chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizzy; weakness; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included seizure from an unknown date and unknown if ongoing , respiratory issues from an unknown date and unknown if ongoing , chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. Additionally patient stated "she was very unhealthy and that she had a lot of health issues".  The patient's concomitant medications were not reported.  The patient experienced dizzy on an unspecified date with outcome of unknown , weakness on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Advice to apply cool compress, and gave BENADRYL and return if swelling, erythema or pain increase.
Itching, then hives, treated with Benadryl, prednisone, Zantac, as of 20 Dec still had some hives.
Patient received an expired dose of Pfizer vaccine. The vaccine had been drawn up on 11/18/21 at approximately 1554. It was administered on 11/19/21 at 1521.  Pfizer was contacted on 11/22/21 for recommendations but they were unable to provide any additional stability data outside of the 12 hrs. CDC guidance recommends revaccination as soon as possible. Patient's PCP was consulted and she also recommended revaccination as soon as possible.
UrticariaPruritus swelling at injection site employee states: she did not have any adverse events from the vaccination until 1 week later when she experienced flaring, itching, and swelling at the injection site.
Rash over my thighs ....butt...and back of upper arm and elbows
At first patient stressed they were dizzy, pharmacist checked patient's heart rate and it was normal. Few minutes later patient was sitting in uncomfortable position and claimed they were nauseous and lost feeling in arms. Paramedics came and said patient was fine.
Black out twice with in 45 min of each episode. Migraine, dizziness, blurry and double vision, vertigo, nausea, fatigue, confusion, dehydration.  Symptoms started 5 hours after the injection.  Today is day 13.  symptoms are still present. Some days are better than others.  No medication helps.  is still waiting for for the symptoms to subside.
After more than a week, the injection area became a hard area about the diameter of a quarter. I massaged this area gently for 3-4 days and the hardarea disappeared and seemed fine. Today(12 days after the shot) there is a large redish pink circle about 2 inches in diameter around the injection site. It is warm to the touch but does not hurt
Patient received her Booster dose at  Pharmacy on 11/1/21.  When she was leaving the clinic, she fell outside.  Her daughter was with her at the time, and expressed that she does not feel the fall is vaccine related since her mom did not feel dizzy; she feels her mom simply lost her balance.   A  staff member helper her up, and EMS was called.  Patient was checked out at the scene.  She did not go to the hospital.  nurse called the patient on 11/2/21, and patient reported that she was fine.
vision was diminished in left eye; extreme eye strain; feels like my eyes are not working together; sensitive to light; facial pain; congestion; congested in ear mostly left side; floaters in both eyes; Anxiety; unable to sleep; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Apr2021 08:00 (Lot number: EW0151) at the age of 45 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). There was no other medical history, no prior COVID. There were no concomitant medications. There were no other vaccine in four weeks; no other medications in two weeks. Vaccination history included: Bnt162b2 (DOSE 1; Batch/Lot No: ER8730;Location of injection: Arm Left), administration date: 29Mar2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: VISUAL IMPAIRMENT, described as "vision was diminished in left eye"; ASTHENOPIA, described as "extreme eye strain"; EYE DISORDER, described as "feels like my eyes are not working together"; PHOTOPHOBIA, described as "sensitive to light"; FACIAL PAIN, described as "facial pain"; NASAL CONGESTION, described as "congestion"; EAR CONGESTION, described as "congested in ear mostly left side"; VITREOUS FLOATERS, described as "floaters in both eyes"; ANXIETY, described as "Anxiety"; INSOMNIA, described as "unable to sleep"; DECREASED APPETITE, described as "loss of appetite". Two weeks after the second vaccine vision was diminished in left eye, extreme eye strain, the patient felt like his eyes were not working together, sensitive to light. He felt facial pain and congestion, also congested in ear mostly left side as well; floaters in both eyes, anxiety, unable to sleep, loss of appetite. He was unable to work on a computer. These events were all reported with onset 29Apr2021 08:00, outcome "not recovered", seriousness "Disability or permanent damage". These events were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) negative. Therapeutic measures were taken as a result of visual impairment, asthenopia, eye disorder, photophobia, facial pain, nasal congestion, ear congestion, vitreous floaters, anxiety, insomnia, decreased appetite. AE treatment: eye drops, steroids, laser treatments  Follow-up attempts are completed. No further information is expected.
Pain at injection site, overall fatigue, joint pain, mild fever of 99.1, sour stomach. Symptoms lasted for roughly 24 hours, one day after second vaccination.
Breakthrough bleeding.  This started 27 hours after the vaccine and at the time of submission continues.  Menstrual Cramping is also occurring   I haven?t had breakthrough bleeding in 20 years. This is not normal for me.   I have not reported this to my doctor at this time.
