chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom?s blood pressure dropped and she passed out while in the shower, she was revived by care helper and passed out a second time.  Home nurse and EMT noted a pulse of 30.  She was stabilized,  taken to ER where her vitals returned to normal.  However she was admitted and kept for two nights in order to perform tests because she was so weak she could not stand on her own.
Pt woke up next day "freezing to death", nausea, headache in right temple, fever of 102F.
About 45 minutes after vaccination. patient noted "dizziness" and some difficulty walking. She noted she has had similar vertigo symptoms with previous URIs. Mild nystagmus noted on physical exam. Epley maneuver was performed that resulted in the marked improvement of symptoms. She was counseled to rest and stay hydrated. Fiance will accompany her home. Counseled that if symptoms persist or worsen to seek further medical attention.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: Gl0446), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 21Feb2023 to 26Feb2023.
Systemic: Hypertension-Severe, Additional Details: Approx 90 min post injection pt returned with "swimmy feeling" in head; dz;difficulty in walking.  In staff EMT recorded bp 120/110; advised er or clinic.  Pt went to er and was told injection prob not the cause given med and released.  I spoke to pt following day and she said hospital thought vaccination not the primary cause and advised pt to see family physician.
Pt recvd 3 doses of Engerix-B vax & 29SEP91 it was determined that pt did not respond to the vax series;
This serious case was received on 21 April 2009 from a health care professional. A 29 year old female patient received YF VAX (lot number UF428AA) subcutaneously in the left arm on 26 January 2009. Four weeks prior to administration of YF VAX the patient received TYPHOID VACCINE (manufacturer and date not known). On 27 January 2009 at 5:00 AM the patient developed chest pain. She was admitted to the hospital for three days, dates of hospitalization were not provided. Pericarditis was ruled out and the chest pain was described mid substernal which was sharp but without radiation. The patient did not have nausea, vomiting, palpitations, or shortness of breath associated with the chest pain. The patient self treated with ADVIL pre hospitalization which was effective. The patient returned for follow up on 06 February 2009 with no further episodes of chest pain at that time. The patient was reported as recovered. The recovery date was not provided. List of Documents held by Sender: None.
***8 days after covid booster on 11/05:  began experiencing vertigo, nausea, vomiting; currently ongoing  within 24 hours of vaccines:  headache, pain at injection site, nausea, vomiting, chills, diarrhea, feeling unwell, lack of appetite, redness                                                                   on arm of flu vaccine
Developed pain in the left lateral, posterior shoulder 3 weeks after the flu shot.  No redness, bruising or swelling noted.  Followed up in Urgent Care and was prescribed with a course of therapy.  Use Ibuprofen. Continues to have aching in the left upper arm.
Swelling (3.5 cm x 4.5 cm) and redness (9 cm x 5 cm) to (L) Deltoid. Onset: 7-29-2017.
shingles outbreak right hip. Last shingles outbreak 10 plus years ago. Have received the shingles vaccine
The pt complained of soreness and a "silver dollar sized" induration on left arm. No fever but the site was warm to the touch. The Grandmother called "Ask a Nurse" and gave Tylenol and cold pack. The following day the babysitter reported the child had no appetite and vomited one time. The pt complained of headache, decreased appetite. The pt was taken to the ER and diagnosed with "sinus infection". Follow up reports that child is much better.
Rash pruritic; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 28-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for painful itching rash (rash pruritic). The outcome of the event was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information was received on 22-DEC-2020 from a Licensed Practical Nurse via medical records concerning a patient of unknown age and gender who had risk factor for hepatitis C. On 28-AUG-2015, the pt. was vaccinated with zoster vaccine live (ZOSTAVAX) 0.65 ml subcutaneously in left arm (lot # L015416 with expiration date of 01-AUG-2016 with sterile diluent with expiration date of 15-MAY-2016.
Fatigue, Brain Fog, Lethargy that doesn't go away, becoming SOB more quickly, was fit and active and now it's harder to be active and fit as I was ever since the vaccine no treatment because no one takes these complaints seriously
lump behind left ear; lymph node swelling; body ache; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (lump behind left ear), LYMPHADENOPATHY (lymph node swelling) and PAIN (body ache) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Cancer surgery of the ear cartilage.) in January 2021.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced EAR SWELLING (lump behind left ear), LYMPHADENOPATHY (lymph node swelling) and PAIN (body ache). On 15-Mar-2021, EAR SWELLING (lump behind left ear), LYMPHADENOPATHY (lymph node swelling) and PAIN (body ache) had resolved.        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.   Treatment reported as self-administered: acetaminophen and ibuprofen. No concomitant medications reported.   This case was linked to MOD-2021-067506 (E2B Linked Report).; Sender's Comments:  MOD-2021-067506:2nd dose US-MODERNATX, INC.-MOD-2021-067506:1st dose case
Pain at injection site lasting 2 days Fatigue Headache Nausea Vomiting Diarrhea  Chills Fever
I began feeling extremely tired and beating-up. Then I started to have stomachaches for about 2-3 days. For those days, I ate easily-digested food like chicken soup and took stomach medicine like Pepto Bismol. After 3 days, I was feeling better, gained my strength back and no more stomach issues.
