chrisvoncsefalvay/vaers-outcomes huggingface dataset:
kidneys were unable to support life; Diarrhea; unable to get up without assistance; shaking so bad; This is a spontaneous report from a contactable consumer (Patient's wife). An 80-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot Number: EN6201, expiry date not reported) as single dose for covid-19 immunization. Medical history included ongoing glomerulonephritis, dementia (He had dementia prior to getting the vaccine) and walking aid user. The patient experienced kidneys were unable to support life on an unspecified date and was reported as fatal, shaking so bad on 01Mar2021, diarrhea on 02Mar2021, unable to get up without assistance on 01Mar2021. Patient's wife reports that her husband didn't have any reactions until the third day. He was shaking so bad that the car seat was vibrating. He also had diarrhea. He had dementia prior to getting the vaccine. After getting the vaccine he was unable to get out of the chair without physically being helped out of the chair. He was able to use his walker before getting the vaccine but was not able to after getting the vaccine. Her husband passed away yesterday. He was shaking so bad on 01Mar2021. It lasted for 12-24 hours and then it was not as spasmodic. He had diarrhea from 02Mar - 03Mar2021. He recovered completely from it. He was unable to get up without assistance on 01Mar2021. That did not change. He required assistance until he died. He was unable to use his walker staring on 01Mar2021. His kidneys were unable to support life. Two weeks before he received the vaccine her husband was up and walking. After he received the second dose this happened. Caller is unsure if this caused kidney failure. An autopsy is not being performed. Her husband died yesterday. He had kidney problems that he lived with for 58 years. After receiving the vaccine his kidney functions took a nose dive. She was told by some of the people taking care of him that the kidneys could have had a decrease in function from the vaccine. He was sent to a dementia facility on 02Mar2021 for long term placement. The patient received his first dose of BNT162B2 on an unspecified date. The patient died on 16Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: kidneys were unable to support life
tc fr mom stating that pt had a t107 p/vax 18AUG95; mom states it took 48-52 hrs for temp to return to norm; rt leg also swelled twice the size was very warm to touch;
Information has been received from a LPN concerning a 4 yr old female with asthma and no drug reactions/allergies who on 28Jan02 was vaccinated with a dose of varicella virus vaccine live (lot639435/0789L). On 17Jul05 the pt developed chickenpox breakthrough, described as approx 50 lesion in her vagina, mouth and all over. The child had no fever. She was treated with comfort measures as needed. Unspecified medical attention was sought. There was no product quality complaint. It was noted that the mother of the pt has cancer and was being treated with chemotherapy at the time of the report. Additional information has been requested.
Patient experienced syncope episode after receiving vaccination listed. Patient was sitting on exam table and fainted. Patient was placed in lateral recumbent position. He was responive to verbal stimulus immediately thereafter. He appeared pale, diaphoretic and cool to touch. Patient evaluated for other anaphylactic signs /symptoms and none were noted. Appeared drowsy, weak and disoriented for several minutes. Patient alert and oriented to person, place and events but complained of headache and nausea 4 to six minutes after onset. Vitals signs obtained and normal. Doctor was notified and provided details of events.  Patient was evaluated and released to father by provider approximately one hour following onset of adverse event.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium
Pt developed severe redness and swelling of right extremity rising from location of polio injection.  This swelling involved nearly the entire arm per client report
Sore arm after injection; This is a spontaneous report from a non-contactable consumer, the patient. A unspecified aged male patient received, an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew 0153) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date the patient experienced sore arm after injection. The clinical outcome of the event sore arm after injection was unknown at the time of this report.   No follow up attempts are possible; No further information is expected.
Narrative: Dizziness, Tachypnea hot flashes and cold and clammy skin. Patient began getting hot flashes and sweating and cool clammy skin. PT then slumped in chair.
H1N1 mist given at vaccination clinic on 10-31-09 appx 1 PM. On 11/1/09 she vomited phlegm, tactile fever x 48 hrs, nasal congestion and progressive coughing. Developed rash 2 days ago, face and legs/buttocks. Child not 2 years old and has asthma. Seen today (PCP) with asthma exacerbation. 11/5/2009 PCP records from 11/4/2009. Patient with c/o's, nausea/vomiting, nasal congestion, irritability, rash, wheezing and cough.  No tx noted DX Asthma w/exacerbation and Urticaria.
