chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anxiety and dyspnea  Narrative:  Employee with a hx of GAD and panic attacks was waiting in the COVID vaccine observation area and started to feel anxious and experienced some dyspnea. She stated that she was also 7 weeks pregnant and was evaluated in the ER over the weekend for vaginal bleeding. She wasn't sure what caused her anxiety. She was taken out of the waiting area to a private area and started to feel better. She had "a lot going one" and was able to drive home.   Other Relevant History:
This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions and medical history were not reported. Stock of vaccine was received on 11-AUG-2016. On 04-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M018636 with expiration date of 12-JUL-2017 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 7 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA013888.
Information has been received from a pharmacist concerning a 38 year old male with type 2 diabetes mellitus and a history of myocardial infarction with stent, who on 18-AUG-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 665707/1407Y, 0.5ml) IM in the left arm. The patient received tetanus (manufacturer unknown) in the same arm. Concomitant therapy included Metoprolol, Metformin, SIMVASTATIN (manufacturer unknown), Clopidogrel bisulfate, LISINOPRIL (manufacturer unknown), aspirin and nitroglycerin - questionable pat compliance. It was reported that the patient experienced pain upon vaccination on 18-AUG-2010. The patient had blood drawn on the same day but which arm was unknown. The patient later the same day as vaccination had pain in deltoid and left shoulder that spread to neck and shoulder area, unable to raise the arm, stiffness, pain in deltoid and left shoulder and swelling. The patient went to the office on 19-AUG-2010 and while in the office lobby, the patient started to have chest pain. The patient had an EKG that was found to be abnormal and patient was taken to a  hospital. The patient was discharged on Friday 20-AUG-2010. At the time of this report, the patient's outcome was unknown. Pharmacist would like a lot check on 665707/1407Y. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax & exp pain down lt arm;this sx subsided w/in 5-10mins;@ least 24hrs later,pt exp pain into fingers,shoulder & neck lt side & these sx persist
diffuse vesicular rash on left leg progressed to anterior and posterior thigh. Burning, painful lesions
Pt recv vax on 9/22/98; on 9/23/98 pt exp fever (103F),no appetite, laid around,sore throat w/ swelling, purple &white spots, couldn't breathe, difficulty swallowing &sleeping, sweating, measlesx5dy, enlarged spleen;dx=tonsillitis;tx=Durace
Thrombosis; Initial information received on 22-Feb-2023 by health care professional following COVID-19 bivalent booster vaccination.  This case is linked to cases 2023SA063143, 2023SA063145, 2023SA063146, 2023SA063147, 2023SA063137 and 2023SA063144 (CLUSTERS).  This case involves a 62-year-old female patient (table 1) who experienced thrombosis while receiving vaccines PFIZER BIONTECH COVID-19 (corona virus 2019) VACCINE and INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect high dose INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect PFIZER BIONTECH COVID-19 VACCINE not produced by lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious thrombosis (latency: 12 days). This event was assessed as medically significant.  Action taken with QUADRIVALENT INFLUENZA VACCINE (INFLUENZA VACCINE (QUADRIVALENT)) and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Thrombosis).  At time of reporting, the outcome was Unknown for the event thrombosis. Reporter's causality: Related; Sender's Comments: company comment dated 27-FEB-2023: This case involves a 62 years old female patient (table 1) who experienced thrombosis while receiving vaccine INFLUENZA VACCINE (QUADRIVALENT). Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
I had hives after the vaccination and it lasted for 4 days I went to see my primary physician and she gave me steroids.
My blood pressure went up to 170/106 and my heart was beating over 100 about 45 minutes or one hour after I was vaccinated, and I also felt nausea. Nurse called 911, and I was transported to emergency. About 1.5 hour later, my heart was even beating more quickly, and I could hardly talked and difficult to breathe. This happened when I walked to the restroom by myself and came back. After they did some medical tests, gave me medication for allergy (the doctor gave me this since he was not sure if it was my allergy reaction to the vaccines), injected 2 IV bags and rest for few hours, my blood pressure went down to about 140/9x and heart beat back to normal. I was released from ER on the next day at 4:00am.
