chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, fever, hot to touch. Pt put on course of antibiotics. Keflex antibiotic.
Child woke crying vigorously and could not be consoled. Was examined by myself in ED about 3 hours later and was fine at that time.  Description from parents sounded similar to a night terror but this child had never before had similar behavior.
Headache, Myalgia, Arthralgia, Fever, Localized pain; chills, fatigue Narrative:  Other Relevant History:
soreness of neck; it was painful/soreness in arm; soreness in wrist and arm,soreness in shoulders; soreness in arm,muscles in upper torso sore; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (soreness of neck), PAIN IN EXTREMITY (it was painful/soreness in arm), ARTHRALGIA (soreness in wrist and arm,soreness in shoulders) and MYALGIA (soreness in arm,muscles in upper torso sore) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NECK PAIN (soreness of neck), PAIN IN EXTREMITY (it was painful/soreness in arm), ARTHRALGIA (soreness in wrist and arm,soreness in shoulders) and MYALGIA (soreness in arm,muscles in upper torso sore). In 2021, NECK PAIN (soreness of neck), PAIN IN EXTREMITY (it was painful/soreness in arm), ARTHRALGIA (soreness in wrist and arm,soreness in shoulders) and MYALGIA (soreness in arm,muscles in upper torso sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Antibody test: levels of the antibody was 2070 (Inconclusive) levels of the antibody was 2070, done through . On 07-Oct-2021, Antibody test: count was 2291, antibody levels went up (High) count was 2291, antibody levels went up.         No Concomitant medications were provided.  No treatment medications were provided.  The events lasted for 8-9hrs.  Patient also mentioned that he heard that younger people had a more intense response to vaccination because their immune system was more rigorous, and older people had less of a response, but he said had response was pretty vigorous.   This case was linked to MOD-2021-051636 (Patient Link).
Redness and swelling lt arm at the site. Extends 2" below site. States he had a fever late nite, shaking but thermometer read normal temp, (per mom).
Fatigue, headache, aches, chills, fever, diarrhea, nausea
Noted on 5/11/21: Patient reported hives in response to the 1st covid vaccination- within a few hours. Recommend patient speak with her PCP about an allergy referral or return in 28 days for a J&J vaccination
Within 12 hrs of vac. admin - fever >103+, chills, severe head pain, injection site (right upper arm) warn and swollen.  "Jolting" episode in spine 9/16 PM sx clearing and fever down after 36 hrs.
Information has been received from a physician and a 65 year old male with no past medical history or allergies who on 10/25/2001 was vaccinated with a second dose of hep A vaccine IM in the deltoid. The pt was concomitantly vaccinated with a typhoid vaccine. There was no illness at the time of vaccination. The pt initially reported he was vaccinated at the end of November 2001, and that three days after being vaccinated, his blood pressure went up to 160/100 mm/Hg/ He also had red, hot flushing in his face. Additional info received from the pt indicated that he was vaccinated with hep A vaccine on 10/25/2001. On 11/19/2001, the pt's blood pressure went up to 160/100 mm/Hg which necessitated two trips that day to an urgent care department. An electrocardiogram revealed no cardiac problems. On 11/20/2001, the pt was seen by his own physician. The pt's physician stated that the pt had been recently found to have "significantly" abnormal blood pressure measurements and was currently undergoing medical evaluation. The pt was advised to cancel any air and long distance travel for the time being to allow for close monitoring of his new condition and to avoid any potential risks to his health. The pt indicated that his blood pressure was usually in the 120s/70s mm/Hg range. Since November/December 2001, his every second day monitored blood pressure alternated between lows in the 120s/70s and highs in the 140s/80s which was higher than his normal range. Since November/December 2001, he also had periodic high flushing of the cheeks. At least once every 48 hours, sometimes twice a day, his cheeks suddenly turned very red and felt extremely hot. Additional info was received from the administering physician. The physician reported that the pt called the office almost a month later on 11/21/2001 to report he had two episodes of high blood pressure in the last few days. The pt was instructed to see his primary care physician for a complete work-up. No additional info is expected.
