chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the authors in literature articles. This was a a retrospective, observational cohort study using administrative and healthcare data from the Vaccine Safety Datalink (VSD), a collaborative effort between the Centers for Disease Control and Prevention's Immunization Safety Office and several large health systems. The objective was to evaluate whether HPV vaccination during pregnancy or peri-conception was associated with increased risks for adverse obstetric events, adverse birth outcomes or birth defects. The cohort consisted of insured women 11-27 years old with singleton pregnancies ending in a live birth from 01-JAN-2007 through 30-SEP-2013. Women receiving the quadrivalent HPV vaccine (4vHPV) vaccine (manufacturer unknown) during pregnancy or in the peri-conception period were classified as exposed. Controls were women with singleton pregnancies and a live birth during the same period who received 4vHPV 4-18 months prior to pregnancy start or last menstrual period (LMP). Risks of gestational diabetes, hypertensive disorders of pregnancy, chorioamnionitis, preterm birth (<37 weeks' gestation), small for gestational age (SGA) birth and major structural birth defects in offspring were evaluated. Using a generalized estimating equation method the authors evaluated adjusted relative risks associated with receipt of 4vHPV vaccine (manufacturer unknown) during pregnancy, the peri-conception period, and risks for both periods combined. 720 women who received the 4vHPV vaccine peri-conception (MARRS# 1701USA001368) and 638 who received the vaccine during pregnancy (exposure during pregnancy) were compared to 8196 with distal 4vHPV exposures. Vaccination with 4vHPV was not associated with an increased risk of adverse obstetric events, birth outcomes, or major structural birth defects during any of the exposure periods as compared to controls. In this cohort of insured adolescent and young adult women, inadvertent administration of the 4vHPV vaccine (manufacturer unknown) during pregnancy or peri-conception was not associated with adverse maternal or infant outcomes. This study provided needed data for providers and expectant mothers on the safety of 4vHPV vaccine, when inadvertently administered in pregnancy. Out of 638 patients exposed to 4vHPV vaccine (manufacturer unknown) during pregnancy, total number of doses (including the dose during pregnancy) was 1 in 273 patient, 2 in 191 patients and 3 or more in 174 patients. 542 patients exposed to 4vHPV vaccine (manufacturer unknown) during pregnancy were included in analysis for major birth defects. Out of 542 patients, 10 gave birth to children with major birth defects: gastroschisis or omphalocele (1 child), cleft lip or cleft palate (2 children), congenital hydronephrosis (3 children), ear defect (1 child), microcephalus and hypospadias (1 child), cardiac defects (2 children) (this report). The fetal outcome in remaining 628 pregnancies (captured in MARRS# 1701USA010441) was not provided. This report is cross-referenced with MARRS# 1701USA001368 and MARRS# 1701USA010441.; Sender's Comments: US-009507513-1701USA001368: US-009507513-1701USA010441.
This spontaneous report as received from a pharmacist refers to a male patient (unknown age) with medical history and drug allergies unspecified by the reporter. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot # and exp date not reported) (dose, frequency, route and indication unknown). No other co-suspects were reported. Concomitant medication was not reported. The pharmacist was informed by the physician that an unspecified patient experienced an allergic reaction, hives to an unspecified product. The patient had received ZOSTAVAX three weeks prior to developing the allergic reaction. The patient sought unspecified medical attention. The outcome of the patient experienced an allergic reaction was unknown. Additional information has been requested.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-395985 (Patient Link).
She got her vaccine, was doing fine, and then on 4/20/22 she woke up and she was not having any energy, had radiation of electric feeling on both sides of her forehead down her face, both of her ears, down her shoulder blades and down to her feet.  She was trying to figure out what was happening.  She just did not feel right, and described how she felt.  She was feeling tired, exhausted.  These symptoms lasted for about 5 minutes, but was still tired and weak.  This feeling continued for about 2-3 days, which she felt was a AE to the vaccine.  She rested for at least a week and then she started slowly getting her energy back and feeling better.  She went to her doctor and told him about it, who said that it was strange.  He did not know if this was a reaction to the vaccine.   She continues with a slow walk like a "little old lady", and said that something is not right.
Vesicular rash in L 1 dermatome associated with diarrhea and nausea. Oncology patient Leukemia in remission year 4.
Symptoms immediately started on Sunday, June 20, 2021.  These effects are exactly like Walking Pneumonia: fever, headache, muscle & bone aches, no appetite (have not eaten a full meal since that Sunday), no bowel movement, 18 hours of sleep per day, with constant run on nightmares that make me feel as if I am going insane.  I have no mental health issues whatsoever.  I will not drive since my brain is clouded.  This is affecting my school time since I cannot focus because of this vaccine.  I will not lose earning my degree over experiment.
