chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness".  Additional information: Reporter withheld said that sometime ago she called in about reporting a reaction which is Dizziness. Caller also mentioned that she received a questionnaire but she messed up on it and requested another one to submit to her Doctor. Caller provided her full name and while providing her address, the call got disconnected.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 inch red circle at injection site, red, swollen, itchy, warm raised circle.
63-year-old pt to ED for respiratory distress/shortness of breath patient states that she has a history of COPD on 2/14. COVID positive upon adm. 2/15 Pt spo2 dropped and intubation team was called. RT adjusted bi-pap FiO2 and pt spo2 climbed. Pt in obvious respiratory distress, 79% on Bipap. Heparin GTT ordered. Pt on Vanco and Cefepime. 2/17 Pt intubated, Fentanyl drip for comfort, SWRx2 to prevent pulling lines/tubes. Pt NST/ST on monitor, stable. 2/18 pt foley removed,Precedex gtt started, Fentanyl titrated off. Pt remains on vent. Critically ill; no acute cardiac issues. 2/21 pt remains on the ventilator, sedated, following simple commands. Pt discharged 2/25 with non productive congested cough noted.
This spontaneous report as received from a medical assistant refers to a 21 year old male patient with penicillin allergy. The patient had no pertinent medical history. On 02-MAY-2013, the patient was vaccinated with the first 0.5 ml dose of GARDASIL intramuscular injection (lot # 0420AE, expiry date 01-DEC-2014). On 17-AUG-2015, the patient was vaccinated with the second 0.5 ml dose of GARDASIL intramuscular injection (lot # K016966, expiry date 10-MAY-2017). Concomitant therapies included ADDERALL. On an unknown date, after receiving the second dose of GARDASIL, the patient developed soreness, 1 to 2 inches in diameter, around the injection site. The patient sought medical attention-he was seen in the office on an unspecified date. No treatment was given for the event and no diagnostic lab studies were performed. The outcome of the event was reported as not recovered. The relatedness between GARDASIL and the event was not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Bilateral rash on upper and lower extremities and torso within 1 1/2 to 2 hours, post vax, (1st time IPV). Reaction is questionable. Pt sent to medical center and they are unsure if reaction to shots and sent pt home. The follow up received on 2/22/02 states resolved within 2 weeks per parent. No further follow up.
skin irritation or hives; Rash; hives like skin irritation; This is a spontaneous report from a contactable consumer. This unspecified age and gender patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were not reported. On an unspecified date patient experienced minor hives like skin irritation below the injection site and rash. Patient stated that I do not need any medical assistance. Outcome of the events was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications and pertinent medical history reported. On 15-OCT-2015, the patent was vaccinated with a dose of improperly stored M-M-R II lot # J016232, (dose, strength, route of administration and expiry date were not reported). No adverse events were reported. The reason for the temperature excursion was because daily vaccine counts cause the storage unit to have temperature fluctuations because of the door opening. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence has been received.
the 24 hour mark i had light itching in my private area at the 48 hour my body had aches as the day went on i felt tired an aches  by lunch time i was tired and nauseous.  i stayed nauseous all day. when i got off at 5:00 i went right to bed.  i did sleep on my lunch.  i stayed in the bed. by about 9:00 pm i made some tea with fresh ginger and had soup and started to feel better.  my story still felt sour.  but i kept sleeping off and on.  when i got up i felt a lot better i drank some more ginger tea and my stomach was better
Mild pain at injection site.  Fever & body aches 3 days later for approximately 3 hours.
interchange of vaccine products; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 Treatment, Paxlovid from 15Dec2022 to 19Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, the pandemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
injection site reactions after receiving flu and pneumonia vaccines while on Ibrance; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 60-year-old female patient received palbociclib (IBRANCE); pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE REACTION (non-serious), outcome "unknown", described as "injection site reactions after receiving flu and pneumonia vaccines while on Ibrance". The action taken for palbociclib was unknown.  Additional information: patient reported injection site reactions after receiving flu and pneumonia vaccines while on Ibrance. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of MMR II. Subsequently the patient developed mumps. On 03-DEC-2009, lab test revealed mumps immunoglobulin M antibody < 1:10, mumps immunoglobulin G antibody 4.29 and amylase 273. This is one of several reports received from the same source. No further information is available.
