chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Febrile seizure; This is a literature report.  A child patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEBRILE CONVULSION (medically significant), outcome "unknown", described as "Febrile seizure". The patient underwent the following laboratory tests and procedures: Body temperature: Unknown results.  VAERS is a passive vaccine safety surveillance system managed by CDC and FDA that monitors adverse events after vaccination. VAERS accepts reports of postvaccination adverse events from health care providers, vaccine manufacturers, and members of the public. Signs, symptoms, and diagnostic findings in VAERS reports are assigned Medical Dictionary for Regulatory Activities preferred terms (MedDRA PTs) by VAERS staff. Reports of serious events to VAERS were reviewed by CDC and FDA physicians to form a consensus clinical impression based on available data. VAERS reports were described by serious and nonserious status, demographic characteristics, and MedDRA PTs. VAERS is a passive reporting system and is subject to reporting biases and underreporting, especially of nonserious events.  No follow-up attempts are possible; information about the lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event febrile convulsion with BNT162b2 can not be fully 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.,Linked Report(s) : US-PFIZER INC-PV202200058294 Same article/drug, different patient/event;
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to metals, Latex allergy and Food allergy. Concomitant products included SERTRALINE and PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 15-May-2020 to an unknown date for an unknown indication.   On 07-Jan-2021 at 7:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 08-May-2021. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 05-Feb-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2020, Pregnancy test: positive (Positive) Positive. On 02-Oct-2020, Ultrasound scan: unknown (Inconclusive) Unknown. On 28-Dec-2020, Ultrasound scan: unknown (Inconclusive) Unknown. On 17-Feb-2021, Blood glucose: passed (Inconclusive) Passed.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Patient demographic, second dose details, Concomitant medication details, Lab test were updated.Gestation Period, Delivery Date, Birth Type and Fetal Outcome has been updated.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Pt hd a large rash and swelling of approximately 3" diameter after administration. She has since recovered.
Chest pains; Dizziness; Slight cough; Some breathing difficulties.; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient reported for himself that he received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Ewo187), via an unspecified route of administration, administered in arm left on 31May2021 at 11:00 AM (age at vaccination was 68 years) as DOSE 1, SINGLE for covid-19 immunisation at pharmacy or drug store. The patient medical history and concomitant medications were not reported. No other vaccines were received within four weeks prior to the administration of bnt162b2. The patient received unspecified blood pressure medication within 2 weeks of vaccination. On 01Jun2021 at 12:00 PM, the next day of vaccination, the patient experienced chest pains, dizziness, slight cough and some breathing difficulties. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: results not reported on an unspecified date. No treatment was received for the events. The outcome of the events was unknown.
Fever chills, and fatigue, swollen red painful arm with  itching Narrative:
On initial reaction patient was ok has never had a reaction in the past from other vaccines. Patient was out in the waiting room with mom and sister making an appoitnment for next vaccine. Patients stated that she started feeling dizzy and stated blacking out pt fell nausea. Mom took her to the restroom where she did not vomit. Pt told mom that she felt better, then I walked in and assisted pt to a room to lay down pt vital I gave pt 2x163mls of apple juice and a cup of water. Pt only had a cup of milk for breakfast. After 20min pt felt better I called Dr. to come and take a look at pt after his assessment pt was ok to go home.
