chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had two (2) menstrual full periods (30May2021 and 30Aug2021) since her first and second dose of COVID vaccine.; period with only cramps; a small spot of blood on one day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 (Lot number: EW0182) at the age of 14 years as dose 1, single and administered in arm left, administration date 16Jun2021 (Lot number: EW0176) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSMENORRHOEA (non-serious) with onset Oct2021, outcome "unknown", described as "period with only cramps"; INTERMENSTRUAL BLEEDING (non-serious) with onset Oct2021, outcome "unknown", described as "a small spot of blood on one day"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "had two (2) menstrual full periods (30May2021 and 30Aug2021) since her first and second dose of COVID vaccine. ". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: My 14 year old daughter has only had two (2) menstrual full periods (30May2021 and 30Aug2021) since her first and second dose of COVID vaccine. Had 1 period with only cramps and a small spot of blood on one day in Oct2021. This is very concerning. Spoken with practitioner about our concerns. She had been fairly regular since onset in 2019. No covid prior vaccination. Patient tested for COVID post vaccination.no other medications has been taken in two weeks. No other vaccine administered in four weeks. No known allergies.  No follow-up attempts are possible. No further information is expected.
LOCALIZED ALLERGIC REACTION REDNESS SWELLING AND EXTREME PAIN EXTENDING ABOUT 3 INCHES BEYOND INJECTION SITE.  LIGHTER REDNESS ON MOST OF THE BACK OF UPPER LEFT ARM
Large knot, red, raised and itchy.  10 hours after injection, current 11/14/2021
arm became sore at the injection site; Fever; Body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2018, the patient received the 1st dose of Shingrix. In September 2018, several hours after receiving Shingrix, the patient experienced injection site pain, fever and general body pain. On an unknown date, the outcome of the injection site pain, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown arm. The reporter indicated that a couple of hours after receiving the Shingrix vaccine her arm became sore at the injection site that lasted for three days. She also started with a fever around that same day of vaccination. She woke up during the night that same night with body aches. These symptoms lasted for a couple of days. For tolerance to 2nd dose, refer case US2019071195.
covid test result: Positive; covid test result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 (Lot number: EL3247) at the age of 35 years as dose 2, single and administered in arm left, administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: NITROFURANTOIN; AMLODIPINE; VITAMIN D3; VYVANSE. Past drug history included: Bactrim, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Dec2021 23:00, outcome "recovered" and all described as "covid test result: Positive". The patient underwent the following laboratory tests and procedures: body temperature: (19Dec2021) 101.0; Antigen (nasal swab): (Nov2021) negative, (20Dec2021) positive, and (22Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. It was reported that patient had fever 101.0 and chills >48 hours, severe night sweats - First 3 nights congestion - 3 days on 19Dec2021 11:00PM. The patient also received the third dose of bnt162b2 on 20Dec2021 administered in left arm (lot number: EL3197).
It started out like a cold in my chest first. It moved up to my head and it was vey hard to breath. On 06/21/2022 I took a COVID-19 test and it was positive. About the end of the week on a Friday, 06/24/2022, I called my doctor and they prescribed an albuterol inhaler. I had a severe cough and a lot of clear fluid drainage that went into my chest. My chest felt very tight. The inhaler has helped but I am still sick. I still have drainage and my head is still stuffy, it feels like a bad cold.
Welt; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Welt) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Welt). At the time of the report, URTICARIA (Welt) 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.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter
PATIENT COMPLAINED OF SORES IN HER NOSE AFTER H1N1 NASAL SPRAY.
Pt recv vax on 11/11/98; on same day pt exp unconsolable crying
This spontaneous report as received from a registered pharmacist refers that unspecified number of doses of M-M-R II (lot# not reported) that reached 69F for 18 hours may have been administered to the patient on an unspecified date. No adverse event was reported. Additional information has been requested.
Pt experienced loss of balance after vaccine, after progression of symptoms was diagnosed with progressive multifocal leukoencephalopathy, JC Virus, Pt expired Jan 3, 2023.
