chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Leakage at injection site (clear to clear-yellowish); This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (Leakage at injection site (clear to clear-yellowish)) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and #006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced VACCINATION SITE DISCHARGE (Leakage at injection site (clear to clear-yellowish)). At the time of the report, VACCINATION SITE DISCHARGE (Leakage at injection site (clear to clear-yellowish)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   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.
A red, bumpy rash on palms, soles of feet, knees and elbows. Painful on hands, slightly itchy on other body parts. Appeared about 4 days ago, appears to be spreading.  Began on my hands. No unusual headaches or nausea.  (No more or less than usual)
Morning after immunizations pt. developed red welts on (L) leg where vaccine given. Pt. was a little fussy - area reddened - induration 1" diameter - apply ice.
dizziness, nausea, headache followed by syncope episode. was working in the ED and observed by fellow healthcare practioners.  pt observed and treated with antiemetics and was discharged several hours later.
lower back pain; This case was reported by a consumer via call center representative and described the occurrence of low back pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 16th April 2019, less than a day after receiving Shingrix, the patient experienced low back pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the low back pain was recovered/resolved.   It was unknown if the reporter considered the low back pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in the left arm at 11am and by dinner the patient had developed excruciating lower back pain.  The patient stated that the pain was located in the center of his lower back.  The patient took Tylenol to help with the pain.  The patient stated that 2 days after the pain started, it started to decrease and by the weekend, the pain was gone completely.  The patient did not consent to follow-up.
Failure to thrive, Pharyngoesophageal dysphagia, PEG placement, Covid
No adverse events noted. Patient came to get a meningitis vaccine. I dispensed MENVEO but did not realize there were 2 components to vaccine to be reconstituted. Patient only received the MENCYW135 liquid conjugate.
Numbness in face; Doesn't have a lot of movement in the right eye; Cannot move upper lip; Numbness in the lip; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in face), EYE MOVEMENT DISORDER (Doesn't have a lot of movement in the right eye), ORAL DISCOMFORT (Cannot move upper lip) and HYPOAESTHESIA ORAL (Numbness in the lip) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Oct-2021, the patient experienced HYPOAESTHESIA (Numbness in face), EYE MOVEMENT DISORDER (Doesn't have a lot of movement in the right eye), ORAL DISCOMFORT (Cannot move upper lip) and HYPOAESTHESIA ORAL (Numbness in the lip). At the time of the report, HYPOAESTHESIA (Numbness in face), EYE MOVEMENT DISORDER (Doesn't have a lot of movement in the right eye), ORAL DISCOMFORT (Cannot move upper lip) and HYPOAESTHESIA ORAL (Numbness in the lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was provided.  Patient reported that the right part of face was mainly affected.  Treatment information was not provided.
My right upper arm became red, itchy & swollen. I could not move my arm due to severe & constant pain.I called my doctor, who told me to ice the affected area. My arm remained red & swollen for approx. 4days, inspite of applying hydrocortisone cream & ice.I have never had any type of reaction to a flu shot before & this episode was most uncomfortable. My right upper arm remained sore for about 10 days.
positive COVID test after second vaccination; positive COVID test after second vaccination; This is a spontaneous report from a contactable consumer. An 80-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Feb2021 as single dose for covid-19 immunisation and patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on unknown date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Feb2021, the patient had positive covid test after second vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 22Feb2021. Patient not received treatment for event. No covid prior vaccination. Patient has covid tested post vaccination. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous). Route, dose and lot number were not reported. In 2013 (reported as a couple of weeks ago on 21-FEB-2013), one day after vaccination the patient experienced the injection site was red, the injection site was itchy and the injection site was painful. The events lasted for one week. The outcome of the injection site was red, the injection site was itchy and the injection site was painful was reported as recovered/resolved. The injection site was red, the injection site was itchy and the injection site was painful was unknown related to ZOSTAVAX. Additional information is not expected.
sore throat, cough, fever from 30OCT93 to 6NOV93; erythromycin;
A report has been received from a Health Professional concerning a 1 year old, Male subject, who had been receiving Nasal FLUMIST, INTRANASAL), 0.2 Millilitres, Unknown. FLUMIST (INTRANASAL) started on 17-Nov-2015. Nurse inadvertently administered FLUMIST to child 18 months old two days ago. FLUMIST was administered in a family health team clinic. The outcome of the event of INADVERTENT ADMINISTRATION TO CHILD <2 YEARS is unknown. The reporter's description of the event (s) was as follows: no asthma. The report was considered to be non-serious. The reporter considered that there was no casual relationship between INADVERTENT ADMINISTRATION TO CHILD <2 YEARS and FLUMIST.
