chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headaches".  Additional Information: I received my Booster vaccine, I cannot get rid of these headaches. Clinical Trial Information (provide if caller indicated they are enrolled in a Pfizer Clinical Trial - remove if not applicable): not provided.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Hives within 1 hour and the next day. No other symptoms. Via photos and telephone call: Advised cetirizine or oral BENADRYL.
Myalgia menstrual irregularity Narrative:  Employee reports was due for menstrual period on 12/25/2020 and had not started it as of 12/28/2020. Reports menses is regular (28-30days) and has not been sexually active in previous 2 months. Reports feels pre-menstrual, but no menses. Reported that several other coworkers also reported menstrual irregularities after receiving COVID vaccine. Employee also experienced "severe pain 10/10" to injection site for several days (pain 10/10 on day 1, 10/10 on day 2, 5/10 on day 3). Reports took Tylenol (unknown dose/frequency) but did not feel any relief. Injection site pain has since resolved.
Information has been received from a health professional concerning a female who on 08-FEB-2007 was vaccinated intramuscularly with the first dose of Gardasil (lot # 653938/0954F). Subsequently the patient developed a rash on her arm and part of her face on approximately 22-FEB-2007. The rash spread to the rest of her body. The patient was referred to a Infectious Disease specialist and was diagnosed with allergic dermatitis and pityriasis rosea. Throat culture was negative. The patient was treated with hydroxyzine hydrochloride (Atarax). Subsequently, the rash resolved. Additional information has been requested. It was reported that another female in her school class experienced allergic dermatitis with pityriasis rosea after vaccination with Gardasil (WAES0703USA04287)
found out last Wednesday that she has HPV; received a dose of GARDASIL on 12/30/2014 and 07/22/2015. The patient then received 1 dose of GARDASIL 9 on 01/03/2017; received a dose of GARDASIL on 12/30/2014 and 07/22/2015. The patient then received 1 dose of GARDASIL 9 on 01/03/2017; This spontaneous report was received from the patient's mother and refers to her 18 year old daughter. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On 22-JUL-2015, the patient was vaccinated with her first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, frequency, route, vaccination site, lot# and expiration date were not reported), for prophylaxis. On 22-JUL-2015, the patient was vaccinated with her second dose of human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, frequency, route, vaccination site, lot# and expiration date were not reported), for prophylaxis.   On 03-JAN-2017, the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, vaccination site, lot# and expiration date were not reported), for prophylaxis.   On 29-MAY-2019 (reported as "last Wednesday "), the patient found out that she had HPV (papilloma viral infection).  At the time of reporting, the patient had not recovered from papilloma viral infection. The reporter did not provide a causality assessment between human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and papilloma viral infection.
After Moderna booster, ringing in left ear, white noise in left ear and almost total hearing loss. Helped with prednisone steroid.
Nausea, headache, vomiting, chills, body aches, pain at injection, dizzy
Inflammation, fluid around the heart had to be removed by surgery, fluid around lung, chest pain, trouble breathing, exhaustion - still treating - colchicine, prednisone, Indomethacin. Symptoms got progressively worse from the time of having the vaccine until November when I went to the emergency room (twice in November, once in December 2021 and once in January 2022) I was admitted to the hospital 3 times.
Around 12:30AM I started bleeding and had small cramping pain low in my pelvic region. I had been instructed to go to the obstetric ER if I had any symptoms like I was having. When going in my blood pressure was elevated they said they were going to induce labor and before they started the Pitocin I started bleeding again and this time it was a big gush and my blood pressure dropped immediately after that and I was very dizzy. It was decided to do an emergency C-section and they tried to do a spinal block but due not being able to hear baby's heartbeat I was given general anesthesia and a C Section was performed, afterward it was determined I has an Placental abruption. A biopsy was done of the placenta. Chronic meconium staining, mild chronic villitis of undetermined etiology.
On day 5 post vaccination I had some axilla pain in my right arm. I couldn't see anything - no redness, nothing swollen, just some pain. It did not warrant medication to be treated. Then on post vaccination day 6, I woke up in the middle of the night to an inflamed area at my vaccination site and by morning the area had spread. As of now it is measuring at 4 cm and is raised, swollen, red, and mildly itchy. From 1/7 to 1/8 it has not changed and may be mildly improved. As a pharmacist, I wanted to report since it seemed to happen beyond the 72 hrs described in the common adverse events reported. As of 1/8, I can still sense the axilla pain but it is not as bad.
