chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; chills; fatigue; weakness; body aches; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 11Apr2021 at 15:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure high and COVID-19 on an unknown date in Jan2021. The patient was allergic to penicillin. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), amlodipine besilate, olmesartan medoxomil (AZOR), metoprolol (MANUFACTURER UNKNOWN) and hydralazine (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 01:00 the patient experienced fever, chills, fatigue, weakness/ body aches. Therapeutic measures were not taken as a result of the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fever, chills, fatigue, weakness and body aches were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Unable to lift arm secondary to pain, shooting pain across posterior shoulder. On exam, pt with pain over humerus at site of injection, neurovascularly intact distal to the injection. Tx=warm packs, stretching, ibuprofen.
No other AE.; products were administered to patients after a temperature excursion; This spontaneous non-valid report as received from an Office Managerrefers to patients of an unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported.  On an unknown date, the patient the patients were vaccinated with improperly stored doses of hepatitis b vaccine (recombinant) (thimerosal-free) (RECOMBIVAX HB) intramuscular injection, lot #T041337 was confirmed to be valid, expiration date: 25-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) subcutaneous injectionunk, lot #U011995 was confirmed to be valid, expiration date: 15-APR-2023, lot #T034389 was confirmed to be valid, expiration date: 08-OCT-2022 administered for prophylaxis (strength, and route of administration were not provided). The administered doses underwent a temperature excursion of 55 degrees Fahrenheit for 14 hours and 4 minutes. There were previous temperature excursions. No additional adverse effect was reported.  This is non-valid report due to lack of the patients' identifiers.  Follow up information has been received from a vaccine provider on 23-FEB-2022, referring to a 19 years old female patient. The patient had no illness at time of vaccination. The patient had no pre-existing physician-diagnosed allergies, birth defects, medical conditions. Fridge thermometer by "05B" point and recovered 14 hours. Temperature excursion. Fridge Door was not reputed to be good. The Temperature excursion occurred as a result of a reading from a digital Data Logger (reported as temp log "revised" for digital thermometer). The suspect vaccine was discarded after excursion developed (reported as discarded vaccine that were no longer usable). On 14-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) (lot# U011995 with expiration date: 15-APR-2023, route/site: subcutaneous/"triage", single use vaccine) at public health clinic hospital. The vaccine purchased with private funds. The patient had titers tested following immigration series. No adverse events. Manufacturer contacted. The vaccine was not available for return/evaluation. The vaccine used according to the instruction leaflet.  This is one of four reports from the same reporter.; Sender's Comments:  US-009507513-2202USA008507: US-009507513-2201USA004692: US-009507513-2202USA008509:
severe migraines, body aches, chills, fever, lethargic, swelling of eyes and face
ongoing headache 5 days and counting, fever 2 days,  body aches 3 days,  blisters from fever, tiredness 5 days,  foggy memory 5 days
She has trouble with her hands./ It flared up her hands. / You don't know the pain I am in; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 86 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She has trouble with her hands./ It flared up her hands. / You don't know the pain I am in".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient developed fever 100.5 - 101.6, fussiness, poor appetite, emesis x 2, weakness, after vaccination, and misadministration of 2 HIB vaccines.
Nerve pain, L upper arm radiating from shoulder to elbow, limited mobility, intermittent, sharp shooting pain when raising arm from shoulder to elbow. No pain noted when moving left upper extremity from elbow to hand.
