chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in to clinic to receive her booster. Vaccinator administered the booster dose without checking the prior vaccination date on the card. Patient's dose 2 vaccine was on 12/29/21 and she was not supposed to receive her booster vaccine until May 2022, so she received it two months early. Staff monitored the patient for a full 30 minutes to ensure no adverse reaction and patient tolerated the dose well. Both prior vaccinations were also Moderna.
3/29/05 Seen for physical in doctors office. 3/30/05 Seizure morning after vaccination. Started on Dilantin. Admitted to hospital on 3/30/05.
Flu symptoms: low grade fever (100.6), mild muscle aches (all over, not just injection site), headache, exhaustion, malaise
cold and clammy; kept clearing his throat; blood sugar was 245; blood pressure 175/111; Runny nose; it could have been a delayed allergic response; This is a spontaneous report from a contactable nurse reporting for husband. A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 10:15 right arm at single dose for protection from virus. Medical history included diabetes from 2005 and ongoing, partial gastrectomy from Jul2016, stroke from 2015, allergic to various things, dementia. Prior Vaccinations (within 4 weeks): None. Patient previously received Shingrix vaccine (first dose) and experienced a similar reaction (have to clear his throat), flu or hepatitis vaccines and not had a reaction. The patient experienced cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose on 04Feb2021 02:00. Clinical course reported as: Her husband had the vaccine at 10:15am. She gave him some Advil. Sixteen hours later at 2:00am her husband was cold, clammy and diaphoretic. He was having to clear his throat. He did have a little dementia and was diabetic. His blood sugar was 245. His blood pressure was 175/111 and he had a runny nose. He did not have any chest pain. He was unable to explain what was happening. She checked his blood pressure again manually and the results were the same. She gave him another blood pressure pill though it was out of the usual time. Gradually his blood pressure came down. The diastolic stayed over 100 for the evening. The systolic came down. She kept trying to read but was unable to find information. She thought it could have been a delayed allergic response. She was going to take him to the hospital but took care off him herself. She gave him a Benadryl and it calmed him down. He was feeling better and was able to fall asleep. Her husband had a Shingrix vaccine (first dose) this summer and had a similar reaction (have to clear his throat). He went to the hospital and they monitored him. They said it was not because of the vaccine. Her husband has not had a reaction in the past to vaccines. He has had every kind of vaccine with no reaction. He has not had a reaction to the flu or hepatitis vaccines. Outcome of events cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose was recovered on 04Feb2021. Events cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose were reported as serious medically significant. Events cold and clammy and kept clearing his throat was classified as related to suspect vaccine.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),  to reported events cannot totally be excluded.
C/O of tachycardia, dizziness 20 minutes post vaccine, placed on monitor.  HR 80-100, B/P 157/102, SaO2 100%.  Progressed to SOB & HR 174 @ 25min post vaccination.  Epi auto injector 0.3mg IM x1 given, called emergency response.  Patient awake, alert, oriented x3. Verbalized improvement in SOB after epinephrine, taken to ED via wheelchair.
Veteran developed marked increase of his blood pressure (160/116) which eventually presented as chest pressure (5/10) that radiated to his left arm. He was sent to local emergency department to evaluate for possible acute MI.
1/5/2021 0718 Pt received 2nd COVID vaccine 1/4/21. Oral temp 100.6, near syncope, muscle aches and head aches. Per EMS NSR, denies SOB, and chest pain. 500 ml bolus received in route. In ED, Pt c/o nausea. Pt anxious, sweating and uncomfortable. 0855 Pt resting comfortably, reports decease in pain/body aches 4/10. 1043 Discharge disposition: home.  Accompanied By: self.  Mode:  walk. --Hospital
received her booster shot of the covid-19 vaccine; received her booster shot of the covid-19 vaccine; injured on her foot; This is a spontaneous report from a contactable consumer (patient) from the Pfizer sponsored program. A female patient of an unknown age received 3rd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 26Sep2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. She received her booster shot of the covid-19 vaccine on 26Sep2021. She got injured on her foot on an unknown date in Sep2021 and her doctor put her on a 6-day regimen for Prednisone. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Skin red and slightly puffy with "knot" under the injection site (right thigh).
Lymph node swelling on the lower left side of neck that's increasing in size; Lethargic; Nauseated; Fever of 102.6F; couldn't stay awake and didn't even have the energy to sit up; couldn't stay awake and didn't even have the energy to sit up; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Jul2021 at 17:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and post-traumatic stress disorder; both from unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications included raloxifene hydrochloride (RALOXIFENE HCL), citalopram (MANUFACTURER UNKNOWN) and cetirizine (MANUFACTURER UNKNOWN); all from an unknown date for unspecified indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 25Jun2021 (at the age of 44-year-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jul2021 at 11:15, approximately 18 hours after receiving the second dose, the patient was lethargic, nauseated, and had a fever of 102.6F. Once this started, the patient couldn't stay awake and didn't even have the energy to sit up for almost 24 hours. The fever lasted approximately 21 hours before finally breaking. On 16Jul2021, two days after receiving this dose, the patient experienced Lymph node swelling on the lower left side of neck that's increasing in size. Reported to PCP who suggested the patient to report the reaction. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever of 102.6F, couldn't stay awake and didn't even have the energy to sit up was recovered with sequelae on 16Jul2021 and of the events lethargic, nauseated and experienced Lymph node swelling on the lower left side of neck that's increasing in size was recovered with sequelae on unknown date in Jul2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt developed a rash in the nasal area across to the left ear & down the neck started the day after immunization & was itchy. Pt saw Dr & Diphenhydramine was recommended.
