chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: STATED BURNING SENSATION IN ARM AND CHEST AND  PATIENT REQUESTED RPH TO CALL 911. 911 ARRIVED IN STORE-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 911 TOOK PATIENT TO LOCAL HOSPITAL
not sure if she has Covid; not sure if she has Covid; she got sick; queasy stomach; hurting of her arm that she got the vaccine in; This is a spontaneous report received from a contactable consumer (Patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 13:00 (Batch/Lot Number: EN6206) at the age of 61-years-old as single dose for covid-19 immunisation. The COVID-19 vaccine was administered in parking lot. Not at Military Facility. The patient's medical history reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historic vaccine included 23 years ago with her 1st flu shot she got sick but has not had any issues since. Patient stated she was scheduled for the 2nd Pfizer shot today and she got sick and was not sure if she has Covid on 23Mar2021. Stated she didn't want to get the 2nd shot and exacerbate her symptoms, states she got symptoms with her first shot. Patient was wondering if she can reschedule her shot in general as it was scheduled for today. Patient stated the symptoms after the 1st shot were not detrimental, she had a queasy stomach later that night and natural hurting of her arm that she got the vaccine in. Stated it started that night after 12 at night. Clarified she got the shot 03Mar2021 and the symptoms started after midnight making it 04Mar2021. Stated the symptoms didn't even last 24 hours and were gone by 05Mar2021. No Emergency Room and No Physician Office visit required. The outcome of the events 'hurting of her arm' and 'queasy stomach' was recovered on 05Mar2021 and the outcome of the events was unknown.
Pt recvd series of 3 Hepat vax given deltoid;1st dose 20SEP89,2nd&3rd doses Engerix-B 20OCT89&5MAR90 respectively;pt tested negative 30JUL90 for Recombivax HBSAB;4th dose Engerix-B given deltoid 7AUG90;f/u indicates pt did not seroconvert;
chills; fever; tiredness; headache; nausea; This is a spontaneous report from a contactable consumer (patient). This 67-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration in arm left on 03Mar2021 at 10:00 am (age at vaccination 67 years) as dose 1, single dose for COVID-19 immunization. Medical history included asthma and HBP (high blood pressure). Patient was not pregnant at time of vaccination and received no other vaccine in four weeks. No COVID prior vaccination, no COVID tested post vaccination and no known allergies. Concomitant medications included losartan, sertraline, simvastatin and amitriptyline all were taken for an unspecified indication, start and stop date were not reported. It was reported that after receiving the dose of vaccine on 03Mar2021 at 21:00 pm, the patient experienced chills, fever, tiredness, headache and nausea. No treatment received for the events. The outcome of all the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. Number of doses/vials were 168. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant live follow-up: Additional reporter added.
Second dose at first could not walk; Now she cannot sit down, basically stand or sit all day long; Stabbing pains; 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 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: GAIT INABILITY (non-serious), outcome "unknown", described as "Second dose at first could not walk"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Now she cannot sit down, basically stand or sit all day long"; PAIN (non-serious), outcome "unknown", described as "Stabbing pains". The events "second dose at first could not walk", "now she cannot sit down, basically stand or sit all day long" and "stabbing pains" were evaluated at the physician office visit.  Additional information: First patient was could not walk and now she cannot sit down and she has to stand or lay down all day long. She went to her family doctor and was told there was nothing she can do. Then she sent to gynecologist and he said there is nothing he can do for her. This occurred after her second dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Effects lasted 6 days. Day 1: extremely drowsy, refused foods. Day 2: awake for 24 straight hrs, extreme hyperactivity. Refused food. Screamed for long periods of time. Day 3-6: exacerbated reflux symptoms. Refused most meals. Lost 1 pound. Requesting medical exemption document for immunizations due to two separate adverse reactions.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 20 months old male patient who was vaccinated with 0.5 ml dose of vaccine FLUZONE QUADRIVALENT (lot number: UJ012AD and expiry date: 30-Jun-2019) via intramuscular route in left thigh "left vastus lateralis" on 17-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included patient received DAPTACEL and HAVRIX on an unknown date. It was a case of actual medication error due to overdose because the patient received 0.5 ml dose of the FLUZONE QUADRIVALENT vaccine. It was unknown if any adverse event was occurred or not following the vaccination. 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. Documents held by sender: none.
