chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Imunocompromised patient received a booster dose instead of a 3rd full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Imunocompromised patient received a booster dose instead of a 3rd full dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Immunocompromised.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced UNDERDOSE (Immunocompromised patient received a booster dose instead of a 3rd full dose). At the time of the report, UNDERDOSE (Immunocompromised patient received a booster dose instead of a 3rd full dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient has to receive now the 2nd booster dose and HCP was wondering if this patient can get the 3rd full dose for immunocompromised patients that had not received before. No further information could be gathered. No treatment information was provided.   Reporter did not allow further contact
Pt began experiencing metallic taste in mouth after 1 st shot on 3/31/21. Pt worked the rest of his shift that night. Pt spouse called in to work on 4/1/21 stating pt felt crummy, arm swollen, and headache.
A full dose of Moderna 0.5 mL  was given when a booster should have been given.
ADMINISTRATION ERROR: Patient is 12 and received the Peds Pfizer-BioNTech Covid-19 Vaccine (ages 5 to 11).
This study case was received from the investigator in a trial on 18 July 2013. A 29 year-old male subject with a history of chest pain was found to have acute pericarditis unspecified 10 days after he had received on 29 September 2009 an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (other manufacturer, lot number, route and site of administration not reported), and Influenza Live Intranasal (other manufacturer, lot number not reported). Results from Troponin 1, ECG, Echocardiogram, MRI (brain, spinal cord, heart) and lumbar puncture were not available. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
9 Days after vaccine noted large lump 2cm on site use warm compresses went down still slight indurated 2 days after measures 1 1/2cm x 1/2cm redden and indurated slight purple /red. Did not have any lump or redness day of vaccine.
Subacute thyroiditis; booster; This is a spontaneous report from a contactable physician (patient). A 36-year-old male patient received third dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: FR2589) via an unspecified route of administration, administered in arm left (reported as left arm) on 28Sep2021 (age at the time of vaccination was 36-year-old) as dose 3 (booster), single for COVID-19 immunization administered in hospital. The patient's medical history was not reported and the patient had no known allergies. Prior to vaccination, the patient was not diagnosed with covid-19 and post vaccination, the patient was not tested for covid-19. There were no concomitant medications. The patient did not receive any other vaccine in four weeks and the patient did not receive any other medication in two weeks. Historical vaccine included, patient previously received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EL3264) via an unspecified route of administration, administered in left arm on 11Jun2021 (age at the time of vaccination was 35-year-old) as dose 2, single and received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EK5730) via an unspecified route of administration, administered in left arm on 21Dec2020 (age at the time of vaccination was 35-year-old) as dose 1, single both for covid-19 immunization. On 28Sep2021, booster was reported. On 08Oct2021, patient experienced subacute thyroiditis. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received NSAID (nonsteroidal anti-inflammatory drugs) and propranolol as treatment. Outcome of the event subacute thyroiditis was not recovered.  Follow-up attempts are completed. No further information is expected.
Noticed bright red 3 x 3 1/2 inch spot -area of injection. Swollen, hot itchy. Increased in size, went to Urgent Care. It is less red but still itching and a much larger area on my arm, forarm. Getting better, resolving slowly. Icing,  Benadryl.
2 weeks After the vaccination got a Very strong headache and vomit ; the next few days got mild  and spacey out . ; headaches also feel poor circulation on my right leg. At the beginning though headache were related to vision or the need to change prescription of my glasses until The J&J announce. I called my primary doctor and they say it is normal and gave me an appointment for the end of the month. Till today I still have sporadic mild headaches some of them only on the right side and eulment on my leg
I don?t know if it?s caused by the vaccine or not as the timing is so apart, but it is crazy to have something rare like pericarditis all of a sudden so I thought it best to submit to VAERS to let you review in case it was related or coincidental.   I?ve had multiple covid tests that are negative but the current theory is this was from a virus I caught while traveling 6/14-6/16. Staring feeling ill 6/17, went to hospital with chest discomfort 6/19, admitted and run through a battery of tests to make sure I wasn?t having a heart attack.
PATIENT HAVE A RANDOM ENCOUNTER WITH A PHARMACIST OF OUR PHARMACY AND SHOW HER ARM TO HER. ARM WAS REPORTED WITH A EXTENDED RED AREA, WITH INFLAMMATION AND DARK SKIN. PATIENT INFORM TO HAVE APPLY DICLOFENAC GEL TO THE AREA BECAUSE IT HURTS. SHE ALSO REPORTED INTOLERANCE TO ASPIRIN. PATIENT WAS ORIENTED AT THE TIME OF VACCINATION AND WAS RECOMMENDED TO ADMINISTER THE VACCINES IN DIFFERENTS ARMS. PATIENT DENIED BECAUSE SHE HAS A STROKE AND SHE HAVE RIGHT ARM DEBILITATED IN CONSEQUENCE. SHE REPORTED THAT SHE ALWAYS HAD HER VACCINES IN THE SAME ARM AND THAT HER DOCTOR RECOMMENDED HER TO ADMINISTER BOTH, FLU AND PNEUMONIA VACCINE. THE TWO VACCINES WAS ADMINISTERED SEPARATED BUT IN THE LEFT ARM. TODAY I CALLED HER TO FOLLOW UP, AND KEEP RECOMMENDING TO SEEK MEDICAL CARE IMMEDIATELY. HER DOCTOR TOLD HER TO STAY APPLYING COLD AND TO KEEP IN OBSERVATION. SHE REPORTED TO HAVE IMPROVE TODAY AND NO RED AREA WAS OBSERVED.
