chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 5 hours of vaccine booster I had intense pain in left leg and considerable fatigue. The Fatigue was to the extent that I mostly slept all day and all night for 6 days. Ability to sleep needed assistance from 650 mg aspirin and 9 mg Melatonin and leg elevation. When those wore off pain would wake me up. The pain was extreme - making it difficult to sit even long enough to pee. That situation lasted 6 days. On the 7th day fatigue was less and pain not as excruciating. Leg weakness, however, produced falls.  Pain still exists, as of today, making it very difficult to walk for more than 21 footsteps. The leg weakness means I require physical support from sister when going up or down the 3 steps
Received MMRV 6/16/06. Presented at Clinic on 6/29/06 with right sided facial swelling that began 6/26/06. No other symptoms present. Arrived from out of the country approx 6/8 no treatment required.
she was very tired" and patient was "immediately tired"; This spontaneous report was received from an office manager via company representative and refers to a 16-year-old female patient. Her concurrent condition included no allergies to drugs. The patient did not take any concomitant medication. There was no information about the patient's medical history provided.   On 11-NOV-2019, the patient was vaccinated with 1st dose of a 3 dose series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, intramuscularly in the left arm , lot number 1621934, expiration date 29-JAN-2022 for prevention of human papillomavirus infection (HPV) related cancers (exact dose was not provided) in the physician's office. On the same date, as soon as she got vaccine she was very tired and patient was immediately tired. The patient sought medical attention in the doctor's office. No treatment was given to patient and she was only observed. It was also reported that the therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) would be continued.   The outcome of fatigue was reported as recovered on 11-NOV-2019. The causality assessment was not provided.
Admission Date: 7/7/2022 Discharge Date: Jul 10, 2022  PRESENTING PROBLEM: Severe sepsis [A41.9, R65.20] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 93-year-old male who presented due to acute confusion at home.  He has a past medical history of atrial fibrillation, pacemaker placement, essential hypertension, diabetes mellitus type 2 and dementia.  Patient was noted to have an increased cough the day prior to admission.  He was able to get out of bed and use a walker initially without difficulty.  The morning of admission he continued to have a cough and was noted to have nasal congestion.  He was afebrile.  He had episodes of chills.  Family noted he was making statements that were paranoid or confused.  He was brought to the emergency department.  He did not have any sick contacts or known COVID exposures.  In the emergency department, patient was found to be hypotensive.  He was given 3 L of fluid.  There was initial concern for sepsis so he was given Rocephin and azithromycin for possible community-acquired pneumonia.  COVID came back positive.  Chest x-ray was unremarkable.  He likely had generalized weakness due to dehydration and COVID-19 infection.  He was started on remdesivir during his stay.  His blood pressure improved with hydration and holding his blood pressure medications and Lasix.  His weakness improved.  He was able to ambulate independently and be discharged home with family on 07/10/2022.  He never required oxygen during his stay.
Significant soreness in left arm and fatigue the evening of the injection. The fatigue resolved by the next morning; the soreness was noticeably better the next morning and faded over the course of the next day. Additionally, I had some mild chills and body aches the day after the vaccination, which cleared up within 24 hours.
Sensation that moved up my jaw to my neck and then to my brain and head then jaw and neck pain  tingling in my whole  head and brain with pressure. Blurred vision   the the next morning have  facial numbness. Dizziness  vertigo  leg tingling. And pain. While Arm pain in injection side. Pain in side of body with injection     Muscle twitching in injection arm  throat tightness and swelling me coughing   Sinus pain  and headache  tiredness feeling unwell. Felling hot all over
Reports that several hours after receiving the vaccine, she noticed her lower lip was tingling and felt full. Over the next 24-48 hours she developed painful oral lesions on the inner and outer surface of her lower lip. These were fixed lesions; some eroded and crusted over.  Presented to primary care clinic on 31DEC2020 and was diagnosed with HSV. She was prescribed a course of PO valacyclovir and topical acyclovir ointment. All lesions are now fully resolved; however, she reports resulting tingling sensation.  Reports she was feeling well on 12/28 and in the days leading up to the vaccine. No known sick contacts. Denies any previous history of HSV lesions. Reports history of acute Varicella infection in her early 20's.   Suspect this was a reactivation of HSV or VZV triggered by vaccination.