Tired; Soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration on an unknown date (at the age of 44-years-old) as a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were reported. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On an unknown date, the patient felt tired and experienced soreness at injection site. The patient did not receive any treatment for the reported events. The clinical outcome of the events tired and soreness at injection site was unknown.    No follow-up attempts are needed. No further information is expected.
CHILLS; FEVER; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included brain injury, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known allergies or drug abuse/ illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and chills. This report was non-serious.
No other adverse effects were reported in the patient; Nurse reports that a patient was inadvertently given a dose of MMR II via the intramuscular route; This spontaneous report was received from a registered nurse, referring to an unknown age and gender patient. The patient's pertinent medical history and drug reactions/ allergies were not provided. Concomitant therapy included sterile diluent (dose: 0.5 milliliter)  On 19-JUN-2020, the patient was inadvertently given a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot# was reported as S012530; strength, dose and expiration date were unknown) via the intramuscular route for prophylaxis (inappropriate route of vaccination). No other adverse effects were reported in the patient.
Symptoms: fever overnight, chills, fatigue, headache, muscle pain, some coughing   Treatment: Tylenol
DIZZINESS; ALMOST PASSED OUT; BAD PAIN IN BACK OF HEAD; NAUSEATED; This spontaneous report received from a consumer via a company representative concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: epilepsy, seasonal allergies, non alcoholic, and non smoker, and other pre-existing medical conditions included: Patient did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, expiry: 29-SEP-2021) dose was not reported, administered on 23-SEP-2021 13:30 for prophylactic vaccination. Concomitant medications included lacosamide for epilepsy, and levetiracetam for epilepsy. On 23-SEP-2021, the patient experienced dizziness. On 23-SEP-2021, the patient experienced almost passed out. On 23-SEP-2021, the patient experienced bad pain in back of head. On 23-SEP-2021, the patient experienced nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad pain in back of head on 23-SEP-2021, was recovering from dizziness, and the outcome of nauseated and almost passed out was not reported. This report was non-serious. This case, from the same reporter is linked to 20210326737.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Headache, Swelling around my left eye, diagnosed with shingles in left eye lid
BOOSTER; scratching/Severe itching; scratching; This is a spontaneous report from a non-contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 3 on 13Oct2021 (Batch/Lot Number: FF2590) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient previously received first dose and second dose of bnt162b2 (MANUFACTURER UNKNOWN), on unknown date (Batch/Lot Number: Unknown) for covid-19 immunisation. The patient stated that "13Oct I received my booster and I want to say shortly after I started with severe itching, it started in my scalp, I thought it just gonna go crazy scratching and scratching so that subsided I used medicated shampoo (treatment) for you know dry scalp and you know whatever thinking that something in there would help, well it did, so now it's my body I'm scratching beyond scratching, I used creams, I ordered a 'Venobath' (treatment) because now I cannot find it in the stores (Further clarification unknown) and I started taking Benadryl (Treatment) so I am wondering I think it's one of the side effects from the booster. I did had other reactions from the injections". The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BlurredVision, Myalgia, Fever, fatigue, tingling in right side of face, distorted vision Narrative:  Myalgia, fever 100.4, fatigue, tingling in right side of face for 2 hours, distorted vision for 2 hours; took Tylenol.
Patient has history of allergies and states started feeling allergy symptoms about an hour or 2 after the vaccine was administered. Symptoms included red rash on arm of injection site,  tongue itchiness/ mild swelling so she self administered her epi pen. Patient states she was unsure if symptoms were due to vaccine or because she was working in the floral department that day.
I want to emphasize this is a real side effect. I have some kind of loss of taste but it is more noticeable in desserts. Items like cakes, ice creams and doughnuts have lost their flavor. It's like they are muted when I eat them. Not quite unpleasant but not fully satisfying.
Shortly after the vaccine on the drive home the injection site got super hot, the arm began to swell and turn red.  I developed a fever and my sinuses got really stuffy.  I began to throw up profusely which made all symptoms from other issues occur causing me to swell all over and because I couldnt take any meds or keep anything down I went to the ER.   While there I began wheezing and experiencing SOB which still is an issue today.  I have foggy moments where my brain seems so foggy that I am having issues with my short term memory.  I was administered IV fluids, IV morphine and IV ibuphropen to help with the symptoms and was hospitalized for less than a day further evaluation
Information has been received on 31-OCT-2018 from a lawyer regarding a case in litigation concerning a male 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 ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 09-DEC-2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-FEB-2016, the patient was treated by a physician at a clinic 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 the patient's 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, 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.
