chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low heart rate / about 45; vasovagal syncope; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 12Apr2021 at 16:00 (Batch/Lot number was not reported) (at the age of 20 years old) as single dose for covid-19 immunisation. Medical history included allergy to latex. The patient was not pregnant at the time of vaccination. Patient did not have COVID-19 prior to vaccination. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 02Mar2021 at 3pm, via an unspecified route of administration, administered in left arm (lot number: unknown) (at the age of 20 years old) for covid-19 immunisation. Concomitant medication included etonogestrel (NEXPLANON) taken for an unspecified indication, start and stop date were not reported. On 13Apr2021 at 11:00, the patient experienced low heart rate and vasovagal syncope. Heart rate at about 45. Heart rate remained under 60 for 48 hours post vaccine. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with IV (as reported). Patient was not tested for COVID-19 post vaccination. The patient underwent lab tests which included heart rate: about 45 on 13Apr2021 11:00. Outcome of the events was recovered.    The lot number for BNT162B2 was not provided and will be requested during follow up.
Patient presented to the ED  on 3/9/22 and received his booster dose while in the ED.  Patient presented to the ED  on 3/16/22 and was subsequently hospitalized for right foot infection (gangrene) and confusion.
Generalized urticaria within 2 hours of vaccinations, lasted >1 week.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing), notes: Other medical history: Afib. 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 Treatment". Paxlovid was taken as therapeutic measures as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300199012 Same patient, different product/events;
This spontaneous report was received from a pharmacist via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route of administration and lot # were not reported). On an unknown date the patient experienced lupus like symptoms. The pharmacist did not provide any further clarification about the symptoms. She sought unspecified medical attention on unknown date. The patient had not been diagnosed with Lupus at the time of the report. The outcome of the event was reported as recovered/resolved on unknown date. Upon internal review the event of experienced lupus like symptoms was determined to be medically significant. Additional information has been requested.
lt arm redness & swelling @ site of inj dec approx 2" diameter edematous area;also c/o itching @ site;
adacel was administered to patient after expiration date with no reported adverse event; Initial information received from on 28-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 50 years old male patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered to patient after expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza Vaccine Inact Split 4V (Fluzone Quadrivalent) for prophylactic vaccination.  On 28-Sep-2022, the patient received a dose 2 at dose of 0.5ml once of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (lot U7528BA; Expiration Date :29-Sep-2022) via intramuscular route in the left deltoid for immunization after expiration date with no reported adverse event (expired product administered) (latency :  same day).  Action taken : not applicable.  Outcome: Unknown.  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.
Fever; Chills; Aches; Really bad diarrhea; A spontaneous report was received from a consumer concerning a patient of 57-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced fever, chills, aches and diarrhea.  The patient's medical history, not provided by the reporter.  Concomitant product used was not provided.  On 5 Feb 2021, approximately 1 days prior to the onset of the symptoms the patient received their first of two planned doses of mRNA-1273 (Batch number: 043L20A) unknown route ,injection site- unknown for prophylaxis of COVID-19 infection.    On 08 Feb 2021, the patient developed fever, chills, aches and really bad diarrhea.   Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event(s) fever, chills, aches got resolved on 9 Feb 2021. The outcome of the event diarrhea was unknown.
Patient had jerking motions,  passed out and fell on the floor. sweating, discoloration of face. 911 was called, and pt was taken by ambulance to hospital
Information has been received from a physician concerning a child who was vaccinated with a dose of hepatitis A virus vaccine inactivated.  The reporter indicated that the patient received a dose that was later recalled.  The vaccine was administered again and the total number of injections was reportedly unknown.  A titer revealed an elevated IgM.  Unspecified medical attention was sought.  Additional information has been requested.
Paralysis on one half of her whole body; Dizzy; This case was reported by a consumer via call center representative and described the occurrence of paralysis one side of body in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included narcolepsy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced paralysis one side of body (serious criteria GSK medically significant) and dizziness. On an unknown date, the outcome of the paralysis one side of body and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the paralysis one side of body and dizziness to be related to Shingrix.     Additional Information: GSK receipt date: 20-May-2022 Reporter's comment: The patient self reported this case. She received a dose of Shingrix about 18 months ago (exact date not provided). She noted that after receiving the vaccination, she became dizzy and experienced paralysis on one half of her whole body.  Her health care professional referred her to the emergency room which she did visit and they did not come to any conclusion and the symptoms did resolve. She also stated she never received the second dose due to the issue experienced and was not sure if she would. Referred to health care professional and provided medical advise disclaimer. The reporter consented to follow up. Note: There is discrepancy regarding the event outcome query was raised for the same.
