chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Its peaceful; This is a spontaneous report from a contactable consumer. A 31-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 29May2021 17:00 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history were not reported. The patient's concomitant medications were not reported. No known allergies reported. On 29May2021 17:00, the patient experienced its peaceful. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, it was unknown the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No COVID tested post vaccination. The outcome of event was recovered.   Information about Lot/batch number has been requested
Client sitting in chair in observation area after receiving vaccine. Observation period for 15 minutes. Client appeared to be hyperventilating and stated she had "extreme needle phobia" to RN. Client skin moist and pale. Vitals taken at 1504: BP 142/104, HR 111 bpm, SpO2 100 %. RN gave client water to drink and removed mask to support breathing. Clt c/o feeling "lightheaded." RN offered to lie down on cot, client refused, remained sitting. Vitals taken at 1511: BP 137/103, HR 107 bpm, SpO2 100%. Client reported at 1511 felt like "anxiety was improving" and "my breathing is better." Skin is dry and appropriate color for Ethinicity, no rash observed. Client denied lightheadedness, chest pain ,nausea, denied dizziness. Vitals taken at 1532: BP 132/92, HR 100 bpm, SpO2 100%. Client appeared more relaxed, no hyperventilation noted. Client reported lightheadedness is gone, stated "I am ready to go home." RN educated s/s of emergency and to f/u with PMD.  Client walked off with steady gait unassisted at 1537. Client with friend.
Typical body aches and myalgias for first night.  Sore arm for 3 days. Itching at injection.  Second day in the afternoon, began with strong palpitations, heart racing and chest pain. Chest pain was dull and heavy and sat on the chest. Palpitations picked up in intensity that night. No sleep. Went to the ER. EKG with inverted t waves but no signs of acute myocarditis. Discharged with referral to cardiology. No good sleep for 7 days due to insomnia, heart symptoms and anxiety.  I was exhausted but my mind and my heart would not let me sleep. I continue to have trouble now, 10 days later.  Extreme stress to the body for over a week.  Epigastric discomfort, Rapid weigh loss, Shaking uncontrollable, cold. Beginning to feel depression.   I never struggled with insomnia in my life. I have had palpitations before but never to this extent and they never keep my from sleeping. Anxiety has never been this severe before.  I now have to have further cardiac testing, take new medications and see psychiatry since the Moderna Booster vaccine.
Tues., the day after the vaccine, I was up early for golf, very tired, lack of energy; couldn't wait to finish. Took husband to his Dr. appt. had to wait quite a while. So tired when we returned home that I could barely fix lunch. Afterwards I laid down and slept soundly for 4 hours. No energy. Had dinner and went to bed. Wed. feeling better except vaccination site very red and quite swollen 4" x 4". Called pharmacy and they said "not unusual".  Upper arm still hurting. Today, Thurs 8/9/2018 redness & swelling down, still painful to the touch. Back to normal energy level.
Discharge Provider: MD Primary Care Provider at Discharge: MD   Admission Date: 8/17/2023 Discharge Date: 8/19/2023 Condition on discharge: Improved   DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Patient is a 84 y.o. female with past medical history of severe profound hearing loss, poor controlled hypertension, CKD stage 4, AFib/prior DVT no longer on anticoagulation, prior GI bleed who had recent admission in August for anemia and left AMA during that admission. She presented to the ER on 8/17/23 as directed by PCP for concern of PE as patient was complaining about pleuritic chest pain in the office.  Upon arrival, found to be severely hypertensive, and COVID-19 positive.  VQ scan with low probability for pulmonary embolism. She is very difficult to provide history as she cannot hear given her severe hearing loss.  Was doing text to talk to communicate with her best I could.   Given patient was not responding to p.r.n. IV meds in ER she was started on nicardipine drip and admitted to ICU as a CC2 hypertensive urgency.  EKG with T wave inversion lead III but otherwise does not show any evidence of new ischemic changes.  Tropes flat x2. Chest x-ray no acute process.  Satting 100% on room air.  Bilateral extremity ultrasound negative for DVT.
