chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot at injection site; burning at injection site; itching at injection site; lump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE PAIN (burning at injection site), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE SWELLING (lump at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 024M20A and 039K20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, LEVOTHYROXINE, VITAMINS NOS, COLECALCIFEROL (VITAMIN D3), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE PAIN (burning at injection site), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE SWELLING (lump at injection site). In November 2021, VACCINATION SITE SWELLING (lump at injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE PAIN (burning at injection site) and VACCINATION SITE PRURITUS (itching at injection site) outcome was unknown.            No concomitant medication details were reported. No treatment medication details were reported. The concomitant information included Probiotics.
Redness, swelling (severe), warmth, and skin firm at site of injection. Examined by Dr and given Prednisone 20mg 1 BID #6 and Benadryl OTC.
4 hours post inject pain at injection site dissipated at 6 hours post injection. 12 hours post injection fever of 100 detected, no pain, no aches, no fatigue, no sweats. 16 hours post injection awakened from sleep by fever of 104.3 and treated with running cool water for 1 hour which brought it down to 102 then 400mg of Nuprin taken (17 hours post) and attempted to lay back down but 20 minutes later fever was back to 104.7 so back to cool water until fever went down to 101 and medicine seemed working (18 hours post). Fever remained at 100-101 until finally dissipating at 40 hours post injection. All throughout there was no fatigue or sweats or aches/pain
It was stiffness and I do home repair but when I would do squats a notice I wasn't as flexible as I normally be, At that time with the booster that was it and mid April I saw my doctor and I had X-Ray and ultrasound and results were normal and no blood clots.
This is a 67-year-old female with a history of hyperlipidemia, depression, anxiety, hypothyroidism and presents for complaint of acute onset abdominal pain, vomiting and diarrhea. Noted that pain awoke her from her sleep this morning. Initially located in the epigastric region but states the pain is worse in the right lower quadrant. She's had several episodes of diarrhea today as well as one to 2 episodes of vomiting. She has a history of hysterectomy. Last known normal bowel movement was this morning.   Review of Systems  Constitutional: Negative for chills, fatigue and fever.  HENT: Negative for facial swelling and trouble swallowing.   Respiratory: Negative for cough, shortness of breath and wheezing.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Positive for abdominal pain (RLQ). Negative for diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria and frequency.  Musculoskeletal: Negative for back pain and neck pain.  Skin: Negative for rash and wound.  Neurological: Negative for weakness, light-headedness and headaches.  Psychiatric/Behavioral: Negative for confusion. The patient is not nervous/anxious.
Initially dizzy and lightheaded after the injection, heart racing, lasted about 30 minutes.  24 hours later extremely tired, no energy, sore upper L arm, nausea, no appetite, talking, reading, writing/typing almost impossible.  This lasted for 3 days. Developed a migraine headache(had migraines 30 years ago) that lasted for the following 10 days and then just a normal headache for 2 more days.  I took Advil and Tylenol without any relief.  Called the nurse at physicians office who told me to increase the dosage and to use only Advil.  If it got worse to go to urgent care to get Tordal and/or steroid injection.  I didn?t want anymore side effects of medication so I just toughed it out.  The injection site became the size of a half of a tennis ball, was red and hot to touch.  It is now 18 days later and there is still a small  knot and tender to touch. Trouble sleeping through the night also started at the time of vaccine and finally stopped last night.  I felt like I was in a dark hole for the first 3 days and was then in a fog for a week.  I had blurry vision off and on for the first 3 days and then again on  day 5.
Shortly after receivcing vaccinations, patient went to stand up and states that he felt a "little woozy" and sat back down. Patient then started complaining that his right arm was a little numb. Patient sat with nurse in the room and then states that he was getting a little short of breath. Nurse had the patient lie down and had me come into the room to evaluate the patient. Patient was perspiring significantly and was breathing rapidly, but deeply and had a normal pulse rate. Lungs CTA bilaterally and heart sounds normal. Patient stated that breathing was getting easier, but that both of his arms were going numb. EMS was called. Patient reported no feeling on pinch testing of bilateral upper extremities and arms were flaccid while both hands were in tetany. Patient was unable to grip or extend fingers. Patient had feeling in legs, but began losing motor use. Patient reported having a loose BM as well. Patient was fully responsive through out, able to recall children's names and ages, asked for his wife to be called and he was able to provide her phone numbers . EMS arrived and found patient with a BP of 120/85 and pulse of 91. Patient was moved to stretcher and taken to Emergency Room for further evaluation. I spoke with ED physician 3 hours later and he stated that the patient was feeling better and was being discharged. Patient had been given solumedrol and benadryl, but cause to reaction  was unknown.
approx 4-5 days p/vax pt began to vomit, diarrhea & fever (104) x 2-3 days; 6APR95 rash-macule sl papular; irritable
Normal pain, redness, and swelling at the injection site the day of and the day after the vaccine. Bruise present, but fading during the week after the vaccine. 8 days after the vaccine (Today 01/22/21), new blotchy redness, warmness, and slight itching at the injection site.