After third shot I still had some minor itching and later a rash. The rash became severe towards the end of my career in 2002. My mood also begin to change as I was becoming much more aggressive. No one could identify what the rash was and it continued to get worse through my marriage after I was out. Eventually I started getting severe headaches and doing very irrational things that I wouldn't normally do. Finally I passed out in the shower and flew me to the hospital to save my life from a brain hemorrhage. This happened twice and I had 5 blood clots throughout. They've tested for every blood clotting Factor known to man they can't come up with anything. My disorder is simply undiagnosed but I have a feeling I know where it came from and I am working hard to play pin-the-tail-on-the-donkey.
On a Friday in early March, I began feeling quite fatigued. I was sure I had COVID-19 because the rest of my household had already tested positive. I had waves of nausea Friday-Sunday. Saturday and Sunday, the fatigue was to the point that I had to sit down after climbing the stairs. I also began feeling a pressure in my fingers, toes, and face a few days into COVID-19. I checked my blood pressure, and it was at 148 over 110, which I had never seen before. Since then, my blood pressure will sporadically go up like that. It doesn't seem to matter what I'm doing; I may check my blood pressure and it will be high like that, but then it will go away on its own. My doctor has prescribed lisinopril for now to see if that helps. I actually never tested positive for COVID-19 through rapid tests. I called my doctor that weekend and was told that based on my symptoms and exposure, I was most likely positive and did not need further testing. I have been feeling some brain fog in the weeks following COVID-19, but that has mostly cleared now.
initially patient had soreness in left arm, eight days later patient experienced fever of 101 degrees,redness, tenderness, swelling to left arm Dr put patient on antibiotics , patient states patient has a " bacterial infection " at the injection site. On doxycycline and Bactrium at this time. Patient stated PMD stated that site of injection " may not have been disinfected well before the shot was given".
Lost taste and smell 3 days after; Lost taste and smell 3 days after; Fever within the first 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 31Aug2021 at 09:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 31Aug2021 at 23:00, the patient experienced fever within the first 24 hours. On 03Sep2021, 3 days after vaccination, the patient had lost taste and smell. 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 fever, lost taste and smell 3 days after were resolved with sequelae on an unknown date in Sep2021.  No follow-up attempts are needed. No further information is expected.
I started experiencing pain on my vulva that I thought was due to a yeast infection. There was a lot of pain. I went to the doctor and so many tests were done, all of which were normal. Vulva-Dynia is the diagnosis. This pain lasted about 6 months. It eased up and now the pain is back.
Mother mentions that after the MENACTRA, Tdap (ADACEL), and Varicella the patient had pain, redness and was warm to touch in the vaccination area.
On November 20, 2022, this was the next day I had chest discomfort. It was pressure and fullness and a bit achy. It persisted and a few days and my doctor. It was pressure. I woke up that morning and I had odd foot pain and numbness. I was unable to stand or walk on it. It was almost like my put was put into a vice. It was contracting my toes and ankles.  I was worried about clotting. My doctor sent me to the ER, and they did a CT, X-Ray and look at my results. I had a vein blow out during getting my blood drawn. The doctor says I seemed to be dehydrated and could be having muscle problems. I am achy in the left side of my chest under my chest, and it moves to the right side. It kind of shoots straight through to my back and then the front of my chest. Today it was a little painful to walk on, but it feels fine today.
Vaccine given left arm 07/23/21.  Armpit Lymph nodes swollen, tender under same arm as well as neck glands 07/30/ 21.  7/31/21 woke to vaccine arm itching, hot,welted, and swelling in diameter to size of softball. Continued thru to today. Have taken benadryl at night and claritin during day for relief.  Today,  Day 3 of arm reaction, now enlarged to double size and covering most of upper arm w bright red,  inch size border.
