chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Diarrhea; Vomit; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown), via an unknown route of administration in the left arm on 18Mar2021 at 13:45 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not tested for COVID-19. On 21Mar2021, after three days of vaccination, the patient experienced diarrhea, nausea and vomit which existed for 4 days. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures, which included nasal swab and rapid test on 24Mar2021, which were found to be negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events diarrhea, nausea and vomit was recovering.   Information about lot/batch number cannot be obtained. No further information expected
Brother states patient developed "Transverse myelitis" from the MMR vaccine then the patient "Fell down and died". Developed paralysis in legs one week after shot. 8/11/08-records received for DOS 12/12/07-1/6/08- DX: Paraparesis secondary to transverse myelitis. Death secondary to pulmonary embolism. Admitted for evaluation of lower extremity weakness for 2-3 weeks, with shooting pain in feet on 12/14/07-balance difficulties noted, tingling in left upper extremity prior to hospitalization Upgoing plantar reflex noted on right side, lower extremity reflex loss at ankles and left patella.  Autopsy refused by family.
stated that he was not eating; has no sense of smell; has no sense of taste; drainage from his sinuses was out of control; Nauseated; throwing up; cough; has lost close to 20 pounds; This is a spontaneous report from a contactable consumer or other non hcp. A 69-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6204; Expiration Date: 21Jul2021) via an unspecified route of administration in Arm Left on 05Mar2021 08:45 as single dose for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing He had shingles three years ago. The patient's concomitant medications were not reported. The patient experienced stated that he was not eating on an unspecified date, has lost close to 20 pounds on 05Mar2021 06:30, has no sense of smell, has no sense of taste on 15Mar2021 06:30, drainage from his sinuses was out of control, nauseated, throwing up, cough on 15Mar2021. Clinical course was reported as he started not eating 06 Mar or 07Mar. he could not smell so he could not eat. he has had so much drainage from his sinuses in past six weeks that he is getting nauseated and throwing everything up. Clarified had a reduced sense of smell in past three years since shingles but now has no sense of smell. he had drainage since shingles but that it has gotten out of control since the vaccine. he would cough so violently and then be in the bathroom throwing up. The clinical outcome of the event lost close to 20 pounds was unknown other events was not recovered.  No follow-up attempts are needed. No further information is expected.
next day after vaccine...developed bad back pain....like an old sports injury....lasted 5 days then resolved...had not had similar symptoms in many years..
A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessment were not applicable and the event was considered to be resolved.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:56 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 48.95.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 15-Apr-2021, the excursion time on initial supply was 09 am, temperature was 34. Total 188 doses were administered for that day, condition of vaccine prior to vaccination was not frozen. Vaccine moved to fridge on 06-Apr-2021 and moved to clinic on 15-Apr-2021. 18 vials were moved to the clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Information has been received from a nurse practitioner concerning an approximately 25 year old female with anaemia and a history of cardiac murmur as infant who on 05-MAY-2011 was vaccinated with the first dose of GARDASIL (lot # not report). On an unspecified date, the patient was vaccinated with the second dose of GARDASIL (lot # not report). On an unspecified date, the patient was vaccinated with the third dose of GARDASIL (lot # 668262/0841AA, expiration date 08-APR-2012). Concomitant therapy included birth control pills. The nurse practitioner reported that the patient stated "she experienced itchy legs after each GARDASIL vaccination. After the second dose, she had an increased heart rate and the itchy legs. Four and one half hours after the third dose of GARDASIL, she was dizzy, shaking, confused and her mouth was drawn to one side she thought she was having a stroke. She said that after each dose the severity of symptoms increased and the onset happened more quickly. She went to a hospital Emergency Room and she did not know if she was admitted." No treatment was given to the patient. No laboratory test was done. The nurse practitioner stated the patient was fine now but she did not ask her how long it took for her to recover from the symptoms. Upon internal review, stroke was determined to be an other important medical event. Additional information has been requested.
1-16-09 vaccine given. 1-22-09 at 6pm began vomiting. At 9:40pm c/o knees "killing me". Mom carried to bed 1-23-09 and 1-24-09, child home playing table games and watching TV, not running around, more sedentary. 1-25-09, 6:30 am patient lying on floor in bedroom screaming " I can't walk". Taken to ER lab work drawn and MOTRIN given. Discharged at 11am walking and ok.
