chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever started tues Pm 101 18JUL95; fever inc to 104 and stayed there x 4days despite tx w/Children's Motrin, APAP, sponging; third day fine rash appeared on face then spread to rest of body; fever dec to 101 all day;
The day I got the vaccine I had severe abdominal cramping.  I was laying down and twice felt discomfort to the point were I felt I needed to stand up and move around to try and alleviate the cramping despite the fact I had no energy and all my muscles felt sore. Not a huge deal.........but it has been just over a week and I am still "spotting".  I am having a bloody discharge that is not typical for me, even on a monthly basis as I have an IUD and have not had a period in many years.  This was first noticed the morning after I had the vaccine and I have no doubt it is in direct relation to the cramping and vaccine from the day before.
Bell's Palsy on right side of face developed 4/22/21.  Pt thought he was having a stroke and went to the ER.  Doctor gave him B12 to inject 2 doses.  Worsening 4/24/21 and having a lot of trouble speaking and eating/drinking.
minor swelling of fingers both hands  Narrative:  swelling occurred within first 5 minutes of observation. Clinical Assessment and vitals normal. Extended observation to 60 minutes and gave 50mg benadryl
COVID vaccine breakthrough case. Moderna 3/1/21 011A21A, 3/30/21 038K20A, and boosted 11/02/21 939905.
Pain (L) shoulder immediately. Lasted several weeks, loss of mobility. Sought treatment with PCP 1/23/17 about. MD considered it a administration issue, felt bursa was affected. Currently in physical therapy.
Pt states "all over joint pain" starting the day of vaccination, continuing overnight into next day. APAP did not help, but Aleve did. Pt states she felt better after 48 hours.
Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.; patient administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The vial was initially stored in refrigerator on 17 Feb 2022 10:00 am. The vials did not undergo any temperature excursions. It was reported that no patients have come out with adverse events. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received contains non significant information.
The patient regurgitated; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant medication was not reported.  On 09-JAN-2020, the patient was administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral route for prophylaxis (strength, dose, frequency were not reported) (lot # S004400 had been verified to be a valid number; expiration date 14-NOV-2020), and the patient regurgitated (regurgitation). The outcome of regurgitation were not reported.        The causality assessment between the vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ), and the aforementioned event was not reported.
CHILLS, BODY ACHES, FEVER, SWEATING, & FATIGUED. SHOT LOCATION, LEFT ARM, HOT, ITCHY, LUMP, & SORE ARM
Patient fainted in chair. Husband helped hold his wife in chair. Patient blacked out and when came back urinated on herself/floor. Then patient felt dizzy and put head on table. About 15 minutes later patient felt nausea and vomited. After vomiting patient felt better and left with husband and kids.
4 days after patient received her second booster, she began to have a sore neck. It radiated to her right arm. She now experiences weakness in this arm with numbness to right thumb. She received her vaccine in the left arm.
chills, diaphoresis, fatigue, fever, congestion, cough, headaches
already had her period and started having heavy bleeding 2 days after the vaccine; This is a spontaneous report from a contactable physician (patient's father). A 15-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left at age of 15 years on 13May2021 05:30 (Lot Number: EW0173) as single dose for covid-19 immunisation. Medical history reported as none. No know allergies. The patient's concomitant medications were none. No other medications the patient received within 2 weeks of vaccination, the patient did not receive any other vaccines within 4 weeks prior to the COVID. vaccine Facility where the most recent COVID-19 vaccine was administered was other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had already had her period and started having heavy bleeding 2 days after the vaccine on 15May2021. No treatment received. The outcome of the event was not recovered.   Follow up attempts are needed. Further information has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bleeding menstrual heavy  cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
rash diagnosed as pityriasis, which spread . torso, neck arms hands thighs. Then extreme fatigue, general weakness, brain fog. arthr in jointsitic symptoms this went on for six weeks, finally began to improve two weeks ago, rash almost gone except for fingers, which are still slightly swollen. I thought it might be autoimmune flare up.
No known side effects reported; a nurse gave PROQUAD and reconstituted the vaccine with normal saline instead of Merck STERILE DILUENT; gave the PROQUAD intramuscularly instead of subcutaneously in the patient's left deltoid; This spontaneous report has been received from a pharmacist referring to a 6 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  It was reported on 12-OCT-2021, a nurse at the reporter's office reconstituted the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) with sodium chloride (NORMAL SALINE) instead of our Company sterile diluent (product preparation error). Then, after reconstituted, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) (0.5 mL (1 dose); lot# T034828 has been verified to be a valid lot number and expiration date was 11-APR-2022) was given to the patient intramuscularly instead of subcutaneously in the patient's left deltoid (incorrect route of product administration) for prevention of chickenpox, measles, mumps and rubella. No known side effects were reported.