Started with chest pressure, shortness of breath, fatigue,nausea,Headaches, stiffness in front of neck to jaw, mid back shooting pains which lasted for two and a half months.
Patient received a second dose of Fluad on 10/10/21.  He received his first dose on 08/19/2021. Patient has had  no side effects.
She started feeling crummy yesterday, developed chills, body aches and subj fevers. Then noted that her arm was quite red at the site of the injection. This redness has gotten worse today, firm and tender. She continues to feel feverish, chills. Some nausea, but no vomiting. cephalexin  500 mg capsule.
pt smelled a burnt smell & had a dry cough; pt had recvd flu & pneumonia shots;
Pt became flushed with C/O's feeling hot with red blotchy areas on neck. C/O's itching. No C/O's SOB. Signee and patient walked to pharmacy. Staff from pharmacy gave two 25mg Benadryl and signee gave two 325mg Tylenol
Severe hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17May2021 (Lot number: Ew0179) at the age of 39 years as dose 1, single and administered in arm right, administration date 17May2021 (Lot number: Ew0182) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfur" (unspecified if ongoing), notes: Known allergies: Sulfur. There were no concomitant medications. The following information was reported: ALOPECIA (non-serious) with onset 12Jul2021, outcome "not recovered", described as "Severe hair loss". The event "severe hair loss" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.
Approximately 10 minutes after receiving 3 immunizations, the infant became lethargic, decreased tone, half open eyes. Color good, BP 88/60, HR 12. Infant responded to exam and stimulation within 2 minutes, although fatigued, pt experienced hypotonia as well.
Thirty min after Fluzone vaccine, Pt developed swelling to eyelids, hyperemia to face, hives on chest and generalized pruritus.
RUQ AND EPIGASTRIC PAIN 3-4 DAYS AFTER ANTHRAX VACCINE 30 JUN 2015. PAIN LASTED ABOUT A MONTH AND GOT BETTER. 2ND ANTHRAX VACCINE 3AUG2015 WITH RELAPSE OF ABD PAIN FEW DAYS AFTER 2ND VACCINE. EXTENSIVE WORK UP SHOWED DELAYED GASTRIC MOTILITY. QUERY WHETHER ABD PAIN/DELAYED GASTRIC MOTILITY IS 2NDARY FROM ANTHRAX VACCINE. SHE HAS NO PRIOR HX OF ABD PAIN OR DX WITH DELAYED GASTRIC EMPTING.
35 minutes post vaccine, felt light-headed, dizzy, itchy throat, tingly body.  O2 @ 2 L NC, lay down, drank water. VS monitored- stable VS. 18:45 continue with symptoms, throat scratchy, face swelling- Benadryl 25 mg PO. By 19:30 she was improved and discharged home to mom. 1/8/21- work up a bit dizzy, nausea. 1/11/21-still with nausea, dizzy- Referred to manager to complete assessment for COVID symptoms. 1/14/21- Per PMD, getting COVID tested, quarantine for 10 days.
When patient returned home stated he had difficulty swallowing, tightness in throat and thick heavy phlegm - body aches, fever, AA flushing watery eyes, no reaction site effects less than 8 hours felt better no treatment.
On 11/1/01, pt experienced cellulitis of the entire right arm. Therapeutic measures taken as a result of this event included prescription of clindamycin and Diphenhydramine. The pt had not recovered at the time of report. The reporter has assessed the relationship of the study medication to the event as possible.
Pt recv vax on 12/10/98; on same day pt exp blue lips, shaking, unresponsive, wheezing
Client reported redness at the site of injection, warmth to touch with slight itching. Advised to use ice pack to sight and take Benadryl.
On 8/25/22 resident c/o not feeling well, unable to perform normal activities due to lethargy, Temp 101.9, Pulse rate 144, c/o body aches. On 8/26/22 symptoms improving.
about 1/2 hr post vax pt thigh was swollen & baby was screaming crying for awhile- was taken to PMD- temp 99.5 degrees ( father's hx)
Development of cellulitis in left arm. Redness,  swelling and burning sensation. Area hot touch.
