chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot# M032641 with expiration date of 07-MAY-2018, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 47-77 degrees Fahrenheit (°F) for 2 hours. Data logger was involved. There were not previous excursions.  No adverse symptoms were reported. No other information was provided.  This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA002222: US-009507513-1705USA002242: US-009507513-1705USA002244:
It is not comfortable. It goes under arm all the way under her boob and down her side. It is not comfortable and cannot rest; It is not comfortable and cannot rest; Pain and Soreness in left shoulder; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Muscle under right arm real sore like lymph nodes are sore/cannot lift her arm; Right arm swollen/arm was swelling/right arm is swollen underneath and on top; her arm was swelling and really hurting; has not been able to sleep in about 2 days because of this; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0150) intramuscularly in left arm on 01Apr2021 10:00 at single dose for COVID-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: diabetes diagnosed 3-4 years ago, blood pressure abnormal, and hiatal hernia. She has to take Prilosec for a hiatal hernia but has been taking it for years. Concomitant medications included omeprazole magnesium (PRILOSEC) for hiatal hernia, and blood pressure medication and diabetes medication. She previously received the first dose of BNT162B2 on 04Mar2021 (Lot EN6202) in right arm in the muscle for COVID-19 immunisation. She took the second one on Thursday and it was not bothering her until Friday night until Saturday morning. On 03Apr2021 05:00, it woke her up and it felt like it went in the muscle under her arm. It was real sore like lymph nodes are sore and she cannot lift her arm. She got the second shot on Thursday morning and that is what caused it. Sometime toward daybreak on Saturday morning is when she first felt that her arm was swelling and really hurting on 03Apr2021 05:00. Her right arm is swollen underneath and on top. On 04Apr2021 08:00, pain in left shoulder is like when old people say they have pleurisy in the back. She has not been able to sleep in about 2 days (Apr2021) because of this. No ER or physician's office required. She felt like going but did not took Ibuprofen. She thought it was going to be great because she did not have any symptoms, but this has whooped her. It is not comfortable. It goes under arm all the way under her boob and down her side. It is not comfortable and cannot rest. She read over the paperwork and saw that there were Lymph nodes and she wanted to know if there was anything she can do for it.  She is just taking blood pressure medication and diabetes medication and has been on them for several years. Event outcome of not comfortable and cannot rest, insomnia was unknown, while for others was not recovered.
the day after the shot i have had a shin reaction and a rash on both arms and both legs. It itches really bad
Sweating, nausea, weakness, tingling in extremities, syncope. Estimate 2-3 minutes of symptoms before fainting, then regained consciousness after about 5-7 minutes.
I almost died when I arrived at the hospital. I was admitted and stayed there for 6 days for treatment. My blood pressure was 30/50. The Doctors did not know what was wrong and ended up being diagnosed with a septic kidney and the Dr. said that normally that occurs from a UTI and I have never had a UTI; however, now, I have three and I just came from the Dr.'s office today with another checkup.
Fever; pain; headache; tiredness; nausea; indigestion; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 2 weeks after receiving Shingrix, the patient experienced fever, pain, headache, tiredness, nausea and indigestion. In December 2019, the outcome of the fever, pain, headache and tiredness were recovered/resolved. On an unknown date, the outcome of the nausea and indigestion were unknown.   It was unknown if the reporter considered the fever, pain, headache, tiredness, nausea and indigestion to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix in his left arm at a local pharmacy.  The reporter did not want to provide any identifying information. The reporter stated he started to experience fever, body aches, headache, tiredness which resolved and was continuing to experience nausea and indigestion symptoms.  No additional information provided. Did not consent to follow up.
