chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This study case was received from the investigator in the trial on 16 August 2013. A 39-year-old male subject was found to have other and unspecified angina pectoris 9 days after receiving the following vaccines on 28 March 2011: an injection of ACAM2000 (lot number, route and site of administration not reported) and anthrax (manufacturer, lot number, route and site of administration not reported). The subject also experienced other, chest pain 10 days after vaccination. Relevant laboratory data included an abnormal ECG on 06 April 2011 and normal troponin I on 07 April 2011. Treatments were not reported. Past medical history included elevated cholesterol, chest pain, chest pressure, abnormal ECG (electrocardiogram), shortness of breath, and headaches. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
pain in chest, like somebody sitting on it; shoulders h/a took advil but had no relief;
Information has been received from a consumer referring to her daughter of unknown age. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date, when the patient was 11 years old, the patient was vaccinated with serious of GARDASIL (lot#, dose, dose# and route unknown) for prophylaxis. It was reported that the vaccine paralyzed her stomach causing her to vomit after every bite of solid food. She lived with a stomach virus "24/7/365" and would for the rest of her life. The patient was now 17 years old and suffered in everyday with her menstrual cycle being a nightmare and excruciating. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected since there was no contact details provided. Sender's Comments: US-009507513-1605USA001123.
Hives; itching throughout her body; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982), intramuscular on the left arm at the age of 77 years, on 27Jan2021 11:30 at a SINGLE DOSE for covid-19 immunization and cefuroxime axetil (CEFUROXIME AXETIL), oral from 25Jan2021 to Jan2021 at 250 mg, 2x/day (250mg tablet, one tablet twice a day by mouth ) for urinary tract infection. Medical history included ongoing diabetes mellitus diagnosed many years ago, ongoing rash because she was still having a problem in her pubic area with a rash that is going on, states this is from the urinary tract infection and urinary tract infection from an unknown date and unknown if ongoing. When she got the vaccine she was on an antibiotic for a urinary tract infection (UTI), she is asking if there would be any correlation or any interaction between the antibiotic and the vaccine. The antibiotic was something she has taken quite often and has taken it before called cefuroxime axetil. Concomitant medication included insulin (INSULIN) for diabetes. The patient developed itching throughout her body, like hives that started late Friday (29Jan2021) and she will get areas on her hands and arms. This morning it was on her legs where it was red and warm. She reported it goes away and comes back. This morning the hives were fairly heavy and now that she has gotten up and cooled her body down, the hives were subsiding. The outcome of the events was recovering.
swollen face specially cheeks; eyes was swollen; RT eye lid skin was dropping down to the point she cannot use it; Running nose; Head Ache; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received BNT162B2, intramuscular, administered in left arm on 22Dec2020 12:00 (Batch/Lot Number: ELo140, also reported as EL0140) at the age of 60 years old as dose 1, single for COVID-19 immunisation. Medical history included high cholestrol. Patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Concomitant medications were not specified but reported that received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Dec2020 04:00 (the next day after she took the vaccination), the patient had running nose that lasts one day and experienced head ache for three days (as reported) which patient took acetaminophen (TYLENOL) for a relief. Then on 27Dec2020 04:00, patient woke up at the middle of the night (as reported) with swollen face specially cheeks and eyes was swollen. Right (RT) cheek was more swollen than the left (LT) side. RT Eye was covered due to RT eye lid skin was dropping down to the point she cannot use it until the next day it retracted back (as reported). Patient still have swollen face, cheeks and eyes. RT eye and RT cheek was more swollen and felt very uncomfortable to wear a mask specially N95. The patient recovered with lasting effects. It was reported that treatment received for events (also reported that no treatment). Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, she has been tested for COVID-19. Nasal Swab: unknown results on 22Feb2021 (COVID test post vaccination), negative on 02Mar2021. Outcome of all events was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Chronic urticaria that started day after vaccine - daily rash since date of vaccine (still have daily symptoms 3 months since vaccine).  Treated with daily oral antihistamine.
