chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash is now going down my nose; dark red rash around mouth; a real bad fever; temperature 99.9 degrees; dark red rash around mouth; rash developed around left jaw line to right ear; rash developed around to right ear; rash started on face; rash then on forehead; rash noted between left index finger and middle finger; rash then on left hand; rash developed around left ear; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash developed around left ear), PYREXIA (temperature 99.9 degrees), RASH ERYTHEMATOUS (dark red rash around mouth), RASH (rash developed around left jaw line to right ear) and RASH (rash developed around to right ear) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced RASH (rash developed around left ear), RASH (rash developed around left jaw line to right ear), RASH (rash developed around to right ear), RASH (rash started on face), RASH (rash then on forehead), RASH (rash noted between left index finger and middle finger) and RASH (rash then on left hand). On 27-Apr-2021, the patient experienced PYREXIA (temperature 99.9 degrees), RASH ERYTHEMATOUS (dark red rash around mouth), ORAL MUCOSAL ERUPTION (dark red rash around mouth) and PYREXIA (a real bad fever). On 28-Apr-2021, the patient experienced ORAL MUCOSAL ERUPTION (rash is now going down my nose). At the time of the report, RASH (rash developed around left ear), PYREXIA (temperature 99.9 degrees), RASH ERYTHEMATOUS (dark red rash around mouth), RASH (rash developed around left jaw line to right ear), RASH (rash developed around to right ear), RASH (rash started on face), RASH (rash then on forehead), RASH (rash noted between left index finger and middle finger), RASH (rash then on left hand), ORAL MUCOSAL ERUPTION (dark red rash around mouth), PYREXIA (a real bad fever) and ORAL MUCOSAL ERUPTION (rash is now going down my nose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 99.9 (High) Patient had temperature of 99.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment details included Benadryl pills every four hours around the clock - rash Benadryl gel cream - rash Hydrocortisone cream - rash Hydrocortisone 10 cream - rash   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Not specified
Patient inadvertently received BOOSTRIX instead of KINRIX.  No adverse events were noted.  Mother was notified of error
Pt presented to the ED on 12/1 with CC of shortness of breath. His O2 saturation per his wife was 51%, was brought to the hospital.  Per pt he had been short of breath for the past 12 hours prior to presentation.  In ED pt was found to be positive for COVID-19.  CXR showed bilateral infiltrates.  His white blood cell was elevated at 22.63, Lactic acid was 6.5,   His blood glucose was elevated at 477, sodium low at 129, elevated procalcitonin of 0.75, and CRP elevated at 12.5.  The patient was admitted to moderate care with high-flow nasal cannula.  He was started on remdesivir and decadron.  Per wife at home his oxygen levels would be low in 80s when he wakes up and after up for a bit will come up with supplemental oxygen otherwise first hour or so runs in 80s.   For Patient's acute on chronic hypoxemic respiratory failure is likely secondary to covid inflammation.  Patient wears 4-6 L of oxygen at home.  Patient received steroids and remdesivir in addition to azithromycin and vancomycin for 3 days.  He was on a steroid taper however on 01/03/2022 patient's respiratory status worsened requiring BiPAP.  His Decadron needed to be resumed at 6 mg on 01/04/2022.  Sepsis workup was reinitiated and although previously Blood cx diptherioids and micrococcus 1/2 positive on 12/1. Repeat cx NG on 12/11.   he received cefepime for 16d. Blood culture again positive for staph 2/2 on 01/04/2022.  Repeat cultures are negative.  Repeat Fungitell and Aspergillus negative.  Patient was restarted on vancomycin per infectious disease.  On 01/07/2022 patient was able to be weaned down to nasal cannula.  Patient has COPD and needs his Trilogy set up at home.  It was recalled.  Pulmonary recommends decreasing his steroid by 1 mg every 3 days.  Patient's hospitalization complicated by alcohol withdrawal requiring phenobarb taper.  Patient also noted to have dysphagia.  He is currently on dysphagia mechanically altered diet per speech recommendation.   On the day of discharge patient denied any significant shortness of breath while on nasal cannula, chest pain, nausea, vomiting, shortness of breath.  He was tolerating his oral intake.
