chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered to 45 patients past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vaccines were stored in a standard freezer. A total of 45 doses from the outlined lot numbers were administered past the expiration date. All 45 patients were adults, who received the Moderna vaccine beyond the 30-day use by date. This case contains information for the 15th of 45 adult patients described by the reporter. The date the lot 007B21A was stored in standard freezer was reported as 16-Mar-2021. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2022: Upon internal Review on 29-Jul-2022, significant correction was made to update case as valid, updated classification. Updated vaccine start date, expiration date , event onset date and narrative.
Feeling of overheating upon mild exertion.  No fever to report. Symptoms have continued for over 10 days after second covid vaccine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 03-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose number, anatomical location, lot number and expiration date were not provided) for prophylaxis. The reporter stated that on 03-JAN-2017, when administering the ZOSTAVAX to the patient, a small bubble formed at injection site ( injection site vesicles). It was reported that the pharmacist then withdrew needle from patient "after about a third of the dose had been given", and re-stuck the patient in a different spot and finished the dose. The outcome of injection site vesicles was not reported. The reporter did not assess the relatedness between the event and ZOSTAVAX.  Additional information has been requested.
BRIEF OVERVIEW: Discharge Provider:  Primary Care Provider at Discharge: No primary care provider on file. None Admission Date: 7/12/2022 Discharge Date: 7/14/2022  PRESENTING PROBLEM: Hyponatremia [E87.1]   HOSPITAL COURSE: Pt is a 67 year old male with a history of hypertension, schizoaffective disorder, who was discharged 2 days prior to coming into ER, who presented with abdominal pain that has persisted for 12 hours. On 06/26 he was admitted complaining of abdominal and rectal pain. Workup at that time did not show any acute abnormalities, but he required psych eval and was ultimately discharged to facility for a couple of weeks. Since discharge patient stated he was experiencing some chills, nausea, weakness, no appetite for 1 day. Patient denied trauma, diarrhea, constipation, blood in stool or urine, fevers, chills, vomiting.  Vital signs were stable. His sodium level was 115 (corrected for glucose), chloride 79, glucose 165, and he was covid positive. Other lab work was unremarkable. CT abdomen showed no evidence of acute pathology. Patient stated that facility was aware of low sodium levels before he left and recommended he follow up with his PCP for further management.  The patient was was transferred from facility and admitted in hospital with hyponatremia for further treatment and management.   The patient's sodium increased above 130 with cessation of Effexor, Geodon, and hydrochlorothiazide. As his sodium improved his abdominal pain improved. The patient reported that he has a psychiatry appointment on Wednesday 7/20. He felt he would be fine off of his medications until follow up with his usual psychiatrist for medication changes.  He was discharged home in stable condition with plan to stop hydrochlorothiazide, hold Geodon and Effexor, and follow a 2,000 ml fluid restriction until follow up with Psychiatry on 7/20.  He was sent a prescription for losartan to replace Hyzaar, and recommended to follow up with PCP for further monitoring of sodium.
crown of head felt swollen, severe pain in sinuses, severe pain in upper teeth, face swollen.   none preformed.   systems went away on own.
Patient's wife states he had a fever beginning that night which broke around 2:30am. That evening his pulse went up to 218 bpm and his blood pressure was 190/125. His arm is still very red.
1 hr after getting the shot felt real tired and the next day woke shaking all over very exhausted, have the sweats
Rash - feeling tired, last about 4 days, pt said started about 2 days after administration, to best of my knowledge did not see treatment.
my flu symptoms were much less and a short duration; Initial information received on 13-Jan-2023 regarding an unsolicited valid social media non-serious case received from a consumer/non- healthcare professional (hcp).  This case involves Adult and unknown gender patient whose flu symptoms were much less and a short duration after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, lot number: unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event of my flu symptoms were much less and a short duration (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, it's not about getting the flu people, it's about not being as miserable. It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE  was not applicable.  It was not reported if the patient received a corrective treatment for the event (my flu symptoms were much less and a short duration).  At time of reporting, the outcome was Recovered / Resolved on an unknown date.
Initial report received from a health care professional on 14 November 2011. This reporter also reported another adverse event, which was captured in case number 2011-09213 and 2011-11124. A 68-year-old female patient received a right arm injection (route not reported) of FLUZONE, sanofi pasteur Inc. lot number UH462AA, on 20 September 2011. The patient's medical history and concomitant medications were not reported. The patient was given the FLUZONE vaccine at the time of discharge from the hospital on 20 September 2011. Two days later on 22 September 2011, the patient presented to the Emergency Department (ED) with cellulitis of the right arm. The patient was treated with intravenous ANCEF and given a prescription for KEFLEX. The patient was re-checked the following day and showed significant improvement. The outcome was reported as recovered. Documents held by sender: None.