Pt had no adverse reaction. Shot was just given on day 14 and not 24 or higher.
approx 30mos p/vax pt exp chickenpox w/approx 30 lesions, fever 99.7f
Arm swollen, red, hot - has had pain since shot was given - Today is 10/4/ and pain conts I went to doctor is on CIPRO, BENADRYL + some pain meds
This literature marketed report has been received from the author of a published literature. BACKGROUND The effect of a third dose of the M-M-R II vaccine in stemming a mumps outbreak is unknown. During an outbreak among vaccinated students at the University, health officials implemented a widespread MMR vaccine campaign. The authors evaluated the effectiveness of a third dose for outbreak control and assessed for waning immunity. METHODS Of 20,496 university students who were enrolled during the 20152016 academic year, mumps was diagnosed in 259 students. The authors used Fisher's exact test to compare unadjusted attack rates according to dose status and years since receipt of the second M-M-R II vaccine dose. The authors used multivariable time-dependent Cox regression models to evaluate vaccine effectiveness, according to dose status (three vs. two doses and two vs. no doses) after adjustment for the number of years since the second dose. RESULTS Before the outbreak, 98.1% of the students had received at least two doses of M-M-R II vaccine. During the outbreak, 4783 received a third dose. The attack rate was lower among the students who had received three doses than among those who had received two doses (6.7 vs. 14.5 cases per 1000 population, P<0.001). Students had more than nine times the risk of mumps if they had received the second M-M-R II dose 13 years or more before the outbreak. At 28 days after vaccination, receipt of the third vaccine dose was associated with a 78.1% lower risk of mumps than receipt of a second dose (adjusted hazard ratio, 0.22; 95% confidence interval, 0.12 to 0.39). The vaccine effectiveness of two doses versus no doses was lower among students with more distant receipt of the second vaccine dose. This report concerned 34 patients of unknown age and gender. On unknown dates, the patients received three doses of M-M-R II (dose, route, lot# and expiration date unknown) for prophylaxis. On unknown dates, the patients experienced mumps. The outcome of the events was unknown. The authors considered the events to be related to M-M-R II. This is one of the several reports that received from the same literature article. Sender's Comments: US-009507513-1709USA014639: US-009507513-1709USA012424.
Pain, redness, and swelling immediately at injection site...and pain, redness, heat, and swelling at injection site for a week. Flu-like symptoms for two weeks ---  general muscular/joint aches and pains and exhaustion. This progressed to ear and sinus pain -- sinus pain was unlike anything I'd ever experienced. Burning in sinus cavity. Terribly painful. Went to Dr. at this point --- was prescribed antibiotics for sinus infection. Was off work for almost three weeks. Have never had an adverse reaction to a shot prior to this.
METALLIC TASTE IN MOUTH, FILM IN MOUTH, SCRATCHY THROAT, AND INCREASED HEART RATE
Tues afternoon got the shot at 3:45 pm at 9 pm my left arm started to hurt - feel like I had been hit there. Continued to hurt at night - occ woke me up. Next day (Wed) arm hurt also annoying  like some one hit me there but I went about my day. Woke up the next morning with a slight headache - took MOTRIN it was better. Had slight chills at noon. Took a nap felt better- Next day on Thurs felt like myself again no issues. The problem I had were slightly annoying - if I worked or whatever they would not have stopped me .
Patient seen in our office on 10/08/2003 for scattered papules.  Temperautre 100.8.  Diagnosis: Chicken pox.
This case was reported by a consumer (the mother of a vaccinated patient) and described the occurrence of explosive diarrhea in a 6 year old female subject (sibling of the vaccinated patient) who was exposed to ROTARIX (GlaxoSmithKline) given to her two month old sister. A physician or other health care professional has not verified this report. Concurrent vaccination received by the vaccinated child included HIB (manufacturer unspecified), DTaP (manufacturer unspecified), poliomyelitis vaccine (manufacturer unspecified) and pneumococcal vaccine (manufacturer unspecified) all given to the patient on 10 June 2011, same day as ROTARIX vaccination. There were no concurrent medications taken by the vaccinated child. On 10 June 2011 at 09:30 the vaccinated child received 1st dose of ROTARIX (oral). On 13 June 2011, 3 days after vaccination with ROTARIX, the subject (sister of vaccinated child) experienced explosive diarrhea and nausea. The reporter suspected that the live oral ROTARIX vaccine given to her child infected the "entire household" (infection via vaccinated person). At the time of reporting the events were unresolved. The vaccinated child did not experience any symptoms from vaccination with ROTARIX.
