chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ON 7/30/21 @ 0329 AM, RESIDENT BEGAN RUNNING FEVER 104.2 DEGREES WITH A RESPIRATORY RATE OF 60 BPM. B/P 54/30. PULSE RATE OF 74 BPM. O2 SAT OF 88% ON O2 @ 4LPM PER TRACHE COLLAR. RESIDENTS BASLINE COGNITIVE STATUS UNCHANGED FROM PERSISTENT VEGETATIVE STATE. DR. WAS CALLED BY NURSE AND ORDERS WERE GIVEN TO SEND TO ER. UPON ARRIVAL, EMS HAD TO START CPR AS RESIDENT CODED DURING PICKUP. RESIDENT WAS PRONOUNCED DEAD AT 0520.
Patient reports feeling nauseous immediately following injection. She then had fever and chills that evening. She says that the next day she continued having "flu-like" symptoms. Patient presented to clinic 5/12/17 at 3:00pm with complaints of pain at injection site. RN observed redness around injection site, upper left arm, approximately 5inches in diameter. Patient denies any difficulty breathing or tightness in her chest.
2-3 days after 2nd dose of Covid vaccine was given she complained of "heart hurting" She was still complaining of it on 12/9/21 when she was seen in the office.
It was reported that an adult male pt was administered an Influenza vaccine on 20-OCT-2001. On 21-OCT-2001 the pt experienced a temperature of 100-101F, diarrhea and myalgia that lasted 8 days. Myalgia in his back and both lower extremities persists. Pt was evaluated by both his internist and pulmonologist and given Percocet for the myalgia.
This spontaneous case was received on 04-Oct-2017, from other-health professional, concerns a 22-year-old, a female patient. On 04-Oct-2017, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, batch number: 1618621 (as reported), expiry date: Apr-2017, route of administration: intramuscular and anatomical location: deltoid). It was reported that the patient was administered with the vaccine that had expired in the month of April of that year. No adverse effects were reported. Revaccination with the current season was advised. The reporter assessed the events as non-serious. Follow-up received on 18-Oct-2017: Age and gender of the patient was updated. Route of administration and anatomical location was updated to intramuscular and deltoid respectively. Amended narrative accordingly.
Swollen arm, underarm area left side of breast. Weakness in arm, gradually diminishing daily
Woke up this Am with left arm deltoid and shoulder red, warm, itchy, painful, swollen and hard. No fever, no  N.V.D. 2 scabbed areas near it. DX with cellulitis and ABX started.
pt was given Pfizer bivalent. as a booster and she is 9 y.o. not indicated for that age group.
Father called H C to report that child developed a rash on stomach and back area, 6 days, post vax. Child was fussy, clingy and had loose stools X 2 days; onset on 2/24/01.
an improperly stored vaccine was administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 25-JAN-2021, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) (thimerosal-free)(RECOMBIVAX HB) (lot # T004378, expiration date 31-OCT-2022, 1 dosage form) for prophylaxis (product storage error). Temperature excursion was above 9 Centigrade (13.4 Centigrade) for 2 hours and 9 minutes. There was no previous temperature excursion. Data logger was involved.
Injection site pain; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 Immunization, reaction(s): "rigors", "headache"; Bnt162b2 (Dose 1), administration date: 2021, for fatigue.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  Additional information: Patient is male and over 50. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
For 1 day following the vaccine,  suffered with a severe headache, chills, fever, and sore arm.
On 2/10/21 I received my first Pfizer Covid shot in my left arm. On 3/2/21, I received my second shot in my right are, as my left arm was still tender. On March 12, I started to have hives appear on both hands, the hives gradually started to go up to my elbows on both arms. I treated the hives initially with OTC  Benadryl. It was not helping and I went to an Urgent Care Center who prescribed  prescription Benadryl, Claritin, and Triamcinolone Acetonide Cream. When I wasn't getting any relief I contacted my GP who told me to see my dermatologist. On March 31, I saw Dr. I just started  a regimen Prednisone 10 mg tablets. Dr. suggested I report this incident, as it may be related. The hives are on both arms now from my elbows to my hands. I am extremely uncomfortable. The arms and hands are itchy and blotchy.