Patient received vaccine on 4/15/21 2nd dose of 2 dose series. He woke up the morning of 4/22/21 at 6:15am with vomiting. His temperature spiked to 104.2 and his O2 sat dropped to 98%. He developed shaking chills, and a loose wet sounding cough. He had chest xray and labs. Started on treatment for pneumonia with rocephin, zithromax and solumedrol. Declined throughout the day and had increasing requirements for O2 and patient passed away at 1355 on 4/22/21.
34 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Moderna vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience tingling and elevated HR. She is having some tingling in her mouth and tingling in her feet. No obvious facial swelling or hives.   She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness and stridor.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, hypotension, increased swelling and rapid progression of symptoms.Treatment included: zyrtec 10 mg, pepcid 20 mg,  Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.     Observed in the vaccine clinic for 1.5 hours I do not see a reason for ER assesment since she is improving.  Tingling in her mouth has improved.    This pt was encouraged to go home and rest She was encouraged to take a dose of benadryl at home. She may call me if worsening. Given precautions for her next vaccine. Discussed with pharmacist.
15 minutes after Moderna injection, patient began to experience "throat tightness" and headache.  Slight rash noted on neck area.  Nursing staff responded and administered EpiPen 0.3mg IM right vastus lateralis and Benadryl 50mg IM Left deltoid once. Ambulance was called to scene and patients symptoms had begun to resolve. Patient remained alert and oriented and did not require additional support. Blood pressure was 122/90 prior to Epinephrine. Per ambulance staff, patient was transported via parent to the ER for further observation.
TEETH PAIN; JAW CLENCHING; FEELING LAZY; FATIGUE; COUGH WORSENED; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included: thyroid cancer, and thyroidectomy, and concurrent conditions included: environmental allergies, seasonal allergies, current respiratory infection (suspected rsv), seasonal mold allergy, shellfish allergy, cough, dust mites allergy, dog dander allergy, eggplant and wheat germ allergy and dust allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient had allergy to Goldenrod. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced cough worsened. On 13-APR-2021, the patient experienced feeling lazy. On 13-APR-2021, the patient experienced fatigue. On 15-APR-2021, the patient experienced teeth pain. On 15-APR-2021, the patient experienced jaw clenching. On 08-SEP-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. Laboratory data (dates unspecified) included: Blood grouping (NR: not provided) O +ve. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teeth pain, and jaw clenching on 17-APR-2021, and feeling lazy, and fatigue on 15-APR-2021, and had not recovered from cough worsened. This report was non-serious.
Swelling redness and warmth at the injection site. Pt was treated with antibiotics: Keflex.
extremely short of breath/shortness of breath; unable to do normal activities; unable to sleep; swelling in my legs and chest; swelling in my legs and chest; discoloration in my legs; high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2021 at 11:00 as dose 2, single (Lot number: Ew0185) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Ew0170, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Apr2021, when the patient was 45-year-old, for covid-19 immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "discoloration in my legs"; DYSPNOEA (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "extremely short of breath/shortness of breath"; HYPERTENSION (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "high blood pressure"; PERIPHERAL SWELLING (non-serious), SWELLING (non-serious) all with onset 24May2021 at 12:00, outcome "unknown" and all described as "swelling in my legs and chest"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "unable to do normal activities"; INSOMNIA (non-serious) with onset 24May2021 at 12:00, outcome "unknown", described as "unable to sleep". The events "extremely short of breath/shortness of breath", "unable to do normal activities", "unable to sleep", "swelling in my legs and chest", "discoloration in my legs" and "high blood pressure" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dyspnoea, loss of personal independence in daily activities, insomnia, peripheral swelling, swelling, skin discolouration. Therapeutic measures were taken as a result of hypertension. Clinical course: The day after the second vaccination she became extremely short of breath and was unable to do normal activities she could before. The symptoms experienced were shortness of breath unable to sleep due to feeling like couldn't breathe, swelling in legs and chest also a discoloration in legs occurred as well from the swelling. She was unable to do anything at times and between walk in clinics and getting a new doctor no one looked at all symptoms as a whole instead would say it was high blood pressure but all blood pressure medications did not work. The blood tests were normal as well as the chest X-ray. Also tested to see if she had previously had Covid and it was negative.
