chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shot given at 1330, rash was noticed at 1340, 50mg of Benadryl was given in the right arm IM. Rash began to fade around 1415. Lung sounds were evaluated after Benadryl was given and were clear, itching began behind the ear, rash covered neck back and chest, face was red, blood pressure and pulse were elevated with highest reported at 146/95 lowest at 126/84 at time of release, and tingling of the tongue. Sent to urgent care clinic and received 60mg Prednisone PO, the prescribed 20mg tablets of Prednisone and 25mg tablets Atarax PO PRN. No anaphylactic response reported.
Caller reported vaccine administered after temperature excursions; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies, and concurrent conditions were not provided.  On 16-AUG-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, a dose of 0.5ml, administered subcutaneously, lot # W017567, expiration date 29-NOV-2023 (dose number, strength and anatomical location were not provided) for prophylaxis (product storage error). The administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) underwent temperature excursion on 10.9 Fahrenheit degrees for 1 hour and 30 minutes. There were no previous temperature excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA000437:02237204 US-009507513-2209USA000235:02237237 US-009507513-2209USA000255:02237256 US-009507513-2209USA000438:02237157 US-009507513-2209USA000361:02237219 US-009507513-2209USA000179:02237190 US-009507513-2209USA000374:02237270 US-009507513-2209USA000350:02237201
Recived the flu shot on 10/28/14. A couple hours later my left arm started going numb and continued to stay numb. Came to work 10/29/14 it still numb. But the numbness and the tingling started coming down my left ribs and up the left side of my face and my lips was numb on my way home that night. The next day the 10/30/14 I went to ER room. I was having facial drooping and completey numbness and tingling in my left upper body and arm and face. After ER dr had seen me and ordered blood work and conducted a neuro test he had determined my left side to be greatly decreased from my right side. He consulted my Primary and a Neuro Dr. They continued to watch me for a few hours and they had agreed it was a reaction to flu shot and had started me on prednisone for 10 day. I was to follow up with primary MD on Tuesday and if the tingling and numbness was not better by Tuesday I am to see a neuro Dr. and I was instructed to not lift with my left arm and if I got any burning or the symptoms I was having got worse to get back to the ER immediately.
Tightness in back of neck and jaw. Tightness started to resolve after about 10 more minutes. Patient admitted that she was stressed and anxious and it might have been those things that caused the tightness. Felt well after 30 minutes.
Rash - 4/15/19 Fever - 4/17/19 -> 103-104 Febrile Sz - 4/17/19 - ED eval
Monovalent Pfizer vaccine administered in error instead of the Bivalent Booster
injection site discomfort; This case was reported by a consumer via other manufacturer and described the occurrence of injection site discomfort in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19, lung disease, smoker (Family History), pancreatic cancer (Family History) and lung cancer (Family History) (Oat cell). Concurrent medical conditions included psoriatic arthritis (diagnosed 30 years ago) and blood pressure high. Concomitant products included valsartan (Diovan).   On an unknown date, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown.   It was unknown if the reporter considered the injection site discomfort to be related to Shingrix.  Additional details were reported as follows: The concomitant medication included Diovan started 3.5 years for high blood pressure. The reporter mentioned that he only takes some health store vitamins.  The patient historical condition included COVID 19 in Mar 2020. They were all smokers in his family and he was not.  His sister died of Pancreatic cancer and his mother died of Oat Cell Lung Cancer. The patient had an issue with a lung disease when he went to another country.  He took Remicade. It was 5 years ago. He was taking this Remicade Arthritis medication administered intravenously and apparently it lowered his immune system and he wound up in the hospital with a lung infection. He recovered completely. The patient had 2nd dose of Shingrix 4 weeks ago in upper left arm and experienced slight injection site discomfort. It was administered in the physician office and he did not went to that doctor anymore.  The patient received Pfizer BioNtech COVID 19 vaccine on 26th Jan 2021 and had slight injection site discomfort.  The reporter consented to follow up.