I HAVE LIMITED RANGE OF MOTION THE SECOND MODERNA COVID 19 SHOT. IT IS VERY STIFF.
warm feeling in fingertips; tingling in fingertips; This case was reported by a pharmacist via call center representative and described the occurrence of feeling of warmth in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number L949T, expiry date 16th April 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 12th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th March 2020, 2 sec after receiving Shingrix, the patient experienced feeling of warmth and tingling of extremity. On an unknown date, the outcome of the feeling of warmth and tingling of extremity were unknown.   It was unknown if the reporter considered the feeling of warmth and tingling of extremity to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of shingrix vaccine in left arm and experienced warm feeling and tingling in his left fingers after the injection. There were no reports of events with dose 1 of shingrix. The reporter consented to follow up.
arm is red and swollen , now is the size of two grapefruits , sx getting better,area still feels hot
Symptoms began 03/21/2022, but case states that she was "feeling poorly since early March 2022. On 03/21/2022 symptoms included; fever, cough, abdominal pain, congestion, diarrhea, fatigue, headache, nausea, poor appetite, runny nose. Case is receiving monoclonal antibodies (treatment) while in hospital.
Gave Moderna COVID19 Vaccine to a patient who was supposed to get the flu shot.; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Gave Moderna COVID19 Vaccine to a patient who was supposed to get the flu shot.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (Vaccinated with DOSE-2 with Pfizer in APRIL 2021) in April 2021.    On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Gave Moderna COVID19 Vaccine to a patient who was supposed to get the flu shot.). On 09-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (Gave Moderna COVID19 Vaccine to a patient who was supposed to get the flu shot.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The reporter stated that on 09-Oct-2021, they gave a Moderna COVID-19 Vaccine to a patient who was supposed to get the flu shot. It was also reported that the patient received their second dose of Pfizer COVID-19 Vaccine in April 2021.
I woke up the following day and my arm was sore and I had a red bump smaller than a pea. By 9PM I had a fever (100.1 F), body aches, and general discomfort. I started taking IB Profin (600 mg). My arm was VERY sore, and hurt during even small movements and anytime it was even brushed against. By 9pm the red spot grew to about the size of a quarter. The next morning (Friday 11/30/12) I was still running a fever, my arm still hurt very badly, and the spot was bigger than a golf ball. I called my doctor to inform them of my reaction, but they said it was normal. By noon it was about 2.5 to 3 inches in diameter and I went to my PCP. I started taking Benadryl, while taking IB Profin and Tylenol. By Saturday morning the red spot was about 6 inches long and 4 inches wide, my arm was still very sore, but my fever and body ache symptoms had subsided. My arm in general is still weak and gets sore with extended use (12/9/12), but all redness and bruising is gone. However, it does itch sometimes.
WEIRD DREAMS; COGNITIVE CHANGES; FEELING LIKE FREEZING; CHILLS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUN-2021, the subject experienced feeling like freezing. On 21-JUN-2021, the subject experienced weird dreams. On 21-JUN-2021, the subject experienced cognitive changes. On 21-JUN-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, weird dreams, cognitive changes, and feeling like freezing. This report was non-serious.
Client received flu vaccine per protocol in R arm IM at approximately 10:30am.  Received phone call from daughter at 3:45pm stating "he has read areas and whelps on his arms, legs and the trunk of his body.  Clients local PMD was contacted by family and he is being treated with BENADRYL/50mp PO Q8hr.
Left leg swollen from knee to thigh. Pt seen at hospital. Discharge home with Ibuprofen and Benadryl.
