chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Vomiting; He is not feeling well; Arm being a little sore; Muscle ache; This is a spontaneous report from a contactable consumer (patient's wife).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6201; Expiration Date: 30Jun2021), via an unspecified route of administration on 16Feb2021 as dose number unknown, single for COVID-19 immunisation. Medical history included chemotherapy 2 years ago from unspecified date in 2019. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, after the patient's shot, it was reported that the patient felt fine other than his arm being a little sore and then he had some muscle ache but felt well enough. So he decided to go to do his exercise program on the day of the report (17Feb2021) and swim laps. While the patient was swimming he got sudden nausea and he threw up, he had vomiting. The patient was well enough to get home. The reporter thought the patient did too much activity too soon after having the vaccine but he didn't have any symptoms, he was well enough, his appetite was really good in the morning of the report and everything. It was further reported that the patient does have some nausea medicine (treatment), he had chemotherapy 2 years ago (history). Then on an unspecified date in Feb2021, the patient was not feeling well and still feeling that until the day of reported. Unspecified treatment was given in response of the events nausea and vomiting. Outcome of event "not feeling well" was not recovered and unknown for all other events.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist via a company representative refers to a 59 year old female patient with extreme dry eye. Drug reactions and allergies were not provided by the reporter. On 22-APR-2014, the patient was vaccinated with ZOSTAVAX (dose, frequency, route, lot# and expiration date were not provided). The reporter stated that the patient developed a bilateral eye infection after receiving ZOSTAVAX (on 28-APR-2014). The reporter also stated that the patient reported this adverse event to the pharmacist and also visited two eye specialists, however their contact information was unspecified. The reporter also stated that the patient had been diagnosed with extreme dry eye before receiving ZOSTAVAX at an unspecified time and was placed on an unspecified steroid (manufacturer unknown) and an unspecified antibiotic (manufacturer unknown) and at some point later she was instructed to stop the antibiotic and continue with the steroid. It was unspecified whether the patient was taking the steroid at the time of receiving ZOSTAVAX. The outcome of bilateral eye infection was unknown. The reporter also stated that the pharmacist did not believe that the bilateral eye infection was related to ZOSTAVAX. Additional information has been requested.
sore right arm; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 03Mar2021 (Lot number: EN6198) at the age of 66 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "stroke", start date: Dec2015 (unspecified if ongoing); "stroke", start date: Feb2016 (unspecified if ongoing), notes: has had a problem with her left side, having weakness since she had a stroke at age 62. Family history included: "her mom had one really bad stroke" (unspecified if ongoing), notes: she was in her 80s. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Mar2021, outcome "not recovered", described as "sore right arm".  No follow-up attempts are possible. No further information is expected.
At 0930 on 6/15/2022, completed administration of immunizations to client (order Right Arm: Hep A, MenQuadfi, Left Arm: Tdap, HPV). After five seconds, client's skin color became pale, lip color turned blue, eyes rolled into head, and client lost consciousness. Client unconscious for thirty seconds before awaking. Client alert but oriented to person. Client anxious, crying. Assured client he was safe and brought mother around into client's vision better. Reclined chair back 45 degrees. Used cool compress to the temples. After five minutes of mother talking and providing touch, client stopped crying and became oriented x 4. Client stated felt dizzy and nauseous. RN gave client some time but also outlined for mother and client goals for client to drink, eat, and be steady on feet before client could leave clinic. Provided water and Graham crackers. After five minutes, client sat forward on own in chair and able to tolerate water and graham crackers. Skin color pink, lip color pink, behavior almost returned to baseline. After five minutes, client wants to attempt standing. Client stood and took five steps in room; client stated feeling dizzy. Returned client to reclined chair, encouraging client to sip water. After ten minutes, client attempts standing again. Client able to tolerate. RN and mother escort client to private vehicle.
chills; pain in her face and neck; pain in her face and neck; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose in left arm and second dose in right arm, both via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced chills, pain in her face and neck on an unspecified date. Outcome of events were unknown.   Information on the lot/batch number has been requested.
June 11, 2022 on 03:00 AM, I woke up with a fever, ear boning, and nausea, pain in my left arm. At 07:30 AM in the morning I lost the sound in my left ear and I also had a high pitch loud sound and sensitive to sound to both ear. Everything sounded loud blasting from my left ear. On Saturday morning, June 11, 2022, Dr. prescribed me medication for my ear, prednisone. Will have a hearing test tomorrow on June 14, 2022.
Pt. got really hot in temp., dizzy, felt like collapsing, loss of hearing w/in 5 min. of receiving flu vaccine.
patient fainted upon walking out of store. face was pale. history of fainting from vaccines. did not wait 15minutes sitting. walked away after about 5 minutes.