The pt developed a local reaction (quarter in size) to left upper arm where the vaccine was given. Hot, red and tender to the touch, systemic-complaints of general malaise, aches, nausea and chills, Afebrile.
second dose administration 21 days later; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administration 21 days later) 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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administration 21 days later). On 15-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administration 21 days later) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  Treatment information not provided.   Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: This report refers to a case of  Inappropriate Schedule of Product Administration for mRNA-1273, lot #  Unknown with no associated AEs.
Pt had abdominal pain, vomiting on 09/10/2007 was seen in Emergency Room and was transferred to another hospital had surgery performed and dismissed on 9/24/2007.  10/09/2007 MR received for hospital DOS 9/10-24/2007 for DX: Incarcerated Intussusception.  Infant presented to local ER with 6-7 episodes of greenish yellow emesis, high-pitched crying and back arching. He had a sunken fontanelle, decreased BS and (+) rectal bleeding.  Transfered to current facility to r/o intussusception vs bowel obstruction.  PE was (+) for a palpable mass in the mid upper abdomen and currant jelly stool.  Child taken to OR for laparoscopic reduction of incarcerated intussusception which was reduced.  However post-op pt developed increasing abd distention and pain.   Taken again to OR for a Diagnostic laparoscopy with exploratory lap and resection of intestinal perferation with primary anastamosis of ileum. 10/29/2007 Vax record received and corrolates to info on VAERS submission.
Fever, dizziness one day post vaccination. One loose stool 2 days post vaccination.
30 minutes following vaccinations, child developed edema & swelling below left eye. No shortness of breath, no pain voiced, ambulating ad ib speech clear. No wheeze, patient assessed by physician BENADRYL 12.5 mg/ml 4ml adm orally.
Within 24 hours of injection, patient presented with a red mark on her left arm. It  was warm to the touch. Patient took ibuprofen and came in to the pharmacy on 10/19. She was achy and had chills, also.
Rashes all over different parts of the body causing severe itchiness and some swelling. Randomly appears in places and disappears after two or so hours.
Information has been received from a physician concerning an over 60 year old male who "a couple of months ago" (in approximately May 2008), was vaccinated with the first dose of ZOSTAVAX subcutaneously. Subsequently, in approximately May 2008, the patient developed shingles. The shingles cleared on its own, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Arm extremely weak, aching, unable to lift anything heavier than a coffee cup for months after the shot. Could not sleep on that side...treatment listed below
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 09-NOV-2015 the patient was vaccinated with improperly stored ZOSTAVAX (lot # L016283, expiry date: 07-AUG-2016) (incorrect product storage). No adverse effects were reported. The outcome was unknown. No product quality complaint was involved. This case is also related to MARRS# 1512USA001180 (same reporter link). Additional information has been requested.
The patient received both FluzoneHD and Pneumovax23 on same day.  She experienced a fever of 103 to 104 for about 48-72 hours after vaccination.  A red, warm welt appeared around the Pneumovax23 injection site and covered a large portion of her upper arm.  The welt has yet to subside after four days.
From 4:00 PM - 5:00 PM my heart rate escalated from 72 bpm to 166 bpm with chest pains, trouble breathing, shortness of breath, nausea, dizziness. For the next 3 days my heart rate was very irregular and high over 115 bpm.  I spoke with my supervisor to let him know I was not feeling well and he stated if I did not feel well to seek medical attention.  At the time I was immobile and could not stand or walk.
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 25-JUL-2016, the patient was vaccinated with an expired dose of ROTATEQ, orally, lot # L004453 and expiration date 27-MAY-2016 (Dosage and dose number were not reported). No other suspect or concomitants therapies were reported. No adverse effects were reported. No product complain was involved. Additional information has been requested.
Itching and warm to the touch at injection site 12 days after the injection. No itching, redness or warm arm immediately after injection. Started 12 days out.
