got COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (they also got COVID-19) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (they also got COVID-19). At the time of the report, COVID-19 (they also got COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: Normal.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The patient did not have information for previous vaccination doses.  Concomitant medication not reported.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750308 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750308:Wife case
Moderna COVID-19 Vaccine EUA  Developed a 2 inch raised bump at the injection site. The bump is red and hard. The bump has been there for almost 2 weeks now
Redness and itching noted after second injection and after first injection on 01/27/2021. Injection on 01/27/2021 patient stated lasted for 3 weeks after injection. Stated she consults with her primary care provider and was advised to take Benadryl as needed.
Left arm - sore and stiff, progressing to numbness. Chest and neck - tightening, chest pain. Shortness of breath; dizziness. Smoker; family history of cardiac disease. Referring to cardiologist because of family history.
Child into IZ clinic for her 5 years old shots - she need DTaP and MMR on 08/25/2003.  Mother brought back to IZ clinic as child left arm was red swollen measured (4 1/2 in x 5 in).  Local tenderness of pain- denies any temperature.  Recommend cool wet compresees and acetaminsphen q 4 hrs or as needed.
within a minute patient felt nervous ..faint, two minutes later he started to sweat, but talkative and I took blood pressure at 1:32 it read 69/41 67 a few minutes later he looked less pale and his demeanor improved I re took the blood pressure at 1:38 and it read 112/85 91 he continued to improve and at 1:45 he stood up said he felt normal, stayed for a few more minutes then  went home
Fever (<100 F), sore throat, fatigue 1 d after vaccination. Exact sx per pt last year after 1+PV9 #1.
1) headache, bodyaches, weakness, chills, and low-grade temp that started 10/3/21 ~0300 that lasted about 12hrs.   2) experienced sore arm that started about 6 hrs after the shot and lasted about 48hrs after. 3) noticed tender lymph node under L armpit ~24hrs after the shot; disappeared today ~96hrs after the shot
**Note - reported wrong lot number on report  #309074  - the correct lot number EL1284 (1st dose) - 1st dose - forgot to state - needle sharp pain in the back of my neck  and I felt it on my left side of my body - this occurred right away after the injection and it lasted for about 30 seconds.** 2nd dose report: was not as severe exp.; some swelling , pain and redness on arm around injection which lasted 2 days. I experienced hot flash like  (face would turn red) - which lasted 5-10 min. When I had the hot flashes the rash would appear as more rash. It wasn't causing me a lot of itchiness. Second day, turning brown and kind of peeling skin off. This lasted for the first week (the hot flashes with the increased rash).  The highest my fever went to 100.  I had some foggy brain and overwhelmed with thinking. Symptoms resolved mostly within the first week. I was back to work by the 29th of January. I could think more clearly and every day I was getting more energy. I am usually someone who has a lot of energy and I exercise. I didn't have energy to exercise. For the whole month of Jan and the first two weeks of February, I didn't really exercise. Just starting to this week. Dr. visit in person on January 28 and he prescribed Triamcinolone 0.1%. Urine test - next month to recheck after testing prior to dose 2 of vaccine but after receiving dose 2 of vaccine.
DEVELOPED CELLULITIS AT INJECTION SITE 8 DAYS AFTER ADMINISTRATION Narrative:
Side effects included chills for nearly 15 hours, extremely sore back, especially lower back, injection site soreness of muscle area  and back of legs were very sore. It was uncomfortable to walk.  Could not get warm until I went to bed and wore fleece  and used a down comforter and a fleece blanket.  Laid on a heating pad to help ease the back pain.  When I got up the following morning, all side effects were gone and nothing hurt.   Also, I had Covid at the end of November, beginning of December 2020.   I will not be getting the second vaccination  - do not trust what is "not known".  The side effects were worse than my experience with Covid.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable other health professional (patient). A 38-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 04Jan2021 at 12:00 (38-year-old at time of vaccination) at single dose; then received the second dose of BNT162B2 (lot number: EK4177) via an unspecified route of administration on 25Jan2021 (38-year-old at time of vaccination) at single dose, both for COVID-19 immunization. The patient's medical history was not reported. The patient had no COVID prior to vaccination. Concomitant medications were not reported. There was no other vaccine in four weeks. On 07Mar2021, the patient tested positive for COVID-19 via the Sofia rapid SARS CoV- 2 Antigen FIA COVID-19 test (via nasal swab). The event resulted in doctor or other healthcare professional office/clinic visit. Facility type of vaccine was hospital. No therapeutic measures were taken as a result of the event. The outcome of the event was recovering.; Sender's Comments: Based on data provided and temporal association, the causal association between the reported events and BNT162B2 cannot be excluded. This case will be reevaluated upon receipt of more information.
