chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vision tingles; Receive vaccine in the gluteus; A spontaneous report was received from a physician for a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vision tingles and received vaccine in the gluteus.  The patient's medical history included breast cancer and had 18 lymph nodes removed. No concomitant product use was reported.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. It was stated that the patient had received vaccine in the gluteus and had experienced vision tingles, noticed by the patient while driving. The vaccine was administered in gluteus on the request by the patient.    Treatment information was unknown.  Action taken with mRNA-1273 for the event, vision tingles, was unknown and for the event, vaccine in the gluteus, was not applicable.  The outcome of the event, vision tingles, was unknown and for the event, vaccine in the gluteus, was resolved.; Reporter's Comments: This report of product administered at inappropriate site refers to a case of for mRNA-1273 with  associated AE of "vision tingles", a causal relationship cannot be excluded.
Severe neck pain. Couldn?t function or turn my head to the left for days. Pain  slowly got better after 6 weeks
Allergic response about an hour and a half after the shot was administered. Minor swelling of the lymphnodes, headache, slight itching of my throat and broke out in hives on my neck and chest. Took some ibuprofen and went away.
Fever of 100.6 (woke up with 99.4 fever; went up during day, and steady) sever Body Aches Lethargy slight headache
woke up sweating; got cold; sore arm; headache; right arm was a little tender; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (right arm was a little tender), HYPERHIDROSIS (woke up sweating), NASOPHARYNGITIS (got cold), MYALGIA (sore arm) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Bone disorder. Concurrent medical conditions included Drug allergy (erythromycin, Cipro and sulfa). Concomitant products included VITAMINS NOS and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced TENDERNESS (right arm was a little tender). On 01-Feb-2021, the patient experienced HYPERHIDROSIS (woke up sweating), NASOPHARYNGITIS (got cold), MYALGIA (sore arm) and HEADACHE (headache). On 03-Feb-2021, TENDERNESS (right arm was a little tender), HYPERHIDROSIS (woke up sweating), NASOPHARYNGITIS (got cold), MYALGIA (sore arm) and HEADACHE (headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include acetaminophen and Ibuprofen.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 03-MAR-2014, the patient was vaccinated with MMR II. lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-FEB-2016, the patient was vaccinated with an expired dose of GARDASIL (lot # J013324, expiration date 12-FEB-2016, exact dose and route of administration were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Swelling and severe pain occurred in both feet within weeks of the 2nd Moderna Covid Vaccine, was unable to walk. Became anemic, weight loss, hair began to fall out. Eventually was diagnosed by rheumatologist (8/2021)  as having psoriatic arthritis.  Now has to receive infusions of Simponi every two months for the foreseeable future, to control the psoriatic arthritis (swelling and pain in feet).
Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Acute illness at the time of vaccination and up to one month before was reported as unknown. Chronic or long-standing health conditions was reported as unknown.     On 21-Feb-2022 at 5:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Feb-2022 at 5:05 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination  or at the time of the adverse event were reported as unknown. Other vaccines given on the same day as Moderna COVID-19 vaccine and other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine were reported as unknown. Vaccine went into 2-8 C thaw state on or about 24-Dec-2021. On 21-Feb-2022 at 05:05:52 PM, the patient took additional dose. No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
head ache; fever; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhaustion), HEADACHE (head ache) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 00B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced FATIGUE (Exhaustion). On 01-Apr-2021, the patient experienced HEADACHE (head ache) and PYREXIA (fever). The patient was treated with IBUPROFEN on 01-Apr-2021 at an unspecified dose and frequency. On 12-Mar-2021, FATIGUE (Exhaustion) had resolved. At the time of the report, HEADACHE (head ache) and PYREXIA (fever) outcome was unknown.            No concomitant medications were provided
This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On 19-MAY-2015, the patient was vaccinated with the first dose of ROTATEQ (dose: 2 ml,lot # and expiration date were not reported) through a G-tube (gastrostomy tube). There was no adverse effect reported. Follow-up information has been received from the reporting medical assistant on 20-JUL-2015 and refers to an 8 months old male patient. On 19-MAY-2015 at 11:40 the patient was vaccinated with the second previously reported as first) dose of ROTATEQ (lot # K016311, expiration date unknown). Dates of the first v vaccination and G-tube insertion were not provided. Outcome and causality of gastrostomy were unknown. Additional information is not expected, since all scheduled correspondence was received. Reporter's information, patient tab, suspect therapy, adverse events and narrative were updated.
had the shot and then got them 3 years later / Suspected vaccination failure; had the shot and then got them 3 years later not a mild case either; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had the shot and then got shingles 3 years later and mentioned that not a mild case either. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible, as no contact details were available.
On the day after the injection, I felt a prickly sensation for several days after, like a sunburn. Then, I noticed some throbbing pain. On Sat., Sept. 14, 2018, I went to Emergency Room, thinking I had kidney stone. They could not diagnose it. On Sunday, rash over kidneys began to appear. It was shingles.
