chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product storage error; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatment medications were reported.
MILD SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced mild side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20221101721.
It was reported that a female received Fluzone SV '99-'00 on 10/22/99. The "same day, post vax, she experienced throat closing, chest congestion, swollen upper lip and reddened eyes". She was self-dx'd and did not see a physician. The event lasted 24 hours. Follow up 06/14/01: During the internal auditing oa all files, it was deemed necessary to amend by updating the Adverse Evernt coding (added lung disorder).
This spontaneous report was received from a pharmacist referring to a 74 year old male patient. The patient's concurrent conditions included hypertension and his concomitant medications included an unspecified blood pressure pill. Not known drug allergies. The patient's medical history was not reported. On 20-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular in the left arm, lot # N025656 and expiration date: 19-APR-2019, indicated for routine vaccination (dose was not reported). Other suspect therapies included influenza virus vaccine (unspecified) intramuscular in the right arm (dose, lot#, expiration date and indication were not reported). On 20-AUG-2018 after receipt the vaccines, the patient's left arm was beginning to become red. The patient reported that as of 22-AUG-2018, the left arm was swollen from the "shoulder down to the elbow like a cuff". It was reported that the patient sought medical attention by calling the pharmacist and additionally, no treatment had been initiated as of yet. The outcome of injection site erythema, extensive swelling of vaccinated limb and peripheral swelling was reported as not resolved. The causal relationship between injection site erythema, extensive swelling of vaccinated limb and peripheral swelling with the suspect therapies was not reported.
Moderna Vaccine administered to a 16yo girl. EUA states 18yo and older.
Immunization stung more than a flu shot, she had some bruising at the injection site.  4/22/14 the deltoid was a lot more sore and became extremely painful.  4/23/14 shoulder hurt towards the back and somewhat towards the front.  By 4/25/14 the deltoid pain was resolving, but the shoulder pain has continued to get progressive worse.  Using her left arm is extremely painful in the shoulder and by this morning 4/30/14 she was in so much pain that she couldn't get out of bed and was crying.  The pain was so bad that it took her 2-3 hours to get ready for work.
Moderna COVID-19 Vaccine EAU. About 6 days after the injection my arm is still slightly sore, not uncomfortable but it has also gotten red around the injection site, almost rash like pattern.
Patient had a redness, swelling, warmth at the injection site on the following day. He was advised to apply cold compress at the reaction site.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, pain swelling at injection site, chills Narrative: Prior covid ab+ 8/17/20 and hospitalized for presumed covid pna however no + NP swab tests + from the period. Evaluated after vaccination by pmd advised against #2 dose of covid vaccine
Fluzone Quadrivalent was inadvertently administered to 10 patients instead of Fluzone HD; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA316262, 2019SA316289, 2019SA316290, 2019SA316263, 2019SA316286 and 2019SA316288.  This case involves a 70 years old male patient who inadvertently received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UJ305AA, expiry date: 30-Jun-2020), via intramuscular route in right deltoid, on 07-Nov-2019, instead of  INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Relevant medical history and concomitant medication were unknown.  The patient did not receive any concomitant vaccinations.  It was an actual medication error due to the wrong vaccine administered. It was reported that the Fluzone Quadrivalent was inadvertently administered to the patients instead of Fluzone HD.  The patient did not report any AE symptoms.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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
ON JANUARY 13TH SHE DEVELOPED RED SPOTS AROUND THE VACCINATION AREA AND IT GREW. IT WENT AWAY ON JANUARY 18TH AND 19TH, BUT CAME BACK ON JANUARY 20TH AS A VERY LITTLE RASH. ON JANUARY 20TH SHE WENT INTO THE CLINIC TO GET A KENALOG SHOT.  THEN ON JANUARY 21ST IT BECAME A BIG RED, ITCHY RASH.  ON JANUARY 22ND AROUND 7 PM SHE DEVELOPED A LARGE BRUISE INSIDE THE LARGE RED ITCHY AREA. IT ALSO STARTED BURNING FOR HER. SHE HAS BEEN ITCHY EVERYWHERE, BUT HAS NOT DEVELOPED HIVES. THE CLINIC ORIGINALLY THOUGHT IT WAS CELLULITIS, BUT NOW FEEL IT IS NOT CELLULITIS. THEY ARE FEELING IT MAY BE AN ALLERGIC REACTION.
