chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fainted; fever of 102; dehydrated; booster; This is a spontaneous report received from contactable reporter consumer or other non HCP . The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 08Dec2021 15:00 (batch/lot number: FTJ1620) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was in a pharmacy or drug store. Relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included: lisinopril; cetirizine hydrochloride (ZYRTEC ALLERGY). Vaccination history included: bnt162b2 (dose 1, batch/lot no: En6198, arm left, at 15:00 PM), administration date: 22Feb2021, when the patient was 51 years old, for Covid-19 immunization; bnt162b2 (dose 2, batch/lot no: EN 6206, arm left, at 15:00 PM), administration date: 15Mar2021, when the patient was 51 years old, for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: IMMUNISATION (medically significant) with onset 08Dec2021 15:00, outcome "unknown", described as "booster"; SYNCOPE (medically significant) with onset 10Dec2021 12:00, outcome "recovered" (Dec2021), described as "fainted"; PYREXIA (non-serious) with onset 10Dec2021 12:00, outcome "recovered" (Dec2021), described as "fever of 102"; DEHYDRATION (non-serious) with onset 10Dec2021 12:00, outcome "recovered" (Dec2021), described as "dehydrated". The events "fainted", "fever of 102" and "dehydrated" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: 102. The patient has not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of syncope, pyrexia, dehydration which included IV fluids.  Additional information: The patient informed that 2 days after receiving the booster, she fainted on the street. The patient had a fever of 102 for 2 days and despite attempts was really dehydrated. The patient informed that this was far worse experience than the previous 2 doses.
I felt okay earlier in day after vaccine, but then I sat down in living room at about 7PM at night and I woke up about 3AM in the morning and my muscles ached and joints ached and so I thought I better go to bed. I was also having very bad chills and sweating and I couldn't get warm and had to put on 3 blankets in the bed. I had a headache and finally I fell back asleep and didn't wake up until 4PM the next day (02/20/2021) and I still felt pretty bad but I wasn't as achy or shaky or sweaty. I felt really weak and then by Saturday I went to bed around 8PM, woke up around 10AM the next day (02/21/2021) and felt more normal. Over the next couple of weeks, I had some headaches and I attributed them to dehydration but it could be related to vaccine. I also had skin problems that I never had before. I had joint aching but it wasn't constant and it would come and go. I am still having skin problems on my back and my shoulders. There's itchy bumps. Has not seen medical doctor but there is appointment in July with PCP. I couldn't lay on left side because of arm pain.
Received # 1 dose of Hepatitis A 5/29/01. Had no itching all day, got home @ 8PM and removed her slacks discovering hives on inner aspect of both thighs and a few on outer thighs, this is the only place she had hives. She did not take any antihistamines and ignored hives and on awakening 5/30/01 noticed hives had disappeared. On Synthroid 100 mcg daily only.
p/vax pt devel bright red rash (erythema); fever; & strong flu-like symptoms
Moderate fever 102.5, chills, headache, muscle aches, head pressure.
wrong second dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (wrong second dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (wrong second dose). At the time of the report, WRONG PRODUCT ADMINISTERED (wrong second dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Wrong second dose of Pfizer's vaccine was given  No treatment information were provided No concomitant medications information were provided
On April 10, 2021, I had a scratchy throat and a little cough that continued through the 12th. I developed a really bad headache. On the 13th I still have the cough and very headache frontal forehead area. Then on the 14th I called my doctor and thought I had another sinus infection. He ordered a Z PAK and Medrol dose pack and he ordered a Covid Test on that day and tested Positive. The next day on the 15th I did feel a little bit better then on the 16th I was a little better but very tired. On the 18th I felt a little short of breath but my O2 was one time in the 80's but then went back to 94-95.  I did recover though I did have a lot of mucous on 04/20/2021. I am being checked for being very tired and some pain on the right side of my body. So, I went to my doctor on 3/24/22 and had my labs on 03/25/2022. I have not scheduled my follow-up for my labs yet waiting for them to reach out to me. I want to note that I was exceptionally careful, wore a mask, and stayed home.
