chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline", notes: Known allergies: Tetracycline.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: it was reported that, Patient taking Paxlovid for COVID-19 treatment, treatment start date: 16Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
High temperature.  Initial seizure, stopped breathing and turned blue.  ( approximately a 25 minute episode.  Patient transported and admitted to hospital.  Fluctuation in temperature from 95 degrees to 104.7 degrees during the following 72 hours.  Two more episodes that were suspected to be atypical febrile seizures occurred on two different days.  Last episode that lasted approximately 45 minutes resulted in patient being transferred to peds ICU.
Over a week after receiving my second COVID-19 booster, I started getting rashes on my skin on different part of my body; below waist, hand, inner side wrist, foot, over groin, under the breast. It was itching and burning. Occasionally I could see and feel very thin elongated bump strips on the rash area. I had also itched on my head under the hair.  The largest rash size was about 4"x3". The rash attack' would build up in few minutes and last close to an hour. I have been having rashes every day till the present day. In recent days the rash frequency has been coming down and the rash area is now smaller and less intensive in terms of itching and burning. I have never experienced such rashes in my life. (All my 3 previous COVID-19 vaccination were Moderna after which there were no rashes.) I would like to point out that my husband received his second booster on 3/11/2022 at the same pharmacy, Moderna lot 045L21A (same as my lot). However, my husband till the present day did not experience any rash
Pfizer-bioteNTecg Covid-19 VAccine EUA. Started about 36 hours after vaccine, continue to present (April 5th). Went to ER on Wednesday March 31st, will follow up with PCP. All labs ordered during ER stay came back normal. Symptoms include:  Continued elevated Heart Rate/palpitations, shortness of breath, chest tightness, dizziness, disturbed sleep due to chest tightness and sensation of electric jolts several times during the night.
PT received the Janssen covid vaccination, after about 5 mins the pt fainted and then regained consciousness. Pt had hit his face on the floor, 911 was called to the pharmacy. 911 indicated not to give anything to the pt to eat or drink. Event occurred around 12:50/12:55. When EMS arrived a few minutes later and pt blood pressure was 125/81 , pt was feeling lightheaded and sweating profusely. Patient was also given an ice pack for his face, EMS took the pt to medical facility for further follow up
None. Varicella vaccine inadvertently given IM instead of subcutaneous. No actual adverse event occurred.  When I called to discurss the event they said I should report it, but there were no signs or symptoms or problems.
fue patient was diagnosed wifu "unspecified HPV related disease".; This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) fill series (lot #, expiration date, route of administration and frequency were not reported) for prophylaxis.        On an unknown date, the patient was diagnosed with unspecified HPV related disease.The outcome of papilloma viral infection was unknown. the causality assessment between the event and suspect therapy was not provided.
Presented today w/mom c/o soreness lt thigh; afebriel 9.1 cm x 11.2 cm red-warm area lt leg where DTP inject as recvd 21APR92; instructed APAP for pain & ice to lt leg;
After administering the vaccine, the patient experienced a severe vasovagal response approximately 5 minutes after receiving the vaccine. Diaphoresis was treated with ice packs. PulseOx was normal, blood pressure and heart rate were stable.
Continued itching over shot site, starting 1 day post shot continuing for 3 days. Still has itching today (day #3)
Blood & clotted blood in urine, at every urination since vaccination. All documented with time-stamped photos 03/28/2019: 3:49 pm ? 4:29 pm ? 5:29 pm ? 6:19 pm ?. 11:57 pm 03/29/2019: 5:14 am ? 8:09 am.
Initially "not feeling well." Then became nauseated, stomach ache, headache, lightheaded, vomited once, and developed fever (102.4F tympanic in office the next day).
Metallic taste in mouth, swollen tongue, felt like she could not breathe, resolved with intervention after approx. 40 minutes.
Patient developed redness at site of injection; also developed headaches, body aches and a fever on 01/11/18. Given IV dose of antibiotic for presumed cellulitis at site of injection. Started on oral AUGMENTIN.
Lower back pain on right side, skin in surrounding area sensitive to touch with random sharp spasms. Shoulder pain on back.
