chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sjogrens Syndrome" (unspecified if ongoing); "Shrimp allergy" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (19Jul2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details: product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 12Jul2022, Treatment stop date: 16Jul2022, Indication: Treatment of COVID-19. The patient tested negative for Covid 19 on 19Jul.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She recieved the flu vaccine on 8-12-09, and that pm felt very sore and swollen at injection site, soreness increased and she stated she could not sleep well because her arm was very painful and swollen, pain radiated to fingers at times. She was seen by an MD on 8-26, and had a lidocaine/cortisone injection. She felt that the vaccination was given too high on her deltoid, almost shoulder area.
02/07/2021- AM have abundance of floaters in right eye, not had previously.  Later in day had some nausea, headaches and extreme soreness at swelling site but those 3 issues went away after a few hours.  That evening I started getting what I will call "Lightening Bolts"  flashing along the outer right edge of my right eye when I moved my head side to side.   02/08 & 09/2021- "Lightening Bolts were constant and I went to hospital.
Patient complained of left arm hurting for a while.  She is losing range of motion.   I referred her to her primary care physician.  He prescribed anti inflammatory for her.   I also recommended she might talk to her doctor about physical therapy.   Dr has not done that yet.
Rec'd Afluria vaccine at 9am. Reports at 5pm began to feel flushed, aching, chilled. Reports during night had shaking chills and felt aching all over. Took Tylenol for complaints. At 9am reports still doesn't feel well. Skin flushed. Cheeks reddened. Temp 99.2 otic. Hands cool to touch. c/o feeling hot/cold. c/o "dry mouth". Reports has had the flu vaccine before but never had a problem before. Reports felt "fine" prior to getting the vaccine and this is "not my usual" when I do get sick.
The day following vaccination, I started having lethargy, chills, lack of appetite, dull pain at injection site and sore neck and shoulders. by end of day, symptoms were as severe as when I had COVID last Nov. The next day, I felt fine, except for continuing site pain.
Fever 100.4 at 4 am. Muscle aches by 8 am, along with malaise, fatigue, headache.  Blood sugar tested at 160 while fasting. Unable to move left arm.
Started with moderate headache. By 5/17/15 severe headache and 101 fever. 5/18/15 severe headache and 101 fever, chills, body aches. Responsive to Tylenol. 5/19/15 fever 103.8, not responsive to Tylenol, body aches, severe headache, nausea, chills.
My symptoms started 12 1/2 after the vaccine.  I had body aches, headache, chills, fever, very dizzy light headed, fatigue. Most of the symptoms lasted for a couple days, by Friday the 12th I was fever free and muscle aches went away. The day after the vaccine I blacked out at school, the nurse took my pulse and blood pressure and everything seemed ok. My husband picked me up and I went home to sleep.  Sunday the 21st for the firs today I made it through the day without sleeping or having any issues.  I did go to the Dr. for a follow  up my heart was a little up and down but still within the normal wrong.  She told me to take a week off.
very drowsy/ very drowsy, kind of a floating feeling; sleeps a lot, normally she doesn't sleep that much; Feeling a little bit cloudy, floating, weird/feels like her brain is over relaxed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset Mar2021, outcome "unknown", described as "very drowsy/ very drowsy, kind of a floating feeling"; HYPERSOMNIA (non-serious) with onset Mar2021, outcome "unknown", described as "sleeps a lot, normally she doesn't sleep that much"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "Feeling a little bit cloudy, floating, weird/feels like her brain is over relaxed".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11JAN96 grandma reported inc sleepiness, pea shaped rash surrounding inj site on rt thigh, fluid filled vesicles around inj site that spread to vagina & entire body;pt taken to MD told poss rxn to vax;rx DPH
Client came into clinic to receive the second dose of Covid vaccine.  The dose was administered a week  too early.
IMMEDIATELY FOLLOWING FIRST SHOT, PATIENT GOT MENSTRAL CYCLE AFTER NOT HAVING IT FOR 8 MONTHS.  THE SAME THING OCCURED IMMEDIATELY AFTER SECOND SHOT.  ADDITIONAL SYMPTOMS INCLUDE MAJOR MUSCLE AND JOINT PAIN TO THE POINT WHERE PATIENT HAD DIFFICULTY WALKING AND PUTTING PRESSURE ON FEET.  PAIN IS NEARLY DEBILITATING FOR PATIENT.  PRIOR TO GETTING VACCINATIONS, PATIENT PARTICIPATED IN DAILY CARDIO AND STRENGTH CONDITIONING AS WELL AS YOGA AT LEAST 2-3 TIMES PER WEEK.  PATIENT IS NO LONGER PHYSICALLY ABLE TO DO ANY EXERCISE DUE TO SEVERE PAIN.  BASIC LIFE ACTIVITIES ARE ALSO PAINFUL (SLEEPING, GOING  UP AND DOWN STAIRS, PICKING UP HEAVY ITEMS, ETC.