She got fever; she started sleeping and jumping all the time through night; she move and hit something up and then after land; she started sleeping and jumping all the time through night; she move and hit something up and then after land; This is a spontaneous report from a contactable consumer. This consumer (parent) reported for a 12-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0196, Expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced she got fever, she started sleeping and jumping all the time through night, she move and hit something up and then after land. The reporter stated, my daughter (consumer) had her (first dose) Pfizer shot vaccinate last two days and she got some fever for this normal and I gave her some Tylenol as treatment but as she after that started to sleeping and jumping all the time like she keep sleeping through every night, she was even last night. She move and hit something up and then after land then another hour, I don't know what was going on with it. It was not a normal reaction. Reporter stated, She was sleeping with me in my sister house in one bed and we are sleeping together. She got fever in the first I think 24 hours, so I didn't go anywhere but she started to jumping all the time, so I was thinking the first night was normal but we have almost 5 nights in a row this thing came and she never do that before. She just took her vaccinate two days on 23rd and this night it was her fever, so we don't pay attention to then. Then on 22Jul, 23Jul, 24Jul and right now when I recently speak today, so it was specially in the night, in the day she is normal, she started to jumping for no reason. Patient was got fever in the first she thinks 24 hours, so she didn't go anywhere but stated to jumping all the time so was thinking the first night was normal, but we have almost 5 nights in a row this thing came and she never do that before. She just took her vaccinate two days on 23rd and this night it was her fever, so didn't pay attention. Then on 22Jul, 23Jul, 24Jul and right now when consumer recently speak today, it was specially in the night, in the day she is normal, patient starts to jump for no reason. The patient received tylenol as treatment for the adverse event. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
PATIENT WAS FEELING FINE AFTER THE VACCINE WAS ADMINISTERED. AFTER 5 MINUTES THE PATIENT LAYED ON THE FLOOR DUE TO SOME DIZZINESS. PATIENT LET US KNOW HE WAS UNWELL AND PROCEEDED TO FAINT WHILE I STOOD NEXT TO HIM. HE WAS VERY SWEATY AND LOOKED LIKE HE WAS HAVING A PANIC ATTACK. HE WAS TOLD TO LAY DOWN AND DRINK SOME WATER ONCE HE REGAINED CONCIOUSNESS. AFTER 45 MINUTES THE PATIENT WAS ABLE TO WALK FINE AND ABLE TO DRIVE HOME.
Narrative:  01/25/21 COVID vaccine dose #1 02/12/21 COVID vaccine dose #2 ADR reported to nurse on 3/10/22 visit, unclear of timing of ADR, as no details included in progress note
Soreness in right shoulder, increasing pain with motion moving arm above shoulder height. 18.5 weeks pregnant when shoulder pain increased. Expected due date is 03-20-2019.
Abdominal aortic aneurysm. Vascular surgery; hospital stay. This visit was within 6 weeks of receiving vaccine.
The patient has a history of COPD, pulmonary embolism, and stroke. She was seen in the ED on 5/10/23 for worsening difficulty breathing and bilateral lower extremity edema over the past three days.   A COVID PCR test done in the ED resulted positive. Ultimately, she was admitted 5/10/23 - 5/14/23. During admission, she was placed on ceftriaxone and azithromycin. Discharge diagnoses include shortness of breath, bilateral lower extremity edema, acute on chronic diastolic CHF, and mild to moderate HFpEF exacerbation, among other diagnoses. Of note, the provider felt the COVID-19 result was a false positive, as a repeat COVID-19 test did result negative. Of note, the patient has recieved the primary COVID vaccine series and two boosters.
PT DESCRIBE SEVERE HALLUCINATIONS WHILE SLEEPING AT NIGHT-PT SAID HE FELT LIKE SNAKES WERE CRAWLING OVER HIM AND HE TOLD HIS (DEAD) WIFE IN HIS HALLUCINATION TO GET A GUN TO KILL THE SNAKES
This spontaneous report as received from a patient's mother refers to a 11 year old female patient. The patient's concurrent condition included asthma. There was none of drug reactions or allergies reported. Concomitant therapies included SINGULAIR and oxycarbonate. On 15-MAY-2015 the patient was vaccinated with a dose of GARDASIL (lot#, strength, dose and frequency were not reported). On the same day, after receiving vaccine, the patient experienced nausea, bumps at the injection site, flu-like symptoms, inability to speak, dizziness and rash. The patient sought medical attention by phone call to health professional office on 15-MAY-2015. She was treated with ADVIL. None of lab diagnostics studies were performed. Therapy with GARDASIL was discontinued. The outcome of the patient's events was reported as recovering/resolving. The relatedness between therapy with GARDASIL and the patient's events was not reported. Upon internal review the inability to speak was coded to aphonia and considered as medically significant event. Additional information has been requested.
Patient states about 3 weeks after shot he started breaking out in a rash on both sides of his body which was very itchy but not painful. About a month after first signs he is almost over the affects but at one point took up to 8 ZYRTEC a day and was also given steroids.
