chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered pharmacist refers to an unknown number of patients (age and gender unspecified). On an unknown date, the patients were vaccinated with improperly stored GARDASIL (lot number, expiration and route not reported). No concomitant medications were reported. No adverse event reported. This is one of the two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from an administrator concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA injection (strength, dose, lot number and expiration date were not reported) for prophylaxis. According to the reporter, VAQTA doses were exposed to the following temperatures excursions: below 32 degrees Fahrenheit (F) with a lowest temperature of 25 F. The timeframe was unspecified by the reporter. There was no previous termperature excursions. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004260: US-009507513-1706USA004261: US-009507513-1706USA004262: US-009507513-1706USA003526:
Drug ineffective; Suspected COVID-19; Suffering from long COVID for the past 10 months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000000637 (Novavax).  A female patient received BNT162b2 (BNT162B2), on 17May2021 as dose 1, single (Batch/Lot number: unknown), on 11Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 09Jan2022 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: POST-ACUTE COVID-19 SYNDROME (non-serious) with onset 18Aug2022, outcome "unknown", described as "Suffering from long COVID for the past 10 months"; DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown". Clinical course: Not doing really well at all.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
New onset, non-ischemic cardiomyopathy and CHF, EF 20-25%.
Patient states that her left shoulder pains her when she tries to lift her arm. Patient states this pain began soon after receiving her flu shot.
Fever, chills, nausea, headache, extreme fatigue. I thought I had COVID again.
Middle of night after vaccination  awakened with headache, nausea and vomiting. Headache and body aches continued throughout night and next day. Low grade fever until single Tylenol dose taken 2 times during day. Lack of appetite and fatigue. Symptoms gone by 2nd day.
Sore arm at injection site, headache, extreme fatigue, all lasted about 3 days; hives developed under both arms, a rash is still present...14 days.
Sore arm; This is a spontaneous report from a contactable consumer (Patient).  A 23-year-old non-pregnant female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL3247) via unspecified route of administration, in left arm on 25Jan2021 12:00 PM as a dose 1, single for COVID-19 immunization. The patient medical history included amoxicillin allergy. The concomitant medication of the patient was not reported. Patient had not received any other vaccine within four weeks prior to the COVID vaccine and patient had not received any other medications in two weeks vaccination. The patient had not COVID prior to vaccination and not tested post COVID vaccination. On unspecified date patient experienced sore arm only after administration of first dose of BNT162B2. Outcome of event was unknown.  Follow-up attempts completed. No further information expected.
inflammation of the pericardium; Chest pain; she could barely catch her breath; her heart rate was 128 resting; Shaking; Sweating; This is a spontaneous report from a contactable consumer (Parent). An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 18Sep2021 11:30 (at the age of 18-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date (at the age of 18-years-old) as dose 1, single for COVID-19 immunization. On 19Sep2021, the patient experienced, inflammation of the pericardium, Chest pain, she could barely catch her breath, her heart rate was 128 resting (these were serious, medically significant), Shaking and Sweating. Reporter stated, she was calling to report an adverse side effect to the vaccine for her daughter. Sure, she got her 2nd dose Saturday morning around 11:30 and 12 am Sunday 19Sep2021 she woke up she had severe chest pain, shaking, sweating, she could barely catch her breath to call me. We ended up in ER, they did EKG her heart rate was 128 resting. They did blood work, they released her about 6 hours later, told me to follow up with doctor, went to doctor yesterday he said that she has inflammation of the pericardium and referred me to the cardiologist. When confirmed vaccine as Pfizer Covid-19 Vaccine she stated, Ofcourse it is Pfizer that's why she calling you. She wouldn't calling you if it was Moderna it was Pfizer. When asked to file a safety report she stated Sure, but she was having a hard time understanding you. Well she may have to put you on hold because she was at work so, go ahead. She stated, She was a girl Height and Weight she stated, "5 foot 9(Confirmed as 5 foot 9 inches), 150(Confirmed as pounds) she guess. Why do you need this for this is ridiculous. She stated, You want to know she was doctor or nurse. No, she was her mother. Email address she stated, email(withheld) she think so she can't really understand you but okay. LOT number: she stated, How would she know that, she don't have that with me so she guess she will be doing this online. Thank you for wasting my time. Product details and pharmacy details could not be probed as the reporter hung up abruptly. Hence limited information available over the call. The patient underwent lab tests and procedures which included blood test: unknown results on 19Sep2021 electrocardiogram: heart rate was 128 resting on 19Sep2021. The outcome for the events inflammation of the pericardium, chest pain, she could barely catch her breath, shaking, sweating, her heart rate was 128 resting was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
