chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to office for routine vaccination.  Paperwork was completed and neither patient, nor father of patient indicated that patient had any previous reactions with vaccines or that patient was unwell when coming to clinic.  Patient was to receive his next dose for Tdap and Menningitis vaccination.  Patient reported that he was very nervous, but neither him nor his father had any questions for nurse.  Patient tolerated vaccine administration well.  Approximately 1 minute after the second vaccine was administered, patient stood up from his seat, remained standing for a few seconds, and then proceeded to fall backward against the wall.  Patient was assisted to a lying position on the ground. Nurse attempted to rouse the patient, however patient was not responding verbally to nurse.  Nurse noted no sign of trauma to patient's head.  Nurse obtained vital signs on patient at this time to be: HR = 57 bpm, BP = 84/56 mmHg, and SpO2 = 97% RA.  Patient's skin was slightly pale and clammy to the touch.  During nurse's assessment of vital signs, patient became verbally responsive and began apologizing for the "fuss."  Patient states, "It's happened before, where I've felt like this, but it's been a long time.  I just got really dizzy like I do when I stand up too fast and then I'm so tall.  How did I end up on the floor?"  Nurse notified patient that he fell to the ground not long after standing up.  Patient denied having any head pain, stating, "I just still feel kind of dizzy, but that's getting better, too."  Patient was encouraged to continue to lie still.  Patient's pupils were observed at this time using a pen light and were found to be round, equal, and reactive bilaterally.  Patient reports, "I'm feeling a lot better, sorry about the fuss," and proceeded to sit up.  Nurse advised patient to remain sitting and lean his back against the wall.  Patient was given water at this time by other staff and encouraged to drink, which he did and finished the entire glass of water quickly.  After additional questions from nurse, patient reports that he was very anxious before receiving his vaccines, did not have any breakfast, the only fluid he drank was one glass of milk, and he will occasionally get dizzy when he stands up too fast.  Patient assured nurse that he was fine now, however nurse accompanied patient to a chair and encouraged him to sit for a few minutes so that she may recheck his vital signs.  Patient and father of patient verbalized agreement.  Another staff member gave more water to patient and encouraged him to drink.  Vital signs were rechecked 5 minutes later and were found to be: HR = 74 bpm, BP = 110/76 mmHg, and SpO2 = 98% RA.  Patient reported that he was feeling fine and apologized again.  Nurse offered reassurance, but advised both patient and father of patient of ER precautions should symptoms arise.  Patient and father of patient verbalized understanding and agreement.  Patient ambulated out of office without difficulty.
Arm swollen at injection site; Arm / red at injection site; Warm at injection site; Extreme headache; Fever; "Not feeling well"; Stomach pain; Lightheadedness; Vomiting; Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced headache, feeling unwell, injection site swelling, injection site erythema, injection site warmth, stomach pain, light headedness, vomiting, diarrhea and fever. On an unknown date, the outcome of the headache, feeling unwell, injection site swelling, injection site erythema, injection site warmth, stomach pain, light headedness, vomiting, diarrhea and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, feeling unwell, injection site swelling, injection site erythema, injection site warmth, stomach pain, light headedness, vomiting, diarrhea and fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. Age at vaccination was not applicable. Patient reported that she had a shingrix shot and after 4 days experienced extreme headache not feeling well at swollen red and warm at injection site stomach pain lightheadedness vomiting and diarrhea and a fever. Caller stated she had to disconnect due to a telehealth appointment with her HCP. Unable to obtain address date of birth dose of shingrix route and dosage of vaccine lot and expiration date. Symptoms started 4 days after injection and not resolved. Unable to obtain HCP information. Did not consent to follow-up.
