chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever started. 4:30AM - fever so high I thought I could fry an egg on the tops of my thighs; chills began as I got into bed; quite cold and shaky; quite cold and shaky; Heart rate hit 100 just lying in bed; lethargy; headache; feeling slightly tired but functional; Sweaty all day; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EP7534, second dose) solution for injection intramuscular in the left arm on 20Mar2021 at 08:15 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history dyshidrotic eczema, rosacea, severe seasonal allergies (grass, tree pollen, etc), oral allergy syndrome ((raw tree-based foods, sensitive to nickel, sensitive to some nuts (almonds)), cholesterol tends to be high but is managed and sensitive to nickel. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), biotin, polycarbophil calcium (FIBER) and FLO PMS vitamin. Historical vaccine included BNT162B2 (first dose, lot EN6198, administration time 08:15AM, vaccination location: left arm) for COVID-19 vaccination on 27Feb2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Mar2021 at 23:30, the patient had fever started, chills began as got into bed, quite cold and shaky, heart rate hit 100 just lying in bed, lethargy, headache, feeling slightly tired but functional. On 20Mar2021, the patient was sweaty all day. At 4:30AM on 21Mar2021, the fever so high I thought I could fry an egg on the tops of my thighs. Lab tests included BMI of 32 at time of shot (2021). Cholesterol tends to be high but was managed on an unknown date. There was no treatment for the events fever, chills, coldness, shaky, heart rate increased, lethargy, headache, sweaty, and tiredness. The outcome of the events fever, chills, coldness, shaky, heart rate increased, lethargy, headache, sweaty, and tiredness was recovered on 23Mar2021. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up needed; further information has been requested.
Had flu shot on late afternoon Oct 7 - a few hives began appearing on Sat & were full blown from head to toe Sat. Sun Mon - went to Dr on 10/11/10 steroids & BENADRYL 2 more days of hives then went away.
On day 8 injection site began to itch. Developed into hive like area covering entire upper arm expanding down to about 1 inch above the elbow. As of today (2/2) still slightly itchy . Redness and inflammation subsiding. At the same time , lasting 2-3 days, I developed a headache, body wide muscle and joint pain  and chills (but no fever).
3 days after vaccine i noticed painful bloating and unable to enjoy daily life. this went on and pain increased in my right abdomen, stabbing pain then started in my left abdomen it became hard to move after eating a small meal. i would cry and grab my abdomen. flank pain started to occur i assumed it was my kidney i went in and out of the hospital. stayed a night on two occasions. nobody could figure it out. finally found a gi to check my stomach they scheduled a gastric emptying study that came back abnormal which means my stomach could either be partially or fully paralyzed. today its been around 4 months since i got the vaccine and im still in unbearable pain.
Per nurse a patient was given expired PNU 23 that was expired; Information has been received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 14-JUL-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot number: S034299 with expiration date on 01-JUL-2021 (dose, frequency, route of administration and anatomical location were not reported) (expired vaccine used). No other concerns or issues were noted by the nurse.  This is one of two cases received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA004708:
Fever of 100.3, muscle and joint aches/pains, extreme nausea, diarrhea,  sweats/chills
CMV infection within 45 d of COVID-19 mRNA vaccination; This is a literature report for the following literature source(s).  A 42-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bilateral lung transplant" (unspecified if ongoing), notes: Time since transplant 22 month; "Bronchiectasis" (unspecified if ongoing); "Cessation of prophylaxis mo/y before first CMV vaccine" (unspecified if ongoing); "idiopathic pulmonary fibrosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tacrolimus for immunosuppression, notes: 500 mg twice day; Mycophenolate for immunosuppression, notes: 500 mg twice day; Prednisone for immunosuppression, notes: 10 mg. Vaccination history included: Bnt162b2 (FIRST DOSE), for COVID-19 immunisation. The following information was reported: CYTOMEGALOVIRUS INFECTION (hospitalization, medically significant), 4 days after the suspect product(s) administration, outcome "unknown", described as "CMV infection within 45 d of COVID-19 mRNA vaccination". The patient underwent the following laboratory tests and procedures: Cytomegalovirus test: No; Lymphocyte count: 1, notes: Admission; Polymerase chain reaction: 15900 IU/ml, notes: highest serum; Polymerase chain reaction (normal high range 200): 42, notes: greater than; SARS-CoV-2 antibody test: negative; Transplant evaluation: 3, notes: months before first CMV  vaccine; plus minus, notes: (±); White blood cell count: 4, notes: admission. Therapeutic measures were taken as a result of cytomegalovirus infection.  Follow-up (29Jun2022): This is a literature report for the following literature source entitled. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.  updated information include : reporter information, RMH, Lab data, product coding, treatment received.; Sender's Comments: As there is limited information in the case provided, the causal association between reported the event  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200916514 original case PV202200004629;US-PFIZER INC-202200916515 original case PV202200004629;
patient received Janssen vaccine around 10:37am . After receiving the vaccine, patient is sitting on the chair and waiting for  observation. After a couple minutes later, he fainted and fell off the chair and laid on the floor.  He was sweeting but alert. Patient stay in the pharmacy for about 30-40 minutes for observation . He was fine after all
I had the flu shot about 1045 Monday 13 September feeling fine went home about 145 felt light headed lay down started to shiver & felt like I had a fever. Had temp 101.4 which broke about 1030pm that night. Still feel achy and weak. 9-22-2010.