2/25/04 severe headache, 2/29/04 severe headache, syncopy, leg cramps, vomiting & diarrhea for 2 days.
Patient experienced fever and fatigue 24 hours after. She self-medicated with over-the-counter Tylenol. She also had redness on her arm near the injection site (approximately 4 inches wide). It was warm to the touch but not itchy or painful at the time of the visit. She previously states that it was sore days after the injection .
Loss of eyesight starting at about two weeks after immunization. "Optic neuritis".  3/3/09 MR received for DOS 12/4-8/2008 with D/C DX:  Optic Neuritis. Pt presented with c/o worsening vision x 6 days. Initially L eye went blurry and several days later R eye. Started on prednisone with improvement noted by day 4. D/C on oral pred.   10/30/09 Medical record received for DOS 12/04/08- 10/15/2009 Adolescent c/o decreasing vision bilat 13 days  s/p vaccine. Unable to read.  MRI positive for optic neuritis. Admit for IV steroid therapy. Sight returning by day 4 w/ improvement of light sensitivity and object recognition. Oral steroids upon d/c.  All lab work normal. LP WNL except for elevated glucose. All titers neg.   Discharge to home. Planned optho follow-up.  Continuous improvement over time. Last eye exam showed refractive error-myopia, astigmatism. Also documented  were obesity and pre-hypertension concerns. Nutritional/dietary consult.  ED visit on 2/25/08 also noted for bilat wheeze, cough, post nasal drip and nasal itching. Exacerbation of childhood asthma.
This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 36-year-old female patient received BNT162B2, via an unspecified route of administration in Mar2021 (Batch/Lot number and expiry date were not reported) as 2nd dose, single for COVID-19 immunization. Medical history included migraines (treated with Relpax and Botox) and not tolerating medication, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 in Feb2021 for COVID-19 immunisation; eletriptan (RELPAX) and botox, both for migraine. The office manager told the physician about her daughter who got the Pfizer COVID vaccine shots in February and March. She did not have any immediate adverse events. However, in April she started having underlying chest pains for 13 days and her rheumatologist diagnosed her with lupus and said it was caused by the COVID vaccine. The patient has a history of not tolerating medication very well. She also has migraines treated with Relpax and Botox. The outcome of the other events was unknown.  The following information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of lupus and chest pains cannot be excluded. 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.
really bad diarrhea on Sunday and Monday morning; A spontaneous report was received from a consumer who is a 66 Years-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea.  The patient medical history was not provided. No concomitant medications are reported.  On 30-JAN-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273.   On 31-JAN-2021, the patient experienced the event really bad diarrhea until 01-FEB-2021.  No treatment medication has been provided  Action taken with mRNA-1273 in response to the events was not reported  At the time of this report, the outcome of the event really bad diarrhea is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  The reporter stated that the vial was frozen this whole time and was thawed out one day before use. Date the vails was initially stored in the refrigerator 23 Oct 2021 and 24 Oct 2021.   This case was linked to MOD-2021-363223 (Patient Link).
Began have have blood in urine approximately 12 hours after receiving second dose of vaccine. This is still ongoing.  I experienced all other side effects as well including fever, nausea, chills, muscle aches, fatigue, and headache but these symptoms have improved.
blood pressure is fine, actually is low; fast heartbeat; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), HEART RATE INCREASED (fast heartbeat) and HYPOTENSION (blood pressure is fine, actually is low) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Allergy.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 11-Feb-2021, the patient experienced HEART RATE INCREASED (fast heartbeat). On an unknown date, the patient experienced HYPOTENSION (blood pressure is fine, actually is low). On 12-Feb-2021, VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, HEART RATE INCREASED (fast heartbeat) and HYPOTENSION (blood pressure is fine, actually is low) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details included medications for hypertension and allergies. Treatment details was not reported by the reporter.