Patient received Pediarix and HIb in right deltoid, MMR in left deltoid, by evening the right arm was swollen with induration and erythema.  The next day swelling advanced from arm to elbow.  The next day it involved the entire right arm.
The ARM is pretty sore. It hurts to lift the ARM. The pain is mostly in the joint. The pain started shortly after receiving the vaccine and has worsened today.  I received my first dose of the vaccine with no problems in 12/2012. I really believe it has to do with where the nurse injected the vaccine.   The injection site was pretty high up on my ARM and it almost felt like I was given an injection in my joint rather than my muscle.
react to Engerix-B vax 1st dose given 3DEC92 caused localized burning & redness in deltoid; 2nd dose given 8JAN93 caused dizziness & nausea the next AM;
Information was received from an investigator on 21FEB2013. Adverse events: Drug exposure during pregnancy and spontaneous abortion. In DEC2012, a 26 year old female (gravida 1, para 0) received dose 1 and 2 of BIOTHRAX (lot FAV309). Based on the first day of her last menstrual period (FDLMP), the estimated gestational age (EGA) at dose 2 of BIOTHRAX was determined to be 1 day. In JAN2013, she received immunization with smallpox vaccination (EGA 2+6). Subsequently, in JAN2013 she found out that she was pregnant. She sought counsel with a physician because she was concerned about having received both anthrax and smallpox vaccines inadvertently during pregnancy. In FEB2013, she reported that she had spontaneously aborted at (approximate gestational age 6+6 weeks). At the time of report, her beta human chorionic gonadotropin levels continued to decrease (from 2227 to 685.3). Comment: Spontaneous abortion reported in a 26-year-old female following an inadvertent exposure to BIOTHRAX and Smallpox vaccination during early gestation period. Pregnancy was confirmed using transvaginal ultrasound. HCG data is in line with an early spontaneous abortion. The available data is inadequate for evaluating a causal relationship with either vaccine.
1 year old patient received Menactra instead of the ActHIB without adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health professional (Nurse) via Agency (Reference number- 00380738) and transmitted to Sanofi on 03-Dec-2020.    This case involves a 1 year male patient who received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) instead of the HIB (PRP/T) VACCINE (Powder and solvent for solution for injection,  , ) ActHIB (produced by unknown manufacturer lot number U6690AB, expiry date 21-Aug-2023) via an unknown route in an unknown administration site for prophylactic vaccination, on 03-Dec-2020 (wrong vaccine administered).    The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.    This was an actual medication error case due to wrong vaccine administered (latency same day).    At the time of reporting, no adverse event was reported.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 is 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 has contributed to or is to be held liable for the occurrence of this medication error.
After 24 hour after vaccine, the left side lymph nodes of my neck started to swell.   It was very painful.  I went doctor about this and they said that it was normal go home.  On Nov 8th, I started to become really itchy.  I was breaking out with red, burning hives.  It felt like my body was on fire.  On Nov 13th, I had a virtual visit with Telehealth.  They just told me to take Benadryl.  On Nov 14th, I had another Telehealth visit, they said that it was really, really bad. They told me to keep taking the Benadryl and gave me steroids to take as well.  Then on Nov 15th, I saw my primary care doctor.  She put me on 4 different medicine.   And she thought that it was a reaction from the vaccine.  She also told me that it would take 3 months to get rid of it.
Tdap vaccine administered L deltoid 12/4/08  12/8/08 noticied indurated red area over injection site  12/9/08 red undurated hot area approx 6 cm over injection site also c/o achy headachy feeling and chills temp 98.8
The patient's husband states that starting the date after the vaccine there was swelling around the injection site. I advised the patient to go to urgent care. The doctor diagnosed her with an infection and prescribed clindamycin 300mg three times daily.