hot in her left arm/ arm got so hot/ neck is hot; crazy dreams; achiness specially around the neck; Threw up twice this morning / all of a sudden, up it went - she has thrown up a couple of times; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot in her left arm/ arm got so hot/ neck is hot), ABNORMAL DREAMS (crazy dreams), NECK PAIN (achiness specially around the neck) and VOMITING (Threw up twice this morning / all of a sudden, up it went - she has thrown up a couple of times) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pfizer (dose 2) on 27-Mar-2021 and pfizer (dose 1). Past adverse reactions to the above products included No adverse reaction with pfizer and pfizer.    On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced FEELING HOT (hot in her left arm/ arm got so hot/ neck is hot), ABNORMAL DREAMS (crazy dreams), NECK PAIN (achiness specially around the neck) and VOMITING (Threw up twice this morning / all of a sudden, up it went - she has thrown up a couple of times). At the time of the report, FEELING HOT (hot in her left arm/ arm got so hot/ neck is hot), ABNORMAL DREAMS (crazy dreams), NECK PAIN (achiness specially around the neck) and VOMITING (Threw up twice this morning / all of a sudden, up it went - she has thrown up a couple of times) outcome was unknown.            No concomitant medications were provided by reporter. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Follow-up received contain significant information - New events crazy dreams, achiness specially around the neck and all of a sudden up it went - she has thrown up a couple of times added. Dates of the events updated. The historical vaccine changed.
Sore arm after vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (son) reported for a female patient (mother). A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Lot number and expiration date was not reported, NDC number of was not reported) dose number unknown via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Other products were not given. No investigation assessment was reported. On an unspecified date the patient experienced sore arm after vaccine. Caller stated that he got both doses of the Pfizer Covid vaccine. No further information provided. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.
Light headed, aurora sensation, nausea immediately.  Then syncope & seizure less than 1 min. Fell from chair when he went unconscious hitting head on floor as per nurse.
Vaccine given, then discovered a power outage had occurred for unknown amount of time while clinic closed.
Severe flu-like symptoms started about 12 - 14 hours after the injection; muscle aches, headache, fatigue, shivering; Symptoms lasted about 12 - 14 hours.
fair bit of pain, including her glutes; has pain up the back of her neck; has pain all the way down to her lower back; pain in the jaw.; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2022 09:00, the patient received Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced pain, neck pain, back pain and jaw pain. On an unknown date, the outcome of the pain, neck pain, back pain and jaw pain were not recovered/not resolved.   The reporter considered the pain, neck pain, back pain and jaw pain to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient was in a fair bit of pain on the day of reporting. The reporter do not know exactly when the pain started. It was communicated to reporter that she had pain up the back of her neck, all the way down to her lower back including her glutes. The patient was also experiencing pain in the jaw. The patient reported of no redness or discoloration in the areas of reported pain. Consent to follow up was not possible as no contact details were available. The reporter thought the events were directly related to the Shingles shot she received last week.
Change in menstruation. I?ve always had a regular period every 28-30 days heavy flow for 3-4 days and light flow for 3-4 days. They lasted exactly 7 days and I had never had spotting before.  On March 11 I began spotting. That lasted for two days then I got a medium flow for an additional 7 days. That period came 2 weeks early and lasted 9 days.  My next cycle came two weeks later and last 9-10 days  16 days later I started spotting again and have been menstruating for the past 7 days.
