chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an 18 weeks old female patient who on 14-JUN-2011 was vaccinated with a dose of ROTATEQ (Lot Number 0059AA is an invalid lot number for ROTATEQ; expiration date unknown). On 14-JUN-2011 the patient received ROTATEQ and developed hives upon the face immediately. The patient did not seek medical attention. The symptoms resolved without treatment within 15 minutes. Follow-up information was received from a registered nurse who stated that the 18 weeks old female patient with no illness at time of vaccination and no pre-existing allergies, birth defects and no medical conditions, was vaccinated with PO with the second dose of ROTATEQ (lot # 669832/0259AA) at 9:45 am. It was reported that within 5 minutes of receiving the second dose of ROTATEQ, the patient developed hives on body. There were no signs of respiratory diseases or facial swelling. There was no diagnostic test performed. The symptoms resolved spontaneously after 15 minutes. Additional information is not expected.
Began in January 2022 with just pain under both arms. The pain was mild then became more severe. Noticed a strange rash under both arms. It started about quarter size and slowly began to spread larger and left a strange white spot in the middle as it spread the white patch grew with blister like rash at the edges. There was no itching, just pain and burning. I saw it growing and became alarmed as the pain and the white spot grew under both arms till they were hand size. I went to the doctor finally after trying everything myself to treat it! In January 2023  the dermatologist did not know what it was he took a sample biopsy. I received two different possible diagnoses. I realize these are both related to autoimmune diseases. Lichen Sclerosis et Atrophicus and Morphea. The lab is sending slices of the biopsy to other labs to confirm. I am also going to a Rheumatologist for more blood work. I had two initial CoVid shots Jan 2021 and February 2021 both Pfizer. Then the booster was Sept 2021. After the booster I became very very tired.
Received vaccine that had been more than 30 days in the refrigerator / vaccinate past its expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine that had been more than 30 days in the refrigerator / vaccinate past its expiration date) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine that had been more than 30 days in the refrigerator / vaccinate past its expiration date). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine that had been more than 30 days in the refrigerator / vaccinate past its expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the carton of vials was stored in the freezer on 01-Sep-2021. Expiration date of vial was 01-Oct-2021.  No Concomitant medication reported. No treatment medication reported.
18Sep90 pt vax w/ hepta B. 24Sep90 pt devel diarrhea and abdo cramps. Stool culture was negative.  Sx resolved after 10 days. TOR pt remained under tx.
Severe headache, nausea, malaise, migraine ( 2 weeks), and fatigue. Took excedrin and imitrex for 2 weeks. Intake of lots of fluids and bed rest. Telehealth visit with doctor.
Within minutes my throat and bronchial air ways became inflamed and I could not stop couching.  My throat was hurting and filling up with mucus.  The medical staff administered an injection of benedryl and it kept the symptoms under control. I stayed for and hour and then went home.  I continued to have inflamed air ways through out the night and all the next day.  I am at this time 24 hours later having mild inflamation in my air ways and overall aches and pains in my neck and all over body.
fatigue, confusion, agitation. racing thoughts, rapid heartbeat, SOB, headache, and body aches X 3 days so far. (Ongoing not as severe as day one)
10/1/21 for COVID pneumonia after presenting with hypotension in the setting of increased ostomy output. increasing oxygen requirements and eventually required initiation of HFNC.
A physician reported that her 16 month old daughter received her fourth dose of Hib-Titer and Infanrix vaccines on 06/08/00. Twelve hours post immunization, she developed an injection site reaction characterized by redness, swelling, and warmth at the site of Hib-Titer administration. She was treated with Zyrtec and had "moderate" relief of the symptoms. Additional information received from the reporter indicated that the child developed a 13cm by 10cm area of erythema and induration at the Hib-Titer administration site. She recovered within 5 days.
Patient presented to emergency department on 10/20/2021 with shortness of breath. He was found to COVID-19 positive on 10/1/2021. He was treated with supplemental oxygen. He was discharged home on 10/24/2021.
Patient told us he already received first dose of Moderna covid vaccine  at another location. He  was overdue for his 2nd dose. We administered the shot. The next day he reported to us that he actually received the Pfizer covid vaccine (his error).   He reported typical symptoms from the covid vaccine (tiredness, achy muscles) .
Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an unspecified number of improperly stored doses of oral, ROTATEQ (lot # K024700 with expiration 13-JUL-2016; lot # K011948 with expiration 07-JUN-2016; lot # L000569 with expiration 13-JUL-2016; dose and frequency were not reported) orally. No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
severe flulike symptoms; fever; joint aches; muscle aches; sweating; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of adverse reaction (1st shot had very little to no adverse side effects).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms, fever, joint pain, muscle pain and sweating. On an unknown date, the outcome of the influenza-like symptoms, fever, joint pain, muscle pain and sweating were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, joint pain, muscle pain and sweating to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received 2 shot series of Shingles vaccine. The patient received the 2nd dose of Shingles vaccine and experienced severe flu like symptoms for about 24-36 hours, fever, joint, muscle aches and sweating, but then it was gone. The patient reported that the vaccine was absolutely worth getting. Follow-up would not be possible as no contact details available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195197:Same reporter
Intense headache started around 3 p.m (vaccinated close to 11:00 a.m.). Nausea followed. Took acetaminophen before bed because of the headache. Woke up in the middle of the night with shakes and chills. Headache worse. Was hot and sweaty. Took temp, was 99. Likely low due to high acetaminophen dose. Shakes lasted for about 2-3 hours. Slept until 12:00 p.m. today. Still having some "hot flashes" but feel much better.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: syncope x3 and hyptotensive event after injection, 911 was called for evaluation, was taken to local hospital, followed up with patient 12/9/21 and patient states he is fine and no longstanding issues.
Minor ringing in ears started day after vaccination.  Did not originally connect it with the vaccination.  It has progressivley gotten worse.  I now have ringing in the ears  2-3 times a day for 1/2-1 hour each time.
Headache; Fatigue; He reports that he the injection site was bothersome; injection site hurts a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (He reports that he the injection site was bothersome), VACCINATION SITE PAIN (injection site hurts a little bit), HEADACHE (Headache) and FATIGUE (Fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 22-Mar-2021. Concurrent medical conditions included Multiple sclerosis (worst balance, fatigue ,gait. Received a monoclonal antibody treatment in March of 2021.) since 06-Jan-2008. Concomitant products included FAMPRIDINE (AMPYRA), MODAFINIL (PROVIGIL [MODAFINIL]), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), BACLOFEN, TELMISARTAN, DILTIAZEM, METHOTREXATE SODIUM (METHOTREXATE INJECTION BP), METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL), MIRABEGRON (MYRBETRIQ), ROSUVASTATIN CALCIUM (CRESTOR), MONTELUKAST SODIUM (SINGULAIR), SAXAGLIPTIN HYDROCHLORIDE (ONGLYZA [SAXAGLIPTIN HYDROCHLORIDE]), LORAZEPAM (ATIVAN), ALBUTEROL [SALBUTAMOL], VITAMIN D [VITAMIN D NOS], CALCIUM, SERENOA REPENS FRUIT (SAW PALMETTO [SERENOA REPENS FRUIT]) and RITUXIMAB (RITUXAN) for an unknown indication.    On 30-Jun-2021 at 7:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced VACCINATION SITE DISCOMFORT (He reports that he the injection site was bothersome) and VACCINATION SITE PAIN (injection site hurts a little bit). On 30-Jun-2021 at 10:00 PM, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). On 01-Jul-2021, HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, VACCINATION SITE DISCOMFORT (He reports that he the injection site was bothersome) and VACCINATION SITE PAIN (injection site hurts a little bit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient took dose 2 on 28-Jul-2021.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-272092 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Added patient demographic, added medical history, added lab data, added dose 2 details, updated concomitant medication details, added event fatigue and updated event outcome.
After 20 minutes of administration patient became dizzy. Patient saw black spots. Patient lost color in face and stated she felt funny and going to pass out. Patient sat down and was told to drink water. Dizzy episode lasted 10 minutes with no loss of consciences. Bp after loss of color was 120/77 with sinus tach present. Was able to ambulate to bathroom. After 30 minute another dizzy  episode happened with loss of color to face and patient slumped over this time with no loss of consciences, patient stated right before she slumped over that she felt numb.  Patient looked dazed and out of it. episode lasted 15 minutes. Patient stated she felt off and ambulance was called. Patient had one dizzy episode in ambulance while emt stated she lost color in face. Iv was placed fluids started, vitals were normal except for sinus tach 110-130's . Patient received fluids in emergency room and monitored where bp remained stable and sinus tach present 100- 120's .
