chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received through the pregnancy registry from a nurse practitioner and a 32 year old female, G3, PO, with a past medical history of having three therapeutic abortions and herpes genitalis treated with acyclovir, who in June, 2002 and on 04APR2003, was vaccinated with a first and subcutaneously 0.5ml second dose of varicella virus vaccine live, respectively. There was no local reaction at the vaccination site and there were no symptoms of varicella or herpes zoster post vaccination. The patient's LMP was 21APR2003. According to the patient's health care provider she became pregnant on 05MAY2003. In March 2002 and March 2003 the patient was tested for varicella antibodies the results of which were negative. On 25NOV2003 at 31 weeks, and on 02DEC2003 the patient had an ultrasound which showed a slight increase in anmniotic fluid. On 31DEC2003 the patient was started on pantoprazole sodium (PROTONIX) or famotidine for heartburn. On 07JAN2004 the ultrasound was normal and it was reported that the increase in amniotic fluid had resolved. No amniocentasis was performed. Routine tested was reported as "all normal". It was reported that during the pregnancy the patient was positive for both B-strept and chlamydia. On 08JAN2004, at 37 weeks and 3 days from her LMP, the patient delivered a live born, normal 6lb, 13oz male. There were no complications during labor or delivery. There were no congenital anomalies or features of congenital varicella zoster syndrome. The fetus was healthy without any known problems secondary too vaccination. On that same day it was noted that the pantoprazole sodium (Protonix) or famotidine was discontinued. Additional information is not expected.
Patient got PREVNAR-13 IMZ on 5/7/18. She returned to pharmacy 5/16/18 for a refill on a medication and asked if she should take her follow-up pneumonia shot after the reaction that occurred with this shot. She showed us a picture of her left arm. It was badly swollen from injection site to elbow. Color was bright red with what looked like a bruise at the injection site. She said that her arm had been hot to the touch (it was still hot at injection site on 5/16/18) and that the injection site had been hard...that it felt like it had a core (it still felt like this on 5/16/18). She stated that her body temp had been 101 degrees for about 5 days post injection. She took TYLENOL to keep fever down. She did not mention any swelling of face or problems breathing.
24hrs after vaccination, injection site noted to be hot to touch, red, and hard 1.5in diameter around site, painful to touch. No change for next 24hrs (48hrs after vaccine).
patient got moderna vaccine on 4/15/2021 at a vaccine clinic. had sore arm, trouble lifting it for about a week. on 4/17 started getting shooting pains down her left arm where she got the shot, it went into her thumb and also down her left back. started feeling some kidney pains around then too. had headaches/fatigue.  also having significant left axilla pain, a week later started having some right axilla discomfort. symptoms have since improved and are resolving. she came into primary care clinic almost 2 weeks after her vaccine.
A few hours after getting vaccine, experienced extreme lightheadedness and had to lay down for hours until subsided. On day 5 after vaccine, arm soreness returned suddenly and severely, pain traveled up arm into neck on side of vaccine. Extreme stiffness of neck and arm, and extreme pain, still present on day 7.
pt recvd vax & devel enlarged parotid gland on 23sep, 2 wks after vax;
9 year old patient received Pfizer bivalent booster indicated for ages 12+ administered by nurse
Patient received Moderna vaccination on 10/8/21.  She stated that she had a rash/swelling  in the injection site and rash on one side of the neck on 10/14/21.  It is now subsided and done, but the rash has left some dark spots on the skin.
Few hours later high fever. Next day more serious- letahrgic, high fever despite several doses of Tylonol and Motrin, vomiting, listless, non communicative, screaming,inconsolable
This spontaneous report was received from a physician and it refers to a 40 year old male patient. The patient had no pertinent medical history. It was reported that the patient had allergy to penicillin. On an unspecified date, reported as "possibly in 2008", the patient was vaccinated with (Oka/Merck) VARIVAX 1350U (dose, lot#, exp. date, route of administration and anatomical location were not reported), 3 years apart from the first vaccination he received the received the second dose of (Oka/Merck) VARIVAX (dose, lot#, exp.date, route of administration and anatomical location were not reported). Concomitant medications included ibuprofen taken as needed. On an unspecified date, approximately in November 2014 (reported as "now") the patient had a negative titer for varicella and high white blood cell count. No treatment was given for the adverse events, the patient was referred to a hematologist. The outcomes of the events were not reported. The relatedness between vaccination with (Oka/Merck) VARIVAX and the events was not reported. Additional information has been requested.
