chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 60-year old female patient was prescribed GARDASIL 9 by her physician. Vaccine has not been administered to the patient. Agent is filing a near miss AE due to the off label prescription of GARDASIL 9.; No additional AE reported. No PQC reported.; This spontaneous report was received from a pharmacist concerning a 60-year-old female patient. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On an unspecified date, the patient was prescribed with off label HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) by her physician for prophylaxis (off label use). It was confirmed that the vaccine had not been administered to the patient. No additional adverse event (AE) was reported.
COVID Arm - red area at injection site approximately size of silver dollar. First noticed on 9th day after receiving vaccination. Four days later (today) red area still visible; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 11:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included antiphospholipid syndrome, allergic to cat dander and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included warfarin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and lovastatin (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. On 18Mar2021, in the arm which she had received COVID vaccine, the patient noticed a red area at injection site approximately size of silver dollar. The patient first noticed it on ninth day after receiving vaccination. Four days later (on the day of report), the red area was still visible. 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 event red area at injection site approximately size of silver dollar; first noticed on ninth day after receiving vaccination, four days later (on the day of report) red area was still visible was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine was improperly stored upon arrival to facility. Patient had no adverse events due to the improper storage of the vaccine.
Around 7 PM (infant presented to ER later in PM) had high pitched cry and jerking all over - seizure? Was afebrile. On ER exam pt had red ears and red throat. No other symptoms were noted or reported. No treatment. Pediatrician was consulted. Told Mom to give Tylenol as needed.
Patient states reaction began about one day after injection. She presents with a red circle surrounding the injection site, roughly 4-5 inches across. Patient states it is warm and tender to the touch. Severity has not increased since Friday/Saturday. Patient has taken TYLENOL. BENADRYL and follow up with a provider have been recommended. Reaction is localized with no systemic symptoms.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 12-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Received MMR in L arm (SC) on 2/11/04. Called 2/13/04 to state arm on left "swollen and hard". Seen 2/13/04 in office- site reddened and swollen. Non-tender, no wheezing. Given Benadryl orally. Returned on 2/14/04 site with decreased redness and swelling. Told to continue Benadryl pm and to call for increased problems or complaints.
rash on day 3 following both shots; 2nd shot of moderna has been taken after 37 days of 1st shot of moderna, 1st dose of the Moderna COVID-19 Vaccine on 16Feb2021, the second shot which she got on 25Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on day 3 following both shots) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd shot of moderna has been taken after 37 days of 1st shot of moderna, 1st dose of the Moderna COVID-19 Vaccine on 16Feb2021, the second shot which she got on 25Mar2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Allergic to sulfa drugs) and Allergy to antibiotic (Cipro allergy).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd shot of moderna has been taken after 37 days of 1st shot of moderna, 1st dose of the Moderna COVID-19 Vaccine on 16Feb2021, the second shot which she got on 25Mar2021). On an unknown date, the patient experienced RASH (rash on day 3 following both shots). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Rash all over, at an unspecified dose and frequency. On 25-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd shot of moderna has been taken after 37 days of 1st shot of moderna, 1st dose of the Moderna COVID-19 Vaccine on 16Feb2021, the second shot which she got on 25Mar2021) had resolved. At the time of the report, RASH (rash on day 3 following both shots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient consulted with her doctor prior to getting the second dose of the Moderna COVID-19 vaccine via a Teledoc appt. Her doctor thought that the rash may had been an allergic reaction to the first dose. No concomitant medication information were provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to MOD-2021-015969 (Patient Link).
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: PATIENT CALLED TO REPORT 3" RED RAISED AREA; PATIENT HAD REQUESTED BOTH THE BOOSTER AND FLU TO BE ADMINISTERED AT SAME TIME IN SAME ARM 1" APART DUE TO UPCOMING PROCEDURE IN LEFT ARM
Fever; Myalgia; This case was reported by a physician via sales rep and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were unknown.   It was unknown if the reporter considered the fever and myalgia to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The caller was Glaxosmithkline medical information scientist reporting an adverse event that was reported to her by a physician. The caller stated that the patient developed fever and myalgia. The reporter requested to use the contact information for follow up with the healthcare professional. The caller was not able to verify a phone number for the healthcare professional.  The caller did not provide any additional information.
Patient vaccine was administered approximately 1:50pm 4/27/21 and patient was asked to wait around for 15 minutes post vaccination. At approximately 1pm the patient's wife indicated he was not doing well.  I went out into the waiting area to assess the patient and determined he was sweating and feeling light headed as though he may faint. After a few moments I had my technician call 911 to send an ambulance. While waiting for the ambulance the patient requested some orange juice and I did provide that. He did drink some of the juice. Patient never did faint or pass out and was conscious the entire time until EMS arrived and as they took him away to the hospital. Patient appeared to be feeling a bit better as time went on.
After receiving her vaccines, patient started having episodes of apnea with pallor. She would turn pale/bluish while sleeping and have to be lightly shaken in order to initiate normal breathing again.  After being aroused from episodes her face would flood back with blood and resume normal color. This began approximately 3 days after vaccination. She also had off and on continued low grade fevers for 3 weeks post vaccination.