Right arm redness, tenderness, swelling x 3 days over entire right upper arm with PNEUMOVAX vaccine on 10/9/10.
Received first dose of the Pfizer vaccination at 09:35am, about 15 mins later I began to develop petechiae to both my arms and abdomen. I had the nurses look at my petechiae that had developed, then had me sit for another 15 mins. During that time, I began to develop heart palpitations and chest discomfort. They had me sit in another room and evaluated me. My blood pressure was high in the 140's systolic, which is abnormal for me, I?m usually 110 systolic. I began to have some shortness of breath; I wasn't able to take a deep breath. I was taken to the ED to be evaluated for my symptoms. There I was asked a series of questions, they had taken an EKG and my blood pressure was 151 systolic, then was taken to a triage room. MD ran a series of blood work and was given SOLU-Medrol IV push for my allergic reaction and Shortness of breath. I was kept in the ED for about 4 hours. Labs came back normal and was prescribed 20 mg Prednisone by mouth and 25mg Benadryl by mouth to take at home. My diagnose was Allergic reaction, Initial encounter. I was to follow up with my PCP. Followed up with my PCP the following day, 3/12/21 and she had run a CMP and CBC, looked at my petechia and referring me to Oncologist/hematologist to further evaluated for my platelet count and petechiae. She wants to make sure I won't be developing ITP.
drenching sweated for another 5 hours; diarrhea; rigors; fever to 102.7; tachycardia to 140 which all lasted for 30 minutes; This is a spontaneous report from a contactable physician reporting for self. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 14Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included asthma, covid-19 from an unknown date. Patient received first dose of bnt162b2 on 17Dec2020. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), fluticasone propionate (FLOVENT). On 15Jan2021 22:00, 36 hours after second vaccine patient had diarrhea, then rigors, fever to 102.7, tachycardia to 140 which all lasted for 30 minutes. After it stopped had drenching sweated for another 5 hours and more diarrhea. Fever lasted for 1 hour after taking Tylenol and Alleve. Felt back to normal next morning and fine since. No symptoms now. Outcome of events was recovered.
On the morning after receiving the vaccine (1/23/2021) I had chills, muscle aches, joint pain and a slight fever (99*) and no energy. These symptoms subsided by 8 PM that night. On the 2nd morning after the vaccine, I had joint pain, lower back pain and a dull headache.
i had the fluarix quad pn 9/17/14 and on 10/30/14 i had skin dermatitis.
COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative and concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient developed covid-19 infection.  On an unspecified date, the patient died from covid-19. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: A patient of unknown age and gender died an unknown time after receiving Janssen COVID-19 Vaccine Ad26.COV2.S (suspension for injection, route of administration not reported) for prophylactic vaccination. Medical history, concomitant medications, and details of the event were not reported. It was unknown if an autopsy was performed. This case has insufficient information to make a meaningful medical assessment.; Reported Cause(s) of Death: COVID-19
itching on my fore arms; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of pruritus 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 pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received shingles vaccine and started itching on his/her fore arms.  The patient asked could this be a side effect from the vaccine.
First day of vaccine, I had a really sore arm. Next day after vaccine, felt very fatigued that continued for 3 days. On 3rd day after vaccine, developed mild cold symptoms/sinus congestion. Day 5 after vaccine, lost taste and smell and  tested positive for COVID-19.
The patient was registered for the new bivalent moderna booster and received the new booster however she never received her primary series
Patients received vaccine with silver metal particles; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT CONTAMINATION PHYSICAL (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 015M20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced PRODUCT CONTAMINATION PHYSICAL (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On 30-Nov-2021, PRODUCT CONTAMINATION PHYSICAL (Patients received vaccine with silver metal particles) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow-up received contains patient details and vaccine information
Shortly after receiving the vaccine the patient began to turn red and stated she was itching. We gave the patient one 25mg dose of diphenhydramine, the patient waited, symptoms resolved and felt fine to leave after 30 mins.