Sweating, nausea, unable to sleep, arm pain, pain in muscles, stiff neck
elevated blood sugar levels of 200-250 mg/dL.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient wife). A 79-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 29Jan2021 as DOSE 1, SINGLE for covid-19 immunization (79 year when vaccinated). The patient medical history and concomitant medications were not reported. On an unknown date, It was reported that since the patient received vaccination his blood sugar levels were elevated. On an unknown date, the patient had his sugar level checked and results show values between 200-250 mg/dl. The outcome of the event was reported as unknown at the time of report.  No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
The patient is a 37-year-old female presenting for adverse reaction to Covid vaccination.  Patient received her second Moderna vaccination injection on Friday.  She states that she has been having increased rash to her chest, face, arm, and her lymph nodes are inflamed.  She denies true fevers but admits to chills.  She denies denies nausea.  She was to worsening body aches.  She has been taking over-the-counter medications without any improvement of her symptoms. There is no respiratory distress.  She was unable to see her PCP today and was directed to come to the emergency department for evaluation of reaction
This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 68-year-old female patient who received SHINGRIX (batch number 3S354, expiry date 7th July 2020) and (batch number X3M27, expiry date 29th August 2020). Concomitant products included SHINGRIX. On 28th March 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, the dose was an unknown dose. On 28th March 2018, less than an hour after receiving SHINGRIX, the patient experienced dizziness, shivering, feeling cold and body temperature increased. On an unknown date, the patient experienced nausea, appetite lost and headache. On an unknown date, the outcome of the dizziness, nausea, appetite lost, shivering, headache, feeling cold and body temperature increased were recovered/resolved. It was unknown if the reporter considered the dizziness, appetite lost, shivering, headache, feeling cold and body temperature increased to be related to SHINGRIX. The reporter considered the nausea to be related to SHINGRIX. Additional details were provided as follows: The patient did not have any other concomitant medications. The patient received the 2nd dose of SHINGRIX, 60 days after the 1st dose in SHINGRIX series. The patient did not receive any other vaccines on date of SHINGRIX vaccination. The lot number (X3M27) and expiration date (29th August 2020) were provided for the solution. The patient was dizzy within 30 to 50 minutes after receiving SHINGRIX. Less than a day (within 5 hours) after receiving SHINGRIX, the patient experienced shivering, described as shivering uncontrollably, feeling cold, and temperature of 99 degree F (body temperature increased). In 2018, less than a month after receiving SHINGRIX, the patient experienced nausea, appetite lost and headache. These events continued intermittently and completely resolved as of 5th April 2018. The reporter denied the events jeopardized or required intervention to prevent life threatening outcomes such as death, hospitalization, or disability. The patient advised the reporter that she was open to contact from GlaxoSmithKline should any additional details be required. The reporter could not confirm or deny the patient provided permission to contact healthcare professional.
Patient is 62 years and 9 months old, she was given the above vaccine in error. Vaccine is indicated for 65 years of age and up.  Patient has been called but has not returned the call. Patient has been seen in the same clinic 11/03/2023 for RSV vaccine. No notes on chart to indicate any adverse effect from the High dose flu vaccine.
Pt recvd 2nd dose of Hep B vax 4OCT91 & 2 day later pt devel pain in rt ear & rt jaw; pt recvd no tx for exp;
Stabbing pains in top of left foot and joint of left thumb. Back aching bad headache, feeling weired, T 100.6. face bright red and patient was chilling.
1/11/2021, I experienced fatigue, sore arm next day. Flu-like symptoms. A week later I experienced achy joints and small swollen clavicle node. Saw doctor. Symptoms subsided about two weeks after vaccination.
One week after receiving the vaccine, patient woke up with her face badly swollen. It has slowly gotten more swollen over time.
Pt received Flu vaccine. Approximately 5 min later c/o itching. Hives noted to trunk & upper extremities. MD called to scene & ordered 25 mg PO BENADRYL. Pt then c/o throat tickle & itching. EPIPEN 0.3 mg administered. Pt voices immediate relief from throat discomfort. Itching remains. D/C home w/ prednisone PO, ZANTAC PO & EPIPEN.
pt recvd vax at work at approx 4pm; suffered a sz at 8pm at home & was admitted to hosp on 31oct94 w/ dx of szs; CT & MRI indicates blood vessel abnormality; now taking Dilantin 4ID;
taste buds are not really there anymore; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: Unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TASTE DISORDER (non-serious) with onset 2021, outcome "recovering", described as "taste buds are not really there anymore"; DECREASED APPETITE (non-serious) with onset 2021, outcome "recovering", described as "loss of appetite".  Additional information: He usually has a very healthy appetite, but it has been going down hill. He has been eating stuff to get something in his stomach.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to the emergency room on January 28th after taking an overdose of a variety of pills. Behavioral health admission and treatment. Hospital admission within 6 weeks of receiving the COVID vaccine. Additional ED visit for overdose on 2/21/2022 - treated and released.
This spontaneous report as received from a health worker refers to a patient of unknown age. On 27-MAY-2014 the patient was vaccinated with an expired dose of M-M-R II (HSA), lot no. h009782, expiration date 15-MAY-2014, 0.5 ml, subcutaneously. No adverse effect reported. Additional information has been requested.
