chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 2, single (Lot number: EW0153) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Borderline high blood pressure" (unspecified if ongoing), notes: Other medical history: Borderline high blood pressure, vasomotor rhinitis; "vasomotor rhinitis" (unspecified if ongoing), notes: Other medical history: Borderline high blood pressure, vasomotor rhinitis. Concomitant medication(s) included: CIPROFLOXACIN, start date: 24May2022, stop date: 26May2022. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline", notes: Known allergies: Doxycycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started from 24May2022 to 26May2022 with Lot no. GA1190. Clinical course: Upon Follow up 02Jun2022, Additional information: This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes: Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the business process. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EW0153 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0153, fill lot EP8692 and the bulk formulated drug product EW8071. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: and PR Link (Previously Investigated CR). Received vaccines and other medication in two weeks.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
tick bite; Caller states he sent an email to the FDA last week and they suggested he contact Pfizer to find out more information since it was a positive side effect; still itches and irritated where tick bite is; still itches and irritated where tick bite is; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via medical information team. A 60-year-old male patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Formulation: Solution For injection, Batch/Lot Number: EW0153, Expiration Date: Unknown) via an unspecified route of administration, administered in left arm on 10Apr2021 (at the age of 60-year-old) as DOSE 2, SINGLE and received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine Formulation: Solution For injection Batch/Lot Number: ER2613 Expiration Date: Unknown) via an unspecified route of administration, administered in left arm on 20Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. Patient medical history and family medical history was reported as none. Patient previously received Flu shot on an unspecified date one time but doesn't remember the date and states it was in the 1990s. Concomitant medications were reported as none. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced tick bite, Patient states he lives in a rural area and was bit by a tick. He states when he pulled the tick off of him it was dead. Patient states another tick bit him and when he pulled that one off it was dead as well. Patient wanted to know if there something in the vaccines that kills ticks. The first tick bite was in Mar2021 and that he was actually bitten 3 times total with this past Wednesday 15Jun2021 being the last time he was bitten. Patient states the bites still itches and the skin is irritated. Patient states he sent an email to the FDA last week and they suggested he contact Pfizer to find out more information since it was a positive side effect. The events did not result in visit to emergency room or physician office. The outcome of tick bite was not resolved and the other events was unknown.  Follow-up attempts are completed. No further information is expected.
COVID+ 1/13/23.  Vaccination status - moderna x3 + Moderna BIVALENT Discharge Summary MD (Physician) ? ? Hospitalist  BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: DO Admission Date: 1/13/2023 Discharge Date: 1/17/2023     Active Hospital Problems   Diagnosis Date Noted POA ? Acute deep vein thrombosis (DVT) of femoral vein of right lower extremity (HCC) 01/15/2023 Yes ? Acute deep vein thrombosis (DVT) of left femoral vein (HCC) 01/14/2023 Yes ? Pneumonia due to COVID-19 virus 01/13/2023 Yes ? Elevated brain natriuretic peptide (BNP) level 01/13/2023 Yes ? Chronic kidney disease (CKD), stage IV (severe) (HCC) 01/10/2023 Yes ? Gastroesophageal reflux disease 01/10/2023 Yes ? Nonrheumatic aortic valve stenosis 02/06/2020 Yes ? Essential hypertension 12/09/2015 Yes ? Acquired hypothyroidism   DETAILS OF HOSPITAL STAY:  Clinical Narrative: Patient was managed for pneumonia and due to COVID-19 virus, she denies any shortness of breath today, she is presently on room air saturating 92%.  She was also started on empirical antibiotics with ceftriaxone and Zithromax for any superimposed bacterial pneumonia while continuing treatment for COVID including Decadron of which she has completed 5 days and IV remdesivir of which she has completed 4 days On discharge should be given a script for 5 more days of Decadron, She was also diagnosed with acute DVT of the right femoral vein, started on Eliquis 10 mg 2 times a day for total of 7 days after which she will continue with 5 mg 2 times a day Discuss risk was not benefit of anticoagulation with patient and the daughter today and they are willing to continue with Eliquis Evaluated by PT/OT and will be discharged back home with assist  Please see the following problem-list oriented Hospital Course below:  No new Assessment & Plan notes have been filed under this hospital service since the last note was generated. Service: Hospitalist
Breakthrough case admission after 3 vaccines Pfizer 4/3/21 lot# ER8734;  Pfizer 4/24/21 lot# EW0172 ; Moderna 12/6/21 lot# 060
Hypothermia. Four days after second dose body temp dropped to 94 degrees F.  Evaluation for sepsis was unremarkable.  CBC was normal, blood cultures were negative.  Hypothermia was treated with warming devices.  Increased seizure activity was noted.  Keppra was started for increased seizure activity.  Hypothermia resolved with resolution of the seizures.