12 y/o M was given a pediatric dose of Pfizer (0.2 ML)
Moderna COVID-19 Vaccine EA. I have a large rash on my arm that is pretty red. It showed up about 2 inches below the injection site and did not notice it until the day after my 2nd dose, pretty late in the evening. It's about 3-4 inches in diameter, depending on where measured as it is a little irregular. It was very tender and warm although it was not raised off my skin, just my skin was very red. It seems to be going down today and is not as red as when it first showed up. I am feeling fine and had no other side effects around the area. The day of my 2nd dose of the vaccine (4/8/2021) I also experienced a lot of fatigue, body aches, and intermittent low fever. The fatigue and body aches continued into the next day even after 12 hours of rest.
Patient saw something red in her left eye, like blood; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Patient saw something red in her left eye, like blood) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2022, the patient experienced OCULAR HYPERAEMIA (Patient saw something red in her left eye, like blood). At the time of the report, OCULAR HYPERAEMIA (Patient saw something red in her left eye, like blood) had not resolved.            No concomitant drug details were reported.  It was reported that approximately 50 minutes after the 2nd booster dose, patient saw something red in her left eye, like blood.  No treatment details were reported.
This case was reported by a consumer via call center representative and described the occurrence of appetite absent in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received SHINGRIX (intramuscular). On 12th February 2019, less than a day after receiving SHINGRIX, the patient experienced appetite absent, headache, chills and injection site pain. On an unknown date, the outcome of the appetite absent, headache, chills and injection site pain were recovering/resolving. It was unknown if the reporter considered the appetite absent, headache, chills and injection site pain to be related to SHINGRIX. Additional details were received as follows: This case was reported by the patient's wife. On the day of vaccination, the patient was feeling bad which was described as no appetite, chills, headache and pain at the injection site, but felt worse on 13th February 2019. At the time of reporting, the patient was feeling better though it was not 100 percent. The reporter did not consent to follow up.
pt recv vax 15SEP98 & then 21SEP98-25SEP98 fever, cough & body rash;mom stated high fever but not measured;
This spontaneous report was received from a physician refers to a 17 year old female patient. The patient supposed to receive a second dose of M-M-R II, a second dose of VARIVAX and an unspecified meningococcal vaccine on 27-FEB-2015. The patient received M-M-R II, and unspecified meningococcal vaccines but she was inadvertently administered ZOSTAVAX instead of (Oka/Merck) VARIVAX second dose, lot # K020801, expiration date: 31-JAN-2016, (dose and route of administration were not reported). No adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Woke up in the early morning and was real dizzy, a little later in the morning in went away. Itchy around the eyes for a day and a half. Seems to of gone away this morning.
1st dose 13months ago, 2nd not yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix received 13 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comment: The HCP (Health care professional) called to ask for information about a patient who received the first dose of Shingrix 13 months ago. The reporter asked about safety information regarding the administration of the second dose. The reporter did not provide the lot number and expiration date of the first Shingrx dose administered.  During this call the HCP was asking how to proceed with the administration of the 2nd dose of Shingrix. The second dose was not yet administered at the time of the call. The reporter consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Narrative: Patient COVID positive despite 3 doses of vaccine. Patient received 2nd booster 4-19-22 post discharge.
1042 wife enters building to report pt lost consciousness.  RNs responded and found pt awake and alert.  RNs dialing 911 and pt and wife refused ambulance or trip to ED.  Pt and wife states this happens to him if he walks too far when it is cold outside.  Pt states he has heart rhythm issues and sees PCP.  Pt was nauseated.  Again refused transport to ED.  BP @ 1049 144/82, HR 89 and regular.  Pt and wife insist he is fine and desire to leave.  Pt in drivers seat of car.  RNs encourage wife to drive if they are to leave.  Pt and wife refuse, and they left with husband driving.