Patient is a 74-year-old who presented with shortness of breath, weight loss, decreased tube feedings through her PEG tube, recurrent emesis and possible aspiration with multilobar pneumonia in the presence of ALS.  Patient required intubation, fluid boluses, Levophed, antibiotics.  Infectious Disease was also on consult.  Patient tested positive for COVID-19 on 02/17.  Was treated with remdesivir as well.   Patient continued to show improvement on the ventilator.  She was weaned down close to being extubated and was tolerating pressure support ventilation adequately.  He started to wake up better on that.  Scopolamine patch was started but showed no improvement in her secretions that were mostly oral and not from her lungs.  Case was discussed with her daughter and spouse in detail.  They understood the current clinical condition.  The patient had been suffering from significant difficulty to her life with recurrent aspirations limiting her activity.  She had not been significantly verbal since September.  And most recently had not been able to tolerate PEG tube feedings either.  At this point the family decided for a one-way extubation.  If the patient is stabilized and did well to continue current care.  However if the patient had any respiratory deterioration then to consider comfort measures.  Patient was extubated on 02/24.  Patient initially was briefly doing adequately well but subsequently started requiring increasing amounts of oxygen, level of consciousness also declined.  Family requested change of plan of care to comfort measures.  These were instituted.  Patient died on 02/25 at 12:09 p.m.   Cause of death was acute respiratory failure.  Secondary to multifocal pneumonia.  Secondary to recurrent aspirations.  Secondary to ALS.  Tobacco did not contribute to the patient's death.
This spontaneous report as received from a nurse refers to a 8 week old patient (unknown gender). On 03-APR-2014 the patient was vaccinated with the first dose of ROTATEQ (Lot # reported as H017721 and exp date 01-APR-2014, 2 ml, oral). No adverse effect reported. Additional information has been requested.
received full dose of Moderna vaccine one month after booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (received full dose of Moderna vaccine one month after booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (received full dose of Moderna vaccine one month after booster). At the time of the report, EXTRA DOSE ADMINISTERED (received full dose of Moderna vaccine one month after booster) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On Mar/2021, the patient received first dose of Johnson & Johnson vaccine (Intramuscular) 1 dosage form for COVID-19 vaccination.  Pharmacist states she and her husband received Johnson & Johnson 1 dose COVID-19 vaccine in March and a Moderna booster last month. They both then received a second full dose of Moderna 4 weeks later.  No concomitant medications were provided.  No treatment medications were provided.
I thought I had allergies. I have asthma and I started to experiencing a cough. About 3 days later, I had a mild sore throat, congestion and a fever of 99. I took a rapid home COVID test and it came back positive. A couple days after that I started to have severe coughing. My fever got up to 102.8. I had a loss of appetite, severe fatigue. On 08/23/2021 I did go to the hospital and my pulse ox was at 92 and I ended up just going home. The following day my pulse ox was in the 70s and 80s so I went to another hospital and they confirmed COVID but because my oxygen level wasn't low enough the did not admit me and sent me home with antibiotics and prednisone. On 08/25/2021 my pulse ox was down to 72 and I was admitted to the hospital. I was on high flow oxygen and my symptoms worsen. After 7 days, I was discharged from the hospital. Once I got home I noticed I lost my taste and smell which lasted about 8. I was also on oxygen from 4-6 weeks post hospitalization. After 2 weeks I was diagnosed with gastroparesis
Patient called 9-17-09 stating she was having itching and slight swelling two hours post getting shot, which went away and two days later she bean to itch again. She states she is leaving for California tomorrow 9/18/09 and is unsure if the reocurring itching is coming from the shot or her nerves. Patient also states she suffers from allergies. She suffers from allergies. Itching is releaved per medication. Encouraged to check with Dr. States she will just take some Benadryl if needed.
This study case was received from the investigator on 21 July 2011. A 20-year-old male subject received on 14 March 2011 the following vaccinations: an injection of ACAM2000 (lot number not reported), Anthrax vaccine (manufacturer and lot number not reported), Typhoid - oral (manufacturer and lot not reported). The subject has no significant medical history. On 29 March 2011, the subject was diagnosed with Non-specific myocarditis. The subject's following laboratory and diagnostic testing were not available: Troponin I, electrocardiogram (ECG), echocardiogram and magnetic resonance imaging (MRI) of the heart. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
I have been sick since I got the vaccination in August 2021. I have had the following symptoms: (Some symptoms are constant and some come and go) -Chronic sinusitis -Hematuria (microscopic & gross) -Systemic inflammation -Heart Palpitations & pain -Daily dizziness -Fatigue -Tinnitus  -Muscle and joint pain -Night sweats -Tingling in hands, feet, and face  -Neck soreness -Scratchy throat
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Pt came in for second COVID shot (with partner/friend) and asked if she should get her second dose at all due to her reaction: she described it as full-body itching and displayed the scars/marks on her neck from excessive scratching and the rash that was there. I advised her to hold off for now. Still itchy as of 28 days later, even with daily Allegra dosing. Also described a skin reaction that sounded a lot like peeling sunburn.
