chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially stored in the refrigerator on 21-Jun-2023 and administered on 25-Jul-2023; No adverse event; Vaccines past the expiration date and administered them to 3 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients), PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 25-Jul-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 25-Jul-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients), PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 25-Jul-2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients) and PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 25-Jul-2023).    Concomitant medication was not reported. Date the vial was initially stored in the refrigerator on 21-Jun-2023. Use by date of vial was 21-Jul-2023. The dose was administered after 30-day Use By Date. Vial did not undergo any temperature excursions. Treatment medication was not reported.  This case was for the 2nd patient out of 3 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735312 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2023: Non-significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735312:Master case/Patient 1
Resident was fatigued and more disoriented - beyond baseline confusion. Right knee swelling and pain present without any fall or injury sustained as resident is non-ambulatory. Resident's lab results 01/26/21 showed PLT result of 118 - Hematology consult was completed, as MD was concerned about sudden onset Thrombocytopenia. Hematology consult was completed 2/8/21 - more lab tests were ordered to rule out further blood disorders (CBC with diff, automated reticulocyte count, total LDH, Hepatic Function panel, Free T4, TSH, Vitamin B12, Haptoglobin, Folate, Free Light Chains, Protein ELP. Results came back on 02/11/21 with PLT level returned to normal (PLT 151) and no further indication that there was a separate blood disorder present. Symptoms resolved and no further follow up required by Hematology or primary MD.
swelling of left index finger; This is a spontaneous report from a contactable (patient). An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on 23Jan2021 16:00 at single dose for Covid-19 immunization in a facility. Medical history included recent finger injury. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 16:45, the patient experienced swelling of left index finger in area of recent injury. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment due to the event. The outcome of the event was unknown. The patient informed that this may not be related to the vaccine but thought it should be reported. The reporter considered the event non-serious; did not results in death; not life threatening; did not caused/prolonged hospitalization, not disabling/incapacitating, no congenital anomaly/birth defect.  Follow-up activities are possible, information on the batch number has been requested.
4/9/21 - second covid vaccine recorded at 9:30 AM. 730 PM  started to get sleepy 830 was exhausted went to bed and slept 14 hrs.   Also started having tinnitus when woke 4/10/21. Has decreased over 24 hrs.
She got the vaccine, felt like somebody was messing with her blood.  She never had that feeling before, and felt very heavy and not able to walk.  My heart was beating hard, shortness of breath and felt slowed down.  Catching her breath was very hard for her.  She could not more, she could not walk, just feeling sick.  She went to the ER and she had some tests, and X-rays of her legs, tests on her heart, and US of her heart, CAT scan of her head, blood work as well.  They told her that her thyroid was very low, they increased her medicine.  Her neck was swelling and said that she had fluid on her heart.  When she went for the  showed that the fluid was normal, but she still could not move well, and they had to hold her to walk.   They felt that she had arthritis and that she needed surgery on her knee.   She went back to the ER again for a check up of her heart and to see what was going on as she was still having problems.  The US showed that the fluid was not going to do anything to her.  She was considered to be OK.  She still has the heaviness feeling when she gets up, but if she sits down or lies down she is okay, but when she stands up she is not able to move.     She got an injection in her knee for the arthritis and also in her foot, she is now able to bend it, and due to favoring her left side now your right side hurts and is having pain in that leg.  They told her that she cannot stand on her own and is at risk of falling so she has to make sure that somebody is with her.  She does use a walker now.  She did not have any issues with arthritis or her knees prior to the vaccine.  She does have high blood pressure but was not having any problems with that.