Patient with extensive PMH- rectal adenocarcinoma with colostomy, sacral ulcers, cardiomyopathy, from Nursing Home. Sent from nursing home due to persistent hypotension for 2 days which did not respond to IV fluids,  sepsis since patient was tachycardic and hypotensive. Urinalysis positive, sepsis possibly due to urinary tract infection, patient also with bacteremia- gram-negative. Patient still hospitalized on antibiotics.
Cough; Migraine; Localised rash; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), MIGRAINE (Migraine) and RASH (Localised rash) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COUGH (Cough), MIGRAINE (Migraine) and RASH (Localised rash). At the time of the report, COUGH (Cough), MIGRAINE (Migraine) and RASH (Localised rash) was resolving.            It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  Concomitant Drugs Not Reported  Treatment Drugs Not Reported  The reporter's causality for the event(s) of cough, migraine and foot rash with Skyrizi was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
12 hours after receiving vaccine, rash appeared on lower legs with raised welts. This lasted 9 days. 16 hours after vaccine, wheezing, chest tightness and throat tightness which improved after 4 days using Benadryl and Pepcid. Visited Dr. on 2/12/2021 and was prescribed an Epi pen, oral and topical steroids.
Hospitalized 8.29.21;  found to be COVID-19 positive;  fully vaccinated. Patient is still hospitalized at this time.   HISTORY OF PRESENT ILLNESS:  Patient is a 78 y.o. female with past medical history significant for T2DM, COPD, asthma, anxiety, bilateral AKA, C difficile, CHF, duodenal abscess, recurrent UTI 2/2 colovesicular abscess and frequent admissions over the last six months who presents today with altered mental status and hypoglycemia. The patient resides at a care facility. She was admitted 8/26-8/28 due to hypoglycemia at which time her Lantus was discontinued and she was discharged on only corrective insulin. Call placed to patient's daughter and granddaughter/reported guardian who state the patient was reportedly doing well since returning to assisted living. Her daughter called to check in last night and was told the patient's blood sugars had been stable all day. However, reportedly later in the night the patient was found down and confused with a blood sugar in the 20s.  She was given an amp of dextrose and brought to the emergency department.  I attempted to call the care facility however the lady was unable to verify that patient was a resident at the facility, and I was unable to obtain further information. In the ED, the patient was initially hypothermic (T95.2), mildly hypertensive with otherwise stable vital signs.  The patient had recurrent hypoglycemia while in the emergency department and received 2 amps of D50 and was then started on a D10 infusion.  To start have leukocytosis with WBC 12.51.  Hemoglobin 10.2.  Potassium 2.8.  TSH was low but free T4 was normal.  COVID-19 PCR was positive. K 2.8, BUN 13, Cr 0.32, Ca 11.3, Tbili 0.2, Alk phos 175, ALT 211, AST 142. CXR negative for acute findings. UA showed moderate leukocytes and received 1g IV Rocephin. The patient will be admitted for further management.  ASSESSMENT / PLAN: Hypoglycemia Type 2 diabetes mellitus, insulin dependent - Recently admitted to ED observation 8/26-8/28 due to hypoglycemia. Lantus was discontinued during admission and patient was discharged on only corrective insulin - Returns today with hypoglycemia; unclear if patient received insulin prior to the event. Attempted to call facility but unable to receive additional information - Interestingly two other patients from same facility admitted today for hypoglycemia - Status post octreotide in ED - Blood sugar improving s/p 2 amp D50 and D10 infusion - Decrease D10 infusion from 150ml/hr -> 100ml/hr due to hx of CHF - Monitor BS q1hr x2, q2hr x4 then q4hr thereafter - Check c-peptide, insulin, proinsulin level, BHB and comprehensive urine drug screen - Consult endocrinology   Covid 19 positive - Reportedly there is an outbreak at patient's facility - Covid test 8/27 was negative but is positive today - No respiratory symptoms. O2 is stable on 2L (which is patient baseline) - CXR negative for acute cardiopulmonary process - Not current candidate for decadron or remdesivir but will monitor daily Transaminitis - Possibly related to COVID infection - Hepatitis panel ordered - Repeat CMP in AM, consider RUQ US if worsening
Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Mild