Allergic reaction to Yellow fever, TWINRIX, Typhoid swelling at the site of injections. Pain, redness, itching.
felt like her hormones have been off; PMS syndromes; They have been breaking out after having the COvID-19 vaccine. She said usually they have clear skin.; had her period 3 times already after getting the vaccine; This is a spontaneous report from contactable consumers. A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Her workplace got their first dose of the vaccine in late Dec2020 and they just got the second vaccine about a week ago. She was in the military. Consumer reported that her co-worker had menstrual problems after getting the vaccine. The patient had asked her if she felt like her hormones have been off. The patient had her period 3 times already after getting the first vaccine in Dec2020; she had her first period at the end of Dec2020 which was weird, then she got her period again a week later, and she got her period again today. On an unspecified date, the patient also experienced premenstrual syndrome (PMS) symptoms and had been breaking out after having the Covid-19 vaccine. She said, usually they have clear skin. The reporter wanted to know if this has been reported in the clinical trials. She received her second dose on 12Jan2021. Outcome of events was unknown.  Information about lot/batch number has been requested.
Left side of scalp sensitive to touch, a day later, left cheek and edge of left lip sensitive to touch.  Three red blotches appeared on outside of left cheek the size of a dime.
The patient's right arm swelled considerably from his elbow all the way up to the top of his shoulder. No fever or other symptoms.
This spontaneous report was received from a Certified Medical Assistant on behalf of a physician via Pfizer, referring to a 69 year old female patient with allergy to penicillin and allergy to shellfish. On 03-MAY-2011, shortly after 10:57 am, the patient was vaccinated with PNEUMOVAX 23 (strength and frequency unknown) Lot No. reported as 0930Z, exp. date: 17-JUL-2011) 0.5ml, intramuscular in the left deltoid. Concomitant medications were not described. On 03-MAY-2011, the patient experienced that her left arm was tender and painful to lift. Additionally, on approximately 05-MAY-2011 (also reported as two days after they were given it) the patient reported redness at injection site, feverish and achy all over. On an unspecified date, the patient developed allergy to PNEUMOVAX 23. The patient was not seen by the doctor, and no hospitalization was reported. There were no other vaccination within 4 weeks prior to PNEUMOVAX 23, and no illness at the time of vaccination. No relevant tests were performed. No Product Quality Issue was reported. At the time of this report, the outcome of left arm tenderness and painful to lift was recovered on 04-MAY-2015. The outcome of redness at injection site, feverish and achy all over was reported as recovered completely on an unspecified date, and the outcome of allergy to PNEUMOVAX 23 was not reported. The reporter considered the events to be related to PNEUMOVAX 23. This is one of two reports received from the same reporter (MARRS #1509USA004264). Additional information has been requested.
I did not have a reaction to the vaccine. I started not feeling well on 09/20/2022 with a runny nose and a little cough. On 09/22/2022, I tested positive with a home test for COVID-19. I contacted my doctor and was prescribed Paxlovid. I was better within five days. I tested negative in seven days of starting Paxlovid. No rebound COVID-19.
Mom reported Patient's injection site became swollen and red. She also noted that it was "hot to the touch". Patient did not show any signs of trouble breathing or itch or any other adverse reaction. I advised mom to place an ice pack on the site and to take Patient to the ER if he shows signs of troubled breathing. Mom said she will watch him. I called mom on 10/3 to see how Patient was doing but mom did not pick up the phone. I asked the mom to call back.
covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided No treatment information provided
Pt developed a low grade fever of 102 that lasted for 7 days. When fever subsided the pt broke out in a rash that lasted for 3 days.
My left arm started to itch and when I looked in the mirror it was a very large red circle 3 inches around and 2 inches below the site of the shot. It was warm and itchy.  My pharmacist advised some cortisone cream. It improved the next day and by the third day it was gone. It was I got the second dose(024M20A) in the same arm and it did not become irritated.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium
Itching and redness to L arm 7 days after vaccine, localized lymphadenopathy. No difficulty breathing or swallowing
Patient is a 55yo female with a history of atrial fibrillation, heart failure with preserved ER (Echo at FMC 11/2020 EF 50-55%), DM, HTN who presented to the ED with DOE for about 1 week. Found to be in Afib with RVR and admitted to for further management. Also found to be COVID positive. Course detailed by problem below. Covid (+) Did not require oxygen and was asymptomatic. Incidental finding on admission. Given rapid resolution of dyspnea, anticipate this was secondary to tachyarrhythmia with possible component of heart failure contributing. Advised 10 day isolation (test positive 1/13/22).
Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection site, chest, neck, and face; developed a rash around injection site, chest, neck, and face; This is a spontaneous report from a contactable other HCP (patient). A 28-years-old female patient (pregnant: No) received first dose bnt162b2 (BNT162B2 lot number: EH9899), intramuscular on Left arm on 30Dec2020 12:00 at single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, Sulfa, Other-medical-history: Allergy induced asthma. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Since 30Dec2020 13:00 Started with sore arm and headache shortly after injection. Since 30Dec2020 6-8 hours later chills and body aches started. At some point in the same time range, developed a rash around injection site, chest, neck, and face. Fever the morning after on 31Dec2020. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for AE included Steroid and Benadryl Injection. The event outcome was recovering. No-covid-tested-post-vaccination. The events were non-serious.