Rheumatoid arthritis flare up; Common cold/ Bad cold; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4240188-00 (AbbVie).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single and intramuscular (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up"; NASOPHARYNGITIS (non-serious), outcome "recovering", described as "Common cold/ Bad cold". The action taken for adalimumab was unknown. The reporter's causality for the event(s) of BAD COLD and rheumatoid arthritis flare with HUMIRA(ADALIMUMAB) was no reasonable possibility. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for the event rheumatoid arthritis flare up with BNT162B2 was possible. The reporter's assessment of the causal relationship of the bad cold with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
TEMPERATURE EXCURSION OF 4 UNPUNCTURED VIALS AT 19.4 DEGREES FOR PERIOD OF 2 HOURS; 8 DOSES GIVEN FROM THOSE INCORRECTLY STORED VIALS; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced 8 doses given from those incorrectly stored vials. On 03-JUN-2021, the subject experienced temperature excursion of 4 unpunctured vials at 19.4 degrees for period of 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion of 4 unpunctured vials at 19.4 degrees for period of 2 hours and 8 doses given from those incorrectly stored vials was not reported. This report was non-serious.
pt recv vax 1APR97 & 9APR97 pt devel a red rash around inj site that consisted of very tiny bumps that were itchy;it was reported that pt did not devel a rash on any other part of body;
Information has been received from a health professional concerning a male who on 18-APR-1996 was vaccinated with a dose of Varivax (Oka/Merck). Subsequently the patient experienced a generalized rash with 50-200 lesions. Unspecified medical attention was sought.  Follow-up information from a health professional indicated that no further information was available. Additional information is not expected.
diagnosed with COVID 19; diagnosed with COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: Caller mentioned being immunocompromised. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with COVID 19". Therapeutic measures were taken as a result of suspected covid-19. Clinical course: Patient called to ask a question her doctor could not answer. Patient was triple vaccinated but was recently diagnosed with COVID 19 and was prescribed with Paxlovid because patient was a high-risk patient. Patient mentioned being immunocompromised and wanted to get a fourth dose of a COVID vaccine. Patient queried whether Paxlovid will interfere with the fourth dose of vaccine. Patient finished the treatment course yesterday (day before reporting) and that was aware that between receiving treatment with monoclonal antibodies and receiving a dose of the COVID 19 vaccine there was a waiting period of 90 days, so patient wanted further information. No further information of the vaccine was given.  The lot number for bnt162b2 was not provided and will be requested during follow up.
9 days after my Moderna booster I got itchy on my hands and feet. It got worse to full blown hives and a rash. I went to urgent care and got on a steroid. The hives got better but not gone after the steroid. Approx Day 2 after steroid hives came back. Very uncomfortable . I also had burning and really red ears. Saw a doctor and allergist and am currently on Zyrtec and Allegra.
Paresthesias of arms and knees concern for vaccine reaction vs GBS  Brain/cervical unremarkable via MRI    Spinal tap not c/w with GBS. Headache
diarrhea & rash on face are reported in a pt receiving 1 dose of fluogen on 4NOV93; 2-3 days following pt exp diarrhea & a rash (pinpoint bright red dots) on the skin around the eyes which abated the next day
On 1/12/21 (5-6 days after receiving the 2nd COVID vaccine) I began to feel new onset heart palpitations/arrhythmia. After 3 days of symptoms throughout the day, I saw my PCP on 1/14/21, who diagnosed them as PVCs. Labs for CMP and thyroid were taken and normal. We agreed to watch symptoms and wait; they came and went but happened at least three times a week for the next several weeks. Had regular physical on 4/9/21 and symptoms still present. PVCs became daily occurrence by mid-May so PCP ordered Zio Patch to be placed to monitor heart rhythm. Zio patch was placed on 6/24/21 and worn for 9 days until 7/2/21. Zio device/monitor is currently undergoing reading and interpretation of results. PVCs occurring multiple times daily
I developed Bells Palsy 10 days after Pfizer booster on November 16.  I received the booster on November 6th.  Doctor has me on an anti-viral and steroids.  I started the anti-viral on Nov. 17 and the steroids on Nov. 18, 2021
Went to Emergency room on 12/28/20 because he was short of breath.  Tested positive for COIVD_19 and was admitted with hypoxia.
Dizziness, R side chest pain radiating to R side of neck and R arm. Evaluated by EMS, cleared.
reports symptoms started 45 minutes after injection that included headache, SOB, wheezing, throat feeling like it was going to close.
Pt's hands & feet became cyanotic w/some edema present 9JAN91, was lethargic; No redness or tenderness @ site of inject, no temp or continuous cry;
Fever of 103/104 extremely lethargic. Could not eat. Arm swelled and was extremely itchy. This lasted for 3-4 days.
The Pfizer COVID-19 Vaccine vials were reconstituted with 1.6mL vs. 1.8mL of normal saline.  This resulted in the patient receiving 33mcg of active vaccine component in the 0.3mL dose instead of the EUA labeled 30mcg.  This has been disclosed to the  DOH and the patient.  Patient reports feeling fine, no adverse side effects.  Reporting through VAERS is required by the  DOH given the increase in dose administered.