rash at injection site (raised, circular red rash); This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP-6955), via an unspecified route of administration in the left arm on 26Mar2021 at 12:00, (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history included anxiety, treenuts allergy, shellfish allergy and melons allergy. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and ethinylestradiol, norethisterone (ALYACEN); both for unspecified indication from unknown dates. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and CECLOR; both for unspecified indication and experienced drug allergy.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL-3247), via an unspecified route of administration in the left arm on an unspecified date in Mar2021 at 12:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 22:00, the patient experienced rash at injection site (raised, circular red rash). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event vaccination site erythema was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Two days after the first Moderna Vaccine on 6/15/21  I started having vaginal bleeding that was 10 days early for my period. This period was heavier that my previous periods have been for 12 months.  This bleeding lasted for 4 days . I had a period in the middle of July around the 12-15th and this period was also very heavy and lasted for 6 days.  I received the second Moderna vaccine on 7/26/2021. One week after that I had vaginal spotting for 5 days then started very heavy bleeding and passing very large clots. The heavy bleeding and clots would start and stop for 5 days. The month of August and September each period was a week earlier than normal and I had very heavy bleeding with clots with the same start/stop pattern. The next period I had started on 10/21/21 and I have had the same pattern of bleeding with on and off heavy bleeding and clots. I can go almost an entire day with light bleeding then suddenly start passing large clots with heavy bleeding.
Approximately 4 minutes after the COVID vaccine the patient said he was cold then passed out while sitting in a chair in the pharmacy waiting area. His mom was nearby and tapped him and called his name. When I arrived Patient was pale, unresponsive and had a  pulse of 66 and his skin was sweaty. His dad called 911. Over a four minute period Patient slowly  began to regain color in his face. He knew where he was as well as the day of the week. 911 arrived and all of his vitals were good. The family declined going to the hospital because Patient felt much better.
1 of 3 pts who was vaxed from the same lot (different vial) exp fever, swelling & excessive redness @ inject site;
Palpitations, chest pain, diarrhea, sinus tachycardia, fatigue, chest pressure
Two minutes in felt a wave of restlessness originating at injection point. Then sweating, dizzyness Eyesight nearly gone, replaced with a blur and couldn't make out anything besides little pinholes in the center. Hearing replaced with a loud noise that drowned out everything else around me. 5 minutes after having all these symptoms together, eyesight came back. 3 minutes after that, hearing came back.  Couldn't sleep properly for three nights afterwards but that fixed too.
Side effects included diffuse myalgias preventing sleep, fatigue, chills, mild headache.
Eight days post third vax, this pt experienced arm pain at injection site, burning tongue, and swollen lymph nodes. He also developed headaches, a rash with large, flat, red areas on the upper and lower extremities and abdomen, arthralgias, gastrointestinal upset. His headaches were unrelieved by analgesics. His gastrointestinal upset was increased with "gassiness" and he subsequently developed generalized aches of the shoulders and chest. He was treated with rofecoxib 50 mg daily for 2 days, then 25 mg for 4 days, then 12.5 mg daily, increased fluids, rest, and pacing of activities. On 07/25, he reported felling better but still experiencing headaches. He also developed a "splotchy" rash over his body with the largest area 5x7 inches on his chest. On 07/26 upon evaluation by nurse practitioner, he reported blurred vision and feeling very fatigued. He still had mild headaches, mild gastrointestinal upset and achey muscles. He was assessed as having viral syndrome and an allergic reaction possibly to the rofecoxib which was changed to hydrocodene/acetaminophen. The most recent information reports the events as ongoing.