The patient was sitting in a chair. I administered two vaccines (Td and Hepatitis A), and he immediately had a seizure (became very stiff and was  shaking). I picked him up and placed him on the exam table. His feet were elevated. The seizure lasted approximately ten seconds. Another nurse joined me at that time and took his blood pressure--it was 140/96. His blood pressure was checked again at 12:11 PM and was 120/82. The patient was able to correctly answer questions relating to his name, date of birth, and current location. We sat him up and gave him Sierra Mist to drink. His blood pressure was re-checked at 12:21. It was 110/72. He indicated he was feeling better and was able to stand at 12:30 PM. At that point, his family exited the health department and was instructed to follow up with a physician.
This spontaneous report refers to a 79 year old female patient. None pertinent medical history or drug reactions/allergies. On 18-SEP-2013, the patient was vaccinated with PNEUMOVAX23, intramuscular in the left arm. Concomitant medication included FLUZONE and unspecified cholesterol medication. It was reported that on 18-SEP-2013, since she received the PNEUMOVAX23, vaccine she has experienced redness, swelling, and muscle pain at the injection site of her left arm. On the same day at the same time she was given a flu shot of FLUZONE, high dose in the right arm. The patient was not treated. Labs diagnostics were not performed. The patient did not seek medical attention. The outcome of redness, muscle pain at the injection site and swelling was reported as not recovered/not resolved. Additional information is not expected.
Employee reports arm swelling and turning purple around shoulder. Felt symptomatic about an hour after the flu shot was given. No treatment needed, 5 days later, arm appears normal. No bruising, swelling, discoloration. Employee's job has not been affected due to the event. Employee did not request to see a provider. Employee requests not to get that vaccination again.
Felt unsteady on feet and felt light headed x a few minutes; NO LOC.  Admitted to being afraid.
This is a spontaneous report received from a contactable consumer (Patient). A 35-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 22Jun2021 at 15:30 (at the age of 35-year-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history reported as none. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with covid-19 and not received any other vaccine four weeks. Patient did not receive any medication two weeks of vaccination. The patient had known allergy to Amoxicillin. On 23Jun2021 at 08:00, the patient experienced dark spots in vision. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The outcome of the event was reported as not recovered. Information on the lot/batch number has been requested.
Pt recvd 2 doses of Recombivax & 1 dose of Engerix-B & was determined to be a nonresponder;
Developed very high fever: up to 103.7. Very cranky, would not bear weight on leg.
This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED WORK ABILITY (i missed work), INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic) and FRUSTRATION TOLERANCE DECREASED (frustrated) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED WORK ABILITY (i missed work), INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic), FRUSTRATION TOLERANCE DECREASED (frustrated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not bathroom properly). At the time of the report, IMPAIRED WORK ABILITY (i missed work) had resolved and INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic), FRUSTRATION TOLERANCE DECREASED (frustrated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not bathroom properly) had not resolved. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered IMPAIRED WORK ABILITY (i missed work) to be related. No further causality assessments were provided for INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic), FRUSTRATION TOLERANCE DECREASED (frustrated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not bathroom properly). Concomitant medication list was not provided. It was reported that the patient received the vaccine and missed work for 2 weeks because of it. Patient wanted to know when these symptoms were going to leave the patient. The patient was more frustrated than before after this shot was given to patient. Treatment information was not provided.
Developed SOB  and fatigue 1 day after vaccine, went to urgent care and tested positive for COVID at urgent care.  Returned to our ED after going to urgent care again on 1/7/21, had o2 sat of 84% on room air, impoved to 98 on 3 liters. Was transferred to another facility for admission.
Pleuritic chest pain & dyspnea onset 6/19/2021 (approx 2 months post vaccination). Negative troponins, negative chest CTA. Diagnosed as pericarditis and improved with colchicine + aspirin.
Patient was to recieve the Pfizer Bivalent Booster, but actually received the Pfizer Monovalent formulation. Patient was notified on 11/7 and reported no adverse effects from the Monovalent formulation. In typical swiss cheese model theory of error, there were plenty of opportunities along the way for this to have been prevented. Starting with the manufacturer. This is a perfect example of a look alike medication. Secondly, the technician should have paid closer attention to the label, and thirdly the verifying pharmacist should have noticed the difference in Lot number. Going forward the different formulations will be labeled and segregated better to avoid the mixup.
Fatigue, swollen throat. muscle aches, dizziness, nausea, bone aches, headaches ,chest pain, short of breath, mental confusion, palpitations.
Symptoms of feeling overheated, tachycardia and shortness of breath began approximately one hour after receiving vaccine. Emergency room administered nebulizer treatment, ZYRTEC, PEPCID, and BENADRYL.
Younger patient receiving shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of off label use in a 32-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (previous epidose prior to the vaccination).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were reported as follows: The age at vaccination was not applicable to this report. The pharmacist inquired about the younger patient receiving the Shingrix vaccine after the recent episode, which led to off label use. The pharmacist wanted to know how long after the shingles episode could the Shingrix be given to the patient. The reporter consented to follow up.
