chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had chest pressure, chest pain, shortness of breath and wheezing immediately following the third vaccine.  I brought my symptoms to the vaccine clinics attention and they ignored my symptoms.  It was necessary for me to go to the emergency room, because of how I reacted to the third vaccine.  My symptoms of chest pressure, chest tightness, wheezing, shortness of breath started within a few minutes of receiving the third vaccine.  Because the vaccine site staff did not take my symptoms seriously, I waited around to see if they would improve, which they did not they worsened.  At that point, an hour later when I was unable to breathe without much difficulty, I brought myself to the emergency room.  At the emergency room, I was not given much medication until many tests were ran. The tests included a chest x-ray, a blood test called troponin T, an EKG, a urine test as well as listening to my heart and measuring my blood pressure and measuring my pulse.  Fortunately all tests came back normal, except my pulse was elevated and my blood pressure was elevated.  I was given two inhalers Atrovent and Ventolin, after which my breathing improved and my chest pain improved.  I was sent home the same evening as when I received the vaccine and I left the hospital about 9 PM.
Pt began to have numbness and tingling in the left side of her face during first 15 minutes of observation. Pt was given 50mg of benadryl IM in the Left arm. (Lot 6121161. Expiration: 1/31/2021. Manufacturer: APP Pharmaceuticals.) Pt denied any difficulty breathing, blurred vision, headache or other signs of reaction. Pt was monitored for another 15 minutes. Pt was talking and laughing without signs of distress. Pt carried conversation with ease and states numbness and tingling was resolving.
Itchy rash with swelling behind knees and around ankles ~4-5 days after vaccine. No other symptoms, remained at home and instructed to come to EC if condition worsened. Evaluated in person at outside EC and prescribed corticosteroids per notes.
Adacel was given in the gluteal area / no adverse event; Initial information received on 06-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.   This case involves unknown demographic patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and Expiry date unknown) via unknown route in gluteal area on an unknown date.  The patient past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.   It was an actual medication error due to Vaccine administered at inappropriate site   it was reported that Adacel was given in the gluteal area.   At a time of reporting no AE symptoms reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.  List of documents held by sender: none.
pt recv vax 20AUG96 & 26MAR97 pt covered w/chickenpox;
LOW GRADE HEADACHE THAT PATIENT DESCRIBED AS "BOTHERSOME, BUT NOT SEVERE"
Diarrhea; Felt flu-like; Body aches; A splitting headache for 1.5 days; Had chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Felt flu-like), PAIN (Body aches), HEADACHE (A splitting headache for 1.5 days) and CHILLS (Had chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Felt flu-like), PAIN (Body aches), HEADACHE (A splitting headache for 1.5 days) and CHILLS (Had chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Felt flu-like), PAIN (Body aches), HEADACHE (A splitting headache for 1.5 days) and CHILLS (Had chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant information not provided.      This case was linked to MOD-2021-053007 (Patient Link).
Varicella Information has been received from a registered nurse (RN) concerning a 6 year old male who on 03-JAN-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, on 06-JAN-2006 the patient experienced varicella. Unspecified medical attention was sought. The RN noted that the patient experienced greater than 50 varicella lesions. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 14-months-old male patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. On 03-NOV-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage).There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 27-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Seasonal allergy.    On 02-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 04-Nov-2020 and the estimated date of delivery was 16-Aug-2021. On 02-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  On 02-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not have any complications or acute illnesses during this pregnancy till date.  Treatment information was reported.
Instant swelling at site of administration that continued to increase. Ice pack placed on area. MD notified and assessed patient. MD believes to be localized reaction. Patient advised that it was more than likely a localized reaction and to keep ice on it and advised of signs & symptoms of anaphylaxis. Patient advised if she has signs or symptoms to immediately call 911.
Pt. reported tingling in arms, fingertips and tongue.  Pt. was seen by Fire Rescue.  Vitals were within range.  No further treatment was given.  Transport to ER was declined.  Symptoms resolved and patient left the park at 1:10pm.
Started itching later around the time I got home from work 5:00 pm. Noticed a small red bump where I received the vaccination. Took Benadryl and went about my day. I noticed the red spot getting larger through out the week. Didn't think anything of it, as I was told this could happen. By 1/27/2021 the redness has spread all the way down my arm and was painful and hot to touch. Saw pcp who put me on Clindamycin. By 1/31/2021 I was in ED as it got worse and spread outside the marked margines. They put me on Prednisone and Kenalog cream, pepcid. My arm did get better but it took time. There still is a red mark there but no longer hurts and burns and itches. Once the Prednisone was finished on Sunday I noticed the rash and redness starting on my face. By 2/10/21 I was in urgent care as it was all over my face, chest, and neck. I was itching and burning just like my arm felt. They put me back on prednisone thinking i wasn't on it long enough and claritin, benadryl, and hydrocortisone cream. I was then scheduled with Dermatology the following day. They want me to continue prednision, claritin 3 times a day, benadryl before bed, cerave itch relief lotion, and face cream.
This spontaneous report as received from a licensed practical nurse refers to two college age female patients. As children these two patients were vaccinated with the primary dose of RECOMBIVAX HB could not be ruled out. Lot #, dose and route not reported). Recently (this month) the two patients had negative titer tests for hepatitis B. No adverse event was reported. The patients contacted office for medical attention. Outcome was not reported. Additional information is not expected.
optic neuritis; loss of vision; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was approximately 56 years old. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 16-NOV-2015, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a primary care facility for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by healthcare providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: optic neuritis and loss of vision. The outcome of the events was not provided. The reporter considered the events of optic neuritis and blindness to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of optic neuritis and blindness were determined to be medically significant.