Per patient she got dizzy and fell after her second shot of COVID vaccine. MD requested to report adverse reaction.
June 2, 2021 became confused, nauseated and dizzy. Kept asking the same questions over and over. Diagnosed with most likely TIA secondary TGA with J and J vac most likely a contributing factor.
Patient is suspected to have been given a dose of Pfizer vaccine beyond the recommended 6 hour post reconstitution recommendation, likely to have been used for 3 hours after this recommended discard time.
Swelling of injection site getting worse not better (more swelling and pain) on day 5, headache, nausea, vomiting, joint and muscle pain over whole body, high fever now being controlled with 2 tylenol every 6 hours
Information was received on 12-JAN-2017 from a medical assistant regarding a 68 year old female. Medical history/concurrent conditions included penicillin allergy. Concomitant medications were not reported. On an unspecified date the patient received VARIVAX (unknown lot number and expiration date). On an unspecified date after administration of VARIVAX the patient reported "negative seroconversion after titers were drawn." On an unspecified date after the "titers were drawn", the patient received ZOSTAVAX (unknown lot number and expiration date). The outcome of  "negative seroconversion after titers were drawn"  was not provided.  The reporter did not rate the causal relationship. No additional information was provided. Additional information has been requested.
This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry unspecified), subcutaneously. No concomitant medications were reported. On an unknown date, the patient developed shingles after receiving ZOSTAVAX. The patient sought medical attention (doctor visit). It was unspecified if any treatment was provided or if any lab tests were performed. The outcome of shingles was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Headache; Chills; I got so sick for 3-4 days; I threw up; I stilll have some cough; I still have some difficulty with endurance; 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. Other Case identifier(s): US-PFIZER INC-202101409427 (Pfizer).  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 (Lot number: EN6205) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 2020 (ongoing), notes: 2 scares for 4 days in Jun-Jul 2020. Fever, Chills, monstrous Headache, phlegmy cough, Rapid heart rate, Zero endurance Unable to walk 1o w/o losing breath. I used glutathione with black current syrup calcium , magnesium, with zinc, echinacea. Concomitant medication(s) included: GLUTATHIONE taken for covid-19; VITAMIN D NOS, start date: 2014 (ongoing). Vaccination history included: Bnt162b2 (First dose, Anatomical location: Upper Left arm, Lot number: Pfizer EN6201), administration date: 12Feb2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "I got so sick for 3-4 days"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "I threw up"; COUGH (non-serious) with onset 2021, outcome "not recovered", described as "I stilll have some cough"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "I still have some difficulty with endurance"; HEADACHE (non-serious) with onset 03Mar2021, outcome "recovered" (2021), described as "Headache"; CHILLS (non-serious) with onset 03Mar2021, outcome "recovered" (2021), described as "Chills". Therapeutic measures were taken as a result of cough.  Additional information: patient who have received two doses of the Pfizer's COVID-19 vaccine wants to know if she can receive the booster dose, she had some long term side effects from a COVID infection, she did have the side effects prior to receiving the Pfizer's COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
She never received her second dose; Suffered from an acute ischemic stroke; This spontaneous case was reported by an other health care professional and describes the occurrence of ISCHAEMIC STROKE (Suffered from an acute ischemic stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Hyperlipidemia, Type II diabetes mellitus and Atrial fibrillation.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced ISCHAEMIC STROKE (Suffered from an acute ischemic stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She never received her second dose). At the time of the report, ISCHAEMIC STROKE (Suffered from an acute ischemic stroke) and PRODUCT DOSE OMISSION ISSUE (She never received her second dose) outcome was unknown.        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 reported. Treatment information was unknown.  This report refers to a case of Product dose omission issue  for mRNA-1273,   with  associated adverse event of Ischemic stroke. Very limited information regarding this event has been provided at this time.  However, multiple underlying co-morbidities may remain as confounding factors. Further information has been requested.; Sender's Comments: This report refers to a case of Product dose omission issue  for mRNA-1273,   with  associated adverse event of Ischaemic stroke.Very limited information regarding this event has been provided at this time.  However, multiple underlying co-morbidities may remain as confounding factors.Further information has been requested.