Patient came in for vaccine with his son. During the screening, the patient's son answered all of the questions regarding the patient. The patient's son denied any previous serious reactions to medications including the components to the vaccine. Only medical condition the patient's son mentioned was hypertension. The patient was vaccinated, and appeared fine. Once he got to the waiting area, he stated, "I feel hot." His coat was removed, the manager was notified,. We gave the patient something to drink, a snack, and a cold icepack. Once the patient's condition continued to decline, vital signs were assessed. Blood pressure was 140/110, pulse oximetry was 87% on room air, and patient was placed on oxygen. I notified the manager to go grab the doctor as I was helping the patient. The doctor brought a glucometer to make sure the patient was not hypoglycemic, and the result was 117 mg/dL. At this point the patient was diaphoretic, and complaining of pain in his abdomen. He also complained of nausea. The squad was alerted, and came to get the patient. At this point the patient's pulse ox was 53% on 6L of oxygen. Patient's family was present with the patient, and the patient was then transported to the hospital via EMS.
PATIENT COMPLAINED OF ARM HAVE NOT BEEN THE SAME EVER SINCE VACCINATION AND IT'S STILL SORE ON 10/26/2015 WHEN CAME IN AND REPORT THE SORENESS. SHE CLAIMED THAT SHE COULD NOT LIFT UP HER ARM TO COMB HER HAIR.
This spontaneous report as received from a pharmacist refers to a 76 years old female patient. Patient's medical history was unspecified. No drug reactions or allergies were reported. On 28-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose: 0.65 ml, frequency and anatomical location were not provided, subcutaneously) (lot # K007548, expiration date: 23-AUG-2015). Concomitant therapies included losartan potassium (manufacturer unknown), SYNTHROID and estrogens, PREMARIN vaginal cream. In approximately 2014 also reported as "after a couple of weeks" after receiving ZOSTAVAX, the patient experienced "three outbreaks of fever blisters on her lips". The patient sought medical attention (she saw pharmacist). Acyclovir was given as treatment for adverse event. No diagnostic tests were performed. No product quality complaint (PQC) was involved. The outcome of "three outbreaks of fever blisters on her lips" was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
booster; severe fever; chills; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: FF8839) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 01Apr2021, when the patient was 30 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 10Mar2021, when the patient was 30 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "severe fever"; CHILLS (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "chills"; MYALGIA (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "muscle pain". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia.  Additional information: The most recent COVID-19 vaccine was administered at workplace clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received by the patient within 2 weeks of vaccination. Prior to vaccination the patient was not tested for COVID-19 or diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.     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 concomitant products were reported. No treatment drugs were reported  It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from 24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt.  The patient did not experience any adverse events after receiving the booster dose of vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: On 10-Feb-2022: Follow-up received contain significant information outcome of the event of product storage error and narrative updated.
102.2 fever, ache all over, headache, sore arm at injection site, minor nausea.
Pt received vaccination on Sat Oct 15 2005. Pt noticed on morning of Monday Oct 17 that the arm she received the injection in was red and warm to touch. Pt had a nurse at the doctors office she works at look at her arm. Nurse circled the reddened area in order to monitor it. No c/o itching, burning. Small hard local bump notices at area of injection site. Pt being treated for cellulitis with antibiotics.
20 post vaccination, c/o itching on left hand and palm and hives on forehead, see by MD, sats O2 97% on RA,  no meds given, given additional time for observation. Symptoms resolved, stable to DC home at 12:11.
This case was reported by a physician via call center representative and described the occurrence of fatigue in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 4th October 2018, the patient received the 1st dose of SHINGRIX. On 4th October 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 5th October 2018, the patient experienced injection site pain. On 6th October 2018, the patient experienced fatigue, headache and muscle pain. On an unknown date, the outcome of the fatigue, headache, injection site pain and muscle pain were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the fatigue, headache, injection site pain and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The batch number and expiry date were not reported. The patient received SHINGRIX at another site, which led to vaccine administered at inappropriate site. After receiving SHINGRIX, the patient experienced fatigue, severe muscle pain, headache and pain at injection site. No further information was provided.
I was feeling warm like I may have a fever, I had a slight fever. During the night I had chills, in the morning I had a slight fever, and sore throat, fatigue. My fever waxed and waned. I used a home COVID-19 test that came back positive.  I called my doctor and spoke to the Physician's Assistant, she suggested the Paxlovid but I decided against. I am feeling better but not one hundred percent.
Left arm pain that does comes and goes but I continue to experience.  I had never felt this until after the COVID vaccine.  I went to the doctor multiple times, had an abnormal ultrasound and then had to get an MRI.  After review of many medical professionals, they said everything is okay.