1/29 vaccine after 12 hours, I had chills, fever, flu like symptoms. Tylenol. Over night, didn't sleep well. HA, felt very sick. Taking ibuprofren and tylenol over next 48 hours.  Lasted until Sunday morning, afternoon back to normal. Still a little bit of body aches but back to routine.
death Narrative:  70 yo male received COVID19 vaccine on 2/16/2021 (first dose) without complications. Patient was admitted to the facility on 3/12/2021 and transferred out to a hospital on 3/15/2021. Patient died on 3/24/2021 due to acute respiratory failure at a medical center. This report is being written because patient received Pfizer covid19 vaccine, Facility requires we report to VAERS if death occurs within 42 days of vaccination. Prior to his hospital admission, his previous one was 5/11/2020-5/14/2020. Please see below for hospital course at the Facility: 70 yo male with PMHx of COPD, CHFrEF 20%, CAD s/p MI and CABG in 1999, HLD, HTN, DM2, GERD, Anxiety and Depression who presented with increased shortness of breath to facility. Transfered on 3/13 to the facility. Noted increased SOB without CP, palpitations, cough, orthopnea or PND. No history of home O2 use but required 2-3L O2 during this hospital stay. Was noted on admit to Facility to have troponin elevation with unchanged EKG. Was started on NSTEMI protocol with heparin ggt, ASA, BB, and statin. Initially received one dose ceftriaxone/azithro for possible PNA. On admission, primary team held home BB. On arrival to Facility, troponin at 3.998 trended to 4.442 and then trended down. underwent CTA to evaluate for PE that was negative. CXR and CT showed pulmonary edema consistent with HF exacerbation and a proBNP 8613. Patient was given 40mg IV lasix x2. RRT was called twice, once for BP 80/50 treated with 500ml IVF, and second for CP that resolved with NTG and tramadol. Cardiology was consulted with goal to cath patient, however some concern for medication adherence going forward so they will reevaluate. Patient began to have tachycardia with rates in the 150s sustained and hypotension. EKG showed likely sinus tachycardia with wide QRS similar to prior EKGs. Patient has ICD in place that was interrogated and showed good function. IV metoprolol 5mg given x3 with rated decrease to upper 120s. Patient remained asymptomatic, awake, and alert. Per discussion with wife after transfer, patient BP has been in the 50s systolic at home for the last month. Cardiac cath was performed showing 99% stenosis of LCX. Did not tolerate procedure with nausea, vomiting, and altered mental status. RRT was called after cath procedure. He is nauseous, diaphoretic. He complained of chest pressure. STAT EKG obtained. Noted ST depressions in the septal leads significant from before. Cardiology concerned pt was having an inferior MI. STEMI call was activated and hospital cath lab was called and report given to the cardiologist on call. Pt was then transported to the Facility and he passed away on 3/24/2021.
I received my first Pfizer vaccine shot Tuesday, 4/6/21, 1115 hour. On following Tuesday 4/13/21, I began to experience nasal discharge problems (running nose).  To address issue I purchased and began to use Claritan OTC medication.  On Monday 4/19/21 upon waking noticed hearing problem: 1) Hissing in both ears, 2) Inability to equalize inner ear pressure [Same problem that one experiences in airplanes at high altitudes], 3) Pressure in inner ear [Similar as having water in your ear], and 4) difficulty in hearing conversations on the telephone.  On Monday 4/19/21, PCP prescribed Allegra.  On Tuesday 4/20/21, I requested PCP give me a prescription for an antibiotic because I do not have and have never had a history of allergy problems, but have had a history of sinus problems.  Began taking amoxicillin on Tuesday 4/20/21.  Today is Thursday 4/22/21, and I have seen no change in my hearing problem.  I still have the same ear problems previously mentioned, and they do not seem to be improving, even though I've continued taking the Allegra and amoxicillin as prescribed and have tried various techniques to clear my ears [Gum chewing. Jumping jacks, hard swallowing] all with no success.  I attribute this ear problem to the covid vaccine shot I received 2+ weeks ago.  I do not plan to receive the second shot, as I feel that it will only worsen my condition/situation.
Tingling in my left hand; severe throbbing pain in my left arm; This is a Spontaneous report from a Contactable other HCP (patient, self-reported). A 77-years-old female patient (patient was not pregnant) received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247 and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021 at 17:30, as single dose for COVID-19 immunisation. The patient's medical history included allergy to amoxicillin. The concomitant medication included vitamins. On 11Feb2021 at 12:00 AM, the patient experienced tingling in left hand for 3-days still present time, 2nd day after COVID Vaccine she had severe throbbing pain in left arm and took tylenol-MAPP 650 Mg every 8 hrs. Also Ibuprofen 400MG 4-hrs after taking tylenol. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not take any other vaccine in four weeks. Patient took tylenol-MAPP 650 mg every 8 hrs and Ibuprofen 400mg as corrective treatment. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the events was considered as not recovered.  No follow up attempts are needed. Information on Lot/batch can not be requested. No further information is expected.