pt recvd vax; swollen, slightly red, hot to touch area at inject site;
Seizure like activity 10 min after injection x 10 seconds, then fatique/weakness, dizziness, chills, hypotension, and patient stated shortness of breath. 911 was called and transported to ER
Nausea/vomiting, fever/chills, watery stools, abd-cramps.
My son began experiencing chest discomfort a few hours after he had received his 2nd dose.  The discomfort only increased with his anxiety and having difficulty breathing.  He also experienced his heart racing.  I took him to the facility the following afternoon - approximately 31 hours after the 2nd dose and the facility completed blood work, x-ray and EKG; I was to follow-up with a cardiologist and that was also completed with Dr. and another EKG was performed, followed by an ultrasound of his heart. I have not received the result of the ultrasound as it was just performed on 06/30/2021.
Fatigue on Friday 1/1/21 (2 naps resolved fatigue on 1/1/21) and daily napping resolve fatigue 1/2/21-1/4/21 Headache on Saturday, 1/2/21. Took nap to resolve Blurry vision Sunday when reading began on 1/3/21 and has not resolved as of 1/5/21. Pain behind left eye on morning of 1/5/21
Severe nausea for 1.5 days.  Lack of eating caused blood sugar to drop.  Felt very weak.
This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored M-M-R II, lot #L005291, expiration date 17-FEB-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature/Time: 9.5C for 2 hours and 30 minutes, Data Logger: Yes, yes it was administered. There was a previous temperature excursion 1.5 C for 1 hour, 10.5C for 1 hour and 30 minutes. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Expired Pentacel given to 3 consumers with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the consumer or other non-professional via Agency (Reference number- 00581215) and transmitted to Sanofi on 28-Apr-2021.  This case involves 3 child (age and gender unspecified) patients who had received expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot number: UJ206ABA, expiry date: 24-Apr-2021 and other dosing details were not reported] on 27-Apr-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  It was a case of actual medication error due to expired vaccine used.  It was reported that, community health service manager refused to provide information of the 3 consumers who received the expired Pentacel. She stated that they called the parents and the parents stated they are not bringing their children back to receive another vaccine.  Product used: Used  At the time of report, no adverse event was reported.  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 the 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.
This spontaneous prospective pregnancy report has been received from a licensed practical nurse referring to a 12 years old female patient. The patient's current conditions included asthma and drug allergies were reported as none. On 10-APR-2017, the patient was vaccinated with the "first and only dose" of GARDASIL 9 lot # M034780 for prophylaxis (expiration date, route and anatomical location were not reported). The patient's concomitant therapies included CLARITIN. At the time of vaccination the patient reported having had a recent period (on an unknown date) and not being pregnant. It was reported that on 22-MAY-2017, the patient went to the emergency room with complaints of nausea, vomiting and lower belly pain and the chief complaint was that the patient stated that she was pregnant. An ultrasound was performed during the emergency room visit and was confirmed that the patient was 23 weeks pregnant with a last menstrual period (LMP) on 12-DEC-2016 and estimated date of delivery (EDD) on 18-SEP-2017. Additionally, unspecified intravenous fluids were administered to the patient; she also received ZOFRAN and MACROBID for urinary tract infection. The outcome of the pregnancy and of the urinary tract infection was unknown. The causality assesment between the vaccine and urinary tract infection was unknown at the time of reporting. Additional information has been requested.
Left deltoid inflammed at site of flu and pneumoniavaccine. States large swelling with heat and tenderness, lasting 5 days on 10/14/08. States area just looks bruised without as much swelling today.
Started with red eyes then eye pain with focusing and blurring to vision in first 24 hours then started prednisolone drops for 4 times a day for a week, 3 times a day for one week, then 2 times a day for week. Eye issue appeared to resolve a few days ago until today when vision started to blur again today. Client diagnosed with bilateral uveitis most likely caused by flu vaccine.
she has covid; she has covid; This is a spontaneous report from a contactable Nurse reporting for herself and also received from the Nurse via a Pfizer-sponsored program. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She was supposed to get the 2nd dose yesterday on 24Jan2021, but was unable to get it since she was on quarantine. The patient mentioned that she had covid on an unknown date in Jan2021, and asking when and where she can get it and if she had to wait 30 days from covid detection, and also asked if the vaccine has made she more susceptible to covid. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Pfizer Bivalent covid-19 vaccine was administered 11Sep2022 then got the 2nd dose on 17Sep2022; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID:   A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 1, single (Batch/Lot number: unknown) and on 17Sep2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 11Sep2022, outcome "unknown", described as "Pfizer Bivalent covid-19 vaccine was administered 11Sep2022 then got the 2nd dose on 17Sep2022".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Shortness of breath, lips numb/tingling/swollen, redness around injection site spreading to right side of neck and across face with onset approximately 20-30 minutes after injection.  Treatment: patient was taken to ED, given clonidine 0.1mg PO, Epi-pen 0.3mg, and solu-medrol 125mg IVP.   Patient recovered and was discharged to home with Medrol dose pack and po Benadryl.  Treating physician advised patient not to take second dose in series.