Hives, itching, erythema. Symptoms lasted for 10 days with treatment. 1st day treatment: 125mg solu medrol, 25mg Benadryl, prednisone pack for the next day. OTC Benadryl.  I can got remember the name of the vaccine?s manufacturer.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/14/21 2nd dose02/11/21 Diagnosed covid positive:08/25/21 Symptom onset: Exposure:Asymptomatic Symptoms:
PATIENT DEVELOPED RED HOT RASH APPROXIMATELY 1 WEEK AFTER DOSE
After my 1st vaccine ever administered on 17-Mar-2021, I had my first ovarian cyst rupture in August 2021. I followed up with imaging since then with my gynecologist, Dr and have had multiple cysts on my ovaries. My second cyst ruptured on April 7, 2023, about 4 months after my 2nd Pfizer booster. Please note all Pfizer vaccine dates and lot #'s have been reported through Pfizer Safety Reporting #COV-2305-Prxw9z. It was then that the ER physician discovered a mass after I had a CT scan w/ and w/o contrast. I followed up with Dr. and this was thought to be an ovarian endometrioma per transvag ultrasound. However, I was referred to a gynecologic oncologist b/c my CA-125 biomarker was elevated at Anything over 35 is above the normal range. I had an MRI w/ and w/o contrast and it showed that the ovarian endometrioma was approximately 6 x 10 x 6 cm and located unusually in front of my bladder. No lymph node inflammation noted. No ascites noted. Uterus unremarkable. I am having surgery tomorrow, 09-May-2023, to remove the endometrioma, get it biopsied, and I also need a salpingo-oophorectomy with a hysterectomy.
Date of onset unknown-- reported on 10/23/15  3cm x 3.5 cm Hematoma left deltoid non tender; 0 induration; negative fever  Treatment: cool compresses.
pt confirmed preg;EDD is 11/3/99;pt took zoloft two times early in preg;ultrasound 4/15/99 & level 11 ultrasound 6/16/99 revealed no anomalies;pt exp severe preg induced HTN;labor induced 37 1/2wk;
Patients received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses of the Moderna COVID vaccine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses of the Moderna COVID vaccine) 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 was placed in refrigerator on 13-Jan-2022 vaccines.   No treatment medications were reported.
duration of 1 week: Nausea, vomiting, fever, severe fatigue, aches duration of several weeks: development of painful blisters on toes that started within several days of vaccination and come and go for several weeks at a time still to this day
The spontaneous report as received from a physician refers to a unspecified number of patients of unknown age. The unspecified patients medical history was not reported. The physician stated that her refrigerator and freezer units began to have temperature excursions as of 05-MAY-2014. VAQTA was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range) since 05-MAY-2014 and also to 49F for 12 hours. On unspecified dates since 05-MAY-2014, an unspecified number of patients received VAQTA which was improperly stored. No product complaint was reported for VAQTA.  This case in linked to: 1411USA001655, 1411USA004433, 1411USA004434, 1411USA004435, 1411USA004436, 1411USA004437, 1411USA004438l, 1411 USa004439. 1411USA004440, 1411USA004441 and 1411USA004442 (same reporter link). Additional information has been requested.
On December 20,2021, I received the Moderna Booster shot. Then, on December 28, I noticed a rash that formed on my left neck the same side I received the shot on ?It itched , but I managed that first night.  Then Wednesday, December 29th, the rash became much worse.  Thursday morning at 4:45am I woke itching so bad that I could barely stand it and the hives had begun to spread to more parts of my body and in the middle of that night I was taken to the ER for the first time and was told it was chigger bites and was given 25 mg injection of Benadryl and a script for Hydroxyzine.  The hives got larger and continued to spread and the itching became even worse, so I returned to ER for the 2nd time and was still told it was chiggers and was given a shot of Toradol and Neosporin to rub on my hands were I had developed large blisters of which I have pics.  24 hours later I was MUCH worse on all accounts and had almost no sleep in days because of non-stop itching and now my feet are overcome with hives and blisters and have swollen to the point that I can barely get on my shoes.  I was taken to the ER for the 3rd time on New Year?s Eve and was given an injection of 50mg of Benadryl and a referral to see a Dermatologist. Unfortunately, it was now a holiday weekend and I had to wait in misery till Monday, January 3rd to see a specialist who finally said, all 3 ER doctors failed to take a History which is true.  Not a single one of those docs asked about when I had my list Covid Vaccination which had only been a week earlier.  Then, the Dermatologist said, ?this is NOT chigger bites but a severe reaction to the Moderna Booster and you have severe Thrombosis Uticaria.  He is trying to prevent a worsening of the situation with HIGH doses of Prednisone and aspirin to thin my blood to reduce any further blood clots.  Today, is January 5th and I see the Specialist again later this afternoon.
The pt experienced a 7x7 cm red, swollen, raised are to the right anterior thigh.