Case number PHEH2014US003952 is an initial spontaneous report from the consumer received on 21 FEB 2014. This report refers to a 08 year old female patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly at a dose of 0.5 ml on 24 JAN 2014. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).  Non significant follow up report received on 25 MAR 2014: Updated physician information only.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
No additional AE; HCP calling to report administration of expired MMR II vaccine.  Caller asking if re-vaccination is necessary. No additional AEs/no PQCs reported.; This spontaneous report as received from a medical assistant referring to a 12 month old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.      On 22-JUL-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (expired product administered) lot # U018893, Expiration Date: 02-JUN-2022, 0.5 milliliter , first dose, for prophylaxis.   Expiration date reported as 02-JUN-2022, but upon internal validation was confirmed as 16-JUN-2023, conflicting information, vaccine probably not expired.
pt recv vax; 10 days later, exp macular papular rash on legs & torso;
Patient received a Dtap, IPV, and MMR the afternoon of August 21, 2007.  One the morning of August 22, 2007 he had a fever.  By 8:15 AM he was unresponsive and had seizure activity.  After a full ER workup and evaluation it was determined that he had a febrile seizure due to the previous days vaccinations.
Rash on entire body, redness and itching. No SOB or S/Sx of anaphylaxis. Refused ambulance transport. Benadryl 50mg PO x1 given with positive effect. Rash resolved in 1 hr of benadryl administration.
tested positive with covid-19 virus; tested positive with covid-19 virus; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: unknown), via an unspecified route of administration on 10Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, patient tested positive with COVID-19 virus. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on unspecified date in Mar2021. Her 2nd dose appointment was on 31Mar2021 and she was asking if she can still get the 2nd dose. She was in contact with some relatives and she got, she tested positive for COVID. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PHARMACIST GAVE ONLY HALF DOSE OF MODERNA BIVALENT VACCINE INSTEAD OF THE FULL DOSE. AS SOON AS THE PHARMACIST NOTICED THIS MISTAKE, THE PHARMACIST INFORMED THE PATIENT TO GET THE OTHER HALF DOSE TO COMPLETE ONE FULL DOSE(FOLLOW CDC GUIDELINE)  , PT HAS NO SIDE EFFECT. (PHARMACIST MISTAKENLY THOUGHT MODERNA BIVALENT AS MODERNA MONIVALENT BOOSTER )
Systemic: Pt reports swelling in L armpit and pain radiating down her L arm-Mild, Systemic: Lymph Node Swelling-Mild, Additional Details: Patient reported significan swelling in L armpit 5 days post injection in addition to pain radiating down her arm. This occurred on 9/4/21; patient reported events on 9/5/21 and says these symptoms have resolved.
PATIENT RECEIVED BIVALENT MODERNA BOOSTER ON 01/13/2023. PATIENT RECORD HAS A RECORDED MODERNA BIVALENT BOOSTER ADMINISTERED ON 10/27/2022 BY ANOTHER FACILITY.
high fever for 18 hours; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (high fever for 18 hours) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE for Rheumatoid arthritis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever for 18 hours). At the time of the report, PYREXIA (high fever for 18 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Mycobacterium tuberculosis complex test: unknown (Negative) Tb Test negative. On 20-Apr-2021, Mycobacterium tuberculosis complex test: unknown (Positive) TB spot test. On an unknown date, Mycobacterium tuberculosis complex test: unknown (Positive) quantiFeron-TB Gold Plus test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information were provided by the reporter.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 31-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S006210 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
ALLERGIES; This spontaneous report received from a pharmacist 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 allergies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergies was not reported. This report was non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing). Concomitant medication(s) included: LOPRESSOR, start date: 01Jan2019; NORVASC; KEPPRA [LEVETIRACETAM]; FINASTERIDE; ALFUZOSIN; NEXIUM [ESOMEPRAZOLE SODIUM].  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 14Dec2022 to 19Dec2022. Lot number= GA9816.
pt recv vax 24APR97 & pt exp numbness of the lips for 30min;all rxn exp by pt have currently resolved;
I am having long term rashes on my skin that pop up, then get tiny sores (almost like chicken pox) and then the skin becomes a scratchy, rough path.  I currently have 3 patches and several other pocks.
Patient was not holding still for vaccination. One nurse attempted to hold the patient and distract the patient by looking in the box while the other nurse gave the vaccine. While injecting the patient pulled away and the syringe with needle came out and scratched the skin. The full dose was not administered. Called the mom the following workday 3/14 to discuss possible option of revaccination for 1st dose. Mom decided to wait until after 2nd shot and get an antibody test. Mom verbalized understanding specific antibody levels have not been established for protective immunity.
Severe migraine headache, blurred vision and dizziness and nauseous and passing out for 5 days so far
Soreness at site, chills, fever, sore throat, coughing, congestion still occurring 2 days after injection
Developed itchy rash all over body 6 days after receiving covid-19 shot. Took Benadryl (25mg) every 4 hours. Rash is starting to diminish on day 3
AFTER RECEIVING THE VACCINE, BY 9PM THE JOINT PAIN HAD ALREADY STARTED.  THE NEXT DAY I RAN A FEVER OF 102.1 AND CONTINUED UNTIL SATURDAY EVENING OR SUNDAY.  I HAVE A COUGH, SHORTNESS OF BREATH, SEVERE JOINT PAIN THAT IS WORSE IN THE JOINT I ALREADY HAD ARTHRITIS IN.  THE SYMPTOMS HAVE CONTINUED ON FOR THE LAST 6 WEEKS.  THE PERIODIC FEVERS STOPPED ABOUT 3 WEEKS IN BUT THE OTHER SYMTPOMS CONTINUE.  IT HAS EFFECTED MY WHOLE LIFE.  I HAVE MISSED DAYS AT WORK DUE TO THE SIDE EFFECTS.