My spouse contracted the virus in March 2020 and passed from it.  I contracted the virus from him late March/April and was sick for approximately 10 days.  I could not receive a COVID test at that time because there were not enough tests available, and they said I had contracted the virus.  I did test positive for antibodies in June of 2020 and continued to test positive right up until I had the vaccine, so natural antibodies were present in my system.  The night I received the vaccine (29 January 2021) first dosage I started with the chills, fever of 103, severe headache and body aches which I knew was the virus again and I was down and out for approximately 24 to 36 hours.  After that period I was back to my normal self.   I am a little nervous about dosage 2 because I have been told by others that is when you do not feel well.  I did check with my doctor and she said to get the second dosage which I will.
Information has been received from a physician concerning a 16 year old female with no known medical history or drug allergies who on 18-APR-2007 was vaccinated intramuscularly with a dose of Gardasil (Lot # 656371/0181U) while pregnant. Concomitant vaccinations included Menactra and DTaP. The patient's last menstrual period was "6 weeks ago" and her estimated date of delivery is 12-DEC-2007. No symptoms had been reported. No laboratory diagnostic tests were performed. Subsequently, on an unspecified date, the patient had an abortion. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. No further information is available.
Pt's face, head and neck were splotchy from crying with shots. Baby calmed down and drank a bottle in office, but splotchiness continued to spread on left leg where DTaP and Hib vax were given. Also noted areas on stomach and continued on head, face and neck. Physician checked on pt and he seemed fine - smiled several time. Observed for 40 minutes form onset. Called mother and she said entire episode lasted 1 hours. Given Tylenol post vax.
after giving injection patient was told to sit in waiting area for 30 minutes.within minutes he complained of dizziness,felt flush.i called EMS.While waiting patient said he felt better and no need to call EMS.I  told him i did not want to cancel call.EMS  came and took vitalss(bp,sugar,oxygen,,) said all was fine.Patient said he felt well and went home.
Narrative:  COVID infection following COVID vaccine series 02/02, Pfizer, dose #1 02/24, Pfizer, dose #2 10/20, Pfizer, dose #3 09/08 pt cc: cough, fever, diarrhea, myalgais, rhinorrhea, nasal congestion, dyspnea exposure: unknown 09/16 SARS-COV-2 Variant Sequencing result: pending 09/16 09/27 COVID swab, result: detected 09/17 CXR impression: No acute disease in the chest. 09/17 FIBRINOGEN: 371 09/17 DDIMER: 0.27 09/27 COVID swab, result: detected 09/30 clinically resolved
Bitter in my mouth all the time for 25 days.  Food and water tasted very bad.
Felt very cold, 100.1 Degree fever, very tired , not abled to eat. (48 hours)
10/23/2021 following 3rd dose, woke up with chills, sweats, and 99-degree fever. It went up to 100, was very uncomfortable the entire day because of the chills, did not take any medication, similar reaction to the second dose but much stronger. That night I was delirious, still had a fever, woke up 2-3 times that night with extreme night sweats, drenched the bed. Labored breathing and was exhausted, struggling to catch a breath. Monitored blood pressure and pulse (resting heart rate normally 55-65 BPM), resting heart rate during the first few days after the shot was 95-105, and unable to be lowered regardless of daily stress. Spiked to 120 BPM if I was doing a normal walk. The original purpose of the third shot was for a surgery, but surgery was scheduled. I called the cardiologist because I could not get my heart rate down, I went in on the 27th, every day was night sweats, labored breathing, and struggling to move. Did an EKG on Oct 27th, ordered blood work, and cardiac MRI. EKG normal, blood work was done in the ER (still on 10/27/21), blood work came back okay. Discharged from ER, the symptoms were still extreme on 10/28, returned to ER, admitted and did cardiac MRI, and a nuclear test for lungs to check for blood clotting. Everything came back normal and was allowed to go back home. Released on 10/29/2021, began to slowly improve with the symptoms. Pulse was coming down, still around 25 BPM above the normal resting rate. On 11/01 was in contact with cardiologist and internist, asked for a beta blocker because of concerns regarding the heart rate. Attempted to ride the exercise bike but was unable to. Within the last 48 hours, I was throwing PACs consistently, and went on a 24-hour harness. Still currently wearing the harness. Have begun to feel significantly better since then. This morning was the first time I experienced zero PACs. Still experiencing the night sweats every night, sweating through the sheets. This symptom does not seem to be improving as quickly.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceftin, reaction(s): "Known allergies: Ceftin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures (Paxlovid)  were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Phizer Covid Vaccine in replace of Moderna .  No adverse reactions. CDC notified and no further actions required.