Information has been received from a nurse practitioner concerning an elderly female who on 06-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck). Subsequently, the patient recovered from rash and felt generally poor. Unspecified medical attention was sought. No product quality complaint involved. Additional information is not expected. The N.P. could not identify the patient that experienced these adverse events.
Information has been received from a nurse concerning a 76 year old female with hypertension who on 12-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 12-JUN-2007 or 13-jun-2007 the patient developed swelling in her feet.  At the time of this report the patient had not recovered.  No medical attention was sought.  There was no other information provided.  There was no product quality complaint involved.  Additional information has been requested.
12Feb91 pt 2nd vax w/ booster dose MMR; 15 min devel pain in left elbow + both knees assoc w/ redness + swelling.  Complained of lightheadedness, nausea, + achiness in knees + ankles. Tx w/ APAP + Benadryl.
Pain, swelling, redness and itching immediately after received it. "Pooling of fluid", left arm.  Any outdoor air made it worse.  (Saw Dr. several weeks after). May 2010 - pain, swelling, redness and itching continues. Consulted MD once again.
Too much pain in my shoulder, arm and done to my fingers.  Movement in my arm is hard and pain is all day, without getting any better after all this time. OTC pain medication doesn?t help the pain.
inadvertently administered the Fluzone High-Dose vaccine twice/no AE; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 66-year-old male patient who was inadvertently administered the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] prefilled syringe twice (lot UJ535AA, expiry date not reported) (extra dose administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received no concomitant vaccines.  It was reported that the patient was inadvertently administered the Fluzone High-Dose vaccine twice, once on 25-Sep-2020 and again on 09-Nov-2020. Patient received no concomitant vaccines. Vaccines were administered at a retail pharmacy.  Pharmacist reported that, so far, the patient has not reported any adverse effects related to the Fluzone High-Dose. Pharmacist had the lot number and expiration date for the second Fluzone High-Dose injection administered on 09-Nov-2020 but not for the first one administered on 25-Sep-2020.  It was case of actual medication error due to extra dose 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.  There will be no information available on the lot number (of first dose) for this case.
side effects of loss hair; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (side effects of loss hair) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (side effects of loss hair). At the time of the report, ALOPECIA (side effects of loss hair) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Immediately after injection, pt noted salty taste in mouth. This subsided but pt also reported numbness/tingling of tongue - tip -> 1/3. Denied SOB, swelling, difficulty swallowing. Pt followed x24 hrs - sx minimally subsided; not complete resolution.
COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Lung fibrosis, Pulmonary hypertension and Drug allergy (Codeine). Concomitant products included GABAPENTIN from 04-May-2022 to an unknown date for an unknown indication.  On 20-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 02-Jun-2022 to 04-Jun-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The patient received unspecified medications/products within 2 weeks of starting COVID-19 treatment. On 02-Jun-2022, the patient also experienced abdominal pain, nausea, diarrhea, vision changes, dizziness, headaches, insomnia and hoarseness and it was recovered on 06-Jun-2022. The device date was reported as 06-Jun-2022.  Company comment: This spontaneous case concerns a 37-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of an unspecified dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for the treatment of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 37-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of an unspecified dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for the treatment of COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Symptoms lasted 2-3 days.  10 days after shot, for the first time in my life I experienced chest pain.  I thought I was experiencing possible blood clots.  I went to the hospital.  EKG and blood results were negative.  The next day after a stress test, I was transferred to another hospital for a heart carth.  I have an artery clogged and will have open heart surgery on 5-13-2021.
Severe right shoulder and upper arm pain with mild rash of upper arm. KENALOG 40 mg IM given, TYLENOL #3 and Ibuprofen 800 mg tid.
Loss of smell and taste, chills, fever, dry cough, fatigue, muscle aches, joint pain. shortness of breath
LMP: 4/23/2021. Vaginal bleeding appeared mid-cycle on the day mentioned in item 5, accompanied with cramping. It appeared like spotting in the beginning and increased to an amount similar to first day of period. Cramps stopped after two days but bleeding has been persistent, with next period occurring early on 5/18 (expected was 5/22).
10 year old male receiving Flublok Quadrivalent in error; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 years old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and reported that 10 year old male receiving Flublok Quadrivalent in error (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 04-Oct-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1924 via intramuscular route in the left arm.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if the patient had any adverse 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 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.
Pt says she experienced nausea fever. Swelling, redness in the arm which was vaccinated with PNEUMOVAX 23.