chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 10 p.m. the evening of the shot i was awoken by a pain i had never had in my lower back, then it spread to my groin area down to my right knee .  I began bleeding when I urinated. I have genetic kidney stones,  but this pain was different as I had never had the pain radiate down to my knee.  I am still passing blood when I urinate and the pain in the low back and knee persists.
Received vaccine on 01/07 - temperature started in afternoon on 01/08 (R) arm - at injection site reddened and swollen on am 01/09 2 grams of ANCEF started on 01/09. Infectious. Disease consulted.
Severe pain at  the injection site, Nausea and vomiting, Malaise and fatigue as well as severe weakness
Pain and soreness immediately following vaccination (as expected).  Pain in site of shot has persisted ever since, now over 30 days since receiving vaccine. Causes sharp, sometimes excruciating pain when performing sudden movements. Cannot perform some basic tasks due to weakness and lack of mobility in that part of arm. Trouble stretching. Trouble sleeping due to pain when sleeping on that side. All symptoms remain consistent throughout this time period.
having big time flu symptoms; he was really sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Lot number: ER8730) 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: INFLUENZA (non-serious) with onset 2021, outcome "unknown", described as "having big time flu symptoms"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "he was really sick".  Additional information: The reporter stated that her son received the first dose of the Pfizer covid 19 vaccine on 3Apr2021 and is having big time flu symptoms. The reporter wanted to know how they should last and should he get there other shot. Reporter stated that her son had the Pfizer vaccine (Unspecified Vaccine) on Saturday and he was having big time flu symptoms and they started Sunday and Monday, he was really sick and today he is really sick.   No follow-up attempts are possible. No further information is expected.
Hives; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: GH9899), via an unspecified route of administration in the left arm, on 17Dec2020 at 09:00 (at the age of 43-years-old) at a single dose for COVID-19 immunization. Medical history included allergic to unknown food. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced hives on 17Dec2020 at 16:00. The event was reported as non-serious and did not cause/prolong hospitalization. Therapeutic measures were taken as a result of the event, which included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of hives was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Light headedness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced DIZZINESS (Light headedness). At the time of the report, DIZZINESS (Light headedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: VACCINE ADMINISTERED AT 10:55AM. PATIENT FAINTED WITHIN 2 MINUTES OF RECEIVING DOSE. WAS ALERT IMMEDIATELY AFTER. EMS WAS CALLED, UPON ARRIVAL PATIENT SITTING UP BUT FAINTED AGAIN. WAS TAKEN TO EMERGERENCY ROOM.
A sudden onset of eczema, spread over my body. Worst areas were forearms and top of back
Numbness and tingling starting in feet, then progressing proximally to include all 4 extremities. Symptoms started approximately 1 wks after receiving flu and Tdap vaccines - had never had flu shot before. Symptoms completely resolved in 1 wk.
Tachycardia as high as 133 while resting.  Tachycardia for 3 days measured by fingertip pulse oximeter at home.
I tested positive for COVID-19 on 04/15/2022. It started off with a lot of congestion, I started taking a Mucinex cough medicine. I felt like I had a bad cold, felt like flu like symptoms. I got nausea, vomiting, sore throat, body aches and a headache. I quarantine myself for about a week. The health department had called me and said that I was go to go. The doctor had given me some meds because of the COVID for people over 60. It was one table of Paxlovid and it contain 3 different ingredients. My symptoms was on the moderate side.
Patient was sitting on edge of exam table. Approximately 5 minutes after getting covid vaccine patient fell backwards on to her back on to exam table, and lost consciousness momentarily. Patient opened her eyes after a few seconds and appeared drowsy. After a minute or 2, patient became more alert. Patient stayed laying on exam table for about 15 minutes. Doctor was informed and assessed patient, Nurse got water for patient to drink. No hives, no bleeding, no swelling, no other signs of distress. After approximately 15 minutes, patient stood up. Patient was balanced, no c/o dizziness. Nurse accompanied patient to their car. Event not considered to be an allergic reaction and plan to ensure patient seated in chair with back support for future vaccinations.
had a stroke at the hospital after the second Pfizer Covid-19 vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 14 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant, hospitalization), outcome "unknown", described as "had a stroke at the hospital after the second Pfizer Covid-19 vaccine.".  Clinical Course: The reporter states that her son had a stroke at the hospital after the second Pfizer Covid-19 vaccine and her son's school wanted him to get the booster. The reporter would like to know how to go about getting a letter that he should not get the booster. The reporter states her son's HCP referred her to us and her son was 15 years old but was 14 years old when he received the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt experienced immediate wheal / flare reaction locally at injection site for Varivax. No other symptoms. Benadryl given, and cortisone cream applied. Observed for 20 minutes, reaction improving. No other signs or symptoms.