Immediate injection site pain, took Tylenol. Three hours later it was difficult to move arm to pain. Grew increasingly worse. Took more Tylenol. Following day was much worse to the point that I couldn't eat or move. As the days went on the pain subsided. Still sore, but feeling better. No medical attention sought.
DTaP given 5/11/2006. On 05/12/2006, left thigh 5cm x 3cm red, indurated area surrounding puncture. Emesis x 2am, T101. Mild tenderness, running around, T in office 97.
Patient stated her fingers were tingling and she was hperventilating. Patient calmed down and stated she was feeling better. Pt refused transport to ED.
a lot of pain under her arm in the underneath underarm in the gland area; area around the vaccination site has a red circle; warm sensation (around vaccination site); burning sensation (around vaccination site); a little itch (around vaccination site); the area around the vaccine site looking rash looking like a hive; the area around the vaccine site looking rash raised; arm was sore; A spontaneous report was received from a consumer concerning a 45-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was sore, a lot of pain under her arm in the underneath underarm in the gland area, area around the vaccination site has a red circle, warm sensation (around vaccination site), burning sensation (around vaccination site), a little itch (around vaccination site), the area around the vaccine site looking rash looking like a hive, the area around the vaccine site looking rash raised.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20a) via unknown route for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the event(s) arm was sore. On 2021, the patient experienced the event(s) a lot of pain under her arm in the underneath underarm in the gland area, area around the vaccination site has a red circle, warm sensation (around vaccination site), burning sensation (around vaccination site), a little itch (around vaccination site), the area around the vaccine site looking rash looking like a hive, the area around the vaccine site looking rash raised.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 24 Feb 2021 the outcome of event(s), arm was sore was resolved. The outcome of event(s), a lot of pain under her arm in the underneath underarm in the gland area, area around the vaccination site has a red circle, warm sensation (around vaccination site), burning sensation (around vaccination site), a little itch (around vaccination site), the area around the vaccine site looking rash looking like a hive, the area around the vaccine site looking rash raised was unknown.
The pt developed erythema on his leg after vaccine. Noted in the afternoon on the day after vaccine. His right leg had a 6cm X 8cm area on thigh that was warm to the touch with swelling. He was treated with Keflex and Benadryl.
On 10/20/2022 we ordered what we thought was the Moderna Bivalent. It was listed as booster dose. At that time it was our understanding that the only booster dose was the new Bivalent vaccine. When we scanned the QR code on box info for the bivalent vaccine came up. We started using thinking it was the new bivalent vaccine. On 10/27 we called Moderna to ask a question about the vaccine. They were given the lot number. On 10/31/2022 they called us back to answer our initial question, but also informed us that the vaccine was not the bivalent vaccine.  16 patients were involved and all have been notified of error. All understood and no one had an adverse effect.
red itchy rash all over torso; red itchy rash all over torso; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 at vaccination age of 47-year-old intramuscularly administered in left arm on 03Jul2021 11:15 (Lot Number: EW0196; Expiration Date: Sep2021) as dose 1, single for covid-19 immunisation. The patient's medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no known allergies. Concomitant medications included ascorbic acid, colecalciferol, nicotinamide, panthenol, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTI VITAMIN); cetirizine hydrochloride (ZYRTEC); calcium; and unspecified birth control pills, all indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jul2021 18:00, the patient experienced red itchy rash all over torso. It was further reported that on day 3 after vaccine, she noticed red itchy rash all over torso. It resembles chicken pox. It's been 6 days of rash and it doesn't appear to be getting any better. The patient has not been tested for covid-19 since vaccination. The patient received treatment for the adverse events which included a prescription for prednisone. The reporter considered the case as non-serious. The adverse events resulted in physician office visit. The outcome of the events was recovered on 22Jul2021. The patient received the second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) dose 2 at vaccination age of 47-year-old intramuscular in the left arm (reported as left bicep) on 24Jul2021 11:45 (Lot Number: FA7484) as dose 2, single for covid-19 immunisation.  Follow-up attempts are completed. No further information is expected.
Eye sight - blurred vision; soreness to arm; loss of appetite; insomnia/sleep problems.
Oct 8 in the morning I noticed tiny red dots all over her arms,legs, face, and feet. She also had MULTIPLE bruises on her legs, hips, arms and I know she had not been injured
As I depressed the plunger on the Fluzone HD quad while it was in the patient's left deltoid, the majority of the vaccine leaked out of the side of the Luer Lock down the patient's arm and onto the floor.  The patient was advised that they should receive a repeat dose since they did not receive the full vaccine.  It was indicated that they would return in a few days time to get a fresh Fluzone HD quad administered.  The patient did not actually suffer any adverse effects from the vaccination itself.
all over body pain and joint stiffness,  severe pain at injection site, debilitating fatigue, headache, drowsiness altered breathing and abdominal pain.