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2014, the patient was inoculated with ZOSTAVAX at a physician's office by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-May-2016, the patient was treated at Community Hospital Oncology Physician's Network by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I can't sleep at night; arm hurts so it has settled in joints, shoulder, and up neck to down to elbow; This is a spontaneous report from a contactable consumer. A 67-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, in right arm on 13Feb2021 as single dose for COVID-19 immun-ization. Patient's medical history and patient's concomitant medications were not reported. On 14Feb2021, Patient reported, I can't sleep at night and arm hurts so it has settled in joints, shoulder, and up neck to down to elbow. Patient wanted to know that how long this will last. Treatment for the events was Tylenol. LOT#: Patient stated that Pfizer GN5318, it looked like. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Painful, Swollen lymph by collarbone.; Painful, Swollen lymph by collarbone.; Swollen lips where fillers injected 12 months ago; Fullness, warmth and tingling on the right side of the neck; Fullness, warmth and tingling on the right side of the neck; Fullness, warmth and tingling on the right side of the neck; Arm pain; Fatigue; General malaise; This is a spontaneous report received from a contactable consumer or other non-HCP (patient reported for herself). A 46-year-old Adult female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN 6205), dose 1 via an unspecified route of administration, administered in Arm Right on 06Mar2021 at 08:15 AM (at the age of 46-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Graves disease ankylosing spondylitis some hypertension and heart murmurs with sometimes irregular heartbeat. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had no allergies to medications food or other products. Concomitant medication(s) included Levothyroxine sodium (SYNTHYROID); vitamin D (VITAMIN D NOS), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination the patient had not been tested for COVID-19. On 06Mar2021, the patient experienced arm pain, fatigue and general malaise. On 16Mar2021 07:30AM, the patient experienced painful, swollen lymph by collarbone, swollen lips where fillers injected 12 months ago and fullness, warmth and tingling on the right side of the neck. It was reported that the patient had Painful Swollen lymph by collarbone. Swollen lips where fillers injected 12 months ago. Fullness warmth and tingling on the right side of the neck. All experienced 11 days later. Day of vaccine had some arm pain fatigue and general malaise. It was unknown if treatment was received for the adverse events. The patient outcome of the events was Not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt received Pediarix injection then Prevnar then Pedvax (Hib) injection. Became pale within a few minutes of the final injection. No cyanosis vital signs good. Exam unremarkable after episode.
My blood pressure shot up the first night. It came down for a while Wed and Fri, but shot back up to 181/102 Sat. I take Clonidine when it goes over 160. I have had several this week. My pulse has stayed in the 60s and 70s. My oxygen saturation has been above 95.
Redness, swelling, itching at site of injection and generalized itching of arms, legs, back continuing for at least 3 days.  Patient takes Citirizine routinely in the mornings.  Notified provide on 02/06/2017. Suggested Follow-up with primary care provider.
Patient came to office for well child check with immunizations. He was 10 months old and due for the 6 months vaccines. He as given unneeded dose of HIB. PEDVAX is a 3 dose series with the 3rd dose being given at minimum of 12 months of age. He should not have gotten this.
I received a flu shot (High Dose for those over 65) on 10/29/2020 at my primary care physicians office. 24 hours following the injection my fasting blood sugar was unusually high at 153. I monitored more closely over the next 48 hrs. On Saturday, 10/31, my blood sugar rose to over 300 mg/dl. I took my blood sugar every two hours until Sunday morning 11/1 when it returned to 117 and stabilized. I'm concerned that I was not warned of this possible side effect and what to do if it happened.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: FLUSHING (non-serious), outcome "unknown", described as "getting flushed"; SKIN WARM (non-serious), outcome "unknown", described as "his skin is in heat"; PENIS DISORDER (non-serious), outcome "unknown", described as "penis went 11 inches and got twice the size". Additional information: A caller had a question about the COVID vaccine. He wants to know if the fourth booster is the third shot. He said he had side effects and he got it from withheld. He started getting flushed and his skin is in heat and his penis went 11 inches and got twice the size. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.