Shingrix dilution with sterile distilled water; Shingrix dilution with sterile distilled water; This case was reported by a consumer via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 26-MAY-2022 Reporter's Comment: The reporter said one person had not properly diluted the patients Shingrix vaccine. The reporter did the dilution with sterile distilled water (water for injection), one normal diluent.  The reporter wanted to know if he could have any reaction, if the vaccine will work, if the patient run any risk. Therefore, the patient would like to talk to those responsible to know the possible adverse effects. Additional supportive information: The reporter did the dilution with sterile distilled water (water for injection), one normal diluent which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Elevated heart rate; Tingling in feet; Lack of sleep; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the arm left on an unknown date in Feb2021 at 08:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included lisinopril dihydrate (LISINOPRIL), cyanocobalamin (B-12), unspecified multivitamin (MANUFACTURER UNKNOWN) and hydrachloricide; all taken for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Mar2021 at 20:00, the patient experienced elevated heart rate, loss of appetite, tingling in feet and lack of sleep. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Since the vaccination, the patient had been tested for COVID-19. On 15Mar2021, the patient underwent nasal swab COVID-19 test and the result was negative. The clinical outcome of the events elevated heart rate, loss of appetite, tingling in feet and lack of sleep were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA (red spot on the injection site and got really big) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA (red spot on the injection site and got really big). The patient was treated with Physical therapy (cold compress) for Vaccination site erythema. On 31-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red spot on the injection site and got really big) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment related information was reported.
pt recvd vax & 1-2 days later pancreatitis developed; hospitalized 15SEP93 for persistent abdo pain, nausea, vomiting;
PATIENT STATED HE FELT SICK AND REQUESTED WATER, PATIENT STARTED LOOKING PALE. TRIAGE WAS CALLED, WATER AND APPLE JUICE WAS GIVEN TO THE PATIENT. PATIENT'S VITALS WERE TAKEN. AFTER ABOUT 10 MINUTES PATIENT WAS SENT HOME BY CLINIC RN.
Pt recvd 3 doses Engerix-B 10NOV90, 7DEC90 & 2MAY91& 15SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Day 8 post vaccination - 4"x3" area surrounding vaccination site red, swollen, hot, itchy - measured 4 degrees hotter than same site on opposite arm.  Day 9 - no improvement, was worse.  Day 10 - much resolved - redness reduced, cooler, slightly itchy.  Day 11 - symptoms resolved.  Consulted doctor by phone but did not have office visit.  No fever or other systemic symptoms throughout the event
Dizzy; flu like symptoms; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN IN EXTREMITY (sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN IN EXTREMITY (sore arm). At the time of the report, DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
pt recv vax 30DEC96 & 1JAN97 pt exp a fever of 103 & a subsequent febrile sz;pt was seen in an ER;
I had vomiting, severe upper respiratory issues, bleeding, sinus problems, weezing, wet coughing, and sinus flare up. I tested positive for COVID-19 at home. I spoke to my doctor and she prescribed me antibodies, cough medication and steroids. The thing that lingered the most was the sinus stuff. I still have respiratory and I can't multitask like I used to.
Developed a red popular rash over the lower legs and cramping in the lower legs on 5/14 (22 days after first COVID vaccine and 6 days before her 2nd vaccine). Had dizziness on 5/13, one day before second vaccine. The day after the second vaccine, she had nausea, myalgias, dizziness, fevers to 102 F, chills, and headaches. She has had persistent dizziness since then.
Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (death, medically significant), outcome "fatal". The patient date of death was unknown. Reported cause of death: "died after he got the his Covid vaccine of myocarditis.". It was not reported if an autopsy was performed.  Clinical information: While reporting on her son, she reported that her friend's son who was 27-year-old died after he got the his Covid vaccine of myocarditis.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died after he got the his Covid vaccine of myocarditis.