The pt felt nausea one hour post vax, joints began to get stiff and there is a tingling in the throat when breathing. Hot flashes, increased heart rate, and shortness of breath.
on anticoagulation wtih xarelto for a fib started having rectal bleeding 1 wk after  moderna #1 2/6/21 then again 1 wk after moderna #2 3/6/21. pt has continued to have intermittent bleeding since 2nd vaccine
Patient hospitalized for placement of a watchman device within 6 weeks of receiving COVID vaccination booster.
02/25 I had my first dose- within the 15 minutes after I felt dizzy and lightheaded. it subsided enough for me to drive home. I was tired for a few days. injection was very high up in my shoulder and about 3 weeks after I had tenderness in my elbow. My physical therapist said it was due to the injection being too high. 03/25- halfway home I had a significant headache. It diminished but I then got very very sleepy. I napped and then made dinner. 03/26 I was doing normal things and I felt cold, then my hands were very cold. I ate lunch but was very sleepy just before lunch. I then had a fever,  My temp is 101.1. I have had a little drainage from one side of my nose.
A report was received on 01/02/02, from an unknown source concerning a 27 year old male patient who experienced influenza like illness the same day as he was administered Fluvirin vaccine on 12/04/98.
Pt describes narrowing/spotty vision and prickling sensation in the fingers/ feeling cold in the extremities that improved after about 30 minutes
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 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (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 concomitant medications were reported  No treatment medications were reported   This case was linked to MOD-2021-395985 (Patient Link).
Sore around injection site within four hours of recieving vaccine, dose 2, pfizer. 101 degree Fahrenheit fever developed eight hours after injection. Fever lasted 48 hours. Swollen armpit (assuming this is swollen lymph nodes)  discovered in the morning of June 3, 2021 (injection received morning of June 1, 2021).
malaise; headache; and fatigue for 24 hours; This spontaneous case was reported by a health care professional and describes the occurrence of MALAISE (malaise), HEADACHE (headache) and FATIGUE (and fatigue for 24 hours) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (malaise), HEADACHE (headache) and FATIGUE (and fatigue for 24 hours). At the time of the report, MALAISE (malaise), HEADACHE (headache) and FATIGUE (and fatigue for 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No Treatments were reported.   This case was linked to MOD-2021-015012 (Patient Link).
THIS WAS GIVEN TOO SOON, 1ST VACCINE WAS GIVEN 12-15-2020
pt exp paresthesias in the lower extremities & torso upon recv vax;pt was subsequently dx w/mild case of GBS which has slowly resolved over the past few months;
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and 2 weeks later got a good case of shingles.
Injection site - hot and swollen; Fatigue; Low grade fever; chills; general malaise.
LIMB EDEMA, REDNESS UNDER THE SKIN ALL DOWN MY LEGS AND ARMS, AND SWELLING AROUND MY BACK, LIKE LYMPHEDEMA. NOW, FIVE MONTHS LATER MY LEGS CONTINUE TO SWELL DAILY WITH CELLULITE ON THE FRONT, REDNESS,FLUID STUCK IN MY KNEES AND SOMETIMES PITTING EDEMA. ALSO CALF SWELLING AND TIGHTNESS.
Headache, itching.  Redness, swelling, hot to touch and hard to touch arm where vaccine was given.
This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient was vaccinated with first dose of PNEUMOVAX23 in October 2003 and second dose (intramuscular, 0.5ml, Lot# reported as H010515, Exp date 13-Feb-2014) on 29-SEP-2012. Concomitant medications included lisinopril, simvastatin, an antihistamine and aspirin. On 29-SEP-2012 the patient began to experience some discomfort in the injection arm. On 01-OCT-2012, the patient presented to the pharmacist with her injection arm red, warm and an area approximately 4 inches by 6 inches swollen. The area of swelling extended distally to the patient's elbow. The patient had sought medical attention via consulting pharmacist and no treatment was given for the adverse events. At the time of reporting the outcome was unknown.
pt went to MD office, pt had erythema multiform-hives;started getting hives on 15JUL98-16JUL98 went to MD again 20JUL98 rash was worse;
Sore arm where shot was given, very tired, fever, chills, achy all over. Symptoms lasted 24 hours.
