chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 1025 patient alerted observation nurse LVN to a sensation of itching and difficulty swallowing. Patient requested water. Patient tolerated water well, no shortness of breath, lung sounds clear. Vitals BP 140/91, Pulse 81, Respirations 21, Temp 97.0, SaO2 97%. Patient appears anxious and tearful. 1040 Benadryl 25 mg PO given due to patient stating itchiness and difficulty breathing. 1045 patient stated it was easier to breath and felt comfortable, patient tolerated water well. Vitals 135/92, Pulse 73, Respirations 21, SaO2 98%. Charge Nurse alerted to patient status. Patient visibly comfortably lung sounds clear, mild itchiness to throat that patient stated was improving. Charge Nurse educated patient to the signs and symptoms of an adverse reaction, patient states understanding. Patient drove alone so nurse advised patient to call for family to come pick her up from site and not be alone. Educated to call 911 or go to ER if symptoms return. Patient agreed to wait in observation with LVN while she attempted to call for family. Patient tolerated standing. 1052 Vitals BP 125/117 Pulse 70, SaO2 97%, Resp 20, Temp 97.2. Vitals reassessed at 141/93, pulse 77, Respirations 20, SaO2 98% Temp 97.3. Nurse present with patient at all times. At 1122 patient once again complained of itchiness in her throat and was in visible distress. Charge Nurse alerted. EPI Pen 0.3 mg administered by nurse to Right thigh, 911 called by charge nurse. BP 161/100, HR 91, SaO2 94%, Temp 96.8. Patient stated she felt some relief after Epinephrine administration. 1127 Vitals, BP 165/98 HR, 94, SaO2 97% but patient still stated she felt ?like something is stuck?. 1129 paramedics arrived and attended to patient. 1131 patient was taken in stretcher with belongings.
Body aches; Tiredness; Chills; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: EP6955) via an unspecified route of administration on the left arm on 18Mar2021 at 09:00 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested positive for COVID-19. On 18Mar2021 at 13:00, the patient experienced body aches, tiredness and chills that began approximately 4 hours after the vaccine and lasted approximately 12 hours. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events body aches, tiredness and chills was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Acquired bacterial infection, lasted for 8 days and as per patient chart, was diagnosed with local cellulitis.
Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent condition, drug reaction or concomitant medication described. On 03-MAY-2016 the patient was vaccinated with ZOSTAVAX lot # L029485 with expiration date of 06-NOV-2016 (dose and rouge were not reported), which had been stored at 37 degree for over 3 month, since 21-JAN-2016. The vaccine did not have previous temperature excursion. No adverse effects reported. Additional information has been requested.
Patient received Pneumovax in R deltoid and Shingrix in L deltoid. Upon awakening the next morning, he complained of rash in groin and both axilla. He had fever 102.5F. He developed swelling and erythema of R deltoid. Rash and fever persisted for 2 days before gradually improving.
I was diagnosed with Meniere's disease approximately 10 to 11 years ago. I have had minor ringing in my right ear since approximately 2009.  However, after the COVID-19 vaccines, the ringing became markedly worse (progressing to a pulsing in addition to the ringing). I received the Moderna booster shot on November 26, 2021. Within a week, I had violent vertigo lasting for approximately 24 hours, calmed by taking meclizine and eventually prednisone. The ringing/pulsing still exists 24/7, at times waking me from my sleep. Also, the vertigo has persisted to a lesser degree. I keep meclizine with me at all times.
A 17 years old patient received third dose of MENACTRA vaccine in 2020 was previously vaccinated with the same vaccine in 2014 and 2019/No AE; Initial information was received on 26-Aug-2020 and additional information was received on 28-Aug-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional.  This case involves a 17 years old male patient who received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on an unknown date in 2014, 2019 and third dose on  26-Aug-2020 (batch number, expiry date and dosing details not reported) for prophylactic vaccination respectively.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication if any, not reported.  It was a case of actual medication error due to extra dose administered. (Latency: at the same time of vaccination).  It was reported that an immunosuppressant drug was taken by the patient when he received Menactra vaccine in 2019.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
After Dose1 I was 10 weeks pregnant went to doctor for sonogram. I went to doctor heart rate 160 doctor stated everything was fine I could start telling everyone I wa pregnant. On 2/5 I started having a miscarriage the fetus was 12 weeks. My blood work was good no abnormalities from the enzymes.(estimated of delivery 8/17/2021)
States whole arm swollen.  States down several inches below the injection site arm is red and sore.  Painful at that place.  Advised to take ibuprofen and Benadryl if able. To continue to watch as may be signs of an infection.  To call md if worsens.  11/2/10 called and spoke with husband. States now bruised at the site lower than the injection site.  Less painful but still remains swollen. Denies possible injury to cause bruise that far from injection site.
