chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had the latest COVID booster done. It was Pzifer. It was done in the AM and at night I was very achy, dizzy, and had a fever. Symptoms lasted 24 hours.
4 doses in total were administered after the 30 day BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (4 doses in total were administered after the 30 day BUD).    4 doses in total were administered after the 30 day BUD. 2 doses on 4FEB2023, 1 dose on 5FEB2023, and 1 dose on16FEB2023. No reported symptoms. No additional doses medications or treatments administered in response.   This case was linked to US-MODERNATX, INC.-MOD-2023-711667 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711667:Master case - 1st adult
PATIENT WHO IS A MINOR RECEIVED A PFIZER BOOSTER ALTHOUGH THE BOOSTER WAS NOT AVAILABLE FOR THOSE UNDER 16 YEARS OF AGE.  PT DID NOT SHOW ANY VACCINE HISTORY IN VIIS.  PT'S MOM CALLED 1 DAY LATER TO REPORT THIS VACCINE ADMINISTRATION ERROR.
c/o dizzy w/cramping in abd;IV fluids/IV Toradol
Severe pain to Right arm radiating to shoulder and neck, unable to lift right arm very high due to pain.  Patient thinks vaccine  was given to her in her joint since she is having so much pain. Using heat and ice to help with pain, taking Neurontin for nerve pain. Phone call to patient on 02/26/21 and she states pain is getting much better, still painful to lift arm but she can tell it is better.
I?m about may my periods started getting a lot heavier, and today started the worst one so far I?m wearing both a tampon and a pad and bleeding through both every 21/2-3 hours
Mild body aches; tired; not feeling well; Loss appetite; kidney pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08May2021 10:15 (Lot number: Ew0185) at the age of 40 years as dose 1, single for covid-19 immunisation at other. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma, allergies, Herpes Virus; "allergies" (unspecified if ongoing), notes: other medical history: Asthma, allergies, Herpes Virus; "Herpes Virus" (unspecified if ongoing), notes: other medical history: Asthma, allergies, Herpes Virus; "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin, amoxicillan. Concomitant medication(s) included: SINGULAIR; WIXELA INHUB; PROVENTIL HFA [SALBUTAMOL SULFATE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; RHINOCORT [BUDESONIDE]. Past drug history included: Amoxicillan, reaction(s): "Allergies: Amoxicillan", notes: Known allergies: Penicillin, amoxicillan. The following information was reported: PAIN (non-serious) with onset 09May2021 07:00, outcome "not recovered", described as "Mild body aches"; FATIGUE (non-serious) with onset 09May2021 07:00, outcome "not recovered", described as "tired"; MALAISE (non-serious) with onset 09May2021 07:00, outcome "not recovered", described as "not feeling well"; DECREASED APPETITE (non-serious) with onset 09May2021 07:00, outcome "not recovered", described as "Loss appetite"; RENAL PAIN (non-serious) with onset 09May2021 07:00, outcome "not recovered", described as "kidney pain". Therapeutic measures were taken as a result of pain, fatigue, malaise, decreased appetite, renal pain.  Additional information: After first dose, the patient had mild body aches, no arm pain. After few days, tired and not wanting to do anything. Simply not feeling well. Loss appetite and kidney pain progressed from time 1st does to 2nd. The patient was treated with Vacyclovir. If Covid prior vaccination: No. If Covid tested post vaccination: No. If other vaccine in four weeks: No  No follow-up attempts are required. No further information is expected.
Initial Headache & fatigue.  Always has allergies & congestion in and off so hard to tell if congestion worse. About 1 month later occasional brain-fog, light-headedness, constipation, extreme fatigue started.  Sometimes call after lunch to pickup at school, come home & sleep. 05/16/22 went to PCP for symptoms. Bloodwork + Allergy meds/sinus infection. Never got better.  Tested for Lyme, thyroid, etc.  06/16/22 labs came back good except slightly low sugar. Dr. Did a POTS test (-) & referred to Cardiologist.
