chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ injection (exact dose, route: defaulted to oral, lot number and expiry date were not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 32 degrees Fahrenheit to 35 degrees Fahrenheit (33.9 degrees Fahrenheit) on an unspecified date, for a time frame of 40.5 hours. A digital data logger was involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA012404: US-009507513-1707USA011460: US-009507513-1707USA012403:
Severe breathing difficulty, by morning had to call emergency services for ambulance to take to hospital/. Spent 5 days, 4 nights in hospital
PT PRESENTED TO ER 3/12/21 FOR COMPLIANT OF 3 DAYS WORTH OF SHOULDER PAIN. PT RECEIVED COVID VACCINE 10 DAYS PRIOR AT VACCINE FACILITY. PT STATES PAIN IS MADE WORSE BY FLEXING HIS SHOULDER, MOVING HIS SHOULDER IN ANY WAY AND HAS ELBOW PAIN AS WELL.PT WAS ADMITTED TO HOSPITAL FOR CARDIAC MONITORING. PT WAS SCHEDULED TO HAVE SECOND DOSE OF VACCINE 3/24/21 BUT WAS STILL HOSPITALIZED SO DID NOT RECEIVE. SECOND DOSE.
Pt waiting in observation with his mother post #1 Pfizer vaccination, at 9:10am c/o  "feeling a lump in throat". No observed SOB or c/o difficulty swallowing. Given Diphenhydramine  50mg at 9:11 am. Hx of anaphylaxis with food only, wheat, nuts.  No rash or difficulty breathing, VS 99% room air 110/60 78 12.  Pt states feeling nervous due to previous Pt who c/o chest pain post vaccination.  Pt observed in clinic until 9:50a and did not have any other symptoms.   Advised to contact PCP to report incident.  Instructions given to Pt and his mother (by spanish speaking RN)  For any further symptoms and implementing 911 if necessary. VSS remained stable, lungs clear, 02 sat 99%.  Pt reports he is feeling fine now and ambulated out of clinic with steady gait.  States he will rest at home today and his mom will be there.
Left arm, upper, red, swollen; Treated for cellulitis (Keflex 250/5 1 tsp qid x 10d)
patient experienced tingling down her arm immediately after receiving the shot. That feeling continued for 2 weeks. She said she can feel the tingling whenever she is using her fingers (on her phone & while typing)
Ongoing difficulty breathing/shortness of breath/tightness in chest. Adverse event worsens following physical activity.  Elevated heart rate and blood pressure.
No adverse event; My children received a Moderna bivalent booster yesterday; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My children received a Moderna bivalent booster yesterday) and NO ADVERSE EVENT (No adverse event) in a 9-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR665B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (Dose 2) in January 2022 and Pfizer COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 11-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My children received a Moderna bivalent booster yesterday). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My children received a Moderna bivalent booster yesterday) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported by the reporter.  The reporter was not sure if the patient was eligible to receive a booster dose at the time of administration. Patient was inadvertently administered a dose of the Moderna COVID-19 bivalent vaccine, instead. Reporter was told by the clinic that the Moderna COVID-19 bivalent vaccine just got authorized for use in children 6 and older and that it should not be an issue. Patient was okay so far and did not reported any adverse reactions at the time report.  No treatment medication was reported.
I was hospitalized with pancreatitis on April 1st due to ongoing nausea, vomiting, abdominal pain. My AST/ALT were in the 1700s and I was admitted to manage the symptoms via morphine and IV fluids. I was discharged 3 days later, however, I still had ongoing nausea, vomiting, extreme weight loss, and reduced appetite. I was hospitalized again on June 6th due to similar symptoms and my liver function levels were in the 1400s again. According to a Physician, they believe my pancreatic episode was never resolved from April to June. They found a blockage and narrowing in my biliary duct, so a GI doctor placed a stent in my biliary duct. The stent was too small and ended up backing bile back into my body, making me worse, so they placed a larger stent (10cm). I still suffered from nausea and reduced appetite due to vomiting. I had the stent removed in August 2021 and they determined possible autoimmune hepatitis as an underlying issue and I am in the process of getting a liver biopsy currently.  The GI doctors do agree there could be a correlation from gallbladder issues due to a strong family history of gallbladder attacks (mother, maternal grandparents, and maternal uncle)
Information has been received from a physical therapist concerning her daughter with no pertinent medical history and no drug reactions/allergies who on 06-OCT-2010 was vaccinated with the first dose of MMR II. There was no concomitant medication. On 18-OCT-2010 the patient developed swollen glands on the left side of her neck. The patient was examined by her unspecified physician on that date and was diagnosed with cervical lymphadenopathy or lymphadenitis. She was prescribed AUGMENTIN. On 19-OCT-2010, the patient developed vomiting and a fever of 104F. She was admitted on that date to an unspecified hospital and was treated intravenously with multiple unspecified antibiotics. The patient was discharged from the hospital on 25-OCT-2010. She was currently taking an oral antibiotic at home. The patient was afebrile but the lymphadenopathy was unchanged. At the time of reporting, the patient was recovering from these adverse events. Cervical lymphadenopathy or lymphadenitis, vomiting and a fever of 104F were considered to be other important medical events by the reporter. Additional information has been requested.
