chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up at 3 am with body aches-got up to take ibuprofen. When I was heading back to bed, my husband heard a loud thud and found me laying on the floor beside the bed, passed out. He rushed over to me and called my name several times before I became conscious. He estimates it was a span of about 30 seconds. When I awoke, I immediately began to cold sweat and dry heave several times. Then I became cold and was shivering. My husband then transported me to the hospital emergency room. I received a cardiac test, which they said was good. I also received intravenous fluids and medication to treat pain and nausea. They drew labs which they said looked normal and  did an X-ray my right shoulder because I struck my head and shoulder on a night stand when I passed out. They released me about an hour later after having me stand and walk to ensure my blood pressure did not drop, causing me to feel faint again. They sent me home with a prescription for Zofran to help with any further nausea, advised me to take ibuprofen for head and shoulder pain and body aches and advised rest. They also said to return if any other incidents occur and to follow up with my family doctor if symptoms persist.
At the time of injecting the dose, I felt strong pain in my entire arm. After spending 1 hour the pain increased and I began to feel rapid heart rate and chest pain. The next day the pain in my arm was stronger and I felt pain in my back, right side and chest. Occasionally I have a rapid heartbeat and chest pain. If symptoms persist outside of arm pain, I will be visiting Hospital.
10x9 cm circular area of redness and slight swelling on the right thigh. Non-tender. Vaccine given 7-11-14. Redness started 7-12-14. Still present 7-14-14. Treated with AUGMENTIN for vaccine reaction vs. early cellulitis.
PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INTEAD OF 0.2ML OF THE 10MCG FORMULA,
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 79-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing); "Hypopituitarism" (ongoing); "Hypocalcemia" (ongoing); "Pituitary adenoma" (unspecified if ongoing); "total Thyroidectomy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for hypothyroidism, start date: Aug2019 (ongoing); TESTOSTERONE taken for hypopituitarism, start date: Aug2019; VITAMIN D [COLECALCIFEROL] oral taken for hypopituitarism, hypocalcaemia, start date: Oct2021; ROSUVASTATIN, stop date: 15Oct2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID". The patient received Pfizer booster exactly 3 weeks before he got sick with COVID. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Did another COVID test of myself today; it becomes positive again; rebound COVID; Thyroid function test: (2023) Normal, notes: 3 or 4 weeks before to ensure my thyroid function was normal. The patient was treated with Paxlovid.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thalassemia moderate" (unspecified if ongoing), notes: Moderate; "mitral valve prolapse" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (unspecified date) Negative; (May2022) Positive, notes: My covid symptoms fully returned and I tested positive again on day 4-5 after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patients covid symptoms fully returned and he tested positive again on day 4-5 after completing Paxlovid. His symptoms are near the same and he is worried and don't know what to do. The patient did have known allergies. The patient did not receive any Other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient came into pharmacy today asking if I could take a look at her arm since she had vaccines a week ago and wasn't sure if it was normal to still have redness of injection site. Arm didn't seem swollen, but is still very red and patchy. Patient also reported that injection site is itchy sometimes and can be warm/hot to the touch. She also said it was a little sore, but not anything too painful.
I tested positive on a RPR test for syphilis, and had 1:1 dilution but negative for antibodies. I know this was a possible outcome but wanted you to know. Vaccine booster was 1/31/2022 rpr test on 3/28
This child had cellulitis on his right leg 4 inches in diameter. Also with an area of ulceration and blister on the center.
It was reported that after the 1st dose his arm hurt and he was tired.; It was reported that after the 1st dose his arm hurt and he was tired.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 38-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's family history included: "heart disease" (unspecified if ongoing), notes: history of heart disease in his family. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "It was reported that after the 1st dose his arm hurt and he was tired.".  Additional information: On 16Sep2022, it was reported that a patient started treatment on Feb2021 with Pfizer-BioNTech COVID-19 Vaccine of two doses for unspecified indication. It was reported that after the 1st dose his arm hurt and he was tired. He had a history of heart disease in his family.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Multiple bouts of diarrhea over last 2 days - currently monitoring and oral hydration.
Doses administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion ) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021 at 11:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:54 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion ). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion ) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.52 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 and 37 degrees Fahrenheit from 09:00 AM to 10:00 AM respectively. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.  This case was linked to MOD-2022-566976 (Patient Link).
lot of allergies like if coughing; very bad; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (lot of allergies like if coughing) and FEELING ABNORMAL (very bad) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (lot of allergies like if coughing) and FEELING ABNORMAL (very bad). At the time of the report, COUGH (lot of allergies like if coughing) and FEELING ABNORMAL (very bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I was on a cruise we were on day eight, I awoke and was not feeling well, I had a sore throat, cough and headache. I went to the sick bay to get checked not really knowing what I had. The doctor checked me for COVID-19, the test came back positive. I was given Nyquil and cough drops and asked to quarantine until we docked on February 13, 2023. I was escorted off the cruise ship so that I did not expose any other travelers. I called my doctor a couple days after returning home, I was told that it was too late to get an antiviral medication. I really did not feel bad for too long. I feel I have recovered with the exception of not having any stamina.
