chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme dizziness; fainted; unable to get a reading because the pressure was so low; diarrhea; felt like I was hallucinating; sweating; shivering; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 26-Mar-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HYPOTENSION (unable to get a reading because the pressure was so low), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt like I was hallucinating), HYPERHIDROSIS (sweating), CHILLS (shivering), VOMITING (vomiting) and NAUSEA (nausea). On 27-Mar-2021 at 1:30 AM, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant) and DIZZINESS (extreme dizziness). 27-Mar-2021 at 1:30 AM, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness) (seriousness criterion medically significant). At the time of the report, SYNCOPE (fainted), DIZZINESS (extreme dizziness), DIARRHOEA (diarrhea) and VOMITING (vomiting) had resolved and HYPOTENSION (unable to get a reading because the pressure was so low), FEELING ABNORMAL (felt like I was hallucinating), HYPERHIDROSIS (sweating), CHILLS (shivering) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Blood phosphorus: 0.6 mg/dl and 4.7 mg/dl. On 27-Mar-2021, Electrocardiogram: abnormal (abnormal) elongated heart rhythm (Arrhythmias) and normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included IV fluids and oral phosphorus.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recvd vax;exp lot of redness,pain & swelling at td inject site;tx w/ apap & ice packs;
Information has been received from a physician concerning an 18 year old female who on 05-JUL-2007 was vaccinated with the first dose of Gardasil. (Lot # not provided). Subsequently on 06-JUL-2007 the patient developed a rash behind both ears. The patient was treated at a local  center with Benadryl and an unspecified topical corticosteroid. Subsequently on an unspecified date the patient recovered from the rash. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A patient (no qualifiers provided) 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: DEATH (death, medically significant), outcome "fatal", described as "dead". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Caller mentioned that her brother and sister took the Pfizer Vaccine shot and are both dead now and his best friend. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-PV202200036809 Same drug, same event, different patient; Reported Cause(s) of Death: dead.
Swelling, redness, pain and itching at injection site. Benadryl tablet taken 2-22-2021 at 8:30 A.M.
Fever re-occurred after 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever re-occurred after 4 days) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever re-occurred after 4 days). At the time of the report, PYREXIA (Fever re-occurred after 4 days) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Dose was clear and not shaken; Dose was clear and not shaken; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 49-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 1st September 2021, the patient received the 1st dose of Boostrix. On 1st September 2021, unknown after receiving Boostrix, 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 details were provided as follows: Age at vaccination was not reported. The patient self reported this case. The physician reported that she received dose of Boostrix which was clear and not shaken by pharmacist, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. HCP will do some testing to evaluate antigen levels after this. No lot number available. The reporter consented to follow up.
Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Severe, Systemic: Joint Pain-Medium, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Unable to Sleep-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: Pt started experiencing syncope, chest pain, and neck pain on 5/31/2021. On the following Tuesday, she developed palpitation. On Wednesday, she was taken to ER by ambulance. At the time, she had rapid heart rate at 127 bpm. She was on IV fluid. On Friday, pt visited her cardiologist. She still experiences chest discomfort, lightheadness, and out of breath.
pt got vaccine 3 days too early ( 7 days before the 28th day)
PATIENT HAD A BRUISE ON LEFT ARM AT INJECTION SITE MAINLY BECAUSE TAKING ASPIRIN. ALSO, HAD A RED RASH THAT WAS VISIBLE FROM BRUISE TO ELBOW. WAS HOT TO TOUCH ON 6/18, BUT WAS BETTER TODAY 6/19. THEY PUT ICE AND BENADRYL CREAM ON IT.
