chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortly after receiving immunization, patient fell backwards while seated. Patient was unconscious and nonresponsive for 2-5 seconds. Patient was brought back with vigorous stern rub and complained of inability to breathe with a perception that throat was closing. Patient given Epinephrine and Benadryl. Patient very pale.
Pt described feeling itching 3 minutes after vaccines was administered, I gave her 25 mg of liquid benadryl and asked her to sit for 15 minutes to be observed. She said this happens sometimes when she takes a vaccine and she usually takes benadryl before hand but this time she forgot. after 15 minutes she said the itching had subsided . She will follow up with doctor if the itching gets worse.
TROUBLE BREATHING; SKIN ITCHES; FELT HEATED UP; MAJOR BODY ACHES; This spontaneous report received from a patient concerned a 60 year old of unspecified sex. The patient's weight was 30 pounds, and height was not reported. The patient's concurrent conditions included abstains from alcohol, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on left arm on 07-APR-2021 around 11:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021 18:00, the subject experienced trouble breathing. On 07-APR-2021 18:00, the subject experienced skin itches. On 07-APR-2021 18:00, the subject experienced feel heated up. On 07-APR-2021 18:00, the subject experienced major body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the trouble breathing, skin itches, feel heated up and major body aches was not reported. This report was non-serious.
GERD Narrative:  Patient is a 75-year-old female with a shellfish allergy to bivalves which causes her to have nausea and vomiting presents with chest pain, swelling of tongue and throat after first Covid-19 Moderna vaccination which was given in her left deltoid at 11:10 AM. Patient stated she was otherwise feeling fine prior to the vaccination. Approximately 10 minutes after first Covid-19 Moderna vaccine given patient began developing tingling in the left hand which lasted for about 10  minutes and then has resolved, 30 minutes later developed chest pain which she described as GERD like and then subsequently developed thickness to the midportion of her tongue and swelling of her throat. She reported the thickness to her tongue has resolved during my interview which is 2 hours since vaccination was administered but she still feels that her throat is mildly swollen. She reports also that the chest discomfort has improved, She was offered Benadryl but states that it sedated her and typically does not work and would rather hold off. Patient followed up with PCP 18 days later and stated to continue feeling some fatigue and heartburn. PCP stated likely non-severe allergic reaction and advised that she NOT get second dose.
A legal complaint was received from an attorney alleging that a male child received his first dose of Prevnar vaccine on 5/22/00. Relevant medical history was not provided. A dose of 0.5cc of Prevnar was administered in the left leg on 5/22/00. Additional suspect medications included hep B vaccine (manuf unk), Recombivax-HB (hep B vaccine), Act-Hib, Tripedia, Pedvax-Hib, MMR II, Varivax and Polio vaccine. Vaccination info contained in the legal complaint indicated that the child received Prevnar, Pedvax-Hib, Act-hib, Tripedia, MMR II, Varivax and poliomyelitis vaccines beyond 12 months of age. Concomitant therapy included Tuberculin test. It is alleged that as a result of cumulative exposure to mercury in the thimerosal-containing vaccine (s), the child developed "toxic neurllogical effects of mercury poisoning." This event was considered medically important (OMIC). No additional info was available at the time of this report.
Cardiac Arrhythmia and high blood pressure, now under the care of Cardiologist
Patient has been having uncontrollable diarrhea since two days after injection. has lost 8 lbs in less than a month. Shot given 1/14/21 and today is 2/8/21. Patient now has blood in stool.
pt states he developed a rash on his torso ~24hrs after being vaccinated w/ both his 1st and 2nd doses of pfizer covid vaccines -- states symptoms cleared on own after couple days or so -- lot # of 1st: ER8729 given 4/1/2021 -- lot # of 2nd: EW0170 given 4/26/2021  pt was given a claritin 10mg tab prior to his pfizer 'booster' 1/28/2022 and then watched for 30min -- no problems during this time -- I called pt 1/31/2022 to see if any rash developed over the weekend and he said NO it did not. He did feel feverish and achy though however these have cleared/resolved now.
on 20Apr2021 found clot in jugular vein.; Headaches after both shots, very pale no appetite.; Headaches after both shots, very pale no appetite.; Headaches after both shots, very pale no appetite.; 25Mar woke with numbness in lips; This is a spontaneous report from a contactable consumer (patient) reported that a 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), via an unspecified route of administration, administered in arm left on 25Feb2021 (at the age of 57-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included barrett's oesophagus, and had known allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN9581), administered in arm left on 04Feb2021 (at the age of 57-years-old) as first dose for covid-19 immunisation, and experienced headaches, very pale no appetite. On 25Mar2021, the patient experienced headaches after both shots, very pale no appetite. On 25Mar2021 woke with numbness in lips, and on 20Apr2021 found clot in jugular vein. The seriousness of the events was provided and were considered as life-threatening and caused hospitalization for 2 days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. The patient underwent testing and put on blood thinners. The outcome of the events was unknown.
pt recvd regular DTP on 28JAN94 instead of Aceullar DTP; returned on 01FEB94 w/red, tender, swollen, warm area of inflammation over rt deltoid; abscess: sterile or infected?; sxs cleared w/o treatment;
Rash - red, raised - to chest, back, stomach, inner thighs. Mom treated with BEANDRYL 1 X 4 days. Mom states this happens every time with immunizations.