This spontaneous report as received from a consumer refers to her 5 year old female daughter with no drug reaction and no medical history. On 15-JUL-2013 the patient was vaccinated with a dose of VARIVAX (Merck), one time injection. There was no concomitant medication. On 28-JUL-2013, the patient developed "chickenpox" after receiving the VARIVAX (Merck) vaccine. The lab diagnostics did not perform. No treatment was given for AE. The patient sought medical attention and saw the doctor. The patient present status was recovering. The AE was not reintroduced. Additional information has been requested.
I was exposed to some one with a positive Covid test on 05/7/2022, she tested positive on 05/08/2022. On 05/09/2022 I had a bit of a sore throat and a running nose, home test came back negative, I kept feeling sicker as the night when on. On 05/10/2021 at about 05:00AM I tested again and it came back positive. I had a headache sore throat, congestion, body aches. I spoke the nurse at my doctors office on 05/12/2022, she asked sx and spoke with the doctor who prescribed Paxlovid which I started yesterday. I feel like I am getting a little better, but I still feel lousy, no energy. I have a strange taste in my mouth, sometimes it is metallic and sometimes it is citrusy.
Pt received flu vaccine 01/04/2005 - on 01/05/2005 pt developed a 3" welt, red and hot to touch. No fever, good ROM. We were notified 01/06/2005. Advised to try tylenol, cold compress. Follow-up 01/07/2005 if not better.
High fever of 103+ on 1/2 dose. Can't take full dose so my doctor gave 1/2 + 1/2.
ErythemaMultiform Narrative: 11 days-red spot continued to inj set, intermittent soreness; rec PCP f/u if s/s progress to infection. Similar reaction to flu vax couple of years ago; reports cellulitis 2/2 last injection of anthrax series 2003
Resident was noted on 1/25 with an increased functional decline as she would not feed herself with utensils, but would eat finger foods if placed in her hand. She was started on Rocephin IM for possible infections. Labs had been obtained on 1/21/21, unremarkable for CBC and CMP. 75,000 colony count on urine. On 1/26/21 she was noted with right sided weakness and further decline. She was sent to Hospital for further evaluation. We were notified that she expired on 1/28/2021. Resident had been noted with a decline in function about 2 weeks earlier when she would not stand or transfer any longer. She was still responsive, taking meds, and feeding herself until 1/26/21. Further information on admitting diagnoses and progress notes from hospital have not been available to date.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. The patient was vaccinated with improperly stored GARDASIL 9 (lot# M017983, expiration date: 30-MAY-2018), RECOMBIVAX HB)(lot# M020926, expiration date: 11-AUG-2018), ROTATEQ orally (lot# M019707, expiration date: 25-OCT-2017) or VAQTA (lot# M030598, expiration date: 13-OCT-2017) on multiple unspecified dates. No adverse effects were reported. Temperature excursion details: Data logger was involved. Temperature: 30.30 F. Time frame: 15 Minutes. Previous temperature excursion: 32 F for 2 hours. Additional information has been requested.
At age 22 has an abnormal pap.; This spontaneous report was received from a physician via company representative and refers to a 22-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date (also reported as between 11 and 12 years-old), the patient was given the 3-dose regimen of human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided).  On 27-JUN-2023, the patient had an abnormal pap (Smear cervix abnormal). At the reporting time, the outcome of the event was unknown.  The causal relationship between the event and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
Stripe of redness/looks like a stripe of redness, like a burn; It is a rash, but not raised; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), VACCINATION SITE ERYTHEMA (Stripe of redness/looks like a stripe of redness, like a burn) and VACCINATION SITE RASH (It is a rash, but not raised) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced LETHARGY (lethargic) and VACCINATION SITE RASH (It is a rash, but not raised). On 29-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Stripe of redness/looks like a stripe of redness, like a burn). At the time of the report, LETHARGY (lethargic), VACCINATION SITE ERYTHEMA (Stripe of redness/looks like a stripe of redness, like a burn) and VACCINATION SITE RASH (It is a rash, but not raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was not on any blood thinner. They are on daily medication, one medication they have been on for 20 years, and the other they have been on for 5 years. Patient declined to mention names of the Concomitant medication.  Treatment information was not provided.  The stripe of redness is about 2 inches by 3 inches, like a burn. It appeared below where the syringe was inserted.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and on 31May2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received proprietary medicinal product name Paxlovid for the treatment of covid-19, date of start of drug 09may2022, date of last administration 14may2022. congestion symptoms returned after 6 days of feeling better after finishing Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Symptoms described as swelling and itching and rash at injection site, followed by subjective fever temp unknown, myalgias  and headaches. Which started 18 hours post injection.