Everything else (medicine) leaked down on her arm,Received 0.125mL; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Everything else (medicine) leaked down on her arm,Received 0.125mL) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL and AMLODIPINE for Blood pressure, VITAMIN D [VITAMIN D NOS], CALCIUM and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .125 ml. On 24-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Everything else (medicine) leaked down on her arm,Received 0.125mL). On 24-Oct-2021, ACCIDENTAL UNDERDOSE (Everything else (medicine) leaked down on her arm,Received 0.125mL) had resolved.            No medical history was reported by the reporter. No treatment information was provided.
Diarrhea; Stomach cramps; Chills; Experience lower back muscle pain; swelling at injection site; Patient experience local pain at injection site.; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Experience lower back muscle pain), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), VACCINATION SITE INFLAMMATION (swelling at injection site) and INJECTION SITE PAIN (Patient experience local pain at injection site.) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE INFLAMMATION (swelling at injection site) and INJECTION SITE PAIN (Patient experience local pain at injection site.). On 01-Mar-2021, the patient experienced BACK PAIN (Experience lower back muscle pain). On 02-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps) and CHILLS (Chills). At the time of the report, BACK PAIN (Experience lower back muscle pain), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), VACCINATION SITE INFLAMMATION (swelling at injection site), INJECTION SITE PAIN (Patient experience local pain at injection site.) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
At the time of the injection, I only felt a little pressure. I didn't feel the prick of the needle. My are was stiff and sore. My symptoms changed about noon the day following the injection. (3/24/21. I had taken Tylenol at 8:45am to help the stiffness in my arm, and I realized about noon that I was starting to run a fever. My fever was 101.8 when I returned home from work at about 1pm. I was feeling very cold, but also hot & my muscles were all very sore. I also  had a sharp headache. I felt as though I had the flu. This lasted for about 24 hours. At about 1pm  on 3/25/21 the aches & pains were gone, my fever was breaking on it's own, but I still had a headache.  On Friday 3/26/2021, my fever was still climbing a little, but then breaking on it's own. My headache was still sharp, but it responded to Excedrin Tension.  My arm was still a little stiff and a lymph node in my left arm pit was sore. I took Tylenol at 4:00pm on Tuesday after my injection 3/23/21 1:00am 3/24/21 8:45am 3/24/21 6:00pm 3/24/21 5:45am 3/25/21 5:10am 3/26/21 (for my headache) My symptoms seem to fit what I was told to possibly expect & I did not need to be seen by a doctor. I just wanted to share my symptoms to help with the growth of information & the vaccine.
Patient presented to emergency department on 11/30/21 for AMS. Patient was admitted for further management of Covid-19. Patient was found to be Covid-19 positive on 11/25/21. Patient di require treatment for symptoms associated with Covid-19 infection. treatment included remdesivir. Patient was discharged to nursing home/rehab facility on 12/10/21.
Inappropriate administration of FLUBLOK to a patient under 18 years of age with no reported adverse event; Initial information received on 14-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old and unknown gender patient who had inappropriate administration of influenza quadrivalent recombinant vaccine [Flublok Qiv] to a patient under 18 years of age with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrivalent recombinant vaccine(strength, formulation was unknown, lot QFAA2234 and expiry date: 30-Jun-2023) via unknown route in unknown administration site for Influenza.  On an unknown date the patient developed a non-serious event of inappropriate administration of flublok to a patient under 18 years of age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) following the administration of influenza quadrivalent recombinant vaccine.  Action taken :not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Headache, UrticariaPruritus, pain, neck pain, fatigue, chills, loss of appetite  Narrative: employee reports pain & itching, and neck pain after first injection; after second injection she reports:pain, swelling, itching at the injection site; severe headaches, backaches, fatigue, chills, muscle aches, and loss of appetite States symptoms only lasted through the day after then mostly subsided still some fatigue and back pain
She was worried maybe they were scheduled to get the Moderna vaccine; This is a spontaneous report from manufacturer support received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled more than 21 days for their second appointment 29Apr2021. Patient knew that it should be 21 days apart to get the second dose of the vaccine. She was worried maybe they were scheduled to get the Moderna vaccine instead of Pfizer vaccine. The outcome of event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On 16-MAR-2017 , the patient was vaccinated with an expired dose of GARDASIL 9 injection (strength, dose, and route were not reported) (lot number L004014; expiration date: 04-MAR-2017) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Dizziness, vertigo, felt like room was spinning, could not see momentarily. Nauseous, headache-top of head. Light headed, flushed. Heart palpitations. Called nurse and doctor. Took some antivert and laid down.