APPROX 3-4 MINUTES AFTER COMPLETION OF VACCINATION (ONLY HEP A AT THIS VISIT) PATIENT WAS SITTING IN DADS LAP AND LOOKED VERY PALE, HE SAID THAT HE DIDN'T FEEL WELL. I CALLED A CLERK FOR ASSISTANCE AND WENT TO GET THE EMERGENCY BOX. THE PATIENT WAS PALE AND APPEARED WEAK BUT WAS BREATHING NORMALLY AND WAS AWAKE. WHEN RETURNING TO THE ROOM APPROX 1 MINUTE OR LESS LATER THE PATIENT REMAINED SEATED WITH DAD, I ASKED FOR HIM TO LAY THE PATIENT ON THE EXAM TABLE. PATIENT WAS PLACED IN SUPINE POSITION AND HIS LEGS WERE ELEVATED 25 degrees. THE PATIENT'S FACE QUICKLY STARTED TO RETURN TO NORMAL COLOR AND HE SLOWLY STARTED TO RETURN TO HIS NORMAL SELF. HE WAS READY TO SIT UP AFTER APPROX, 4 MINUTES OF LAYING DOWN BUT I ASKED HIM TO REMAIN IN SUPINE POSITION FOR A LITTLE BIT LONGER. THE PATIENT STATED PRIOR TO BEING LAID DOWN THAT HIS THROAT WAS HURTING BUT HE DID NOT HAVE ANY DIFFICULTY WITH BREATHING. HIS RESPIRATIONS WERE NORMAL, HE DID NOT COMPLAIN OF ITCHING, HE WAS SUNBURNED BELOW HIS EYES - OTHER REDNESS WASN'T NOTED, NO HIVES AND NO COMPLAINTS OF ABDOMINAL PAIN.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported.
Swelling, fever, rash, redness, extreme itching at site of vaccination in upper arm
On 4/20/00, the pt received his 1st dose of Havrix. Physician reported that he was experiencing severe fatigue, epigastric discomfort and diarrhea. Physician reported that the pt had severe eosinophilia and that he could not be sure it was not present prior to the Havrix. Additionally, he was not sure that the fatigue developed after the Havrix. The gastrointestinal discomfort has improved. The diarrhea occurred for 1 day only, then resolved. On 5/19/00, physician visit: Physician noted that the pt had a 1 month history of unusual fatigue and eosinophilia noted on peripheral blood counts. No fever was noted with the pt's recent symptoms, but the pt did complain of abdominal discomfort and a sense of abdominal fullness and nausea after completing 1/2 of his meal. He had diarrhea for 1 day in early May, 2000, with normal stools since that time. He had been so fatigued that he had been unable to participate in his usual tennis competition and had missed some school. There is no history of unusual exposure to illness or toxins and no travel to exotic sites. He did receive a routine Hep-A vaccine. Physical exam was normal. On 5/19/00, Allergist visit: It is unclear whether the pt's symptoms began before or after receiving the Havrix on 4/20/00. However, his parents contacted physician on 4/27/00 with at least a 1 week history of fatigue, malaise and epigastric discomfort. He had no other GI symptoms (except for car sickness) prior to this episode. Allergist had no explanation for the pt's significant eosinophilia. The fact that he has had prior normal eosinophil percentages on his hemograms suggested that this was an acute event (which was hoped was resolving) rather than something related to his prior peanut allergy or mild allergic rhinitis. It is possible that he experienced an idiosyncratic reaction to the Hep-A vaccine. It is possible that he may have eosinophilic gastroenteritis. Hypereosinophilic syndrome would require absolute eosinophil count, 1500 per micro liter for more than 6 months. Current eosinophil count was 1458. He had no signs or symptoms of specific organ involvement other than mild epigastric pain and severe fatigue. Physician reports that the fatigue and the eosinophilia are still resolving and are definitely better. He had a "complete work-up" and all tests were "normal". Physician reported that the pt had prior CBC with differential that was normal. WBC-6,000 on 4/27/00. The vaccinee has regained 6 of the 10 pounds that he lost. Current WBC count is 12,000 with 2% eosinophils. The elevated SGOT and SGPT values resolved by 6/1/00. The most recent information, received on 8/9/00, reports the outcome of the event as improving.
Narrative: Pt was a 72y.o. male who died on 01/29/2021 w/ h/o DVT, venous insufficiency, CHF, BPH, frontotemporal dementia, restrictive lung disease, hypertension. Pt received Moderna Covid-19 Vaccination 1/2 on 01/08/2021. Pt presented to ED on 01/23/2021 for evaluation of fall and shortness of breath. Pt admitted for palliative care. Pt died inpatient on 01/29/2021 with physician reporting Death was caused by: Acute Hypoxic Respiratory Failure . Unlikely that Moderna covid-19 vaccine caused/contributed to pt death.