17 hours after I was given the Covid-19 moderna vaccine I became very febrile, with a fever of 102.2. This was with chills, extreme fatigue, diaphoresis, nausea, and diarrhea. I realize that these are side effects, but I?m reporting it because I am not going to get the second dose. The effects of the vaccine were worse than when I had covid.
shortness of breath; resting heartbeat went below 60 and below 90; received the third shot of the Pfizer Biontech COVID19 vaccine two and a half weeks ago; received the third shot of the Pfizer Biontech COVID19 vaccine two and a half weeks ago; This is a spontaneous report from a contactable consumer (other non-HCP) reported for himself. A 80-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date in Aug2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. second dose; during the first two inoculation, he has no adverse event and just a little unsettledness. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. first dose; during the first two inoculation, he has no adverse event and just a little unsettledness. On an unspecified date in 2021, the patient experienced shortness of breath, resting heartbeat went below 60 and below 90 and received the third shot of the Pfizer Biontech COVID19 vaccine two and a half weeks ago. Caller was a consumer who received the third shot of the Pfizer Biontech COVID19 vaccine two and a half weeks ago. Caller wants to know if it was safe for him to get a haircut. Caller stated that during the first shot, it took one month before he was safe. Caller said that during the first two inoculation, he had no adverse event and just a little unsettledness. In his third inoculation, his resting heartbeat went below 60 and below 90 and he also experienced shortness of breath for 1 week after the shot and it started after couple of days after the shot. Caller also wants to know what it means and if he should discontinue more shots in the future. The patient underwent lab and medical procedure of Heart rate twice on an unspecified date in 2021, with results of below 60 and below 90. The clinical outcome of the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.
Rash on left arm where shot was given but expanding beyond it. Rash red with a slightly dark red outlining the outside of the rash. Hot to the touch, slight itching but more of a burning sensation. Itching/burning sensation being mild.
A few months after I have had chronic inflammation in my body and back of my neck swells huge and get stiff neck.
Morning of 6/29/2021 light headed, increased pulse rate. Visit to local hospital and checked in for tests. Bilateral Pulmonary Embolism. Prescribed Eliquis.
Patient received 1st dose of Pfizer COVID-19 vaccine and was placed in Observation area for monitoring, subsequently left the clinic in stable condition. Patient later took PO Benadryl and had no relief of itching. Patient came back to the Vaccine Clinic and reported to the EMTs on site post vaccination experienced itching, nausea and vomiting x 1, slight mouth swelling and new complaint of chest discomfort. VS: Stable. While walking patient experienced a syncopal episode lasting 2 seconds. Post A&O x 4, pt placed in trendelenburg position, ice applied to itchy areas of neck. VS and O2 sat stable. Visible rash, mouth swelling and itching present. Benadryl IM administered by EMT, patient continued to be assessed for an additional 15 minutes, then complained of more chest pain. VS remained stable, EMTs transferred to ER. Later received epi IM x 1 with relief.
contracted covid-19; A spontaneous report was received from a health professional concerning a 26-year-old, female patient who received Moderna's COVID-19 vaccine and experienced COVID-19 infection.  The patient's medical history was not provided. Products known to have been used by the patient were not provided.  On 21 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 06 Jan 2021 , after she received the mRNA-1273 vaccination, the patient experienced COVID-19 infection. Patient is still having symptoms. Treatment information included only that the patient took tylenol.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, Covid-19 infection, was considered unknown.; Reporter's Comments: Based on reporter's causality , the event COVID-19 is assessed as unlikely related to mRNA-1273.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case  received from a Nurse. This case involves a five-years old male patient who received a dose of vaccine FLUZONE QUADRIVALENT on 15 Oct 2018 and another dose of the same vaccine at the school on 19 Oct 2018, (lot number not reported) via unknown route in unknown administration site for both. Patients past medical history, medications, vaccinations, concomitant therapies were not reported. It was a case of actual medication error due to extra dose administered. It was not reported if the patient had any adverse event. 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.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-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 (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (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 any concomitant medications were reported. No any treatment medications were reported.  The patient had no adverse events.