A rash occurred about 6 weeks after the second dose. It may not be from moderna vaccine but I was advised to report it. The rash began on the chest with 5 dots in a circle pattern, then spread up to the neck and sparsely down the body. Did not itch for the first few days but began itching on the 3rd day.
after first shot of Covid vaccine patient became ill and tested positive.; Tested positive; Ill; This is a spontaneous report from a Pfizer Sponsored Program. A contactable physician reported for a patient that:  The patient of an unspecified age and gender received bnt162b2 (solution for injection) (Batch/Lot Number: unknown) via unspecified route of administration on an unknown date as SINGLE DOSE for covid-19 immunisation. The medical history and concomitant medication were not reported. It was reported that after first shot of Covid vaccine patient became ill and tested positive. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
5/20 24y.o. adult with a medical history significant for obesity, obstructive sleep apnea, hypertension, gestational diabetes, factor V leiden mutation, bipolar disorder, SVT, tobacco abuse, who presented to Hospital on 5/20/2022 from home with a chief complaint of palpitations.
I did not have an adverse reaction to the vaccine. I had a headache the morning of 12/19/2022 and later I tested positive for COVID-19. I was exposed at a work event the previous Friday. I contacted my medical insurance nurse line and got a prescription for PAXLOVID. I had no complications taking the medication. As of today, I have no lingering COVID-19 symptoms.
Unknown arm sore at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "Unknown arm sore at injection site". Additional information: The reporter mentioned that her mother had arm soreness after receiving the COVID vaccine. She had both doses and soreness was after first one.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6 weeks of daily headache & migraine, exhaustion, weakness, dizzy, nausea, malaise, achey all over, night sweats and chills. 3rd day high energy and feeling well, 4th day energy reduction ( 5 th day full on symptoms return from 2nd day including unable to think clearly.)
12-22-2020 1am- arm soreness at sight 12-22-2020 7 am -arm, armpit, and chest muscle soreness 12-22-2020 1 pm chills, muscle pinches , shooting muscle pain (legs, body upper body) 12-22-2020 4 pm additional pain in right toes along with same symptoms above, facial muscle pain, irritable, tiredness 12-22-2020 10 pm headache
Muscle aches, mild fever, chills, headache, fatigue for approximately 18 hours
fever; upset stomach; real sore; face was tight; redness and swelling at the injection site that seems to be getting bigger; redness and swelling at the injection site that seems to be getting bigger; This is a spontaneous report from a contactable Other-HCP.  A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications. Patient received the suspect vaccine at morning, however on 24Feb2021 by 4-5 o'clock she was sick with a fever, she had an upset stomach, felt real sore, her face was tight. Eventually she stayed at the emergency department at the Hospital all night. She stated there was redness and swelling at the injection site that seemed to be getting bigger. The outcome of the events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Nurse Received call from Employee at this time. Pt. states he is calling due to his "arm is quite sore." Pt. reports he was given a TDAP to the right arm on Friday 03/24/23. Pt. reports his arm is sore when he lifts it to turn on the light. Pt. denies redness, swelling, and/or bruising to right arm injection site at this time. Pt. reports pain as a "4" on a 1-10 pain scale at this time. Pt. reports taking Tylenol this morning. Pt. states, "tender when I push on it." Pt. denies taking Motrin as he reports having recent gastritis issues.  Pt. was forwarded to the vaccine hotline for guidance. Nurse Received call from vaccine support hotline staff member stating she spoke with the pt. and counseled him to wait another two days to monitor site and "exercise it out." also reports she counseled the pt. to call back if it gets worse.
Within 10 seconds lost consciousness for 10 seconds probable vasovagal reaction. Tongue & hands were cool, felt tingling. BENADRYL given at 10:05, pulse ox raised from 83 to 99% in 15 minutes. It took 1 hour to recover.
Client developed a welt on left deltoid the night of the injection 10/16/2001. On 10/17/2001 the welt wrapped around arm and was hot to touch. By 10/19/2001 the welt was about an inch in size. Client continues to complain of achiness in left arm. Mom took her in to se MD on 12/06/2001 for continued achiness. MD encouraged her to call in and make appointment. No treatment. Continues to complain of pain.
