chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sneezing all day; Nose is running; Pain where she received the injection; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing all day), RHINORRHOEA (Nose is running) and VACCINATION SITE PAIN (Pain where she received the injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ANTIHYPERTENSIVES for Blood pressure, LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced SNEEZING (Sneezing all day), RHINORRHOEA (Nose is running) and VACCINATION SITE PAIN (Pain where she received the injection). At the time of the report, SNEEZING (Sneezing all day), RHINORRHOEA (Nose is running) and VACCINATION SITE PAIN (Pain where she received the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Join pain, muscle weakness and pain, tendonitis treated first with medrol dpse pack with rebound tendonitis and muscle pain and weakness requiring 7 days of 60 mg prednisone followed by a slow taper. Patient developed adrenal insufficiency which improved with time
Vacine 5/30/18. Reoccurent soreness at injection site 6/9/18. Headache 6/11/19. Nauseated 6/12/18. Fever (99.4) 6/13/18.
This spontaneous report was received from a 65 years old male consumer reporting on himself with no drug reactions or allergies and a history of bypass surgery twelve years ago who on 28-AUG-2012, was vaccinated on his left arm a dose of ZOSTAVAX (dose, route and lot number not reported). Concomitant medications included finasteride (manufacturer unknown), doxazosin mesylate, amlodipine, benazepril hydrochloride, simvastatin (manufacturer unknown), NIASPAN. Hydrochlorothiazide, irbesartan and aspirin. The consumer reported that on 28-AUG-2012 (reported as Wednesday), he was experiencing a small itching looked like acne. By Thursday of the same week, the consumer had full blown rash on the right hand side of his buttocks as well as the scrotum and penis. Acyclovir was given for the experience for ten days five doses a day. No lab diagnostics studies were performed. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for patient developed full blown rash on the right hand side of his buttocks as well as the scrotum and penis was unknown for ZOSTAVAX. Additional information has been requested.
Information has been received from a physician concerning a 15 year old female, who, on an unspecified date, was vaccinated with a first dose of Gardasil (Lot # 655165/1425F or 658488/0930U).  Subsequently the patient fainted after administration (also reported as the patient "did not completely faint, but was close to it").  The patient recovered on an unspecified date.  The patient recovered on an unspecified date without incident after sitting in the office.  She went home without complication.  This is one of 3 reports from the same source.  Additional information has been requested.
same day after shot-headache same evening-headache and chills next day-headache, chills fever 2nd after shot , early afternoon fever broke and started feeling better
Sore arm; went for a flu shot and walked out with a Pfizer COVID vaccine; not approved yet for that age group; Off-Label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "went for a flu shot and walked out with a Pfizer COVID vaccine; not approved yet for that age group"; OFF LABEL USE (non-serious), outcome "unknown", described as "Off-Label use ".  Additional information: Reporter stated, "So today I went  for a flu vaccination and received a Pfizer COVID vaccination instead which is the third and my 11 year old son also went for a flu shot and walked out with a Pfizer COVID shot (AE filed), again he is a 11 year old not approved yet for that age group."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to an 11 months 15 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
NUMBNESS IN FEET; MARCH 12 2021, WOKE UP WITH NO FEELING IN FEET, WENT TO ED, DX'D WITH GUILLAN BARRE, FATIGUE FEW DAYS AFTER VACCINE Narrative: REFERRED TO NEUROLOGIST/PCP AS RECOMMENDED BY NEUROLOGIST WHO SAW EMPLOYEE IN ED FOR WORSENING SX.
Shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on an unspecified date in Dec2020 at single dose for COVID-19 immunisation. Medical history included shingles. Concomitant medications were not reported. Patient got the first COVID Vaccine three weeks ago (Dec2020). Patient supposed to get the second dose tomorrow (11Jan2021). Patient had a previous history of shingles. Patient had shingles that broke out in the meantime. Patient didn't necessarily think it was from vaccine but patient wondered if he/she needed to delay getting the second dose or it is okay to take valaciclovir hydrochloride (VALTREX) and get the dose. When probed for confirmation if got shingles after taking the COVID Vaccine, patient stated, Yes, but it was about two and a half weeks after that he/she started having symptoms (Jan2021), after he/she got the first dose. So, patient did not know if it is from the vaccine or not. Patient had to take the second dose tomorrow and patient just wanted to know if it's safe or if it is not safe then can he/she took valaciclovir hydrochloride and get the vaccine. Patient didn't want to mess up the efficacy or anything. Patient said he/she is a healthcare worker but he/she just couldn't get the information. Patient didn't want to report adverse event, just needed to ask. Patient didn't think it was from the shot, just need to know if it was safe. Outcome of the event was unknown.   Information on Lot/Batch number has been requested.
I had a little tenderness in my at the injection site for a day.  I tested positive for COVID-19 via a home test on 07/20/2022. I had scratchy throat, tired, digestion upset and stuffy head.  I contacted my doctors office and was given the prescription for Paxlovid. That helped with my symptoms. After I completed the prescription, I had a rebound of COVID-19.  I did not take anything for my symptoms during the rebound stage. No long term COVID-19 symptoms.