3RD DOSE PFIZER COVID VACCINE GIVEN 8/16/21, #FC3181; 4TH DOSE COVID VACCINE GIVEN 4/25/22, MODERNA, #056M21A; pt had a positive COVID test on 9/12/22; c/o fatigue, LE edema, difficulty walking; 9/17/22 pt to ED and admitted to hosp with severe sepsis and AHRF; O2 supplementation; eventually requiring intubation; given Decadron; 9/25/22 respiratory cultures positive for MRSA; transferred to MICU; no improvements despite maximum support; family transitioned pt to comfort care; extubated and pt passed away in the hospital
Subsequent to receiving on dose of varicella virus vaccine live the pt developed a maculopapular rash with vesicles consistent with varicella. High temperature was 97.6F. It was reported that the pt was recovering.
Patient complains of redness and swelling at injection site all the way down to her elbow. That evening and all of last night her right hand from the wrist down to her fingertips were numb and painful. She experienced nausea as well.
Cellulitis of right leg -  He was given vancomycin, Zosyn and transferred to local hospital where nurse set a iodoform wick to facilitate mechanical debridement of non viable clot and allow for healing by secondary intention. The patient has been instructed on daily wound care and will discharge home ncomycin and zosyn were continued. Ultrasound showed a 1 x 2.5 cm evolving hematoma at the site of prior blood blister.  ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Numbness, tingling in upper and lower extremities. Muscle weakness in upper and lower extremities. Facial edema, upper extremity edema.  Lower back pain, upper extremity and lower extremity pain without injury.
Systemic: pt said "room is moving," all vitals fine, inject site fine, no redness normal warmth, no pain discomfort. Dizzness rechecked in 15 minutes and gone.-Mild
Information has been received from a 65 year old female pt with an unspecified allergy and a history of cataract extraction left eye (15Dec03), left near total parotidectomy (16Mar04) and adenocarcinoma of thyroid (1989) who on 20Jan04 was vaccinated with pneumococcal 23v polysaccharide vaccine in the left upper arm. On the morning of 21Jan04 the pt noticed a mass of quarter size on the left side under the jaw bone area which was rapidly expanding to the tail of the parotid gland described as painless, mobile. On 11Feb04 a fine needle aspiration revealed atypical cells highly suspicious for malignancy. On 05Mar04 a CT Scan showed large slightly hyper-dense mass arising from left parotid approximately 4 cm in length with maximum AP diameter of 3.1cm, depth of 2.2cm. On 16Mar04 the pt was diagnosed with myxofibrosarcoma intermediate grade (also known as myxoid variant of malignant fibrous hystocytoma). The pt was hospitalized and is being treated with radiation therapy. The reporter considered myxofibrosarcoma intermediate grade to be an other important medical event and was life threatening. No further information is available.
Pt recvd vax & exp pain @ inject site; the arm of inject swelled up & pt devel a fever & redness; treated w/APAP; pt recovered;
Sore arm; feverish; Mild headache that can get very bad; Tossed and turned all night; A spontaneous report was received from a consumer concerning a 31-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, feverish, tossed and turned all night, mild headache that can get very bad.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) via unknown route for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the event(s) sore arm, feverish, tossed and turned all night, mild headache that can get very bad.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 23 Feb 2021 the outcome of event(s), tossed and turned all night was resolved. The outcome of event(s), sore arm, feverish, mild headache that can get very bad was unknown.
Initial arm pain at site.  14 hours later fever up to 101.7°, chills, aches.   Approximately 32 hours later all but sore arm was subsiding.
This spontaneous report has been received from a 53 year old male pharmacist, who was reporting on himself. The patient had no pertinent medical history and no drug reactions or allergies. On 26-JUN-2015, the patient was vaccinated subcutaneously with an unknown dose of ZOSTAVAX (lot # and expiry date were not reported). No concomitant medications were administered. On 08-NOV-2015, the patient experienced shingles, which started in the center of his chin, then spread to his left cheek, the right corner of his mouth and near his right eye. The patient did not experience pain. Subsequently, the patient saw his physician, who prescribed a seven-day course of VALTREX, which was finished on 17-NOV-2015 (reported as "yesterday"). No lab diagnostics studies were performed. The outcome of the event was reported as recovering. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
expired doses of IPOL; Initial information received on 14-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2019SA231643 and 2019SA233553 (same reporter).  This case involves a patient who received an expired doses of vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient received any concomitant vaccines during the same visit   On 09-Aug-2019, the patient received a single dose of suspect IPV (VERO) lot N16511M, exp date 02-Aug-2019  It was of actual medication error due to expired vaccine used..  It was unknown whether  adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
06-03-2018-Hospital-CAT scan. 06-04-2018 - 06-07-2018 and 06-09-2018-2nd hosp. 06-11th - 06-15th-2018-third hosp. 06-16th to 06-21st-2018-4th hosp. 06-21st to 07-11th-2018-care center for rehab. 07-11-2018-home health.
had a reaction to first covid vaccine today - she felt lightheaded, dizzy, and her arm felt numb after the shot. called 911 to get her medical attention, but she left the store on her own (with her husband). checked back at 1:45 same day and husband said doing better
expired booster doses given; Product storage error; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired booster doses given) and PRODUCT STORAGE ERROR (Product storage error) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired booster doses given) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired booster doses given) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Rec'd shingles vaccine 12/3/14 within 30 days severe back pain between shoulder blades worse at night, some days better than others becoming chronic. Other symptoms also.