This case was reported by a consumer and described the occurrence of influenza in a female patient who received Influenza vaccine. Concurrent medical conditions included chronic obstructive asthma (with obstructive pulmonary disease). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown. It was unknown if the reporter considered the influenza to be related to Influenza vaccine. Additional information received: The reporter mentioned that a lot of people have taken the flu shot but still gotten the flu. For example, her sister received the flu shot but still got the flu. No further details were provided.
This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received DTaP vaccine. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), Pertussis (serious criteria GSK medically significant) and cough. On an unknown date, the outcome of the vaccination failure, Pertussis and cough were unknown. It was unknown if the reporter considered the vaccination failure, Pertussis and cough to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, in 2014, there was an outbreak of Pertussis in a patient. The patient tested positive, but had no symptoms to minimum symptoms with less coughing. When tested the patient's were pertactin lacking. The reporter was not sure which brand of DTap that was provided. This case was considered as the suspected vaccination failure since the details regarding basic immunization schedule, time to onset for the event were not reported. This case is 1 of the 5 cases, as reported by same reporter.
Got sick after second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick after second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick after second shot). At the time of the report, ILLNESS (Got sick after second shot) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-053335, MOD21-053410 (E2B Linked Report).; Sender's Comments:  MOD21-053335:Cross link MOD21-053410:Cross link
New hire received a MMR 5/11/13 (susceptible to measles) at local store near her home.
Patient is seen upon arrival to emergency department.  Vitals are reviewed and noted for a low-grade temp of 99.6 as well as a heart rate of 101.  Patient is 95% on room air.  Patient is extremely hard of hearing, and left his hearing aids at home.  His daughter at bedside.  Patient will have an IV established, blood work performed, chest x-ray and a rapid Covid test for further evaluation.  Patient's labs are reviewed, noted for hemoglobin of 7.9, is his baseline.  WBCs are low at 3.5.  Given this blood cultures and lactate are ordered.  His sodium is noted to be low at 126.  Chest x-ray shows evidence of right lower lobe pneumonia.  Patient will be given Rocephin 1 g IV and azithromycin 500 mg IV.  He is also given Decadron 10 mg IV. Rapid Covid test is positive.  Patient and daughter at bedside have been updated of this.  Patient has been continued to be monitored in the ER, and his oxygen does go down to 87% while he is at rest.  Given this, and patient's chest x-ray findings of pneumonia and Covid, I did offer admission, and they are agreeable to this.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Additional Details: called 911. paramedics arrived. pt felt much better lying on the floor. after 20 minutes, paramedics took blood pressure and pulse. he didn't want to go to hospital so paramedics let him go. we advised him to go to doctor's office or similar place for his second shot where he can be monitored. pt didn't have any injection site reaction but this report doesn't let me submit without selecting a bubble.
Extreme diarrhea within 4 hours of vaccine, joint aches, nausea, fatigue. All symptoms decreased after 5 days except diarrhea. @ weeks later still have explosive diarrhea - yellow in color. Follow up visit with facility on 6/14/06.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.4 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 30-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Client vaccinated with Pfizer vaccine for Covid on April 4 (client not sure of exact date) and May 4 (client is positive about that date) and subsequently tested positive for Covid on 8/2  and was symptomatic starting on  7/31.    Reported as breakthrough Covid case following full vaccination.
1st day after the 2nd shot, high fever, malaise and fatigue for 8 or so hours 2nd day after the 2nd shot, chest tightness/discomfort that worsened when laying down, difficulty sleeping due to chest discomfort, palpitations began and continued for a few months.  After that developed occasional heart block when resting,  SVT when exercising and trigeminy PVCs, now have non conducted PACs
LD lower area is red and swollen. Patient states the area also hurts. No fever,dizziness or headache per patient. MD informed and he went in to talk to patient.
Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F; This spontaneous safety report, with reference number 02244297, was received by a partner on 12-SEP-2022 and forwarded on 13-SEP-2022, from a Health Professional.   This case was considered non-valid since no patient identifiers were provided (temperature excursion only).   Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION with reference numbers 02244297 / 02244285 was received by partner on 21-SEP-2022 and forwarded to Regulatory Agency on 22-SEP-2022 from a Health Professional.  Twenty-nine (29) administration dates and temperature excursion durations were reported for Vaxelis with batch # U7151AA (expiration date: 17-JUL-2024):  255 HRS 02 MIN 9/7/2022 60 HRS 24 MINS 8/19/2022 60 HRS 24 MINS 8/16/2022 19 HRS 2 MINS 8/4/2022 193 HRS 42 MINS 9/1/2022 193 HRS 42 MINS 8/30/2022 255 HRS 02 MIN 9/1/2022 62 HRS 20 MINS 8/25/2022 60 HRS 24 MINS 8/17/2022 60 HRS 24 MINS 8/15/2022 60 HRS 24 MINS 8/22/2022 255 HRS 02 MIN 8/31/2022 62 HRS 20 MINS 8/23/2022 60 HRS 24 MINS 8/15/2022 26 HRS 47 MINS 8/12/2022 62 HRS 20 MINS 8/25/2022 60 HRS 24 MINS 8/16/2022 22 HRS 3 MINS 8/8/2022 62 HRS 20 MINS 8/25/2024 22 HRS 3 MINS 8/8/2022 19 HRS 2 MINS 8/5/2022 22 HRS 3 MINS 8/8/2022 60 HRS 24 MINS 8/16/2022 22 HRS 3 MINS 8/9/2022 5 HRS 32 MINS 8/2/2022 22 HRS 3 MINS 8/9/2022 62 HRS 20 MINS 8/25/2022 62 HRS 20 MINS 8/25/2022 62 HRS 20 MINS 8/25/2022  The case is maintained as non-valid.  Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION with reference numbers 02244297 was received on 17-Oct-2022 from a Health Professional.  ID, DOB, Vaxelis administration date, gender, age, dose number, concomitant vaccines and confirmation of no adverse event were provided for 29 patients.  Due to the nature of the event, the causality between the event "Multiple vaccines were administered following temperature excursions; to over 200 patients; lowest temperature was 33.1F" and Vaxelis was not applicable.   No further information is expected.  Notes: Source case MCM-004036, originally non-valid temperature excursion. With receipt of FUP information, 29 valid cases were created.
Patient reported redness and swelling around there elbow a couple days following administration of the vaccine.  Patient was counseled to take ibuprofen and continue to monitor and follow up if no improvement.
Fever and seizure for 5 mins 911 called transported to hospital eval and d/c from ED.
03Oct90 pt vax w/ hepta B. 04Oct90 pt devel rash w/ raised welts on both calves. pt tx w/ DPH.  by 05Oct90 rash remitted. pt recvd 2nd vax one month later w/o reaction.
w/grandma 1/2hr-stiff, stop breathing, t100.3-APAP given; taken to ER for observation-not admitted; MD advised not more DTP/DT only
Mom found him with vomit in his crib in the morning. Low grade fever(99). He is also cutting teeth. Vomited again after arising. Decreased appetite, mild diarrhea.
Pt. vaccinated on 9-25-13. Arm felt fine for 2 days. On 2nd day pt said arm was very stiff and difficult to move arm; Also painful. Follow up w/pt. on 10-16-13 arm still very sore has been using Ibuprofen and creams to help relieve pain. Very slowly getting better.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03AK26A) for COVID-19 vaccination. The patient's past medical history included Dry eyes (She previously has had dry eyes in past). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown. Not Provided. Relevant concomitant medications were not reported. Treatment information was not provided. Action taken with mRNA-1273 in response to the event/s was not applicable. This case was linked to MOD-2021-071131.
Fever, chills, body aches, mild headache, fatigue, and menstrual bleeding.  Occurred about 10 hours after administration of the vaccine and lasted 24 hours.    Tylenol to help relieve symptoms of fever and body aches.  Stayed hydrated with water and Gatorade.