chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; temperature excursions have been administered to patient; temperature excursion that had occurred in a refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator), POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 12:30 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator). On 23-Sep-2022 at 12:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator), POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator) and POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient).    Concomitant medication was not reported. It was unknown if the patient had ever tested or been diagnosed with COVID-19. The patient received previous 3 dose of vaccine intramuscular in deltoid. Vaccine 4th dose reported as 0.5 in Deltoid muscle. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.  Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:
My first vaccine I had a knot come up and last for about 3 days. Went away and then came back a week later and had a red heated mark on my right arm. Second shot I got in my left arm. Every week 2-3 x a week since my second show in February  i feel heat coming through my shirt burning. When I take my shirt off I have a red rash that is on fire. When I check the temp on that spot its always right at 100 or above. It covers about a hand print size on my top arm/shoulder where the shot was given.
Pt stated that he had nausea and vomiting the night he received his shot and also felt tired and a little feverish. He stated that the nause and vomiting may have been from some pizza he had that night. His nausea and vomiting went away the next day and but he still felt a little fatigued.
This case was reported by a physician via call center representative and described the occurrence of injection site pigmentation changes in a infant female patient who received HIBERIX (batch number 2S27K, expiry date 17th September 2017). On an unknown date, the patient received HIBERIX. On an unknown date, unknown after receiving HIBERIX, the patient experienced injection site pigmentation changes. On an unknown date, the outcome of the injection site pigmentation changes was unknown. It was unknown if the reporter considered the injection site pigmentation changes to be related to HIBERIX. Additional details were provided as follows: The healthcare professional reported that after administration of HIBERIX the patient had a black dot appear at the site of injection. The patient did not have further symptoms. The physician did not want to be contacted further regarding this adverse event. This case had been linked with the case US2017131735, reported by the same reporter. The reported batch number 2527K for HIBERIX did not exist and was updated to 2S27K as per sales database.
48 hours after injection, patient experienced swelling, redness & pain in right ark. (below skin). Treatment: warm compress to arm every 4 hours. Motrin for pain & inflammation.
drying; peeling skin on face; Itchiness/severe itchiness; hives in arms; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167 SHC-VC) via an unspecified route of administration in the right arm on 13May2021 at 00:00 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL) and hydrocortisone cream (MANUFACTURER UNKNOWN); both from an unknown date for an unspecified indication. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0159) via an unspecified route of administration in the right arm on 22Apr2021 at 00:00 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 13:00,  2 days after vaccination, the patient experienced itchiness, hives in arms. On 15May2021, on day 4, the patient experienced severe itchiness, drying and peeling skin on face. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with OTC hydrocortisone cream and Benadryl. The clinical outcome of the events itchiness, hives in arms, severe itchiness, drying, and peeling skin were recovering.  No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist, referring to a 62 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-MAR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU, administered subcutaneously, lot number reported as "M041669" with an expiration date on 09-JAN-2018 (dose and anatomical location were not reported) for prevention of shingles. On an unknown date in March 2017, the patient came back to the pharmacy with an "itchy, red, circular, silver dollar sized bump" around the injection site, which she also described as a "small rash".  The reporting pharmacist stated that the patient was advised to take BENADRYL as treatment, also recommended by her physician and no lab diagnostics studies were performed. The pharmacist reported that she had seen other vaccination site reaction with ZOSTAVAX, but it was much worse than this one (MARRS# 1703USA013799); also it was reported that two of her unspecified sisters experienced other reactions to unspecified influenza vaccines on unspecified dates. It was reported that the improperly stored vaccine has a temperature excursion of 15 Fahrenheit (F) to 46 F, during 14 hours. The reporter stated that no previous temperature excursion occurred or digital data logger involved. The outcome of the events was reported as not recovered and the causality between the vaccination with ZOSTAVAX and the events was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA013799.
was aching bad at thirty minutes a doctor looked at me and gave me a Zyrtec. I was feeling better at 0ne hour. Three hours after itching was back eyelids burning, I took a claritin 10mg Had to take one every thee hours to stop the same. My blood pressure stared to clime and stayed his through the next day . It was a high as 187/115 I called the heart doc on call I told him I took extra carvedilol he said not to take any more and if blood pressure went over 200 to go to closest ER. It started to go down about 1:00am on the 2 of Feb. I Went to see doctor he said to see heart Doc before taking second injection  I have continue to itch all over and takin multiple claritin and Zytrec. The itch is still bad today.