Patient came to BOH on 3/27/07 to report adverse reaction from flu shot. She had no complaints until before Christmas (cannot give exact date) C/O burning in L arm, no redness, no swelling. Did not see MD. In Jan she felt lump in L arm (50 cent size) MD said it was bursitis - now lump is 25 cent size, no pain, no redness.
Every time that he tries to lay down, his heart beats really fast/when he gets up, it slows down; Recieved a booster dose at 0.5 mL; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Every time that he tries to lay down, his heart beats really fast/when he gets up, it slows down) and INCORRECT DOSE ADMINISTERED (Recieved a booster dose at 0.5 mL) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MIRTAZAPINE for Post-traumatic stress disorder.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 23-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Recieved a booster dose at 0.5 mL). On 26-Oct-2021, the patient experienced HEART RATE INCREASED (Every time that he tries to lay down, his heart beats really fast/when he gets up, it slows down). On 23-Oct-2021, INCORRECT DOSE ADMINISTERED (Recieved a booster dose at 0.5 mL) had resolved. At the time of the report, HEART RATE INCREASED (Every time that he tries to lay down, his heart beats really fast/when he gets up, it slows down) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, Heart rate increased: increased (High) Increased.         No treatment information was provided.
p/vax pt exp edema & swelling above & below elbow; throbbing; severe pain x4 days; partial loss of function due to pain
Extreme large circle on arm approx 5 inches in diameter.   (this was from the second day of the shot  Distortion of smell that began as any aroma smelling metallic.  This changed after two days and any aroma smelled rancid/overly sweet and nauseating.  Taste became the same rancid/sweet smell.  No differentiation between smells- every smell and taste was this distorted smell and taste.   This distortion caused violent vomitting on May 14th and May 15th I was seen in the ER for rapid heart rate and AFIB.  This did not happen until after the vomitting episode.
Information has been received from a nurse concerning a 65 year old White female with a history of left breast cancer and hypertension and with no known drug allergy who on 16-JUN-2008 was vaccinate with a first dose of ZOSTAVAX (Oka/Merck) (lot# 659408/0300X) 0.65ml intradermally in her right forearm. The area of the forearm had a circle of fluid at the injection site and the 50 cent size rash caused pain. The patient felt achy and not well for the first week post vaccination. The arm finally was back to normal on approximately 21-JUL-2008 (also reported as approximately 21-JUL-2008). The patient will be getting re-immunized on 04-AUG-2008. The patient sought medical attention in office. Additional information is not expected.
Received shot and waited for the 15 minutes as required, feeling no good with no symptoms. While driving home after leaving the pharmacy, I started experiencing light headed ness and dizziness.  This eventually turned into tunnel vision which I thought was going to result in me fainting.  This led me to start pulling over, but then the tunnel vision went away.  During my short 10 minute drive home, this happened to me twice.  After getting home, I had about 3 similar episodes during which similar light headedness happened.  These all felt like they were getting close to fainting, and at one point while walking up the stairs in my house I could not stand.  All of these symptoms started approximately 20 minutes after leaving the store, and then took place in a 20-30 minute timespan. Roughly 4-5 episodes in total, including the drive home and short time spent at home.  No issues after lightheadedness stopped, besides feeling tired.    I do not have a history of anxiety attacks due to needles.  Donated blood and plasma in college, and have recieved many vaccines and never had this happen.
Has not received a Second Dose, 3.5 months after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received a Second Dose, 3.5 months after the first dose) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received a Second Dose, 3.5 months after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received a Second Dose, 3.5 months after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
issues with "my" teeth; issues with "my" jaw; Booster dose taken before 22Sep2021; Booster dose taken before 22Sep2021; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received third (BOOSTER) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FO8448) via an unspecified route of administration in the left arm on 09Sep2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown whether the patient had any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 56-years-old) and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 08Oct2021, the patient experienced to have issues with her jaw and teeth. After she had spoken to others, it was reported that they were experiencing the same issues, and the patient queried "why was this?" (as reported) and wanted someone to call her. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and the patient was about to see a dentist. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent Nasal Swab, SARS CoV-2 test and the result was negative. The clinical outcome of the events issues with jaw and teeth were not resolved at the time of this report.
Local reaction of palm size 9 cm x 8 cm reddened area. Raised & warm & tender. Is 8 cm below site 1 cm bruise at site. Treated with cold compress/ice, BENADRYL.