No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 30-JAN-2020, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with one dose of improperly stored VARIVAX (lot # M041080, expiry date 06-OCT-2018) for prophylaxis at a temperature of 6 degree fahrenheit to 14 degree fahrenheit for a time frame of 4 hours 55 minutes (incorrect product stored). No adverse effects reported. The call was because of a data logger.
Patient started vomiting about 3 minutes after the administration of the vaccine. Patient reported social anxiety and felt nervous at time of the administration. Patient also reported eating food before vaccine administration. Patient received some water and was fine afterwards.
Patient experienced burning sensation throughout body after each dose of the covid-19 vaccine as well as facial numbness on the left side.
This spontaneous report as received from a pharmacist refers to an approximately 62 year old female patient. On unknown date in 2010 (when the patient was 58 year old), the patient was vaccinated with her first dose of PNEUMOVAX 23 (lot#, strength, dosage, frequency and route unknown). On unknown date in 2014 (reported as "now") the patient had cancer. The outcome of cancer was reported as not recovered/not resolved. Upon internal review, cancer was determined to be medical significant. Additional information has been requested.
Rash located forehead, nose & cheeks around to lt ear began Sat or SUn 9MAR91 or 10MAR91 - no fever @ present fever at time of Immun controlled by Tylenol;
RASH AND SWOLLEN AROUND INJECTION AREA. EXPERIENCE PAIN BUT SEEMS LIKE GETTING BETTER ON 4TH DAYS AFTER RECEIVED.
I got the vaccine and still got shingles/Suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown 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 Information: GSK receipt date: 05-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the vaccine and still got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
High fever for approximately for twelve hours (ranging from 100.5 to 102.1), severe body aches and chills for over 12 hours, and severe pain at injection site with rash.  No treatment(s) used.  Fever, body aches, and chills resolved 30 hours after injection.  Injection site pain resolved 72 hours after injection.
Patient started having lower extremity itchiness about 3 days after vaccine administered.  He did not notice any rash on his legs, but itching continued. Then on morning of 4/15 (7 days after vaccine administered),  he noticed a rash on upper arms and upper back. Rash is scattered erythematous papules. Somewhat itchy, not painful. Rash has started to spread down arms. No other symptoms noted. Recommended try benadryl, start steroid dose pack if persistent/worsening, try topical steroid
Neuropathy of both feet dxed as small fiber neuropathy by neurologist. Blood drawn on neurology appt showed positive ANA and anti double stranded DNA. Also 1 gram/24hrs oh urine protein. Seeing rheumatologist tomorrow. Theses are new findings. Also have extreme tiredness
Pain, burning, warm, red, cellulitis--Keflex and Prednisone for 10 days
seizure occcurred 8 days p/administration of vax 5MAY93; pt lost consciousness, entire body shook for short time; pt was slow to respond p/sx; pt did not have fever but did have beginning ear infect @ time of sz;
Major brusing on arm, very sick, numbness in both hands, swelling in both hands (almost had both carpel tunnels cut in wrists to relieve swelling).
Headache  Tingling in hands  Numbness in hands and legs  Pain in legs Tired  Pain in back and neck  Blurry vision  Heart flutter
Dizziness, Headache, congestion and sinus pressure Narrative:  pt c/o experiencing headaches and dizziness apprx 510 minutes after receiving COVID vaccination. later reported nasal/sinus congestion and increase in headache. denied any other symptoms.  Other Relevant History:
3 hours after vaccines and PPD started with hot flashes, body tingling, syncope. Symptoms reoccurred to include tunnel vision, dizzy, nausea the day following day.
Two days after receiving shots, there was swelling in his arm, pain moving arm and his arm felt hot.  This lasted for three days.  On 09/28/2003 he started coughing.  The next day his cough worsened and his temperature was 38.7 C.  On 09/30/2003 he stayed home from school because he was sick.  His fever remained 38.7 C, he had no energy, and was excessively sleepy.  The night he received his shots, he had night terrors that continued for three days.
Pt received vaccines 7/20/12 at 1439. That evening she started to have chapped lips with 1 mm papules on upper lip. Seen by dr 7/21/12 - advised to apply VASELINE TID.
Hives, widespread. Anaphylaxis. Hypersensitivity of skin (welts). Ongoing.
Sneezing, nose running continuously, wheezing, rapid pulse, pressure on chest lasting over 12 hours. Pressure on chest lasted over 48 hrs. Contacted doctor to let him know. He said to call him if I had anymore problems or if it didn't go away.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 28-JUL-2017 the patient was vaccinated with ZOSTAVAX lot # L036454, expiration date 22-DEC-2016 for prophylaxis. Concomitant therapies included sterile diluent. On 28-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. The outcome of expired product administered is unknown. The reporter considered expired product administered to be not related to ZOSTAVAX.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022; No adverse event; patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022) 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 EXPIRED PRODUCT ADMINISTERED (patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 05-Jul-2022).    Concomitant medications were not reported.   Patient received half dose.They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions.  Treatment medications were not reported.