Initial and follow-up information has been received from an office manager concerning a 44 year old female with seizure disorder, severe mental retardation, high cholesterol and no drug reactions or allergies or illness at time of vaccination who in 2005 was vaccinated with the first dose of PNEUMOVAX 23 vaccine (It was reported in follow-up that there was no previous dose). On 27-Aug-2008 at 12:00 the patient was vaccinated IM in the left arm with the second 0.5 ml dose of PNEUMOVAX 23 (lot# 660717/0224X). Concomitant therapy included influenza virus vaccine (unspecified). On 27-AUG-2008, the same day, the patient's guardian called the doctor's office to report that the arm at the injection site was hard and swelled up to a size of a baseball. The patient was taken to the emergency room by the guardian. The patient was not hospitalized, and was treated with MEDROL DOSEPAK and or BENADRYL. The patient sought medical attention in the doctor's office. No lab tests were performed. The office manager reported in follow up that after few days, the patient's injection site swelled up to a size of a baseball was recovered. Additional information is not expected.
Vaccine was administered post use date. Patient's provider Dr. contacted parents or guardian on 02/20/23 stating manufacturer's vaccine activity at the time of administration.   Manufacturer Statement: Pfizer reviewed the stability of the vaccine you received and determined that it maintained the activity necessary to protect against COVID-19 at time of administration. Pfizer cannot guarantee the protection you have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you. However, if you wish to undergo revaccination, we will provide you access as outlined below.
Hospitalized 11/11/2021; COVID-19 positive 11/11/2021; fully vaccinated  Discharge Summary MD (Physician) ? ? General Medicine BRIEF OVERVIEW: Discharge Provider MD Primary Care Provider: MD Admission Date: 11/11/2021 Discharge Date: Nov 13, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Altered mental status, unspecified altered mental status type [R41.82] COVID-19 [U07.1] HOSPITAL COURSE: Patient is a 87 yo who presented with progressive weakness, dyspnea and cough. In the ED patient tested positive for COVID-19 PNA requiring 2 liter of oxygen via NC. He was admitted to the medicine service.   # Acute Respiratory Insufficiency with Hypoxia Secondary to COVID-19 PNA He was noted to be fully vaccinated but no booster, 2nd dose of Pfizer vaccine received in March. Reported symptoms initially started 11/10. CXR on admission was notable for left lateral airspace disease and mildly on peripheral of right mid lung, with interstitial edema and trace pleural effusion bilaterally per radiology read. COVID-19 PCR positive (11/11/21). BNP testing was found to be unremarkable. He was treated with Decadron and Remdesivir. He completed 3 days of Decadron while hospitalized with not ed improvement in CRP and was able to wean to room air at rest. Pulmonary was consulted and provided oxygen for home (1 liter to be worn with activity). Weakness improved and patient was found to be independent with activity while hospitalized. He was discharged home in stable condition on decadron to complete therapy in hopes of weaning oxygen off completely. He was provided discharge instructions.
tiredness; sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tiredness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt called 27NOV90 c/o lt arm pain & numbness.  Pt seen by RN, reported no unusual sxs, required no further tx.  F/U 04DEC90 indicated px resolved.
Widespread Rash, began on back within 60-90 min of administration. Has continued to spread and change. Does not itch very much,  started as wide finger print sized splotches on back, with tiny red dots the size of the ball on a ball point pen spread around and in between. The small head of a pen sized one's have spread to chest and arms. Again no itching really or pain. But it has been there without even fading a little bit sinceI got the vaccine. I did not go for the second or 3rd dose because of the reaction.it has been approximately 45 days since the vaccine with no signs of fading or going away.