Body aches, redness, swelling, itching, and soreness on left arm(injection site). Then, a blister appeared about 12 hours after. That night(5/02/2015), I had a fever, chills and body aches.
Patient as well as her husband who is about the same age both experienced severe dizziness for approximately 10 days. Once this subsided there were no issues.
ADMINISTERED VACCINE FROM A PUNCTURED VIAL LONGER THAN 6 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced administered vaccine from a punctured vial longer than 6 hours. The action taken with covid-19 vaccine was not applicable. The outcome of administered vaccine from a punctured vial longer than 6 hours was not reported. This report was non-serious.
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself).  A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization.  The patient's medical history was not reported.  Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy.  The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL).  The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant.   On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly.  On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened.  The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown.  The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot 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.
accidentally gave patient the high dose influenza vaccine instead of the pcv20 vaccine . no signs that were noticed at this time
Experienced an episode of rapid heart rate and chest pain consequently diagnosed as Atrial fibrillation in the emergency room. Was cardioverted and  placed on Apixaban and Diltiazem . Returned home
Patient got a rash at the 15 minute mark on her chest after getting vaccine and was given Benadryl. At the 30 minute mark she started c/o and itchy throat  and the rash spread to her back. She was sent to the ED.
face started tingling/most in her cheeks as opposed to her forehead; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (face started tingling/most in her cheeks as opposed to her forehead) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PARAESTHESIA (face started tingling/most in her cheeks as opposed to her forehead). On 12-Feb-2021, PARAESTHESIA (face started tingling/most in her cheeks as opposed to her forehead) had resolved. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
I developed a nose bleed about an hour after injection. This lasted for about an hour. My arm was sore for a few weeks, with a red "bullseye". This lasted for 2 weeks.
Chills, fever, malaise, headache, body aches & nausea x 2 full days. I was bedridden. Then extreme vertigo which caused nausea & projectile vomiting  . I could not even walk. I had to crawl to get to the bathroom.
Narrative:  Pt is an 88 yo male with PMH of CAD, CVA, aortic stenosis, HTN, HLD, and carotid artery stenosis. Death was reported to medical facility by coroner's office. Nothing reported in chart to suggest death was caused by vaccination.
I have a watch, and at 1pm the day after my vaccine my high heart rate alarm started to alert.  As of 2:50pm it has gone off 4 times.  I have been sitting on my couch working on homeschool lessons with my children; nothing strenuous.  I also have some joint pain and a mild head ache.  I have tried taking an over the counter Alieve for the discomfort. It was taken about an hour before the 1st heart rate alert.
Hives through out back, arms torso. Self dosed Benadryl and resolved by next morning.
This case was reported by a physician via call center representative and described the occurrence of weakness of arms in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included ADACEL for prophylaxis. In June 2018, the patient received SHINGRIX and ADACEL. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced weakness of arms, injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the weakness of arms, injected limb mobility decreased and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the weakness of arms, injected limb mobility decreased and pain in arm to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The physician reported that the patient received SHINGRIX and ADACEL in the same arm a month ago. The patient was complaining about her arm was felt weak and it was still sore 1 month later. The heath care professional (HCP) also reported that she experienced limited range of motion and decreased strength in injected arm.