right cheek and fingers like a freezing sensation; Right cheek and fingers like a freezing sensation; Burning sensation; She forgot to remove the band-aid on her arm and she had a reaction and now she has like a wheel mark; left cheek like an anesthetic sensation that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (right cheek and fingers like a freezing sensation), PARAESTHESIA (Right cheek and fingers like a freezing sensation), BURNING SENSATION (Burning sensation), DERMATITIS CONTACT (She forgot to remove the band-aid on her arm and she had a reaction and now she has like a wheel mark) and ANAESTHESIA (left cheek like an anesthetic sensation that comes and goes) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fractured mandible (Mandible disorder). Concurrent medical conditions included Seasonal allergy, Pollen allergy and Dust allergy.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced ANAESTHESIA (left cheek like an anesthetic sensation that comes and goes). On an unknown date, the patient experienced FEELING COLD (right cheek and fingers like a freezing sensation), PARAESTHESIA (Right cheek and fingers like a freezing sensation), BURNING SENSATION (Burning sensation) and DERMATITIS CONTACT (She forgot to remove the band-aid on her arm and she had a reaction and now she has like a wheel mark). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, FEELING COLD (right cheek and fingers like a freezing sensation), PARAESTHESIA (Right cheek and fingers like a freezing sensation), BURNING SENSATION (Burning sensation), DERMATITIS CONTACT (She forgot to remove the band-aid on her arm and she had a reaction and now she has like a wheel mark) and ANAESTHESIA (left cheek like an anesthetic sensation that comes and goes) outcome was unknown.            Patient has forgot to remove band-aid due to that reaction had occurred, like a wheel mark has been formed on her arm . Patient has stated that she has been using Allergy medications as a concomitants.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.    This case was linked to MOD-2021-231475 (Patient Link).
Headaches, fever, chills, fatigue, weakness, pain, nausea, tinnitus,  malaise,
My right arm where I had the injection has a baseball size lump. It is painful and extremely sore. I can?t lift my arm.
I got COVID in May 2022 and then I got really sick, a headache, cough, sore throat, neck swollen, diarrhea, chills and a mild fever.  My symptoms was moderate. My symptoms lasted for about 11 days. My doctor prescribe me some steroids. I am much better now....
Patient is fully vaccinated.  COVID + 1/15/2022 at ED visit. 75-year-old female presents complaining of intermittent episodes of lightheadedness over the last 2 days.  The patient admits to some congestion, sinus pressure, postnasal drip.  She was exposed to COVID on Sunday.  She denies any fevers, chills, nausea or vomiting.  She denies any abdominal pain, chest pain or shortness of breath.  She denies any leg pain or leg swelling.  BP 116/66  | Pulse 76  | Temp 98.1 °F (36.7 °C) (Oral)  | Resp 19  | Ht 162.6 cm (5' 4")  | Wt 59 kg (130 lb)  | SpO2 97%  | BMI 22.31 kg/m² Chest x-ray shows no acute process.  Labs reviewed, no significant abnormalities.EKG shows normal sinus rhythm. IV fluids given.  Ct 1.17.CT head:  No acute intracranial hemorrhage, mass effect, midline shift or extra-axial fluid collection.  Sable/discharged.
4 days after 1st covid vaccine states tinnitis and hearing loss in left ear.  symptoms unchanged then 3-4 days after 2nd vaccine complete loss of hearing in left ear.
Localized reaction described as red, 4-5 inches around site of injection, swollen, and warm to the touch and received antibiotic from MD for cellulitis.
arm a bit sore; a bit achy/ slightly aching; feeling groggy; This case was reported by a consumer and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included acyclovir.   On 21st August 2019, the patient received the 1st dose of Shingrix. On 22nd August 2019, 1 days after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced pain in arm, pain and groggy. On an unknown date, the outcome of the pain in arm, pain and groggy were unknown.   It was unknown if the reporter considered the pain in arm, pain and groggy to be related to Shingrix.  Additional case details were provided as follows: The patient was taking acyclovir 1g (1000mg) daily due to dentist induced herpes virus.  The patient received Shingrix in right arm. The batch number and expiry date was not known. The next morning, she woke up to achy right arm and feeling groggy.  The patient stated, she had no real side effects except her arm was sore, was slightly aching but nothing serious. The patient did not want to receive mail from GlaxoSmithKline and did not consent to follow up.