Patient reports that the injection site was too high and felt pain at time of injection which later radiated down from his shoulder manifesting in chest tightness and back pain. He went to the ER a few days later where he reports they did a bunch of tests and concluded his pain was from the injection being given to high and into his rotator cuff
74 year old male patient refers after getting his second dose he started to experience discomfort in puncture area and pain when he moves his arm. Patient reports still having same symptoms today. Patient has not visited his doctor.
On-Call Doctor was contacted to receive immediate care instructions after vaccinator discovered second dose of bivalent pfizer booster provided to the patient. Per MD no adverse effects to be expected per CDC guidelines. At the time of administration the patient did not have any side effects, symptoms, signs that indicated adverse reaction.
injection site soreness headache chills body aches fever (101.5 highest) fatigue reduced appetite  Next day:  pain and slight lymph node swelling in left arm pit.  lasting 2 days
Several hours after getting H1N1 injection, felt like left side of face was drooping. With left occipital headache, lower lip (left) tremor - sensation is resolving.
I Broke out in red bumps all over my  body,the bumps are really itchy All the time. It's been three weeks since it started, and it's not going away.
Headache red body swollen Rt arm fever. ER I.V. antibiotics, short of breath. Started feeling better Sat 10-15-16.
Information has been received from a Registered Nurse concerning various unspecified patients of an unknown ages and genders. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown different dates the patients were vaccinated with unknown dose numbers of improperly stored GARDASIL 9 (concentration, route and dose not reported) lot # L020015, expiration date 16-AUG-2017 and lot # L043213, expiration date 28-AUG-2017. It was reported that the GARDASIL 9 was stored with a temperature of 0 degrees C for 72 hours, it had not been out of range before and the vaccine was back in range on an unspecified date. There was no data logger, neither adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Facial flushing with extension to anterior neck approximately 10 minutes status post vaccination. Mild pruritis forehead reported. Denies SOB and other symptoms. Epinephrine x 1 administered 15 minutes after vaccination left thigh. After epinephrine felt better and transported to ER via ambulance without incidence.
LETHARGIC MORE THAN USUAL; FELT NOT VERY GOOD; FEVER / FELT HEAT LIKE FEVER / FELT HOT BUT NOT LIKE BOILING, WARM FELT IT IN VEIN; TIRED; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic type 2, ibuprofen allergy, alcohol user (Rarely), and nonsmoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. Age at time of vaccination 74 years old. No concomitant medications were reported. On an unspecified date, the patient experienced lethargic more than usual, felt not very good, fever / felt heat like fever / felt hot but not like boiling, warm felt it in vein, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic more than usual, felt not very good, fever / felt heat like fever / felt hot but not like boiling, warm felt it in vein, and tired. This report was non-serious. This case, involving the same patient is linked to 20220606610.
a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.; low grade headache; nausea; low abdominal discomfort and pain below the stomach; gas; bleed at the time of injection; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.), ABDOMINAL PAIN LOWER (low abdominal discomfort and pain below the stomach), FLATULENCE (gas), INJECTION SITE HAEMORRHAGE (bleed at the time of injection) and NAUSEA (nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE HAEMORRHAGE (bleed at the time of injection). On 03-Mar-2021, the patient experienced ABDOMINAL PAIN LOWER (low abdominal discomfort and pain below the stomach), FLATULENCE (gas) and NAUSEA (nausea). On an unknown date, the patient experienced CONTUSION (a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.) and HEADACHE (low grade headache). At the time of the report, CONTUSION (a bruise about 3 inches long and 2 inches wide. It's quite dark, purple color.) had resolved and ABDOMINAL PAIN LOWER (low abdominal discomfort and pain below the stomach), FLATULENCE (gas), INJECTION SITE HAEMORRHAGE (bleed at the time of injection), NAUSEA (nausea) and HEADACHE (low grade headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-034833 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Significant: event outcome updated On 02-May-2021: form with pictures
RECEIVED FIRST DOSE PFIZER 3/24/2021. RECEIVED SECOND DOSE J&J AT HEB. DATE NOT KNOWN FOR REPORT.