Bladder irritation and severe pain, similar to a very painful UTI, preventing me from walking or sleeping. I asked my urologist's office about vaccine safety prior to vaccination; the NP answered that other Interstitial Cystitis patients told her irritation and pain had been reported, and a good prevention of the pain was staying well hydrated, similar to treatment with a UTI. I followed through - the first dose was manageable, but the second dose (the Lot number above) was much, much worse. I was unable to walk, or sleep because of the pain, and it took a month to recover. Symptoms included bladder pain, pelvic pain, trouble urinating, painful urination, restless sleep, insomnia due to pain, trouble walking from pain, bladder discomfort, pelvic discomfort, abdominal pain, frequency urinating, urgency especially at night. Treatment included testing for UTIs, staying well hydrated with water and cranberry juice,  seeking treatment from urgent care, antibiotics (which helped with the pain, but not much else), and heat sacks for the pelvic pain.
Vaccine was adminstered past 30 day thawing date Vaccine expired on 14-Apr-2023  and was used for vaccination on 20-Apr-23; No adverse event; Patient was administered vaccine past in 30 day thawing date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past in 30 day thawing date), PRODUCT STORAGE ERROR (Vaccine was adminstered past 30 day thawing date Vaccine expired on 14-Apr-2023  and was used for vaccination on 20-Apr-23) and NO ADVERSE EVENT (No adverse event) in an elderly 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-2023, 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 20-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past in 30 day thawing date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was adminstered past 30 day thawing date Vaccine expired on 14-Apr-2023  and was used for vaccination on 20-Apr-23) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past in 30 day thawing date), PRODUCT STORAGE ERROR (Vaccine was adminstered past 30 day thawing date Vaccine expired on 14-Apr-2023  and was used for vaccination on 20-Apr-23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past in 30 day thawing date) and PRODUCT STORAGE ERROR (Vaccine was adminstered past 30 day thawing date Vaccine expired on 14-Apr-2023  and was used for vaccination on 20-Apr-23).    No concomitant medications were reported.  No treatment information was provided.
THE SAME EVENING AFTER RECEIVING THE VACCINATION, PATIENT NOTICED RED RASH COVERING AREA WHERE VACCINES WERE GIVEN. THE FOLLOWING DAY, PATIENT NOTICED RED AREA IS WARM TO TOUCH. PATIENT REPORTED ARM BEING EXTREMELY SORE THE FIRST NIGHT AND SORENESS HAS BEEN RESOLVED. RED AREA IS STILL WARM TO TOUCH FOUR DAYS LATER.
Fever, body aches, nausea, injection site soreness for ~36 hours after injection.
stomach upset; Dry heaves; Stuffy nose; Sore arm; chills; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Mar-2021 and was forwarded to Moderna on 07-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach upset), RETCHING (Dry heaves), NASAL CONGESTION (Stuffy nose), PAIN IN EXTREMITY (Sore arm) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 05-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), RETCHING (Dry heaves), NASAL CONGESTION (Stuffy nose), PAIN IN EXTREMITY (Sore arm), CHILLS (chills) and HEADACHE (Headache). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset), RETCHING (Dry heaves), NASAL CONGESTION (Stuffy nose), PAIN IN EXTREMITY (Sore arm), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Pt with a history of varicella exposure at ages 5 and 7 and was vaccinated with varicella virus vaccine live and subsequently experienced approximately 70 Lesion, redness at the injection site "immediately after vaccination", thirst, chills, mild headache, neck ache and itching. The pt also experienced a red, raised rash with white heads.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 30-OCT-2013 the patients were vaccinated with ROTATEQ lot number J003465. Dose, route and frequency were not provided. On 30-OCT-2013, the patients were vaccinated with ROTATEQ stored as high as 47F for up to 44 hours. No adverse effects were reported. This case was linked to MARRS case numbers 1311USA008054, 1311USA007704, 1311USA007705, 1311USA007695, 1311USA007696, 1311USA007699, 1311USA007700, 1311USA007701, 1311USA007702, 1311USA007703, 1311USA007696, 1311USA007697, 1311USA008057, 1311USA008058, 1311USA008059, 1311USA008055, 1311USA000906, 1311USA008061, 1311USA008056 (same reporter link). Additional information has been requested.
Acute shoulder pain at injection site and limited range of motion.  Symptoms increasing in severity 5 days after initial onset with further range limitation and pain.
1715: Received vaccine 1738: C/o jaw tingling, chest pressure and fast heart rate , HR 76 palpable 1741: 100mg PO liquid Benadryl given 1800: pt sent home from clinic, felt comfortable going home.
