chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected Vaccination failure; Shingle in her eye days after her second dose of SHINGRIX; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: Shingle in her eye days after her second dose of SHINGRIX) (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroids). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 19-JUL-2023 Reporter was a Field Representative that was at a work related lunch gathering. Field Representative states at lunch a Nurse Practitioner reports that a colleague, another nurse practitioner, was diagnosed with Shingle in her eye days after her second dose of Shingrix.   Nurse Practitioner reports to Field practitioner that this adverse event happened six months ago and was not reported. (AE Symptomatic) Also, reports that the shingles in eye was treated.  This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consented to follow up. This case has been linked to the case US2023099643 reported by the same reporter.; Sender's Comments:  US-GSK-US2023099643:same reporter, different patient
Bell's palsy started Monday morning at 710. Right sided facial weakness, inability to close right eye, right sided facial drooping.
Vaccine administered 12 hours post punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post punctured) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 04-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post punctured). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 12 hours post punctured) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Follow up added patient demographics, vaccine information start date, dose number, route of administration and anatomical location was added.
Vaccinator report: 3 min post Pfizer dose #1, patient felt dizzy and needed to sit down. She did not pass out and was conversational. Got into a wheelchair to be observed by a medic. She became somnolent. EMS was summoned. Patient evaluated and transported to ED for evaluation and treatment.
Pt is fully vaccinated against COVID 19 with the Pfizer 2 dose series (given 8/3/2021 and 8/24/2021 respectively). Pt tested positive against covid on 10/5, received Regeneron on 10/8, presented to ED 10/10 with dyspnea, weakness, cough, decreased urinary output, and dizziness.  He was admitted to the hospital at this time (10/10) and diagnosed with COVID-19 pneumonia.  Covid treatment course thus far: " COVID-19 pneumonia o SARS-CoV-2 + 10/5/21, symptom onset about 9/26 o Fully vaccinated, immunosuppressed o S/p monoclonal antibody therapy 10/8 (casirivimab/indevimab) o Oxygen supplementation as needed o Continue dexamethasone 6mg daily o Monitor inflammatory markers o Empiric antibiotics are appropriate given onset of symptoms and significant immunosuppression-will give ceftriaxone and azithromycin initially but will have a low threshold to discontinue if respiratory status improves quickly o Lymphopenia noted but can be med effect (tacrolimus, mycophenolate) o Note that recent case study in Ann Rheum Disease indicated that holding mycophenolate perivaccination can increase humoral response to COVID vaccination-unfortunately, this was released >1 month after he received his vaccine series and his indication for immunosuppression is transplant status so may not have been appropriate regardless "
AFTER VACCINE WAS GIVEN ABOUT 5-10 MINUTES LATER, PATIENT WAS EXPERIENCING DIFFICULTY SWALLOWING , NUMBNESS IN MOUTH.  TOLD PATIENT TO LAY DOWN,  GAVE EPIPEN 0.3MG AND CALLED 911.  STAYED WITH PATIENT UNTIL EMT'S ARRIVED.  AFTER PATIENT WAS HELPED BY EMT, HE WAS ABLE TO WALK OUT OF THE RX.  SPOKE WITH PARENT AT 330PM ON 5/25/21 WHO STATED THAT THEY TOOK HIM TO URGENT CARE WHERE HE WAS STARTED ON ZYRTEC AND GIVEN AN RX FOR AN EPIPEN. PATIENT WILL FOLLOW UP WITH ALLERGIST, AND I RECOMMENDED IF HE IS TO GET A 2ND DOSE, THAT HE HAS IT IN AN MD OFFICE.  LEFT A MESSAGE WITH PATIENT'S PEDIATRICIAN ABOUT WHAT HAPPENED.
PT PRESENTED 6 DAYS AFTER INJECTION WITH RED RAISED RASH APROX 7 INCHES IN DIAMETER SURROUNDING THE INJECTION SITE, PT COMPLAINS OF PAIN AND HEAT AT INJECTION SITE AS WELL.  PT WAS REFERRED TO PRIMARY CARE PHYSICIAN, WAITING FOR RESULTS.
A single dose of expired Moderna Covid-19 vaccine was given accidentally; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A single dose of expired Moderna Covid-19 vaccine was given accidentally) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 007D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A single dose of expired Moderna Covid-19 vaccine was given accidentally). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (A single dose of expired Moderna Covid-19 vaccine was given accidentally) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.
Approximately 16 hours after ingestion, experienced bilateral lower extremity trembling/shivering. Approximately 20 hours post injection, had neck and back pain and headache. Denies worst headache of her life. Has felt hot and cold but no recordable fever.