46-year-old female with history of fibroids and hypertension reports she was diagnosed with Covid 4 days ago. She's had ongoing cough and worsening shortness of breath. Her cough is dry. She feels like she can't take a deep breath. She has loss of smell and taste. Positive for chills, fatigue and fever. She is immunized against Covid 19. No diarrhea. She's been taking cough medication given to her at the urgent care 4 days ago with no relief. Her temp is 100.4 on arrival and her SPO2 is between 93 and 96%. Discharged.
His left arm is smelling really bad I have spoke to his Drs office an they advised Benedryl and ibuprofen I?ve done that as well as draw a line around the swelling. Today the swelling is worse further down his arm very red hard and hot. I also marked and dated today?s redness. N/A
This spontaneous report as received from a other health professional refers to a patient of unknown age. No medical history or concurrent conditions were reported. On 09-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J011882. It was reported that the patient was administered ZOSTAVAX that may have gone through an unsupported temperature excursion due to delayed shipping from 13-DEC-2013 to 17-DEC-2013. No adverse effects were reported and no further information was provided. This is one of a total of two reports form the same source document. Additional information has been requested.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. No reported symptoms. will consider revax
rash on lower right hip raised welt like and very itchy continued into groin hip area. Put   steroid cream on and left after several days
Dizziness started 1 1/2 hrs after vaccination, then evening started aches/ pains, headache, lethargic.
Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium
Racing heart rate even  when lying down.  Normal resting heart rate is less than 60, she was over 150bpm.  Bilateral blood pressures were equal, no other symptoms.
On 5/1/08 pt felt hard, hot area on L upper arm.  After observing area she noticed it was red.  On 5/3/08 pt states "all cleared up without medical treatment, ointments, etc."
9/15/21: presents to the ED with cough, SOB, fever and lack of taste. admitted and given dexamethasone and remdesivir. discharged on 9/20/21 9/26/21: patient presents again with weakness and diarrhea - discharged the dame day
BURNING SENSATION DURING URINATION; REALLY BAD TINNITUS; GENERAL MUSCLE ACHES; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number  was not reported) dose was not reported, administered on 06-APR-2021 to Right Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced really bad tinnitus. On APR-2021, the subject experienced general muscle aches. On 07-APR-2021, the subject experienced burning sensation during urination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation during urination, and general muscle aches, and the outcome of really bad tinnitus was not reported. This report was non-serious.
Headache, severe joint/muscle pain, dizziness, nausea/vomiting, temp of 102.5, tightness in chest/ difficulty breathing, fatigue chills, aches...all lasted 36 hours. Pain, swelling and redness at injection site lasted 5 days.
Blister like rash starting at injection site and spreading down my arm. Rash has also started bruising.
pt had been treated in a hospital for colonic pseudo obstruction; while in hospital, pt tested positive for COVID; transferred to rehab center for PT/OT; breathing found to be more labored than before; pt found deceased in her bed in the rehab facility
This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis. No Medical History information was reported. On 11-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received a vaccine that under went a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received a vaccine that under went a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received a vaccine that under went a temperature excursion). Patient's weight was reported as 37. Vaccine was administered on 11-Aug-2022 and site was reported as LQ. Concomitant medication list was not provided. It was reported that Moderna COVID-19 vaccine experienced one temperature excursion. Some vaccine was stored in the freezer and other vials in the refrigerator. 38 patients received Moderna COVID-19 vaccine that underwent one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at the time of the temperature excursion. The excursions were picked up by state review of the temperature data logger 2 weeks later after the excursion. Storage condition at the time of the excursion was refrigerated storage. Date vial was moved from freezer to refrigerator was 08-Aug-2022. Maximum or minimum temperatures reached, as applicable was positive 14 degrees Celsius. Excursion duration was 3 hours and 5 minutes. They were administered and discarded. Proposed desired Use by date was 18-Aug-2022. Number of vials/ per doses impacted was 1 vial. The excursion occurred on 07-Aug-2022. The vials were not punctured until they were used for a patient and then discarded. No side effects were reported. Treatment information was not provided.
Information has been received from a currently 66 year old female patient referring to herself. Information about medical history and concurrent condition was unspecified. On an unknown date the patient was vaccinated with one dose of PNEUMOVAX 23 (one shot one time, lot number, expiration date and dose were unknown) intramuscularly. Concomitant therapies included PREVNAR 13. On an unknown date, long after the vaccination, the patient developed pneumonia. The patient sought medical attention via contacting physician. The outcome of the event was reported as not recovered. The causality between the event and PNEUMOVAX 23 was unspecified. No product quality complaint (PQC) was involved. Upon internal review, the event pneumonia was considered to be medically significant. Additional information has been requested.
Narrative:  70yo male in need of lung transplant died on 7/2/21 at hospital. Pt had received covid EAU vaccinations on 2/12/21 & 3/17/21. It appears death is unrelated to covid vaccinations.
Very lethargic, slight nausea, slight headache, joint pain, fever 100.8, unable to go to work. Fever gone next day after shot, still tired, slight headache, but much improved.
