chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CELLULITIS OF INJECTION SITE OF LEFT THIGH--VERY RED, HARD AND WARM TO TOUCH MOM NOTICED THE REDNESS ON SAT. OCT 11, 2008 AND PROGESSIVE GOT WORSE OVER 24-36 HOURS.  SHE WAS TREATED WITH BACTRIM ORAL SUSPENSION X 7 DAYS
Pt's night arm was in a lot of pain in the evening of vaccination. By next day, it was swollen and itchy. At 6:30pm on Friday (10/18/17). the entire arm from shoulder to elbow was swollen 6 inches length, and warm to touch.
a little achy headache; a low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Feb2021 15:00 (Lot number: EM9809) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "bile/acid reflux", start date: 2009 (ongoing), notes: bile/acid reflux, botox during endoscopy (Jun2021); "achalasia", start date: 2018 (ongoing), notes: botox during endoscopy (Jun2021); "AAA repair", start date: 2004 (ongoing), notes: AAA repair, repair-2006; "current aneurysm", start date: 2011 (ongoing); "fibromyalgia", start date: 1994 (ongoing); "schwannoma", start date: 2018 (ongoing), notes: only nerve root, displacing carotid monitoring for growth; "breast cancer", start date: 2017 (unspecified if ongoing), notes: lumpectomy Anti estrogen drug; "lumpectomy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Date: 19Jan2021 (3.00 PM), Anatomical site of injection: left arm, Route: Intramuscular, Batch/lot number: EL0142), administration date: 19Jan2021, when the patient was 76 years old, for Covid-19 immunization; Flu (High dose Flu, Anatomical site of location: Left arm), administration date: 23Sep2021, when the patient was 76 years old. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "a little achy headache"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "a low grade fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that after her second vaccine dose all she had was a little achy headache and a low grade fever for 24 hours but after the booster she had 5 days with a 102 fever, severe vomiting and stomach pain. She reports that she was going to head to the ER but didn't have to because she had a GI cocktail with lidocaine on hand. Manometry was performed on 23Apr2021.Also reported that her husband got his dose and all he was tired, he took a nap and he was fine.  Follow-up attempts completed. No further information expected.
Severe Headaches starting at the base of the neck up to my forehead. Also rash all over my body like chicken pox
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-JAN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 48, 1 and R; 72, unknown and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
On 9/21 Pt developed Pericardial effusion of chyle. Suspect Chylous pericardium. Well over 1200ml was drained from his heart. Doctors say that this had been building up for weeks. His second dose was administered on 6/15/2021. Surgery was required to drain his heart. A drain was left in for a week and the fluid has stopped producing. Treatment is ongoing and he is still in the hospital, but urgency seems to have subsided. Questions remain as to cause.
About 20 minutes after my tongue and throat started to feel numb and as i was driving home my hand started to hurt and developed a weird rash on my right hand only.
itchy hives/rash on right ankle and top of foot continued to next day. Similar to my reaction to iodine injection for previous MRI
Received first ever flu shot. Next day felt ill, chilled, tachycardia. Following day broke out in classic whole body drug-rash, and was seen in office. No further treatment needed.
Case number PHEH2014US007650 is an initial spontaneous report received from a pharmacist on 15 APR 2014. This report refers to a 13-year-old male patient. Past medical history and concomitant medications were not reported. On 19 NOV 2013, he was vaccinated with FLUCELVAX (batch number: 010021A) intramuscularly. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 15 APR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
LMP 7/13/2021 patient states vaginal spotting with blood clots consistent with miscarriage starting 8/26/2021 confirmed post vaccine first trimester miscarriage by ultrasound by beta hcg
Patient was pale and  complaining of her ears feeling full and would pop when she drank. She was sweating and having flu like symptoms including nausea. We had her sip water wait in the pharmacy waiting room and discussed how she was feeling. after about 20 minutes she was starting to feel better.
(L) arm swollen proximal 1/2 to mid humerus & pinkish-red, 33cm diameter below deltoid on (L) arm.
Noticed a small pea sized lump near collarbone day after vaccine. Seems to be getting larger slightly and warm. Called pharmacy to report reaction was told this was not a reaction to the shots. After reading on the CDC site I see that it is a rare reaction to the tDAP shot. I visited my regular Dr on 10/5 and she also didn't think the shots would cause this type of reaction. I have an ultrasound scheduled for 10/8 to be sure it isn't something serious. Believe to be a lipoma. This just appeared after the shot.
w/in 2 hrs p/recvd dose #5 of engerix-B exp t99.9, swollen gland of lt throat, felt sick;
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy 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 02-JUL-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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.
This spontaneous report as received from registered nurse refers to a patient of unknown age and unknown gender. On 15-JUL-2015, the patient was vaccinated with M-M-R II (lot#, dose and route were not reported) which was expired on 20-JUN-2015. No adverse effects were reported. No product quality complaint (PQC) was reported for M-M-R II. Additional information has been requested.