Flushing on the face; Heart started to race; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing on the face) and PALPITATIONS (Heart started to race) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced FLUSHING (Flushing on the face) and PALPITATIONS (Heart started to race). On 30-Dec-2020, FLUSHING (Flushing on the face) and PALPITATIONS (Heart started to race) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.    No treatment information was provided.
This non-serious spontaneous case, was initially received on 14-Aug-2017 from physician, concerning a 06-year-old, female child. Physician reports 10 patients who were vaccinated after multiple temperature excursions. This report was fifth of 10 reports. On 22-Mar-2017, the patient was administered with FLUCELVAX QIV (batch number: 186686 (reported as 185586 and 186686), expiry date: (reported as 31-May-2017), dose, route of administration, anatomical location: not reported). It was reported that multiple temperature excursions were occurred on 02-Mar-2017, vaccine was stored at 47F for 14.7h (1st excursion), 03-Mar-2017, vaccine was stored at 47F for 16h (2nd excursion) and 04-Mar-2017 at 47F for 19.75h (3rd excursion) which was considered as incorrect product storage. As the patient was administered with vaccine which was stored at 46F to 77F up to 24 hours instead of storing at 36-46F was considered as drug administration error. Non-significant case correction received: 14-Aug-2017. Batch no. (186686) was captured in the case form and narrative was amended accordingly.
ACHES, PAIN (JOINT), SWEATS, LOW GRADE TEMP, MALAISE, N & V, AND SEVERE HEADACHE
Received expired dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
Developed a fine maculopapular rash along b/l anterior upper & forearms. Some scattered on posterior, on 12/23/20. Mostly non-pruritic, except after shower on the 1st day.  Took Cetirizine on 12/23 with some relief. Dues to persistence on 12/27/20 repeated cetirizine. Photos available.
Inflammation in all joints causing high amount of pain and lack of mobility.  Hands swollen so much cannot make a fist or grab anything.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 22-JUN-2013 the patient was vaccinated with a dose of M-M-R II, 0.5 ml, subcutaneously (lot # H014977, expiry date: 09-AUG-2014). No concomitant medications were reported. The nurse noted that the dose of M-M-R II that was administered to the patient was unsupported due to a temperature excursion. No adverse effect was reported. No further patient information was available.
Fever 104.1, chills, sweats, headache starting at 7:00am on the day following the shot and lasting until around 3:00am, then fatigue the rest of the 2nd day following the shot.
Date place in refrigerator was 29/Oct/2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator was 29/Oct/2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date place in refrigerator was 29/Oct/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator was 29/Oct/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  The vial was placed in refrigerator on 29-Oct-2021. It was reported that the expired lots were administered due to the confusion with expiry date printed in the carton and the expiration date when the QR code was scanned. The vials did not undergo temperature excursion. The patient did not experience any adverse event.  No Treatment medication reported.
The morning after the Covid Booster was administered to me, I woke up in serious pain. All my joints were inflamed. I couldn't even close my mouth because my jaw was in so much pain. Now I can barely walk. My pelvic joint is so painful I can't lift my legs and can't dress myself. My wrists hurt so bad I can't squeeze a tube of toothpaste. I'm a swimmer, Kayaker, Bicycle rider, sailor - but now I can't even lift a glass of water. This has been steadily getting worse and now I am unable to function as a person. Even my ears hurt! I haven't been able to see a doctor because I can barely move. I'm taking 5Mg of Ibuprofen every 5 hours now and taking CBD oil also.
Not sure if got second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not sure if got second dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043221A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not sure if got second dose). On 20-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Not sure if got second dose) had resolved.            Concomitant product use was not provided. Treatment information was not provided.
100,1 degree Fever for approximately 24 hours.  Treated effectively with Motrin and Tylenol.
on April 15th the employee stated that her whole left side was in pain, she stated the pain is running back to back.  It ran from injection site up her left shoulder, and started to spread on left side of her back.  There was redness and tenderness to touch, these areas also felt a little warm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 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: "Bipolar disorder" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "GI issues" (unspecified if ongoing); "chronic sinus inflammation" (unspecified if ongoing); "prostatitis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: Positive, notes: although continued to test positive off and on for the next 6 days; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were taken as a result of covid-19. Recovered 3 days after beginning Paxlovid, although continued to test positive off and on for the next 6 days. On day 9 (4 days after Paxlovid) all initial symptoms returned. Have been ill for 1 1/2 days now. The patient did not have any known allergies. Patient received Lisinopril on 13Apr2022 and Lamotrigine on 01Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.