chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness in left shoulder; numbness in left pink and ring finger; numbness of the tongue on left side; numbness of inner cheek in mouth on the left; This is a spontaneous report from a contactable consumer (patient). A female non pregnant patient of the 25-years-old female received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9264) via unspecified route of administration in the left arm on 08Feb2021 at 10:15 am as a single dose of COVID-19 vaccination. The patient's medical history was not reported. Other concomitant medications in two weeks ibuprofen. Patient has allergy of penicillin. 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 08Feb2021 at 10:45, the patient experienced numbness in left shoulder, numbness in left pink and ring finger, numbness of the tongue on left side, numbness of inner cheek in mouth on the left, numbness of the cheek externally on the left closer to the jaw and mouth away from the ear and nose. No covid prior vaccination, No covid tested post vaccination. The patient did not receive any treatment for the events. The clinical outcomes of the events are not recovered.
joint pains/ all joints hurt but it hurts more on legs and left side of body; sinus headache; a little arm pain/sore; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headache), VACCINATION SITE PAIN (a little arm pain/sore) and ARTHRALGIA (joint pains/ all joints hurt but it hurts more on legs and left side of body) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (a little arm pain/sore). On 18-Mar-2021, the patient experienced SINUS HEADACHE (sinus headache). On 23-Mar-2021, the patient experienced ARTHRALGIA (joint pains/ all joints hurt but it hurts more on legs and left side of body). At the time of the report, SINUS HEADACHE (sinus headache) and VACCINATION SITE PAIN (a little arm pain/sore) outcome was unknown and ARTHRALGIA (joint pains/ all joints hurt but it hurts more on legs and left side of body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: unknown (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Patient stated that he is taking medication for heart rate.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received included lab data was added and outcome of event updated from unknown to recovered.
Multiple lymphadenopathy and left breast pain Treatment - ordered diagnostic mammogram outcome - slow to resolve
Morbilliform diffuse macular pink blanching rash covering her trunk, groin and face for 18 hrs, rhinorrhea. No fever or irritability.  Father thought it was pruritic, however, she was not scratching it here.
42-year-old female with history of bipolar disorder presents with allergic reaction. Patient states she received the Johnson and Johnson vaccine and subsequently developed itching and scratchiness in her throat on 4/11/21 and developed hives. Felt as though throat was closing. . Denied ever having any shortness of breath or difficulty breathing. Patient was given steroids epinephrine and Benadryl and transported to the hospital.  Proceeded to ED and given Epi 0.5mg and Benadryl 50 mg PTA. Discharged and instructed to go to ED if ASAP if develop new/worsening symptoms and follow-up with PCP within next 24-48 hours. Patient denies any complaints at this time. States she never had a rash and denies any shortness of breath difficulty breathing. Denies any chest pain. Denies abdominal pain nausea vomiting or diarrhea and denies any urinary symptoms including urgency frequency or dysuria.
Large rash 3" x 2" around site of injection. Patient also reports itching and swelling of site.
Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 0.001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of Tdap (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine exposure in utero, thus 27 (0.4 percentage) neonate patients experienced complications including ventilation required during first 24 hours. Patients were hospitalized on an unspecified date. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Patient says arm was initially swollen, red, sore, and itching and the swelling and redness is gone but the arm still itches. Did not go to Dr. Spoke to him again today.
Cough & later fever. Next day fever spikes to 104. Headache & tummy ache also.
Fever fluctuating between 100-103 degrees for one week, fatigue, headache, loss of appetite, nausea with two vomiting episodes (day 3 and day 5), body aches, continued nausea, loss of appetite, and stomach heavyness for about 5 days after the first week. Nausea, appetite, and stomach improved by 15 days after the second dose. Irregular vaginal bleeding began occurring on day 13 since the dose, and has continued for 4 days (current).
Patient was received received from observation room after receiving the maderna vaccine complaining of difficulty swallowing and a "funny feeling" in her throat. On observation no signs of swelling or redness tho throat, no hives noted. denies itching. Patient in no distress. vitals BP-174/84, p-84, r-20,  o2Sat- 99. Patient stated she felt better after some rest and drinking water. Patient advised that she must report to the ED is any signs of difficulty breathing, wheezing, hives. patient expressed understanding. Patient left facility with two other individuals.
Case number PHEH2015US000662 is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 69-year-old female patient. She was vaccinated with FLUVIRIN, (batch number: 145205) at a dose of 0.5 ml intramuscularly on 22 Oct 2014. It was reported that the patient received FLUVIRIN which reached below 36 F for 3.5 non-consecutive days and the vaccine reached 33.1 F for less than 12 hours. The pharmacist did not believe that the vaccine was frozen and thought it was a thermometer mal-function. No adverse event reported following this medication error (incorrect storage of drug).