Pharmacy technician prepared and administered Moderna booster past the BUD for the vaccine. The vial used was from 12/16 and should have been claimed and put in hazardous waste bin per policy. The pharmacy technician bypassed the double check of prepared vaccine per pharmacy policy.
high dose; A "high dose J&J shot" on 20MAR2021 followed by a "high dose Moderna shot"; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (high dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A "high dose J&J shot" on 20MAR2021 followed by a "high dose Moderna shot") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J shot on 20-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J shot. Concurrent medical conditions included Immunocompromised.    On 03-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (high dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A "high dose J&J shot" on 20MAR2021 followed by a "high dose Moderna shot"). At the time of the report, ACCIDENTAL OVERDOSE (high dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A "high dose J&J shot" on 20MAR2021 followed by a "high dose Moderna shot") outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Delayed lower leg rash on both legs - more on the right.  Very itchy.  Still continues to be uncomfortable on the lower right leg with flare ups every day since.  The bumps have not gone away on both legs.  No treatment recommended by the CDC - should go away on its own.
Hemophagocytic lymphohistiocytosis; This is a literature report for the following literature source(s):   A 52 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Viral syndrome" (unspecified if ongoing), notes: for 4 months; "Malaise" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (death, medically significant), outcome "fatal", described as "Hemophagocytic lymphohistiocytosis". Symptom onset after vaccination was 1 day after 1st vaccination. HLH-2004 diagnostic criteria included: fever (greater than or equals to 38.3 Centigrade); splenomegaly; ferritin greater than or equals to 500 ug/L; hypertriglyceridemia and/or hypofibrinogenemia (fasting triglycerides greater than or equals to 265 mg/dL, fibrinogen less than 1.5 g/L); hemophagocytosis in bone marrow or spleen or lymph nodes; soluble CD25 (soluble IL-2 receptor) greater than or equals to 2400 U/mL. The patient underwent the following laboratory tests and procedures: blood fibrinogen: less than 1.5 g/L; blood triglycerides: greater than or equals to 265 mg/dL; body temperature: greater than or equals to 38.3 centigrade; il-2 receptor assay: greater than or equals to 2400 IU/mL; serum ferritin: greater than or equals to 500 ug/L; H-score: 239. Therapeutic measures were taken as a result of haemophagocytic lymphohistiocytosis which included Dexamethasone, etoposide. The patient date of death was unknown. The reported cause of death was febrile neutropenia, bacteroides bacteraemia, haemophagocytic lymphohistiocytosis. It was not reported if an autopsy was performed.; Sender's Comments: Based on the information currently available and currently known drug safety profile, the reported event more likely represent intercurrent illness, but not related to BNT162B2.; Reported Cause(s) of Death: Neutropenic fever; Bacteroides bacteremia; Hemophagocytic lymphohistiocytosis
This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not provided). Concomitant medications were not reported. On an unknown date, the patient experienced unspecified exacerbation of multiple sclerosis subsequently following administration of ZOSTAVAX and the patient also gained an unspecified amount of weight since receiving ZOSTAVAX. The outcome of the reported events were unknown. The patient sought medical attention. Additional information has been requested.
Received vaccine on Thursday, 1-21-10 at rehab, went to living facility and on Saturday, 1-23-10, nausea and diarrhea, on Tues, 1-26-10, acne type breakout of rash on face. (Forehead & left cheek).
Rapid heart beating, irregular and lasted 3 weeks. Myocarditis continuing still on occasion. Never had these problems before
Developed a low grade fever that lasted from 10/1/2021 - 10 21/2021. Fever responded to Acetaminophen most of the time. During fevers i had a headache, brain fog, mid sternal chest pressure band across my chest, extreme fatigue. A COVID test on 10/3/2021 was negative. An exam and COVID test at Health Clinic on 10/10/2021 was negative. Dr. visit on 10/12/2021 diagnosis was Viral Syndrome and lab work showed an elevated Sed. Rate. Placed on antibiotic, I believe Azithromycin, for 5 days starting 10/18/2021 and on Saturday 10/23/2021 woke up symptom free with no further symptoms.