Trunkal to acral rash: systemic with raised pruritic maculo papular rash worst in pelvic distribution, no SOB rx with BENADRYL and prednisone.
Frequent Sneezing; Frequent Watery eyes; Congested nose in early mornings which later becomes runny nose thru out the day. Did not seek medical help/treatment yet.
Fever 101F 6 days after vaccine given lasting 4 days. Rash 6 days after vaccine given. Has not resolved after 4 days.
HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Dec-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-408599 (Patient Link).
Chronic hives/itchiness/red patches for over two months since recieving the vaccine. So bad I needed to go to the emergency room.
Chickenpox; This solicited report was received from a medical assistant and refers to a currently 4 years old female patient. The patient's pertinent medical history, allergies and concomitant drugs were unknown by the reporter. The patient's concurrent conditions were not provided.  On 13-MAY-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneously for routine vaccination (dose, frequency and strength were not reported. Lot number R026547 with expiration date on 17-SEP-2020). The vaccine was reconstituted with properly stored sterile diluent.  On 15-MAY-2019, the primary reporter stated that patient's mother noticed bumps on the patient's skin. It got worse the next day, so the patient sought medical attention and was diagnosed with chickenpox. The physician referred the patient to an ophthalmologist as there was a bump near the patient's eye. No treatment was given for the adverse event. None laboratories diagnostics or other studies were performed. At the moment of this report the patient had not recovered from chickenpox.   The relatedness between the event occurrence and varicella virus vaccine live (Oka/Merck) (VARIVAX) administration was not reported.  Follow up information has been received from medical assistant on 17-MAY-2019.  Medical assistant called to ask if it was okay to remove a scab from patient and place it in sterile urine cup until the ship it out. Instructions from the varicella zoster virus identification program (VZVIP) were reviewed with the medical assistant.  Follow up information  has been received from medical assistant on 21-MAY-2019.  A callback was received from medical assistant, who confirmed that vesicular sample was obtained from the patient's right wrist.
PT'S DAUGHTER OBSERVED INCREASED TALKATIVENESS, PT EXPRESSED FUTURE PLANS LIKE SHE HAD NOT DONE FOR YEARS PREVIOUSLY.  PT JUST SEEMED TO HAVE INCREASED AWARENESS OF HERSELF AND OF THE PEOPLE AROUND HER.
10 days post vaccination I began to have an itchy raised area under but R big toe. It continued, isolated for 4-5 days.  By 5-6 days it began to spread in the region around the initial lesion on the plantar surfaces on and below my toe and on my heal. At a similar time it presented on my R palmar surfaces in the region of my thumb, forefinger and middle finger.  Very itchy and painful and had periods where they were quiet then would flare up. Finally after a couple days I saw the doctor 1 week from the initial presentation.  The Dx was erythema multiforme minor likely medication or vaccine related.
Chest pain, stomach pain, back muscle spasms, shaking, chills, head pain, muscle ache, fever. Initial report received on 14 September 2009 from a health care professional in the United States. A 39-year-old female patient, who had no concurrent illnesses, but has medical conditions  of seasonal allergies and asthma for which she takes ALLEGRA D and PULMICORT as needed, had received a yearly intramuscular left deltoid injection of FLUZONE SV 2009-2010 on 10 September 2009 at 14:00 hours. Four hours post vaccination, the patient started having muscle aches, shaking chills, back spasms, stomach, chest and head pain and fever. It was not reported whether the patient received any treatment.  At the time of this report, the patient had recovered (date not reported.) Documents held by sender: None.
Client vaccinated in private area due to history of syncope with needles. After vaccination, patient lied down for ~30 seconds. Client proceeded to stand up and walk 2 steps towards post observation area before falling down. Client reported no loss of consciousness, but did report dizziness and blurry vision immediately prior to falling down. Patient continue to lie down while medical staff adjusted posture. Patients legs were propped up on chair where an abrasion on her right knee was noted. EMS was called and was assessed. Patient denied any need to go to the hospital for further evaluation.
Patient, sent to Hospital,, finding unknown, then returned to Hospital, from urgent care approx, 18th October,with Low Blood Pressures, and Shortness of Breath, hospitalized- for days, and released, approx 23rd, with fallowing drugs, -famotidine-twice daily,lisinopril-pressures under 100,carvedilol-pressures under 60,isosorbide mononitrate-pressures under 100,prednisone three tabs day-lowering dosages daily,albuterol- by nebulizer,- as of this day 11/07/2020, patient still can not sleep lieing down, or all night, shortness of breath and heart pressures still far below normal, - days inbetwwen being able to bathe and dress, him self,
4 months old female during a well baby visit was administered Fluzone Quadrivalent; Initial information regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff) on 14-Nov-2019.  This case involves a 4 months old female patient for whom it was reported that 4 months old female during a well baby visit was administered fluzone quadrivalent (PT: Product administered to patient of inappropriate age), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  The patient's past medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included Prevnar 13, Pentacel and Rotavirus.  On 13-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number: UJ270AA) via intramuscular route in the left thigh for immunizations.  It was an actual medication error due to Inappropriate age at vaccine administration (PT: Product administered to patient of inappropriate age).  It was unknown whether any adverse event was occurred or not.  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."
Fever, Body aches, erythema at site, tenderness. Provided NSAIDs and H1 blocker orally.
Short terms of Dizziness 2 days after 2nd dose; Spinning 2 days after 2nd dose; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukemia and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient took concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 17Feb2021 at 13:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. On 12Mar2021, 2 days after vaccination at 18:45 the patient experienced short terms of dizziness and spinning. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events short terms of dizziness and spinning was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.