Numbness on patient's right half of tongue, inability to close patient's right eye, limited facial movements on patient's right side of face.  Tongue numbness began 3 days after vaccination, with rest of symptoms occurring suddenly 36 hours later.  Preliminary diagnosis of Bell's palsy.  Perscribed Prednisone and Valtrex.
This spontaneous report has been received from a practice manager referring to a patient of unknown age. Information about concomitant medications, concurrent conditions, and medical history was not provided. On 25-JUN-2018, the patient were vaccinated with improperly stored M-M-R II (strength, dose number, anatomical location, route of administration were unknown; lot # M034856 and expiration date 27-JUL-2018) for prophylaxis. No adverse effects were reported. The reporter reported multiple temperature excursions over the past year and a half found during an audit. The excursion temperature in 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017; 30-JAN-2018, 23-FEB-2018, 18-MAY-2018 was 6 degree Celsius for max 8.75 hours. In 02-MAR-2018 was 7 degree Celsius for max 8.75 hours. In 07-DEC-2017 was 8 degree Celsius for max 15 hours. In Data logger was not involved. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959.
injection given approx 230pm  on 8/17/23.   pt states reaction started a little more than an hour later  around 4pm.   pt did not notify pharmacy until next day at approx 930am on 8/18/23.   reaction manifested as skin rash on chest, arms and body with hives like response.  Recommended diphenydramine 25mg  1 cap every 6 hours (gave pt 4  capsules  to take with them for treatment on 8/18/23 at 930am)  instructed pt to contact md if hives do not improve or worsens.
12/18/2020 , 12/19/2020 felt sore and felt fine then Tues, middle of night with head ache and heart rate high blood  did not feel good took tyler and head ache chills and heart rate high blood and e k g tack cardi tylernol fever on/ slight fever and lots of water and second 01/08/2020 email the second dose taken fine. Fatigue and tylernol and sore 01/11/2020 headache, headache
I had the 2nd Shingrix shot Friday 1/10 around 4pm at the pharmacy. I woke up Saturday morning at 4:30 feeling awful. All day I had a fever of 100, horrible headache, aches, chills, a bit of nausea. I felt better that night, after taking Ibuprofen and Excedrin Migraine during the day. Sunday it had passed by the afternoon.
Vertigo; booster; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female non-pregnant patient received the third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 30135BA), via an unspecified route of administration, administered in left arm on 01Oct2021 16:15 (50-year-old at time of vaccination) as dose 3 (booster), single for COVID-19 immunisation. Medical history included GERD, high blood pressure, high cholesterol, and hypothyroidism. Concomitant medications (patient received within 2 weeks of vaccination) included benazepril (BENAZEPRIL); escitalopram oxalate (LEXAPRO); trazodone (TRAZODONE); omeprazole (PRILOSEC); estradiol (ESTRADIOL). The patient previously received the first dose of bnt162b2 (Lot Number: EL9265) administered in left arm on 29Jan2021 (49-year-old at time of vaccination) for COVID-19 immunization; previously received the second dose of bnt162b2 (Lot Number: EN6198) administered in left arm on 26Feb2020 09:30 (49-year-old at time of vaccination) for COVID-19 immunization; previously received promethazine (PHENERGAN) and experienced allergy: phenergan. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced vertigo on 24Oct2021 04:00. The event was assessed as non-serious. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient has been diagnosed with vertigo that will not go away. She has been suffering for 6 days now. Therapeutic measures were taken as a result of vertigo and included Meclizine and Zofran. The outcome of the event vertigo was not recovered.
lt deltoid swollen & red; hot to touch; itching & very uncomfortable; reported to charge nurse;
DTaP given to a 7yr old will count as a valid dose, but requested VAERS form submitted. There was not an adverse event. Date of vaccination 2/24/09
Pt recvd 3 doses of Engerix-B on 15FEB90, 14MAR90 & 22AUg90 for antibody protection against Hep B; 29MAR91 HBSAB RIA resulted as neg;
Swollen face/eyes. Hives. Rash all over. Weight gain. Hair loss. Fatigue.
