chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccines that were previously exposed to temperatures below 32 degrees F; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA192699, 2019SA193109, 2019SA193112, 2019SA193105, 2019SA193110, 2019SA193111, 2019SA193107, 2019SA193106, 2019SA192700 and 2019SA192698 (Same reporter).  This case involves female patient of an unknown age who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UI969AAB, expiry date- 04-Apr-2020) via unknown route in unknown administration site, which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown whether 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.
Arm pain, not as bad as first Shingrix.  Severe shivers, body ache, headache, tiredness all day on 12/22/2019.  Weakness still on 12/23/2019.
Extreme dizziness to the point of almost fainting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extreme dizziness to the point of almost fainting) and NAUSEA (Nausea) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (Extreme dizziness to the point of almost fainting) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Extreme dizziness to the point of almost fainting) had not resolved and NAUSEA (Nausea) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Approximately 18 hours after the 2nd H1N1 vaccine she had a headache, shaky/weak feeling and fatigue & fever. Two days after vaccine she lost consciousness for a few minutes. We aren't sure whether she passed out or seizure. By the way the witnesses described what happened it sounds like she may have seizured.
This spontaneous case was reported by a physician and describes the occurrence of LYMPHADENOPATHY (woke up Friday with a swollen, tender supraclavicular lymph node on my left side. It has since gotten larger) and LYMPH NODE PAIN (tender supraclavicular lymph node on my left side) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.- 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 1 dosage form. On 19-Nov-2021, the patient experienced LYMPHADENOPATHY (woke up Friday with a swollen, tender supraclavicular lymph node on my left side. It has since gotten larger) and LYMPH NODE PAIN (tender supraclavicular lymph node on my left side). At the time of the report, LYMPHADENOPATHY (woke up Friday with a swollen, tender supraclavicular lymph node on my left side. It has since gotten larger) and LYMPH NODE PAIN (tender supraclavicular lymph node on my left side) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.It was reported that patient had no reactions to first 2 vaccines.No relevant concomitant medications were reported.No treatment information was provided.
Information has been received from a physician concerning a 13 year old female, who did not eat anything and was very anxious before the vaccine, who on 19-JUN-2007 was vaccinated with a dose of Gardasil. There was no concomitant medication. The patient fainted immediately following the injection. Unspecified medical attention was sought. there were no laboratory or diagnostic tests performed. At the time of the report the patient was recovering. The physician reported that the patient will continue the series of vaccines. Additional information has been requested.
Severe Dizziness day of injection and mild dizziness for next 3 days severe migraine like headache with vomiting starting 4 days after injection and continuing to present. Day 8 post injection the headache has started to move into front of my head and face. As well as retaining fluid and swelling in my lower legs.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer which was successfully treated." (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21May2022, outcome "unknown", COVID-19 (medically significant) with onset 21May2022, outcome "not recovered" and all described as "I did not feel well, and took a Covid home rapid test 21May2022 that came out Positive/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) positive, notes: home rapid test 21May2022 that came out Positive; (28May2022) negative, notes: took a rapid home test 28May2022 that came out Negative; (30May2022) positive, notes: Two days later, took another rapid home test that came out Positive; (30May2022) positive, notes: today when I tested Positive again. Therapeutic measures were taken as a result of Covid-19 included Paxlovid from 21May2022 to 26May2022. Clinical course: The patient did not receive any other vaccines in 2 weeks or other medication in 2 weeks. Patient had no known allergies. The patient did not feel well, and took a Covid home rapid test 21May2022 that came out Positive. Doctor had prescribed Paxlovid that was delivered to patient within 3 hours. Took first dose (3 pills) at 5:00 pm that day. Continued taking Paxlovid for the 5 days. Final dose was 8:30 am 26May2022. Felt better, patient took a rapid home test 28May2022 that came out Negative. Two days later, took another rapid home test that came out Positive. That day (today) patient was not feeling well. None of the symptoms were extreme or severe even on the first day when patient began the Paxlovid treatment or today when patient tested Positive again. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Around 500AM - She started itching and after her shower noticed hives, 5 good size ones over body and few small ones. Arms and torso - treated with CLARITIN and STERAPRED DS 12 days.
pt recvd vax 7OCT94 & 2 to 3 days later devel muscle pain in arm of inj & shoulder; pt is only able to raise arm to shoulder level & required assistance of other arm to raise it any further; also numb; sweating-foul odor, neuralgia, weaknes
Chronic hives that started on my neck and all around my eyes. They would disappear and reappear. They are also on my hands and they turn crusty. Currently seeing an allergist and an Oncologist for further diagnosis.
