chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Evaluated patient in Covid vaccine clinic after alerted that patient developed severe occipital headache about 10 minutes after his 2nd dose of Moderna Covid vaccine.   He denies any history of headaches.   He denies any other symptoms.   No nausea, no vision changes, no numbness or weakness.   No swelling, itching, rash, no shortness of breath, dizziness, or abdominal symptoms.   He denies side effects from his 1st Covid vaccine.    He denies a history of significant health problems and states he takes no medications.     Exam revealed a middle aged male sitting comfortably in NAD.  Alert and oriented x3    PERRL, no photophobia, EOMI, CNs grossly intact.  RRR without murmur.  Neuro exam without focal deficits.   Normal gait.   Patient was monitored for about 20 min at which time he felt he could safely drive himself home - 4 blocks down the road.   He was instructed to take some Tylenol when he gets home and rest.   Call 911 in the event of numbness, weakness, vision changes,  dizziness, slurred speech or other severe symptoms.    He is supposed to work and plans to call in sick so he can rest.      I did mention his elevated BP which is probably isolated but he should make an appt with his PCP for a recheck of his blood pressure.     Vitals BP=157/94; Sitting Temp=97.1 F Oral; Pulse=76; Resp=20; Vitals Comment: SaO2 96% 3/31/2021 2:20 PM by  MD
I started getting symptoms of scratchy throat on 5/16/2022. The next day I had a runny nose and fever with chills. I got a positive at home COVID-19 test. I did a virtual visit with my doctor and was prescribed Paxlovid. I did develop a cough as well. Most all other symptoms have went away expect low grade fever, cough, and sinus issues.
Within minutes of administering the dose the patient became very nauseous and vomited.  Patient said he was still nauseous when they left about 30 minutes later.  Dad carried him to the car because he was unstable and was having trouble keeping balance.
Left arm aches. Massaging feels good. Started after getting the vaccine. Pain from left shoulder to left hand.
Before giving the vaccine the patient filled out a questionnaire answering "No" to all questions on form.  However she warned me to say she is afraid/dislikes shots. After giving the vaccine by about 5 minutes patient shouted "help me, I am about to pass out". I ran over to her, told my tech to call 911, laid her on the floor and lifted her legs up unto the chair. She was breathing fine but was perspiring. She told me as she lay on the floor that this has happened to her before (an episode at her Doctor's office before a procedure she was having where she fainted & even vomited). She also stated that she believes her blood sugar dropped because she has not eaten all day. Fire department & EMS arrived quickly on the scene after about 5 minutes. Only symptoms patient experienced include, nervousness, shakiness, sweating, feeling faint.
Rotator cuff tear; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of ROTATOR CUFF SYNDROME (Rotator cuff tear) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for an unknown indication.    Concurrent medical conditions included Uterine cancer. Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.   On 04-Feb-2021, the patient started LENVATINIB MESILATE (LENVIMA) (unknown route) 20 milligram once a day. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (Rotator cuff tear) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ROTATOR CUFF SYNDROME (Rotator cuff tear) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication were provided.   This case was linked to MOD-2021-112220 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Initial additional document was received on 07-MAY-2021.It contains identification number and follow up AER number. It contains non significant information.
MD called stating pt recvd flu shot approx 11AM 10OCT92 & @ approx 130PM exp dizziness, passed out, hit head & went to ER for suturing of laceration on head; while in ER, dizziness did not resolve;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jul2021 as dose 1, single (Lot number: EW0198), in right arm, on 26Jul2021 as dose 2, single (Lot number: EW0198), in right arm and on 27Jan2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 15 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Common Variable Immune Deficiency" (unspecified if ongoing), notes: Common Variable Immune Deficiency. Concomitant medication(s) included: IMMUNE GLOBULIN subcutaneous, start date: 02Feb2022. The following information was reported: COVID-19 (medically significant) with onset 13May2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Antiviral details: The patient received treatment product: COVID 19 Treatment (Paxlovid). Treatment start date: 04May2022 and stop date: 09May2022. Indication is used for treatment of COVID-19. administrator route: Oral. The patient had no known allergies. Other medications in 2 weeks Immune globulin, Xembify and administrator route: Subcutaneous. Reported Event Patient completed course of Paxlovid then experienced rebound symptoms. The patient not received treatment.  No follow-up attempts are needed. No further information is expected.