By 11:30pm started with severe chills, maybe had fever, severe headache that lasted for several hours, severe nausea but did never threw up; did not sleep all night or next morning. The headache was so severe that even eyes hurtfelt like her head was going to explode.  Patient considered calling ambulance but knew that it was not an anaphylactic reaction. Did not want to scare mom that was in the other room so at 8am called her to bring some aspirin.  Symptoms improved 3-4 hours after taking medicine; slept from 12pm to 7pm.   After headache was gone could walk but weakness lasted for the next 2-3 days. Patient did not take any other medication. Spoke to pharmacist about the adverse event and was encouraged to call VAERS; pharmacist mentioned that had another patient reporting similar symptoms.  Mother and brother-in-law had no symptoms and sister had severe headache but nothing like patient's. Patient had severe chickenpox in childhood and shingles episode at 42 years
This literature marketed report has been received from authors of the literature article entitled as stated above and refers to a 52-year-old African American female with end-stage renal disease on dialysis with a medical history of obesity, obstructive sleep apnea, antiphospholipid syndrome, bilateral pulmonary emboli, and multiple deep venous thrombosis presented to the dialysis unit with 5 days of headache, myalgia, and progressive shortness of breath. No information regarding the patient's reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with Hepatitis B vaccine (recombinant) (manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient had not mounted an antibody response. The outcome of the event was unknown. The author considered the event to be related to suspect vaccine. This is one of two reports derived from the same literature article. A copy of the published article is attached as further documentation of the patient's experience.
Swelling to elbow, redness, warm to touch, painful. Benadryl: warm compresses.
12 hrs after Tdap, MCV4, and HPV #2 were given, patient had a generalized tonic clonic seizure at home, lasting less than 5 minutes. Pt. evaluated in ER and found no abnormal labs, normal CT scan of head.
Received at approximately 2:30pm. At just after midnight following vaccine, woke up and had what appeared to be Vertigo/dizziness.  This has not completely gone away since onset on 1/21/2021.  I began having "floaters" in my vision beginning about 8am following vaccine.  This has not gone away.  I did have a bout of vertigo in January 2020, that had not reoccurred since that time.  I have not had "floaters" prior to the 2nd dose of the vaccine.
bad armpit pain; the site of the shot is still hot; my arm pit is swollen; This spontaneous case was reported by a patient and describes the occurrence of AXILLARY PAIN (bad armpit pain), VACCINATION SITE WARMTH (the site of the shot is still hot) and SWELLING (my arm pit is swollen) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced AXILLARY PAIN (bad armpit pain), VACCINATION SITE WARMTH (the site of the shot is still hot) and SWELLING (my arm pit is swollen). At the time of the report, AXILLARY PAIN (bad armpit pain), VACCINATION SITE WARMTH (the site of the shot is still hot) and SWELLING (my arm pit is swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow-up information received on 30-MAY-2021. Patient reported that her armpit is still very sore, and the place where she had the shot is still very hot.
Information regarding Prevnar was received from an investigator concerning a 4 month old male participant in a study who experienced transient neutropenia. The participant received a dose on 4/30/01 at 3 months of age. The patient's concurrent illness includes a febrile illness. The indication for Prevnar was immunization. The product was administered on 4/30/01 and the patient received 1 dose. Concomitant medications were not reported. On 6/17/01, the patient was hospitalized with transient neutropenia. Relevant lab tests were not provided. No additional information was available at the time of this report. The investigator considered neutropenia possibly related to the study product. The medical monitor considered neutropenia related to the patient's febrile illness and not related to the study product.
10/22/2014:  Shot administered by pharmancy. 10/22/2014:  Begining experiencing usual and severe pain within 3 days. 10/29/2014: Returned to pharmacy to find out why so much pain in shoulder and down arm. 11/03/2014:  Went to doctor and told about severe pain:  Checked mobility and prescribed Steroid pack and Trodal: No relief or help from medicine. 11/11/2014:  Returned to doctor and told him I need a referral for a MRI, which I am waiting on now. Doctor prescribed:  Meloxicam and Tramadol/APAP 37.5mg / 325 MG tab.  THESE PROVIDE NO RELIEF. 11/12/2014:  Called doctor and left message that MRI cannot see me till Monday 11/17/14 and I could not wait that long living with this severe pain.  Have not heard back yet. 11/13/2014:  Still living with severe to almost unbearable pain in left shoulder down to fingers. I have limited mobility in my left arm:  Daily activities are almost impossible if my left arm is needed. I cannot lift anything higher than chest high. I cannot open a kitchen cabinet door and take down a bowl with my left arm.  Getting dressed is nearly impossible with assistance.  Washing my hair, blowing my hair, and putting on makeup is a real chore and I experience high level of pain doing it.  Sleeping is nearly impossible because i can't find a position to place my arm that is pain free. It seems that while in bed I experience the most pain. I cannot put the telephone on my left shoulder and hold it with my head, this is totally impossible because I drop by phone and bend over in unbelievable pain. I have to pick my arm up with my other arm to position it when I am working or in bed. I have had a flu shot every year for probably 6 years and have never experienced anything other than a couple of days of being sore. This is the worse pain I have ever had and I need to get this fixed so I can have my life back.  I hope this will help you all find a way that this does not happen to any other person. If you need any other information, please call me.