substantial hoarseness; This is a spontaneous report from a contactable physician reported that: A 73-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via intramuscular on 29Jan2021 as single dose for covid-19 immunization. The patient's concomitant medications were unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Facility type Vaccine: Hospital. On 02Feb2021, patient experienced substantial hoarseness, but no other signs of allergy, no respiratory distress. Treatment received with Xyzal. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
client observed sitting in chair when suddenly she loses consciousness and collapses to floor. Vaccine crew arrives immediately and she is assessed. No skin lesions, redness, swelling noted. Client gains consciousness and when asked about incident, she states: "I have fainted before when receiving a vaccine. EMS arrives and further assesses client taking over patient care.
shaky all over and cold; second dose but the pharmacist refuse to administered it because they were worry the second dose may make it worse.; Condition aggravated; A month ago the tremors started affecting their voice as well; similar case of tremors\, initially affecting their whole body, now mainly affecting their hands and face; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (similar case of tremors\, initially affecting their whole body, now mainly affecting their hands and face), FEELING COLD (shaky all over and cold), PRODUCT DOSE OMISSION ISSUE (second dose but the pharmacist refuse to administered it because they were worry the second dose may make it worse.), CONDITION AGGRAVATED (Condition aggravated) and TREMOR (A month ago the tremors started affecting their voice as well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety (for over 14 years now, since 2001.), Panic disorder NOS (for over 14 years now, since 2001.) and Post-traumatic stress disorder (for over 14 years now, since 2001.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced TREMOR (similar case of tremors\, initially affecting their whole body, now mainly affecting their hands and face). In April 2021, the patient experienced TREMOR (A month ago the tremors started affecting their voice as well). On 28-Oct-2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated). On an unknown date, the patient experienced FEELING COLD (shaky all over and cold) and PRODUCT DOSE OMISSION ISSUE (second dose but the pharmacist refuse to administered it because they were worry the second dose may make it worse.). At the time of the report, TREMOR (similar case of tremors\, initially affecting their whole body, now mainly affecting their hands and face), FEELING COLD (shaky all over and cold), CONDITION AGGRAVATED (Condition aggravated) and TREMOR (A month ago the tremors started affecting their voice as well) had not resolved and PRODUCT DOSE OMISSION ISSUE (second dose but the pharmacist refuse to administered it because they were worry the second dose may make it worse.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       They prescribed them a muscle relaxer but it did no good. Patient has been taking 3 pills for PTSD anxiety and panic for over 14 years now, since 2001.They feels that its it is getting worse and they are worry, as this could affect them for life and want to help people, and save them of this embarrassment No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Significant follow-up appended- Events and medical history updates On 29-Oct-2021: Follow up document received contained non significant information.
I had the vaccine on the afternoon of Friday, May 8.  At 3:00 am on Saturday morning, May 9, I woke up with a fever.  I checked my temperature and it was 101.4.  I was shivering.  I stayed in bed most of the day.  When I checked my temperature at 10:00 pm on Saturday it was normal 98.0.  I stayed in bed most of the day on Sunday too.
My wife became delusional for a short while, then lost her short term memory. She still does not have it back.