This spontaneous report as received from a pharmacist refers to a 64 years old female patient with drug allergies to sulfa and cephalosporin. The patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot # 671662/1160AA, expiration date 18-OCT-2012) on 19-JUL-2012. In July 2012 the patient experienced redness around injection site after receiving ZOSTAVAX. The patient sought for medical attention via speaking to the pharmacist. No treatment was given. The outcome was unknown. Additional information is not expected.
9:10 am - After client received his 2nd dose of the Moderna vaccine he began complaining of tingling and itching in his hands and feet, feeling light-headed and dizzy and shaking .Client became red and flushed, he was  wheeled to the stretcher were he was advised to lay down.  BP-144/83; P-62 ,wife was at his side. 9:45am -Bp-160/102 ;P-57  Client still complaining  of feeling dizzy, throat itchy ,client was asked to remain on stretcher a little longer 10:00 am BP checked again 156/104 ;P-61 ,client feeling better no further complaints of dizziness. Client was advised to follow-up with primary care MD if he continued having mild  reactions and to call 911 if he began   experiencing chest pains ,difficulty breathing  or any other severe reactions. Client released with his wife and 2 other family members.
reconstituted with Saline water and administered; reconstituted with Saline water and administered; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On 12th October 2021, the patient received Hiberix. On 12th October 2021, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not provided. The reporter was aware of Hiberix is a solution for injection supplied as a single-dose vial of lyophilized vaccine to be reconstituted with the accompanying vial of saline diluent. However, the powder was reconstituted with Saline water and the vaccine was administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have patient information neither lot number/expiration date available in that moment. The reporter consented to follow up.
No more Arthritis after the 2nd dose; arm sore; tired; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (No more Arthritis after the 2nd dose), PAIN IN EXTREMITY (arm sore) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease. Concurrent medical conditions included Arthritis.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (No more Arthritis after the 2nd dose), PAIN IN EXTREMITY (arm sore) and FATIGUE (tired). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (No more Arthritis after the 2nd dose), PAIN IN EXTREMITY (arm sore) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, White blood cell count: low (Low) Patient's white blood cell count was slightly low..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Treatment information was not provided.   This case was linked to MOD-2021-090656 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received on 07-JUL-2021, medical history added.
Pain in arm grew, and encountered body aches & heighten back pain (had some over previous days).  Restless sleep. In morning I was overcome with sweats, and was ?sick? with all these symptoms most the rest of the day ? despite taking it easy and taking Tylenol   After an early dinner Friday evening, I went to bed for the next 12 hours,  Though I woke up a few times all sweaty during that stretch, by morning I was feeling pretty normal.  So, I figure my body was under duress for  30-33 hours.  Although I didn?t feel real bad for some 12 hours after injection, I did encounter some indigestion starting a few hours after the shot.
3 year old male brought in by his mother with acute onset of vomiting and fever to 104 @ 4am 7/14/09. Recieved Hepatitis A vaccine 7/13/09. Has had a decreased appetite but has been drinking milk. Advised tylenol or motrin as needed for fever. If vomiting persists and is unable to keep fluids down or if fever persists, advised to call or seek urgent medical attention.
pt c/o red, swollen area where inj was given;pt was prescribed meds;
Received H1N1 vaccine injection immediately felt dizzy & shaky fell to floor from a sitting position. Patient crying & upset Vital signs normal no mental status changes. given juice as patent had no eaten breakfast. Observed by a nurse for 1 hour and symptoms resolved and returned to class.