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/11/2023 LOWER GI HEMORRHAGE
Information has been received from a female licensed practical nurse concerning a 15 year old female patient with no medical history who on 20-Aug-2007 was vaccinated with her first 0.5 ml dose of Gardasil (Lot #654741/1208F) intramuscularly.  There was no concomitant medication.  On 01-Nov-2007 the patient was in the doctor's office to receive her second dose of Gardasil but did not want to receive it at that time.  She stated that within a few hours after receiving the first dose on 20-Aug-2007 she developed hives on her torso but not at the injection site.  She took Benadryl and her symptoms resolved within a day.  The second dose of Gardasil was not administered.  Additional information has been requested.
Patient called approximately 6 hours after receiving Shingrix vaccine.  When removing the bandage, she noticed active bleeding along with a hard lump under the injection site.  She denied any rashing or expanding redness or fever.  She states that shortly after receiving the vaccination, she bumped the injection site on the wall.  She did not notice significant bleeding at the time, but also did not remove the bandage.  During our phone call, she applied ice to the site and the bleeding slowed significantly.  I advised to continue with ice and add antiinflammatories if needed.  Seek out medical intervention if bleeding does not stop within the next 15 minutes.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-MAY-2017 the patient was vaccinated with with an expired dose of ZOSTAVAX lot # L037790 with an expiration date 30-DEC-2017 for prophylaxis (dose, route of administration, anatomical location were not reported). According to the reporter, administered dose of ZOSTAVAX did not experienced any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Fever ranging from 99 to 101, severe  joint pain, body aches. This lasted until 02/19/15.
pt recv vax 5JUN95 clinic today 8JUN95 has 5cm x 6cm red, tender, induration lt deltoid; was seen by MD;
Patient received the COVID Moderna vaccination on 3/1/21.  On 3/2 she reported chills, nausea and an arm ache Spoke with patient today, she is feeling much better, has a slight headache that is resolving as the day goes on Advised on supportive care (fluids, rest, good nutrition) and to call back if symptoms returned or worsened.
Patient received the vaccine lower than it should have been given . She came in one week after the shot and had broken blood vessels and bruising in the area.
I received my first dose of Moderna Vaccine on February 3, 2021. On February 13 and 14 I noticed some very mild tingling/itching at the injection site, which didn?t happen immediately after the injection. Today, February 15, there?s substantial itching, and my arm has a large, bright red rash.
After I took the shot, the sec dose in my right arm, May 17,2023, the morning of,  there was a little soreness where the shot was injected, but other than that there was nothing. The next morning, around 7 or 8 am, I still had the soreness in my right arm, and then I noticed the swelling of my right hand, it was painful for me to rotate my hand inward and outward. Not only was my hand swollen, but my wrist was swollen as well. At that point, I called my pcp and requested the prescription I normally take for gout. It was forward to my pharmacies and I went and picked it up. It was the normal medication my pcp gives me when I have a flare up of my gout, Methylerednisolone (4mg tablet). I took 2 doses of that, first day and the second day. It didnt have any effect of the condition of my right hand. So that is what prompt me to do a report. I am sitting here now in pain, and cannot use my hand. I have made contact with my pcp about my condition. I had a virtual appointment.
Chest pain; pericarditis sx: EKG with Diffuse ST elevation; Elevated TnI - 9 Pericarditis/myocarditis 01/12/07-records received and reviewed: DX:Myocarditis and Pericarditis
A non-serious spontaneous report of cold has been received from a consumer concerning a 34-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST in 2009. The patient stated that she developed symptoms that resembled a cold after receiving FLUMIST. The patient was not hospitalized. The outcome of the event was resolved. Additional information received on 11-May-2011 and incorporated into case: Updated event term and resolution was provided.
started chills after few hours of vaccination; bodyache; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 46-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 29Dec2020 at 11:15 at a single dose for COVID-19 Immunization. Medical history included COVID-19 prior vaccination. The patient had no known allergies. Concomitant medications included atorvastatin (ATORVASTATIN) and multivitamins. The patient had no other vaccine in four weeks. The patient had not tested for COVID post-vaccination. The patient started having chills after a few hours of vaccination and body ache on 29Dec2020. No treatment administered for the events. The events resolved on an unspecified date.    Information on the lot/batch number has been requested.
Breakthrough case admission after 2 vaccines Pfizer 4/16/21 Lot# Ew0158;  Pfizer 5/13/21 Lot# EW0186