Two days after first injection, experienced significant knee pain (right knee), lasted for two weeks.  Two days after second injection, experienced even worse pain in right knee.  Pain increased dramatically with two weeks.  I had difficulty walking, using stairs, etc.
tired; little soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and MYALGIA (little soreness in the arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (tired) and MYALGIA (little soreness in the arm). At the time of the report, FATIGUE (tired) and MYALGIA (little soreness in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Injection site arm is red, swollen, and hot - started 1 day after administration. 2 days after administration red rash was at its worst.
He has had some cough and rhinorrhea. After the Hepatitis A shot he developed RUQ pain. He was given a candy which he swallowed, but dad did not perceived any choking with this and he did not seem upset when he was eating the candy. (it was a small mint sized fruit candy). On reexam he had wheezes in his lungs in the right base which were not apparent before. He was abdomen exam revealed no guarding but RUQ tenderness. After the neb he had scattered wheezes no further pain. Pulse ox was 99%. Wheezing-?, bronchitis, ? Hep A reaction, unlikely foreign body aspiration but reconsider if worse or symptoms persist. If so get x-ray. Follow up in one week, earlier with concerns.
Visual disturbances (black spots, blurry), lightheaded. Put head between legs for few minutes. Sxs resolved during 1 hour.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history was not reported. On 26-JUL-2016 (reported as today), the patient was inadvertently vaccinated with a dose of PROQUAD and a dose of VARIVAX (lot#, dose, route and site of vaccination were not reported for both). No adverse effects were reported. Additional information is not expected as the reported refused further contact.
nausea, body aches, exhaustion, chills, low grade temp, got dizzy while standing, eyes were going fuzzy and felt as if I was going to pass out.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Medium
Narrative: Vaccinated, not boosted pt admitted for AHRF requiring intubation 2/2 COVID. Extubated but eventually worsened requiring BIPAP. Transition to palliative care and ultimately deceased.
Information has been received from a physician and a medical assistant concerning a pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed erythema, swelling and pain of the upper forearm. Unspecified medical attention was sought. Subsequently the pt recovered. No product quality complaint was involved. Additional information has been requested.
Left deltoid had erythema, was tender and indurated 2 1/2cm X 3 1/2cm with 3 vesicular lesions.
Pulmonary Embolism with Pleural Effusion; Pulmonary Embolism with Pleural Effusion; This is a spontaneous report received from a 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 28Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Concomitant medication(s) included: FLU VACCINE VII, on 14Oct2021 as unk unk, single. Past drug history included: Known allergies: augmentin, reaction(s): "Known allergies: Augmentin". Vaccination history included: BNT162b2 (Dose 02, Lot number: EL3248), administration date: 24Mar2021, when the patient was 41-year-old, for COVID-19 Immunization; BNT162b2 (Dose 01, Lot number: EL3248), administration date: 03Mar2021, when the patient was 41-year-old, for COVID-19 Immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), PLEURAL EFFUSION (non-serious) all with onset 05Mar2022, outcome "recovered with sequelae" and all described as "Pulmonary Embolism with Pleural Effusion". The event "pulmonary embolism with pleural effusion" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of pulmonary embolism, pleural effusion. Clinical course: Yes other vaccine in four weeks. Yes COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up (06Jun2022): Follow-up attempts are completed. No further information is expected.
chest tightness, anxiety.  25mg PO diphenhydramine administered and patient was held for additional 15 minutes and sent home after symptoms resolved.
Client stated she felt light headed and slight throat swelling and itching on left wrist and arm Calming measures, vital signs monitored, Benadryl 50mg @ 1219 pm
I broke out in hives on both my arms and back, shortness of breathe, cough, sneezing, developed cellulitis.
SORENESS IN ARM; This spontaneous report received from a patient concerned an 82 year old female. The patient's weight was 100 pounds, and height was 162 centimeters. The patient's concurrent conditions included osteoporosis, hypothyroid, pollen allergy, alcoholic, and cigarette smoker, and other pre-existing medical conditions included patient did not have any drug abuse/illicit drug use. patient had healthy appetite.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in arm. This report was non-serious.