First sign was a burning sensation in my arm that lasted over 1 hr. Then beginning at 4:30 pm I felt tickling in my nose. Blowing my nose ongoing until 8:00 pm then violent sneezing, eyes began itch and swollen. Eyes were running and throat felt very bad. I was experiencing what I would call a severe allergic reaction. I have never experienced anything like that.
Felt like razor blades in the throat; Facial swelling of eyes; Had an allergic reaction; This spontaneous case from the United States was received on 04-Feb-2021 reported by other non-health care professional (consumer) via Med Communications (reference number: SEQW21-00404) and concerned a 56-year-old, female patient.  The patient had no relevant medical history. The patient's concomitant medications included metoprolol, Baby aspirin (acetylsalicylic acid), Zetia (ezetimibe) and Crestor (rosuvastatin calcium), all for an unreported indication.  On an unspecified date in Jan-2018, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, route of administration, anatomical location, dose, batch number and expiration date: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in Jan-2018, during the night after receiving Afluria Quadrivalent, the patient experienced an allergic reaction, facial swelling of eyes and felt like razor blades in the throat. The patient missed work the next day due to reaction and was clear the following day to return to work. The patient did not receive any treatment.  On an unspecifed date, the patient recovered from the events.   The reporter did not provide causality assessment.  Company comment: A 56-year-old patient was administered Afluria Quadrivalent. During the night after receiving Afluria Quadrivalent, the patient experienced an allergic reaction, facial swelling of eyes and felt like razor blades in the throat. The patient missed work the next day due to reaction and was clear the following day to return to work. The patient did not receive any treatment. Chronology is plausible. Causal role of the suspect vaccine is assessed as possibly related for eye swelling, oropharyngeal discomfort and hypersensitivity.; Sender's Comments: A 56-year-old patient was administered Afluria Quadrivalent. During the night after receiving Afluria Quadrivalent, the patient experienced an allergic reaction, facial swelling of eyes and felt like razor blades in the throat. The patient missed work the next day due to reaction and was clear the following day to return to work. The patient did not receive any treatment. Chronology is plausible. Causal role of the suspect vaccine is assessed as possibly related for eye swelling, oropharyngeal discomfort and hypersensitivity.
Patient was getting a booster dose. Had no problems with the primary series. Mother called 1 1/2 hours after patient had the vaccine to say that patient had itching all over and tingling. Instructed to give benadryl and watch if needed to take into the emergency room. Spoke with mother again today and said the symptoms had all gone away after the benadryl and patient was fine now.
Patient reports shivers and flu-like symptoms beginning in the evening, several hours after vaccination. She attributes the symptoms to the PNEUMOVAX as the pain was central to her right arm. Patient reports these symptoms continued for about 4 hours and were gone by the following day, though her right arm still hurt at the time of her call (after noon).
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-OCT-2014 the patient was vaccinated with PNEUMOVAX 23, dose 0.5 ml, intramuscular (lot number and expiration date not reported) and on the same date, the patient was also vaccinated with PREVNAR. No adverse effects reported. Additional information has been requested.
9/20 PM - Arm soreness, lack of energy, felt feverish, tired, headache. 9/14/18 - symptoms started again today.
Fever; Severe body aches; Headache; Diarrhea; Loss of appetite; Tired; Unwell; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 18Mar2021 at 11:00 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 18Mar2021 at 11:00, the patient experienced initially tiredness and unwell feeling. fever up to 103, severe body aches, headache, diarrhoea and loss of appetite. Three days later severe symptoms started and still ongoing (unknown date) over 4 days later. The patient might seek medical attention if not the condition becomes better. The patient not received treatment for the adverse events. The clinical outcome of the events tiredness, unwell, fever, severe body aches, headache, diarrhoea and loss of appetite were not resolved at the time of this report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Patient received her first dose of the Pfizer vaccine today. She has a history of multiple allergies and had been cleared by her allergist prior to vaccination. Approximately 15 minutes after administration, she developed tingling to her lips, dizziness and nausea. She was diaphoretic and pale. She had no other symptoms at this time. See vitals below.  EMS was called immediately.  A 20G IV was started in her right AC. She was given solu-medrol 125 mg IVP, Pepcid 20 mg IVP and Benadryl 50 mg IVP.  She then felt like her throat was closing. She was talking in complete sentences without any issues. Her heart rate was in the 90's and her oxygen was 96%. EMS arrived and she was transferred to the nearest hospital.  The patient notified her husband.     05/28/21 1250 BP: 130/80 Pulse: 82 Resp: 14 SpO2: 97%
TOOK ONLY ONE DOSE OF VIVOTIF; This spontaneous case report (PVX2019-2065) was received from a healthcare professional on 09-Aug-2019. It described a male consumer who "took only one dose of Vivotif" (PT: Incomplete course of vaccination), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took only one dose of Vivotif on 25-Jun-2019 and threw the remaining doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took only one dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only one dose of Vivotif" was considered as not applicable.
first dose on 24Aug2020; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 19-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Standard flu like symptoms, then on the 4th day I felt chest pain right underneath my sternum and my left arm started to go numb. Was diagnosed with myocarditis and released from the hospital 3 days later with a prescription for colchicine and metoprolol.