No additional AE reported.; BCG vaccine that experienced excursion was administered to a patient.; This spontaneous report was received from a pharmacist and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On 08-FEB-2023, the patient was vaccinated with bcg live (BCG VACCINE), strength 50 milligram (mg), powder for injection, administered for prophylaxis (lot number W026958 is an invalid lot number for bcg live (BCG VACCINE); expiration date was reported as 31-MAY-2023; dose and route of administration were not provided). The bcg live (BCG VACCINE) experienced excursion and reached a high temperature of 9.7 degrees Celsius for 5 minutes on 08-FEB-2023 (product storage error). No additional adverse event (AE) details were available.
This case was reported by a physician via sales rep and described the occurrence of local reaction in a 4-year-old female patient who received KINRIX for prophylaxis. On 15th June 2018, the patient received KINRIX. On 17th June 2018, 2 days after receiving KINRIX, the patient experienced local reaction. On 18th June 2018, the patient experienced induration. On an unknown date, the outcome of the local reaction and induration were unknown. It was unknown if the reporter considered the local reaction and induration to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient came on the reporting day to the physician since she had  experienced large local reaction approximately 10 cm on right leg which started on  Sunday. On Monday, 18th June 2018, 3 days after receiving vaccination, the patient came in with 8 cm of hardness. The reporter did not agree to follow up.
SEVERE DIARRHEA (8-10 EPISODES PER DAY); FATIGUE (MEDIUM TO HIGH SEVERITY); LOW GRADE FEVER; DISORIENTED (MEDIUM TO HIGH SEVERITY); SHUFFLING FEET AND UNSTEADY (NEEDED TO HOLD ON TO STUFF TO PREVENT FALLING); This spontaneous report received from a consumer concerned a 72 year old male. The patient's weight was 180 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol use, non smoker, and penicillin allergy, and other pre-existing medical conditions included no drug abuse or illicit drug usage. the patient was healthy as a horse. patient did not had diagnostic data available'. The patient experienced reaction to a flu vaccine when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2008, the subject experienced reaction to a flu vaccine. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. On 01-MAY-2021, the subject experienced disoriented (medium to high severity). On 01-MAY-2021, the subject experienced shuffling feet and unsteady (needed to hold on to stuff to prevent falling). On 01-MAY-2021, the subject experienced low grade fever. On 02-MAY-2021, the subject experienced severe diarrhea (8-10 episodes per day). On 02-MAY-2021, the subject experienced fatigue (medium to high severity). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe diarrhea (8-10 episodes per day) on 10-MAY-2021, disoriented (medium to high severity), and shuffling feet and unsteady (needed to hold on to stuff to prevent falling) on 03-MAY-2021, fatigue (medium to high severity) on 15-MAY-2021, and low grade fever on 08-MAY-2021. This report was non-serious.
COVID-19; 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), on 02Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing), no known allergies. There were no concomitant medications, reported as, no other medications/products within 2 weeks.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: for five days; (2022) Positive, notes: for the last five days. Therapeutic measures were taken as a result of covid-19 included (Treatment start date: 13May2022, treatment stop date: 18May2022). Clinical course was reported as, Paxlovid created rebound COVID. After testing negative for five days the patient was tested positive for the last five days. Patient was recovering from symptoms and no treatment received for symptoms. Vaccine lot was not available/provided to reporter at the time of report completion  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immediately after vaccines dev. soreness/pain in arm. Next day AM developed fever, SOB, dizziness.  Used Albuterol - some relief. (+) MOTRIN tablet taken for pain -> (+) relief. Also   to arm x3-4d.