This spontaneous report was received from a medical assistant referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates since 07-JUL-2017, these patients were administered improperly stored ROTATEQ (lot# M034799 with expiration date 01-FEB-2018, lot# N000172 with expiration date 10-JUN-2018, lot# M043838 with expiration date 18-JUN-2018, lot# M046008 with expiration date 29-JUN-2018, oral, dose not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 47 to 77 Fahrenheit (F) for 43 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004623: US-009507513-1709USA004621: US-009507513-1708USA007735: US-009507513-1709USA004619: US-009507513-1709USA004620.
Information has been received from a physician concerning a 14 year old female who on 01-SEP-2009 was vaccinated with a dose of GARDASIL. The patient fainted after getting GARDASIL. She "fell and hit her head". She regained consciousness afterwards and was "fine". She was given MENACTRA and ADACEL. The patient seemed very nervous about getting the shot and had not eaten anything that day. On the same day, the patient recovered. The patient sought unspecified medical attention. Follow-up information received from the physician indicated that the patient was a female who on 01-SEP-2009 was vaccinated with her first dose of GARDASIL (Lot # 6599621/1740U), there were no illnesses at time of vaccination. Concomitant therapy included MENACTRA (Lot # U2905) administered on her right arm and ADACEL (Lot # UF457) administered on her left arm, both received on 01-SEP-2009. The physician reported that on 01-SEP-2009 the "child" had a vasovagal/passing out event. According to the physician the patient lied down on a table for 15 minutes and improved. No diagnostic tests were performed. No further information is available.
Woke up with a huge headache. When I got up from the bed I felt dizzy and weak. I felt like I didn't even sleep. My body was aching. I took Tylenol and also a shower to see if I felt better. I didn't feel better so I called DR and he told me to come in. I had a slight fever of 100.1. He told me to rest for a couple days and to drink lots of fluid. To keep check temp, if it gets higher to go to ER. Not to go anywhere. If fever stop for a good 24 hr. then I can go back too work. I was feeling terrible for two days. After the second day. I didn't have any of the symptoms. I felt much better.
PATIENT STATED SHE FELT LIGHTHEADED. WAS SITTING ON STOOL IN EXAM ROOM. ASKED IF SHE WANTED TO MOVE TO ROOM WITH A COUCH TO REST. ASSISTED HER 12 FT DOWN HALLWAY. SHE LEANED AGAINST THE WALL AND FAINTED. SHE WAS ASSISTED TO THE FLOOR WITHOUT INJURY. SHE WAS TURNED TO HER SIDE. AN ICE PACK WAS PLACED ON HER NECK. SHE AROUSED SPONTANEOUSLY. SHE DENIED ANY INJURIES. SHE KNEW HER NAME AND WHERE SHE WAS.  SHE WAS OFFERED WATER TO DRINK.  SHE RESTED ANOTHER 5 MINUTES, THEN MOVED TO THE COUCH. SHE WAS THEN ACCOMPANIED TO PRIVATE VEHICLE WITH GRANDMOTHER AND TWO OTHER TEENAGE SISTERS.
Developed marked local swelling, erythema, and tenderness at the site of immunization (right upper arm) accompanied by paresthesias in the right arm (later in all extremities) and a vessicle on the right shoulder presumed to be active zoster infection.
a 63 years old patient received a dose Fluzone Quadrivalent High Dose /No AE; a 63 years old patient received a 0.7 ml dose Fluzone Quadrivalent High Dose /No AE; Initial information received on 24-Nov-2020 regarding an unsolicited valid non-serious case received from a Nurse Practitioner via Medical Information (Reference number- 00370456).  This case involved 63 years old female who received a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) via an unknown route in unknown administration site on 11-Nov-2020 for prophylactic vaccination (Product administered to patient of inappropriate age and Overdose).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  This case was of an actual medication error due to inappropriate age at vaccine administration and it was a case of overdose (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Fatigue, swollen glands, swollen joints, swollen fingers, headache, dizziness, light headidness
A dark red lump developed at injection site and a large lighter red circle developed around the lump. The large red circle was raised, hot to the touch, and slightly itchy. On 10/25 the circle was 2 inches in diameter accompanied by headache, on 10/26 the circle was 3 inches in diameter, on 10/27 the circle was 4 inches in diameter. On 10/28 the circle remained the same size and continued to be raised, hot, and itchy.  On 10/30 the redness began to fade. On 11/8 there was still a small light red lump at injection side and a faint trace of the larger red circle. On 11/19 the outline of the large red circle is still visible, no other symptoms present.
pt recv vax 9APR96 & later that day pt to ER w/fever of 104 & a sz;pt was treated w/APAP & released;on 10APR96 the caller contacted the mom;stated baby was doing well;addtl info was recv 15MAY96; pt remains recovered;
My period is clotted. The clumps fall out when I'm getting into the tub and I can feel them sliding out when at work. Never had this issue before taking  that stupid shot