This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) lot # L004651, exp 11-FEB-2017, lot # K006135, 29-APR-2016. No adverse effects reported. Temperature of -12 degree centigrade, time frame of 94 hours and 50 minutes. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient developed a temperature of 104 degrees at night he received FluLaval vaccination bilious emesis one time. Fever lasted until the next afternoon around 2 PM when it resolved.
Within 3 hours of getting second shot I began experiencing chills, swollen lymph nodes under both arms, encephalitis headache, shooting pains in legs and arms, muscle pains, flare up of my costocondritis. I was unwell in bed and unable to do anything for 5 days. A complete and total body inflammatory response.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No medical history was reported. On 13-APR-2015, the patient was vaccinated with ROTATEQ (lot # J012525, exp date 09-APR-2015) (2 ml, once, oral). No concomitant therapy was reported. The reported stated that the patient received an expired dose of ROTATEQ. No adverse events were reported. The outcome of the events was unknown. The events were considered to be not related to ROTATEQ. No product quality issue was involved. Additional information has been requested.
This spontaneous report was received from a nurse cnocerning an unspecified number of patients (demographics unknown). On unspecified dates since 25-AUG-2015, the patients were vaccinated wiht doses of oral ROTATEQ (Lot # K019372; expiration date: 16-JUL-2016) which were exposed to temperature outisde of the recommended range. No adverse experience had been reported. This is one of several reports received from the same source. Additional inormation has been requested.
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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 at 12:00 as dose 1, single (Lot number: EN6202), in right arm, on 26Mar2021 at 12:00 as dose 2, single (Lot number: ER8730), in right arm, on 01Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 11Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: statin drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet"; Naproxen, reaction(s): "Known allergies: Naproxen".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No chronic conditions or illnesses at this time other than Covid.  No follow-up attempts are possible. No further information is expected.
Very Sore Left Arm, Extreme Muscle Ache in shoulders, Sore Legs
At the onset there was a scratchy throat, bleeding in left tonsil with a large debris; sore throat persisted the next day.  I then became very fatigued and I felt warm but can't say I ever had a high fever.  I did not have any muscle aches. Lots of sinus congestion throughout my head. I had a runny nose constant. Severe headache which persisted throughout entire experience. I had a cough. My lungs were clear but my upper respiratory area ad bronchial tubes will filled with phlegm and bloody mucous. It was dark grey/green. I contacted my doctor, he prescribed azithromycin 250mg x 6 tablets 5-day course of antibiotics on 12/15/2022. Event started when my wife and I flew to see family for a vacation before Christmas. Someone in the airport coughed on me and I believe that's where I got sick from. I did not take any action to contact my PCP. I was completely without any medication until I flew back home and went immediately to bed. From that point on, I was isolating myself for the next two to three weeks. I was miserable with these symptoms until the medication kicked in. My sinuses started to clear and my headache started to go away. I had a bacterial and viral infection at the same time. I was pretty much symptom free by about the 4th week. As of today, I still have a little of upper respiratory congestion and spitting up a little bit of phlegm and a cough. My nose finally feels like a nose again since about a week ago with no longer running. I had also lost my sense of taste and smell but gradually has come back.
Notes  COVID VACCINE CLINIC  Subjective Patient is a 18 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She denied any history of previous adverse reactions to vaccines and denies reaction to her first dose. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience throat tightness.  She denied difficulty breathing, difficulty swallowing, wheezing, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. 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 rapid progression of symptoms and tongue swelling.   ALLERGY REVIEW OF SYSTEMS:  Patient denies facial swelling, chest tightness, shortness of breath, rash and dizziness    + throat tightness:     Previous Reactions: Denies previous reactions to vaccinations.     Objective    Vitals Vitals:   01/08/21 1143 01/08/21 1204 01/08/21 1227 BP: (!) 144/89 131/81 104/76 Pulse: (!) 125 (!) 109 99 Temp: 98 °F (36.7 °C)     SpO2: 99% 99% 98%     Physical Exam Vitals signs and nursing note reviewed.  HENT:     Head: Normocephalic and atraumatic.     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema.     Comments: No swelling of lips or tongue. Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing or rales.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.       Assessment/Plan  Treatment included: benadryl 25mg po and solumedrol 125mg IM.  Follow up response to treatment: good. Patient had improvement in throat tightness. Does mention being lightheaded after. Patient discharge: Stable to go home and follow up with PCP. Patient called a friend for a safe drive home. She was instructed to go home and rest for the remainder of the day. Denies having any symptoms on discharge. Discharged at 1229.   If she experiences any adverse symptoms in the future, advised to F/U in ER.