RT red and swollen 5cm x 9 cm (PCV 13 inj). Noticed this AM (7/13/10) at 10 AM. No pain, no itching.
Blood in urine, resolved after the aforementioned medications for 3 days, returned after second dose of Moderna COVID19 Vaccine.  Additionaly flu like sxs were in evidence.
I had an infection in my eyes that resulted in my eyes watering, runny nose, and pain in the left and right eye. The left eye was worse. I went to an urgent care on 10/8/2021. The doctor said it was an unusual eye infection, and the ducts in my eyes were plugged. I was prescribed Ofloxacin eye drops 4xday and told to wash my eyes with cotton balls.
pt had pain, redness, swelling @ inj site rt thigh seen @ walk in clinic 26MAR97;had 3cm area of redness & swelling w/o induration @ inj site;no fever;
sore throat; feels tired; a bit achy; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter's husband got his Covid vaccine last week. The patient's wife mentioned that he developed a sore throat 4 days after receiving the vaccine (20Jan2021) and wanted to know if this was a normal reaction from the vaccine and if this will happen again once he receives his 2nd dose. Also added that he also feels tired and a bit achy. The outcome of the event sore throat was not recovered while of the other events was unknown.
No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported.  This case was reported for patient 7th out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master Case
Cg reported being dx w/shingles 2 weeks after her first covid vaccine dose.  she states she is sure it is d/t the vaccine and requested a VAERS report be completed.
expired dose of TENIVAC was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Agency (Reference number- 00541423) and transmitted to Sanofi on 30-Mar-2021.  This case involves a 72 years old male patient who experienced expired 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6187AA and expiration date 06-Feb-2021) via intramuscular route in an unknown administration site for prophylactic vaccination(Expired product administered) on 29-Mar-2021.  The patient's medical history, past medical treatment(s), vaccination(s), family history, risk factor and concomitant medication were not provided.   It was an actual medication error due to expired vaccine used (same day latency).  It was not reported that the patient experienced any adverse event.  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 the 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.
I continue with the feeling of nausea no diarrhea or vomiting but severe constipation. I told my doctor she put me on miralax it worked after about three days but my stool came out with mucus, I went to see a gastroenterologist, who stated that was because my stool had been sitting inside me for too long. I was then advised to add fiber I increase prune a intake and still had pain I constantly feel like I have to go to the bathroom but nothing comes out. I got tested for a uti it was fine I had a blood test done at the gastroenterologist clinic for low thyroid results were normal. Because miralax was heavy Neysa the prescribed lactaid that made me nauseous so the first day I tried it I stopped and went back to miralax. I kept calling the UW facility complaining because I have had constant pain in my stomach and can't produce a stool unless I use miralax or drink prune juice. I wasn't this way before the vaccine it's been several months and my constipation has not gone away and my intestines put pressure on my bladder and give me pain and make me feel like I have constantly urinate.  I toss and turn in my sleep because I'm always full of stool but it never comes out unless I use miralax or drink prune juice. Even if use miralax to flush out my system it feels like there's a hard part on my stomach. I tried telling the Urgent Care doctor at an emergency urgent care appointment I had there even though at the appointment he felt my stomach and could see what I was talking about didn't seem to be in the doctor notes.  All the doctors kept telling me to change my diet even after doing that it's not better. I now live in constant discomfort and I constantly turn in my sleep.
mom reports that p/vax in MAR about 3 to 4 days later devel a hard lump @ inj site & had vomiting which lasted for several days; no fever noted, but felt warm;
24 hours after vaccination - compressed breathing, extreme shortness of breath, swollen chest and difficulty speaking or catching air. Extreme headache, fatigue and continuous projectile vomiting. Also experienced irregular heartbeat and increased heart rate. Hands and feet were swollen, red, itchy, hot to touch and joints were stiffened to the point where I couldn't walk or grip. After 48 hours the fever and vomiting were omitted from the symptoms. For the last 2 weeks the chest pain, heart irregularities, swelling of hands and feet and chronic inflammation, fatigue, etc. have continued.
It was reported that a 56 year old female received Fluzone 98-99 on 10/9/98. Reportedly the pt experienced large red area 4 inches in diameter at the injection site, also experienced pain and swelling since administration.
At approximately 6:30 pm, I began vomiting and feeling lethargic. This lethargic feeling lasted for approximately 2 days.