The day after I didn't have much energy.  Woke up the day after with a little rash which spread all over my body. Secon day energy back but rash was worse, rataher angry red and beginning to itch.
Patient reports having SOB and ansiety after receiving the 1st dose clear up to the 2nd dose. She decided to get the 2nnd dose while still experiencing these symptoms. Patient reports never having anxiety or SOB before 1st dose. No recent stress or stress triggering issues. She did not take anything for this. It is now minimal, but experiences it rarely.
A report has been received from a Health Professional concerning a 48 year old, Female patient. The patient's concurrent diseases included asthma triggered by infection, smoke, pollen and changes in the weather. She had symptoms when she run. The patient was a former smoker. She had respiratory issues two consecutive years. Family history included sinusitis. Concomitant medications included MENOCET, ascorbic acid, biotin, minerals nos, nicotinic acid, retinol, tocopherol, vitamin b nos, vitamin d nos and calcium. A nurse reported that another employee in the office from a previous season had asthma and got FLUMIST and made her have as asthmatic episode both in 2010 and 2011. They lasted for 2-3 days. The symptoms were fever, wheezing, coughing, and nasal and chest congestion, chest tightness and sputum production. The patient experienced these symptoms for about one week after receiving FLUMIST. The patient stated that she was treated at the office with XOPENEX inhaler and used it for a week. She was out of work both episodes for 2-3 days. At the time of the reporting the patient recovered from the events of asthmatic episode, wheezing, fever, chest congestion, coughing, chest tightness, sputum production and nasal congestion. The report was considered to be non-serious by company physician. Summary of follow-up information received by AstraZeneca/MedImmune on 07-Nov-2012 from health professional: new events of wheezing, fever, chest congestion, coughing, chest tightness, sputum production and nasal congestion added, event outcome updated, patient medical history added, concomitant medications added, patient details updated, reporter information updated, narrative updated.
Sore arm at injection site for a few days then on 3/30 began to feel flushed (red face, arms, trunk, thighs), fatigue, mild headache, aches, nausea but no vomiting; took Benadryl just after shot at MD direction and an aspirin and slept first day a lot then took again on Tuesday and improved. Wednesday 3/31 felt good then Thursday evening 4/1 stated to feel like I was fighting off a cold - fatigue, nausea, flushed, slightly elevated temperature (@1 degree), chills, strong left arm injection site pain returned - iced arm, aches, mild headache, by Friday 4/2 morning still flushed red and all of above plus lungs felt icy (feeling I?ve had before having lung infection) and ozzie lungs - took Benadryl and lung icy and Ozzie feeling stopped in 30 minutes or less, continued to feel under weather with above symptoms for five to seven days. Took aspiring and Benadryl on and off during this time. Feeling better by 4/7 into 4/8/21
Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy; arm got a big thing on it; Arm got a big thing on it, on hands. It hurt a little bit and it itched; Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (arm got a big thing on it), VACCINATION SITE PAIN (Arm got a big thing on it, on hands. It hurt a little bit and it itched), VACCINATION SITE PRURITUS (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy) and VACCINATION SITE ERYTHEMA (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE REACTION (arm got a big thing on it), VACCINATION SITE PAIN (Arm got a big thing on it, on hands. It hurt a little bit and it itched) and VACCINATION SITE PRURITUS (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy). On 24-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy). On 20-Aug-2021, VACCINATION SITE REACTION (arm got a big thing on it), VACCINATION SITE PAIN (Arm got a big thing on it, on hands. It hurt a little bit and it itched) and VACCINATION SITE PRURITUS (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Arm got a big thing on it, on hands. It hurt a little bit and it itched./It came back again. It's pink and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported
On 12/12/07 about 5pm pt reports swelling, pain and unable to raise right arm.  On 12/14 PHN notes swelling in Rd deltoid area 5 1/2" x 5 1/2", warmth and redness.  Able to raise arm.  Also reported chills & myalgia on 12/12.
After the vaccine I feel sleepy, all day I want to sleep, pain in the spine, legs. I have a bad headache (every other day). I went to the doctor after 2 weeks and he told me that it was the effects of COVID, since I had COVID in December. He gave me Magnesium and Zinc.
Onset 2-3 hours after vaccine administration. Hives/rash on neck, chest, back. Redness in thighs felt. Patient took BENADRYL 50 mg which resolved adverse reaction.
Patient requested a flu vaccine along with her Pfizer Booster. Patient verbalized that she was 18 when I asked. I administered a Flublok vaccination in her right deltoid along with her Pfizer Booster in her left deltoid. Patient waited the 15 minutes post administration without any concerns. After she left, upon documentation I realized that she was 17yo. I notified my healthcare provider and filled out appropriate reports.