Broke out in hives all over her body; This spontaneous report was received from a currently 29 year old non pregnant female patient via a company representative. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  In 2008 (reported as: "a decade ago"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) route reported as: "injection" (strength, anatomical location, lot number and expiration date were not provided) for prophylaxis.  In 2008 (reported as: "a decade ago"), the patient broke out in hives all over her body (urticaria). At the tome of the report, the patient recovered from the urticaria on unspecified date.  The reporter did not assess the relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Arm swelling, hot to the touch and it is red, and on the way here her arm started to hurt, it is an achy, stiff muscle in her joint and it hurt down to her left wrist.
got 1st dose on 10/05/2020, 2nd dose on May 31st 2022.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 5th October 2020).   On 31st May 2022, the patient received the 2nd dose of Shingrix. On 31st May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 03-Jun-2022 Reporter's comment: The nurse reported that the patient got 2nd dose later than the recommended interval. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient got 2nd dose later than the recommended interval, which led to lengthening of vaccine schedule. The case was linked with case US2022084620, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022084620:same reporter
mom reports change in appetite;pt c/o bones aching all over, dizziness since got vax;no rash;T101;encourage to take pt to PMD;saw MD 9/13/99;
symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (symptoms) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (symptoms). At the time of the report, ADVERSE EVENT (symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
JEV (Lot # JEV09M40F) expiration Date 09/30/2011, JEV given 10/03/2011, No adverse symptoms noted to patient.
Pt had been given the HBV and Td and I just finished giving him the Varicella, his eyes rolled back and body went tonic. I eased him down to the floor protecting his head. He relaxed and became conscious about the time he was lay fully on the floor. Total of 10 sec unconscious tonic, he and family denied any seizure history or history of reaction to shots. They stated he had not eaten and was anxious about starting a new school.
High fever; uncontrollable shaking/unbelievable shaking; shivering; Trouble walking/trying to drink water; severe upper GI stomach cramping and sharp pains; horrible nausea; blood pressure was so low; dehydration; stomach cramping and sharp pains; my arm to be very sore; I couldn't raise my arm for 3 days; I was in the bed; This case was reported by a other health professional and described the occurrence of pain in arm in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included viral meningitis (had aseptic viral meningitis at age 47 and was hospitalized).   On 9th June 2020, the patient received the 2nd dose of Shingrix. On 12th June 2020, 3 days after receiving Shingrix, the patient experienced fever, tremor, shivering, walking difficulty, gastrointestinal cramps, nausea, low blood pressure, dehydration, stomach cramps and bedridden. In June 2020, the patient experienced pain in arm and mobility decreased. The patient was treated with ibuprofen and intravenous fluid (nos) (Intravenous Fluids). On an unknown date, the outcome of the pain in arm, mobility decreased, fever, tremor, shivering, walking difficulty, gastrointestinal cramps, nausea, low blood pressure, dehydration, stomach cramps and bedridden were unknown.   It was unknown if the reporter considered the pain in arm, mobility decreased, fever, tremor, shivering, walking difficulty, gastrointestinal cramps, nausea, low blood pressure, dehydration, stomach cramps and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shringrex and had arm sore and it was to the point it could not raise arm for 3 days. The patient had high fevers, average 103.5 and had uncontrollable shaking and shivering so bad had trouble walking or trying to drink water from a glass. The patient had severe upper GI stomach cramping and sharp pains along with horrible nausea.  The patient was eating Ibuprofin trying to get temperature under control and for the next 6 days was in the bed, fighting high fevers Day and night and unbelievable shaking. The patient was driven to a walk in clinic where my blood pressure was so low from dehydration and had IV fluids.  The patient was also tested for Covid 19 which was negative.  The medical staff diagnosed and had severe reaction to the Shringrix shot.
Patient came in and got her first dose of the Pfizer COVID vaccine at 1515. Patient stated she had no allergies and no issues with vaccines in the past. Patient received the vaccine in the right deltoid, IM. Patient tolerated procedure well. Patient walked to main lobby to wait for her 15 min observation time by a staff member. Approximately 5 minutes after receiving the vaccine the patient approached the staff member observing patients that are in their observation window and stated ?something doesn?t feel right?. At this time the staff member called for a nurse to the lobby. When I got to the lobby and asked the patient what was going on she stated ?that she feels weird in her entire body?. I asked the patient if she was able to walk and took her back to the clinic to an exam room. Once in the exam room the patient stated that she ?just feels weird and that her heart is racing?. The patient started to get red blotchy spots on her shoulders. The patient stated that she was having no trouble breathing and did not feel like her throat or tongue was swelling. The patient?s blood pressure was 190/100, HR 89 and oxygen saturation was 98%. I gave the patient 50 mg of Benadryl PO. Patient stated she was only allergic to erythromycin and takes sertraline and vitamins as her only medications. I had the patient lay down as she felt a little dizzy. The patient was breathing heavily but was not having any trouble with SOB at this time, she called her husband to come join her. The patient continued to feel the same symptoms but they were not worsening. Approximately 5 minutes later her blood pressure had decreased to 170/94. The patient stated that she was feeling the same. 20 minutes after the patient took the Benadryl her red blotchy spots had decreased and she was starting ?to feel better overall?. The patients husband stated that he would watch her tonight and continue to monitor for symptoms. I recommended that she go in and be evaluated if her symptoms persist. The patients blood pressure 30 minutes after taking Benadryl was 140/94, pulse 73, oxygen 97%. The patient left with her husband with the understanding that if her symptoms get worse or persist to go in and be seen.