Extreme Dizziness, Blurry Vision, Near fainting and Nausea
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a non-hcp (office staff). Linked case: 2018SA267493 (same reporter). This case involves a 22 years old female patient who received expired vaccine FLUZONE QIV. The patients medical history and concomitant medications were not reported. On 21-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5899MA via intramuscular route in the left deltoid. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This case was reported by a pharmacist and described the occurrence of elevated red blood cell count in a 76 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On Oct 20 2005 the subject received a dose of Fluarix (lot AFLUA1200AA). the pharmacist did not report a previous history of vaccination to influenza virus. On Oct 21 2005, one day following vaccination with Fluarix, the subject experienced an elevated red blood cell count, leg weakness, a high fever and pain throughout her body. The subject was hospitalized on Oct 24 2005 for testing. The events were ongoing at the time of initial reporting, Oct 31 2005. The pharmacist considered the events to possibly be related to vaccination with Fluarix, The pharmacist also stated that , no cause has been determined for her symptoms other than the patient had received the flu vaccine the previous day.
At 11:50 pm on 1/26/2021, I could not swallow even a sip of water. My Esophagus appeared to have closed.  I debated calling 911, but had sick animals I couldn't leave. Went to bed and when I woke, I could swallow again. However I had severe hives as well as debilitation itching and swelling of my fingers, hands and later, my toes and feet as well. These symptoms have continued in varying degrees ever since I received my first Moderna vaccination.
Narrative: Reports soreness at injection site for about 3 weeks, fatigue & body aches on day 10
TWO DAY AFTER VACCINE PATIENT HAD SEVERE LOWER ABDOMINAL CRAMPS AFTER AHVING MILK SHAKE AND ON 4/9/21 HE HAD RECTAL BLEEDING X 3 FIRST TIME BLOOD MIXED WITH STOOL ,SECOND TIME BLOODY DIARRHEA .THIRD TIME BLOOD
2nd dose was not given within 36 days from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose was not given within 36 days from first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose was not given within 36 days from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose was not given within 36 days from first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.
Increased swelling, pain and bruising noticed about 10 days after receiving FLUAD vaccine waking patient up in the middle of the night. Pain was described as hurting and awareness. As time passed, pain has lessened to intermittent frequency and on 12/18/18 site is observed as a dark, yellow bruise about 2in in diameter. Initial injection site was described as slightly bruised, with lessening bruising over time until the night darkening of site was drastically increased.
Second Shingles Shot--night of shot, could not sleep on that side, next day felt very achy all over, did not want to move. Felt like I was in slow motion, arm has large red circle at injection site. Very itchy. No extra treatment other than TYLENOL. Today--still red, swollen, sore, itchy.
High fever over 102, shivering, sever headache, vomiting, mild chest pain. Lasted until 6:00 AM. When vomiting ceased treated with 2 aspirins every 4 hours.
Case number PHEH2014US019561, is an initial spontaneous report from a pharmacist received on 26 Sep 2014. This report refers to a 70-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered MenCYW-135 liquid component of MENVEO (batch number: X14022) intramuscularly inadvertently instead of intended different vaccine very similar to PNEUMOVAX on 16 Sep 2014. No adverse event was reported following the administration error (wrong vaccine administered).
~1h following Pfizer #2 given 9/1/21 c/o mild dizziness, tight chest, irregular pounding HR, and need to take deep breaths r/t not feeling like getting enough oxygen. Pt had no other sx and was able to function.
Tingling and numbness in lips; blotchy rash on neck and chest; Tingling and numbness in lips; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received her first dose of BNT162b2 (Pfizer -BioNTech Covid-19 mRNA VACCINE; lot number: EP7534) via an unspecified route of administration in the left arm on 15Mar2021 at 10:30 (at the age of 68-years-old) for COVID-19 immunization. Medical history included diabetic. The patient had allergy to sulfa based drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 10:45, the patient experienced tingling and numbness in lips, blotchy rash on neck and chest. Therapeutic measures were taken as a result of tingling and numbness in lips, blotchy rash on neck and chest and included treatment with diphenhydramine (BENADRYL) from an unknown date. The clinical outcome of tingling and numbness in lips, blotchy rash on neck and chest were recovered at an unknown date. No follow-up attempts are needed. No further information is expected.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 22-Apr-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.).    Concomitant medication was not reported.  Patient received dose 1 monovalent Moderna vaccine 25 micrograms on 20-Mar-2023. Batch numberAS1903B. The route of administration of suspect Moderna bivalent dose 2 was reported as BI. No adverse effects were noted.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Linked master case
Received shot high in shoulder area and had pain at the onset. A week later pain and weakness in hand and arm were still present. Went to doctor and he referred him to another specialist with possible MRI.