Patient presented to the ED and was subsequently hospitalized for CVA, TIA within 6 weeks of receiving covid vaccination.
another irregular cycle it came a week early and lasted 8 days; After most recent dose (3rd) I have experienced another irregular cycle; After most recent dose (3rd) I have experienced another irregular cycle; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FC3180) via an unspecified route of administration in left arm on 26Aug2021 10:00 (at the age of 25 years old) as dose 3 (booster), single for COVID-19 immunisation in pharmacy or drug store. Medical history were not reported. Historial vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208) via an unspecified route of administration in left arm on 15Mar2021 13:15 (at the age of 25 years old) for covid-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0150) via an unspecified route of administration in left arm on 05Apr2021 13:15 (at the age of 25 years old) for covid-19 immunisation and experienced irregular periods for about 3 menstrual cycles after 2nd dose. Concomitant medication(s) included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported; drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for birth control from an unspecified start date and ongoing; bupropion hydrobromide (APLENZIN) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.On 08Sep2021,after receiving third dose patient was experienced another irregular cycle it came a week early and lasted 8 days .No treatment was received for the event the another irregular cycle it came a week early and lasted 8 days. The patient underwent lab tests and procedures which included Nasal Swab: negative on 01Jul2021.The outcome of the another irregular cycle it came a week early and lasted 8 days was recovering. Follow-up attempts are completed. No further information is expected.
Patient vaccinated 5/12 as part of ER Patient care team.  Had major reaction 5/19 with some accompanying malaise, axillary lymphadenopathy, slight fever, which resolved by post-vaccination day 9.  On P.V. day 14 (Monday 5/26), maculopapular rash on both forearms, upper chest and back, and face, appeared described as non-blanching, non-migratory and not itchy, although sensitive to hot water.  Currently disappearing.  Patient did not experience fever, eye inflammation, and noticed rash resolving rapidly as of 5/30.  Patient feels as if he is recovering as of 5/30.  Patient took Benadryl on first day of rash, but its only effect was to make him sleepy; no effect on rash.
24 hrs after receiving the High-Dose flu shot, pt complained of a severe headache. He had 3 seizures in the next 5 hrs. Pt seen in ER x2 and remained in hosp 48 hrs.
Ipol was inadvertently administered instead of tubersol/no AE; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional..  This case involves a 33 years old male patient who was inadvertently vaccinated with 0.1 mL IPV (VERO) [IPOL] (batch number P1F54 and expiry date 07-Dec-2020) via intradermal route in the left arm on 26-Aug-2020 for prophylactic vaccination instead of TUBERCULIN TEST [TUBERSOL] for tuberculin test (wrong product administered).  Medical history, concomitant therapy,  medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever for 8 hours with max 101.7, Tylenol taken x2 doses Chills and body aches for 30 hours Sore arm for 60 hours
I on march 22nd, 2022 my temperature went up to 102 and remained for 4 days. I was unable to eat, had night sweats, fatigue and muscle weakness. I was taking multiple 2 hour naps. With lymphoma I have my blood drawn each month. My hemoglobin was on 13 grams usually. On Monday 04/11/2022 my hemoglobin was just under 9 grams. I am feeling good today and normal. My spleens enlarged in March by 2 centimeters. It still is technically within normal limits.
Patient had received her 2nd COVID vaccine and was about 10 minutes into her post vaccination waiting  when she began feeling lightheaded, clammy, and nauseated.  She got up and walked over to the staff desk where she continued to feel lightheaded and developed tunnel vision.  Staff got her into a wheelchair and she subsequently lost consciousness.  They noticed brief arm and leg jerking motions.  She had no bowel or bladder incontinence or tongue bite.  There was no postictal period.  She is brought to the ED.   She has had minimal to eat or drink today.  She does note that she has had multiple syncopal episodes in the past including with blood draws and at the dentist.  She currently feels fatigued and slightly nauseated.  She was lightheaded and had difficulty standing after the episode so she was brought to the ED  The episode sounds more consistent with syncope than seizure given the lack of postictal period, no tongue bite, bowel or bladder incontinence.  She likely had some myoclonic jerks due to syncope in an upright position.  EKG shows normal sinus rhythm without evidence acute ischemia or infarct, low suspicion for ACS or malignant dysrhythmia as cause for syncope, particularly since she had a clear prodrome prior to syncope. Symptoms appear most consistent with vasovagal syncope related to vaccination.  Patient feeling improved after rest and p.o. intake.  Able to ambulate steadily in ED.  Appears appropriate for outpatient follow-up.
10 min following adm of flu vax developed sig. area of erythema, swelling and discomfort around inj site no respiratory prob. Ice pack applied and oral antihistamine advised.