Headache, Myalgia, Fever, CoughWheeze, Syncope, fatigue, injection site pain Narrative:  no active treatment although event was more than mild due to report of being bed ridden times 2 days.
Pt called the pharmacy and said she was experiencing lower facial numbness, headache, and a racing heart that she said all started around 20 min before calling (3 days after the vaccine).  She confirmed that the numbness was in the lower part of her face specifically mentioning mouth, lips, and jaw. Denied any itchiness or swelling. She stated the racing heart may have just been from her concern over the facial numbness and headache.  Advised the pt to wait for a little bit and see if her racing heart resolves and that if it does not she should seek immediate medical attention.  Pt was advised to speak with her dr about the numbness and that it has not resolved by tomorrow to seek medical care.
Tachypnea, Tachycardia, Tingling in Arms, Flushing 911 was called and patient was transported to hospital emergency room
Fever within 4 hours of immunization. Nasal Congestion and dizziness.
4/8 @ 12:00 pm - headache 4/8 @ 11:20pm - cold chills to the bone , fever of  102.0  for 3 hours, headache, could not sleep 4/9  all day - body temp of 100.1, cold chills, sweating, bones aching, skin hurting when touched, headache, dizzy and off balance when standing to walk, could not sleep 4/9 @ 2:30pm - fever  of 102.3 for 6 hours 4/10  all day - headache 4/11 all day -  slight headache
Chills; I was bleeding through mouth, bleeding of my tongue, blood was coming out of my mouth.; I was bleeding through mouth, bleeding of my tongue, blood was coming out of my mouth.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 15Apr2021 (at the age of 56-years-old) as dose 2, single for COVID-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included clopidogrel bisulfate (PLAVIX) taken for high blood pressure, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 25Mar2021 (at the age of 56-years-old) as dose 1, single for COVID-19 immunisation. On 15Apr2021, the patient had a side effect like bleeding through her mouth, bleeding of tongue, blood was coming out of mouth, that was about 6 0' clock yesterday. About 05:30 to 6 0' clock yesterday when the blood was coming out. She took the test at 1 0' clock yesterday she started bleeding out the mouth at 18:00 last night. On 16Apr2021 (today), she had the chills but her most concern was about bleeding through the mouth. The patient underwent lab tests and procedures which included blood test with unknown results on 25Mar2021 and sars-cov-2 test with unknown results on 25Mar2021 and 15Apr2021. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2/22/21 patient reports that the next day after her injection her throat and the inside of her mouth felt tight. She had body aches and had not energy. Today she reports that her lips and inside of mouth still feel numb. Patient wondered what she should do about her next injection. This was reported to CNP and she advised that patient does not receive the second dose of the COVID vaccine as scheduled. Continue to observe and report any new findings. Patient was called with instructions from CNP
5 x 6 erythema and warm, hard, edema at the site of injection with linear area of bruising that was noted when the band aid was removed.  There was no excessive pain on injection.
Patient experienced numbness, tingling, and inability to use the immunized arm. This occurred shortly after shot until 10/19/10.
Narrative:  63yo patient with hx of morbid obesity, HTN, COPD, sleep apnea, Osteoarthritis, GI reflux & anxiety Dx died on 9/27/2021. Pt had received one covid vaccine on 5/10/21 from the agency. Pt resided in community care nursing facility. Likely pt's death is not related to covid vaccine given pt's medical history, and length of time between date of death & date of vaccine administration.
COVID Arm - warm, red, itchy,  splotchy rash with ~3" radius around the injection site.