Day 1 11/10/22 - 104.6 fever, severe chills, severe body aches (even skin hurt)   Started Tylenol 500mg 2 every 6 hours. Day 2 11/11/22 - 102 fever, severe chills, body aches (even skin hurt) Day 3 11/22/22 - No fever Just weak from last two days
Reported 12/13 dizziness and headache.  Took BP and was elevated.  Reports SOB also at that time.  Continues to have problems today since 12/13.  BP 166/100, no SOB noted.  Leaving here to go to ER.
pt recv vax & the next day devel pain in the neck radiating to the shoulder; some swelling of the upper back lt shoulder was noted; pt was treated w/ASA & DPH q 4 hr as needed;
A report was received from a regulatory authority on 11/18/02, concerning a 31 year old male vaccinee who experienced headache, collapse, and neck pain which were considered to be medically significant, 2 minutes after receiving the Fluvirin vaccine on 10/11/02. The patient had no known allergies and no known previous adverse reactions. On 10/11/02, the vaccinee collapsed within 2 minutes of receiving the Fluvirin vaccine and injured himself in a fall. Since then, the vaccinee has had persistent occipital headaches and some pain on moving his neck, especially rotation to the right. He had a week off work and has received treatment with non-steroidal anti-inflamamatory drugs. The headaches and the pain on movement have considerably improved. There was insufficient information to determine the reporter's causality assessment.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live,full term birth) on 17-Apr-2015. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 14-Jan-2020 to an unknown date, ACETYLSALICYLIC ACID (BABY ASPIRIN) from 14-Jan-2020 to an unknown date, FOLIC ACID from 14-Jan-2021 to an unknown date, ASCORBIC ACID, CALCIUM, COLECALCIFEROL, MAGNESIUM (CAL-C-MAG WITH VIT D) from 14-Jan-2020 to an unknown date and SERTRALINE HYDROCHLORIDE (ZOLOFT) from 14-Feb-2021 to an unknown date for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 31-May-2020 and the estimated date of delivery was 07-Mar-2021. On 08-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy.  On 08-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jun-2020, Pregnancy test: positive positive (Positive) positive. In 2021, Ultrasound foetal: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Internal review on 27-JUL-2021 resulted in update of Lab data, medical history, Number of fetus, Gravida, para, Birth type and fetal outcome. On 23-Feb-2021: significant additional information updated.
At 2 months old patient received vaccines (routine) PEDIARIX, Hib, PREVNAR, Rotavirus - 4/21/08. On 4/22/08 mom noted bloody stools and cramping. Since that time, although less, continues to have hematochezia.4/28/09-records received-office visit 4/23/08-C/O blood in stool, day prior stool green. Fussy. Feeding well on breast milk. Assessment:hematochezia. 5/16/08-diarrhea times 10 days. Assessment:diarrhea. 6/5/08-rash over body in different areas. Assessment: eczema/seb. 6/14/08-bloody mucous stools for past month.  6/14/08-blood streaked stools since age 2 months, gets fussy due to gas. Assessment: food induced enterocolitis syndrome.
Began to feel really cold; Muscle pains; Joint pains; Throbbing headache; Fever of 101.7F; Shivering chills; Second dose of BNT162b2 was given 17 days after 1st dose; This is a spontaneous report from a contactable physician, the patient. A 27-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Jan2021 11:15 AM (at the age of 27-years) as a single dose (Lot Number EK9231) for COVID-19 immunization. Medical history included asthma and no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 via an unspecified route of administration in the left arm on 18Dec2020 12:00 PM (at the age of 27-years) as a single dose (Lot Number EH9899) for COVID-19 immunization. The patient had not received any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 04Jan2021, approximately 10-12 hours after 2nd dose of vaccine the patient began to feel really cold, had some mild muscle pains, joint pains, and a headache. Overnight these symptoms worsened to severe muscle pains, joint pains, and a throbbing headache, shivering chills, took a temperature and had a fever of 101.7F. These symptoms did not subside until late the next morning. The headache had persisted. The patient reported taking paracetamol (TYLENOL) 1000 mg, which helped. The outcome of the events feels really cold, muscle pains, joint pains, throbbing headache, shivering chills, fever of 101.7F, were reported as recovering.
REDNESS AND SWELLING AT INJECTION SITE.TREATED FOR MILD CELLIUTIS WITH KEFLEX AND PREDNISONE(40 mg).
Pain in shoulder night of, next morning-headache, shivering, fatigue, light fever, ringing in ears, diarrhea.
Significant erythema, swelling, and tenderness 5cm x 3cm at left interior thigh. The hospital discharge summary states, "cellulitis."