Information has been received from a 23 year old sexually active female who on 08-MAY-2007 was vaccinated intramuscularly in the left deltoid with a first dose of Gardasil (657622/0388U). Concomitant therapy included sitagliptin phosphate (MSD).  On 14-MAY-2007 the patient experienced fever, chills, excessive swelling, swollen uterus and swollen ovaries, hot flashes, perspiration, excessive swelling, yellow discharge, odor, irritation, and itching. She took an unspecified pill for itching that was for yeast infections and it helped. As of 15-MAY-2007 the patient started with not being able to hold urine for long periods of time and burning. A complete urinalysis was performed revealing cloudy urine with the presence of ketones, occult blood, protein, leukocytes esterase, white blood cells, squamos epithelial cells, and bacteria all consistent with vulvovaginitis and a Urinary Tract Infection. Atthe time of the report the patient had not recovered.  Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Patient received treatment with Paxlovid. Treatment start date: 01Jul2022, Lot number: Gc4762. indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
10 days after receiving shot 2/2 of the Pfizer MRNA Covid vaccine, my mother died suddenly without any explanation. Based on her history of high blood pressure and high cholesterol, the ER physicians guessed that she died of either a heart attack or stroke. My father did not opt for an autopsy. Her death in relation to timing of her covid vaccines appear to suggest that if she died of a heart attack or stroke, the covid vaccine contributed to some sort of hypercoagulation that made her prone to clots.
Red, swollen, painful at injection site and increasing in size. Prescribed antibiotics at Urgent Care AM 12/25/2015.
I went into the store to receive a tetanus booster shot. The pharmacist administered the shot   Letter that evening I received a voicemail from the pharmacist to call. I called the following morning and the pharmacist told me she had given me a moderna Covid vaccine instead. I already had two doses of the Pfizer vaccine the second dose was administered on March 10.
Eye was swollen shut; Developed a sty on his eye; Right knee pain that was excruciating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE SWELLING (Eye was swollen shut), HORDEOLUM (Developed a sty on his eye) and ARTHRALGIA (Right knee pain that was excruciating) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included EZETIMIBE (ZETIA) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ARTHRALGIA (Right knee pain that was excruciating). On an unknown date, the patient experienced EYE SWELLING (Eye was swollen shut) and HORDEOLUM (Developed a sty on his eye). At the time of the report, EYE SWELLING (Eye was swollen shut) and HORDEOLUM (Developed a sty on his eye) outcome was unknown and ARTHRALGIA (Right knee pain that was excruciating) was resolving.        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.   Treatment medications taken were Unspecified pain killer combined with an anti-inflammatory, unspecified antibiotics.
Information has been received from a registered nurse concerning unspecified number of patients who were vaccinated with Gardasil. Subsequently, the patients "felt vaccine going down their arm." This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a 68 year old female with no allergies, who on 11-JUL-2007 was vaccinated with a dose of PNEUMOVAX 23 (lot# 654977/0888F). Concomitant therapy included NEXIUM. On 11-JUL-2007, the patient experienced redness, swelling, and soreness at the injection site and ringing in her ears. It was reported that the arm swelled up to two inches. Unspecified medical attention was sought. No diagnostic laboratory studies were involved. It was also reported that her arm was still red. The patient  was recovering from swelling and soreness at the injection site and ringing in her ears. No product quality complaint was involved. Additional information is not expected.
11/22/21: Sore arm began that evening at around 8pm but laid down for bed at 9pm. From 10pm-2am, I experienced a fiery burning in every joint in my body for the course of four hours. It was some of the most severe pain I have felt in my life. I can only explain it as a hot poker being jabbed into every joint, even my ribs. I could not move either. At around 2am, the pain almost instantly stopped, and I immediately got cold. My teeth were chattering, and I could not warm up. I did not take my temperature but assume it had to be high. To warm up, I took a half hour shower. When I got out, I had a migraine and started throwing up. By 3am or so, I got into bed, sweating and feeling extremely hot rather than freezing. I woke up again in the morning, feeling rundown. After waking up at 8am, I also slept from 10am-11:30am, 1:30pm-3:00pm, and 4:30pm-10:30pm. I did not have an appetite all day.   Throughout the course of this, I took Tylenol at 650mg dosage, but it only affected the injection site, which I thought was odd. I do not normally swallow pills, so my tolerance is extremely low, and I am usually able to get away with a dose of children's Tylenol, even as a 25 year old.   By 11/24, I am not exhausted, but I still have lingering pain that comes and goes. At the time of writing this at 5pm on 11/24 most of the pain is gone, though some joints still throb if they're bent for too long.
Fever started on 11/16/08 101-104 Degrees axt. Rash chest/diaper area. Increased irritability & crankiness.