Presented to clinic with Fever temperature 104.1, chills, body aches, activated EMS, taken to hospital.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I'm in the military and I'm sick from the anthrax vaccine tainted with squalene. Little did I know that after taking the shots, my life was going to change forever. I had my 6-serious of anthrax vaccine overseas from 1998 to 2000. My problems started out as bilateral tennis elbow. I didn't do any repetitive activities that would cause this. Tennis elbows continued and I was diagnosed with rosacea. My left elbow tendon tore for no reason and I had to have surgery to repair the tendon and radial nerve release. My tennis elbow continued on the right. I injured my neck while shoveling snow and was diagnosed with myofascial pain syndrome with trigger points. I was diagnosed with hypertension and obstructive sleep apnea/CPAP. My hands swelled up and every joint in my hands hurt requiring me to wear lidoderm patches and splints 12 hours a day 24/7. Rheumatologists can't find the problem but they have found 3 cysts in my right hand. I have a bone cyst on my C-2 vertebra. I have sacroiliac syndrome that is almost crippling with pain; I can't stand for more than a couple minutes before I sit down. I can't walk more than 1.4 mile a day. My feet are swollen and painful. (OMIC)
pt recvd flu vax & pt devel cellulitis @ the site of inject; pt was hospitalized 4 days & treated w/ATB;
Patient recieved the influenza and tdap shots in his right arm, followed by the menactra in his left arm. Following the completion of the menactra dose, he slumped forward for 5-10 seconds. His mother (me) tried to see if he was hunched over in pain, or if he was trying to hide if he was crying... but he was passed out. He then straightened out laying supine on the exam table. His eyes had rolled back in his head. Honestly, it almost appeared to be seizure-like. He tried to sit up after 10-15 more seconds, but we had him stay laying down. He was perspiring. We applied an ice pack to his forehead and neck, and had him drink water. He appeared to be fine after that. He received the HPV vaccine after that.  I will be honest that I am not sure if it was all due to holding his breath or from the vaccine, but this has never happened before.
Warmth of left upper arm including injection site; Redness covered most of the Left Upper arm including injection site; Swelling eventually covered most of the upper arm including Injection site; Mild itching eventually covered most of the Left Upper arm including the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Warmth of left upper arm including injection site), ERYTHEMA (Redness covered most of the Left Upper arm including injection site), PERIPHERAL SWELLING (Swelling eventually covered most of the upper arm including Injection site) and PRURITUS (Mild itching eventually covered most of the Left Upper arm including the injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced FEELING HOT (Warmth of left upper arm including injection site), ERYTHEMA (Redness covered most of the Left Upper arm including injection site), PERIPHERAL SWELLING (Swelling eventually covered most of the upper arm including Injection site) and PRURITUS (Mild itching eventually covered most of the Left Upper arm including the injection site). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 09-Feb-2021, FEELING HOT (Warmth of left upper arm including injection site), ERYTHEMA (Redness covered most of the Left Upper arm including injection site), PERIPHERAL SWELLING (Swelling eventually covered most of the upper arm including Injection site) and PRURITUS (Mild itching eventually covered most of the Left Upper arm including the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FEELING HOT (Warmth of left upper arm including injection site), ERYTHEMA (Redness covered most of the Left Upper arm including injection site), PERIPHERAL SWELLING (Swelling eventually covered most of the upper arm including Injection site) and PRURITUS (Mild itching eventually covered most of the Left Upper arm including the injection site) to be possibly related.    Concomitant product information was no reported.  Treatment information also included icepack.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received: Patient's race and ethnicity updated, treatment information and event related information was updated.
Low fever, body aches, chills, sinus congestion, throat feels like cotton mouth, could feel heartbeat strongly, pulse was high in 80s when feeling that, sneezing, coughing, exhausted.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included gluten sensitivity (that caused neurological symptoms). On 10th September 2018 19:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th September 2018, 1 days after receiving SHINGRIX, the patient experienced headache, sleepiness, foggy feeling in head, neurological symptom and nervous system disorder. On an unknown date, the outcome of the headache, sleepiness, foggy feeling in head, neurological symptom and nervous system disorder were unknown. It was unknown if the reporter considered the headache, sleepiness, foggy feeling in head, neurological symptom and nervous system disorder to be related to SHINGRIX. Additional details were provided as follows: The reporter was husband of the patient. The patient received dose of SHINGRIX in the left arm in the evening, a day before the date of reporting. On 11th September 2018, in the morning, the patient woke up and felt like she had been exposed to gluten and with a bad headache and she had trouble waking up and staying awake and she was in a fog. It felt like her nervous system was not working right. These were symptoms very characteristic of her reactions to gluten. The reporter was concerned that the patient was exposed to gluten from the SHINGRIX.