Patient was administered 0.5mL dose of the Moderna COVID19 vaccine for their third dose when the patent was not immunocompromised. POA could not be reached for follow-up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient was inadvertently vaccinated with an expired lot (669379/0453AA, exp 03-AUG-2012), 0.5 ml PNEUMOVAX on 11-NOV-2012 (site of administration not reported). No adverse effects reported. Additional information is not expected.
For approximately 24 hours, full-body joint aches, sensitive skin/scalp, fever ranging from 99-104 degrees F.
1)arm soreness that lasted for a couple of days 2)bad headache that started 2 days after the vaccine and require Motrin
Pt c/o pain/tenderness to vacc area. Red, warm to touch, raised area to right upper arm.
Information has been received from a female licensed visiting nurse who "in the past few days", on approximately 29-AUG-2006, came in contact with rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) on her face while she was administering the vaccine orally to a child who regurgitated. "One day later", on approximately 30-AUG-2006, the nurse experienced symptoms of fever and diarrhea.  At the time of the report the nurse had not recovered.  Unspecified medical attention was sought.  No product quality was involved.  No other information was provided.  Additional information has been requested.
One-two hours after shots began whining, had poor feeding, fever, lethargy which lasted 7-10 days also jerking.
Blood pressure, which is normally low, rose to the point of needing medication for 4 weeks
received doses that were impacted by the voluntary recall; received doses that were impacted by the voluntary recall; received doses that were impacted by the voluntary recall; received doses that were impacted by the voluntary recall; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced recalled drug administered, drug dispensing error, recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered, drug dispensing error, recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received both the doses of Shingrix from recalled batch in the clinic, which led to recalled drug administered and drug dispensing error. The reporter asked if the patient need to be revaccinated. No further details provided on the call. The specialist neglected to note potential event during call, and thus limited details were obtained, and specialist neglected to ask whether safety had permission to follow up. This case was linked with case US2021AMR213388 and US2021212537 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021212537:same reporter US-GLAXOSMITHKLINE-US2021AMR213388:same reporter
I developed the "COVID Arm" exactly one week after my shot. Began itching last night & a lump formed but today it seems to be gone, so it was very brief.
Information has been received from a medical assistant concerning a female patient of unknown age. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 09-JUL-2018, the patient was vaccinated with a dose of improperly stored (wistar ra 27-3) -M-R II lot # R002930 and expiration date of 30-JAN-2019, subcutaneously (anatomical location was not reported) for prophylaxis, which was stored in the range of 73.9 Fahrenheit degrees for 17.5 hours. The vaccine was reconstituted with properly stored sterile diluent(manufacturer unknown) (lot # unknown). No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved.
PT REPORTED  AN OUTBREAK OF SHINGLES 1 WEEK FOLLOWING ADMINISTRATION OF VACCINE.  SHINGLES STARTED ON 3/6/2021
CHILLS, SLIGHT FEVER, WAS BED RIDDEN BY SATURDAY.   DEVELOPED EXTREME FATIGUE BY FOLLOWING WEDNESDAY,  I COULD NOT STAY AWAKE, IT TOOK ALL THE ENERGY OUT OF ME FOR 2-3 DAYS,  HORRIBLE STOMACH ACHE THAT INCREASED TO SEVERE NAUSEA THAT REQUIRED MEDICATION TO STABLIZE.  SEVERE HEADACHE, FLUSHNESS IN MY FACE, CHILLS, COULD NOT GET MY FEET TO WARM UP.  MY SYMPTOMS SUSTAINED FOR CLOSE TO 7 DAYS OF EXTREME DISCOMFORT UNTIL I FELT SOME RELIEF.
Double vision, entire body sweated profusely, higher body temperature than usual 102, aches in all joint area, especially the hips and knees, nausea, headache.
Patient denied pregnancy and stated she had used condoms at time of administration of vaccines. When calling on May 9, 2023 to confirm appointment for next doses, patient stated she thought she was about 7 weeks pregnant. That would put patient at 3 weeks pregnant at time of administration of doses.
I HAD COVID-19 IN 2020 AND I RECEIVED MODERNA VACCINATIONS THREE MONTHS AGO.  I HAD AN ANTIBODY TEST DONE ON 07/15/2021  THAT READ,  "ANTIBODIES NOT DETECTED IN THE BLOOD"  .
Unknown cardiac event. Found on sidewalk down. Revived but resulted in extensive neurological damage. Was put in life support. Never came to. Passed away 05/05/2021.
This spontaneous report was received from a registered pharmacist, referring to a currently 24-year-old female patient. It was reported that the patient did not have any pertinent medical history or concomitant medication. It was reported that the patient had an allergy to gluten. On an unspecified date in 1996, the patient received the first dose of VARIVAX (strength, route, lot number and expiration date unknown by the reporter) for prophylaxis (reported as "recommended by pediatrician at the time"). On an unspecified date, after receiving the first dose, the patient developed chicken pox (varicella post vaccine). It was reported that the patient did not receive treatment for the event and there was no lab diagnostics or studies performed. On an unspecified date, the patient had recovered from the event. There was no causality assessment provided between the event and VARIVAX.