Following vax pt exp 3 day fever 29JUN91-1JUL91; t102-103, vomiting, diarrhea, generalized red macular papular rash 2JUL-5JUL91;
Low grade fever started around 7 pm. Acetaminophen was taken. The fever reached 105. Antipyretics every 4 hours would bring the fever down, but never below 100. Averaged a temperature of 102 throughout the day following vaccination. Temperature was below 100 by early the next morning . Nausea resolved with antacids throughout 10/5 Body aches mostly resolved when the fever broke. Surprising event: Incontinence starting the night of 10/4 and throughout the next day. Urgency to urinate and inability to hold it long enough to reach the bathroom. Very sore left arm
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Nov-2021 at 11:24 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021 at 11:24 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). On 04-Nov-2021 at 11:24 AM, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On 28-APR-2016 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # L038018, expiration date: 13-SEP-2017) (dose and route unspecified). Other suspect and concomitant therapies were not reported. No adverse effect reported. The RECOMBIVAX HB was exposed to 49.7 degree Fahrenheit for 1 hour and 45 minutes; there was no previous temperature excursion reported. This is one of several reports received from the same source. Additional information has been requested.
Right deltoid muscle became very sore on 1/7/13 the evening of when pt. received her shot. By 1/8/13 the pt. developed a large area of redness below the injection site. The area is hot to touch. Pt. did run some fever.
Patient hasn't received 2nd dose yet because of health issues; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet because of health issues) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet because of health issues). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet because of health issues) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Mother called to report L-arm was warm to touch, swellen and reddened significantly at injection site.  Advised her to refer to VIS statement - can occur after dose 4 or 5 of DTaP. Advised cool compresses to site and Tylenol or Advil for discomfort. Mother denies any difficulty in ROM.
Fatigue, Nausea, Arm soreness  Currently pregnant: EDD 08/20/2021
Redness, swelling and pain (RT) upper arm. Treated w/doxycycline for cellulitis.
ACUTE PULMONARY EMBOLISM 4/10/2023 HTN (HYPERTENSION) ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 4/10/2023 HTN (HYPERTENSION)
Patient developed itching, swelling, redness, and hot to touch on right side of injection site. Area measured 15cm in length and 18cm wide.
No additional AE reported; Expired dose of PROQUAD was administered to the patient on 12-APR-2022; This spontaneous report has been received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not reported.  On 12-APR-2022, the patient was administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 milliliters (ml) as prophylaxis (route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number T034828 has been verified to be valid, expiration date reported and established as 11-APR-2022) (expired product administered).   The vaccine was not exposed to any temperature excursion up to the date of administration. No additional adverse event was reported (no adverse event).
This spontaneous report was received from a office manager referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of M-M-R II lot# M049212, expiration date 16-DEC-2018 (dose number, route of administration and anatomical location were not reported) reconstituted with properly stored sterile water diluent (MRK) were administered to the patients. The doses were stored in temperatures from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 1 hour and 5 minutes. Digital data logger was involved. There was no previous temperature excursion reported. No adverse effects have been reported. Product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA007201: US-009507513-1708USA005756:
Immunization given @ 10AM mom walked back into clinic baby shivering all over, pale, circumstantial crying. O2 applied and O2 sat 77%- given. Breath sounds, increased RR, some , baby not crying temp 101 axillary. Pinked up, given Benadryl. refusing PO fluids, so sent to ER for hydration. crying and active when left but pale again.
Pt. broke out in hives day after shots. Pt carried to ER & ordered to administer BENADRYL. Followed up at office & ordered to continue BENADRYL.
- Large local reaction to 7days, L deltoid area. - Subcutaneous golf-ball sized induration beneath overlying erythema 5cm in diameter, with increased warmth and increased / darker red in center.
had covid 6 weeks ago; had covid 6 weeks ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient in her 80's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "had covid 6 weeks ago". Therapeutic measures were taken as a result of suspected covid-19, received PAXLOVID and stated it worked unbelievably. Stated it stopped it in its tracks. Reported that its phenomenal; within hours she was feeling better. Patient wanted to get the Pfizer booster, reporter mentioned all went well with the prior COVID vaccines. Reporter asked if there was any issue with having COVID-19 booster 6 weeks after having COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1) Pt has received Hep B # 1 = Developed quartersize reaction/whelping. 2) Pt received Hep B #2 11-5-08 & developed large lemon sized reaction with mild angioedema. 11/5/08 P=78 R=18  O2 Sat=98%. Pt received 2nd Hep B & within 3-5min had localized erythema to deltoid area received Benadryl 25mg po / Depomedrol 80mg IM No SOB - mild angioedema to lips bilat - VARS report made & advised pt to not have 3rd Hep B IM due to reaction.