This spontaneous report was received from a healthcare worker and refers to a 20 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 30-JUL-2015, the patient was vaccinated with improperly stored doses of M-M-R II (lot # J010208, expiration date 23-AUG-2015, exact dose and route of administration were not reported) and VARIVAX (Merck) (lot # J009987, expiration date 12-AUG-2015, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Dose administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Dose administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Dose administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Dose administered to adult patients from pediatric vials instead of bivalent vaccine) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Dose administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medications were reported.  It was reported that total 26 doses of Pediatric vials of Moderna COVID-19 Vaccine were administered to adult patients instead of Bivalent booster doses on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022.  No treatment details were reported.  This Case is for patient 23 out of 26 patients
My period is almost a week late with no signs of making an appearance. After receiving the first 2 COVID shots my periods were different too. They were heavier, but still came on time each month. Please acknowledge the fact that these vaccines have an effect on a woman's cycle.
Shortness of breath and weakness, leading to ER visit and hospitalization x 3 days- dx was pulmonary embolism, asthma, anxiety, hypokalemia, hypomagnesemia.   Unknown if related to vaccine. 03/19/07-records received from facility for DOS 2/16-2/19/07-DC DX:Pulmonary embolism, subsegmental nonocculding. Asthma. Anxiety. Hypokalemia. Hypomagnesemia. C/O shortness of breath times 1 week. Productive green cough and post nasal drip. Dyspnea on exertion but no PND or orthopnea. No chest pain but C/O palpatations.  PE:WNL. SOB likely due to underlying asthma exacerbated by viral upper respiratory infection and anxiety. Patients symptoms relieved with lorazepam.
This spontaneous report as received from a nurse refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose and frequency were unknown). On an unknown date in 2011, the patient experienced a horrible reaction. The nurse stated that the patient had a condition that causes her to be immunocompromised. The outcome of the adverse events was unknown. The relatedness of the events with PNEMOVAX 23 was not provided. Additional information has been requested.
PT PRESENTS WITH BILATERAL LOWER EXTREMITY MOTOR NEUROPATHY OF UNKNOWN ETIOLOGY, CONCERN FOR GUILLIAN-BARRE SYNDROME.  CURRENTLY BEING TREATED WITH IVIG. COVID positive, however no respiratory issues.
Vaccines given on 2/26/02 and on 3/2/02 the pt had a sudden onset febrile seizure and was listless and limp for 45 minutes.
24hr p/1st dose of vax pt devel redness @ inj to elbow w/sl swelling; event resolved spontaneously p/2 days;
Erythema and edema at injection site approx 3.5cm by 5cm oval shape
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 at 10:00 as dose 1, single (Lot number: EK9231), in left arm, on 05Feb2021 at 10:00 as dose 2, single (Lot number: EL8982), in left arm and on 29Nov2021 at 10:00 as dose 3 (booster), single (Lot number: FE3592) at the age of 58 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Non Hodgkin's Lymphoma" (unspecified if ongoing); "Invasive Ductal Carcinoma Right Breast" (unspecified if ongoing), notes: Invasive Ductal Carcinoma Right Breast. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Paxlovid Treatment start date-01Jun2022, Treatment stop date-06Jun2022, Lot number=GA2279. Follow-up attempts are completed. No further information is expected.
second dose not administered within 36days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not administered within 36days) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not administered within 36days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not administered within 36days) 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.   No relevant concomitant medications was reported.  Treatment information was not provided.
Pt recvd Hep B vax & following vax the pt devel an unspecified rxn;
The night I received the GARDASIL vaccination I developed a migraine that lasted about 3 day. The next day I noticed I developed a full body rash. Rash was red and raised. It was not itchy. I went to the Dr.'s office the next day and saw by the PA. I was put on prednisone as well as ZYRTEC. The rash resolved within a week's time span.
I had my vaccination on 12/10/2021. On 08/10/2022 I had a severe headache. On 08/11/2022 I tested COVID-19 positive. I was prescribed Z-PAK a week after testing COVID-19 positive. I am feeling great as of 12/13/2022.
laid around for 2 days; hot and cold chills; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine moderna (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation; Fluvaccin (DOSE NUMBER UNKNOWN, SINGLE), for Influenza immunisation. The following information was reported: DYSPNOEA (non-serious) with onset 2023, outcome "unknown", described as "Shortness of breath"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 2023, outcome "unknown", described as "hot and cold chills"; FATIGUE (non-serious) with onset 2023, outcome "unknown", described as "laid around for 2 days".  Additional information: Reporter was asked if she would like to complete a safety report on behalf of her mother when reporter stated her mother had the Pfizer Vaccine also and her mother experienced hot and cold chills, had shortness of breath and laid around for 2 days and that was it. She added her mother took over her appointment and got that Pfizer vaccine as the caller was buying her prescriptions and the caller said go head of her for the vaccine. The reporter and her mom got the shot so they did not get covid as they are up in their age and have been doing Moderna constantly but they were out of the Moderna that day so they got the Pfizer.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300356607 same reporter/drug, different patient/AE;
Pt developed a rash all over body, mild SOB, and mild chest tightness approximately 20 minutes after receiving the 1st dose of COVID vaccine. Her SpO2= 95% on RA, HR= 105, BP= 111/62. She was given 25mg of IM Benadryl by (RN); code blue called, and team evaluated patient and sent pt. to ER; pt. remained conscious throughout.