ALTERED MENSTRAL CYCLE, BODY ACHES, EXTREME FATIGUE, MENSTRAL CYCLE EXTENDED FOR LONGER AND WITH MORE SYMPTOMS SUCH AS EXCESSIVE BLOATING, CONSTIPATION, MUSCLE ACHES, HEADACHE/NECK ACHE. INSOMNIA.
Co. Public Health Mass vaccination exercise, Client vaccinated with 317 vaccine (influenza) about 10 Am. at 6pm that evening experienced difficulty breathing, stated "Throat closed" called Hospital and Advised to take Benadryl, which resolved situation about 10 pm. Did not go to ER - Called Dr who Advised no flu iz.
Five months after my Pfizer booster (on top of the J&J vaccination almost a year prior to the incident) I attended a large business gathering, during which I remained masked, but attended a big dinner (when I was largely unmasked).  I was informed a few days later that several people in attendance were diagnosed with COVID-19, and three days after returning (and five since the dinner) I experienced symptoms.  A home test was positive, so I visited a testing center and got a proper PCR test, and it was positive.  In summary, a year after getting the J&J, and five months after getting a Pfizer booster, I came down with COIVID-10
I have developed cellulitis in and around the injection site  my left arm is inflammed, I have a 7*7 wheal that is hard, red, raised and red streaks going down my arm. I called the doctors office, they never called me back. I had to report to Urgent Care for treatment, the prescribed Cephaxelin 500mg QID
day 5 of the second shot I woke up extremely hot, felt like my skin  And everything around me was burning/overheating; I also had mild hot flashes after the second vaccine and headaches; I also had mild hot flashes after the second vaccine and headaches; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (pregnant: No)  received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685) intramuscular at left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. Medical history included Asthma, hypothyroidism, ADD. Concomitant medications were not reported. Patient had known allergies to erythromycin and seasonal allergies. it was unknown if covid prior vaccination. There were other medications in two weeks. Patient used took first dose of BNT162B2 (lot number: Ej1685) on 17Dec2020 at left arm at single dose for COVID-19 immunization and experienced extreme episode of overheating (at night) the first time, got up and almost passed out. It was reported day 5 after both shots patient had an extreme episode of overheating (at night) the first time she got up and almost passed out. day 5 of the second shot she woke up extremely hot, felt like her skin and everything around her was burning, it was inescapable, she had to open a window and wait it out, lasted about 30 minutes. she also had mild hot flashes after the second vaccine and headaches. adverse event start date was 10Jan2021. No covid tested post vaccination. no treatment received for the events. Patient was recovering from the events.
Narrative:  99yo male died on 06/23/2021. No information provided about his death. Pt does not receive primary care from clinic. Pt received one covid vaccine on 1/14/21 from pharmacy. Likely death is not related to the vaccination given pt's advanced age and given 6 months has pasted since he received the covid vaccine.
Narrative: she received both the influenza and the meningococcal b in her arm earlier on 9/27 @ 1100. She woke up at -0230 on 9/28 with facial and lip swelling that resolved on its own while in the ED. She subsequently declined observation at the ED. She subsequently declined observation at the ED and went home where she took a dose of diphenhydramine and went back to sleep. She woke up at 0700 9/28 w/complaints of wheezing and lip and tongue swelling. ED provider states she does seem to have L jaw swelling, as similarly noted at ER.
I RECEIVED THE VACCINATION AT 3:00PM. AT 8:00PM I BEGIN TO FEEL FUNNY. AT 9:00PM I STARTED TO GET SEVERE CHILLS AND A VERY SEVERE HEADACHE. IT PROGRESSIVELY GOT WORSE SO I WENT TO BED COVERING WITH MANY COVERS, FINALLY WAS ABLE TO STOP SHAKING AROUND 1:00AM.  FROM 1:00AM TO 5:00AM I EXPERIENCED, RAPID HEARTBEAT, SHALLOW BREATHING AND JUST ABOUT THE WORST "PRESSURE" HEADACHE I HAVE EVER EXPERIENCED. I WAS FINALLY ABLE TO "FALL" ASLEEP AT THAT TIME AND AWOKE AT 9:00AM FEELING MUCH BETTER. SPENT THE DAY IN BED AS I FELT EXHAUSTED! THE NEXT DAY I FELT PRETTY GOOD.