Pt Fainted shortly after receiving vaccination. Pt came for a moderna covid vaccine with his friend, both first doses. Pt said he "fainted recently" from a shot where he fainted "for a couple minutes" according to his nurse, and he was sure it was psychologically induced by anxiety. He said he was more mentally prepared this time. After I gave the dose to him and his friend, he got lightheaded and slowly started losing consciousness in his seat after a few minutes.   Pt was alert and responded to our questions. I quickly stepped out to give the pt a bottle of water, and upon coming back to the IMZ room, his friend said he urinated himself. He was less responsive, but still alert. I notified the technician. He started to turn pale and felt more cold. He pulse was weak. I encouraged the pt's friend to keep him alert while we call EMS. I reminded the pt to keep breathing.   The technician called EMS, and I stayed with the patient to kept him calm, but alert until EMS arrived. Pt slowly felt better after a few minutes (color return, and temperature normalized). Pt said he was okay, and he was able to walk. EMS arrived and tested blood sugar; he was within normal range. Pt did not need EMS service, and went home with friend.
moderate pain at site about 18 hours after shot- lasted another 24 hours after that- fatigue and achy (no fever) feeling about 30-36 hours after shot. all symptoms gone by 48 hours after shot given
Information has been received from a physician concerning a 20 week old female with a history of bronchiolitis who on 08-DEC-2006 was vaccinated with Rotateq (Lot # 654489/0941F) PO first dose and then was vaccinated again on 08-FEB-2006 with Rotateq (Lot # 654489/0941F) PO 2nd dose. There was no illness at the time of vaccination. On 05-MAR-2007 the patient developed signs and symptoms of rotavirus. A stool test for rotavirus was positive. The patient subsequently recovered. Additional information has been requested.
Patient presented with swollen joints and rash 7 days after receiving FLUMIST. She had low grade fever. She had back pain. General malaise/fatigue. We treated her with BENADRYL and prednisone.
Date and time adverse event started: 3/10/2021 at approx. 12:30pm, a few moments after rcvding the vaccine. Pt reported that a few moments of rcvding the vaccine she felt pressure in her whole head, ears were clogged up, and had lumps in her throat; these symptoms lessen as the days goes by and she felt better by day 3. On day 4 (3/13/2021), pt reported she felt like she had a bad cold which turned into bronchitis and that lasted for 2 weeks that was accompanied by symptoms of stuffy head, stuffed up sinus and drainage, had low grade fever, and coughed up phlegm). Pt reported that she have history of tinnitus and post-nasal drips, the ringing in her left ear and the post-nasal drip was still ongoing prior to rcvding the COVID vaccine and these symptoms seems to have been exacerbated after she got the vaccine because she felt like it has gotten worse. Pt reported that she took otc Mucinex and Claritin on the 5th or 6th day from rcvding the vaccine. She went to see her PCP and got a chest x-ray (results: negative for any infections). Pt also reported she got tested twice for COVID-19 on 3/17/2021 & 3/23/2021 (results on both dates: negative). Pt reported that her PCP had advised her against getting the second dose. Advised pt that per her ADEs these are not a contraindication to getting the 2nd dose per CDC guidelines and per consulted Dr. The decision to get the second dose is up to her and her PCP. Advised pt that there is not knowing if the 2nd dose will make her tinnitus worse or if she will experience any ADEs. Also advised per CDC guidelines, "if it is not feasible to adhere to the recommended interval, the second dose of BioNTech COVID-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose. There are currently limited data on efficacy of mRNA COVID-19 vaccines administered beyond this window. If the second dose is administered beyond these intervals, there is no need to restart the series". 4/18-Patient feeling much better, symptoms have resolved with the exception of weakness and fatigue. Patient has taken Advil to help alleviate migraine. No longer has migraines. Caller called back to adv that she is still having tinnitus and post nasal drip from the 1st shot.