This spontaneous report was received from a pharmacist referring to a 34 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 17-NOV-2017, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 19-NOV-2017, the patient began experiencing extreme fatigue. On 20-NOV-2017, the patient experienced fever and chills.  On 21-NOV-2017, the patient stated that he had severe weakness in his legs and talso reported hat his legs felt like jello (feeling abnormal). The reporter stated that it was unknown if this was patient's first dose of GARDASIL 9 series. The reporter stated that the patient sought medical attention. On 22-NOV-2017, the patient went to the pharmacy to report all the above mentioned events. Furthermore the patient did not received treatment to the aforementioned events. The outcome of muscular extreme fatigue, fever, chills, severe weakness in his legs and feeling abnormal was reported as resolving. Additionally, the reporter did not provide causality assessment between the events and vaccination with GARDASIL 9.
(L) deltoid swollen, hot, localized allergic reaction 48 hours post injection. Tx: Diphenhydramine, topical cooling.
rash; eye lids were a little swollen; Skin on Neck Noticable Red particularily on right side; side got vaccine on right; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in Arm Right on 24Feb2021 at 11:45 (at the age of 71-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included, she had the one you have every 10 years, ah yes, the Tetanus shot in Dec, and she had no reaction and never had other reactions other than the enhanced flu shot for immunization. The patient started reaction I had, I never had a reaction to a shot, I did take the enhanced flu shot in the fall, on a Friday and by Sunday had a rash, and felt it was form the flu shot, I had another shot with no reaction. Concomitant medications were vitamins and 2 others. On 04Mar2021 09:00 the patient experienced rash, eye lids were a little swollen and she felt some tightness around her eyes, skin on neck noticable red particularily on right side; side got vaccine on right. It was reported that, the Dermatologist at that time gave me a strong cortisone cream and within 4 days it knocked it out. I looked on the internet people who get a rash on arm related to Injection site, mine was right arm, Right side of my neck is notably worse. a few red marks, neck on my left side and where my arm attaches, the skin is red not like hives. I took one Zyrtec and also put some zinc oxide on my chest area. Also providing information on antihistamines. For the rash from this time, caller stated that it started yesterday, she got shot in her right arm and she has red marks all on the right side of her neck, and on her left side she has a little bit and around where her arm is, and it is trying to be a rash on her chest. Patient received treatment as Zyrtec antihistamine and also put zinc oxide on her chest. Cortisone cream on the rash. Patient did not any AE(s) require a visit to emergency room and physician office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events rash and skin on neck noticable red particularily on right side; side got vaccine on right not recovered and eye lids were a little outcome of unknown.  No follow-up attempts are possible. No further information is expected.
Shortness of breath, chest tightness, headache, sore throat, painful to breathe, flushing of the face. An ambulance was called and patient was taken to the ER, patient was given Diphenhydramine and returned to duty with instructions to follow up with primary care as needed.
Starting 05/11/2022, I thought I had allergies. Due to COVID being rampant, I decided to take 2 COVID at home tests and both were positive. My symptoms were headache, sore throat, cough, stuffy/runny nose and fatigue. I went to see a doctor to get meds. They gave me Paxlovid. I went home and rested, and stayed in my room for 5 days. Today, 05/20/2022, I am feeling good, but usually in the morning I am the best, but by afternoon I am fatigued and usually need a nap. I re-tested on 05/18/2022 and it was negative.
Pt. states that after receiving the 1st dose of Phizer 08/21/2021, started experiencing symptoms 08/26/2021 of off-balance, pressure behind the (left) ear. Primary visit 08/27/2021 treated with *Flonase. Accident at work (fell dizziness), Emergency Room visit. ENT Specialist seen 09/2021, Minor Hearing Loss (Left) Ear *treated with Steroids. Still experiencing symptoms, swelling on the leg side of the neck, Emergency Room visit *MRI preformed. Recommendation of PT *due to left side weakness and off-balance. Brain Fog and fatigue symptoms in addition.