Swelling, redness, warmth at injection site, headache, general body ache.
Upper arm sore to touch for five day, 1-5. Upper arm red and warm to touch five days, 2-6. Upper arm very itchy for six days, 2-7.
tightness in chest; joint pain; headache; nausea; swollen lymph nodes; fatigue; itchy eyes; bacterial vaginosis; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Feb2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication,phentermine (PHENTERMINE) taken for an unspecified indication,metoprolol tartrate (METOPROLOL TARTRATE) taken for an unspecified indication, ascorbic acid (VIT C) taken for an unspecified indication, ergocalciferol (VIT D) taken for an unspecified indication. The patient experienced bacterial vaginosis with outcome of recovering. The patient had tightness in chest, joint pain, headache, nausea, swollen lymph nodes, fatigue, itchy eyes on 09Feb2021 with outcome of recovered.  Information on the lot/batch number has been requested.
Abdominal cramps overnight with back pain, then awoke with fever, chills, headache, significant body aches including continued back pain and fatigue. Symptoms improved the morning of 12/23
This retrospective pregnancy case described the occurrence of tongue tie in a male infant. The 17-year-old mother was a subject enrolled in an open label study. The subject received MENVEO .5 ml on 23rd March 2012. The parent's medical history included gestational diabetes mellitus (associated with pregnancy) and sebaceous cyst (not associated with pregnancy). The mother's last menstrual period was on 13th February 2012 and estimated date of delivery was 19th November 2012. The infant was exposed to MENVEO at week 5 of gestation and during the first trimester of pregnancy. The pregnancy resulted in a live neonate with a congenital anomaly. At 40 weeks and 2 days, the infant was born via unknown delivery and weighed 3260 grams (7lbs 3oz) at birth. The infant was diagnosed with echocardiography abnormal. Additional event(s) included tongue tie (serious criteria GSK medically significant and congenital anomaly) and fetal exposure during pregnancy, first trimester. The outcome of echocardiography abnormal was unknown. The outcome(s) of the additional event(s) included tongue tie (unknown) and fetal exposure during pregnancy, first trimester (unknown). It was unknown if the investigator considered the echocardiography abnormal and tongue tie to be related to MENVEO. See case US2017GSK175493 for details regarding the mother case. Additional details were provided as follows: The parent's concomitant product exposures included folic acid, FLUARIX, Influenza vaccine, prenatal vitamins, GARDASIL, ZOFRAN ODT, BENADRYL and SUBLIMAZE. The patient's mother was not diagnosed with medical conditions or maternal complications. On 23rd March 2012, the patient's mother received a dose of MENVEO (batch number 10135). On 4th June 2012, alpha 1 foetoprotein, Human chorionic gonadotropin, unconjugated estriol and Inhibin B test showed no congenital abnormality. On 28th June 2012, abdominal ultrasound showed a congenital abnormality cardiac echogenic focus noted in left ventricle measuring 2mm. A singleton male live infant (the patient in this case) was born at gestational age of 40 weeks. The pregnancy resulted in a birth defect. The birth defect was shortened frenulum of tongue not noted prior to birth. The pregnancy did not result in fetal loss. The temporal relationship with the development of this defect and the timing of the exposure to vaccine could not be ruled out for a possible association. The etiology was unknown in most cases and could be familial. The cardiac echogenic focus was not a defect as it was not a Congenital Defects Program defect. It was unknown if the shortened frenulum of tongue was attributed to vaccination or not. Other factors that might have contributed to this outcome were unknown.
Swelling and redness in arm, shortness of breath, and cough -- started ~24 hours after immunization
Information has been received from a registered nurse concerning a 7 year old white female with no known medical history or allergies who on 19-OCT-1999 was vaccinated with a first dose of Varivax (lot # "07265"). There was no illness at the time of vaccination. On 07-APR-2006 the patient developed a rash with less than 50 lesions. The patient was afebrile. The patient was seen in the office on 11-APR-2006. No laboratory diagnostic tests were performed. On 14-APR-2006 (previously reported as 11-APR-2006) the patient recovered. Additional information has been requested.