PER PATIENT, SHE STATED SHE FELT IMMEDIATE PAIN AFTER THE FLU SHOT WAS INJECTED INTO THE LEFT DELTOID. SHE MENTIONED THE PAIN WASN'T FROM THE NEEDLE BUT FROM THE VACCINE ITSELF. IT WAS A BURNING PAIN THAT SHE NEVER FELT BEFORE COMPARED TO PREVIOUD FLU VACCINES. PATIENT WENT HOME WITHOUT FURTHER PAIN FOR ABOUT 2 WEEKS. 2 WEEKS AFTER THE ADMINISTRATION OF THE FLUBLOK QUAD VACCINE, PATIENT CLAIMED THE FEEL PROGRESS PAIN AT SITE OF INJECTION, THEN RADIATES TO WHOLE ARM CONTINUING TO PRESENT TIME. THE SITE IS OK WITHOUT PHYSICAL EXERTION OF THE LEFT ARM (E.G. MOST PAINFUL IF RAISING THE LEFT ARM OR PUTTING ON A SHIRT. THERE IS NO REDNESS OR SWELLING. THE SITE IS SLIGHTLY PAINFUL TO THE TOUCH, AND PAIN INCREASE WITH INCREASED PRESSURE. HOWEVER, PATIENT STATED THE ARM IS FINE TO SLEEP OR WHEN NOT DOING ANYTHING. PATIENT IS CURRENTLY FEELING "BLAH, LOW-GRADE  ALL-OVER TIREDNESS". PATIENT HAS NOT TAKEN ANY PRESCRIBED OR OTC TO HELP WITH PAIN, BUT PATIENT IS PLANNING TO TAKE MOTRIN TO HELP WITH THE PAIN. PATIENT HAS INFORMED HER FAMILY DOCTOR AND WAS ADVISED TO CONTACT THE PHARMACY/ PHARMACIST THAT ADMINISTERED THE SHOT TO REPORT TO VAERS. SHE IS PLANNING TO SEE HER ORTHOPAEDIC FOR FURTHER ASSESSMENT WITHIN A WEEK. PATIENT IS WORRIED. SHE VERBALIZED HER PAIN WITH SOUND DIALOGUE, NORMAL VOLUME, QUICK REACTION TO QUESTIONS, AND WITHOUT RESPIRATORY PROBLEMS OVER THE PHONE.
Extremely swollen armpit lymph node, very tender.  Tiredness, body muscle aches, headache
Suspected vaccination failure; Had The Two Dose Shingle Vaccine And I Still Get Shingles; This case was reported by a consumer described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported.  After receiving 2 doses of Shingles vaccine, the patient got shingles. 1st dose of Shingles vaccine made the patient really sick. For the tolerance of 1st dose, refer linked case US2021AMR041526. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR041526:Same reporter.
I had tingling in my hands and itchy all over from head to toes. Asthma intermittent after that, Sep 8 and 10 and Sep 12-14 2021. Doctor didn't let me see in person and could only do tele doctor. Headaches, chills and fatigue arm, left arm pain. Might have asthma and cough but don't fully remember. Fever and generally did not feel well but not as long as the 3rd booster.
On 5/20, patient experienced a sore arm. Then on the same day she developed dizziness, tightness in the throat, body aches, a low grade fever, headache, fatigue and it felt like the roof of her mouth was on fire. Now nearly 3 weeks later she still has a low grade fever (99.7.) She has been taking Tylenol and Ibuprofen and is staying very well hydrated. She does not know if her temperature is actually higher than what is registering because she is medicating herself. She also still feels very tired and has an occasional headache. The sore arm barely lasted a day. Her biggest complaint is that the fever has not subsided and she still feels tired.
This spontaneous case, initially received on 20-Jan-2017, was reported by a non health professional and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced the flu (medically significant, outcome: not reported).