knee pain; patient fell 4 times in 20 minutes; The patient was clammy; The patient was ashen; The patient injured both of his knees during the falls. one of his knees had cuts all over it due to the shattered glass; Initial information received on 19-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 58 years old male patient who fell 4 times in 20 minutes (fall), was clammy (cold sweat), ashen (pallor), had injured both of his knees during the falls. one of his knees had cuts all over it due to the shattered glass (joint injury) and knee pain (arthralgia), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TAMSULOSIN HYDROCHLORIDE (FLOMAX) and no other vaccines were given to patient.  On 16-Oct-2020 a 08:50, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiration date not reported) via intramuscular route in the left arm for prophylactic vaccination.  On 17-Oct-2020, the patient who fell 4 times in 20 minutes (fall), clammy (cold sweat), ashen (pallor), had injured both of his knees during the falls/ one of his knees had cuts all over it due to the shattered glass (joint injury), 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date, the patient developed a non-serious knee pain (arthralgia) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  All these events were non serious. Health Care Professional was concerned that he may have a blood clot.  Relevant laboratory test results included:  On 17-Oct-2020: Blood pressure measurement - 50/44 [BP in the ambulance was 50/44]. On an unknown date: Magnetic resonance imaging - Negative; Scan: Negative  The patient was treated in the ER (emergency room) for 6 hours and then discharged.     At the time of reporting, the outcome was unknown for all the events.  There will be no information on the batch number for this case.
Injection site was huge like a welt.  Now it wraps around the arm and is getting bigger.  Doctor prescribed steroids and antibiotics.  NOTHING is helping.  Symptoms now include: body chills, fever, and bodyaches.
Generalized achiness at 8 hrs post vaccine, persisting on and off for 48 hrs. Moderate fever and chills at 16 hrs. Severe night sweats at 40 hrs.
very hot to touch; feeling very stressed as her husband surgery is due in 29th march; Not sleeping well; very red; very itchy; much larger; very swollen; progressed down to arm in between right elbow and wrist; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (very red), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (much larger) and VACCINATION SITE SWELLING (very swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M2/(Z)0(O)A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 14-Feb-2021, the patient experienced VACCINATION SITE RASH (very red), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (much larger), VACCINATION SITE SWELLING (very swollen) and PAIN (progressed down to arm in between right elbow and wrist). On an unknown date, the patient experienced VACCINATION SITE WARMTH (very hot to touch), TENSION (feeling very stressed as her husband surgery is due in 29th march) and INSOMNIA (Not sleeping well). On 24-Feb-2021, VACCINATION SITE RASH (very red), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE ERYTHEMA (much larger), VACCINATION SITE SWELLING (very swollen) and PAIN (progressed down to arm in between right elbow and wrist) had resolved. At the time of the report, TENSION (feeling very stressed as her husband surgery is due in 29th march) and INSOMNIA (Not sleeping well) outcome was unknown. Not Provided          Concomitant medication was not provided.  Treatment information was not provided.     This case was linked to MOD-2021-048181 (Linked Report).; Sender's Comments:  MOD-2021-048181:cross linked for first dose
Swollen right arm, prednisone 20 mg 2 tablets QD x 4days. Continue MOTRIN PRN & ice.
I have been smelling smoke like something is on fire. No one else smells it but me. Comes and goes but the odor is very strong. I haven?t been able to find anyone who can smell it.
Patient 52 y.o. year old   Date of incident: 03/23/21 Time of incident: 0215 Location of incident: Vaccination facility Pertinent patient history: history of anaphylaxis Description of incident:  Following administration of COVID-19 vaccine, patient experienced throat tightness and shortness of breath, trouble swallowing   Initial Vitals at 14:25 Blood pressure:  167/90 Pulse: 91 Respirations: 20 O2 saturation:  100   Actions taken: Patient self administered one dose of own epinephrine pen at 1423. EMS called.  HCP at bedside to assess.    Orders initiated per RN protocol: EpiPen administered per protocol   Patient outcome: Patient remained alert/oriented. Continued to have trouble swallowing. At time of discharge to EMS at 1440, patient reports improving some.    Re-Check of Vitals at 14:30 Blood pressure:  160/89 Pulse:  93 Respirations:  20 O2 saturation:  100   Vitals at 1435: 147/81 Pulse 100 Sa02 100         Patient left vaccine clinic via Ambulance: Time of EMS arrival: 1438
Sore left arm after vaccination. My son was given the wrong dose of the covid bivalent vaccine. He was administered an adult dose instead of the pediatric dose.