Patient describes rash/hives all over body, this occurred 3 hours after vaccine administration. Pt. reported this today.
nervous about rash; "heart beat rate because of panic"; "foggy brain"; "real dizzy"; rash on the face; headache; swollen lymph node left side; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (nervous about rash), PALPITATIONS ("heart beat rate because of panic"), FEELING ABNORMAL ("foggy brain"), DIZZINESS ("real dizzy") and RASH (rash on the face) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) for Allergy.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (swollen lymph node left side). On 07-Jun-2021, the patient experienced NERVOUSNESS (nervous about rash), PALPITATIONS ("heart beat rate because of panic"), FEELING ABNORMAL ("foggy brain"), DIZZINESS ("real dizzy"), RASH (rash on the face) and HEADACHE (headache). The patient was treated with HYDROCORTISONE ACETATE (CORTISONE [HYDROCORTISONE ACETATE]) (topical) for Rash, at an unspecified dose and frequency. On 30-May-2021, LYMPHADENOPATHY (swollen lymph node left side) had resolved. At the time of the report, NERVOUSNESS (nervous about rash), PALPITATIONS ("heart beat rate because of panic"), FEELING ABNORMAL ("foggy brain"), DIZZINESS ("real dizzy"), RASH (rash on the face) and HEADACHE (headache) outcome was unknown.
Red rash on both sides of my neck and on the arm where I got the shot. They are not itchy, just weird and annoying. I have not had this response with previous vaccines that I've had in my lifetime. I'm giving this a week to subside and if it doesn't I'll go see a doctor.
Five minutes post vax, pt experience paleness, dizziness, light headedness. Helped to the floor - laid down. Rested for 10-15 minutes with cool cloth on forehead. Assisted to chair and car. At home pt became dizzy and fell down. At emergency room, she was given Epinephrine with an additional shot. Also complained of difficulty breathing.
Swelling of the face. The Next Morning hives were seen all over the body and swelling to the face. Doctor administered Benadryl and steroids orally. 2 hours later, redness and hives disappeared. Around 8pm that night, couple dots of redness showed on the face. Again, the next morning baby had same symptoms. I gave him Benadryl and steroids again per doctor. I also gave him Benadryl every 6 hours prior.
After both my first and second shots I became incredibly thirsty.  I needed to pee more than usual and could not stay hydrated.  This morning I nearly fainted and think it was due to dehydration.  I also ran a low fever, had chills, body aches and a very strong headache.  But the thirst seems unusual.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/23/21 2nd dose01/12/21 Diagnosed covid positive:08/26/21 Symptom onset:08/26/21 Exposure:community Symptoms:Headache.
At about 9 days past vaccine, I developed a really itchy arm that became inflamed and lasted for just about three days.  At 14 days past vaccination, I have developed "Covid Tongue."  My tongue is coated with white and scalloped around the edges.  I quarantine stringently due to my diabetes and have only been to the grocery store once where I was double-masked.  That is my only contact outside of the home.  No one comes into our home - it's just my husband and me - and we both quarantine the same.  I did an appointment with a doctor who suggested that it is probably a side-effect of the vaccine since I have no other symptoms at all.
Per employee email: I want to let you know that I believe I had an adverse reaction to the flu shot I received Wednesday evening. Within a few hours of the vaccine, I felt nauseous and vomited. I tried to work the next day, but had to leave work due to vomiting. I also had a low grade fever. I have never had an adverse reaction to the flu shot, and have gotten one every year for 20-30 years. I am not sure what happened and what I should do next year. I was fine by Friday evening. I wonder if having the surgery on my pancreas has anything to do with how I responded.
as if got hit by the truck; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (as if got hit by the truck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (as if got hit by the truck). At the time of the report, FEELING ABNORMAL (as if got hit by the truck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment details were not provided.   Reporter did not allow further contact
Very sore muscles from right lower shoulder blade, upper and lower arm. Holding arm out in front would make much worse. Ibuprofen helps.  4 week later much better but not completely gone.