Case number PHEH2013US025310, is a spontaneous initial report received from a physician on 05 DEC 2013 with a follow up  received on 18 FEB 2014. This report refers to a 59-year-old female patient. Her medical history and concomitant medications were not reported. She had no prior vaccinations. It was reported that she was inadvertently administered only MenCYW-135 liquid (batch number X12104) intramuscularly into the right deltoid on 04 DEC 2013 and did not receive Men A lyophilized conjugate. The reporter stated that she did not experience any adverse event due to the maladministration (inappropriate preparation of medication). Two weeks later she was vaccinated with full MENVEO (batch number not reported). Follow  up received from physician on 18 FEB 2014. Updated patient demographics (date of birth and age), site of application of MENVEO and reporter comment.
Rash on chest, 2 near syncopal episodes alond with  fever and bodyaches all occured about  24 hours after vacinnation.   one week later hair stated falling out.  employee com[plains of daily fever and continued hair loss. as of  10-1-2021
Patient presented to office today (08/08/2016) to report that she had an adverse reaction to her vaccine. She states that starting approximately 48 hours following her vaccine that she had fever (103 degrees F) with muscle/joint aches and neuropathy (burning pain to her skin) to her extremities and trunk. She describes the pain as severe enough to take ibuprofen for this consistently. The fever resolved within a day. The neuropathy to her extremities has also resolved and the muscle/joint aches are lessening. Her neuropathy to her trunk continues but is slowly improving.
Lump in thigh about three inches in size with a visible rash and itchiness. Diarrhea. Rash and itchiness still prevalent today (two days after vaccine).
Pt with h/o Asthima here with c/o itching and rash to body. Pt accompanied by mother is also having the same problem. Pt states that she got flu shot on Thursday (10/01/09) and since yesterday noticed having some rash to the neck area associated with feeling of warmth in the same area. Pt states that she started having itching involving the chest/neck and arms this morning which is worsening now. Pt denies any shortness of breath or dizziness. Pt denies any change in diet or any other routine. Denies any change in cosmetics/detergent or diet. The history is provided by the patient. This is a new problem. The current episode started yesterday. The problem has been occurring constantly. The problem has been gradually worsening since onset. There has been no chest pain, no abdominal pain, no headaches, and no shortness of breath. The symptoms are worsened by nothing. The symptoms are relieved by nothing. She has tried nothing for the symptoms.
Sepsis; Legionnaire's disease; Psoriatic arthritis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4306423-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEPSIS (hospitalization, medically significant), outcome "unknown", described as "Sepsis"; PNEUMONIA LEGIONELLA (hospitalization, medically significant), outcome "unknown", described as "Legionnaire's disease"; PSORIATIC ARTHROPATHY (hospitalization, medically significant), outcome "unknown", described as "Psoriatic arthritis". The action taken for adalimumab was unknown. Clinical course: Patient was hospitalized for sepsis and pneumonia. She was diagnosed with Legionnaires' disease. After the second COVID vaccination she had really bothered psoriatic arthritis. On 04Jan2022 till 14Jan2022, she was on oxygen. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Sepsis, Legionnaires Disease and Second Covid Vaccination Bothered Psoriatic Arthritis was not provided. Agency's opinion is that the events of Sepsis and Legionnaires Disease are not assessable. Agency's opinion is that there is no reasonable possibility that the event of Second Covid Vaccination Bothered Psoriatic Arthritis is related to Humira (Adalimumab).  Causality for Pfizer Biontech COVID-19 Vaccine (Tozinameran): The reporter's causality for the event Sepsis and Legionnaire's disease was not reported, that the event of Second Covid Vaccination Bothered Psoriatic Arthritis was not related   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Sepsis, Legionnaires Disease and Second Covid Vaccination Bothered Psoriatic Arthritis and the use of suspect product BNT162B2 cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Evening of both doses I had nausea which went away overnight, (also had very strange dreams with frequent waking up which might have had nothing to do with the vaccine).  Second dose nausea the first night, extreme fatigue the second day which was gone by day 3. Headache from day after vaccine until today (5 days later)  with more severe headache and dizziness today, but not bad enough to make me not be able to function.
Pt. developed chills, myalgias/arthralgias about 12 hours after TD vax given, temp to 102 po 15 hours after injection. Rx'd with 2 ADVIL, temp resolved by morning; mild nausea the following morning; (-) local reaction symptoms gone by 28 hours after shot.
Client was 16 at the time of administration of vaccine. Moderna is approved for 18 and older.  No side effects after vaccine.
Irritability developed and approximately 48 hours after vaccines. 4 days after vaccines developed fever, elevated irritability and lethargy. A complete sepsis evaluation done and admitted for IV antibiotics. All cultures negative. Fever resolved 48 hours later.
Warm, redness, sore injection site then over the course of 5 days worsening redness and spreading from deltoid to 70% of bicep just past elbow, with hardness in middle. Used cold compresses & ADVIL. After 5 days worsening, started to get better, redness area shrinking, now gone after 9 days.