Pt report "bumps" she believes are chicken pox that itch developing.  A few on each arm, a few on back and stomach.
Two weeks ago I received a varicella vaccine for work and now I am experiencing swelling/redness in the area I got the shot. I also have blisters I believe that have popped up all over my body.  Location Left upper arm with swelling that started 2 weeks after getting the shot, overnight started to get vessicular lesions about 30-40 all over the body. + itching
I recieved my covid-19 booster (3rd shot) on 1/4/2022 at 11:15am. The only effect of the shot immediately after (15 minutes) was a bit of dizziness that subsided within 15-20minutes.  I went home and laid down for around 4 hours. I felt groppy, tired and a bit warm,  with soreness at the injection site, expected after vaccination.  I tried getting up after 4 hours and felt soreness and pain in my lower back. I chalked it up to an immune response and continued resting for the next 24 hours. For days after vaccination all other symptoms subsided, but the back pain increased and persisted for 3-4 days. It gradually reduced in pain after a week but has returned at the same intensity after over a week after injection. Pain in very severe making it difficult or not possible to conduct some tasks and bend over. I would rate the pain 2/10 standing, 3/10 sitting, 6/10 bending at the waste or handing leg off something. Most painful period was around 7/10.   Treatment has been self administered. Rest and stretching. 400mgs of Ibuprofen once daily for pain, twice daily when working. Ibuprofen provides significant, but not complete relief.  Contacted the Clinic about the symptoms 1/14/2022. Symptoms still persist 11 days after vaccination as of this report.
4 month old female received Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2023, the patient received the 1st dose of Shingrix. On 6th February 2023, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 6-Feb-2023 Reporter's comment: The reporter did not had the exact information for the vaccine facility or vaccine information such as lot number/expiration date but told that such information could be shared on follow-up. The reporter consented to follow-up. Additional supportive information: The patient accidentally received a dose of Shingrix at inappropriate age, which led to inappropriate age at vaccine administration.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021; Vaccine administered past its 30-days Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered past its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 5:34 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 12-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered past its 30-days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered past its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment medication was reported. It was reported that vaccines went into 2-8 degree on or about 20 Dec 2021. It was reported that the Expiry date of vaccine was 04 Apr 2022.   This case was linked to MOD-2022-542869 (Patient Link).
Hardly been able to move; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Hardly been able to move) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (Hardly been able to move). At the time of the report, MOVEMENT DISORDER (Hardly been able to move) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.
Body ache, chills, stomach cramps, pain in the site of the injection and I feel very tired and weak.  I took 1 500 mg Tylenol pill.
First thing I noticed was I woke up coughing in the middle of the night. I had a sore throat, congestion, and extreme fatigue. I knew it was COVID because I had been exposed. I slept the next 2 days. I never ran a fever. I did take Paxlovid. On the third day I did feel nauseous and couldn't keep anything down. The doctor then recommended that I stop taking it.
possible Type 3 hypersensitivity (immune complex mediated) to Pfizer - facial swelling, peeling erythematous rash, eye swelling 2-3 weeks after vaccinations (twice).