No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report as received from a physician refers to an 13 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 21-JUL-2017, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766:
"Patient felt like her tongue was getting thicker 5 mins s/p injection. Patient was escorted to the triage area. Vitals done: Pulse 54/min, BP-RUL supine - 137/63mm of Hg. On Exam: Tongue- no obvious swelling noted. - warm and moist. Skin, Auscultation - Patient has bilateral good air entry , no wheezes. Pulse- Radial normal. Patient is alert and oriented. Patient was given Benadryl 25mg oral. S/p med 10mins, patient felt her tongue feels better now. S/p 30mins patient states she feels well and has no symptoms. Patient was observed ambulating in the triage area- stable. Patient was then allowed to leave the facility, her husband who accompanies her will be driving her home."
lying prone on his back and as soon as he laid prone on his back his head went into a storm like a brain storm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 95 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Mar2021 14:30 (Lot number: EN6205) at the age of 95 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing); "slow heartbeat" (ongoing); "thin blood" (ongoing); "cholesterol" (ongoing); "stroke" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension, cerebrovascular accident (ongoing); ATORVASTATIN taken for blood cholesterol (ongoing); METOPROLOL taken for heart rate decreased (ongoing); WARFARIN taken for blood disorder (ongoing). The following information was reported: DIZZINESS POSTURAL (non-serious) with onset 15Mar2021, outcome "not recovered", described as "lying prone on his back and as soon as he laid prone on his back his head went into a storm like a brain storm". Therapeutic measures were not taken as a result of dizziness postural.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. It was reported that the patient left the clinic in good shape and the next morning on Monday 15Mar2021 at the time he got up in morning he goes through a throat exercise for the stroke he had. The reporter stated he was lying prone on his back and as soon as he laid prone on his back his head went into a storm like a brain storm, it was hurricane velocity everything in bedroom was flying all over place in his head. He lifted his head a little bit and that was the end of that storm it broke. The patient got out of the position as fast as he could and was fine. Patient stated that "he relayed to the nurse his experience and the only thing on paperwork he was saying other people have had was dizzy and the nurse put down he was dizzy". It was further reported that on 19Mar2021 (Friday morning), he laid on back in prone position and the same thing happened, he lifted his head a little and saw his mattress coming at him and he grabbed it to hold on and he stated he was not going to try it again. The event stayed about the same and that he was not going to do it anymore it would take a month or two months to try again.  No follow-up attempts are possible. No further information is expected.
Physician reported pt received vaccine on 10/6/00, on 10/8 he developed a generalized rash over his upper body. As of 10/18, the rash persisted. Pt did recover.
Patient is a 79 y.o. male patient of DO with history of hypertension, chronic A. fib on anticoagulation, CAD, dyslipidemia presented to Hospital with generalized weakness, cough and shortness of breath admitted for COVID-19 Clinical Summary   Covid-19 Virus Infection Date of onset of symptoms: 2 days PTA Symptoms present on admission: DOE Date of covid positive test: 12/19 Vaccination status: vaccinated Imaging: CXR Oxygen requirements on admission: 2 lit Current oxygen requirements: 2 lit Medical therapy: steroids Consultants following: None Anticipated special isolation end date: 12/29  - Supplemental oxygen requirement resolved   Weakness Secondary to COVID PT and OT consult   Paroxysmal afib In NSR. On amio and cont on Eliquis   HTN Cont on Lisinopril and Toprol   Diabetes type-2 Hold Metformin, add SSI   BPH Cont on flomax   Dyslipidemia Cont on Statin
No symptoms appeared immediately after vaccination, although patient passed away around 6:00 pm unexpectedly. Staff talked with her last time at 5:30 pm and then found her at 6:00 pm passed away.  Unknown at this time if death is directly related to receiving the vaccine.
inadvertently given expired product, with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA419169(CLUSTER) and 2022SA420010(CLUSTER).  This case involves a 6 years old female patient who was inadvertently given expired product, with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.5 mL total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation and strength not reported; lot UT7378MA and expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date, the patient was inadvertently given expired product, with no reported adverse event (expired product administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
Headache, Fever, NauseaVomiting, fever 101.5 , GI issues, HA, Narrative:
really sick 12 hours after injection; joint pain; nausea; headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ILLNESS (really sick 12 hours after injection), ARTHRALGIA (joint pain), NAUSEA (nausea) and HEADACHE (headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced ILLNESS (really sick 12 hours after injection), ARTHRALGIA (joint pain), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, ILLNESS (really sick 12 hours after injection), ARTHRALGIA (joint pain), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170/90 mmHg (High) 170/90.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
pt started w/fever of 102 rose to 104 shortly afterward; vomited; unable to keep any food or liquid down Thursday noc or Friday; mom took pt to MD lethargic;
chills, 101 fever, aches, tiredness, sore arm, a rash on the arm but not at the site of the injection for a couple of days.