Heart was racing 2 days after first booster; Could not catch her breath 2 days after first booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PALPITATIONS (Heart was racing 2 days after first booster) and DYSPNOEA (Could not catch her breath 2 days after first booster) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS (Arrhythmias began after Knee Surgery in 1990's) in 1990. Concurrent medical conditions included Arrhythmia (controlled with unknown medication) since 1990.   In 2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced PALPITATIONS (Heart was racing 2 days after first booster) and DYSPNOEA (Could not catch her breath 2 days after first booster). At the time of the report, PALPITATIONS (Heart was racing 2 days after first booster) and DYSPNOEA (Could not catch her breath 2 days after first booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: Scan of the heart was done but they did not find anything. On an unknown date, Electrocardiogram: Did not find anything.         Patient was taking unknown medication for Arrhythmias as concomitant medication.  It was reported that patient never had COVID Disease and never had a positive PCR test.  Treatment information was unknown.
Client noted pruritic rash (generalized body rash) 11-18-10 AM; He was treated with antihistamines orally and topical steroidal cream (Claritin and HC 1% tid)- treatment started 11-18-10. Pt returned to clinic 11-19-10 as symptoms did not improve and rash significantly worsened; he was treated 11-19-10 with Benadryl 25 mg i every 6 hrs prn itching/rash and given prescription for Clobetasol topical cream; On 11-18-10 pt received Rocephin 125 mg IM for urethral gonorrhea infection, however rash was already present before this was administered by 24 hrs.
Leg/Hip pain for approx a week before. Complained of gas and cramping. Date of event felt bad and called ambulance. Cardiac Arrest shortly after and doctors unable to restart heart. Death.
Patient was hospitalized from 3/11-3/15 for mental status changes. No obvious etiology found. On admission she was found to be + for SARS-Co-V2. She had no respiratory symptoms and was not treated. She was discharged to
Client had syncopal episode after receiving vaccination. Recovered after 15 minutes with juice and rest. Reported he had not eaten anything in the morning and had too much caffeine. No injuries resulted from the fall to the floor.
Pt reported on 3/30/2021 Back pain & numbness in leg w/1st dose and worsened experience with pain after second dose.  No numbness.  2/9/2021 Office Visit:  1. Sacroiliitis  Patient will start Mobic daily.  She will call if symptoms worsening over the next couple of days and we will consider starting muscle relaxant.  Discussed PT eval also, so patient declined at this time. - meloxicam (MOBIC) 7.5 MG tablet; Take 1 tablet by mouth daily.  Dispense: 30 tablet; Refill: 1   2. Anxiety   The patient likely has inflammation of her left SI joint secondary to her immune response to the COVID vaccine. There were no back muscle spasms noted but she did have tightness in her hamstring, which could explain the radiation of the pain down her leg. There are no symptoms concerning for an infectious etiology of the joint. No recent injury or neurological symptoms, making bone and nerve injury less likely.    Plan to start the patient on Mobic to reduce inflammation in the SI joint. Advised that if her symptoms do not improve by the end of the week, we can consider adding flexeril.   2/15/2021 Started Physical Therapy.  DX  lumbar back pain with rediculapathy affecting Left Lower Extremety, Sacroiliitis, Impaired functional mobility and activity tolerance.