leaked and only a partial dose was given; backsplash or leakage of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (leaked and only a partial dose was given) and DEVICE CONNECTION ISSUE (backsplash or leakage of the vaccine) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced UNDERDOSE (leaked and only a partial dose was given) and DEVICE CONNECTION ISSUE (backsplash or leakage of the vaccine). On 06-Aug-2021, UNDERDOSE (leaked and only a partial dose was given) and DEVICE CONNECTION ISSUE (backsplash or leakage of the vaccine) 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.   Concomitant product information was not reported. Treatment information was not provided.
Injection site reddened, swollen, and very itchy. Happened within 10-15 min. of "injection". Still reddened, swollen and itchy as of 10/24/14.
Patient experienced some dyspneo after vaccination.. Pain radiated down arm. Onsite EMS called  HR 107 BP 200/91 100% O2 , patient  recovered and went home.
Acute allergic reaction.  Itching,  rash, redness, unable to control the itch. This started Friday evening and continued through to Monday when I finally went to the ER.
I broke out with burning and itching. Eventually, in March, I developed this really bad rash and the doctor couldn't figure it out. I then went to a dermatologist and they prescribe some cream. The rash was all over my body except my face. I had someone to come to my house to see if I had bed bugs or something in my house and it wasn't. It cleared up in the middle of March. Everything has cleared up. I can't say that it was the vaccine or not but I have never had any of this before.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. 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: 206A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 24-JUN-2021 to left arm for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On 15-DEC-2021, the patient started having lost of taste and smell, low grade fever, cough and runny nose (suspected covid-19 infection). A day after on 16-DEC-2021, the patient got a positive Antigen Rapid Test for Covid 19, (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208053.; Sender's Comments: V0: 20211247761-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Fever (102.5); chills; muscle aches; headache; nausea; diarrhea; extreme fatigue; This is a spontaneous report from a contactable consumer (patient) received via the Regulatory Authority. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 01Mar2021, at 12:30 (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. Medical history included diabetes and hypertension. She was also diagnosed with COVID-19 prior to vaccination. The patient has no known allergies and she was not pregnant at the time of vaccination. Concomitant medications included atorvastatin, lisinopril, metformin, and (OZEMPIC). She did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unspecified date in Mar2021, the patient experienced fever (102.5), chills, muscle aches, headache, nausea, diarrhea, and extreme fatigue. The patient was not tested for COVID-19 post vaccination. No therapeutic measures were taken as a result of the events. The patient was recovering from fever (102.5), chills, muscle aches, headache, nausea, diarrhea, and extreme fatigue.  No follow up attempts are possible. No further information is expected.
Information has been received from a nurse concerning a 42 year old female patient with no pertinent medical history and sulfonamide allergy who on unspecified dates was vaccinated with doses of MMR II (lot number not reported). The nurse stated that the patient did say she got the vaccine as a child. Titer drawn on 31-JUL-2009 showed the patient was not immune. On 07-AUG-2009 the patient was vaccinated with a dose of MMR II (lot number not reported). Titer drawn on 03-OCT-2009 showed that measles was equivocal. Unspecified medical attention was sought. At the time of the report, the outcome of the patient was not reported. The patient had a medical history of Anti-HBs antibody negative after being vaccinated with a 3 doses of hepatitis B virus vaccine rHBsAg (manufacturer unknown, WAES # 0910USA00596). This is one of several reports from the same source. Additional information has been requested.
12/29/2021 I woke up with a sore throat congested all night , one side was congested, one side running, headache, cough, but I was not coughing anything up. I went to clinic, the doctor checked me there, my  lungs were clear,  she offered me antibiotics.  She told me to treat it like a sinusitis. And said it was too early to test me for COVID-19. I wasn't feeling worse, so I did not go back to the clinic. So I never got tested.  I'm still stuffed up and coughing. I think it's the weather. I get the sinus stuff every year.
Patient received Pfizer COVID vaccine intramuscularly in the right arm. Patient reported initially she has a shellfish allergy. Patient was being monitored in designated location when the patient reported her tongue was becoming numb  and experiencing dizziness. Onset of symptoms was about 7 minutes after her shot. The patient denies difficulty breathing .  Patient was sent to the emergency room where labs were drawn with no critical results. Patient was discharge on a medrol dose pack and discharged from the ED after feeling better.
This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, patients were vaccinated with the improperly stored doses of (Merck) PROQUAD (lot number K019102 and expiration date 15-APR-2016) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.