12 minutes after administering FLUARIX 2016/17 flu shot the patient stated that he was feeling nauseous and ill. Patient looked flush.
muscle ache; Chills; soreness at site of injection; headache; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: el3247) via an unspecified route of administration in the left arm on 18Feb2021 at 10:15 (at the age of 44-year-old) as a single dose for COVID-19 immunization. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: el3247), via an unspecified route of administration in the left arm on 28Jan2021 at 10:15 as a single dose for COVID-19 immunization. On 18Feb2021 at 21:00 (reported as 12 hrs after injection), the patient experienced chills, soreness at site of injection, muscle ache, headache and fatigue. The patient did not receive any treatment for the events. The outcome for the events was recovered on an unspecified date in Feb2021(reported as symptoms lasted 18 hrs).  Follow up attempts are completed. No further information is expected.
First 5 days after injection, I could not lift or move my arm at all. Horrible pain in shoulder and arm. Pain in should continued for 3 weeks whenever performing range of motion, pushing or lifting anything heavy. Went to a doctor, they felt my arm and felt a lump, she stated thinking my muscle was just swollen from so many antibodies. I was given a steroid prednisone 7 day pack. Pain was relieved for the 7 days. The day after the last pill pain in my shoulder returned a bit more intense then before I started steroid.
78y.o. male with a past medical history of COPD, DM II, and HTN who presented to the hospital's emergency department from an extended care facility. Patient was recently hospitalized and treated with IV antibiotics for HCAP. Patient tested positive for COVID on 3/24/2021. EKG was negative for ischemic signs but patient had an elevated troponin. CXR showed right pleural effusion. Patient was admitted with COVID-19 pneumonia and severe respiratory failure.  Patient's oxygenation continued to deteriorate despite Remdesivir, decadron and lovenox.  Patient went into respiratory failure and expired from progressive respiratory failure.
Patient reports that her arm has been sore to the touch for weeks. She also has trouble raising her arm. She has not talked to her doctor about it yet, but has an upcoming appointment.
Found sitting, short of breath, pale, shaky, tight chest. Initially with HR 150s, o2 sat 88%. Transferred to a gurney. Repeat vitals and color improved within 10 minutes, HR 100, 37.2, 142/95, o2 sat 100%. Employee was monitored for 1 hour. Still felt slightly dizzy so transferred to the emergency department for further observation.
heart started beating a little faster; soreness around the injection site; slight fever; felt a little tired; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (heart started beating a little faster), VACCINATION SITE PAIN (soreness around the injection site), PYREXIA (slight fever) and FATIGUE (felt a little tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced TACHYCARDIA (heart started beating a little faster), VACCINATION SITE PAIN (soreness around the injection site), PYREXIA (slight fever) and FATIGUE (felt a little tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (heart started beating a little faster), VACCINATION SITE PAIN (soreness around the injection site), PYREXIA (slight fever) and FATIGUE (felt a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided Treatment information provided as ibuprofen
Information has been received from a licensed practical nurse (LPN) concerning an unknown number of infants who were vaccinated orally with 2 ml of Rotateq and subsequently spit up vaccine after administration.  Follow up information was received from an LPN, who reported there was only one patient, a four month old male, who had spit up after receiving Rotateq.  No additional doses were given that day to the infant.  No additional patient details were available.  No further information is expected.
13 year old who received his second Pfizer COVID vaccine on July 3, 2021 (3 days ago). He describes a low grade fever on the day after the vaccine which did not initially concern him.  He presented to the ER yesterday with complaints of midsternal chest pain and shortness of breath and a vague history of palpitations that started yesterday morning and continued to progress over the day.  The chest pain did not vary with position and was not aggravated with respiratory effort.   He had an elevated troponin and CRP and was admitted for management/observation. His chest pain has resolved since starting Ibuprofen (600 mg q 6 hours).  Serial troponins peaked at 22.9, now trending downward. Notable changes on serial EKG's with resolving ST segment elevation and T wave inversion. The echocardiogram showed low normal LV function but was otherwise normal.   PT presentation is consistent with the newly recognized post Covid vaccine myocarditis in adolescent males.  Timing of the chest pain in relation to the vaccine, EKG and echo findings and elevated troponins all support the presumed diagnosis of myocarditis.  He met the criteria for a cardiac MRI to be obtained prior to discharge- results pending.