chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My feet were very red and itchy on the bottoms; My feet were very red and itchy on the bottoms; I had a rash on my lower legs and thighs on both legs; This is a spontaneous report from a contactable other hcp (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 08Mar2021 12:00 (Batch/Lot Number: EN6204) as dose 2, single (age at vaccination 71-year-old) for covid-19 immunisation. Medical history included Hypothryroid, High Blood Pressure, depression from an unknown date and unknown if ongoing Other medical history: Depression, Complete Hysterectomy(Need hormone replacement), Known allergies: Penicillin from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, start and stop date were not reported; estradiol (ESTRADIOL) taken for hysterectomy, start and stop date were not reported; amlodipine (AMLODIPINE) taken for hypertension, start and stop date were not reported; lisinopril (LISINOPRIL) taken for hypertension, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for depression, start and stop date were not reported. Historical vaccine information included bnt162b2 (COMIRNATY) 1st dose on 15Feb2021, administration site (Left arm,), administered at 12:00 PM, lot number EM9809 for COVID-19 immunization. On 08Mar2021 23:45, the patient experienced my feet were very red and itchy on the bottoms, i had a rash on my lower legs and thighs on both legs. It was reported that patient had a reaction last night. patient got her shot at 12 noon yesterday her second vaccination (unspecified medication), patient went to bed around 10.30. patient was awoken around midnight with itching on the bottom of her feet and rest of my leg but it wasn't on her arm, it didn't appear to be on her arm or on rest of her body just her legs and her feet so patient got up and stayed up for couple for hours. patient was worried that it was an allergic reaction, patient wanted to make sure. it didn't get worsened surprisingly the rash faded and went away. patient did not have the rash near the injection site, but her feet were very red. The outcome for all event was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 21st June 2018, the patient received the 2nd dose of SHINGRIX. On 22nd June 2018, 1 days after receiving SHINGRIX, the patient experienced shivering, upset stomach and fever. The patient was treated with TYLENOL and PEPCID. On an unknown date, the outcome of the shivering, upset stomach and fever were unknown. The reporter considered the shivering, upset stomach and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. This case was not reported to anyone previously. The patient received SHINGRIX in the left arm a day before the reporting date. On 22nd June 2018, in the morning, the patient awoke with shivering, fever and upset stomach. The reporter had contacted the pharmacist, who advised TYLENOL and PEPCID. The reporter was referred to his wife's physician, as he was seeking treatment recommendations from GSK. The side effects of this kind reported in clinical trials were reviewed but noted not able to provide medical advice. The patient's husband had declined additional questions, and was requesting medical advice.
Patient received vaccination at 1556. Pt reported right hand tingling/numb and lightheadedness. Pt requested anti-gravity chair and reported decreased dizziness immediately. Vitals assessed: 102/62 BP, 118 pulse, and 99% O2. Pt received diphenhydramine 25 mg/10ml oral solution at 1613. At 1628, pt reassessed. Right wrist slightly numb and dizziness  diminished. Pt reported no pain and left facility with steady gait. Pt left with mother at approximately 1638.
Fever, muscle pains, pain shot area, headache, chills, swollen arm pit. Took Aleve for the headache that last two days, second day dizziness and continued arm pit pain and swelling.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine at pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-MAY-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
11 hours after vaccine- nausea, insomnia, chills, severe headache  Continued until the next morning. Headache continued. Chills came and went.   The 2nd morning, all issues were gone.
Patient had a seizure lasting about 1 minute. EMS was called. While waiting for the ambulance to arrive, we comforted the patient and gave him water to sip. By the time the EMTs arrived, he was alert and feeling better. He was evaluated by the EMT and it was suggested he go by ambulance to the emergency room; however, his father refused the ambulance. We do not know if he was taken to the hospital for evaluation.
After vaccination patient had an episode of vasovagal response with syncope. Patient was laid down on the exam bed, vital signs taken, cold pack placed at back of neck. No O2 was required as Patient's SpO2 was 100% on room air. Initial BP @ 0938 was 104/59  P- 65 R- 42. Patient aroused within approximately 1 minute after episode of syncope. Vitals repeated @ 0940 BP- 118/70 P-85 R- 24. Mom reported patient had not eaten. Patient fully recovered.