Patient reported bruising around the site of injection that started 2 days after injection. Bruising still on 9/25/20.
Arm is still sore; Initial information received on 15-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves an unknown age and unknown gender patient who had arm is still sore after being vaccinated with INFLUENZA VACCINE.  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 INFLUENZA VACCINE produced by unknown manufacturer, formulation, strength, lot number and expiration date via unknown route in unknown administration site for Immunisation.  On an unknown date the patient developed a non-serious event "arm is still sore" (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Arm is still sore).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event arm is still sore.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Chills-Medium, Systemic: Shakiness-Medium
2 wks p/vax pt exp rash on arms & legs w/some itching; rash on legs progressed to petechiae & edema by that evening; exp arthralgia knees, shoulders, elbows, wrists & hands during noc; edema knees, lower leg, feet, wrists & hands;
Client complained of dizziness and vertigo within 3 hours of immunization and tachycardia about 1 hour later.
Pt was seen for a well visit at 09:30 and received MMR and HIB at about 12:30 to 13:00. He developed a fever and was given Tylenol and was put down for a nap. At about 17:00, he awoke from his nap with a generalized tonic/clonic seizure which lasted about 8-9 minutes. He was taken to ER by EMS with a fever of 104F on arrival. He was treated with Cefotan. Diagnosed was UTI
Stabbing feeling in the ear, headache, shivers, arm bruised, itching legs.
Information has been received from a registered nurse (R.N.) referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 23-MAY-2016, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (lot # L040442, expiration date 15-JAN-2017; route was not reported; temperature: 13 Fahrenheit; time frame: 10 hours; no previous temperature excursion). No adverse effects were reported. Additional information has been requested.
headaches, nausea, joint pain, diaharrea had fibromyalgia then it went to PMR - (Polymyalgia Rheumatica) which is worse than Fibromyalgia still have diaharrea til  this day. PMR, Headaches, nausea
New onset of headaches with vomiting and syncopal/near syncope episodes since time of vaccinations - occurs only with physical exertion in heat.
Arm soreness below injection site approximately one hour following injection Headache approximately 4.5 hours after injection. Took 2 Ibuprofen. Medicine has not had an impact yet Nausea approximately 8 hours after injection. Took Gavascon and that helped. Still feeling a little stomach discomfort
I took shot at pharmacy, done fine for about 3 hours, could not swallow, breathing fast, saliva running down my chin, I called Dr. next day and pharmacy made appt. to go in. Laid in bed for 3 days. I get shot every year a pharmacy - same one never hurt me before something in this shot that will kill me.
Myalgia, Arthralgia, Fever, chills and injection site discomfort Narrative:
The patient went to urgent care on 4/7 complaining of back pain that was "sharp" and would sometimes numb her foot. She was told to take ibuprofen/Tylenol. The patient went to the emergency room on 4/10 complaining of the same pain. Was given an injection that helped. Went to the emergency room again on 4/22 complaining of the same back/leg pain.   The patient states this all started after receiving her first covid vaccine on 3/20. She returned on 4/17 (one week late) for her 2nd dose.
Patient was given the Pfizer monovalent shot as a booster instead of a Pfizer Bivalent booster shot
Warm/burning stomach sensation for about 8-12 hours. Potential swelling of thyroid and/or existing nodules that are benign for 8-12 hours