Night sweats x 4 hours and fatigue x 48 hours despite alternating ibuprofen 800 mg q3h with acetaminophen 1000 mg from time of vaccination
By morning right upper arm red, hot, swollen, swelling travelled down arm, difficult to use arm for about 2 days. never had that type of reaction before.
I had immediate soreness in the arm which continued from Saturday until about midday Tuesday. On Sunday I spent 2 hours in the direct sunlight at 75-80 degrees, after which I felt very light headed and nauseous. It may have been a combination of the shot and the sun.
I had long haul COVID before the vaccination. Within a day after my vaccination, I got more fatigued, shortness of breath, loss of balance, blurred vision. Then I got COVID again in October 2021. I still have long haul COVID symptoms. I am on oxygen 24/7. My vision is even more blurred, extreme fatigue, cough, fast heartbeat, cognitive decline, slow speech, and balance issues and have fallen a few times. I have an itchy feeling all over my body. I went to the urgent care then was told to go to the hospital. I was diagnosed as COVID with pneumonia. I was hospitalized for 12 days. I have been to my PCP multiple times and they have no answers on what to do about long COVID. I have had physical therapy to build up my strength. I went to the ER and my blood pressure was very low and my heart rate was very high. I was told to take less heart medications. I will also be going to speech therapy.
pt recv vax  & devel rash p/shot, went to MD who states it was measles from the vax;told would expect rash from vax 1-2wk & not contagious;has measles rash per pt states feel as usual except rash;felt sick 1/2hr p/vax & threw up, t103;
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 27-MAR-2015, the patient was vaccinated with a dose of VAQTA (lot # K007827) 0.5 ml (expiration date, route and site of administration were not reported) that underwent temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored (in temperature 34-35 -unit unknown) unspecified doses of PNEUMOVAX23 (lot#K020214, expiry date 25-MAR-2016 or lot # K021030, expiry date 22-JUN-2016 or K016264, expiry date 28-APR-2016 or lot # K021881, expiry date 30-JUL-2016 (dose, site and route of administration were not reported). This is one of several reports received from the same reporter.  Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EL0142), on 21Jan2021 as dose 2, single (Lot number: EL3247), on 05Apr2022 as dose 3 (booster), single (Lot number: FK9896) and on 29Sep2022 as dose 5 (booster), single (Lot number: 301558A) at the age of 68 years for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Lot number: GH9702) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid Treatment of COVID-19 via Oral route, start date on 23Dec2022, stop date on 28Dec2022. Rhinitis, cough following Paxlovid treatment for COVID-19. This may be rebound. patient was fine, with minor Symptoms, but was encouraged to file this report. Symptoms developed 7 days after completing Paxlovid 5 Day course.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300006844 same patient, different SD/dose and AE;US-PFIZER INC-202300006825 same patient, different SD/dose and AE;
No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 11-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Patient was with mom. Received the vaccination and was fine got up and after a few minutes as walking away from the pharmacy felt light-headed and fainted. Came back to consciousness immediately after falling and hitting head on the ground. We iced her head and gave water. We counselled to seek medical attention if not feeling well and the proceeded to leave the pharmacy area.
Extreme lower back pain, not able to lie down or walk very well, couldn't sleep, ended up in the ER and received a MRI and blood work, Pain was gone in 2-3 days.
her husband had a reaction after 1st dose of Covid Vaccine.. Clarified husband is on warfarin had a potential reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; warfarin (WARFARIN) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "her husband had a reaction after 1st dose of Covid Vaccine.. Clarified husband is on warfarin had a potential reaction". The action taken for warfarin was unknown.  Additional information: Clarified husband was on warfarin had a potential reaction Wanted to know what were they supposed to be looking for as potential reactions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt has prophylactic like reactions, she had swelling of throat, could not breathe, lips were tingling
the day after getting the shot i had a fever and chills and body aches on top of terrible vomiting that lasted all day.  I was unable to keep any water down at all while my fever kept getting worse and i considered going to the hospital by the end of it. i only had fever from my first shot and i wasn't prepared for how bad the second shot would be.