Menveo inappropriately reconstituted; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA583A, expiry date 31st August 2022) for prophylaxis.   On 22nd August 2022, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The registered nurse reported that one day before the reporting date, a patient received the the powder (MenA) portion only of Menveo diluted with sterile solution and another patient received the liquid portion of Menveo (MCWY) diluted as well with sterile solution.  It was unknown which patient received each part of the vaccine. The reporter mentioned that the patients were a female and a male but it was unknown which one received the powder portion or the liquid portion. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received Menveo vaccine which was incorrectly reconstituted, which led to wrong solution used in drug reconstitution. This case is for 1 of 2 linked patients reported by same reporter.; Sender's Comments:  US-GSK-US2022122728:Same reporter
Patient required hospitalization due to breakthrough infection. She received JnJ vaccine on 05/21/21. Hospitalized from 07/18/21 - 07/26/21. Below is copied from discharge summary:   Hospital Course:   This is a 64-year-old female with past medical history of morbid obesity/arthralgias, presents with lower extremity edema and pain along with shortness of breath after testing positive for COVID-19.  Patient has been vaccinated withJ&J vaccine last month.     Acute hypoxic respiratory failure secondary to COVID 19 Better, tolerating nasal cannula Completed remdesivir.  Continue decadron  Keep PRN albuterol inhlaer Muccinex PRN D/c to a facility.   Essential hypertension / NIDDM  Resume outpatient medications   Bilateral lower extremity arthritic pain  Continue p.r.n. pain medications US neg for DVT   Seizure disorder  - stable continue Trileptal
Per patient report: Soreness and pain in right away after injection. That night severe pain and difficulty sleeping related to pain. Decreased of ROM and decreased weight bearing. Increased pain with elevated of arm and needed to provide support to raise arm. Injection was to close too shoulder. 9/15/2017 Today slow improvement but still pain decreased ROM and problems occasionally sleeping related to pain. Would like PT/OT order.
pain started in jaw line under left ear in the A.M. swelling began shortly after first pain. went to the doctor about 1:00 P.M. he said it was a salivary gland infection and gave me a prescription for amoxicillin 500 mg capsule 3 a day for 10 days, The swelling continued by 5:00 P.M. the entire left side of jaw was swollen from ear to jaw line. On Nov 3 when I got up in the morning my neck was very swollen.
Patient reported mild case of hives following her immunization. Patient is treating with Benadryl and has mostly resolve after 2 days.
Severe swelling at point of injection occurs w/in 2 minutes of administration. Ice helped control swelling. Pt. was taken to physician was diagnosed it as simple hematoma.
Right arm pain (injection arm) that began at 8:35 AM. Rated pain 6/10.  Vital signs: T 98.1 F, BP 145/103, HR 90, RR 18, SPO2 98%. Assessed by onsite MD. Staff also complained of feeling  tired. Returned to work after injection. Staff advised to take ibuprofen 800 mg with a meal and monitor symptoms. Advised to contact PCP if not improving over next 3 days. Also advised cool compress to area by MD.
Vaccination site inflammation; Hives; itch left arm; left arm red; inflammed left arm; Rash; Injection site itching; Injection site redness; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Vaccination site inflammation), URTICARIA (Hives), PRURITUS (itch left arm), ERYTHEMA (left arm red) and INFLAMMATION (inflammed left arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid cancer on 07-Jun-2015. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 07-Jun-2015 to an unknown date and LIOTHYRONINE for Hormone replacement therapy, CALCITRIOL and CALCIUM CITRATE for Hypoparathyroidism.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced VACCINATION SITE INFLAMMATION (Vaccination site inflammation), URTICARIA (Hives), PRURITUS (itch left arm), ERYTHEMA (left arm red), INFLAMMATION (inflammed left arm), RASH (Rash), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) (oral) on 17-Jun-2021 for Symptomatic treatment, at a dose of 1 dosage form; NAPROXEN SODIUM (ALEVE) for Symptomatic treatment, at a dose of 1 dosage form; HYDROCORTISONE on 17-Jun-2021 for Symptomatic treatment, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) on 17-Jun-2021 for Symptomatic treatment, at a dose of 1 dosage form. On 17-Jun-2021, VACCINATION SITE INFLAMMATION (Vaccination site inflammation), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 18-Jun-2021, URTICARIA (Hives), PRURITUS (itch left arm), ERYTHEMA (left arm red) and RASH (Rash) had resolved. At the time of the report, INFLAMMATION (inflammed left arm) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant follow up On 09-Aug-2021: Follow up received and contains No new information.