27 patients from 2 months -12 YO got Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Feb-2023 Reporter's comment: The reporter reported that total 27 patients of varying ages from 2 months through 12 years old received Kinrix. Exact ages correlating to number of patients was unavailable at this time.  The reporter did not had additional adverse event information at this time.  The reporter gave consent for safety team follow up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. This was 1 of 27 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023019068:Same reporter. US-GSK-US2023019068:Same reporter.
I?ve had Covid arm for Pfizer COVID shots 3-6. (The very first two- dose did not give it to me). Covid arm appear anywhere from 12-24 hours after injection. Just thought I would report it since I seem to get it every time now.
Mom states redness, warmth, and swelling of Right arm from elbow to above sholder starting afternoon after shots.  Had been giving Tylenol started Benadryl and Motrin on 4-9-03.  States is noticeable through turtleneck.  No fever or malaise.
INAPPROPRIATE ROUTE OF VACCINE ADMINISTRATION; BURNED/STUNG; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (unspecified manufacturer) for prophylactic vaccination (dose number in series 1). No events reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intravenous, batch number: 1855194 expiry: UNKNOWN) (unspecified manufacturer) dose was not reported, administered on 03-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s booster dose the patient experienced inappropriate route of vaccine administration and burned/stung. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate route of vaccine administration and burned/stung was not reported. This report was non-serious.
Post vax, pt fainted and had short seizure which lasted a few seconds. He became very pale and vomited. No treatment received other than lying down with feet elevated.
Received the vaccine in the left arm and had muscle aches then the right arm at same place left arm injection site, it became extremely painful and has continued to be painful. Now day 5-6 I?ve had a continual headache and I never get headaches.
Onset; after the Pneumococcal vaccine;  Initial symptoms; coughing, feeling weak, achy, fevers and chills. Since this his symptoms are staying the same and not worsening. Coughing up scant phlegm, worse at night. Phlegm is tenacious.  Has not seen what it looks like.  Taking Excedrin when he feels the fever coming on and Nyquil at night. Falls asleep but will awaken by the cough. Started on Doxycycline 100 mg BID x 10 days on 8/11/10.
Resident was vaccinated for COVID as noted, tested positive at home on 5/19/22.
Employee reported significant arm/shoulder pain and decreased ROM several after receiving COVID vaccine. Co-worker who examined site stated that vaccine appeared to be "given quite high on her arm, almost to the acromion process". Employee noted improvement in sx the next day which continued. Employee self-treated with analgesia and did not require medical evaluation.
Pt. presented to the COVID-19 Vaccination Clinic on 7/27/2021 for his first COVID-19 vaccine. He received the adult-formulation of Pfizer with the lot number EWO183-H. However, a routine audit later revealed that his age at the time of vaccination was 11.95 years old, rendering this dose inappropriate for his age, as he should have been 12 years old in order to receive it. The physician was contacted regarding the occurrence and reported that he had no medical concerns regarding this vaccination and that revaccination would not be required.   The client?s guardians were called on 4-13-2022, 5-8-2022, emailed on 5-8-2022, and called again on 5-15-2022. The facility left voicemails after each attempt to call the client?s guardian. On 5-17-2022, the client?s guardian called this writer back and reported that the client had been brought in for a vaccination in order to prepare for a trip the client was going to attend with the other boys. The client?s guardian was made aware that the vaccine had been received shortly before the client?s 12 birthday and that the dose was technically inappropriate for his age at the time. The client?s guardian was informed of interventions put in place to reduce the risk of such occurrences and informed of the physician?s guidance and response. He verbalized understanding and reported that he had not noticed anything out of the ordinary following his son's vaccination.  All staff at the COVID-19 vaccination clinic have been educated on a new procedure designed to reduce such errors: vaccination staff ask clients to confirm their name and DOB and then respond by speaking the client?s age aloud and verbally confirming which vaccine the client is receiving. They will also verbally confirm the vaccine type aloud when they choose the vaccine type from the drop-down menu in order to reduce the risk of documentation errors.
Minutes after receiving 2nd vaccine, patient felt her heart racing and chest tightness.  She stated the back of tongue felt like it was tingling.  Vitals at 0808: 98%RA, 110 HR, BP 145/80, RR 20.  PO Benadryl 25 mg was given at 0811.  Vitals rechecked at 0813: HR 75, BP: 124/78, 98% RA, RR 18.  Patient states her chest tightness had lessened, but still reported the tingling in her throat and tongue.  Stayed with patient and gave her water.  Vitals at 0818: 100% O2, HR 73, RR 18.  Patient stated at that time she is doing well.  Reports that she is working from home today.  Told patient to take Benadryl at home if symptoms still present .  Last vitals, 0823: HR 75, RR 16, 02 sat 99.  At this time, patient stated she was ok to leave and feeling better.  Chest tightness subsided.