first shot on 1/10/2021 no side effects immediately normal sore arm at injection site  1/17/2021  site started itching, became warm to the touch, and red lasted about 5 days  1/24/2021 symptoms, itching, warm to the touch and red moved down the arm about 3  inches up from the elbow joint.  second shot is scheduled for2/7/2021
12/8 Received first Pfizer vaccines. Had some arm pain after but otherwise felt well. 12/9 early AM, woke up with palpitations (felt heart throughout his body). HR was 92 and BP 130/93. 2-3 more similar episodes that morning and early afternoon. That morning, also developed non-exertional, non-positional L chest pain. Quality- mild and stabbing. Some lateral radiation. Will last a few minutes and then resolve. Occurs several times per day. Has gradually become less bothersome. No associate dyspnea, lightheadedness, leg swelling, PND, or orthopnea. Also developed mild but persistent chest tightness. Has had intermittent tremors throughout body, more vibratory sensation than visible tremor. Keeping him from sleep. ROS+ for 12 hours of sleep for the first 2 nights after vaccine  12/13 - Presented to clinic for evaluation. Continues to have intermittent chest pain, vibratory sensation, chest tightness, and fatigue. Chest pain may be more infrequent. Chest tightness has improved. Palpitations and sensation of skipped heartbeats have resolved. No fevers, headache, or vision changes.  Started on Aleve and tizanidine qhs prn (pt did not trial).  12/17- Seen at clinic for follow-up. Continued symptom improvement but persistent tremors. HR 108. Recommend increasing to Aleve 440mg BID for 1-2 week trial and tizanidine qHS for tremors.
Pfizer-BioNTech COVID-19 Vaccine EUA Got vaccinated on 8/24/21, starting 8/26/21 I have severe pain and decreased movement in my right shoulder. I cannot perform daily tasks or use my right arm.
Information has been received from a physician concerning a 17 year old female who in 1999 was vaccinated "twice" with a 0.5 ml dose of Varivax. On 24-MAY-2006 it was reported that "last week" the patient had "zoster on her forehead". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
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 40-year-old male patient received BNT162b2 (BNT162B2), on 11Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Benzonatate, reaction(s): "Known allergies: Benzonatate", notes: Known allergies: Benzonatate. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reportedly the patient did not receive other medication in 2weeks. On 12Jul2022 the received antiviral for Covid-19 treatment (stop date 16Jul2022).   No follow-up attempts are possible. No further information is expected.
Tiredness; This case was reported by a consumer and described the occurrence of tiredness in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The day before reporting, the patient received dose of Shingrix and experienced tiredness. The patient asked, how long should tiredness side effect last.
At day 4-5 after receiving shot I noticed significant central vision blurriness while reading a book.  Upon further investigation, by looking at things around the house I noticed a significant color difference between the left eye and the right eye in the center area where the blurriness is.  I also notice distortion when looking at a straight lined object.  I tried using dry eye drops for a day.
arm swelling, pain, fatigue, chills, feeling flushed and body aches. Started 12/9/2020 and still having fatigue and chills today.
Dizziness, headache, rapid heart rate 155, fainting, confusion, injury to face  from fall during black out, generalized weakness
This spontaneous report as received from a Licensed Vocational Nurse (L.V.N.) refers to two patients of unknown age and gender. On 24-JUL-2014 the patients were vaccinated with a dose of ZOSTAVAX that were improperly stored for (dosage and route not reported). Lot # J011829, expiry date 26-DEC-2014. No adverse events were reported. The outcome of event was not reported. Additional information has been requested.
There was no adverse effect, vaccine was administered on February 23, vaccine has expiration dose on February 17.
fever, rash on abdomen, back around mouth, including hands and feet. Rash is pruritic, watery stool
Information has been received from a health professional concerning an 18 month old white male with no known medical history who on 09Jun04 was vaccinated IM with a first dose of varicella virus vaccine live (lot 647093/0886N). Concomitant vaccination the same day included a first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 646707/0815N) given IM, a fourth dose of Hib conj vaccine (lot 647150/0717N) given IM and a fourth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) (lot U1027BA) given IM. There was no illness at the time of vaccination. On 19Jun04 the pt broke out with several pox and developed chicken pox. Unspecified medical attention was sought. There were laboratory or diagnostic tests performed. No product quality complaint involved. Follow up information from the RN indicated that the pt subsequently recovered. It was reported that the pt or his sibling did not experience adverse events following prior vaccination. No further information is available.