Patient  woke up scratching on arms and legs.  He had Hive about 3cm in diameter
The shot was given to me extremely high on my arm and burned really bad.  I have never experienced burning like this and I get a flu shot every year.
I received a second dose. The vial was punctured more than 12 hours since opening.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I received a second dose. The vial was punctured more than 12 hours since opening.) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (I received a second dose. The vial was punctured more than 12 hours since opening.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I received a second dose. The vial was punctured more than 12 hours since opening.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported.   Reporter did not allow further contact
4x5 cm of swelling, redness & tenderness around inject site lt anterior thigh;
ARTHUS REACTION:  swelling of upper left arm (injection site), fevers, muscle aches and stiffness all over the entire body, mental fogginess, followed by muscle spasm.
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 52-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EM9809), in right arm, on 01Apr2021 as dose 2, single (Lot number: ER8727), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: EN0182), in right arm and on 10Apr2022 as dose 4 (booster), single (Lot number: IK9895), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: High BP; "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; LISINOPRIL; HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 09Jun2022 to 13Jun2022. Clinical course: The event did not result in any other seriousness criteria.  No follow-up attempts are possible. No further information is expected.
Patient received 3 doses; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a adult unk patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of shingrix on an unknown date.) and Shingrix (Received 2nd dose of shingrix on an unknown date.).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follow: The case was reported by other health professional. No patient information was provided in this case. The patient received 1st and 2nd dose of shingrix on an unknown date. The patient was administered with 3rd dose of shingrix which leads to extra dose administered. The healthcare professional did not reported side effects. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021079379:Same reporter
Hours after high dose vaccine given patient began to feel achy in whole body, then she felt jaw tightness and experienced difficulty speaking. This lasted about 2 1/2 weeks. Has had regular dose last 16 years with no problem.
12 month old infant developed general ecchymosis unrelated to trauma, followed by spontaneous mucus membrane bleeding.  Evaluated in Emergency Department with platelet count of 3,000.  Work-up confirmed ITP.
numbness in right arm initially and then in her left arm.; High Blood Pressure; Achy; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (numbness in right arm initially and then in her left arm.), HYPERTENSION (High Blood Pressure) and MYALGIA (Achy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in right arm initially and then in her left arm.), HYPERTENSION (High Blood Pressure) and MYALGIA (Achy). At the time of the report, HYPOAESTHESIA (numbness in right arm initially and then in her left arm.), HYPERTENSION (High Blood Pressure) and MYALGIA (Achy) outcome was unknown. Not Provided          Patient visited her doctor and doctor asked her to get tested for some blood work.  The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
In December I started having issues with red lesion's on my left thigh then to my right thigh. The doctor took a skin sample and they found that I have Sirius/eczema. It has now spread to my back and my forearms and the back of my triceps. The doctor prescribed some creams were a low dose cortisone. My eye doctor told me I should discontinue it because I have a eye condition. Tacrolimus is the name of the cream I was given. I think the creams are helping and then out of nowhere I will have a weird reaction somewhere else on my body. Calcipotriene cream is another ointment that I have been instructed to use as well. The medicine the doctor wants me to stop taking triamcinolone.
Took first dose of Vivotif with food; Spontaneous report received on 13DEC2019.  A pharmacist reported that a male consumer who "took first dose of Vivotif with food" (PT: Product administration error), while being on Vivotif for immunization. On an unknown date, the consumer took first dose of Vivotif with food. Action taken with Vivotif with respect to reported event was not applicable. Outcome of the reported event was unknown.  Company Comment: A consumer took first dose of Vivotif with food (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif with food (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.