Asymptomatic screening for admission  ED to Hosp-Admission  Current  10/27/2021 - present (8 days) Hospital SURGERY PROGRESS NOTE   Background:   The patient is a 75 year old male with history of follicular lymphoma with imaging-proven cancer involvement of the abdomen, who presented to the ED with one day of severe abdominal pain. Patient was febrile and tachycardic, with peritonitis noted on physical exam. A CT scan of the abdomen and pelvis revealed findings of foci of free air in the right lower quadrant, and diffuse bowel thickening, raising concern for viscus perforation. Patient now s/p laparotomy with 30 cm small bowel resection.        Subjective    NAEON.  Pain is well controlled.         Objective      Temperature:  [36.9 °C (98.4 °F)-37.5 °C (99.5 °F)] 37.5 °C (99.5 °F) Heart Rate:  [84-119] 109 Resp:  [16-18] 18 BP: (110-114)/(66-72) 110/68 Body mass index is 27.55 kg/m².   11/03 0701 - 11/04 0700 In: 540 [P.O.:360] Out: 950 [Urine:950]   Physical Exam: General - awake, alert, NAD Respiratory - non-labored CV - RRR GI -abdomen soft, minimally tender to palpation. Midline incision OTA with no drainage.  Ext - WWP   Labs & Images reviewed.        Assessment/Plan     75 y.o. male with small bowel perforation secondary to lymphoma status post exploratory laparotomy with resection of 30 cm of distal ileum and primary anastomosis, now 8 Days Post-Op.    o Home medications including aspirin and PO plavix restarted.  o PRN Oxy and ATC Tylenol  o Continued Leukopenia.  o Oncology consult- Patient will resume chemotherapy as an outpatient, no need to treat leukopenia unless ANC less than 1 o PT/OT: Recommending discharge to facility,  24/7 care cannot be provided at home. o DVT prophylaxis: SCDs, Lovenox o Adult diet Regular; Yes o Dispo: Will require hospitalization until 14 days after his COVID diagnosis and can then be discharged to facility   MD 11/4/2021 7:27 AM         MD at 11/3/2021  7:48 AM
Shots were administered in right deltoid muscle on 8/17/20, administered 1 inch apart.  patient reports arm is red, swollen, and warm to touch.  Her bicep muscle of that arm is also swollen
3/17 Vaccination By 6PM, stiff shoulder, stiff neck. Got progressively worse thru night. The diarrhea went away within 24 hours. The floaters in L eye appeared that first night. It started to increase, swatting at 'flies'.  3/18 It got worse; floaters. I made appt with eye doctor.  3/30 Saw Dr. She stated was a lot of floaters in L eye.  It is still a few every couple of minutes. Has improved but still ongoing.
Swollen lymph node in the right armpit. The dose was administered in the right deltoid. Side effect noticed approx. 18 hours after vaccination. Tennis ball size at the Lymph node area. Tender to touch. Soft to touch. No other side effects noted.
Almost immediately lost vision; Had a seizure for about 5 seconds; This is a spontaneous report from a contactable consumer (patient). A 22-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 26Sep2021 at 10:45 (Batch/Lot Number: FF2589) as dose 1, single (at the age of 22 years-old) for Covid-19 immunisation. Medical history was not reported. There were no concomitant medications. No other medications in four weeks. Pharmacy did not monitor after the vaccine was administered. The patient came out to the car and almost immediately lost vision and had a seizure for about 5 seconds on 26Sep2021 at 11:15 AM. The patient had no Covid prior to the vaccination and Covid was not tested post vaccination. No treatment was administered for the events. The outcome of the events was unknown. The events resulted in: Doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.