6 hrs p/vax pt started screaming unconsolable for 3 1/2-4 hrs; MD notified but did not return call till p/crying ceased; fell asleep & just irritable when arising;
Headache; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 46-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 14Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included ongoing diabetes mellitus. Concomitant medications were not reported.  The patient previously took first dose of BNT162B2 on unspecified date for Covid-19 immunisation. In Feb2021, the patient experienced headache. The headache started about 12 hours after he received the shot. He still has a headache although it is getting better with time. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, between 01-SEP-2015 and 30-SEP-2015, the patients were vaccinated with improperly stored doses in immunization series of (Merck) VARIVAX, lot # K001390, expiration date 29-JAN-2016 (strength, dose and route of administration were not provided). Concomitant therapy was not provided. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
She tested positive for Covid-19 on 13Sep2021; She tested positive for Covid-19 on 13Sep2021; This is a spontaneous report received from a contactable consumer. This 55-year-old female consumer(patient) reported for herself.  A 55 years female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 14Apr2021 and 2nd dose on 06May2021 at single dose for COVID-19 immunisation. The patient medical history included "she received monoclonal antibody" and concomitant medications were not reported. On an unspecified date in sep2021, patient said she can't smell, taste, and is losing her voice. Patient said the symptoms started on Monday and has not went away and is getting worse. Patient wants to know if this is normal and is seeking guidance on what to do. However, patient tested positive for Covid-19 on 13Sep2021. She also mentioned that she received monoclonal antibody. At the time of reporting, the outcome of the events were unknown   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Redness, swelling, severe pain in arm. Talked to MD and she suggested to try ice, TYLENOL, and BENADRYL for reaction (according to patient at time of report- reaction was not better, but not worse)
Difficulty controlling sugar levels; Has lost some weight; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP), Program ID. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EP7533) at the age of 64 years, on 27Apr2021 as dose 2, single (Lot number: EW0170) and on 15Nov2021 as dose 3 (booster) single (Lot number: FG3527) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE ABNORMAL (non-serious), outcome "unknown", described as "Difficulty controlling sugar levels"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Has lost some weight". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood glucose abnormal.  Additional Information: Additional Context: Transferring agent states that the patient was asking about how to get the Prevnar 20 vaccine. The patient mentioned that he was seeking the vaccine due to difficulty controlling his sugar levels. The patient also mentioned he has had the three Covid 19 Vaccines. Transferring agent states that the procedure for the Prevnar 20 vaccine has been explained to the patient. he comes onto the line and verifies information received from the transferring agent. he states that he has been taking medications for his sugar levels for about 6 years. States his sugar levels have been harder to control since the Covid Vaccines. Difficulty controlling sugar levels:He states that it has been about a year or a year and a half since he thinks he took the vaccines in 2019. He says he has been in (Place Withheld) and has been trying to eat healthy and exercise. States he has been walking his dog and has lost some weight. He had stated that he thought he took the vaccines in 2019, but the year for his vaccines is actually 2021. He states that he is on a bunch of medications. States he takes insulin for his sugar levels and has been taking it for about 6 or 7 years. Denies any other medications, medical conditions, labs, testing, or treatments relevant to these events. He states that the transferring agent explained to him that the doctor has to approve and request the vaccine to get it from Pfizer. He says he was thinking, he doesn't know if this is a program they have to apply for to get the Prevnar 20 through Pfizer? Does it have to be through the doctor? Says he knows that it does have to go through the doctor, but is this a program where they can get the Prevnar 20? He agrees to transfer back to the Pfizer Patient Assistance Program for clarification.  If follow-up activities cannot be or are not conducted: No follow-up attempts are possible. No further information is expected.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 21-May-2021. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 12-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
About midnight I woke up with some moderate body aches, joint pain and chills. I did take a Tylenol because I didn't want to get a fever. I felt better in the morning from these symptoms. Extreme  fatigue a couple days later.  Fatigue is still there weeks later.  First pregnancy; estimated date of delivery is 9/20/2021.
Headache, nausea, fever, muscle ache, chills, sore throat.
I had a bad cough nausea vomiting & fever & I was short of my breathe so while I was at work I got tested for covid first test was negative & second test was positive.
On 10/5/2001, varicella vaccine. On 10/7/2001, exposed to active varicella. On 10/11/2001, varicella eruption.
HR up to 103; This case was reported by a pharmacist via call center representative and described the occurrence of heart rate increased in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 57LJ9, expiry date 14th April 2023) for prophylaxis.   On 5th April 2022, the patient received the 1st dose of Shingrix. In April 2022, 2 days after receiving Shingrix, the patient experienced heart rate increased. The patient was treated with clonazepam. On an unknown date, the outcome of the heart rate increased was recovered/resolved.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comment:The reporter stated that the patient received in left arm.  2 days later, the patient was sitting at her desk and her apple watch showed her HR at 103.  She took her clonazepam and HR (Heart rate) went back down to normal.  She then asked if patient should get the second dose.