It was around December 19, 2021. I was experiencing discomfort in the center and left side of my chest. Initially it was a dull ache, like a muscle pull feeling. That went on for about 3-4 days. Then the evening of the last day, sharper pain as radiating up my clavicle up to my jaw on the left side. It was fleeting and it repeated itself. It was a fast type of feeling. It stopped after ½ an hour and that's when I decided to call 911 in the morning and they took me to the hospital. In the morning, my BP was fine and I wasn't having a heart attack and they recommended me to come with them to the ER. I also had some dizziness, but I was not out of breath or anything. Just dizzy and balance issues, but again- fleeting. They registered me at the ER and they monitored me, took chest x-ray, checked me out head to toe and closely monitored me. After a couple hours, they were waiting for a room and wanted to admit me for further observation. I was admitted to the coronary observation unit, and I was there for 5 days. Released home, instructions were to follow up within 10 days with cardiologist and just continue with the meds I had already been taking. Continue with managing my diabetes and so on. They did a stress test and monitored me, and they did a pass through the vein and they saw I had two blockages at about 50%.
about 4 hrs p/immun given pt irritable; pt then had a 3-4 min generalized sz w/cyanosis; no treatment was given & baby did well;
Headache, Arthralgia, Injection site pain, injection site erythema, Injections site swelling, Fatigue Narrative:
Given immun @ approx 1030AM; 3PM temp 101, crying, vomiting; c/o h/a, aching body; 6PM t104, vomiting; 8PM vomiting again; Taken to Hosp @ 9PM; Blood work done neg results; still c/o h/a & body aches;
Episode of syncope in observation area. No s/sx of distress. AOx3. Given water, assisted to stretcher & sx resolved (BP 118/75; HR 71; RR 16; O2 sat 100%). No health hx or medications. Released from vaccine site with mother
Yesterday I received my 2nd Pfizer vaccine at 9AM. My first dose was a non-event. About 50 minutes after the jab, I broke out in hives on my upper thigh and stomach. By 7 PM, I felt really sick, my arm felt as though the strongest person in the world punched me, and by 8, I was shivering and wrapped in a ton of  blankets, by 10, every muscle in my body ached beyond its capacity and my fever was 101.8.  It got to 102.1. My head was weighed down with an unrelenting headache. Finally, an hour ago, my fever broke. I have Systemic Lupus and CRPS and do not vaccinate because my body is always attacking itself. But this year I got my first ever flu vaccine. Same results. So sick.
he had the first dose and arms are a little sore; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date caller mentioned he had the first dose and arms are a little sore. Outcome of the event was unknown.  Information about Lot/Batch number is requested.
Injection site soreness (mild) and mild muscle soreness during first 24 hours after 2nd dose of vaccination. At about 29-30 hours, noticed mild numb feeling along right jawline from middle of mouth to right ear, and around the right ear. By morning (about 48 hours post vaccination), numb feeling appears gone on right jawline, but seems to have moved to left jawline (still mild). No trouble breathing or eating at all. Consulted primary care doctor out of concern over odd sensation, but not treatments at this time. Considering taking a benadryl tablet just to see if it has any effect.
20 min later of vaccination the back of my tongue started getting swollen. I felt like my throat was closing. I felt like I was going to pass out & I felt very dizzy. I went to the Hospital the same day and they said that everything looked red inside my mouth and to follow up with my primary the next day. They gave me an IV. The dizziness continued for a few days & then I got very shaky the next day it lasted for a week but the swelling came down the next day.
This initial spontaneous report was received from a registered nurse regarding an multiple unspecified patients of unknown demographics. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date, the patients received a doses of improperly stored LIQUID PEDVAXHIB lot # L012838, expiration date 10-MAR-2018 and lot # L012835, expiration date 11-MAR-2018 dose and route were not provided (incorrect product storage). It was exposed to temperature of 47.7F for 1 hour and 4 minutes. Previously it was exposed to temperature of 50.3F for 1 hour and 20 minutes as well as 48.9F for 2 hours. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Hot area with Redness, swelling, itching and pain on left upper arm  at the injection site that started 1 week after the vaccine was given. Initially treated with  Hydrocortisone  2% topical cream 2 to 3  X day, ice pack at night. Currently still ongoing, swelling has come down as well as pain and redness, itching continues to be bothersome 3 days later.
Patient received 0.2ml of undiluted pediatric pfizer covid-19 vaccine. Patient, patient's mom and the HCP were notified, patient monitored for required 15 minutes following vaccination. Patient encouraged to drink water. Patient denied discomfort, pain, no signs or symptoms of adverse reaction or distress. Continued to monitor for additional 30 minutes, after no changes patient left clinic. Notified that the HCF would contact to follow up, encouraged to seek treatment if any changes occurred, and VAERS documentation would be done by RN.