Monovalent Covid-19 (Pfizer and Moderna) boosters were administered to 24 patients after FDA removed their authorization: these errors occurred from 9/1/22 to 9/7/2022. No more monovalent booster vaccines administered after we received the Bivalent Boosters on 9/8/2022. No adverse event noted. RN.
1 mL Flashpoint needle syringe containing 0.3 Pfizer COVID vaccine was inserted into patient's right deltoid. As syringe was plunged, the vaccine fluid was forced out of faulty syringe onto patient's arm.   An additional dose/needle/syringe of the vaccine was required to properly vaccinate patient.
Uncontrollable body shakes without a fever; Pain in lymph node under left armpit; full body aches; Headache; This is a spontaneous report from a contactable consumer or other non hcp reported for himself. A 26-year-old male patient received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247; Expiration date was unknown), via an unspecified route of administration, administered in Arm Left on 10Feb2021 10:15 (at the age of vaccination 26-year-old) as 2nd dose single, for COVID-19 immunization. Medical history included asthma, Heart arrhythmia. Patient previously received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247; Expiration date was unknown), via an unspecified route of administration, administered in left arm on 19Jan2021 13:30 (at the age of vaccination 26-year-old) as 1st dose, single for COVID-19 immunization. The patient's concomitant medications were not reported. The 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 had not been tested for COVID-19. Patient had no known allergies. On 11Feb2021 01:00 the patient experienced uncontrollable body shakes without a fever, pain in lymph node under left armpit, full body aches, headache. Patient did not receive any treatment for events. Reporter considered all the events as non-serious. The outcome of event was Not Recovered/Not Resolved.  Follow-up attempts completed. No further information expected.
I looked in the mirror & saw my bottom right eye orbit swelled.; I had fatigue & chills the following day after i got my vaccine.; I had fatigue & chills the following day after i got my vaccine.; I took ibuprofen for the pain in my back & arm; I took ibuprofen for the pain in my back & arm; When I stared to rest, I felt pressure when opening & closing them; This is a spontaneous report from a contactable other hcp (Patient). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8737) via an unspecified route of administration at arm left on 30Mar2021 16:45 as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history was not reported. Concomitant medication included vitamin d nos (VITAMIN D NOS). On 31Mar2021 The patient experienced and had fatigue and chills the following day after she got vaccine and took ibuprofen for the pain in my back & arm and when stared to rest she felt pressure when opening & closing them and looked in the mirror & saw her bottom right eye orbit was swollen and was conserved if she was having a reaction to the vaccine and called a nurse & tell a doc. They advised me to do cold compressions & take benadryl. Therapeutic measures were taken. The outcome of the events was recovered.; Sender's Comments: The causal association between the event bottom right eye orbit was swollen and the usage of the vaccine BNT162B2 cannot be excluded based on strong temporal association. As there is limited information in the case provided, the case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
rash over body; hives, SOB, wheezing; condition poor in ER improved, thru noc;
Patient under-dosed for section vaccine shot. Pfizer consulted and suggested that patient be brought back in to receive balance of their full dose (full dose = 30mcg).  Patient came back to clinic to receive balance of full dose.
Flu-like symptoms, Headache, muscle ache, Joint pain, injection site pain, fatigue. No treatment, eventually went away.
Ten days post vax the pt developed 50 varicella lesions with a fever, pharyngitis, cough, and malaise.
Guillain-Barre syndrome; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced guillain barre syndrome after receiving a flu vaccine dose. The reporter stated that the patient did not know what brand of vaccine she received prior to onset of Guillain-Barre syndrome. The reporter consented to follow up via email. No further information was available.
Patient had excessive swelling on left side from face to toes (shot was on left side) received shot at 9am - symptoms came at 5pm.
Left breast doubled in size, two painful lumps over two inches in size, each directly behind nipple and one on left side, rash all over chest, hot to touch and lasted two weeks followed by skin sloughing off all over chest. Then right arm developed painful rash that felt like I had come into contact with fiberglass insulation which lasted two days. Over all had a feeling of  severe anxiety and depression with suicidal idealizations for three weeks.  Completely fine and no symptoms now.