Information has been received from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB pediatric formulation 5 microgram/0.5 ml (dose, lot # and route unspecified). Information regarding medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
constant crying from time of vax for about 5 hrs wouldn't take formula, unable to quiet-pt taken to ER; t101; instructed to return to HD; infant wouldn't swallow APAP brought to HD observed for 1 hr;
migraine, soreness in arm, unable to lift arm or turn head, whole body aches, extreme chills, slight nausea
very swollen, inflamed thigh around inj site & fever 104;viral illness concomitantly;
I noticed Tuesday after physical therapy for my tennis elbow that my calf was feeling tight and tense. I was scheduled for a follow up visit for my elbow on Thursday or Friday, he looked at my leg and sent me to have a doppler of my calf. That night in the hospital they sent me for a CT scan of my calf as the blood clot was mid-way up my calf down to my ankle. They also ordered a CT scan with and without contrast of my chest and discovered tiny blood clots in my lungs. They put me on a heparin drip to slowly break up the blood clots.
Immediately post vax, the pt experienced sharp pain in his injected left arm. Thereafter, he experienced muscle aches in his calves with weakness and found it difficult to shave. Also, he has experienced joint pain, premature atrial contractions, paresthesia, fatigue/lethargy, and he felt his mentation was clouded. Per medical records, the pt believes he has had a possible allergic reaction to the Lyme vaccine, and the physician questioned if he had a possible adverse reaction. His symptoms were treated with Vioxx and prednisone with no effect. Upon physical exam his joints were not swollen or warm and no joint fluid was obtained. Information received on 5/30/00 reported the symptoms as ongoing. The pt complains of migratory muscle pains shooting in his arms, and as of 5/10/00 he felt achy and more lethargic.
pt recvd flu vax & pt devel redness, edema, & hardness @ inj site; Medical Affairs comment: inj was given SC; flu Shield is labelled for IM inj;
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA308762, 2018SA308764, 2018SA308765, 2018SA308766 (same reporter). This case involves a 40 years old patient (unspecified gender) who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE lot UJ029AB via intramuscular route instead of FLUZONE QUADRIVALENT on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (It was reported that nurse accidentally opened a box of FLUZONE HD instead of FLUZONE QUAD, and administered 5 patients under the age of 65 a dose of FLUZONE HD inadvertently). It was a case of accidental overdose. It was not reported whether the patient experienced any adverse events or not. 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. List of documents held by sender: none.
I felt fine until I rubbed the knot at injection site around 6 PM. (somewhere I had heard you should do that.)  In 15 minutes I became dizzy, weak and nauseous. My blood pressure was 141/85 P60.  (BP was 120/62 at Dr. Office earlier in the day) The dizziness persisted until around 2:30 am. I went to bed at 8 pm, awoke at midnight still dizzy, but awoke at 2:30 completely well but with a feverish knot at injection site.
Legs feel heavy; Walking through sludge; Injection site is now itchy more like a mosquito bite; Chills; Shot felt more uncomfortable; Liquid going in a vein in her arm; Feeling tired; Dull headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Shot felt more uncomfortable), VASCULAR COMPRESSION (Liquid going in a vein in her arm), LIMB DISCOMFORT (Legs feel heavy), GAIT DISTURBANCE (Walking through sludge) and VACCINATION SITE PRURITUS (Injection site is now itchy more like a mosquito bite) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced FEELING ABNORMAL (Shot felt more uncomfortable), VASCULAR COMPRESSION (Liquid going in a vein in her arm), FATIGUE (Feeling tired) and HEADACHE (Dull headache). On 31-Mar-2021, the patient experienced CHILLS (Chills). On 01-Apr-2021, the patient experienced LIMB DISCOMFORT (Legs feel heavy), GAIT DISTURBANCE (Walking through sludge) and VACCINATION SITE PRURITUS (Injection site is now itchy more like a mosquito bite). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 30-Mar-2021, FEELING ABNORMAL (Shot felt more uncomfortable), VASCULAR COMPRESSION (Liquid going in a vein in her arm) and HEADACHE (Dull headache) had resolved. On 31-Mar-2021, FATIGUE (Feeling tired) and CHILLS (Chills) had resolved. At the time of the report, LIMB DISCOMFORT (Legs feel heavy), GAIT DISTURBANCE (Walking through sludge) and VACCINATION SITE PRURITUS (Injection site is now itchy more like a mosquito bite) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information also included ice packs   This case was linked to MOD-2021-066039 (Patient Link).