Patient was given first dose of Meningococcal B (Pfizer/Wyeth) by MA. She was then escorted to exit door by MA who noted patient walking differently. MA alerted LPN of patient status. Patient states that she felt weak and faint. Patient was assisted to a row of chairs to recline and elevate legs. Ice pack was place on back head, cool cloth to forehead, juice box and crackers given.  5:12pm: BP 120/60 P59 O2sat 99% laying 5:20pm: BP 120/70 P81 O2sat 99% sitting 5:30pm: BP 120/72 P88 O2sat 99% standing Patient reported feeling fie and ready to leave. Father was outside in car. Patient escorted to the car without incident.
Arm was very red and swollen. It was also very warm to the touch where the redness was. She also said she had felt more tired than normal since receiving the vaccination. Patient thought redness had spread over the past 36 hours. She said that the vaccine hurt a lot when she received it and that her arm was still very tender. She did not report any trouble breathing and said that the area did not itch. She had been using an ice pack on it and had taken some ibuprofen. She said that the ibuprofen seemed to help a little. I recommended that she take another dose of ibuprofen before bed (it had been 6 hours since her previous dose) and that she continue to ice it a little (15 minutes on and 15 minutes off). Since she said she thought the redness was spreading we used a black marker to make a small mark at the lowest and highest points of the redness and I told her that would allow her to see if it continued to spread or get better. If it continued to spread or got worse by tomorrow morning I recommended she go see her doctor. However, I told her if she had any trouble breathing tonight that I would go to an urgent care or emergency room immediately. I am a visiting pharmacist so I am going to make sure that the pharmacy manager follows up with her in the next 24 hours to see how she is doing. She stated she has never had a reaction to a vaccine like this before. According to her file she has received the PREVNAR 13 and HD FLUZONE from us in the past. Pregnancy is not a concern (patient is 80 years old). I am not the pharmacist that administered the vaccination. The patient came in tonight due to being worried about the reaction from having the vaccine the previous day. As of right now she has not gone to a doctor or clinic, but may do so if symptoms worsen overnight.
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/20/2023 ACUTE CHOLECYSTITIS
pulmonary embolism; injection was very painful; left arm weakness/can't move arm; insomnia; irritability; high energy level; leg and calf pain with severe right calf pain; pain worsening from the injection area to the back of his ear and shoulder; pain worsening from the injection area to the back of his ear and shoulder; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on 15Jun2021 (at 11 AM) as single dose for covid-19 immunization. The patient medical history included allergy (he also states that he is allergic to "all the antibiotics" but does not specify which ones). The patient's concomitant medications were not reported. He reports a history of pulmonary embolism (prior to the vaccine). He states he has had ongoing side effects after the first dose of the vaccine and he wants to know if it's recommended that he get the second dose. He reports that his ability to swallow has improved. On an unspecified date in Jun2021, the patient experienced pulmonary embolism, injection was very painful, left arm weakness/can't move arm, insomnia, irritability, high energy level, leg and calf pain with severe right calf pain, and pain worsening from the injection area to the back of his ear and shoulder. The outcome of all the events was unknown.  Information on the lot/ batch number has been requested.
Patient received first covid vaccination today, at around 1140 Volunteer monitoring patients noted that individual scooted down in his chair.  She asked if he was okay and stated he was feeling dizzy.  Vaccination clinic staff responded.  Patient was able to assist to floor.  Feet were elevated.  He was provided water and ice pack.  Patient did not appear to lose responsiveness at any point.  He was able to state he was at the hospital as well as his name, DOB and where he was from, but patient was slow with answers.  Patient then stated he was starting to feel better.  He denies SOB or chest pain.  As staff continued to interact with him, he was slower to respond again. He shared he had nobody in attendance with him and no family in the area.  A code medical was called.  BP cuff arrived BP was 164/110.  ER nurse began assessment.  Patient was able to get to standing position with staff assistance.  He was taken to ER via stretcher for evaluation.
