chrisvoncsefalvay/vaers-outcomes huggingface dataset:
head feeling like it is in a vice, then brain fog; head feeling like it is in a vice, then brain fog; being tired; seeing spots before her eyes; in the dark seeing flashes of light; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE), administration date 01Mar2021 (Batch/Lot number: unknown) 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: TENSION HEADACHE (non-serious), FEELING ABNORMAL (non-serious) all with onset 02Mar2021, outcome "unknown" and all described as "head feeling like it is in a vice, then brain fog"; FATIGUE (non-serious) with onset 02Mar2021, outcome "unknown", described as "being tired"; VISUAL IMPAIRMENT (non-serious) with onset 02Mar2021, outcome "unknown", described as "seeing spots before her eyes"; PHOTOPSIA (non-serious) with onset 02Mar2021, outcome "unknown", described as "in the dark seeing flashes of light".  Additional information: This report was received via Pfizer-sponsored program. The course of the events was as follows: Patient had her first COVID-19 vaccine last Monday, on Tuesday complaints of head feeling like it was in a vice, then brain fog, being tired, seeing spots before her eyes, and in the dark seeing flashes of light.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received her flu shot about 3:00pm & by 5:00pm she said her left arm felt "numb & painful". She did not seek medical treatment but took some ibuprofen. The pain/numbness was gone/resolved by the next morning.
The pt received immunization at 09:00 and returned to office the same day in the afternoon reporting breathing difficulties, crying since 09:00 and pale. No apnea seen or reported.
Information has been received from a healthcare worker (certified medical Assistant C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 26-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Individual got tested on6/27/2021. Case investigation interview has not been completed at the time of this note.
Information was received from a nurse concerning a 52 year old female with rheumatoid arthritis who on approximately 09 FEB 2005 was vaccinated with a dose of MMR.  There was no other vaccination at the same time.  Concomitant therapy included LEVAQUIN for rheumatoid arthritis.  On 06 MAR 2005, 26 days later, the patient developed a macular rash.  No treatment was suggested.  Unspecified medical attention was sought.  The outcome was reported as not recovered.  There was no product quality complaint.  Additional information was requested.
Fluzone High Dose Quadrivalent vaccine was administered in the dorsal, mid-forearm to a patient, no AE; Initial and additional information regarding an unsolicited valid non-serious case received from a pharmacist via agency (Reference number- 00303301) and transmitted to Sanofi on 06-Oct-2020 and 07-Oct-2020.  This case involves a 75-years-old female patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) via an unknown route in the dorsal, mid-forearm (product administered at inappropriate site) on 28-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatments, vaccinations and family history were not provided. Patient had no concomitant medications.  It was an actual medication error case due to vaccine administered at inappropriate site (latency same day).  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 holders 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 on the batch number for this case.
flu; sick; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced flu (influenza) and sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that Social media case, Product name: product name was not provided. Since this is a public post on flu shot campaign. They are assuming the consumer is referring to the flu vaccine. Reported adverse Event Information: patient skipped the flu shot one year when patient thought that patient could not afford it. Well patient got the flu and it cost 500 dollars Plus patient was sick as hell Think about it comment id: 382901882934023. Medication Details and reason for taking the medicine: Indication, dose and frequency: unknown.   It is unknown if patient physician provided consent to be contacted It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
pt devel an inj site rxn characterized by pain & swelling p/vax;pt recovered p/4 days;this is 1 of 4 pt from this site to develop an inj site rxn p/vax;
A report has been received from a Health Professional concerning an 11 year old, Male subject who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 06-Feb-2015. The patient had been administered expired FLUMIST which started on 06-Feb-2015. The outcome of the event of EXPIRED FLUMIST is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by AstraZeneca/MedImmune 12-Feb-2015 from consumer: Patient demographics information updated. Narrative amended.
Tingling, Numbness Narrative:  5 min after vaccine administered IM to L deltoid she developed L arm and L trunk tingling. Tingling these locations resolved. Developed mild perioral tingling. At 1149 mild numbness tongue and lips. At 1155 resolving perioral tingling and numbness.
Erythema - Right upper thigh red raised warm area. Feb at 101.1 axillary - Cephalexin 250 mg PO TID x 7 days.
Lower extremity edema, fever, confusion, headache, elevated glucose.  Symptoms lasted 48 hours.  I saw her on 1/31/12, edema was improving and other symptoms had abated.