Itchy; chills; Nauseous; Slight headache; This is a spontaneous report from a contactable consumer (her self). A 49-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration (Lot Number: EN203) as single dose for covid-19 immunisation. Medical history included asthma, allergy, bipolar, high cholesterol, obesity, low thyroid and allergy to penicillin. The patient's concomitant medications were not reported. The patient previously took aripiprazole (ABILIFY) and lithium and experienced drug hypersensitivity. On 24Feb2021 14:00, the patient experienced itchy, chills, nauseous, slight headache. There was no treatment for the events. The outcome of the events not recovered.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with "at least one dose" of GARDASIL. The physician reported that on an unspecified date, when a Pap smear test was done, the patient had an abnormal result. The patient sought the physician for medical attention. At the time of the report, the patient's outcome was unknown. The physician stated that the patient will continue with the GARDASIL series. Additional information has been requested.
Got shot at 1:30pm. At 7:30 pm got very tired. Went to be at 8pm. Chills, headaches body aches, very tired
22 days after receiving influenza vaccination patient complaining that left upper arm is still sore - especially at night if trying to sleep on left side - arm feels "heavy" in the morning. There is no swelling or redness seen. Client has not received any treatment for condition. Stated she has had flu shots in the past but the pain has never lasted this long. Pain is not getting worse but it is not getting better. Writer encouraged client to follow up with her medical provider if pain does not start to improve soon.
The first two days I had a fever, nausea, headache, and fatigue.  After a week, a hard, hot, itchy, and painful rash showed up on my arm.  The first day it was just one about 2 inches in diameter but by the second day two more smaller dots showed up around it.
SEVERE BODY ACHE; CHILLS; SEVERE HEADACHE; FEVER; FELT EXHAUSTED; FELT WEAK IN FIRST HOUR; HEAVY CONGESTION IN HER SINUSES; LIGHTHEADED IN FIRST HOUR; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 28-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 28-MAR-2021, the subject experienced heavy congestion in her sinuses. On 28-MAR-2021, the subject experienced lightheaded in first hour. On 28-MAR-2021, the subject experienced felt weak in first hour. On 28-MAR-2021, the subject experienced felt exhausted.  On 29-MAR-2021 01:00, the subject experienced severe body ache. On 29-MAR-2021 01:00, the subject experienced chills. On 29-MAR-2021 01:00, the subject experienced severe headache. On 29-MAR-2021 01:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, severe body ache, chills, fever, heavy congestion in her sinuses, lightheaded in first hour, and felt weak in first hour, and the outcome of felt exhausted was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comments not required as per standard procedure, as the case is assessed as non-serious.
I had my Shingrix vaccines one month apart; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had Shingrix vaccines one month apart, which led to shortening of vaccination schedule. The reporter asked if that was dangerous.
10x7 cm area of erythema, induration tenderness, and urticaria at vaccine administration site. Pt afebrile - local reaction only.
p/vax pt devel  inj site rxn characterized by swelling, erythema, pain & warmth that extended to elbow;pt was seen by MD on 12/11/98;swelling & erythema  resolved;lt elbow & bursa swollen, painful & erythematous;dx cellulitis vs allerg reac
1/27/21 @ 10:40 PM: Client stated after injection, her left arm, shoulder, and fingers started to tingle with some numbness.  Client stated today she has a fever (100.1), with nausea and still has mild tingling to left arm, shoulder, and fingers. Client stated she did not informed PCP, but was told to call PCP for advise prior to next vaccine dose.  Client was agreeable.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: I checked in with her, she first said her throat felt scratchy. I asked if it felt tight. So I got her some benadryl, gave her 2 25mg tabs. Then checked in with her in about 5 minutes, she said she felt better. Had her sit around for longer. About 5 minutes later asked again how she was feeling and she said she felt better and that the feeling her throat all went away and she was feeling good to go.