Shortly after very sensitive area of vaccine. It has been 1 month. I phoned dr stated severe pain in left arm, can't even lift it - hurts constantly. Wakes me up at night throbbing. He said to fill out this form 1st.
pt said she had fluid in ear/could not hear well as well as fever/chills. eventually ended up having ear infection
itchy; skin rash; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 49-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date was not reported) (at the age of 49-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced itchy and skin rash. Events took place after use of product. It was reported that following first Covid vaccination dose, patient felt itchy and experienced a skin rash and after the second dose, felt symptoms similar to pneumonia for one day. The clinical outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021377013
After removing the vaccination needle from my arm post first vaccination attempt, the vaccinating nurse examined the syringe for several seconds as if she suspected that something had not functioned correctly. As she was examining the syringe, a stream of fluid under pressure emerged from the end of the syringe and fell to the floor. I was VERY concerned that a significant portion, if not the entirely of my dose volume, had been ejected from the syringe only AFTER it left my arm, and that, therefore,  I had likely NOT been administered a therapeutic volume of vaccine. I advised the supervising physician of my observation and my grave concern. After consulting with the CDC and other advisors, the supervising physician agreed to authorize that I immediately receive a "second" first dose.  I received the "second" first dose in the opposite arm within about an hour of having received the first dose. I was observed for fifteen minutes, and then went home without further event. That evening and the following day I experienced mild arm soreness at the site of the first injection, and significant arm soreness at the sight of the second injection. I never experienced any other side effect.
I have a history of having Herpes Simplex 1 and had an outbreak 5 days after vaccine given.  I am also an autoimmune type 1 diabetic and hypothyroidism
My arm was reasonably sore same day of injection. The next day, around the injection site, it was red, hot and swollen.
This is a spontaneous report by a 47 year old female pt who received her 1st dose of Lymerix on 7/7/99 and 15 days later on 7/22/99, she went to the ER due to a fever of 104.6 and joint pain. She was given medication (nos) to lower her temperature and a 21 day supply of doxycycline. The fever abated and the joint pain decreased. The pt received her 2nd dose on 8/4/99 and subsequently, she experienced fatigue, joint pain and malaise. Her joint pain is getting worse, and the bones in the top of her feet and hands also hurt. Today, she says the joint pain is getting much worse (not the same joint pain one gets with the flu). The most recent information, received on 8/31/99, reports the condition of the pt is ongoing.
This age pt. was given DTaP instead of Tdap. He did not get sick or had any complications.
No further AE; Medical Tech calls to report vaccine given during an excursion.  No PQC. No further AE  TE Case02454494; This spontaneous report was received from Consumer and refers to a. patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 15-AUG-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, one time, lot #w024333, expiration date: 01-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 15-AUG-2023, Medical Tech called to report vaccine given during an excursion. No PQC. No further AE. TE Case02454494.