Pt was give MENACTRA & Tdap twice in the same year. First doses given 3/7/2011 then again today 8/1/11.
A non-serious spontaneous report of administered expired FLUMIST was received from a consumer concerning a female greater than five-years-old. No medical history was provided. The reporter indicated that the lot number and expiration date printed on the outside of the product package had a different lot number and an expiration date than the inside of the package. The outside of the package had an expiration date of Dec-2008 and the doses inside the package had an expiration date of Jan-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
pt found unresponsive @ home; EMT;s called transferred to ER; attempted resuscitation efforts unsuccessful; pronounced dead in ER:
Histimine reaction: re-emergence of poison-ivy type rash on left wrist area (had poison-ivy in this area in 2019) Treating with Benadryl spray / topical, and with Benadryl oral. 48 hours itch and rash still present / no significant change
I had a 102°F fever from 9am to around 6pm (9 hours). Along with that the normal headache and muscle pain. After 6pm, everything went back to normal and I?ve felt fine
Developed a very sore arm about 36 hours post injection.  About 48 hours post injection developed swelling; redness; itching and pain at injection site.   Acetaminophen used but ineffective.
Covid19 breakthrough.  Vaccinated on 05/22/2021.  49 y/o presents with c/o abdominal pain, diarrhea and white stools. with PMHx of no short term memory due to anoxic brain injury, decub on right buttock and Vtach Oct 1st, AICD.  On 12/24/21 pt to HCF with colitis which has worsened last 4 days and accompanied by vomiting.  Pt not requiring O2, CXR with chronic changes-no acute.   Covid considered incidental finding.
low grade fever of 99.9 degrees; rigors; muscle soreness; extreme knee joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 27Feb2021 14:00 (Lot number: EN6203) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "enlarged descending colon", start date: 2016 (unspecified if ongoing), notes: In 2016 patient was hospitalized with diff and an enlarged descending colon.; "right ear pain" (unspecified if ongoing), notes: In 2019/2020 patient was seeing ENT for right ear pain; "Eustachian tube balloon sinuplasty" (unspecified if ongoing), notes: ultimately undergoing a Eustachian tube balloon sinuplasty; "mild herniation", start date: 2012 (unspecified if ongoing), notes: In 2012 patient had a mild herniation; "lumbar pain" (unspecified if ongoing), notes: the patient had a mild herniation at L5/S1 causing lumbar pain and neurological symptoms in left outer calve taking approximately 2 years to resolve; "Depression" (ongoing); "slight tear sustained to a sagittal band of the third metacarpophalangeal joint" (unspecified if ongoing), notes: In 2020 patient saw an orthopedist for a slight tear sustained to a sagittal band of the third metacarpophalangeal joint. Concomitant medication(s) included: WELLBUTRIN taken for depression, start date: 20Apr2020 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st , Date: 06Feb2021, Time: 10:00, Anatomical site of injection: Left deltoid, Route of Administration: Intramuscular, Batch/Lot number: EL9264), administration date: 06Feb2021, when the patient was 39 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "low grade fever of 99.9 degrees"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "rigors"; MYALGIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "muscle soreness"; ARTHRALGIA (non-serious) with onset Feb2021, outcome "unknown", described as "extreme knee joint pain". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
p/vax pt fainted;aroused;fainted again;transported to ER told by MD episode d/t HBV;
PATIENT GIVEN A DOSE OF HEP A WHEN THE PATIENT DID NOT REQUIRE ADMINISTRATION OF HEP A.
Patient who was previously vaccinated for Covid with Johnson & Johnson vaccine was hospitalized 10/10/21-10/11/21 for Covid-19. He subsequently received a Pfizer booster dose on 10/22/21. Patient also reports receiving his flu vaccine recently, but hospital unable to confirm the date. Patient reports progressive weakness to bilateral lower extremities with difficulty ambulating for the previous 3 days when he presented to the hospital on 10/25/21.
Information has been received from a registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was  administered dose of GARDASIL on 11-JUN-2013 lot # reported as 1495AA expiration date: 22-AUG-2015. No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
muscle stiffness during morning walk, nausea while eating cereal, stood up and fainted some nausea while on floor for 2.5 hours sleeping three hours later
General feeling of un-wellness, headache, chills, left arm soreness and unable to raise left arm above shoulder.   Started about 7-8 hours after injection lasting through the following evening at bedtime.   Waking on Sunday, following my Friday afternoon shot,I felt back to normal.   No reaction from either of the first and second shots.