Dose administered >12  hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12  hours post puncture) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2021 at 12:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12  hours post puncture). On 28-Dec-2021 at 12:00 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered >12  hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date and time vial was first punctured: 27-Dec-2021 at 3 PM. The vial was stored in the refrigerator post puncture for 23 hours and 45 minutes.  No treatment medication were reported.
Initial report received from healthcare professional on 10 October 2013. A 77-year-old female patient, received first dose of FLUZONE HD (lot number U4765AA, expiration date unknown) (route and exact site of administration not reported) on 09 October 2013. On 09 October 2013, the patient had local reaction including redness, bruise. It went all the way down to the elbow. Red, dark coloring, rash, slightly raised. The physician thought it was a reaction to the vaccine. Laboratory investigation and corrective treatment not reported. The patient had not recovered from the events. Documents held by sender: none.
Palms of hands became itchy, followed by raised flesh colored bumps on trunk and legs.
Patient Pulled Back and Flinched when Vaccinator administered vaccine in right deltoid. Less than half of the vaccine was administered. 1.5mL was re administered in the left deltoid.
COVID breakthrough. Patient presented to the hospital on 9/19/22 with extremity weakness, cough, and fatigue for 1 month. Tested positive for COVID.
This was by Pfizer booster shot received 6 months after 2nd Pfizer vaccine. No adverse reactions to both vaccines; however, about 6-7 hours after the booster, broke out in raised hives across both arms. Primarily in the inner portion of the arms, both by shoulder and inside of arms.  Have since had rashes, hives, and breakouts almost daily, with overall body itchiness, specifically around legs, feet, arms/upper arms, head, and back. Feet/toes and finger will also itch.  Taking Zyrtec helps with symptoms but they come back almost daily. Sometimes with neck and chest fully red.
Vaccine exposure during pregnancy; This is a spontaneous case, initially reported by other non-health professional to agency (reference number: SEQ19-02746) on 16-Sep-2019, concerning a pregnant, female patient of unspecified age.  The patient's medical history and concomitant medications were not provided.  On an unspecified date in 2019, the patient was administered Afluria Quadrivalent [Influenza Vaccine; dose, route of administration, batch number, expiry date and anatomical location: not reported] for unknown indication (explicitly coded as 'Vaccine exposure during pregnancy').  No adverse event was reported.   The reporter did not provide information about seriousness or causality.  Company comment: The event of 'Vaccine exposure during pregnancy' is considered not related to Afluria Quad.; Reporter's Comments: The event of 'Vaccine exposure during pregnancy' is considered not related to Afluria Quad.
Other severe and personal injuries which are permanent and lasting in nature; shingles including any and all of its sequelae; This initial spontaneous report was received from a lawyer and a 63 year old male patient regarding a case in litigation on 24-MAR-2020. His medical history, concurrent conditions, concomitant medication, drug reactions or allergies were not provided. On an unspecified date in 2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, lot number, expiration date, route of administration, and anatomical location not provided) as prophylaxis. As a result of his receipt of zoster vaccine live (ZOSTAVAX), in 2014, the patient suffered shingles, including any and all of its sequelae. As a result, patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. Also, the patient was caused to suffer other severe and personal injuries (unspecified), which were 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. The patient required and/or would require more health care and services and did incur medical, health, incidental and related expenses. The patient was informed and believed and further alleged that would in the future be required to obtain further medical and/or hospice care, attention, and services. At the reporting time, the outcome of shingles and the other unspecified permanent injuries was considered as not recovered. The reporters considered the events to be related to zoster vaccine live (ZOSTAVAX).   The reporters considered the other severe and permanent injuries (unspecified) to be a disabling event.