This spontaneous report as received from a nurse refers to her daughter who is female patient of unknown age. The patient's concurrent condition include juvenile type 1 diabetes mellitus diagnosed at 5 years. The patient's historical drugs include varicella vaccine (manufacturer unknown) and developed chickenpox during childhood (reported in MARRS # 1611USA009929). Reporter stated that patient had no titers for rubella or hepatitis B despite being vaccinated for those during childhood (captured in MARRS # 1611USA009930 and 1611USA009931 respectively). On an unspecified date in August 2014, the patient was vaccinated with GARDASIL (dose, lot # and expiration date not reported) dose 1. In two weeks, unspecified date of 2014, the patient experienced one throat infection after another, and her blood sugar was out of control with her A1C level reaching 10. Patient also experienced elevated ketones, vomiting 25 - 30 times per day, pain in her chest and pain around her liver, and such severe joint pain, especially in her feet and ankles, that she stopped all of her normal sports activities, including her competitive swimming. Patient also experienced anxiety and a 20 pound weight gain. Reporter stated that patient saw both a psychiatrist and an endocrinologist in December 2014 to evaluate the symptoms. Patient's thyroid tests and other testing came back with normal results, except for expected blood glucose tests, as patient had been a Type 1 diabetic since age 5 years. The patient seemed to improve and continued with school. In August 2015, patient received her second dose of GARDASIL (dose and route not reported) lot K010215, expiration date unknown. Reporter stated that all of her daughter's symptoms came back, just like before. Patient experienced joint pain, headaches, frequent vomiting, severe menstrual pain, and stomach aches. Reporter stated that patient described rib pain, back pain, anxiety, and a second 20 pound weight gain. Reporter stated that patient experienced frequent insomnia, and had multiple ER visits totaling 5 or 6 ER visits over two years, with one hospital admission for rapid heartbeat. Patient tested ANA antinuclear antibody positive. At the time of this report the patient's present status was unknown. Causality assessment was not provided. Additional information has been requested.
No adverse events we were instructed to report to VAERS because vaccine was given to a pt under 18 yrs old.
We are a Pharmacy. Today, April 9, 2021, we had a patient. She was scheduled for her first dose of the Pfizer vaccine at 9:30 am. The pharmacy manager gave her the vaccine inside the store at around 9:30 am. She was accompanied by her husband. After the shot, she sat down in one of the chairs in front of the pharmacy to wait for the mandatory 15 minutes wait for any reactions. At 9:43 am, we noticed that she was looking a bit dizzy. As we were approaching her, she slid down the chair and became unconscious. Luckily her husband was right beside her and caught her before she fell. Pharmacy manager then helped her husband to quickly lay her down flat on her back. The husband asked to call 911. The pharmacy technician was there to assist and she called 911. The patient regained consciousness roughly around 30 seconds after she fainted. She was alert and breathing normally. We asked again if they wanted us to continue calling 911. They said yes. Roughly 5 mins later, the paramedics came and assisted the patient. The sugar was good, blood pressure was good, temperature was good. They asked her if she wanted to go to the hospital. The patient denied. The paramedics left and the patient stayed for more time at the pharmacy and eventually left.
Raised hot itchy red rash at at injection site. Cold compress, topical cortisone, ibuprofen
63 year old male received Fluzone High Dose, no AE; 63 year old male received Fluzone High Dose, no AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from  healthcare professional (medical assistant).  This case involves a 63 years old male patient who received 0.5 ml dose of  vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ221AB, Exp. Date 01-Apr-2020 via intramuscular route in the right deltoid on 02-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was also a case of overdose.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
The shot site didn't hurt at first but each day after the injection my left shoulder started hurting more and more. My osteopath was out of town so I decided I would try to go get a therapeutic massage. I had to ask the masseuse to stop because I could not bear the pain. I cannot raise my arm over my head or move my arm behind my back. I have better range of motion moving forward. The pain often radiates down my arm to my hand without doing anything and I cannot sleep on my left side at all. I am a caregiver for my 88 yr old father (and a recording artist by trade) I don't do anything strenuous...I haven't even been to the gym in months. It took speaking with a loved one on the phone that is married to physician that it might have been from my flu shot. I immediately called the pharmacy once I made the full connection. I wanted to initiate this complaint in case your agency can advise what tests/treatments can be done. I have an appointment with my osteopath.
Patient received the Moderna vaccine on 1/15/21 and 2/12/21, so was fully vaccinated when they tested positive for COVID-19 on 8/30/21.
Pt complained of a swollen tongue and feeling dizzy post vaccine. She hypotensive 70/40 mm/Hg, 44BPM,rested and BP slightly improved to 86/57 mm/Hg, 56 BPM. At d/c BP was 104/70 mm/Hg & 75 BPM.
febrile illness-t105 began 27MAY96;pt examined no rash or signs of infect;rx APAP & monitor
Within 3 hr of recv 2nd dose vax, pt devel fever 100. "Shaking all over". Tx w/Tylenol. recv another inj Typhoid vax 10/31/97 without adverse rxn.
Patient has not experienced any adverse effects  only 1 bivalent authorized. Patient received one Pfizer bivalent on 10/7/22 and a second Pfizer bivalent vaccination on 1-12-23