10-6-08 received pneumococcal vaccine right arm.  That evening upper arm swollen, turned red, was so painful he thought his "arm would fall off".  Shortly after, sweats and fever developed, then very sore throat, itchy watery eyes.
On 10/11/13 woke up with "extreme" sore throat and persistent thru 10/12/13. On 10/13/13 Sunday (5AM) reports throat started to swell. Patient takes 2 BENADRYL 25mg every night for sleep. Took BENADRYL (2) Q 4 hr x2 - swelling less pain persisted.
At approximately 9:00PM om March 7, 2021 I started to feel very tired and was starting to have trouble breathing. My O2 level was  between 89% and 91% and my heart was racing. The oximeter I have showed 98/99 BPM. I also had a temperature of 99.9 degrees.  Most of these symptoms started to subside after about 2 hours
Call center received call from pt on 4/26/21. Pt states she has her regular menstrual period from 3/31/21-4/2/21. On 4/7/21 pt got her Janssen vaccine at the vaccine site. Pt states on 4/7/21, her menstrual period started again and has been heavy, with some pieces still ongoing today. Advised pt to go to ED.
Information has been received from a nurse concerning an 18 year old female with no known allergies and no other pertinent medical history reported.  On 18-AUG-2006, the patient was vaccinated intramuscularly in the deltoid with a 0.5 ml "single dose prefilled syringe" of HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0702F).  There were no concomitant medication reported.  On 18-AUG-2006, the patient developed severe injection site pain with HPV rLi 6 11 16 18 VLP vaccine (yeast) injection.  The patient remarked that "it hurt and felt that the injection went to her head".  The nurse reported that the patient felt faint immediately after the vaccination.  The nurse had the patient lay down.  It was reported that the patient "got up after 1 minute and said that she was ok.". The nurse reported that the "patient left the office immediately after this and the nurse was following up with the patient later today to make sure that the patient was ok."  The nurse reported that she had not agitated the syringe prior to injection.  The patient sought unspecified medical attention.  There were no laboratory diagnostic studies performed.  On 18-AUG-2006, the patient recovered from the events.  Additional information has been requested.
Issue with prostate infection; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATE INFECTION (Issue with prostate infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Prostate infection in 2016.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PROSTATE INFECTION (Issue with prostate infection). At the time of the report, PROSTATE INFECTION (Issue with prostate infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported .  The patient reported that the patient took the first dose of moderna 32 days ago. The second dose is pending. The patient also mentioned that two weeks back again patient experienced the same symptom. The patient is not clear that if this was a side effect of the vaccine.  The patient is taking antibiotics currently.; Sender's Comments: This case concerns a patient of unknown age and gender conservatively taken as "male" due to the medical history of prostate infection who experienced the unexpected event of prostate infection. The event occurred after the first dose of Spikevax. The medical history of prostate infection remains a confounder. The benefit-risk relationship of drug Spikevax is not affected by this report.  The event prostate infection doesn´t  seem to be serious by medical judgement and from a clinical or regulatory standpoint.
This spontaneous report as received from a consumer refers to her daughter of unknown age. On an unknown date the patient was vaccinated with first dose of GARDASIL (dose and route of administration were not reported). The patient missed her second dose of GARDASIL a year later. Additional information is not expected, because there were no contact details reported.
Information has been received from a medical assistant referring to a 9 week old female patient. No relevant medical history or concurrent conditions were reported. On 17-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
This spontaneous report as received from a nurse, refers to a 10 patients of unknown age and gender. On an unknown dates, the patients were vaccinated with RECOMBIVAX HB (dose, route, lot# and expiration dates were not provided) that had been improperly stored. No adverse effects reported. This is one of two reports received from the same source. Additional information is not expected, because there was no consent to contact the reporter.
1. Left arm very sore, could not abduct more than 40 degrees, hard time sleeping, lasted for about 26 hours 2. Elevated temp to 100.2 F with chills and myalgia, lasted about 8 hours on second day 3. Diarrhea and indigestion for 2 days
Hot to the touch, Bump/Raised  Rash , itchy to area where shot was injected
Report of fever, nausea, body aches, HA and mild congestion with lying down, but no congestion with sitting and standing day 1 post vaccination. Treatment: Ibuprofen. Outcome: Mild improvement , no interference with ADLs.