About 10 seconds after receiving her first Pfizer Covid vaccine, she said she had trouble breathing, she mentioned her throat was tingling .   She was spitting up mucous but I did not observe any labored breathing or wheezing.   We immediately called 911,  was read to administer an EpiPen dose, pt  wanted to wait for paramedics.  When the police arrived, they also did not observe any respiratory distress but offered her O2, then the proceed to take her to Hospital at the pt's request.
Induration, erythema and warmth approx 6-7cm surrounding injection site approximately 3cm ecymoses.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent medical conditions included celiac disease. Concurrent vaccination included MMR II (Merck) given in the right deltoid on 7 June 2012 and VARIVAX (Merck) given in the right deltoid on 7 June 2012. There were no concurrent medications. On 7 June 2012 at 15:00 the subject received 1st dose of KINRIX in the left deltoid. The area of the injection was prepped with alcohol and a product called PAIN EASE. The next day, on 08 June 2012, the mother of the subject called the office to report redness and swelling at the injection site. The subject was seen by the medical staff the following Monday, June 11th. There was no warmth at the site of tenderness. The subject was advised to take BENADRYL. At the time of reporting the events were improved. The healthcare professional considered the events were possibly related to vaccination with KINRIX. Follow-up information was received on 01 August 2012 via healthcare professional. According to office visit notes, the subject was seen by physician on 11 June 2012 for reaction to KINRIX on arm at injection site, described as red and blotchy. The subject received KINRIX on 07 June 2012 in the left deltoid. The mother of the subject noticed some redness and swelling the next day; slowly improving. But on 11 June 2012 it had not completely resolved. The subject denied pain and stated it itches occasionally. She was moving her arm well, no fever or chills. The subject's skin was examined at the left lateral deltoid: 5 centimeters area of faint erythema, mild swelling, no warmth, non- tender. The subject's left shoulder was examined FROM (free of marks), non -tender, full strength, no deformity or swelling. Left elbow was also FROM without tenderness, no swelling or redness; no pain with resisted motion. The subject was diagnosed with a moderate localized reaction to KINRIX and recommended to use BENADRYL as needed for itching. The healthcare professional attributed the events to erroneous administration and suspected transmission of infection agent via a medicinal product. At the time of the report the events resolved.
given flu vaccine in LD IM, site bleed and started swelling to size of golf ball. by 1130 am no swelling noted, bruise present. PT reported numbness in arm and dull ache, fingers twitching continuing off and on.
Pt. reports feeling feverish and HA and chills. Onset 1 day after vaccination lasting 2 days. With spont. resolve.
No signs or symptoms reported.; Medical assistant called to report a temperature excursion that occurred on 3/AUG/2021 and 5/AUG/2021. See case number 02007815 for TE details. ROTATEQ was administered to four patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On an unspecified date in 2021, the patient was vaccinated with a one (1) time dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (concentration, dose number and vaccination scheme frequency were not reported; lot number 1707449, was verified to be a valid lot number with an expiration date reported and established as 28-MAR-2021) for prophylaxis after that the vaccine experienced a temperature excursion of 35.4 degrees Fahrenheit (F) and 35.8 degrees Fahrenheit (F) during a time frame of 15 minutes (cumulative) that occurred on 03-AUG-2021 and 05-AUG-2021 (product storage error). It was stated that no previous temperature excursion was reported.  It was reported that the patient did not experienced any signs or symptoms after the administration. No additional adverse event (AE) was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002597:
Patient called today and said her arm really hurts and kept her up at night. It is also swollen , red and hot to touch.
Pain in the injection site, headache, tiredness, chills, body aches, sore joints, redness and swelling at the injection site, fever (did not take temp but definitely have a fever.  Had Tdap Vaccine administered to me at approximately 1715 on July 15, 2008.  The following day around 1200, started feeling extremely tired and by 1600 the rest of the above mentioned reactions were coming on.  At this time I have not seeked Medical attention.
Patient arrived in Clinic to receive Pfizer Bivalent booster.  This is patients 5th dose.  Screening questions reviewed.  Patient stated she has Rheumatoid arthritis and would like to continue with getting vaccine.  Patient received vaccine at 8:35am.  Patient instructed to wait for 15 minutes post vaccine. At 8:50am, after waiting for 15 minutes patient stated that throat "felt funny."  Patient denies SOB, difficulty breathing or swallowing, denies swelling of tongue or lips.  Patient given water and RN continued to monitor for additional 10 minutes.  At 9:00 patient states that symptoms where continuing to linger and felt throat tightness.  RN administered 50mg Benadryl IM to Right deltoid.  Response team called to come evaluate.  Vitals BP 150/86, HR 86 SpO2 96%, RR 20, lungs sound clear, negative strider. At 9:18, BP 142/84, HR 84, SpO2 96%, RR 20, patient states that she felt shaky.  Response team arrived, evaluated patient and took her to ER.
