chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Janssen COVID-19 Vaccine EUA" Got chills and then got very hot took temp was 100 and then when down from there and within 4 hours was down to normal temp.  Took Tylenol twice that day.  Never felt nausus. Has been fine since then.
covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in an 18-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742650:Same reporter, Different Patient
Client reports feeling fatigues day after vaccine.  however, on 3/28 he reports his face bilateral near the nose is firm swollen and red. he reports no relief with gels or antihistamine.  He sought dermatology assistance and is seeking allergy evaluation and is contacting his primary MD.
Vomiting and abdominal pain began on 5/7.  Also had bloody, mucousy stool.  Admitted to hospital and barium enema confirmed intussusception.  Transferred to Hospital in early AM of 5/8/08.  Repeat barium enema confirmed diagnosis, but unable to reduce completely.  Surgical reduction performed on 5/8/08.  At time of this report, patient recovering in hospital.  5/15/2008 MR received for DOS 5/8-10/2008 with D/C DX: S/P Intussusception reduction.  Infant presented to ER with c/o nausea, vomiting, bloody bowel movements and cramping and abdominal pain.  PE (+) for pallor and a 2x2cm abdominal mass in the R abdomen. Reduction attempted by Barium Enema x 2 at local hospital but unsuccessful at reduction.  BE at current facility also unsuccessful x 3 attempts. Pt taken to OR for Exploratory Lap with IS reduction and appendectomy. Pt developed fever 1 day post-op but was D/C on POD#2
Information was received from an unspecified healthcare worker regarding a male patient, age unknown. The patient received the first dose of GARDASIL (dosage and route of administration not provided) on 14-NOV-2012. The patient received the second dose of GARDASIL (dosage and route of administration not provided) on 04-DEC-2012. No adverse effect reported. Additional information has been requested.
A few hours post vax, the pt developed redness, swelling, induration which covered a 10 x 10.5 cm area. The pt was treated with Kenalog, Claritin.
My blood pressure was 172/95 right after I took Vaccine,  since then my BP was 155/100 last night , 147/101 this morning. I never had h/o high BP
Irregular menstrual bleeding between cycle; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old patient of unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, anxiety, PTSD and bipolar disorder. The patient was allergic to penicillin. Concomitant medications included chlorphenamine maleate, paracetamol and pseudoephedrine hydrochloride (THERAFLU) started on an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not 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 08Apr2021 the patient experienced irregular menstrual bleeding between cycle. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event irregular menstrual bleeding between cycle was recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
The pt experienced hives which started at the injection site and spread to torso. No wheezing was noted. The pt was brought to the office and given Solu Medrol and Benadryl, Medrol dose pak.
I have experienced a dramatic FLARE of Osteoarthritis in both knees and hips to the point that I have had to start using a cane to walk. Previous to this, the Osteoarthritis was only obvious in my left knee, but was in remission and I had not had to take any pain medication for months.  After the second Moderna vaccination, the Osteoarthritis has flared and become extremely painful, even while in the bed lying down. It now is very painful in both the right and left knee and both, the right and left hip sockets. I have to take 2 Excedrin Extra Strength pills every six hours to lessen the pain. I also now have to use a cane for walking because it is too painful to bend my knees and support my weight. I am morbid obese - at 297 pounds (down from 391 pounds on September 30, 2019).
Patient started puking up clotting blood around 10:20PM on 4/13/21 and went to the ER.  He was admitted to the hospital and is in procedure currently for a scope to determine more information.
Seizure; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is a 1st of 2 reports.   A 27-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0176) dose 1 via an unspecified route of administration, administered in arm right on 21Jul2021 at 18:00 as (at the age 27-years-old) DOSE 1, SINGLE for covid-19 immunization. No relevant medical history was reported. The patient's concomitant medications were not reported. Patient concomitant medication were not reported. Historical vaccine included tetanus shot (had a tetanus shot before Pfizer shot, further clarifications unknown). The patient experienced seizure on 03Oct2021. It was reported that patient took Pfizer vaccine and a while after had a seizure which never had, and patient was over the normal age for somebody to have normal seizure, had to take her to the emergency and they did a CT scan and the Neurologist said that it was not normal to somebody who was 27 years (not clarified) old to have a first-time seizures, It was also reported that patient never had a second shot. The patient underwent lab tests and procedures which included blood test: unknown results on an unknown date in 2021, it was 20th. It's almost 2 weeks, computerized tomogram (CT): unknown results on an unknown date in 2021 when patient was asked the name of tests and stated as they did bunch of tests. Therapeutic measures were taken as a result of event included Keppra 500 mgs, twice a day. Patient was prescribed at their after-emergency room. The neurologist prescribed Keppra (treatment) which was an anti-epileptic and anti-seizure medicine. Patient had been on medicine so that doesn't happen but, she would like to not be on that. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101416172 same product and event, different patient
Fever (low grade), abd pain, nausea, muscle aches all over, headache.