Swollen achy knees since the middle of August 2022.  I've never had knee issues.  My left knee keeps me awake at night and aches constantly.  I'm finally getting an MRI on Oct 31.
On March 26th I had a minor fever and felt allergies or sinus issues I kept getting worse and had SOB and ended up in the ED and was diagnosed with pneumonia I've been on 5 doses of antibiotics and steroids I went to the ED 3 different times because my pneumonia has only worsen  I lost 14lbs in month and  a half I've had night sweats and headaches I was tested for TB and that was negative I don't smoke my pulmonologist does not know why its not clearing up I was diagnosed with MAC I've had a slung biopsy and a upcoming endoscopy.
This spontaneous report was received from a registered nurse, referring to a an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions or concomitant medication were not reported. Since 01-JUN-2017, the patients may have been administered incorrect storage doses of GARDASIL 9 (dosage information, route, lot number an expiration date were not informed) for prophylaxis. No adverse effects were reported. It was also reported: temperature/time: 49.8F for 30 minutes. There was no previous temperature excursion. "Data logger" was involved. The outcome was reported as: supported. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA003517: US-009507513-1706USA004962: US-009507513-1706USA004960:
pt recvd vax & 8 days after vax, pt became fussy; ran t 101, 10 days later devel severe hives; rash over body; to MD given steroids;
Temp elevation from 1130pm 4-11-07 to 10:00pm 4-12-07. Highest temp 105 deg.
On 11/5/18, was seen in family practice clinic and reported that she had gotten the flu shot and the next day woke with bad headache. Took TYLENOL and ALEVE. Called the clinic and was prescribed meloxicam and didn't help. Had cataract surgery in 2012 which resolved the cloudiness in her eyes. Has had cloudiness in eyes come back off and on since August 2018. Vision has not been worse with her current headache. No photophobia. No vomiting. No recent nasal congestion. Often gets sinus infection in winter. Pain is a 9. Worse since last week. History of migraines 5-6 times a year, usually on days of high humidity. Her migraine pain is also behind her right eye. Takes ADVIL for that pain and headaches usually take 2-3 days to go away. Referred to ophthalmology and was seen 11/7/18. They reported that APD, normal color testing. Due to mild temporal pallor of both optic nerves, patient will need HVF 24-2 and OCT RNFL in the future. They recommended MRI of brain and orbits which were done 11/12/18.
9/9/21 SEEN IN THE ER WITH LOW OXYGEN 88%. SENT FROM PRIMARY CARE MD FOR HYPOXIA ON AMBULATION.  ADMITTED TO HOSPITAL  DUE TO PNUEMONIA SECONDARY TO COVID. ACUTE CHF.
Fever for 12 hours over 101 F. Joint pain, neck pain, headache, chills, naseua
Moderna COVID-19 Vaccine EUA, Chills, Fever, Lethargic, Headache, Nausea, Muscle Pain in Thoracic area of back down to mid-thighs
Painful, Red, swollen knot at injection site; warm to the touch; knot/lump raised about a 1/4 inch, began small and continued to grow over next 3 days
vaccination site mass; This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site lump in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site lump to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The pharmacist reported that the patient complained about a lump on the arm after receiving shingrix on an unspecified dates. No clarification information was provided, no further information was provided. This is 1 of the 5 patient case reported by the same reporter.
1 of 3 pt's who experienced an inject site rxn which included swelling 2'' in diameter, induration 1-2' in diameter, redness & hot to touch; Tx included heat @ inject site & Advil or APAP for the pain; Pt is currently asymptomatic;
Pt. states that after receiving the 2nd dose of Pneumo Polysaccharide 10/08/2021 (received the High-Dose Influenza Right arm), started experiencing symptoms 30mins after of pain in the left arm at injection site, chills, fatigue, muscle aches, and flu-like symptoms. Soreness still continuing in the left arm. No noted Primary visit/communications.
Cellulitis at site of injection Fever and chills Patient also had concurrent gastroenteritis probably unrelated to vaccine
I had a mild headache and felt tired a few hours after the vaccine. Approximately 12 hours later, I felt very cold and could not get warm. I spent the night shivering tossing and turning with a bad headache, and woke up around 5 AM with a slight fever. I was very ill the rest of that next day, unable to get out of bed, with a bad headache and feeling very sleepy and sick like I have the flu. Plus my arm where I had the shot is and was very sore.