Intermittent hives on palms/wrists starting day after first shot, continuing through 2 weeks after second shot, in spite of continual use of antihistamines; persistent headache for 5+ days starting 1; headache; This is spontaneous report from Non-contactable consumer (patient). A 38-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8732, Expiration date was not reported), via an unspecified route of administration, administered in Left arm on 02Apr2021 15 as single dose for covid-19 immunisation. Medical history included asthma. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) and fluticasone propionate, salmeterol xinafoate (ADVAIR) both are taken for an unspecified indication, start and stop date were not reported. Allergies to medications, food, or other products reported as no. Historical vaccine included first dose of bnt162b2(Pfizer COVID-19 vaccine, Lot number: EN6208), on 12Mar2021 15:45 PM on left arm for COVID-19 immunization and experienced Intermittent hives on palms. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 03Apr2021 09:00 patient experienced Intermittent hives on palms/wrists starting day after first shot, continuing through 2 weeks after second shot, in spite of continual use of antihistamines; persistent headache for 5+ days starting 1 week after 2nd shot. Patient did not receive treatment for the adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient experienced a rash approximately 3-4 hours after receiving vaccine. Rash located in the same arm as vaccination was placed. Rash extended to the elbow. Patient took benadryl 25 mg and rash subsided.
Extreme itchiness at the site of the vaccine. It lasted all day on Wednesday and Thursday. It is relieving  A LITTLE today, Friday.  There is no rash but the site is still puffy. I had slight itchiness a week after the first vaccine for one evening. There was a little rash but it didn't bother me.  I spoke with my dermatologist who advised me to use a Hydrocortisone ointment 2.5  that had been prescribed for me in the past.
Client states around 10pm he began to have chills.  He thought he had a fever, however, did not use a thermometer. Vomited 1x.  Slept all day Saturday and Sunday. Had no energy.  Sunday evening he developed blisters in his mouth and by Monday morning blisters around the outside of his mouth. He states eating and drinking is very difficult. Advised client to call MD to report condition and to have lesions in the mouth evaluated.
Developed chest pressure 8.5 hours after vaccine, unrelieved after 3 hours, went to ED, elevated troponin, EKG changes. Admitted to hospital low grade fever next day
I started out having normal, expected lethargy, but it quickly got worse to the point where I was drooling slightly, my breathing slowed down for about half an hour (4:30-5pm), my speech was slurred and slowed, and my mood and behavior were somewhat erratic for about an hour (4:30-5:30pm). A friend I talked to on the phone while these symptoms were ongoing described me as sounding ?kinda drunk.?
Patient was inadvertently given Pfizer 5-11yo dosing formulation by MA in error instead of ordered and recommended Pfizer 12y+ formulation. Parent was notified immediately upon realization of error. Per CDC guidelines for COVID vaccine errors and deviations (Administration Errors Revaccination Guidance chart), repeat dose is not indicated. Discussed error with team/staff and immediately implemented strategies to prevent it from happening again. Provider reported error to VAERS. No known complications have occurred due to error at this time.
Initial unsolicited report received from a nurse via phone on 31-Jul-2018. This case is linked to 2018SA212665, 2018SA212615, 2018SA212638 and 2018SA212627 (Same reporter). This case involves a 6 months old male patient who experienced received third dose of vaccine PENTACEL lot number C5529AA (expiry date: 04-Oct-2019). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE RHBSAG (HEPA-B) for Immunisation; PREVNAR 13 for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. It was an actual medication error due to inappropriate reconstitution technique. It was reported that a lyophilized powder portion of ACT-HIB that was not given from a box of 5 single doses of Pentacel and the reporter was unsure which one of the 5 patients who recieved doses from this lot didn't get the ACTHIB portion. It was reported that the patient had no reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This spontaneous report was received from a pharmacist, referring to a 50 year old female patient, which was a pharmacy technician at the reporter's pharmacy. The patient had no allergies, concurrent conditions or medical history reported. On 25-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # M018453 expiration date 28-AUG-2016), subcutaneously. Information about concomitant therapy was not provided. After vaccination, on the same date the patient stated that there was "a quarter sized red area" that was swollen and raised at the site (injection site erythema and injection site swelling). On 26-AUG-2016, had a "red and swollen area the size of the patient's palm at the injection site", also the patient mentioned some itching at the site of the injection (injection site pruritus). The outcome of injection site erythema, injection site pruritus and injection site swelling was reported as recovering.  The relationship between the vaccine and the events was unknown. Additional information has been requested.
Child under the age of 12 (guardian completed form with incorrect DOB and stated 12, but when confirmed dob in ehr, dob is incorrect).
Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 23-Jul-2020 and the estimated date of delivery was 22-Apr-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided  No treatment medications provided
Left arm pain, axillary lymph node enlargement  (size of small plum), nausea, vomiting, fever 101.7, near syncope, fatigue and body aches
had inj on Tuesday PM 330PM-Wednesday felt dizzy & nauseated-Thursday exhausted-no energy nauseated-Friday felt better still puny & nauseated;now remembers having DT booster about 4yrs ago