No adverse effects reported; one unspecified "15 month old patient" received both MMR II and VARIVAX via intramuscular route on the same day.; This spontaneous report was received from a pharmacist referring to a 15 months old patient of unknown gender.  Information of concomitant medication, concurrent condition, pertinent medical history and drug reaction/allergy was not provided.  On 03-SEP-2019, the patient was vaccinated with both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, lot # and expiration date were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, lot # and expiration date were not reported) via intramuscular route for prophylaxis(subcutaneous injection formulation administered by other route). Other suspect therapy included sterile diluent (strength, dose, lot # and expiration date were not reported) via intramuscular route for prophylaxis. No adverse effects were reported. The outcome of the event was unknown.
Had family members and friends that had miscarriages and lost their children, their actual children have died due to the Covid-19 shot/knows four people personally who have had miscarriages; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient (pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "Had family members and friends that had miscarriages and lost their children, their actual children have died due to the Covid-19 shot/knows four people personally who have had miscarriages". The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death.  Clinical course: Non-HCP general public is calling about the Pfizer BioNTech Covid 19 vaccine and how unsafe the vaccine is, as it has been attributed to 20 million deaths, stillbirths, miscarriages, infertility, spontaneous abortions. The reporter got the vaccine, he even states that there is a depopulation issue, and they have to bring in dreamers to help with jobs. Famous OB GYN has come out and stated that it has caused spontaneous abortions and fertility issues. There was no decrease in birth rate in 2020 so it can't be from just Covid, its attributed to the vaccine. It was a 10 minute video talking about the rises of spontaneous abortions, and due to "standard deviations"- he didn't understand what that meant, his wife had to explain it to him, his wife had to explain it to him. The miscarriages have been on the rise for the last year and a half. Early data is showing an enormous amount of miscarriages, and there could be people having trouble conceiving and delivering. Breastmilk could be dangerous to infants. They could be wiping out an entire generation that's needed to continue the human race. He knows four people personally who have had miscarriages, their children are dead. Their OB GYNs feel bad they recommended this. His wife is a psychologist who speaks with people who have vaccine remorse. People know they were lied to. Asked about data there is on miscarriages, pregnancy and infertility. He especially wants to see where Pfizer says its safe. Had family members and friends that had miscarriages and lost their children, their actual children have died due to the Covid-19 shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201375068 same reporter/drug/AE, different patients;
Some shortness of breath, Blood Pressure Spike 15 points or more both ends, mild bleeding in urine; some vision difficulties early in the day; headaches, some disruption-mild of bowel movement (probably anxiety due to above); some soreness near bladder area-mild
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In July 2014 the patients were vaccinated with an improperly stored GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Follow up information has been received from the Licensed Practical Nurse. The Licensed Practical Nurse stated that she did not have the information (patient identifiers, lot numbers, expiration dates, and date of vaccine administration) available at this time. No further information was available at this time of reporting. Follow up information has been received from the Licensed Practical Nurse on 28-OCT-2014. The patient identifiers were reported and the patient was 11 years old child. The patient was vaccinated with GARDASIL on 16-JUL-2014. Lot was reported as H020901, expiration date 05-JUL-2015 for the GARDASIL. Additional information has been requested.
She came back in on 6/3/16 with a cutaneous abscess of the right upper extremity thought to be at the injection site.  She reported that 2 days after getting the injection, she developed flu-like symptoms and noted a large red area over her arm that had since shrunk in size.  On approximately 6/1/16, she was in the shower and noted thick yellow bloody drainage from her arm.  She did not have fever or chills.  She applied triple antibiotic ointment and did hot compresses.