DEATH; This spontaneous report received from a consumer concerned a female of unspecified age and unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported, the company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 08-APR-2021, after 3 days of vaccination the patient died due to unknown cause. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:  This is a spontaneous report of a female of unspecified age who died 3 days following the administration of the Janssen COVID-19 vaccine.  Cause of death, details surrounding the death, the patient's medical history and concomitant medications were not reported. There are insufficient details to make a meaningful medical assessment at this time.; Reported Cause(s) of Death: UNKNOWN CASE OF DEATH
After each of my vaccines, I was constantly coughing. I saw my Dr and he prescribed Prednisone 10mg. It helped resolve it.
Developed shingles infection with first sign of rash appearing on Saturday, September 11, and shingles full rash by Tuesday, September 14. After Pfizer shot number 2 I did not experience any side effects. After this booster, I experienced all of the normal list side effects including nausea, vomiting, diarreah, headache, muscle aches and fever. This began at 1:30 AM Thursday morning, and it continued until I woke up Friday morning. Friday was a fairly normal day, and Saturday my headache began to come back. It was more of a shooting pain or zinging pain. The rash began to develop on Saturday. It appeared to maybe just be a heat rash, but by Sunday, it was obvious it was shingles. My primary care doctor was unavailable for an appointment, so I visited the Clinic listed above.
Came down with shingles  about 3 and a half weeks after second vaccinaation. Symptoms: pain, sore throat, headache and a few days later shingles rash on half of face diagnosed at MD and later by my internist.
A report was received from a health care professional on 12/2/03 concerning an unspecified number (approximately 5 to 6) vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates, the vaccinees inadvertently received Fluvirin 0.5ml IM. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/20/04: A follow up report was received from a health care professional concerning a 3 year old male vaccine who inadvertently received Fluvirin on 11/5/03. On 11/5/03 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. No follow up pending. All information received.
Chest tightness,  arrhythmia,  palpitations,  shortness of breath on walking, out of breath easily
A nurse described the occurrence of limb swelling in a 12 month old male who was vaccinated with Infanrix for prophylaxis. The subject was described as a "well child" with an allergy to amoxicillin. There were no concurrent medications reported. The subject received his fourth injection of Infanrix on 9/24/02 (557A2) at the age of 12 months, rather than at the recommended age of 15 to 20 months. On 9/24/02, the subject also received injections of Comvax and MMR II. On 9/25/02, the subject developed an injection site reaction characterized by redness and swelling from the knee to the groin. As of 12/17/02, the injection site reaction had resolved.
PATIENT HAD NOT HAD ANYTHING TO EAT THAT MORNING AND WAS NERVOUS ABOUT THE SHOTS. HE RECIEVED HIS SHOTS AROUND 11:15 AM THAT MORNING OF TDAP, MCV4, VARICELLA AND A TB TEST. RIGHT AFTER RECIEVING HIS SHOTS HE GOT UP FROM THE CHAIR AND FOLLOWED HIS MOM TO THE CASHIER WINDOW AND FAINTED AND FELL BACK ON TO THE FLOOR HITTING THE BACK OF HIS HEAD. THERE WAS NO INJURY TO HIS HEAD.HE CAME TO RIGHT AWAY AND WE HAD HIM LAY THERE FOR ABOURT 5 MINUTES TILL HE FELT BETTER, THEN WE WALKED HIM BACK TO THE ROOM WHERE WE HAD HIM WAIT FOR ABOUT 20 MINUTES. HE SAID HE FELT FINE AND WAS READY TO LEAVE.DURING THE WAIT WE FED HIM SOME CRACKERS AND DR.PEPPER. PATIENT WAS BROUGHT BACK FOR A TB READING ON MONDAY 06/09/08 TWO DAYS LATER, ( THE INCIDENT HAPPENED ON 06/07/08 SATURDAY).MOM CLAIMS THAT HE WAS FINE FOR THE REST OF THAT SATURDAY 06/07/08 AND HAS HAD NO PROBLEMS.
After vaccine was entered in system, it stated vaccine "NOT VALID" due to age. Patient was 17 years old when she received JJ vaccine which is only for 18 yrs. old and up.  It is unknown if patient had any symptoms or adverse events due to this, but I was told to file a report.
I got the vaccine and a few weeks later I contracted COVID-19. I started with a severe sore throat and sinus congestion, headache and body aches as my first symptoms. As days progressed, I developed body chills and low-grade fever. I had slight diarrhea the day after. I had some chest congestion, too. I went to my doctor due to my severe hypertrophic cardiomyopathy; they prescribed me PAXLOVID that I did not take due to my cardiologist saying it could cause heart arrhythmia triggered by my heart condition. Instead, I took some TYLENOL and rested to allow the symptoms to subside on their own. As the days, I'm still improving and getting better.