Patient received an additional dose (third dose, 0.5mL) of the Moderna COVID vaccine on Tuesday, 11/30/21. Pt is immunocompromised and was instructed to receive a full dose per doctor. We administered the correct dose. During the 15-minute waiting period (post-vaccine), pt began feeling dizzy, light-headed, and experienced a racing heartbeat. When the 15 minute observation period was over, the RPh was on the phone and not available for consultation right away. Pt did not want to wait and informed the cashier of her side effects, then she went home directly. Pt asked for the RPh to call her as soon as she got a chance. Pt reported the adverse reaction to her doctor and also to the pharmacy manager between 11/30-12/2. Pt attempted to reach RPh, but pharmacy was short staffed and told the pt we would call her back. Pt never received a phone call from the pharmacy until Friday, 12/3 when the adverse vaccine reaction was communicated to a different RPh. This other RPh called the pt on 12/3, obtained details of reaction, submitted an internal vaccine incident report with Costco, and also submitted a VAERS report.  Between Tues. 11/30/21 and Fri. 12/3/21, pt began to experience more adverse effects, and the reaction to the vaccine progressed and worsened. On 11/30 (evening), pt began experiencing normal vaccine side effects about 4-6 hours post-vaccine. Pt reported these side effects: fever, painful arm (so sore she could not move it), fatigue, nausea, muscle pain. Over the course of the next couple days (between 11/30-12/3), pt continued to experience a fever and developed further adverse effects. Pt reported abdominal pain, joint pain, bright red & swollen fingers, bright red & swollen knees, bruises on both hands (with no injuries), and extreme fatigue. Fever peaked at 102 degrees F. Pt has been taking Tylenol around-the-clock since 12/1 to control fever; currently no fever on 12/3 while taking Tylenol. Pt was seen by her PCP on Fri. 12/3. Per report from pt's doctor, the adverse vaccine reaction appears to be an arthritic reaction and presents like Raynaud's syndrome. Pt was given a double dose of steroid injection (IM) in the doctor's office on 12/3, and she was also prescribed short term prednisone tx. Pt is being referred to a rheumatoid arthritis specialist for further tests and ongoing medical care.
Injection site pain; chills; headache; body aches; nausea; swollen lymph nodes; fatigue; swollen, tender lymph nodes in the neck and armpits; This is a spontaneous report from a non-contactable other health professional. A 23-year-old female  patient reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 20Jan2021 at 08:00 AM for COVID-19 immunization. The patient medical history was unknown. Concomitant drug  was Sertraline and Mili tablets. Within 4 weeks prior to the COVID vaccine the patient received the vaccine TDAP on 08Jan2021 in the right arm. On 20Jan2021 at 09:00 PM the patient experienced injection site pain, chills, headache, body aches, nausea, swollen lymph nodes, fatigue. These started about 12-14 hours after getting the vaccine and worsened over the next several hours. Most symptoms resolved, but she still had swollen, tender lymph nodes in the neck and armpits as well as some mild body aches and headache (at the 48 hour mark). No treatment was received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Golf ball size whelt 24 hours after shot -> baseball size whelt after 48 hours (Left Arm); Diagnosed as allergic reaction today by dr. Treated with Xyzol and Diprolene cream bid 5 mg
Pt received his booster shot and went to observation area to be monitored for 15 minutes. While sitting pt stated he became dizzy and felt lightheaded. Pt was told he could be taken to private room for closer monitoring. While pt was walking to room he fainted and started shaking slightly, closely resembled seizure activity for a few seconds. Pt was lifted by crews and taken into private room and assessed. Fire Department was called and pt was transported to hospital by fire department.
AFTER THE PATIENT WAS VACCINATED WITH THE COVID-19 SPIKEVAX AND FLUZONE SHE WAS SITTING DOWN AND SHE SPASED OUT AND PASSED OUT. WE CALLED 911 BUT THE PATIENT REGAINED CONSIOUSNESS AND SAID SHE FELT NAUSEOUS. PATIENT WAS SEATED AND WE ASKED HER TO STAY SEATED IN HER CHAIR WHILE WE CALLED 911, THE TECNNICIAN CALLED 911 AND INFORMED THEM ABOUT THE SITUATION. THE PARAMEDICS TOLD US NOT TO GIVE HER ANYTHING BY MOUTH. PATIENT SAID SHE FELT SWEATY AND WE THE HUSBAND IF SHE ATE ANYTHING BEFORE COMING AND HE SAID YES. I ASKED HAS THIS HAPPENED BEFORE AND THE HUSBAND REPLIED NO SHE HAS GOTTEN 4 VACCINES BEFORE NO PROBLEM. THE PATIENT STATED THAT SHE TAKES BLOOD PRESSURE AND THYROID MEDICATIONS, DOESN'T KNOW THE STRENGTHS. I ASKED THE PATIENT TO TAKE DEEP BREATHS AND RELAX WHILE THE PARAMEDICS CAME IN. THE PATIENT THREW UP AND THE PARAMEDICS GOT THERE AND ASKED US WHAT HAPPENED AND THEY TOOK OVER FROM THERE.