This spontaneous report as received from a Licensed Practical Nurse refers to a 13 months 3 weeks old patient. The nurse reported that" a patient was administered VARIVAX (lot# 0306AE), concomitant with an unspecified hepatitis A vaccine, on 02-JUL-2012". 12 days later, on 14-JUL-2012 the patient experienced fever of 104F and 10 disseminated vesicles of varicella. The patient was seen in the office but no treatment was prescribed. The outcome of the AEs was unknown. Additional information is not expected.
Headache, Myalgia, NauseaVomiting, Chills/ Fatigue
This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, a single injection subcutaneously (anatomical location, lot # and expiration date not reported) for prevention of herpes Zoster (shingles). On an unknown date, the patient developed blistering at the injection site after receiving ZOSTAVAX. It was unknown if the patient received any treatment, sought medical attention or if laboratory diagnostic tests were performed. At the time of the report, the outcome of the event was unknown. The causality between the event and ZOSTAVAX was not reported. Additional information has been requested.
fever; headache; blood clot on right calf; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot on right calf) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthroscopy (right knee) on 19-Oct-2021.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced THROMBOSIS (blood clot on right calf) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (headache). The patient was treated with RIVAROXABAN (XARELTO) at a dose of 15mg twice a day for 21 day then 20mg d. At the time of the report, THROMBOSIS (blood clot on right calf), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2021, Ultrasound scan: blood clot (abnormal) blood clot..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has under gone 5 surgeries before.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported.  Company comment This case concerns a 40-year-old male patient, with medical history of Arthroscopy 12 days before the event (after the surgery there was a blood clot on right calf), who experienced the serious unexpected event of THROMBOSIS. The events occurred approximately 6 months after the administration if the second dose of mRNA-1273 vaccine. Re-challenge was not applicable. Patient´s medical history of Arthroscopy 12 days before the event (after the surgery there was a blood clot on right calf), remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 40-year-old male patient, with medical history of Arthroscopy 12 days before the event (after the surgery there was a blood clot on right calf), who experienced the serious unexpected event of THROMBOSIS. The events occurred approximately 6 months after the administration if the second dose of mRNA-1273 vaccine. Re-challenge was not applicable. Patient´s medical history of Arthroscopy 12 days before the event (after the surgery there was a blood clot on right calf), remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report was received from a 77-year-old non-pregnant female patient regarding herself. Patient did not have any medical history and had no drug reactions/allergies. Concomitant medication included ZYRTEC. On 13-MAY-2014, the patient was vaccinated with ZOSTAVAX shot for preventions of shingles (dosage schedule was not reported). Since the shot, the patient had a total of 4 outbreaks of "mild" shingles. First outbreak was on 20-MAY-2016. Second was on 23-JUL-2016. Third outbreak began on 26-JAN-2017. The fourth was just this month, 10-JAN-2019. Each attack was a "mild" outbreak of shingles appearing somewhere on her waist. It started in the front, then moved to her right side, and was currently on her back. Each time she had a break out she was treated with calamine lotion for itching, ice packs on the rash, a 10-day regimen of valacyclovir (manufacturer and dose unspecified) and fluticasone propionate cream 0.05% (manufacturer unspecified) for the itching and pain. The patient reported that last time she took the "purple pills" (valacyclovir), she got a blood pressure reading of 192/87 on 10-JAN-2019 and prior to this reading 130/80 was her normal blood pressure range. The patient also added that the attacks were relatively mild compared to what she had seen on television. The patient reported that the shingles had all appeared in her waist area, the rash was circumventing her waist, center, right side and back. She had to wear loose underwear and put ice in the small of her back on the rash. The patient sought medical attention by visiting the physician's office. Outcome of the events "First Shingles outbreak", "Second outbreak was on 23-JUL-2016" and "Third outbreak of shingles began on 26-JAN-2017" was unknown. Outcome of the event "The fourth outbreak of shingles was just this month, 10-JAN-2019" was reported as not recovered. Causality of the events were not reported.
Both doses of the Moderna Covid 19 vaccine were given to a 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Both doses of the Moderna Covid 19 vaccine were given to a 17 year old) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   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 an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Both doses of the Moderna Covid 19 vaccine were given to a 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Both doses of the Moderna Covid 19 vaccine were given to a 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment medications were reported.