Information has been received from a healthcare worker concerning a 5 year old female patient who on an unspecified date, was vaccinated with a dose of MMR II (Lot# not reported). The healthcare worker stated that the patient fainted after receiving a dose of MMR II. The patient fully recovered within a few minutes. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Awoke a.m. of 10/05/2009 with generalized facial swelling, neck stiffness and large hives on face, neck, and upper chest.  Hives gradually began to resolve over next few days, but then on 10/09/09 pt. c/o sudden fever onset of 103 degrees F, pulse of 120, and reported to his primary care provider who administered IM steroids, and gave client a course of p.o. prednisone and Benadryl to take. Pt states that all symptoms and hives resolved by about 2 1/2 weeks after the initial injection
The injection was very high on my arm and felt like it went into my shoulder. I have had right shoulder pain since the injection. It's been almost one month and I still struggle to use my right arm. Tying my shoes, exercising, holding my baby are all difficult with my right arm. The pain is not going away.
This spontaneous report as received from a nurse practitioner via a company representative refers to a patient of unknown gender and age. Medical history was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX23 (indication not provided). Concomitant medication was not provided. On an unknown date, 2 weeks after onset of therapy the patient developed flu-like symptoms. The outcome of flu-like symptoms was not reported. Additional information has been requested.
jerks; Initial information regarding an unsolicited valid serious case was received from a other health professional (physician's assistant) via Global Medical Information (GMI) via call-center (Reference number- 00344045) and transmitted to Sanofi on 03-Nov-2020.  This case involves a 41-years-old patient (gender not reported) who experienced jerks (dyskinesia), while he/she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious jerks (dyskinesia) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  This event was assessed as medically significant.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for dyskinesia.  Batch number has been requested for suspect product for this case.; Sender's Comments: A 41-years-old patient (gender not reported) who presented with dyskinesia following the vaccination with FLUZONE QUADRIVALENT. Time to onset is unknown. Medical history, concomitant medication, precise final diagnosis and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Pt described her side effect to the pharmacy on 4/9 symptoms: swollen, pain at injection site, itchiness.
Developed underarm pain & swollen lymph node on side of arm vaccine was given later that same evening.
Lack of energy; Feeling of not being able to think clearly; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 18Mar2021 at 17:45 (at the age of 59-years-old) as single dose for COVID-19 immunisation. The patient had no medical history and allergies to medications, food, or other products. The concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021 at 18:00, the patient experienced lack of energy and a feeling of not being able to think clearly. No therapeutic measures were taken for the reported events. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of lack of energy and feeling of not being able to think clearly were recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Donor stated he had difficulty breathing, chest pressure and headache that lasted 5 minutes then went away.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild
Tinnitus; hard to fall asleep and even woke him up at times; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) and INSOMNIA (hard to fall asleep and even woke him up at times) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced TINNITUS (Tinnitus) and INSOMNIA (hard to fall asleep and even woke him up at times). At the time of the report, TINNITUS (Tinnitus) and INSOMNIA (hard to fall asleep and even woke him up at times) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant medications was not  provided.
Within 5 minutes of vaccination patient experienced a red rash on thighs, lower legs, and backs of arms. We administered 50 mg of diphenhydramine onsite. The reaction did not progress so the patient left the pharmacy after 30 minutes. She continued to take scheduled diphenhydramine until 4/21/21. The patient also reports needing to use her rescue albuterol inhaler more frequently than usual for the first two weeks following the vaccination. The rash remained for 1 to 2 weeks. The patient sought medical care with an immunologist Hospital. Dr.  prescribed no additional medication, but told the patient not to receive the second dose.
tested positive for COVID; tested positive for COVID; 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 female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Caller recently acquired Paxlovid and wants to know if she should receive the medication if she had two doses of the primary series of the Pfizer COVID-19 vaccine and a booster dose. Almost a year later since she received the shots (6 to 7 months) she tested positive for COVID.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 11 years old female patient who received a expired 0.5ml dose of MENACTRA batch number: U5833AA, expiry date : 25-Feb-2019 via unknown route in unknown administration site on 12-Mar-2019. 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 expired vaccine used. The patient was not experiencing any adverse effects so far. 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. List of documents held by sender: none.
Chills, Fever of 102.5  from 9pm until 9am the following morning. Nausea, Headache, Vomiting.
On the day following the shot, for a duration of 3 days.   A painful swollen lump in my armpit, of the same arm where the vaccine was administered. Resolved on it's own after 3 days.  Pain was treated with 2 advil liquid gels, 3 times a day.