Nodule on (L) thigh, increased erythema 2-22-13, pain today 2 x 2 cm.
Hives over entire body; hand, feet and face swelling a few hours after the vaccines were given.
The day after 2nd vaccine, temp went to 100, body aches, severe fatigue. My temp went back to normal on 3rd day, however had fatigue and body aches for 4th and 5th day.
eye weakness and sensitivity; visual hallucinations; Chest Pain; Fatigue; all day Headaches; Stomach for one day; GI pain for one day; Apasthesia tingling on entire body starting at feet/weird sensations; chills; burning sensations starting at legs and working upwards over time; body aches; face numbness; pain on one side; minor itching; heart palpitations; eye weakness and sensitivity; slurred speech; slow thinking; clicking and buzzing sounds in head; Only minor arm soreness day 1.; brain fog; many other neurological symptoms; extremely fast vibration feeling like I am on massage chair but starting at head, very different than body; rashes with red blood spots; This is a spontaneous report from a contactable consumer.  A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in right arm on 12Jul2021 (at the age of 32-years-old) as dose 1, single for COVID-19 immunization at pharmacy or drug store. Medical history included schizoaffective disorder - depressive type, asthma and long term smoker. Known allergies of Amoxicillin, history of mild allergic reactions, hives, rashes. Patient had no COVID-19 prior vaccination. COVID-19 tested post vaccination reported as yes. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19. Patient did not receive any other medications within 2 weeks prior to the COVID-19. The patient had not been tested for COVID-19 nor before neither since the vaccination. Concomitant medication was not reported. The patient experienced chest pain, fatigue, all day h eadaches, stomach/GI pain for one day, apasthesia tingling on entire body starting at feet, chills and burning sensations starting at legs and working upwards over time, body aches, face numbness and pain on one side, minor itching and rashes with red blood spots, heart palpitations, eye weakness and sensitivity, brain fog, slurred speech and slow thinking, many other neurological symptoms and 'weird' sensations, clicking and buzzing sounds in head, visual hallucinations, extremely fast vibration feeling like patient was on massage chair but starting at head, very different than body tremors/shakes and only minor arm soreness day 1 on 13Jul2021 at 12.00AM. Evening of day 2 other symptoms begin severity increasing every day, ongoing for 18 days now, unable to get out of bed or leave house because of body weakness and neurological symptoms. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 16Jul2021 COVID-19 test name post vaccination= LUCIRA ALL IN ONE. SARS-CoV-2 test: negative on 21Jul2021 Negative, COVID-19 test name post vaccination= LUCIRA ALL IN ONE. SARS-CoV-2 test: negative, on 27Jul2021 Negative COVID-19 test name post vaccination= LUCIRA ALL IN ONE. Adverse events resulted in Doctor or other health care professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. Treatment received for the adverse events reported as unknown. The outcome of the events were not recovered.
Gave second dose 14 days after the first dose.  No need to repeat dose per CDC guidelines.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022 at 11:04 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-Feb-2022 at 11:04 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient received vaccine past its 30 day expiry date on 14-Feb-2022 at 11:04:17 AM. Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment information was reported.   This case was linked to MOD-2022-542869.
Pt came to ER c/o fever, weakness, cough, SOB.  Started about a week prior but worsened day of ER visit.  Had first covid shot 9 days prior.
She received her DTaP at about 10:00 AM. That afternoon she was not interested in eating any food, and she vomited at midnight, and three more times in the next five hours, and once more the next day. She also was running a 101 temperature. She nursed fine during/after her reaction, but didn't eat solid food again for 10 days.
I started to have headaches behind the eye, increased heart of 114, it would pound for hours, then go away., shortness of breath. Then I would not experience again for a day or two, then it would happen again. There were no other stress inducing factors in my life that may have caused this. I went to the doctor for a regular visit and mentioned what was going on. He could not tell by vitals as they were all normal that anything had damaged any organs.
Develop skin rashes and itchiness around both eyelids.  Severe left eyelid twitching. Several twitches within a minute throughout the day starting on November 24, 2020.   Around Dec 24, the muscle around the right armpit area started to twitch, several twitches.