mild nausea; Headaches; leg pain/ She has problems with her right leg,she hurt it; This is a spontaneous report from a contactable other-HCP (patient, self-reported). A 73-year-old female patient (age at vaccination: 73 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK9231 and expiry date was not reported), via an unspecified route of administration, on 01Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if she could take Tylenol for headaches and leg pain that she experienced after the shot and Meloxicam for hip pains that were not related to the vaccine. She wanted to know could she take Tylenol or Tums and also if she could take Melaxicam, she thought that was how you spell that. She said the Melaxicam was like Ibuprofen, but it was 24 hours, she said basically she was talking about mild symptoms. She had problems with her right leg, she hurt it on an unknown date in Feb2021, so that was why she was wondering about the Tylenol. Then she had some nausea on 01Feb2021, a small amount and she didn't want to take something if she shouldn't take anything. The issue with her leg was happening before the vaccine. The nausea was began since the dose of the vaccine and it was mild, she went ahead and took Tums which she did if she had the occasional nausea and it helped but her daughter told her she shouldn't take over the counter medications because it could interfere with the vaccine, but she did not know if her daughter knew what she was talking about. She guesses the nausea began a little bit the day of the vaccine toward the end of the day and then some today but the main thing she wanted to find out was, was there going to be any interaction issues if she took the Tylenol and Tums. She said the nausea was about the same since yesterday, but it was off and on took. She took Tums and it went away but after a while it comes back. She had only taken the Tums 3 times and she took 2 but she just wanted to make sure. No further information provided. She thought she should go to physical therapy but to do that she needed to see the orthopedic but she didn't want to do that until after she gets the second shot, and she was supposed to do that 22Feb2021 so she was just hanging in there. She confirmed she thought she could benefit from physical therapy due to issues she had prior to getting the vaccine. She said that has nothing to do with the vaccine. Outcome of the event mild nausea was not recovered and for all other events, it was unknown.  Follow-up attempts are completed. No further information is expected.
On 4/21/21 developed an itchy rash, redness and huge fluid filled blisters on her right lower leg and ankle. She was seen in the emergency room and was diagnosed with bullous pemphigoid. She has not had a recent medication change and has been on her current meds for years. No new soaps, detergents, etc; the only "new" thing is her COVID vaccines.
Patient presented with afib w/ RVR, acute metabolic encephalopathy, found to be Covid + in ER, Covid-19 infection likely contributory to symptoms. CXR no acute findings. Vitamin C, Budesonide.
Pt recvd 2 doses of Engerix-B vax 6MAY91 & 28JUN91 & 11NOV91 pt exp burning while inject was being given which cont for a few hrs;
pt devel a pea-sized, nontender lump @ the inj site;2mo post vax pt devel bruising @ the inj site;pt seen by MD 14AUG97;MD dx sterile abscess & referred to surgeon;pathologist dx necrotizing granulomatous inflammation consistent w/fat necro
Patient said she experienced chills all day of vaccine.   Left Arm had some swelling and redness
muscle ache/ some muscle ache, joints; muscle ache like flu symptoms; I experienced some muscle ache, joints; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiration date not reported) via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The first dose of the COVID-19 vaccine on 07Jan2021 and was scheduled for his second dose on 28Jan2021 in (state name). He also mentioned that he experienced the side effects of the vaccine (described as muscle ache like flu symptoms) 5-6 days after the first dose. Consumer stated, "I had my first COVID vaccine Pfizer, last Thursday on 07Jan2021. On 12Jan2021 when I woke up, I experienced some muscle ache, joints. I was just wondering is it possible to have a side effect 6 days later after the shot or should they come immediately after the shot?" Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Initial report was received on 08 March 2011 from a consumer, who is also the patient. A 24 year-old female patient with no reported past medical history, had received an intramuscular left deltoid injection of FLUZONE (lot number not reported) on 03 March 2011 at 10:30 am and three and a half hours later at 2:00 pm, experienced a strange taste in her mouth, dry mouth and "could not get enough to drink". She reported the strange taste in her mouth was like a dough or yeast taste. She reports having several flu vaccines in the past but had not received the H1N1 vaccine. Concomitant medications included birth control pill. The patient had no illness at the time of vaccination and had no reported adverse events following prior vaccinations. No further information was available at the time of the report. The patient's outcome was unknown. Follow-up information was received 11 April 2011 from a health care professional. The patient had received FLUZONE, lot number UT3640AA. No laboratory or diagnostic testing was performed. According to the reporter, the patient's symptoms resolved approximately two weeks after onset. The patient's outcome was recovered. No additional information was provided at the time of the report. Documents held by sender: none.
Increased urge to eat.  15 pounds weight gain in a few weeks.  Menstrual period started earlier than usual for two months following and now only spotting. Extreme stomach bloating that hasn't decreased.
Patient had palpitations for several weeks (starting one week after the vaccine).  On the 6th week of the vaccine the patient had a syncope episode and was taken to the Emergency department.  She was noted to have tachycardia.  The next week her symptoms progressed to muscular weakness, brain fog, shortness of breath.  Was re-evaluated at the emergency department on 1/5/2023 for concerns for a pulmonary embolus with a CT angiogram which was negative.  She was sent home.  She then saw pulmonary medicine and neurology the following week and was diagnosed with dysautonomia, POTS.  She was then hopsitalized due to progression of symptoms on 1/15 - 1/16, was diagnosed with a second neurologist with dysautonomia.