This case was reported by a pharmacist and described the occurrence of an unspecified adverse event in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. On an unspecified date several years ago the subject received unspecified dose of Engerix-B.  The pharmacist reported that "a physician mentioned to me that at an unspecified time after vaccination with Engerix B, the subject, he thinks, had a reaction to it (Engerix-B)".
DAY 1-mild headache during the day became migraine at night. Experienced chills, sweat, dizziness, fatigue, and sore arm (like tetanus). DAY 2-Migraine all day, chills, sweat, dizziness, fatigue, and sore arm. DAY 3- Migraine downgraded to functional migraine (I could open my eyes), sweat, dizziness, sore arm, fatigue, chills gone. DAY 4-headache,  painful to move arm. DAY 5-Arm still painful to use.
pt recv vax 9NOV95 & later that day devel an inj site rxn,characterized by numbness & burning;pt devel numbness from the neck down to the lower spine;approx 24 to 48hrs p/vax devel weakness in arms & had trouble lifting them;
On the evening of the day I received the vaccine, I had  fatigue and severe chills. The following day, I had severe chills still that were not improving, a headache, vomiting, muscle weakness, and slight shortness of breath. The chills started the evening of the vaccine around 6:30pm, and have not stopped. The vomiting happened the day after my vaccination at 8:30am.
Information has been received from an RN concerning an 18 year old female patient who had delivered her first child in January 2007 who on 20-OCT-2007 was vaccinated IM with a a first dose of Gardasil. Within 2 weeks she had a positive pregnancy test at another facility. Her LMP was 05-OCT-2007. Sonagrams on 14-DEC-2007 and 17-DEC-2007 did not detect a fetal heartbeat. It was reported that she "later" miscarried. Medical attention was sought in the office. Her outcome was not reported. Upon internal review, miscarriage was considered to be an other important medical event. Additional information has been requested.
Hand and arm started swelling and hurts like hell/really really hurting and fingers were swollen; Arthritis; Hand and arm started swelling and hurts like hell/really really hurting and fingers were swollen; Chickenpox settled in arm; Headache; This spontaneous case was received on 11-Nov-2021 from other non-healthcare professional (consumer) via Regulatory Authority (reference number: SEQW21-05295) and concerned a 73-year-old, female patient.  The patient's medical history and concomitant were not reported. The patient never had a reaction to a flu shot before.  On 01-Nov-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On 07-Nov-2021, six days after receiving Fluad Quadrivalent, the patient's hand and arm started swelling and hurts like hell, and she had a headache. She used Biofreeze (ilex aquifolium) and her daughter gave Cannabidiol (CBD) cream and it seemed to help. The pain was annoying, first day as reported. The patient thought possibly the vaccine or chicken pox settled in her arm, it could be arthritis or change in pressure related to weather. Pharmacist told her to go to the doctor, but she do not like to go, they did not know anything. She was taking arthritis strength Tylenol (paracetamol).  On 08-Nov-2021, the next day as reported, the pain was horrific.  On an unspecified day in Nov-2021, the patient's fingers were swollen.   At the time on initial reporting, the patient had not recovered from the events as she was still really really hurting and her fingers were swollen.  The reporter did not provide a causality assessment. The patient thought possibly the vaccine or chicken pox settled in her arm, it could be arthritis or change in pressure related to weather.   The case was assessed as non-serious.  Company comment: A 73-year-old patient developed swelling and pain in arm, arthritis, Varicella, and headache six days after receiving the suspect product Fluad Quadrivalent. Causality for the event Varicella is assessed as not related based on biological implausibility. Due to plausible chronology, causality for the rest of the events is assessed as possibly related.; Sender's Comments: A 73-year-old patient developed swelling and pain in arm, arthritis, Varicella, and headache six days after receiving the suspect product Fluad Quadrivalent. Causality for the event Varicella is assessed as not related based on biological implausibility. Due to plausible chronology, causality for the rest of the events is assessed as possibly related.
Drug ineffective; after the 1st dose, her mother tested positive with the Covid-19; This is a spontaneous report from a contactable consumer reported for mother (patient). An unspecified age female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number, expiration date: not reported), via an unspecified route of administration in Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received her first dose of the vaccine in February, around the beginning of the 2nd week. The patient did not remember the exact date but after the 1st dose, the patient tested positive with the Covid-19. but after 14 days of quarantine, her mother(patient) got tested again and came out negative. The outcome of events was recovered on an unspecified date.
Received FLUARIX vaccine at 0815. One hour later experienced intense itching, hives to arms. BENADRYL 50mg IM given & epinephrine.