Patient fainted approximately 30 seconds after vaccine. Eyes closed and patient did not respond for approximately 30 seconds but still had pulse. When patient's eyes opened he stated his vision was slightly blurred; also pale and sweating. After elevating feet and providing ice packs patient began to feel better. Blood pressure and pulse stable 30 minutes following. Patient felt fatigued but otherwise back to normal when leaving pharmacy.
RASH; This spontaneous report received from a patient concerned an 88 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAR-2021 on left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on 27-MAR-2021. This report was non-serious.
pt recvd vax; to md w/ 10 gen chicken pox like spots;mom felt might have been fire ant bites;f/u:spots inc by next day & followed chicken pox devel;
Patient reports that the night after getting the vaccine she woke up with night terrors then developed a splitting headache which is not normal for her.  Shortley thereafter she got chills and body aches and her whole body broke out in bright red hives and blisters (when I saw her about 80% of her body looked like it had been scalded with blisters on her toes and lips and flank.  She felt like her skin had been scalded.  Of note a similar reaction occurred after she had the actual COVID virus back in january but MUCH less mild.   After being treated with steroids for her adverse vaccine event and severe inflammatory like response her skin started to cool down and now her skin is peeling where the redness was. Prior to the skin peeling she developed central petechia in the areas of the most severe redness.  she continues to feel fatigued and her skin is very itchy now.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that patient received their first dose of SHINGRIX on 2nd July 2018. The patient called the health care professional to report that while they raise their arm, they have been having arm soreness. No additional information was provided.
Janssen COVID-19 Vaccine EUA Patient had her Janssen vaccine on May 10th at a Pharmacy. On May 18th the patient presented to the ED with complaints of abdominal pain and chest pain. At that time troponin was negative, ECG was without acute ischemia or ectopy, D-dimer = 1.94. CT was negative for acute pathology, Ultrasound negative for hepatobiliary etiology. Patient requested discharge home and was referred to GI and cardiology. Patient presented to ED again on 5/19 with worsening symptoms. Repeat CT consistent with bilateral adrenal hemorrhage. Heparin Induced Platelet Antibodies PF4 Absorbance elevated at 2.138 and interpreted as positive. D-dimer greater than 20, and platelet count less than 79. MRV of Head demonstrated a non-obstructing thrombus at the junction of the transverse and sigmoid sinuses. Thombosis with Thrombocyopenia Syndrome / Vaccine induced thrombotic thrombocytopenia.
A-fib episodes 2/12022, 7/10/2022, 7/26/2022.
Pt had a red swollen bump around injection site (R) SQ. Warm to touch. Pt came to office 5-25-10 still having problem. Dr. states pt had allergic reaction then scratched it causing an infection.
This is a spontaneous report from a contactable pharmacist. A patient (age, gender and origin unknown) received PREVNAR 13 on an unspecified date. Relevant medical history, concomitant medications and past product history were not reported. On an unknown date, following administration of the vaccination, the patient developed swelling of the lymph nodes. Treatment was not reported. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 16-JUL-2016, the patient was treated at a medical clinic for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir and gabapentin to manage his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
neuropathy in her left foot/ numb like tingling, a lot of tingling feeling/feel it every now and then throughout her body; numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body; numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body; felt weird; Iinterfering with her brain; makes her "like I want to cry."; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 01Apr2021 (lot number: ER8737) as single dose (at the age of 42-years-old) for COVID-19 immunisation. Medical history included temporomandibular joint syndrome (TMJ), headache and clench my teeth; from an unknown date and unknown if ongoing. Concomitant medication included butalbital, caffeine, paracetamol (BUTALBITAL, ACETAMINOPHEN & CAFFEINE) taken for "clench my teeth", start and stop date were not reported; the patient was also taking unspecified vitamins, supplements and an unspecified headache medication. The patient received the first shot of BNT162B2 for Covid-19 immunisation on an unspecified date. The patient had both the shots and was wondering because she was left with like this neuropathy in her left foot, it was kind of numb like tingling, a lot of tingling feeling and she kind of feel it every now and then throughout her body. It was like setting on her left foot and she got the shot on her left side. She got the last second shot and got it on Thursday (01Apr2021). She told her doctor right away the she saw this only after the last shot. She told the guy it was weird, it felt weird and then he said, you know it was a kind off to the side and was just "mental". But it has not gone away, it was like neuropathy, she doesn't remember if it was with the first shot because it was so quick in between. She wanted this to go away, it was really annoying. It was interfering with her brain, it was not good, it makes her "like I want to cry." The patient had a lab work done on Thursday morning (08Apr2021) and stated that her blood work was fine. They did a thyroid check, did her blood sugar and everything was fine; and her B12 to make sure her B12 wasn't low but everything was fine. The patient does not know the name of the tests. The patient wanted to know if the side effects she was experiencing was normal and was it going away. The outcome of the events was unknown.