Patient had no swelling, redness, or pain when given the injection on 9/19/2018. Once she got home, she began to have headache about 2 hours after the shot. This progressed to severe, debilitating headache, dizziness, flu-like symptoms, and an aggravation of her neuropathic pain symptoms. This lasted about 4 days. On the fifth day, she now feels almost back to normal. She did not contact her physician and did not report any of these reactions to me until 9/23/2018 at 4:54pm.
mild upper back pain; pain in teeths and gums; pain in teeths and gums; pain radiating to shoulder; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (mild upper back pain), TOOTHACHE (pain in teeths and gums), GINGIVAL PAIN (pain in teeths and gums), ARTHRALGIA (pain radiating to shoulder) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No past medical history was provided.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced BACK PAIN (mild upper back pain), TOOTHACHE (pain in teeths and gums), GINGIVAL PAIN (pain in teeths and gums) and NAUSEA (nausea). 30-Apr-2021, the patient experienced ARTHRALGIA (pain radiating to shoulder) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 03-May-2021, TOOTHACHE (pain in teeths and gums) and GINGIVAL PAIN (pain in teeths and gums) had resolved. At the time of the report, BACK PAIN (mild upper back pain), ARTHRALGIA (pain radiating to shoulder), HEADACHE (headache) and NAUSEA (nausea) had resolved. Not Provided          Treatment information was included Ibuprofen.  No concomitant  product was reported   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Narrative was updated.
Pt reports she has had an increased heart rate in the 110-120s for the past three days after receiving the COVID19 vaccination.  Pt reports increased dizziness today, nausea, and in the past hour some chest tightness.  Pt also reported recent travel to and from out of town, about 14 hours travel time in the past week and half.    Pt given fluids, ruled out for illness and PE.  Pt improved with fluids.
loss of eye sight for 3 hours and then the eye sight returned and the vision was blurry; his right arm, he developed a rash in that same arm which progressed to a bloody rash; instant pain in the base of the neck and back of the forehead; blurred vision in one eye; double vision; pain in the base of the neck and back of the forehead; his right arm, he developed a rash in that same arm which progressed to a bloody rash; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Not reported), via an unspecified route, administered in right arm on 26Aug2021 (at the age of 55-year-old) as Dose 2, Single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration, Dose 1, Single on unspecified date for Covid-19 immunization. The patient previously took fenofibrate and had a similar rash developed and reported it developed into an infection under the skin which had to be treated with silver and some other medications. The reporter stated that received his second Comirnaty vaccine dose on 26Aug2021 and was still had major adverse reactions. He reported immediately after receiving the vaccine in his right arm, he developed a rash in that same arm which progressed to a bloody rash on 26Aug2021. He had instant pain in the base of the neck and back of the forehead, blurred vision in one eye, double vision, and loss of eyesight for 3 hours and then the eye sight returned, and the vision was blurry on 26Aug2021. Reporter consider case as non-serious. He reported his doctor had given him steroids. Therapeutic measures were taken as a result of adverse reactions with steroids. At the time of this report, the outcome of event loss of eyesight for 3 hours was recovering, and all other events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
My adverse event started on 10/2022. I've noticed my arthritis flamed up. I received other COVID-19 vaccines but nothing happen I was fine. The last one I had it made my arthritis worst. I had swelling of my knees and hands. I had moderate pain. I've taken ibuprofen at least 2 times a day for my pain. I didn't see any doctor for this. This is an ongoing issue. I am still experiencing it. It's there all the time.
Haven't had an appetite; Uneasy feeling in stomach, but have not vomited; Diarrhea; Chills; Fever; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0170) via an unspecified route of administration in the left arm on 29Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and allergy to mango. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. Any other vaccines received by the patient within four weeks prior to the COVID-19 vaccine was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 30Apr2021, the patient experienced chills and fever. On 03May2021, the Monday following the injection, the patient did not have an appetite and had an uneasy feeling in stomach, but did not vomit. The patient also presented with diarrhea. On 30Apr2021, the Friday prior, the patient had chills and a fever, but felt better over the weekend, but was hit again on Monday and wasn't let up since. The patient felt it lasted too long to be something common. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 07May2021, the patient underwent SARS-CoV-2 test via nasal Swab and the result was negative. The clinical outcome of the events did not have an appetite, uneasy feeling in stomach, but did not vomit, diarrhea, chills and fever was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Whole arm swollen, red splotching over entire arm, full-body myalgias, fever, chills, all of which lasted for > 4 days (still present).