Seen in office yesterday 4/13/20 for her 4 year well visit. Received Kinrix only (had already received MMRV). Developed fever to 103 at 4AM this morning (4/14/20), which came down with Tylenol. fever returned around 8:15AM to 1025. one episode of emesis. Temp at 1pm virtual office visit was 99-101 using mom's thermometer.
Patient presented with redness, swelling, and itching at injections site.  Pt was given antibiotics for treatment.
Menstrual cycle abnormalities - no stop bleeding since first shot, became significantly worse with second shot. 2 months have passed and I still have excessive menstrual bleeding and very large menstrual blood clots.
Tinnitius - After receiving Pfizer Booster, ringing in the ears developed.  Ringing in the ear is disrupting my sleep.  Using a sound machine (white noise) to help.
pt recv vax 6JAN & 8JAN started to notice numbness & small amounts of weakness in lt 4th-5th digit; mostly numb along C8 nerve distribution;has been there about a month @ times feeling nl;
Redness, soreness, swelling, itching to Rt Arm at injection site.
Patient reports that 2 weeks after receiving the Moderna booster he developed rash on both hands. Significant eczematous changes and some vascular changes were present (decreased capillary refill, cool extremities, etc). He went to ER and there was suspicion for a systemic vasculitis. He was started on steroids and referred to rheumatology. I have been caring for him for the past 5 months. He does not have a systemic vasculitis. He does have extremely dry skin on both hands. He is improving with topical steroids and will soon be off of systemic steroids.
reports to weird rashes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (reports to weird rashes) 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 RASH (reports to weird rashes). At the time of the report, RASH (reports to weird rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were reported.
Low grade fever; chills; Wiped out; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), CHILLS (chills) and FATIGUE (Wiped out) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Achalasia (Autoimmune disorder of esophagus.) and Swallowing disorder. Concomitant products included TRAZODONE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever), CHILLS (chills) and FATIGUE (Wiped out). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (Low grade fever), CHILLS (chills) and FATIGUE (Wiped out) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-393447, MOD-2021-391917.
Patient received vaccination without incident, although she now states that her arm hurt from the vaccination. She presented at the Pharmacy on 11/27 stating that she had just come from her MD office and that she is still having difficulty raising her arm and her MD thought the vaccination may have hit a tendon. They prescribed 5 day course of prednisone for the inflammation that may be causing the pain.
Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL had a fainting episode. The patient had visited the office. At the time of the report, the patient's outcome was unknown. No further information is available.
Itchy and tender rash about 1 inch below vaccination site. Rash about 1 inch in diameter
COVID-19 Infection after my booster the next month following. It was very mild. It was similar to having a mild flu without any temperature or fever. My left arm from the the shoulder to the fingertips it feels like my arm is vibrating. It does hurt and it feels very achy.  I have been to a neurologist and they cleared me for neuropathy. I went to the cardiologist and they were unable to diagnose me as well. They said that there is not heart condition. As of now I have not had any tests done. There are new health events that I don't believe are related to the vaccine. I am taking physical therapy for my left leg. My hand is currently not shaking, but it is aching and painful.  I have also been having some issues with my eyes. I have cataracts that have been recently found in my right eye.
PATIENT WAS VACCINATED OUTSIDE OF GUIDELINES - VACCINATED AT AGE 17.  MODERNA IS LICENSED FOR AGES 18 AND OLDER.
Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Unbareable Headache that pain relievers  will not help; Continues eye twitching; Exteremly tired; 102.5 Fever that doesn't want to come down; Body Aches; This is a spontaneous report from a non-contactable nurse (patient).   This female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B for COVID-19 immunization and experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers will not help, continues eye twitching, extremely tired. After second shot, on an unspecified date the patient also experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers will not help, continues eye twitching, extremely tired, 102.5 fever that doesn't want to come down and body aches. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
according to materanl & paternal grandmothers stated pt devel hives & fever about 3 mins p/vax; pt was taken to ER;
Metallic taste in the mouth, tingling of the mouth, nausea. Refused evaluation from EMS,  cleared by medic on site.
This spontaneous report as received from a pharmacist refers to a 67 year old female patient with allergy. On 16-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot# J003483, exp 29-JUN-2014, 0.65 ml, once, subcutaneous in the left deltoid area). On 17-OCT-2013, patient began to develop a reddened welt at her injection site. The patient reported that, though the pain and swelling seem to be subsiding, the area of redness was "radiating in a wider area" and the area is beginning to itch. The pharmacist had not observed the patient's injection site, so he did not know if she was developing a rash. The patient sought medical attention and no treatment was given. The outcome of the adverse events was reported as not recovered. Additional information has been requested.