Arm hot, swollen, and red. 3 inches in diameter, next day spread to 8 inches and called physican who told her to put on warm compress.
body ache like flu symptoms, fatigue, general pain in body .. bones ache  Took a total of 2 advil, one at a time over 8 hour period .   The advil helps .. feeling better today, 10/18/2019
Skin felt on fire and itching over intire body (no welts). Itchiness worse on scalp & other places that grow hair. Belly button & ears were red, itchy & sweaty. Took Benadryl and finally went to sleep waking up many times throughout the night.  Arms and hands had tingling sensation (like they were asleep) all night and still that way if not moving them on 12/15/12 at noon. Extreme tiredness & did not get out of bed until 11:30 AM on 12/15/12.  Itchiness is still there but not as severe, will continue taking Benadryl until symptoms go away.
.  On an unspecified date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an 23 Feb 2021, one day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 002A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced the event(s) dizziness, nausea, vomiting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was considered to be not applicable.   The outcome of event(s), dizziness, nausea, vomiting was unknown.
other related health complications; shingles; This spontaneous report as received from a lawyer refers to a 66 year old female patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. In July 2013, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) at a pharmacy. As a result of her receipt of zoster vaccine live (ZOSTAVAX), in 2013, patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions, patient requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. As a foreseeable, direct, and proximate consequence of Company's actions, omissions, and misrepresentations, patient suffered shingles and other related health complications. In addition, patient requires and will continue to require healthcare and services. She has incurred and will continue to incur medical and related expenses. Patient also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. Patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering.  The outcome of shingles and other related health complications was reported as not recovered/not resolved. The reporter considered shingles and other related health complications to be related to Zoster Vaccine Live(ZOSTAVAX).  Shingles and other related health complications were considered to be disabling.
Cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold symptoms). At the time of the report, NASOPHARYNGITIS (Cold symptoms) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of COLD SYMPTOMS was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Initial unsolicited report received from a consumer (patient) on 29-Jun-2017. This case involves a 76-year-old female patient, who was vaccinated with first dose of ADACEL via intramuscular route (batch number, expiry date, dose not reported) in left deltoid on 20-Apr-2017. Patient's illness at time of vaccination was unknown and pre-existing physician diagnosed allergies birth defects, medical conditions were reported as Viox, Vicodin, Coumadin, Codeine, PCN, Valium, Sulfa drugs. Concomitant medications were not reported. On 22-Apr-2017, within 2 days following the vaccination, the patient's her legs were swollen and she has pain with movement in the left arm which continues to date. Patient required ER/doctor visit. Lab test and corrective treatment was not reported. Patient did not recovered form events'. Documents held by sender: none.
Arm pain, difficult to lift arm starting approx 1 hour after vaccination and continuing for four days following vaccination Headache starting approx 1 hour after vaccination and continuing for one day following vaccination Mild fever starting approx 8 hours after vaccination and continuing for one evening Nausea starting approximately 15 min after vaccination and continuing for approximately 7 hours following vaccination  To treat arm pain, 2 ibuprofen every 8 hours as needed for three days No other symptoms were treated, as all were tolerable
Excessive Swelling, pain, itching lasting more than 24 hours at site of injection. Stiffness to the arm where injection occurred. Chills, body ache, head ache, general tiredness and itchy lasting longer than 24 hours
Approximately 16 minutes after receiving the vaccination, I began to get quite dizzy.  The staff was notified by my wife; and, a Pharmacist responded immediately to check on me.  As minutes passed, I became more dizzy and was experiencing a mild "out of body" type experience as though I was in some sort of a dream.  Knowing in advance that many people had experienced adverse reactions from these vaccines, my wife and I had brought along an "eppie pen" in the event I might experience something similar.  The problem was that my "pens" had expired in 2015.  My condition improved when I lifted my facemask to get more air.  While the Pharmacy was obtaining a new "Eppie pen" for me, the Pharmacist told me to take the mask off.  This stabilized me until  we left after 45 minutes.  I did not need to use the new Eppie pen.  Still dizzy, my wife helped me to my vehicle.  Enroute, being somewhat weak, I clasped against a parked car and to the pavement.  During the trip home, my muscles began to ache and my joints stiffen and hurt.   A heaviness began to present on my upper chest.