I had deep vein thrombosis and a pulmonary embolism. I went to the emergency room and was admitted to the hospital for a thrombectomy. I stayed in the hospital for two days and now I'm anticoagulation therapy and blood thinners.
Feeling weird; Laying down with Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling weird) and CHILLS (Laying down with Chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and HYDROXYZINE for an unknown indication.   On 02-Nov-2021 at 7:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Laying down with Chills). On 03-Nov-2021 at 9:30 AM, the patient experienced FEELING ABNORMAL (Feeling weird). On 04-Nov-2021 at 6:30 AM, FEELING ABNORMAL (Feeling weird) and CHILLS (Laying down with Chills) had resolved.            The patient stated didn't feel normal until Thursday morning 6:30 am. No treatment medication reported by reporter.   This case was linked to MOD-2021-375327, MOD-2021-375339, MOD-2021-375342 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up information received on 08/Nov/2021: Added patient race and demographics. Added concomitant products.
Pt developed tingling/numb feeling of lips, tongue felt "thick", feeling weird to swallow about 10 minutes after receiving vaccine. Felt dizzy/lightheaded, but attributes alot of this to increased dose of gabapentin, although it did seem worse than before.  She was roomed in clinic and vitals monitored. She had no worsening symptoms and this sensation had resolved within approx 30 min.
she went to the ER complaining of pain in head and was diagnosed with a sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (she went to the ER complaining of pain in head and was diagnosed with a sinus infection) 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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SINUSITIS (she went to the ER complaining of pain in head and was diagnosed with a sinus infection). The patient was treated with PREDNISOLONE for Adverse event, at a dose of 5 pills. At the time of the report, SINUSITIS (she went to the ER complaining of pain in head and was diagnosed with a sinus infection) outcome was unknown.            Patient had reported of visiting the ER, a week ago, complaining of pain in head and was diagnosed with a sinus infection and was treated with 5 pills of Prednisone Patient also wanted to know how long does she needs to wait for receiving her Booster dose of vaccine.  Concomitant product use was not provided by the reporter.   Reporter did not allow further contact
03/10/22 presents to ED for "Chest pain". PMHx of "HTN, HLD, hypothyroidism, COVID-19 infection in December 2021BPH, anxiety, opioid dependence"
7 days after injection, experienced delayed injection site swelling, redness, and itching. Symptoms are a minor discomfort.
Infra clavicular lymphadenopathy noted on 12/21/20. Followed by supraclavicular lymphadenopathy noted on 12/30/2020. Since I have extensive family history of brear cancer and lymphoma I got lab work and a CT scan with contrast of my chest and neck.  Labwork (cbc, cmp, ana, crp) was normal. Peripheral smear showed increased in Roloux phenomenon. CT showed unilateral generalized lymphadenopathy on axillary, infraclavicular, supraclavicular and cervical region. With some noted measuring > 1cm.
On 11/5/05, developed fever 103.5, swollen left arm, stiff neck for 2 days, severe body aches and headache for 1 day. Was unable to attend work on 11/7/05 because of pain, discomfort and stiffness.
Patient was given vaccine and 10 minutes after , while patient was waiting for her form, she started to feel dizzy , lost consciousness , and slumped down to the floor.