This spontaneous report was received from a medical student and refers to a 29-year-old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD injection (dose, route of administration, lot number and expiration date were not reported). The dose of the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) injection (dose, lot number and expiration date were not reported). No adverse effects were reported.
headache; ears very clogged; both thighs very painful; her left arm was very painful; lower back very painful; I wanted her to rule out pericarditis before having full cardiac workup; sharp left-sided chest pain began with increased pain in groin and left hip; sharp left-sided chest pain began with increased pain in groin and left hip; sharp left-sided chest pain began with increased pain in groin and left hip; this pain in chest, especially when taking a deep breath; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in left arm on 11May2021 18:00 (Lot Number: EW0185) as 1st dose, single dose for covid-19 immunisation. Medical history included had pericarditis a number of years ago (unknown date) that lasted one year then went away and rheumatic fever at age 7 (unknown year). The patient was very healthy and felt perfectly fine prior to vaccine. The patient was not diagnosed with Covid-19. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamins nos (VITAMINS NOS reported as vitamins) and supplements. The patient received the most recent COVID-19 vaccine from a pharmacy or drug store. The patient reported that 4 hours after she got the shot (11May2021), her left arm, lower back, and both thighs very painful. The next morning (12May2021), she had headache, ears very clogged, and lower back and thighs were very painful. It was reported that 7 days later (May2021), the patient experienced a sharp left-sided chest pain began with increased pain in groin and left hip. These symptoms are still continuing to this date. The patient reported that she had pericarditis in past and this pain in chest, especially when taking a deep breath, is very similar (May2021). She called her primary care physician (PCP) to try to get appointment to see her, but she was told to go to ER. The patient did not want to get to the ER due to the deductible to meet before her insurance kicks in. She wanted to rule out pericarditis before having full cardiac workup. All symptoms were still continuing, however chest pain is not as severe. The patient does not plan to get second shot. The patient considered the events was non-serious. The patient has not been tested for COVID-19 since vaccination. The patient did not received treatments for the adverse events. The outcome of the events was not recovered.
Two days later, I noticed that my arm where I got the shot started to get red but it was not raised. I thought it was going away, but I slightly scratched it on January 23rd, and it started turning into a hive. Today is January 26th, and I still have a hive, and now it is raised. It's not too itchy, but it does feel warm and it feels hot. There has been no wheezing or other reactions to it. I feel fine.
Fever, difficulty breathing, headache, weakness, fast heartbeat, dizziness and general malaise. Took 440mg of Aleve liquid gels and then laid down to sleep about 11:00 PM.
To urgent care with c/o sx palpitations, fast and pounding heartbeat. C/O dizziness and like was going to pass out. Had c/o tingling in hands and face. C/O sx onset 20 min. after flu vaccine, felt lightheaded and BP high. Pt took Clonidine-metoprolol with resolution of sx. In ED only BP increased. ED MD Dx: Dystonic Drug Rx - flu vaccine.
Syncopal episode, low blood pressure, clammy/sweaty, lasted approximately 30 minutes
pt states within 45minutes of receiving vaccine, she started to get "severe" throat pain, swollen lymph nodes on the left side of her neck, trouble swallowing due to throat pain. Pt went home and over the next two days continued to experience extreme fatigue, weakness, hot and cold flashes, headache, body aches.
Fever local reaction tender, redness 20 hours after pneumovax. Responded to Benadryl. Temp increase to 105 degrees.
Pfizer-BioNTech COVID-19 Vaccine EUA was administered on 4-13-21 at about 10:45 A.M. Within 48 hours of receiving said vaccine, I had a Vitreous Detachment in my right eye causing severe floaters and flashes. This detachment was confirmed by my opthamologist . My opthamologist did not attribute the Vitreous Detachment to the vaccine, but I am making this report on the advice of the information given to me by the administering clinic.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 13-JAN-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 02-JAN-2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Large red area on upper right arm that was warm to the touch progressively got worse from day 7-13. Improved with antibiotics started on day 13. was told it was skin infection from injection site.
This is a 81-year-old male with no significant past medical history.  Does not take any medications at home.    Patient is extremely hard to hear and poor historian as well.  He reported that he came to the hospital with a chief complaint of progressive worsening generalized weakness for about 7-10 days.   He reports that he is also having some worsening shortness of breath especially on exertion during this time.  Vaccine date: 03/13/2021 Hospitalization date: 08/16/2021
Mild chills - onset 8-12 hours after  Body aches - onset 8-12 hours after Fatigue - onset 8-12 hours after
Muscle weakness in both arms. Situation keeps getting worse. Each vaccine and booster made the pain worse. It started only in left arm and is now in both arms and starting to move to legs as well.
Light-headed, few seconds. Red & swollen arm, three wks. No treatment by Dr.