patient received covid vaccine.  screening questions answered.  administered vaccine at 1321pm.  patient wheeled to vaccine waiting room.  patient became lethargic and blacked out.  patient not alert and awake for approximately 1 minute.  patient came to, pulse 80, blood pressure 93/70, oxygen saturation 98%, husband at side, emergency cart and AED and oxygen brought to location of the patient. oxygen 2L nasal canula placed on patient. EMS called and Dr. came to site.  assessment obtained with Dr. at site.  patient awake, was able to speak full name but stated she was not aware of where she was.  this reaction happened approximately 6 minutes post immunization.  within approximately 3 minutes of episode where she states she felt she was going to "black out" she began to shake/ full body involvement.  during this episode patient was following nurse commands.  momements were rhythmic and lasted approximately 10 seconds then stopped.  Patient brought back to exam room.  at 138pm- temp 97.5, blood pressure 144/31, pulse 51, respiration 18. patient stated she felt warm and reports she felt she was going to black out.  this episode lasted approximately 3 seconds and patient became alert at that time.  vitals at 140 pm- blood pressure 124/60, pulse 75, respirations 16.  vitals at 144pm- blood pressure 119/75, pulse 75, respirations 16.  patient has dialysis 4 times a week for CKD stage 5.  patient has lengthy medical history.  patient reports her primary care doctor is Dr. who sees her frequently.  patient reports she has an issue with internal bleeding with source unknown and at times has to have blood transfusions.  no recent illnesses reported.  patient states she ate breakfast around 10am today.  patient states she has never had a vaccine reaction int he past or reaction to needles.  EMS arrived on site approximately 1345.  report given to EMS.  patient alert with EMT.  patient transferred from her personal wheelchair to EMS cot.  patients husband left with patient to go to Medical Center.  Patient tolerated vaccine well immediately after immunization.  She reported no pain at injection site.  Paper tape and 2x2 gauze placed at injection site due to allergy to tape.  Allergy list was reviewed prior to administration of vaccine.  Patient alert and oriented prior to vaccine to person place and time.  Husband present in room.  Verbal consent obtained by patient to receive covid vaccine today .  Vaccine information handout and emergency use handout given to patient.  Patient wheeled out of exam in wheelchair.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-JUL-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 08-JUL-2022).    No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Jun-2022.  The vial did not undergo any temperature excursions.  Patient received half dose.  No treatment medications were reported.
Allergy; This non-serious case was reported by a physician via other manufacturer and described the occurrence of allergy in a 57-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.  On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced allergy (Verbatim: Allergy). The outcome of the allergy was not reported.  It was unknown if the reporter considered the allergy to be related to Flu vaccine.  It was unknown if the company considered the allergy to be related to Flu vaccine.  Additional Information: GSK Receipt Date: 08-JUN-2023 The reporter had reported that the patient had experienced allergy after receiving the flu vaccine. The reporter consented to follow-up.
Pt recv vax. Pt reported to be pregnant. Meds during pregnancy: Prozac,magnesium,aspirin,terbutaline,prenatal vitamins.Pt  labor 20Sept97 @37 wk. Vaginal deliver girl baby.No congenital anomalies noted but baby had "SGA", apnea.
13 Year old female on a catch up schedule, Tdap was administered on the left Deltoid. Mother was holding child while administering vaccine. Pt then fainted. As per mother patient has hx of syncope after vaccines. Pt was positioned with her feet elevated while seated and performed sternal chest rubs. Patient was observe 1hr after vaccine administration.
Fever onset of 9:00pm on 7/14/09, by 3:00pm on 7/15 temp was 101.7 oral and patient called HD.  Patient also c/o body aches, tired and dizziness.  Instructed to continue Motrin she had been taking and monitor temp.  TC on 7/16 and temp is now 100.1 and patient no longer has any other symptoms.
Pfizer vaccine mixed with bacteriostatic saline and administered to the patient. Advised to re-administer.
Slight soreness the day of administration. When waking the next morning, my arm felt swollen and was very painful to touch from my wrist up to the side of my neck. Pain lasted for about 2 days. I could no move my left arm on my own, I had to use my right hand to move my arm.
Pt was given vaccinations one in each arm. Pt proceeded to waiting room and sat in chair and had a vasovagal response. Pt was evaluated by 2 physicians in the office prior to leaving
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 02-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Within 5 minutes tongue began to go numb, a few minutes later cheeks and mouth went numb, heart rate was 115 white sitting down, blood pressure was 115/60 (typical blood pressure is 120/75), felt lightheaded and "out of body." Instructed to take Benadryl or have facility call an ambulance. Waited at site for nearly an hour for symptoms to improve, lightheadedness and out of body feeling improved, left site, took a 10 mg dose of liquid Benadryl at about 3:10, tongue and facial numbness went away about 4:30 pm same day.
Information has been received from a physician concerning a 4 year old female who on 18-MAY-2005 was vaccinated with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 18-MAY-2005, the patient developed hives and swelling of lips. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 22-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally (LOT# R034700, expiry date 16-JUN-2020) for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees (F) for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1906USA011674:
pt recv vax 15JAN97 & spiked temp 104.8 on 16JAN97 seen on17JAN97;WBC 6.2;dx virus vs immunization rxn;