Joint tightness; swelling; Pain; pain around the legs, ankles and feet; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: FA7484, Expiration date: unknown) via unspecified route, administered right arm on 21Jul2021 19:30 (at the age of 50-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was a naturalist. She wasn't taking any medicine and did not go to the doctors. Twenty-two years ago had a vaccine called (Name) or something that was missed in her shot record. Stated she had no reaction. On 22Jul2021, the patient experienced Joint tightness, swelling, pain around the legs, ankles and feet and pain. She had really bad joint swelling, tightness and pain around the legs, ankles and feet. She explained they swole up. Right side of her body was swollen same side as the injection and then the left side after that. It initially started on one side and then switched to the other side after a couple of days. she clarified swelling was specific to legs, ankles and feet. She asked if she could take Tylenol / Advil. Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include joint pain. On (26Jul2021) new information received the patient Experienced swelling that started on her right side and it went to knees, and feet. Joints hurt really bad and are tight. Thursday night noticed it was hard to get out of the bathtub. It was real tight. Had to roll out of bed Thursday (23Jul2021). Friday, 23Jul2021, it progressively got worse. She blew it off, but was experiencing real bad tightness. Went downhill from there. First noticed the tightness on the right side on 22Jul2021. Tightness, swelling, and pain moved to the other side on 27Jul2021. Stated it is just swollen on side and moved to the other side. Stated it is about the same as yesterday, but not any worse. Prior Vaccinations, any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. Vaccinated as a kid. The patient visited physician office. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. The events did not cause Emergency Room visit. The patient underwent laboratory test and procedures which includes Blood Pressure was fine and Vitals were fine. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
pt recvd vax & w/in 30 mins pt devel SOB, chest tightness, swelling of extremities, numbness & heaviness in both arms, lightheadedness & nausea; pt seen in ER & hospitalized for 4 days; ECG upon admission was unchanged; exp anaphyl react;
ALMOST PARALYZED; This spontaneous report received from a consumer by a company representative via a social media (J and J Corporate) concerned a male of unspecified age, race and ethnicity. 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 not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date 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 was almost paralyzed, and unable to perform work and lost the job. The reporter stated that "my brother is almost paralyze. Took the jab to keep his job now he's unable to perform he lost the job." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost paralyzed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221166143- Almost paralyzed. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
a little ill; headache; feeling feverish; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (a little ill), HEADACHE (headache) and PYREXIA (feeling feverish) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Borderline personality disorder. Concomitant products included ARIPIPRAZOLE (ABILIFY) for an unknown indication.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced ILLNESS (a little ill), HEADACHE (headache) and PYREXIA (feeling feverish). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 20-Sep-2021, ILLNESS (a little ill) and PYREXIA (feeling feverish) had resolved. At the time of the report, HEADACHE (headache) had not resolved.            Patient stated that headache comes back every time.
Initial misuse report received from a healthcare professional on 07 June 2013. MENACTRA was given to a 15-month-old child who didn't require it. No adverse event was reported. List of documents held by sender: none.
Patient did not have any adverse events.  Patient was administered wrong dose of medication (received 1ml instead of 0.5ml)
This report is for a vaccine error only (no adverse event). After diluting the vaccine and drawing up in the syringe, I removed the air bubbles and there was only 0.4ml left in the syringe. I ended up giving the vaccine to the patient at 0.4ml and later found out anything under 0.45ml doesn't count and has to be re-administered 4 weeks later. I have left a voicemail for the patient and will continue following up with him to correct this error.
Pt. had flu shot at about 145PM. Returned 30 mins later with left side sharp pain, same side as flu shot. No SOB, lightheadness, clamminess, pain lasted 5-6 mins. Heart sounds, lung sounds-NL. BP may have been elevated 2 degree nervousness. Pt. told to call MD or go to ER if returns.
Child with c/o shortness of breath treated with Benadryl at home slight improvement noted. 6 am child continued with complaint of shortness of breath which progressed to audible wheezing (around 12pm). Pt taken to emergency room after speaking with MD. Chest xray completed and child given nebulizer treatment. Child improved. Sent home with inhaler for use as needed.