Fever of 101 after fever reducing meds, chills, aches and extreme lethargy for 8 hrs. Low grade fever, chills, aches and fatigue for subsequent 24 hrs. Intense pain and bruising at vaccination site.
~8 hrs. after receiving vaccine, experienced rigors, temp 102.4 F, vomiting. No previous flu vaccine reactions. Injection site not sore, red, or swollen. Denied headache, shortness of breath or pain. Treated w/ compazine, tylenol, & cool compresses. Responded to treatment. Afebrile, alert & feeling back to baseline ~12 hrs. after adverse event.
This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown gender and ages. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were inadvertently vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) (route: intramuscular) that had been improperly stored at a temperature of 34.5 F for 5 hours. The outcome of the excursion was reported as supported. No adverse effects were reported. The outcome of the events was unknown. Additional information had been requested.
Information has been received from a licensed visiting nurse concerning a 11 year old patient, with no pertinent medical history and no drug reactions/allergies, who on 16-AUG-2008 was vaccinated IM with the first 0.5mL dose of GARDASIL. Secondary therapy included the second dose of VARIVAX (Merck) (MSD). Other concomitant vaccinations included MENACTRA and Tdap. No concomitant medication was included. On 16-AUG-2008 the patient experienced warmth on the same arm as that of GARDASIL and this warmth traveled to her chest. The patient sought unspecified medical attention (was seen). At the time of the reporting, the patient had recovered. Additional information has been requested.
little redness; Chills; initial soreness in arm & soreness in arm has returned; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (initial soreness in arm & soreness in arm has returned), ERYTHEMA (little redness) and CHILLS (Chills) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (initial soreness in arm & soreness in arm has returned) and CHILLS (Chills). On 28-Apr-2021, the patient experienced ERYTHEMA (little redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (initial soreness in arm & soreness in arm has returned), ERYTHEMA (little redness) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  Patient is actively experiencing symptoms which started on 28Apr2021, of soreness in arm has returned and a little redness.
Diffuse erythematous, itchy rash across the left arm, left shoulder, anterior chest and neck. Resolved with Benadryl and time.
A report was received from a health care professional on 24Feb03 concerning a 54 year old female vaccinee who experienced throbbing and warmth at the injection site an unspecified length of time after receiving Fluvirin on an unk date in Oct02. On an unk date in Oct02 the vaccinee experienced throbbing and warmth in her left deltoid shortly after receiving Fluvirin. The area was warm but not red or swollen and the vaccinee had no fever. The vaccinee had a history of fibromyalgia which was under control at the time of vaccination. The vaccinee received the flu vaccination in the past and experienced no adverse event. The throbbing and warmth had not resolved at the time of the report. The reporter has assessed the relationship of the vaccine to the event as unk. Update 1 25Mar03: A follow up report was received from a health care professional which stated that the vaccinee experienced throbbing in the left upper arm the day after she received Fluvirin on 18Oct02. There was no pain at the time of the injection or on the day of the injection. The arm was warm to touch, not swollen or erthemic. It was so painful at night that she needed to wrap arm in an ice wrap and take unspecified pain medication. The reporter diagnosed trigger point pain exacerbation of fibromyalgia secondary to the injection. The vaccinee needed to wrap her arm in an ice wrap at night and take analgesia as it was so painful. An x-ray of the left humerus on 24Feb03 was normal. At the time of the report the vaccinee was receiving physical therapy with positive slow progress and was still having some bad nights.