Muscle soreness and rash seeming to originate from Left deltoid and moving down inside forearm. PT said it is spreading on the Right arm as well. There isn't any itchiness they are noticing but rash is visible and it is becoming raised. Recommended the patient use BENADRYL and monitor for the next few hours. If it progresses, they were directed to see a walk-in clinic/emergency afterhours clinic.
Mother called nurse practitioner at 9:30pm on 06/11/02 stated child had sudden raise of temp >101.7 vomited X T was pale and lethargic there was no local reaction.
erythematous painful wheel @ injection site Pain managed 2/ Ibuprofen + Antihistamine worsening over 3 days
Injection area has scab and red circle; pain at injection site; red dry skin that is itchy and spreading from stomach to knee; left arm that was black and blue; not myself; sick; Over Sleeping; Diarrehea/Chronic diarrhea; Chills; Headache; body ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red dry skin that is itchy and spreading from stomach to knee), DIARRHOEA (Diarrehea/Chronic diarrhea), FEELING ABNORMAL (not myself), ILLNESS (sick) and HYPERSOMNIA (Over Sleeping) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (body ache) and FATIGUE (fatigue). On 26-Feb-2021, the patient experienced DIARRHOEA (Diarrehea/Chronic diarrhea), ILLNESS (sick), HYPERSOMNIA (Over Sleeping), CHILLS (Chills) and HEADACHE (Headache). On 28-Feb-2021, the patient experienced FEELING ABNORMAL (not myself). On 03-Mar-2021, the patient experienced URTICARIA (red dry skin that is itchy and spreading from stomach to knee), VACCINATION SITE DISCOLOURATION (left arm that was black and blue) and VACCINATION SITE PAIN (pain at injection site). On 29-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection area has scab and red circle). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency; BACITRACIN ongoing since an unknown date at an unspecified dose and frequency and HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. On 02-Feb-2021, PAIN (body ache) and FATIGUE (fatigue) had resolved. On 26-Feb-2021, ILLNESS (sick), CHILLS (Chills) and HEADACHE (Headache) had resolved. On 28-Feb-2021, FEELING ABNORMAL (not myself) had resolved. At the time of the report, URTICARIA (red dry skin that is itchy and spreading from stomach to knee) was resolving, DIARRHOEA (Diarrehea/Chronic diarrhea) had not resolved and HYPERSOMNIA (Over Sleeping), VACCINATION SITE DISCOLOURATION (left arm that was black and blue), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE ERYTHEMA (Injection area has scab and red circle) outcome was unknown.            On 03-Mar-2021, the patient self administered "Mycitracin, Neosporin, Triple Antibiotic" ointment and hydrocortisone cream daily and two doses of acetaminophen. Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Added patient demographics. Added new events and event outcome. On 05-May-2021: TCR received. Patient is doing fine. Rashes reported were not due to vaccine. Received email
Burning of arm at time of injection, pain at injection site starting 3 hours post injection and lasting for 3 days, fatigue for 3 days, chills/fever for 3 days, myalgia for 3 days.
Constant migraines ×4days; Body aches; Tiredness; Cough; Runny nose; Loss of voice; Blurry vision; Swelling to injection site; Watery eyes; Congestion; Sob; This is a spontaneous report from a contactable other health care professional.  A 42-years-old female non-pregnant patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EW0175), via an unspecified route of administration, in left arm (at the age of 42-year-old) on 02Jun2021 16:00 at a dose number unknown, single as for covid-19 immunization. Medical history included Arthritis, Depression, Anxiety, PTSD, COVID-19. Concomitant medications included diclofenac taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jun2021 20:00 the patient experienced constant migraines for 4days, body aches, tiredness, cough, runny nose, loss of voice, blurry vision, swelling to injection site, watery eyes, congestion, sob. The patient did not receive any treatment. The outcome of events was recovered with sequelae on an unspecified date in Jun2021. Information on Lot/Batch number was available. Additional information has been requested.
felt like hit by a moped; enormously dizzy; fainted and blacked out; fainted and blacked out; blood pressure high,149 over 98; This case was reported by a consumer via call center representative and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th January 2022 09:15, the patient received the 1st dose of Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced blood pressure high. On 19th January 2022, the patient experienced faint (serious criteria GSK medically significant), blackout (serious criteria GSK medically significant) and dizziness. On 19th January 2022 17:30, the patient experienced discomfort. In January 2022, the outcome of the faint, blackout and dizziness were recovered/resolved. On an unknown date, the outcome of the discomfort was unknown and the outcome of the blood pressure high was not recovered/not resolved.   It was unknown if the reporter considered the faint, blackout, discomfort, dizziness and blood pressure high to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. One day before reporting at 9:15 am, patient received 1st dose of Shingrix vaccine and at 5:30 pm 8 hours 15 minutes after vaccination, the patient was all of the sudden felt like he/she was hit by a moped.  The patient reported that he/she understood that this was normal.  However, less than a day after vaccination, within 5 minutes of that happening patient then became enormously dizzy to the point where he/she fainted and blacked out completely and came to almost an hour later. Since this happened, patient's blood pressure had been extremely high about 149 over 98 (unit unspecified). The patient was concerned about getting the second dose in March 2022 due to the side effects. The patient enquired of how much immunity did one get after one shot of the vaccine.