Itching started "that night" on L leg and on upper stock. Itching x 3 days and then rash with itching occurred x 1 week. Pt then used Cortizone cream for some relief. Occas. itching now.
lost his appetite; constantly dizzy; throwing up everything he eats; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost his appetite), DIZZINESS (constantly dizzy) and VOMITING (throwing up everything he eats) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (lost his appetite), DIZZINESS (constantly dizzy) and VOMITING (throwing up everything he eats). At the time of the report, DECREASED APPETITE (lost his appetite), DIZZINESS (constantly dizzy) and VOMITING (throwing up everything he eats) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.
Shingrix administered instead of Menveo; 18 year old received Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 18-year-old male patient who received Herpes zoster (Shingrix) (batch number 3ZX3E, expiry date 02-JUL-2025) for prophylaxis.   Additional patient notes included Patient was not immunocompromised..   On 14-AUG-2023, the patient received the 1st dose of Shingrix. On 14-AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Shingrix administered instead of Menveo) and inappropriate age at vaccine administration (Verbatim: 18 year old received Shingrix).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 31-AUG-2023 A 18-year-old was administered Shingrix instead of Menveo, which led to Wrong vaccine administered and Inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 2 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023119223:1st Report
One week after the second dose he had surgery for a "really bad issue" with his back; received two days of IV Decadron and a 10 day course of oral Decadron post surgery for inflammation; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported)), dose 2 via an unspecified route of administration on Jan2021 as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced one week after the second dose he had surgery for a "really bad issue" with his back, received two days of iv Decadron and a 10-day course of oral Decadron post-surgery for inflammation. The patient underwent lab tests and procedures which included antibody test was negative on Jun2021. Therapeutic measures were taken as a result of one week after the second dose he had surgery for a "really bad issue" with his back (back disorder), received two days of iv Decadron and a 10-day course of oral Decadron post-surgery for inflammation (inflammation). The outcome of the events was unknown.
PATIENT WAS GIVEN THE PFIZER SERIES DOSE, SHOULD HAVE BEEN GIVEN THE BIVALENT DOSE
she is breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (she is breastfeeding) in a  patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.    On 05-Apr-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Apr-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (she is breastfeeding). On 05-Apr-2021, EXPOSURE VIA BREAST MILK (she is breastfeeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Information about concomitant medications and treatments were not provided by the reporter.   This case was linked to MOD-2021-075635 (Patient Link).
Injection site pain, erythema.  Fever onset overnight.  Already hospitalized for methotrexate overdose.
Upon receiving the second dose of the Pfizer Covid19 Vaccine, my arm was sore, but I have a pretty high tolerance for pain and believed it would go away over time.  Unfortunately, the soreness did not go away.  Within a month of receiving this second dose, I noticed that I could not perform my regular work out routine (which includes lifting weights / jumping rope and yoga).  The shoulder pain has worsened over time and over the past four months, I have gradually lost my range of motion (painful to lift arm up to do very simple things - like reaching for clothes in my closet, reaching to obtain dishes from kitchen shelves).  It's painful to pull pants / panty hose up.  It's painful to get dressed, bathe, exercise (upper body).  Most recently, my right hand has developed a tremor.  The tremor affects my ability to write / print by hand in the manner that I used to.  The tremor also affects my ability to hold a glass of liquid steadily.  The pain also wakes me up several time per night (this has become consistent and is a nightly event).  I'm very concerned that this issue appears to be getting worse, not better.  Upon first reporting this to my immunologist, I was prescribed Meloxicam (which did not help at all with pain or symptoms.  After reporting worsening to my primary care physician, I was referred to both a neurologist and an orthopedic specialist.  At the current time, the neurologist I have seen is scheduling me to have an EMG as he noted weakness and the tremor in my right arm and right hand.  I will be seeing the orthopedic specialist on July 9th.
vaccine received more than 6 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine received more than 6 hours after first vial puncture) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine received more than 6 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine received more than 6 hours after first vial puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.