fever to 102.6 day 3 after vaccine, chills, headache, increased nasal congestion
The vaccinator was administering the COVID-19 Pfizer vaccine that was drawn up in a vanishing point needle (VanishPoint Syringe), nurse injected into the left deltoid, pushed on the plunger and the needle malfunctioned. He states that the needle immediately retracted and shot the vaccine onto the skin of the patient. It was determined by the clinical team that >50% of the vaccine was not adminitered into the deltoid. Per CDC guildelines and DOH guidelines, if there is a lower than authorized dose volume administration error due to equipment failure and >50% of the vaccine is not administered or it is unable to be determined how much was administered, then it is recommended to administer the authorized dose in the opposite arm.  For this patient, 0.3 mL of the Pfizer vaccine (Lot #EW0185) was administered into the Right Deltoid. Patient was observed for an additional 30 minutes to an abundance of caution. Patient understoof and agreed with the plan. He attested and agreed with the recommedation.
Problem with his arm / The pain is 9 out of 10- almost 10; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Problem with his arm / The pain is 9 out of 10- almost 10) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041421A, 45B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced VACCINATION SITE PAIN (Problem with his arm / The pain is 9 out of 10- almost 10). At the time of the report, VACCINATION SITE PAIN (Problem with his arm / The pain is 9 out of 10- almost 10) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2021, Pain assessment (Unknown-10): 9 (High) 9 out of 10- almost 10.         No concomitant medication and treatment medication reported. Paitent did not blame the booster, but paitent could not  move his arm of injection (left). Three weeks later, he was still having problem with the arm; paitent could not  comb hair, paitent could not  sleep, Paitent was having a bad pain. Paitent doctor gave him a referral to get an Xray, but he has not gone back to see the doctor due to the holidays.
Patient came in to show us his arm, which was red and painful. Patient also stated area was itchy and under his armpits were also slightly painful. He informed us he took an Advil to help with the soreness.  I informed the patient that most of the symptoms he is experiencing is consistent with an injection site reaction. He was advised to continue to take advil every 6 hours along with applying an ice pack. He was also advised to go to an urgent care, should his symptoms get worse or if he is not better within 7 days of onset.
Very cold, shaky, weak, no energy, headache, nausea, fever, no appetite, sleeping all day after and the next.  Fever, very weak, no energy and headache persisted a total of 3 days.  Weakness, no energy and headache continue today 5 days later. Unable to go to work.
This spontaneous report was received from a physician via a company representative refers to a patient of unknown age and gender. No medical history was reported. On an unknown date in April 2013 (reported as within the last month), the patient was vaccinated with dose 1 of ROTATEQ (lot #, expiry not reported) orally. No concomitant medications were reported. On an unknown date in April 2013, the patient experienced diarrhea the day after the patient received ROTATEQ. It was unspecified as to how long the patient had diarrhea. The patient sought medical attention (called the physician). The outcome of diarrhea was unknown. Additional information is not expected.
4/27/21: mild pain at injection site (as expected) 4/28/21: pain increased to moderate to severe at rest; moderate nausea and loss of appetite beginning in morning 4/29/21: nausea began to decrease in morning; pain began to decrease; developed shortness of breath throughout afternoon/evening 4/30/21: pain/nausea/SOB resolved; awoke with itchiness and mild rash in morning, decreasing by time of this report Pain somewhat controlled with acetaminophen and Biofreeze; shortness of breath managed with levalbuterol
MD ordered a pediatric vaccine to an adult patient; Storage in clinical Practice; No adverse event / not notified of any symptoms or side effects; expired dose of PROQU AD was inadvertently given to a 45-year old adult instead of a child; expired dose of PROQU AD was inadvertently given to a 45-year old adult instead of a child / a pediatric vaccine was given to an adult patient; This spontaneous report was received from a nurse manager and refers to a 45-year-old male patient. No information about his medical history, concomitant medications and concurrent conditions was reported.  On an unknown date, the medical doctor ordered a pediatric measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for an adult patient (product prescribing issue). On 28-FEB-2022, instead of a child, the patient was inadvertently administered with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot# T028297, expiration date: 16-FEB-2022 (dose was not provided), subcutaneously in right arm for prophylaxis (expired product administered, product administered to patient of inappropriate age). Additionally, a medication error occurred during storage in clinical practice (product storage error) (also reported the product did not have any temperature excursion and was stored properly, discrepant information). No additional adverse event information was provided, the reporter was not notified of any symptoms or side effects (no adverse event).
suspected vaccination failure; shingles / Not as bad; shingles shot 3x; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case reported by the patient herself/himself. The age at vaccination was not reported. The patient stated that he/she got the Shingles shot three times and still got shingles. The patient received the 3rd dose of Shingles vaccine, which led to extra dose administered. The patient stated that the shingles was not as bad as the first time The reporter stated that he/she still recommended getting the shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.