Started with severe cramps in feet and calves for several days, as cramps improved nerve twitching began primarily in the calves of both legs.  As time has progressed the twitching has become worse . . .  always in the calves of the legs,.and is now randomly all over the body including the left lower eyelid, in the scalp above the ears, biceps, mid back, thighs, feet - to name a few.  It occurs daily with the most persistent in the calves of the legs.
Hips and back began to hurt after the vaccine; Hips and back began to hurt after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Hips and back began to hurt after the vaccine) and ARTHRALGIA (Hips and back began to hurt after the vaccine) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     Concurrent medical conditions included Arthritis.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced BACK PAIN (Hips and back began to hurt after the vaccine) and ARTHRALGIA (Hips and back began to hurt after the vaccine). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BACK PAIN (Hips and back began to hurt after the vaccine) and ARTHRALGIA (Hips and back began to hurt after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.
On 2/18/2021 at 10 am the Pt received the Maderna Vaccination IM to her right deltoid and 8 hours later the Pt developed nausea with a rash on chest, shoulders, front and back of neck that went down to her right arm to her wrist, the Pt also c/o SOB and was not able to lift her right arm. Today 4 days later the Pt still has slight right upper arm pain a vaccination site with minimal rash on her chest, with a slight sore throat, stuffy nose, with minimal nausea , will f/u with Pt in one week for f/u, sent note to Dr  (ID Specialist)
faint; This case was reported by a physician via sales rep and described the occurrence of faint in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, unknown after receiving Menveo, the patient experienced faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown.   It was unknown if the reporter considered the faint to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patients fainted after receiving Menveo. The reporter stated that they encourage the patients to wait for 15 minutes after vaccination but the patients did not always wait. This case was linked to case US2019AMR122570, reported by same reporter
This spontaneous report as received from healthcare worker refers to a patient of unspecified age and gender. Concurrent conditions and medical history were not reported. On 23-MAY-2016, the patient was inadvertently administered an expired dose of PEDVAXHIB with lot # J010383 and expiration date 21-MAY-2016, (strength, dose and route unspecified). No adverse effect was reported. Product quality complaint (PQC) was not involved. No further details were provided. Additional information has been requested.
L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation resolved following benadryl. tingling still present at 14 hours but has improved.
A medical assistant was giving a pre filled injection the vial broke in her hand. Patient nor medical assistant were harmed when this happened.
Diffuse upper and lower extremity swelling and erythema when extemities are warm. Cyanosis of the swollen extremities when they are cool. Also facial swelling. Also, acting very cranky. Possible slight fever, but none now.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 26-AUG-2015, the patient was inadvertently vaccinated with a dose of GARDASIL which was expired on 06-AUG-2015. No adverse effects were reported. Additional information has been requested.
Within minutes after vaccine felt that her whole body on fire/ hot; Felt body burning up; About to pass out; Eyes swollen; Lips swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Within minutes after vaccine felt that her whole body on fire/ hot), BURNING SENSATION (Felt body burning up), PRESYNCOPE (About to pass out), EYE SWELLING (Eyes swollen) and LIP SWELLING (Lips swollen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Allergy (Severe allergy problems to shots.).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced FEELING HOT (Within minutes after vaccine felt that her whole body on fire/ hot), BURNING SENSATION (Felt body burning up), PRESYNCOPE (About to pass out), EYE SWELLING (Eyes swollen) and LIP SWELLING (Lips swollen). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of every 4 hours. and PREDNISONE at a dose of 40 mg once a day. At the time of the report, FEELING HOT (Within minutes after vaccine felt that her whole body on fire/ hot), BURNING SENSATION (Felt body burning up), PRESYNCOPE (About to pass out), EYE SWELLING (Eyes swollen) and LIP SWELLING (Lips swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Blood pressure measurement: 90/60 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment included prednisone 40 mg daily for 5 days and later prescribed a taper dose of prednisone.
Rcvd flu vaccine 10/29/10. States within 6 days, had (+) body aches, nasal congestion, occ. fever. Soreness at injection site. States 3rd year this has happened. VAERS report filed 10/7/08. No reports of any problem with 2009 flu shot. Had ov 12/20/10 for above sx. CBC-NL, CRP-NL, RF 22(H), ESR-NL. Doxycycline 100mg bid x 7 days. 1/3/11 c/o "flu-like" sx. nasal cong, sinus pressure, nausea. Only took Doxycycline x 3d. 5/6/11 - Spoke with pt. - feels well.