PT WAS NOTED TO HAVE A RED RAISED AREA APPROXIMATLEY 10/5MM INDURATION AFTER VACCINE WAS GIVEN. PT WAS ASKED TO STAY IN CLINIC FOR OBSERVATION, 1 TEASPOON OF BENADRYL WAS GIVEN PO. MOTHER WAS INSTRUCTED TO MONITOR FOR OTHER SIGNS AND SYMPTOMS OF ALLERGIC REACTION INCLUDING HIGH FEVER OVER 102 AFTER ADMIN. CHILDREN TYLENOL/MOTRIN, RASH THAT CONTINUES TO INCREASE IN SIZE OR THAT GOES ALL OVER BODY, SOB,LETHERGY NEDDS TO BE REPORTED TO EMERGENCY ROOM AND/PRIVATE PHYSICIAN ASAP.MOTHER STATES THAT SEE UNDERSTANDS. PT ALSO INSTRUCED TO INFORM PRIVATE DR. OF REACTION ASAP.
HYPOTENSION 11/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
4"band around both arms with strong pain & pressure, finger joints "lit up " pain, chills, fever, headache, cold feet/hands & back, light headness -feeling might pass out, sneezing, coughing, extreme fatigue,nasal discharge, loss of taste, nausea, stomach ache, knots in throat (very painful) & swelling.
Starting date and time not remembered exactly. It was some time in March 2021. I felt an itch on my upper back, then it started on my lower back, my stomach, groin area and lap. There were some red spots also. It lasted until November or December 2021. I saw a dermatologist and received a  steroid shot for itch relief. The doctor also prescribed a topical medication. He said it was eczema. We did not associate it with the COVID-19 vaccine at the time. I later on changed my mind.
Patient had MENACTRA on 6/11/13. Developed complaints of leg and arm weakness, tingling first week of August 2013. Diagnosed with neuromyelitis optica in mid August, between 8/16 and 8/20/13.
Information has been received from a physician concerning an approximately 14 or 15 year old male patient who approximately three weeks ago, on approximately 13-SEP-2010 was vaccinated with a dose of VARIVAX (Merck) and with hours of immunization he had a bad reaction of cellulitis at the site of injection probably around 8 cm with pain, swelling, tenderness, warmth and redness around the injection site. The patient was treated with BENADRYL, however his symptoms did not go away. At the time of the report the patient had not recovered. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from the Healthcare worker via Company Representative refers to a patient of unknown age and gender. Patient's pertinent medical history and drug reactions/allergies were not specified. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). Concomitant medication were not specified. On an unknown date the patient experienced shingles. It was not specified if the patient sought medical attention and if the treatment was given for the event or lab diagnostic studies were performed. There was no intervention to prevent serious criteria. The patient recovered from shingles on unknown date. Relatedness between the event and ZOSTAVAX was not specified. Additional information has been requested.
itchiness on and off in the arm/itchiness in the legs; terrible pain in the arm; intense pain; Foot very swollen and the other one less swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on and off in the arm/itchiness in the legs), PAIN IN EXTREMITY (terrible pain in the arm), PAIN (intense pain) and PERIPHERAL SWELLING (Foot very swollen and the other one less swollen) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchiness on and off in the arm/itchiness in the legs), PAIN IN EXTREMITY (terrible pain in the arm), PAIN (intense pain) and PERIPHERAL SWELLING (Foot very swollen and the other one less swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness on and off in the arm/itchiness in the legs), PAIN IN EXTREMITY (terrible pain in the arm), PAIN (intense pain) and PERIPHERAL SWELLING (Foot very swollen and the other one less swollen) had resolved.            Concomitant medications include high blood pressure medications, cholesterol  medication, diabetes medication.  It was reported that the doctor changed some of the medication the patient had been on and she started to improve.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up  information received on 25-May-2021 does not contain any new information. On 17-Jul-2021: Follow-up received on 19-JUL-2021 and event outcome was updated from unknown to recovered/resolved