I have had severe body aches and joint pain for the last six or seven days when I get off work in the afternoons I'm so tired I can barely get up the stairs I work as a nurse and I sit at a desk all day. Muscle pain in shoulders neck back and I am constantly tired.
Vaccinated 2/11 and symptoms started 2/13 at noon. Sudden bronchial spasms, obstructive apnea, cyanosis. EMS gave a breathing tx, O2 sats WNL. Declined transfer to hospital at that time for fear of Covid. Client exhibited confusion, oriented x 0, short term memory loss. Bronchial spasms resumed, EMS again called, transported via EMS to MC. Diagnosed with transient global amenesia and hypercapnia. Client was transported to MC for CT and MRI for r/o stroke. Stroke was ruled out. Client with c/o severe H/A, nausea, dizziness, myoclonic seizures. Severe h/a which lasted 4 days. Still experiences mild memory loss, confusion, and h/a are becoming less severe. Client states that sensory processing is slowed
Rash appeared after that (but specific timing unknown), located on her chest/ rash on back; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. PharmD reported that the patient was vaccinated with the Shingrix and after that patient experienced rash which was  located on her chest and back. She did not thought that it to be Shingles rash and still had the rash after 1 month later also. The reporter consented to follow up.
pain; weakness; Arm feels week when holding it; Decreased range of motion; This case was reported by a other health professional via call center representative and described the occurrence of pain 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, less than 2 years after receiving Shingrix, the patient experienced pain, weakness, weakness of arms and joint range of motion decreased. On an unknown date, the outcome of the pain, weakness, weakness of arms and joint range of motion decreased were unknown.   It was unknown if the reporter considered the pain, weakness, weakness of arms and joint range of motion decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health professional reported that the patient had daily pain, weakness was 2 to 4, at worst 6 or 7 out of 10.  The patient's arm felt weak sometimes when holding it up.  If thought about it was always there.  The reporter disinclined to did this again getting the second dose.  The patient had decreased range of motion.      Lab Comments: Lab test performed on unknown date
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 17-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
The patient received vaccine at 1245. At 1246 patient started having an adverse event. The RN noticed that the patient started to get white and pale. The RN asked him if he was okay. He stated yes and then he started to faint. The staff gently got him on the floor. They checked his vital signs. His vital signs were within normal limits. They monitored patient for 15 minutes while he was lying on the floor and another 15 minutes in a seated position. They took him to their observation area where they monitored him for another 30 minutes. The patient's mother came in and stated that this happens every time the patient gives blood or receives an injection.
high pitched crying for several hr;ended up w/a 2 day episode of constant crying;also had diarrhea & fever;
having issues with sinus infection; This case was reported by a consumer via call center representative and described the occurrence of sinus infection in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced sinus infection. On an unknown date, the outcome of the sinus infection was not recovered/not resolved.   It was unknown if the reporter considered the sinus infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.  The patient received the shot for the shingles vaccine and was hoping to get the 2nd shot this week, but patient still had issues with sinus infection. The patient inquired that would it be safe to get the second shot now.
Patient came in with a rash from her shoulder going down her arm.  She doesn't know if it is from the shot or the sun.
Pt exp pain @ site 2 hr, h/a 10PM, fever 10PM, chills 3AM, vomiting 13FEB92 all day;
This report describes the occurrence of death in child of unspecified age who received hepatitis B vaccine recombinant (Engerix-B) injection.  The report was received as part of litigation proceedings and has not been verified by a physician or other health care professional.  The pt received the first injection of Engerix-B vaccine (Lot # ENG3329A2) on 03/27/2001.  He also received injections of DTAP (Tripedia, AP); inactivated IPV (IPOL, AP); and HIB (Hib-Titer, Lederle Labs) on 03/27/2001.  On 12/10/03, the pt's attorney alleged that "the thimerosal contained in the vaccine administered to the children (child) contributed to and/or caused their deaths."  No further information regarding the specifics of their claims is available at this time.  It is unknown whether an autopsy was performed.