1st vertigo episode; dizziness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 at 10:00 as dose 2, single (Lot number: ER8733) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Meniere's disease" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6207, Route of administration: Intramuscular, Vaccine administration time: 10:00 AM.), administration date: 18Mar2021, when the patient was 61-year-old, for COVID-19 immunization; Flu vaccine (In Nov2001 I had the covid vaccine and flu vaccine), administration date: Nov2001, when the patient was 42 years old, for immunization, reaction(s): "dizziness". The following information was reported: VERTIGO (non-serious) with onset May2021, outcome "unknown", described as "1st vertigo episode"; DIZZINESS (non-serious) with onset 2021, outcome "unknown".  Additional information: Patient stated that, first vertigo episode was started in May2021. Patient went 6 months with vertigo or dizziness. On an unknown date in Nov2001 patient had the Covid vaccine and flu vaccine and that afternoon patient started having dizziness about every afternoon for 4 weeks.
Case number PHEH2016US029677, is an initial spontaneous report received from a pharmacist on 09 Nov 2016. This case is also associated with quality complaint number(101776). This report refers to a patient of an unknown age and an unknown gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUAD (unknown whether seasonal or pandemic, batch number: 166101, Expiry: Apr 2017) on an unknown date. At the time of vaccination, the plunger fell out, it was inserted into the syringe once pressure was applied, vaccine squirted out and a partial dose was administered. It was reported that the package condition was good. The plunger rod was loose and it fell out completely during administration of vaccine. No adverse event was reported following this medication error.
Left side back pain in the middle of the night. Woke up vomiting and nauseous with a bad headache feeling light headed. My body was very weak and achy. I ran a fever reaching 101.3. My belly was tender to the touch the pain along with the back pain hurt so bad I was in tears thinking I may have had a kidney infection, as it felt like one in the past. Ct scan, X-ray and blood work all seemed to come back normal and they determined I may just be having a bad reaction to my second dose of the vaccine. After leaving the hospital I just slept because I was so fatigued, woken back up by the back and belly pain as the meds wore off and my eyes were now swollen as well. I have absolutely no energy. Still monitoring symptoms.
Extreme itchy from head down to between my legs.  Stomach and chest is very itchy to where I'm breaking the skin.  It's been this way for at least 1 full week not getting better.
tested positive for influenza A; Initial information was received on 25-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and gender patient who was tested positive for influenza after receiving influenza quadrival A-b high dose HV vaccine [Fluzone high-dose 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 an unknown dose of suspect influenza quadrival A-b high dose HV vaccine (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on the batch number will not be available.  On an unknown date, the patient had tested positive for influenza a (influenza) (Reportedly, 3 to 4 days later) unknown latency) following the administration of influenza quadrival A-b high dose HV vaccine.  Relevant laboratory test results included: Influenza A virus test - On an unknown date: Positive  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  No follow-up possible as caller declined to respond to questions and refuses future follow-up.
Caller is an office manager who reports administration of vaccine following temperature excursion. No adverse effects of administration. No further information provided. No other AE/no PQC.          ?    Names of vaccines involved (including lot/ex; Caller is an office manager who reports administration of vaccine following temperature excursion. No adverse effects of administration. No further information provided. No other AE/no PQC.          ?    Names of vaccines involved (including lot/ex; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml/once per oral route, lot #1821247, expiration date: 23-JUL-2022 (strength was not provided).   On 25-APR-2022, a product temperature excursion issue occurred, a call was made by an office manager who reported the administration of vaccine following temperature excursion. No adverse effects after administration. Temperature was 11.4 degree Celsius (C) time frame of 4 hours 45 minutes, prior excursion 10.7 C for 1 hour 15 minutes. No further information provided.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was administered a dose of incorrectly stored PROQUAD lot # M022399 with expiration date of 01-NOV-2017 or lot# M042498 with expiration date of 17-APR-2018 or with an improperly stored dose of VARIVAX lot # M046926 with expiration date of 21-NOV-2018 or lot# M035140 with expiration date of 03-AUG-2018. The reporter was not sure which vaccine and lot# the patient received. Sterile diluent used to reconstitute vaccines was properly stored. Administered doses of vaccines underwent a temperature excursion from -9 degrees Celsius to 8 degrees Celsius, which lasted for 2 hours. No previous temperature excursion was reported. A digital data logger was involved in recording the excursion. No adverse events were reported. Product quality complaint was not involved. Additional information has been requested.