This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had most of the common side effects. The patient wanted to know how long the patient would feel sore, feverish. The patient not even called the doctor.
Blurred vision, pain in arm/shoulder, and felt like she was in a fog - not knowing how to even do [her] job.  Later in the evening she started to feel very dizzy and vomited.  Will take OTC acetaminophen as directed to help with symptoms and rest.
I had spontaneous tumor growth after having received my first Pfizer  shot which has been confirmed to be desmoid fibromatosis.  Tumor size and related symptoms did not exist prior to vaccine. I believe that the vaccine affected important T-cells that normally block the tumor growth.
Developed Swelling around injection site extending to an area of approximately 2.5 inches in circumference, pain at site, extending to left side of neck, left upper extremity "tightness" reported. Treatment: took OTC Benadryl.
onset of fatigue, headache, within hours of vaccine, difficulty with concentration, cognition, memory, headaches 1 month after vaccination
Body aches and fever and fatigue one day post vax.  2-5 days post vax injection site became red, swollen, painful, itching, hard and hot to the touch.  On 3/13 spoke with a teladoc and stated it was infected and prescribed antibiotics stated if it wasn't better by the evening I needed to be seen at an urgent care or ER.  3/13 6:00pm - injection site was worse. Went to urgent care was prescribed steroid shot, oral steroids, topical cream and ibuprofen. Provider stated it may be an allergic reaction to something in the COVID vax
severe skin rash on buttocks area, burning sensation, developed about 36 h ours after first doze of vaccination, lasted 5 days, treated with mupirocin oitment
Approximately 15 minutes after vaccines given the patient developed watering of right eye with mild swelling and redness of right eyelid as well as rhinorrhea from right nostril. His right upper lip also became mildly swollen. He had a few skin blotches near his right temple. He was given a dose of Benadryl and within 20 minutes his symptoms as described above resolved.
Patient complained of lightheadedness with slight disorientation, chest heaviness.  Patient transported to ER for further evaluation & treatment.
Day 1: Hurt, starting swelling Day 2-4: Swollen, painful, hot, red, itchy Day 5: Itchy, warm (less warm then day previously) Pt didn't want to take Benadryl due to side effects of that medication in past-pt didn't seek Dr attention
Moderna COVID-19  Swelling and hardness at injection site.  Red blotchy skin.  Itchiness.
Red, non-raised rash appeared one day after vaccination on the arm a few inches below the injection site. Patient stated it lasted about 4 days and then went away
Patient was given Tdap vaccine. Advised to wait. In waiting area, reception noticed pt was slumped over the table. Pt was approached, taken by wheelchair to the exam room. She was coherent, however, dizziness and nausea noted. Pt resting on table, feeling warm, given cold compresses, checking BP, pulse and oxygen levels. Vitals stable except mild tachycardia into 110s.  Given cold water, emesis basin.
Initial unsolicited report received from nurse on 21-Sep-2018. This case is linked to cases 2018SA267253, 2018SA267274, 2018SA267282, 2018SA267283, 2018SA267295, 2018SA267294, 2018SA267293, 2018SA267304 and 2018SA267305. This case involves a [53 years old] female patient who was vaccinated with a single expired dose 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI815AA, expiration date: 30-Jun-2018, site of administration: left deltoid and route was not reported) on 17-Sep-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. No reaction 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. List of documents held by sender: none.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-MAR-2016, the patient was vaccinated with first dose of PEDVAXHIB (lot unknown, expiry date unknown) (route: intramuscular). On 08-JUN-2016, patient received second dose of PEDVAXHIB (lot unknown, expiry date unknown). On 19-AUG-2016, patient was inadvertently received third dose of PEDVAXHIB (lot #M001813, expiry date: 14-OCT-2018). No adverse effect reported. Additional information has been requested.
Ferritin 1590; 1/4 On 1 L - but keeps pulling of NC  dry cough.  Cr 6.4.  Last day of azithromycin; 1/5 comfortable on room air.  Patient now agreed to dialysis 1/6 s/p HD.  Daughter noted improving mental status and breathing.   1/7 breathing okay.  Dry coughing.  1/8 no diarrhea, on room air.  1/9 continuing on room air, WBC elevated 13.7 - from line placement, chest x-ray better, blood culture today and monitor WBC.  No phlebitis noted 1/10 in HD today.  WBC 11.6.  Remain on room air, past speech evaluation   1/11 stable on RA, WBC approaching Normal. D/c Airborne plus Isolation at this point. HD placement Pending approval .1/12 last day of Decadron.  Daughters reporting back to baseline mental status
Difficulty breathing; chest pain and pressure; chest pain and pressure; wheezing; dry cough; constant fatigue for 7+ days so far; Arm numbness; This is a spontaneous report from a contactable consumer (patient). A 32-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm, on 28May2021 at 16:30 (at the age of 32-years-old), as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included COVID-19. The patient previously took sulfa and experienced drug allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29May2021, the patient experienced difficulty breathing, chest pain and pressure, wheezing, dry cough, constant fatigue for seven plus days till the time of report and arm numbness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events difficulty breathing, chest pain and pressure, wheezing, dry cough, constant fatigue for seven plus days till the time of report, arm numbness was not resolved at the time of this report.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Pt developed varicella.  Symptoms started on 01/04/06, included fever, malaise, rash.