swelling and pain at the injection site; swelling and pain at the injection site; 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(patients mother).  A 15 year-old female 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: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "swelling and pain at the injection site".  Additional information: NDC number, Expiry Date  and reason for no lot number of Pfizer Covid 19 Vaccine was not provided, caller unwilling to complete the report of Pfizer Covid 19 Vaccine: Not Provided. Investigation Assessment was not provided. The reporter stated that she doesn't know if what she experienced is a side effect of the vaccine but she was told to call and report any possible side effects. Also stated that both of her girls are 15 years old, and when they got their Pfizer Covid 19 vaccines they both got swelling and pain at the injection site, but one of them has started to feel a stabbing pain. Verified that both girls are 15. Stated, she thought the vaccine was FDA approved for kids? Declined to provide mailing address or email address. Caller stated she thought that Comirnaty is already FDA approved for children. Caller asked if the vaccine is FDA approved for adults. Caller also asked what EUA means. She also enquired "what was Pfizer's statement about vaccine mandates?" Caller stated she doesn't understand why at school at news they require children to be vaccinated in order to be attending in person. She also stated it's confusing why it's mandated even if the vaccine is not yet FDA approved for children. Caller said there's still lot of things not known which makes it upsetting.  Follow-up attempts are completed. No further information is expected.
Severe and almost debilitating fatigue. Almost wrecked falling asleep while driving to and from work, falling asleep while sitting at the computer, slept for over 14 hours for 3 straight nights, difficulty waking up-sleeping through alarm. So severe that I considered going to the ER.
experiencing side effects; arm hurts; muscle ache; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (experiencing side effects), PAIN IN EXTREMITY (arm hurts), MYALGIA (muscle ache) and FATIGUE (feeling tired) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced ADVERSE DRUG REACTION (experiencing side effects), PAIN IN EXTREMITY (arm hurts), MYALGIA (muscle ache) and FATIGUE (feeling tired). At the time of the report, ADVERSE DRUG REACTION (experiencing side effects), PAIN IN EXTREMITY (arm hurts), MYALGIA (muscle ache) and FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recvd vax 7NOV93 & 17NOV93 devel tenderness & swelling in the axilla area; @ the time of the report, the swelling persisted; No further details were provided;
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 19-Apr-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
left arm rash, red, blotchy spots at injection and warm to the touch; injection site on the left arm was swollen; left arm rash, red, blotchy spots at injection and warm to the touch; left arm rash, red, blotchy spots at injection and warm to the touch; soreness that went away 2 to 3 day later; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness that went away 2 to 3 day later), VACCINATION SITE WARMTH (left arm rash, red, blotchy spots at injection and warm to the touch), VACCINATION SITE SWELLING (injection site on the left arm was swollen), VACCINATION SITE RASH (left arm rash, red, blotchy spots at injection and warm to the touch) and VACCINATION SITE ERYTHEMA (left arm rash, red, blotchy spots at injection and warm to the touch) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness that went away 2 to 3 day later). On 12-Apr-2021, the patient experienced VACCINATION SITE WARMTH (left arm rash, red, blotchy spots at injection and warm to the touch), VACCINATION SITE SWELLING (injection site on the left arm was swollen), VACCINATION SITE RASH (left arm rash, red, blotchy spots at injection and warm to the touch) and VACCINATION SITE ERYTHEMA (left arm rash, red, blotchy spots at injection and warm to the touch). The patient was treated with HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) ongoing from 12-Apr-2021 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness that went away 2 to 3 day later) had resolved and VACCINATION SITE WARMTH (left arm rash, red, blotchy spots at injection and warm to the touch), VACCINATION SITE SWELLING (injection site on the left arm was swollen), VACCINATION SITE RASH (left arm rash, red, blotchy spots at injection and warm to the touch) and VACCINATION SITE ERYTHEMA (left arm rash, red, blotchy spots at injection and warm to the touch) outcome was unknown.        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.   Patient stated that pharmacist recommended Benadryl for the symptoms which she has not started. Patient also used cold pack as a part of treatment.  No concomitant medication information was provided.
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 04Jan2021 (Lot number: EK9231) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seizure disorder", start date: 2014 (ongoing); "reflux", start date: 2003 (unspecified if ongoing); "hypothyroidism", start date: 1989 (unspecified if ongoing); "arnold chiari malformation", start date: 1990 (ongoing); "hydrocephalus" (unspecified if ongoing); "hydromyelia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "cervical fusion" (unspecified if ongoing); "latex allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID (ongoing); PROZAC (ongoing); OMEPRAZOLE (ongoing); VIMPAT, start date: 14Oct2020 (ongoing); LAMOTRIGINE (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
muscle soreness at injection site; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) at the age of 36 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "muscle soreness at injection site"; FATIGUE (non-serious) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional information: The patient had no COVID prior vaccination and was not covid tested post vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.