Bells Palsey / side face paralysis from eye to mouth; This case was reported by a other health professional via call center representative and described the occurrence of bell's palsy in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   In November 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). In January 2020, between 1 and 3 months after receiving FluLaval Tetra 2019-2020 season, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved.   It was unknown if the reporter considered the bell's palsy to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received flu vaccine which was believed to be Flulaval quadrivalent in January 2020 experienced bells palsy and also had left side paralysis from eye to mouth. The reporter mentioned that, patient went to emergency room when symptoms developed. The reporter did not had any additional information about medical healthcare. The reporter consented to follow up.
This spontaneous report was received from a nurse via a company representative concerning a 59 year old male patient with diabetes. On 17-FEB-2014 the patient was vaccinated with PNEUMOVAX 23 lot # H014196, expiration date 19-MAR-2014 dose 1, intramuscular in the arm. The nurse reported that the patient developed an injection site reaction described as a cellulitis from the top of the arm to the elbow within 12 hours of vaccination, on approximately 17-FEB-2014, with the first dose of PNEUMOVAX 23. The patient was treated with KEFLEX and the patient was currently recovered. The nurse requested a lot check. Additional information has been requested.
16 year old received 1st dose of vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received 1st dose of vaccine) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received 1st dose of vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received 1st dose of vaccine) outcome was unknown. Not Provided      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.   Concomitant product use was not provided. No treatment was reported.
About a week after started saying he wasn?t feeling 100% but couldn?t tell me why- then a couple days after started with harder time breathing, fatigue and no energy..went to PC, who ran tests then sent to cardiologist who ordered tests and day before he was to get treadmill he hyperventilated, passed out and 911 called. In ICU for 4-1/2 days had emergency ablation to remove several large blood clots pushing on heart. Blood clots started in his l leg went into chest and lots in lungs.
No adverse event reported; but a vaccine error was made. Vaccine was administered 47h 15m after being brought to room temperature, exceeding the manufacturers 12h limit. Moderna was contacted for guidance and vaccine activity was confirmed; vaccine not re-dosed.
rash started 12 days after second COVID19 vaccine. unknown if related to vaccine. started prednisone taper
Patient experienced a headache on & off day 5 & 6 after receiving the vaccine & was very tired with a lack of energy.  She was still tired as of 8 day after the vaccine.  She experienced some joint pain  (different than she had before) in the knee that was previously operated on.  She also had some muscle pain related to that joint that was different.  She took a COVID test which was negative.
pt standing-fell to the ground hitting back of head on a table-unresponsive x approx 30sec;extremely diaphoretic, pale/dusky in color;BP 74/48;pulse 60 et weak;resp 12 labored;given epi;c/o lightheaded et dizzy;amb dispatched;
booster; experiencing a flare up; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (141003).  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization; Bnt162b2 (Dose number: 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "experiencing a flare up". Therapeutic measures were taken as a result of condition aggravated.  Additional information: Patient reports prior and worsened since xeljanz: discouragement and depression at times. reports new: missed 1 week of therapy prior to receiving covid booster vaccine. no adverse events due to the missed dose. MD discontinued xeljanz due to increased flare ups, however patient was s still taking and finishing up the supply on hand. Currently experiencing a flare up and on prednisone 15mg daily.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up activities closed. Batch/lot number not available
Injection given 3/4/08-within 24 hours, she complained of fever, weakness, vomiting, and severe dizziness. Was also given a PPD that day Parkedale Pharmaceuticals Lot # 44608 exp 4/09.
Had a localized red, painful, hot to touch about 2 inches below injection site.  No fever.  No treatment given (patient notified us after had resolved).  Reported to us 10/15.
Headache forehead, nausea, stiff neck. Stiff neck, pain at base of skull and nausea became worse. I am still experiencing all the adverse effects on 9th day.
Tdap vaccine administered on 10-5-11. Patient began to experience swelling that evening. When clinic contacted on 10-7-11, patient experiencing soreness/severe swelling encompassing entire forearm. Also tingling in fingers due to compression of nerves, pt advised MOTRIN (2) 4x's a day for next several days.