Pfizer covid vaccine first dose given on 4/20/21 Tuesday. First sign/symptoms of right palm and finger numbness noticed on Saturday 4/24/21. This numbness sensation continue through 4/24 to 4/26, while frequency increased and also noted becoming more severe and noticeable. On 4/27 to 4/28, noticed also right thigh and right buttock numbness occurred, and right hand (arm) numbness noticed on top of right finger/palms.  On 4/28 and 4/29, noticed the numbness increased in severity. Noted a bit numbness or stiffness of neck, especially right side.  A bit concern if it's adverse event from covid vaccine, and if this is temporary. Will continue monitor and self assess, may need contact local health facility or emergency room if continue worsen.
Temp 104.8(R) & screaming in the evening of 14FEB90; Developed viral exanthem 16FEB90;
This spontaneous report was received from a physician refers to a 12 year old female patient. Patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with first and second doses of GARDASIL injection (dose, frequency, lot # and expiration date unspecified). Concomitant medications were not reported. On an unknown date directly after receiving both first and second doses of GARDASIL, the patient experienced dizziness, vomiting and swelling. The patient was not administered with third dose. No product quality complaint (PQC) was involved. Causality assessment was not provided. Additional information has been requested.
Approximately 12 hours after receiving the injection I experienced, and continue to experience as of 11/9/21, a slight tingling sensation on the upper and lower lip (left side only) and in my left hand index and middle fingers (more on index than middle).
pt running temp 104.2, 101, 102.8; irritable, not eating well;crying all noc, diarrhea, lethargic, resp arrest & sz-pt died;
Patient reported that after receiving PNEUMOVAX 23 vaccine, her entire left upper arm and part of lower arm became red and swollen, with 2 scabs on the arm. She said that she also had a fever and felt lethargic. She went to her primary care physician, who advised her that she may be having an allergic reaction, possible to the PNEUMOVAX since she has had flu vaccine several times with no problems. He advised her not to receive the pneumococcal vaccine again in the future. The patient reported this to our pharmacy on 8/14/17.
5-6-08 night, right ankle started hurting, got better, raising leg up.  Later that night, joints started hurting in legs.  5-7-08 elbow and forearms (more on right arm) and hand swollen, weakness.  5-8-08 arms (more on right arm) pain, swollen and limited ROM, muscle tightness.  Client had taken Tylenol and Aspirin; still had sore on shins.  5-9-08 hands swollen still.  Knee sore, muscle cramping and throat sore.  5-14-08 feeling better.  Just little sore on elbows and knees, (probably from limping before).  Still taking Tylenol and antihistamine recommended by PMD.
Lumps/soreness in armpit; Lumps/soreness in armpit; This is a spontaneous report from a contactable healthcare professional, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an intramuscular route of administration in the right arm on 01Sep2021 at 15:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an intramuscular route of administration in the right arm on 11Aug2021 at 16:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 02Sep2021 at 10:00, the patient experienced lumps/soreness in armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lumps/soreness in armpit were not resolved at the time of this report.
Vaccine received on 5-3-07. Lump and redness at site noticed on 5-5-07. Continues on 5-8-07. Some tingling sensation at injection site noted on 5-8-07. Tender 3cm nodule at injection site, 5-8-07, no wheezing, no distent rash, no orthostatic, hypotension, no oral swelling.
Chills, shivering, low fever, Heart rate at 150 to 160 bpm for a period of an hour on the morning after injection from 7am till 8am. Sore shoulder and general body aches. Soreness in joints. Very fatigued and poor sleeping the evening after vaccination
This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, or concomitant therapies were not reported. On 07-JUN-2017, the patient was vaccinated with a properly stored but expired dose of VAQTA injection administered intramuscularly (dose was not reported) lot number K018181 and expiration date 04-JUN-2017, for prophylaxis. No adverse effect was reported. Additional information has been requested.
PEDVAX HIB WAS ADMINISTERED INTO CHILDS R THIGH @ 1415 WHEN PT WAS FINISHED WITH APPOINTMENT AT AROUND 1440 STAFF NOTICED A WELT AND REDNESS AROUND THE AREA THE VACCINE WAS ADMINISTERED IN NURSE EXAMINED PATIENT DOCTOR CAME TO SEE PATIENT AND ORDERED TO ADMINISTER BENADRYL. PATIENT WAS SENT HOME WITH BENADRYL.