She had no appetite until now; a fever right now. It was 106 last night; fatigue/She was tired; So weak; I have muscle pain; Chills; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (So weak), DECREASED APPETITE (She had no appetite until now), PYREXIA (a fever right now. It was 106 last night), MYALGIA (I have muscle pain) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol, Blood pressure high and Allergy. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 17-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced ASTHENIA (So weak), MYALGIA (I have muscle pain) and CHILLS (Chills). On 17-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DECREASED APPETITE (She had no appetite until now), PYREXIA (a fever right now. It was 106 last night) and FATIGUE (fatigue/She was tired). At the time of the report, ASTHENIA (So weak), PYREXIA (a fever right now. It was 106 last night) and MYALGIA (I have muscle pain) had not resolved, DECREASED APPETITE (She had no appetite until now) was resolving and CHILLS (Chills) and FATIGUE (fatigue/She was tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2023, Body temperature: 100.6 F. On 17-Oct-2023, Body temperature: 106.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug included blood pressure medicine and high cholesterol medicine.  After taking Spikevax, patient had side effects. Patient asked if she could take like a Paracetamol or blood pressure medicine and high cholesterol medicine along this. Within 24 hours she had 100.6 F fever. She had muscle pain, was weak and had chills. She was tired and fatigue. She had no appetite until now. It been 3 days, she was finally working herself to eat. This was the worst her side effects ever been. Previously she only felt tired. This feels like she had flu symptoms.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2023: Live follow-up received: Additional reporter, patient details, suspect details, concomitant vaccine, additional events and narrative was updated.
This report describes an ear infection in a 2-month-old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  This report was received from the vaccinee's mother and has not been verified by a physician or healthcare professional.  The mother also reported some of the events to Wyeth (Reference number, HQ2290213MAY2002.)  The vaccinee's medical history reportedly included reflux treated with ranitidine (Zantac); intolerance to breast milk; and allergies to dairy, rice, peanuts, barley, Baker's yeast, and "possibly" wheat.  It was stated that following the receipt of an injection of hepatitis B vaccine (manufacturer unknown) after birth, patient was "up all night, restless, crying and seemed to be in pain".  On 09/20/1999, the vaccinee received her first injection of Infanrix (lot DTPA909A2).  That same day, she experienced a low-grade fever and crying, both of which resolved.  It was reported that within one week of vaccination, approximately on 09/26/1999, the vaccinee experienced hives, a cold, and an ear infection.  These events resolved by 09/28/1999.  The mother reported that in mid-October 1999, the vaccinee experienced an upper respiratory infection which resolved in late October 1999.  The vaccinee received her second injection of Infanrix (lot DTPA909A2) on 11/05/1999.  According to the mother, on approximately 11/24/1999, the vaccinee became "physically agitated-kicking, thrashing". The mother thought this might be a seizure.  These events resolved after one hour.  Reportedly, the pediatrician considered the events to be "unlikely" related to Infanrix administration.  The mother stated that her daughter seemed to be "chronically ill" for weeks after each vaccination.  As of 05/10/2002, all events had resolved.  At six months of age, the vaccinee received her third injection of Infanrix without adverse event.  The Infanrix injection schedule was delayed.
Report 20000319041 describes burning (sensation) (injection arm) in a 40 year old female who received Engerix-B. Reportedly, the vaccinee had no medical history, allergies, concomitant medications, or illness at the time of vaccination. On 09/27/2000 15:00, the vaccinee received her second IM-left deltoid dose of Engerix-B. Approx. 15-20 minutes later, her injection arm started "burning." The reporter advised the vaccinee to apply an ice pack and to take acetaminophen (Tylenol). Vaccinee stated that symptoms subsided after approx. one hour. As of 10/25/2000, the outcome of the event is resolved.
bronchitis; This is a spontaneous report received from a contactable consumer (patient) to a Pfizer sponsored program.   A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Unknown; Expiration Date: Unknown) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced bronchitis on an unspecified date. Caller has received first Covid vaccination and now has possible bronchitis. Put on a steroid. Inquiring if that would affect the covid vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Left deltoid raised, red, hot to touch.  Approx. 7 cm x 10 cm size bump.
Headache, Nausea Vomiting, fatigue, chills Narrative:
Menstrual cycle began one week early on 5/28 after receiving 2nd dose of Pfizer vaccine on 5/18. Today is 6/15 and period has not stopped yet. Seeing the doctor this week.