nausea; chills; general feeling of unwell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 11:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization, reaction(s): "chills and aches from my fingertips to my toes", "general feeling of unwell", "chills and aches from my fingertips to my toes", "sore arm". The following information was reported: NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "nausea"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "general feeling of unwell". Additional information: Patient got her second dose yesterday at 11. she had some nausea, chills, and general feeling of unwell. 2 weeks later she had a bout in the bathroom. Caller stated she had already reported this to the previous agent.  she asked yesterday, on phone and received some information. She reported adverse effects yesterday, minimal and nausea and that they could call her if they needed more information. She stated she wasn't having symptoms, she was trying get ahead of symptoms, She stated that her doctor said to take Advil before she gets symptoms, because it is harder to get rid of it once it starts. With the first Pfizer covid vaccine, she stated she had a really sore arm, the doctor said to take advil after the shot, this way to get ahead of any symptoms because they are hard to get on top of, and then she stated she took it after vaccination, 4 hours later than again before bed, she  took 3 doses. She stated she had 2nd dose of the Pfizer vaccine on Tuesday, and asked that she should be okay from not getting severe reactions or symptoms?, as she wanted to be around people. People are getting cysts around eyes when wearing mask and she  was having that problem too. how long after the second dose, do you have full protection? She stated she thought it was 2 weeks? But just read 7 days on Pfizer website. she is immunodeficient, and just wondering if she is aware.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash all over my face and neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over my face and neck) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced RASH (rash all over my face and neck). At the time of the report, RASH (rash all over my face and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication given.  No treatment information provided.
Received vaccine around 15:00 on 10/25/2005 by 16:00 on 10/25/2005 patient started feeling light headed, dizzy, sweating progressed to the point of loss of control, slurred speech, unable to tie shoes. Presented to ED with Temp of 91F, near syncope, K=2.5 mmol/L, Blood Glucose = 37 mg/ol. Medical records state sweat, asthenia, hypothermia. msv
This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L039659 with expiration date: 15-MAR-2017; lot # L015460 with expiration date: 20-JUL-2017; exact dose and route of administration was not reported). No adverse effects were reported. The administered doses experienced a temperature excursion of 10 degrees Celsius for 1 hour and 16 minutes. The temperature excursion was detected by a data logger. There was no previous excursions. Additional information has been requested.
pt c/o pain along bank of neck x 1hr p/vax;pt denied: h/a, n/v, vertigo, fatigue, rash, pruritus  & fever;mom was advised of rxn;pt took advil @ home reporting improved comfort level p/2hr;
Patient fainted immediately after first shot. Has experienced extreme fatigue,memory loss, trouble concentrating and after the third shot started experiencing seizures. 2/13/09 MR received for multiple DOS. Pt seen in ER 4/14/08 following apparent seizure.  Pt found unresponsive in bed. Difficult to arouse and confused. Post ictal upon arrival to ED. Small lac on lip. Later, a H/A. Neuro consult with PE (+) for epigastric tenderness and tenderness of the paracervical and shoulder muscles and intrascapular region. Event suggests nocturnal seizure. Returned 7/20/08 following grand mal seizure in bed. Post ictal upon arrival in ED. Both seizures following start of new antidepressant. Impression:  Breakthrough seizure.  Returned 11/14/08 with c/o shakiness, lip and chin quivering and an abnormal sensation like being unable to feel touch. Now having seizures every few weeks. Recently has been feeling ill, with face flushing, muscle aches and joint cracking. Final impression:  Paresthesia and tremor.  Seizure d/o.   3/11/09 Neuro consults received beginning 5/12/2008-12/29/08. Records reveal nocturnal seizure 10/15/08 where pt bit tongue.  Seizures seem to be around time of menses. Pt c/o episodic dizziness. Neuro exam WNL.  Started on Lamictal.  Seizure 11/14/08.  H/As in good control on Lamictal.   3/17/2009 MR received from PCP. Pt seen 4/18/08 with multiple c/o since about 10/2007. Recently hospitalized above for syncope/seizure.  Since 10/2007 pt not acting herself, grades have dropped, diffuse H/A, overwhelming fatigue, puffy face. Seen in 6/08 with anxiety, fatigue.  Requests meds for "nerves"-given.  Assess:  Abnormal results thyroid funtion study, syncope and collapse, anxiety state. By 8/08 feeling dizzy, nauseated with dry mouth.
pt recv vax 6AUG96 & 21OCT96 pt exp gen rash w/less than 50 lesions;reporter noted pt had been exposed to children @ school w/chickenpox;no further details were provided;