Moderna COVID-19 Vaccine EUA  Generalized body aches especially back, ribs, and sternum, chills lasting throughout the night, but all dissipated within 24 hours.
I am requesting that your office file this Vaccine Adverse Event Report. Here is my experience regarding Tdap vaccine. Prior tetanus shots (alone and with other vaccines) in the military and locally provided no adverse reactions. 10/27 9:30am. Vaccine administered. 12 noon Had lunch. 2pm Felt tightness in upper digestive tract. 5pm Could not eat supper. Upper tract still blocking digestion. 6pm Went to bed. Slept the night with poor digestion. Had chills and then fever. Did not take temperature. 10/28 Stayed in bed all day and night. Had continuing diarrhea and headache. Very tired not wanting to accomplish anything. No pains or redness at site of vaccination. 10/29 Continuing diarrhea. No headache. Tired, not wanting to accomplish anything. 10/30 Better, still some stomach discomfort. I have checked all symptoms experienced on the yellow sheet attached. This was supposed to be just a tetanus booster. I accepted that Tdap was appropriate. My concern is that this process was just part of a trial for the combined vaccine. Why would it be administered to a 76 year old? Your feedback will be appreciated and that the report was filed. 10/31/11 Call placed to pt, pt feeling better. He would like his symptoms reported.
Patient started experiencing pain and slight itching in the shoulder area the day after his 2nd dose of Moderna. I recommended diphenhydramine for treatment. I recommended that he seek medical treatment if his symptoms get worse and to call 911 or go to emergency room if he starts experiencing any difficulty breathing .  He will follow up on any changes to his condition.
Woke up with body aches and headache. By noon fever of 101.4 - continued throughout Saturday. Sunday full recovery.
Metallic taste immediately after both vaccines; extreme salt taste on tongue 2 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2021 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic migraines" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown., Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 11May2021, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "Metallic taste immediately after both vaccines", "extreme salt taste on tongue 2 days later". The following information was reported: DYSGEUSIA (medically significant), outcome "not recovered", described as "Metallic taste immediately after both vaccines"; DYSGEUSIA (medically significant), outcome "not recovered", described as "extreme salt taste on tongue 2 days later". The events "metallic taste immediately after both vaccines" and "extreme salt taste on tongue 2 days later" required physician office visit. Therapeutic measures were taken as a result of dysgeusia, dysgeusia. Clinical course: Patient was not having COVID prior to vaccination and Patient was not tested for COVID post vaccination. The patient has no known allergies. The patient has experienced Metallic taste immediately after both vaccines, then changed to extreme salt taste on tongue 2 days later. This has not improved at all (it's been over a year). He was told to take zinc on a daily basis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Within 12 hours severe pain in entire body.  9 out of 10. All nerve endings .  After 12 hours of pain had another 12 hours of aching pain and upset stomach and fatigue then the next day felt normal
Fevers x 7 days, up to 102. Body aches, decreased appetite, headache, fatigue. Pt seen in the ER for this today.
This spontaneous report as received from a 67 year old female consumer with a history of shingles from 15-DEC-2012 till March 2013 (it was also reported that patient had none pertinent medical history) reporting on herself. On 21-AUG-2013 the patient was vaccinated with ZOSTAVAX (strength, dose not provided). Concomitant medication include cholestyramine but the patient did not take the day of vaccination. On 22-AUG-2013 the patient was sick, nauseous, had a fever, flu symptoms, body aches, chills, runny nose, huge spot the size of a lemon and skin underneath this area was very thick at the back of the arm at the injection site, could not use left arm and had problems putting on and taking off clothes. The consumer stated that on 22-AUG-2013 at 12 PM, she experienced a sharp pain on the left side of rib underneath the breast and a warming sensation on the back of the arm in which she discovered a huge mark. The patient went to the pharmacist who administered with ZOSTAVAX and saw a nurse practitioner at her physician's office. The patient mentioned she took an unspecified ace inhibitor (manufacturer unknown) that made her cough. Also was reported that an ibuprofen, dose: 800 mg a day, was given as a treatment for adverse event. The outcome of events was reported as not recovered/not resolved. This report is one of 2 reports from the same reporter. Additional information has been requested.
fatigue, deep pain in ears and neck Pt reported fatigue x24 hours and pain in  both ears and neck