Fever up to 103, chills, migraine-type headache (pain, photophobia), nausea, weakness.  The acute symptoms resolved in just over 12 hours.  I felt just a little tired 36 hours after vaccination and perfectly fin 48 hours after.
Patient had onset of symptoms of chicken pox with vesicular rash approximately 10 days after receiving VARIVAX vaccine.
Started having really bad spasms in my legs and tingling. Over the next several weeks the spasms and tingling got steadily worse. Around 11/27/2014 I started noticing weakness in my legs when I stood up and my fingers were starting to get tingly. By December 8th I started falling as my legs weren't holding me up. On December 17th I went to the ER. I fell in the x-ray dept. as I couldn't stand on my own. I was sent home on December 22nd I could no longer stand at all and went to another emergency room where I was admitted and then diagnosed with Guillain-Barre Syndrome.
Patient received second dose of moderna vaccine at 3:31pm on 4/22/2021, during observation patient reported to feel "dizzy" and reported heavy breathing. Felt like she would lose consciousness/fall over. While discussing her symptoms, she began to feel pain in the center of her chest and continued with feeling of being faint and difficulty breathing. Patient appeared flushed and was warm to touch which later resolved. Ambulance was called and patient decided to leave by ambulance at 4:21pm after it arrived at 4:16pm.  Her husband was onsite and was notified by herself. No further incident.
Pain and pressure in the ears about a day after the shot, followed by severe vertigo that set in about a week after the shot.
received two doses out of three of GARDASIL 9/ 2nd dose was administered over one year ago; No further AE reported; This spontaneous report was received from a registered nurse and refers to a female patient in her 20's. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a first dose of GARDASIL 9 (exact dose, route and site of administration, lot# and expiry date were not reported) for prophylaxis. On an unknown date, over one year ago, she received second dose of GARDASIL 9. It was also reported that the patient received those two doses a year ago. The reporter wanted to know if third dose could be given or if the series should be restarted. No additional adverse events were reported.
p/vax pt exp a rash w/pruritus;pt also devel juvenile rheumatoid arthritis which was described as disabling/incapacitating & is ongoing;the reporter did not consider the event to be r/t vax;
I am calling to register because I am pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I am calling to register because I am pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (Patient have allergy towards hair dyied.), Endometriosis in May 2019, Diabetic, Cyst of ovary and Blood pressure increased. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 11-Jul-2020 and the estimated date of delivery was 16-Apr-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (I am calling to register because I am pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 29-Dec-2020, EXPOSURE DURING PREGNANCY (I am calling to register because I am pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2020, Pregnancy test: positive (Positive) Positive. On 30-Nov-2020, Ultrasound foetal: unknown unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details was reported.  Company comment: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Pt developed onset of h/a, chills, myalgias, arthralgias, nausea, & emesis w/in 30 min of receiving vax; orthostatic & febrile to 102.6F; pt assessed having severe flu-like rxn, w/hepatocellular damage; mild subclinical DIC; B. marrow  abn.
Began with joint aches, chills and sweating then got a terrible headache and diarrhea
fatigue; headache; feeling very bad; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue, headache, and feeling very bad for several days. Events took place after use of product. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Immediately pain and burning sensation upon administration followed by a large painful reddened indurated area involving the right inner aspect of the arm below the elbow that increased over the next 72 to 96 hours.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Paramedics were called, they assessed, but did not take the patient with them. He had recovered
Majority of the vaccine was not administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Majority of the vaccine was not administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Majority of the vaccine was not administered). On 01-Apr-2021, INCORRECT DOSE ADMINISTERED (Majority of the vaccine was not administered) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
L Bell's palsy started 15 days after Moderna vaccine. Since she was already on Prednisone 50 mg daily (day #4) for her L rotator cuff injury, she went to urgent care, and was advised to increase it to 60 mg daily x 5 days (started on 01/23/2021, until  01/27/2021), then 20 mg daily x 5 days  (from 01/28/2021-02/01/2021). Seen by reporter (neurologist) on 01/27/2021. Has mild symptoms of Bell's palsy, with improvement based on her report. Still not aCle to raise L eyebrow, but now has good eye closure, and still with flat L nasolabial fold. No ear pain, fever, ear tenderness, change in taste.