Information has been received from a laboratory technician concerning a female patient who was subcutaneously vaccinated with a standard dose of PNEUMOVAX 23 on 07-OCT-2008. Within 3 days the patient developed what was diagnosed as cellulitis. She was placed on an unspecified antibiotics and was recovering. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
19 YO M presenting f/u allergic reaction s/p immunizations. Pt reported SOB,throat swelling, and small bumps on body after immunizations. Pt was treated with prednisone, solumedrol, zantac, benadryl. Pt reports that sxs gradually resolved after four days. Pt denies hx of anaphylaxis or known allergies. A/E 20 min post vaccination.
Headache, Myalgia, Fever, Palpitations, chills Narrative:
urticarial rash-Susphrine, Decadron, Albuterol sulfate-breathing tx;
severe nausea; She felt horrible/ felt like she was dragging; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She felt horrible/ felt like she was dragging), PYREXIA (Fever) and NAUSEA (severe nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A2A and 031M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included METOPROLOL and CLOPIDOGREL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION COMPLICATION (She felt horrible/ felt like she was dragging) and PYREXIA (Fever). On 11-Mar-2021 at 5:30 AM, the patient experienced NAUSEA (severe nausea). The patient was treated with PARACETAMOL (TYLENOL) on 10-Mar-2021 for Fever, at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION (She felt horrible/ felt like she was dragging), PYREXIA (Fever) and NAUSEA (severe nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.6 (High) degrees Fahrenheit @ 23:30. On 11-Mar-2021, Body temperature: 100.6 (High) degrees Fahrenheit @ 05:30.
Expired vaccine. The expiration in vaccine tracking system was 5/31/22. We were unaware that the use by date was 3/17/22.
headache, chills, muscle ache, fever, dizziness, extreme fatigue began I day after vaccine. All these persisted for two days.   It has been 5 days since injection and dizzyness is worse. Fatigue is less, but still present and keeping me from performing normal activities.  Feesl like blood pressure is low. Tingling feeling in body. Heachache. I am a woman who weighs 105lbs.
It was just a 101 temp, flu like symptoms, achy, and tired. It lasted 12 hours.
Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Ankylosing spondylitis.    No Medical History information was reported.   On 16-Nov-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) was resolving.            The concomitant medication was not reported by reporter. On 06-Aug-2021, the patient experienced psoriasis flare after first covid vaccine.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The treatment medication was not reported by reporter.   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.
Patient administered PFIZER first dose, Moderna second dose in error. CVMS down, unable to verify first dose information.
Information has been received from a registered nurse concerning a 22 year old female who on 25-MAR-2009 was vaccinated with the first dose of GARDASIL (intramuscular administration, lot#, site of administration not reported). On 02-JUN-2009 the patient received the second dose of GARDASIL (lot# 662229/1497X, intramuscular administration) which may had been administered in the bursa muscle. The patient experienced pain and tingling in the shoulder after receiving her second vaccination. The injection site was red and swollen and the pain radiated to the shoulder. On 08-JUN-2009 patient was seen in the office for pain. At the time of reporting the patient was not recovered. In follow up, a pharmacist called regarding the patient, requesting information on whether the dose should be repeated if it is administered in the bursa. Additional information has been requested.
My daughter has the Nexplanon arm implant to address her irregular menstrual periods and for the past two years has basically not had a menstrual period. Approximately 3-4 days after receiving the first dose of the Pfizer vaccine, she started a very heavy menstrual period and is still experiencing it. It is precisely the type of menstrual bleeding that resulted in the Nexplanon being prescribed.
Pt had a vaso-vagal reaction w/ near syncopal episode.  Pt laid down and vs Checked.  Pt given water and fans w/ ice pack.  Pt soon stablized and felt okay to go home.  Pt reported that this reaction has happened once before and it is the "bubble" from the vaccines that causes his response. Pt stable and released from the vaccination site.
On  March 9 at around 3:15 pm, I received the Shingrix vaccine. About 11 hours after receiving the vaccine, in the middle of the night (~2:00 am), I woke up with a fever, chills, muscle pain, headache, nausea. I took Ibuprofen (400 mg), which helped with symptoms, but my sleep was restless.  I had to take a day off work the day on March 10 as my symptoms persisted, and I was fatigued, felt "unwell," had headaches, muscle aches. On this day, I took Ibuprofen (400 mg) every 4-5 hours, which helped. By March 11 in the morning, I felt better, took 400 mg of Ibuprofen, but still not 100%, so I called into work a few hours, but had to leave because of fatigue.