Symptom: Sore arm. Pain when lifting. Unable to lift above shoulder height. Began: Within 10 hours of receiving shot Duration: 2 days  Symptom: Fever, chills, headache, night sweat, dizziness, fatigue, loss of appetite, nausea, lightheadedness, inability to balance while walking Began: Within 24 hours of receiving shot Duration: 3 days
Swelling in left shoulder, in muscle above clavicle. Visibly swollen. Left side of neck felt stiff. Swelling  went down  on 4/20, but still visibly swollen and sore. Les swollen and sore on 4/21, but still noticeable. Coughed sporadically the night of 4/19, dry cough, sometimes short of breath.
mild facial swelling - after observation until 5:46pm. stated felt much better and swelling had subsided.
Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided. It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01-Apr-2022. It was confirmed that the vial didn't undergo temperature excursion issue. On 04-Apr-2022 vial was initially stored in refrigerator.
01-08-2021 went home from work at 1 pm with fever, body aches, headache.  Joint pain developed and was severe and longlasting.  Unable to grip to open bottles.  Put on pain medication for joint pain. 02-24-2021 Seen for palpitations and tachycardia. 03-04-2021 seen for testing  June 15, 2021 was seen for follow up, put on beta blockers and referred to cardiologist.  Has appointment in September scheduled.  Heard heart murmur that had developed since the March visit.  Added inhaler, Zalera.
Gave patient booster vaccine. Patient received 2nd dose on 10/5/2021. Not due for the booster until 4 months. NP made aware. Patient monitored for 15 minutes and was stable. Patient  also made aware.
Left index and middle finger tingles constantly; Sore upper arm muscle; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 24Jun2021 at 15:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included women multi vitamin from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 25Jun2021 at 08:15, the patient experienced left index and middle finger tingles constantly as well as sore upper arm muscle. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of events left index and middle finger tingles and sore upper arm muscle were not resolved at the time of this report.
normal pregnancy with no visible issues untill miscarriage 2 months after taken the vacine estimated date of birth was October 2021
I was vaccinated on Wednesday, that day I felt fine, on Thursday I felt fatigue, fever, pain in my feet, in arm; on Friday I had severe back pain that radiated to my stomach, on Saturday morning 4:40 I was awakened by a tachycardia and afterward I had severe chest pain, I could not tolerate the pain. I went to the emergency room and they found my Troponin at 7000. They  took good care of me in the hospital. They did tests on me and later on Sunday I had it again at dawn but not so strong, I am a healthy person and have not done anything out of the ordinary, the only thing different was the vaccine that I took in those days. Now I have to take medications (amlodipine, aspirin, omega, atorvastatin) I don't know for how long.
At about noon I started getting itchy all over my body. It got worse and until I started taking Benadryl. I took a bunch of Benadryl and was still getting itchier and itchier. the itchiness went up to my throat and I just rode it out taking a lot of Benadryl.
Per mom client broke out with hives 6/13/12 am - getting worse throughout day temp elevated 102 last evening 100.1 this am.
PT. ADMITTED TO HOSPITAL 7/8/2021 WITH SOB AND BACK PAIN HAD MODERNA VACCINE BUT DATE UNKNOWN
C/o fever the night of flu vaccination. C/o "really sore arm at injection site for 3 days" first influenza vaccination.
Hives/rash started soon after the first dose. Comes and goes all over the body. Rash was blanching and looked urticarial. Only one time there was a petechial rash.  Had the second dose on 6/6. On 6/12, to relieve discomfort, a doctor prescribed a short course of dexamethasome and famotidine, and also started her on Zyrtec. She is still taking the Zyrtec daily. The rash disappeared while taking the steroids but starting coming back when she stopped. The Zyrtec helps but the rash still comes and goes.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: itching of eyes, feeling warm-Mild
Patient developed occipital headache within 1 hour of receiving FLUMIST. Mild, controlled with OTC meds, but persists after 1 day.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12/21/2020 0200 hrs  severe chills & Temp 104.2 F took Tylenol 500 mg , 0400 hrs Temp 103.4F.  0600hrs Temp 104F took Tylenol 500mg . 0700hrs 103.6F. all day temp ranges from 102.8F to 103.4F 12/22/2020 no chills Temp ranges from 101.6F to 103F 12/23/2020 Temp ranges from 99.5F to 102F
Developed hives over most of his body.  No airway swelling and no respiratory symptoms.
Patient received vaccine at 1:20 pm and started bleeding with blood dripping down arm immediately after shot was given. Swelling occurred at the injection site and looked like a dime-sized balloon. Patient started feeling dizzy and said she had tightness in her throat and was given Benadryl. Arm swelling decreased and throat tightness stopped after Benadryl was given . Patient felt cold and blood pressure taken was slightly elevated. Patient's son arrived and took patient to the hospital.
PATIENT WAS ADMINISTERED WITH ADULT PFIZER INSTEAD OF KIDS DUE TO PARENT PROVIDING WRONG DATE OF BIRTH YEAR.