Within several hours my arm began getting really sore and I became extremely tired. I laid down for a nap in the recliner. I awoke 2 hours later (around 9:30 p.m.) with the whole left side of my body temporarily paralyzed. The whole side felt heavy/sore like my arm - almost as if the vaccine had spread down my side. It really scared me because I initially couldn't move. I finally worked my way into a sitting position, then stood up and walked it off, then was fine. No more problems with it. Just today (2/27) I am starting to feel better as far as fatigue and soreness and nausea go. No more paralysis.
3"x4" red, swollen area on rt deltoid @ inj site;started 14JUL98;pt took Ibuprofen;
Site: Pain at Injection Site-Severe, Systemic: sore arm-Severe, Additional Details: pt reported a sore arm after injection and friday thru weekend she felt unable to more arm without difficulty. pt called her md who advised her "to give it a few days" and check back with office if still bothering her
tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received first dose, then tested positive for covid, wants to know if getting second dose is appropriate. The outcome of the events was unknown.  No follow-up attempts are possible; no further information is expected.
Headache, chills, 103 fever, arm pain. Fever lasted over 24 hours.
Went to Urgent Care over the weekend for temperature, swollen lymph nodes on back of head/neck. On 5/1/06, pt had a red rash (pin wheel dots) on trunk and spreading. No fever. Mom states it is a reaction to the MMR or Varicella vaccine that pt received on 4/18/06. (Went to Urgent Care not the ER).
has a Patient who received her first covax and had tongue swelling.; This is a spontaneous report received from a Pfizer sponsored program  support. A contactable pharmacist reported for a female patient. An unspecified age of female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on unspecified date (Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date the patient experienced that patient who received her first  and had tongue swelling. Reporter is asking what the patient should do for the second. Provided number and transferred to medical information, hold que. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME ACUTE PULMONARY EMBOLISM
Mother states a couple hours after I administered Rotateq at 11:30 am patient broke out in a raised rash on chest and face. Mother took him to emergency room and was told by ER doctor that it was some type of allergic reaction not sure from Rotateq. Instructed to give Benadryl. No other symptoms. Patient had received Rotarix on 02/02/2010. I talked to mom on 04/22/2010 and she said it was improved by evening and today it was much improved.
a small amount of the vaccine leaked out; a small amount of the vaccine leaked out; This is a spontaneous report from a contactable other hcp (Nurse). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a small amount of the vaccine leaked out. The reporter stated that they had a patient who while he was receiving the second dose of his Pfizer COVID 19 vaccination a small amount of the vaccine leaked out. She states that they followed the agency recommendations on if it was estimated to be less then half of the vaccine dose, not to revaccinate. This patient is concerned that he is not fully protected since some of the vaccination leaked out.   Information on the batch number has been requested.
severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and otherareas of her body; chills; sweats; shingles; severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and otherareas of her body; severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and otherareas of her body; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On 13-JUL-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), in September 2016, patient suffered debilitating injuries including internal shingles, severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and other areas of her body, as well as chills and sweats. These symptoms greatly diminished her quality of life and ability to function. These symptoms lasted for months and resulted in several hospitalizations including the administration of many tests and medications including valacyclovir hydrochloride (VALTREX). The cause of these injuries was never determined by her healthcare providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and caused by the zoster vaccine live (ZOSTAVAX). As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and debilitating personal injuries and suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Internal shingles, severe and debilitating nerve, muscle and joint pain over her entire body including, but not limited to, her spine, flank, extremities and other areas of her body, chills and sweats were considered to be disabling.  Additional information has been requested.
consumer answered yes when asked if they experienced any side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects). At the time of the report, VACCINATION COMPLICATION (consumer answered yes when asked if they experienced any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were provided.   Reporter did not allow further contact
Pt recv vax on 3/18/98; on 3/19/98 pt exp respiratory problems.  Pt saw allergist; advised allergy tests.
She denies any further AE/PQC; patient has received the supported vaccine prior to temperature excursion evaluation; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 23-DEC-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot # T017688, expiration date 21-MAY-2022 (route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine was stored in the temperature of - 6.7 degrees Celsius for 22 hours.  There were no previous temperature excursions reported. The improper storage was recorded by digital data logger. There was no additional adverse event reported.; Sender's Comments:  US-009507513-2012USA013037:
Patient became very lethargic, feverish at 6 PM 10/15/12 - and left leg painful to touch, wouldn't stand on it. Slept for 14 hrs. - presents with fever, lethargy and leg pain.
Patient came to the pharmacy today, 12/21 stating that she received her booster shot last week and that since that day, a rash formed.  When asked if she had treated the rash with anything, she said she used benadryl cream and this made it worse. The patient showed me the rash and said that it was also holding heat.  There seemed to be a small rash, but it was honestly hard to tell. Since the patient had used benadryl cream already, I suggested seeing her primary doctor to see if he could call her in a steroid of some sort or give her something else for treatment