fever, dizzy, lightheaded, cant' move, hurts to do anything;hurts when tries to breath in;feverish T100;color pale;deep muscle pain lasted 12hr;
PT HAD BLEEDING AND SWELLING AFTER VACCINE . INJECTION SITE. CLEANED UP THE WOUND. PUT ICE PACK . ADVISE PT TO TAKE MOTRIN EVERY 6 HOURS AND TYLENOL EVERY 4 HOURS AS NEEDED
Information has been received from a nurse practitioner concerning an 18 year old female who on 29-JAN-2007 at 10:20 am was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (lot# not provided). On 10-APR-2007 at 14:30 the patient was vaccinated in the right deltoid with the second dose of Gardasil (lot# 03480). On 10-APR-2007 three to four hours post vaccination the patient experienced a swollen throat and had a hard time breathing. The patient was seen in the emergency room due to the severity of the experience. The patient complained of a "feeling of choking," slight nausea with no emesis. The patient reported that no other people in her home were ill with any sickness and she had no known allergies. A quick strep test and throat culture were both negative. The patient was treated with ibuprofen 600 mg, PO every eight hours as needed as well as salt water and loratadine as needed for discomfort. Subsequently, on 12-APR-2007 the patient recovered from the experience.
Blood pressure and O2 levels plumetted; BP 74/54, then 84/42, then 64/48 (6.5 hours later) , then 104/66 (7 hours later) Oxygen was 84%, heart rate 42; then 76% with heart rate of 103; then 87% with heart rate of 96 (7 hours later)  There was no treatment except spouse/caretaker monitoring stats, as patient refused to go to the hospital or doctor visit.  It was reported to primary care on 5/6/2021.
Potentially sub therapeutic dose.  When we were returning the vaccine to another store we realized that it was only good 30 days from the deep freeze.  We thought is was good   until 10-30-2022 when kept in the fridge.  We got this medication from supplier on 06-02-2022 and vaccinated 08-02-2022.  We contacted the mfg and they are going to do batch testing to see if we need to re-vaccinate.
Ipol administered after the excursion at 134.70F for 6 minutes due to a refrigerator malfunction with no reported adverse event; Ipol administered for 8 year old patient with no reported adverse event; Initial information received  on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional via office manager.   This case involves a 8 years old male patient for whom poliomyelitis vaccine (inactivated) [IPOL] being administered after the excursion at 134.70 f for 6 minutes due to a refrigerator malfunction 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 Hepatitis B vaccine for Immunisation.  It was reported that Office Manager reported a temperature excursion involving punctured, and administered after the excursion, IPOL at 134.70F for 6 minutes due to a refrigerator malfunction on 18-MAR-2023 (not human error). The product was not supported by the extended stability data (product storage error).  On 21-Mar-2023, post excursion, the 8 year old patient received a dose of suspect poliomyelitis vaccine (inactivated) IPV (VERO) Suspension for injection of standard strength at dose of 0.5 ml (lot: V1B901M, expiry date: 02-Jun-2024) via intramuscular route in the deltoid nos for prophylactic vaccination with no reported adverse event (product administered to patient of inappropriate age) (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 guidelines. 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.
Menveo administered without reconstitution; Menveo administered without reconstitution; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA724Z, expiry date 30th September 2023) for prophylaxis.   On 14th September 2022, the patient received Menveo. On 14th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The nurse reported that a new staff member administered a dose of Menveo to the patient without reconstituting with the powder portion. Therefore, the patient only received the liquid CYW component of the vaccine. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. This case is for 1 of 2 linked patients, reported by same reporter. Additional supportive information: The patient received only liquid CYW component of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022135068:Same reporter
tingling in hand, then on 2nd day, whole body trembling;was bitten by pet racoon that had an encounter w/a stray racoon;racoon died 12JUL94 an exam revealed rabies;pt bitten 3-4wks a/animal died;
2 yo child received seasonal influenza vaccine 0.5 ml IM in R deltoid on November 9, 2010 at community seasonal influenza clinic with no apparent injury. This nurse received phone call from mother on January 31, 2011. Child developed ear infection January 23, 2011. Seen by family doctor on January 25, 2011 and started on oral AUGMENTIN, dose unknown, received 2 doses on January 25, 2011 and one dose on January 26, 2011. Developed hives on January 26, 2011 in morning. Child was seen by family doctor January 27, 2011 with pinpoint rash on right buttock and bilateral ankles and feet. Antibiotic changed to CEFTIN, unknown dose. According to mother, he seemed fussy when shoes applied to feet. On January 28, 2011 noted R foot swollen and parents unable to apply shoes, was seen in Emergency Room. Later on January 28, 2011, parents noted bilateral feet swelling, right knee swelling. Returned to Emergency Room where attending physician diagnosed "Serum sickness". Also noted right wrist pain at that time. Child started on Prednisone, unknown dosage.
large local rxn w/swelling, warmth, erythema extending from deltoid where inj given to elbow;hypersensitivity sx consistent w/serum sickness;