Redness around neck; This case was reported by a consumer via interactive digital media and described the occurrence of red neck in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced red neck. On an unknown date, the outcome of the red neck was unknown.   It was unknown if the reporter considered the red neck to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Oct-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had redness around his/her neck. Additional supportive information: The follow-up would not possible, as no contact details were available.
This spontaneous report was received from a health care worker concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date in April 2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 lot # M043424 with expiration date: 20-JUN-2018 and lot # M037533 with expiration date: 17-MAY-2018, as prophylaxis (Strength, dose and route were not reported), which experienced a temperature excursion of 12.7 Celsius degrees for 2 hours and 15 minutes. There were no previous temperature excursions reported. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA006461: US-009507513-1705USA014914:
Possible error of administration.  Live attenuated vaccines were administered to a transplant recipient.  The minor is been monitored.
mom states 2-3 hrs p/vax given 31MAR94 pt in crib crying when picked pt up noticed pt pale, limp & had blue color around mouth; transported to ER by EMS given 02 on way;
Muscle soreness continued for appx. 1 week after injection, became a dull pain for several weeks . Thereafter became a sharper pain at different ranges of motion and arm positions limiting ability to lift, stretch, wash hair/back and raise left arm.
bruises are darker than normal since he has started Eliquis; Constipation; swollen index finger and swollen toe/determined to be gout; felt lousy; This is a spontaneous report from a contactable consumer, based on information received by Pfizer.  This spontaneous case was reported by a physician and describes the occurrence of GOUT (swollen index finger and swollen toe/determined to be gout), FATIGUE (felt lousy), CONTUSION (bruises are darker than normal since he has started Eliquis) and CONSTIPATION in 92-year-old male patient who received apixaban (Eliquis) tablet (batch no. 1790398) for Venous thromboembolism. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for an unknown indication. The patient's past medical history included Large intestine infection, Hypercoagulability and Constipation. Concurrent medical conditions included Gout. In February 2021, the patient started Eliquis (batch no. 1790398) (Oral) at an unspecified dose twice a day. On an unknown date, the patient started Covid-19 Vaccine (unknown route). On 27-Mar-2021, the patient experienced FATIGUE (felt lousy). On 29-Mar-2021, the patient experienced GOUT (swollen index finger and swollen toe/determined to be gout). On an unknown date, the patient experienced CONTUSION (bruises are darker than normal since he has started Eliquis) and CONSTIPATION. The action taken with Eliquis(Oral) was unknown. At the time of the report, GOUT, CONTUSION and CONSTIPATION outcome was unknown and FATIGUE resolved. For Eliquis(Oral), the reporter did not provide any causality assessments. The reporter stated that he was put on Eliquis for ninety days and has used it for thirty days so far. He has had some issues that require an enema. Concomitant medications included: dark Cherry Extract - started on or after 29-Mar-2021. The reporter stated that he had been taking Eliquis for 45 days for blood clots that stemmed from a colon infection with secondary hypercoagulability. On Saturday 27-Mar-2021, the patient had his second injection of the Pfizer Covid vaccine. After receiving the vaccine, he said he felt lousy and had common side effects for a vaccine that lasted for about 2 days. On 29-Mar-2021 he woke up with a swollen index finger and swollen toe and this was determined to be gout. The gout in his index finger he had before. The patient stated that whenever he got bruises he had noticed that the bruises were darker than normal since he had started Eliquis. The patient also stated that he has had considerable constipation that started before Eliquis, but still persisted at times and he had treated with enemas. Patient was a retired physician.   Follow-up (30Mar2021): This is a follow-up spontaneous report from a contactable physician, based on information received by Pfizer  Most recent follow-up information was received from a physician on 30-Mar-2021 included the following: the event adverse event nos was amended as information on adverse events were received, new events and suspect product added, patient attributes, medical history, product attributes and narrative updated.