chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adrenal nodule; Flu; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), ADRENAL MASS (Adrenal nodule) and IMMUNISATION REACTION (Vaccination adverse reaction) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). In September 2021, the patient experienced INFLUENZA (Flu). On an unknown date, the patient experienced ADRENAL MASS (Adrenal nodule). In 2021, IMMUNISATION REACTION (Vaccination adverse reaction) had resolved. At the time of the report, INFLUENZA (Flu) and ADRENAL MASS (Adrenal nodule) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: Negative. On an unknown date, Computerised tomogram: Adrenal nodule.         Concomitant products were not provided. Treatment medication were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.
This spontaneous case was reported by a patient and describes the occurrence of EAR PAIN (Ears star hurting/ ears starting to hurt right away), EAR SWELLING (Ears star hurting and swelling), TINNITUS (Has a ringing like a florescent light that is about to go off in the ears), TYMPANIC MEMBRANE DISORDER (Ear drums are swelling) and LYMPHADENOPATHY (Her glandes swell/ glands swell in the throat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021b21a and 048a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient never had COVID-19 Positive test or diagnosis and did not took other vaccines within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Egg allergy and Seafood allergy. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EAR PAIN (Ears star hurting/ ears starting to hurt right away), EAR SWELLING (Ears star hurting and swelling), TINNITUS (Has a ringing like a florescent light that is about to go off in the ears), TYMPANIC MEMBRANE DISORDER (Ear drums are swelling), LYMPHADENOPATHY (Her glandes swell/ glands swell in the throat), RASH (Got the rash) and VACCINATION SITE LYMPHADENOPATHY (She had swelling of the lymph nodes in the same arm of the injection). At the time of the report, EAR PAIN (Ears star hurting/ ears starting to hurt right away), EAR SWELLING (Ears star hurting and swelling), TINNITUS (Has a ringing like a florescent light that is about to go off in the ears), TYMPANIC MEMBRANE DISORDER (Ear drums are swelling), LYMPHADENOPATHY (Her glandes swell/ glands swell in the throat), RASH (Got the rash) and VACCINATION SITE LYMPHADENOPATHY (She had swelling of the lymph nodes in the same arm of the injection) had not resolved. Patient stated that she had an office visit in order to seek medical care caused due to AE. Patient also stated that she never experienced a similar event in the past and no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. And also reported worsening of symptoms. Treatment information includes doctor gave her antibiotics.
approximately 2 minutes after vaccination patient began to have light headed sensation- near syncope without long term disability or injusy
No known adverse reaction.  Phone number given by patient does not work. Patient said it was her first dose, so moderna  covid vaccine administered and 2nd dose scheduled. Upon entering dose in database, found that Pfizer covid vaccine dose was administered to patient on 1/31/21, so patient rec'd mixed dose of mRNA vaccines.
WHEN PATIENT STOOD UP AFTER FINISHING HIS REQUIRED WAIT TIME IN THE OBSERVATIO AREA, HE FELT LIKE EVERYTHING AROUND HIM BECAME BRIGHT AND IT FELT LIKE THINGS/PEOPLE AROUND HIM WERE MOVING AND HE WAS STANDING STILL. HE ALSO HAD PHOTOSENSITIVITY. HE FELT BETTER AFTER BEING OBSERVED FOR AN ADDITIONAL 20-30 MINUTES AND WAS DISCHARGED HOME.
diarrhea a side affect from vaccine shot the second time; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea a side affect from vaccine shot the second time) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea a side affect from vaccine shot the second time). At the time of the report, DIARRHOEA (diarrhea a side affect from vaccine shot the second time) outcome was unknown.            No concomitant medication information as provided.  No treatment information was provided.
Painful visible and palpable swelling of lymph nodes. Starting at jaw line to axilla and left breast.  The swelling is significant and presents with pain mimicking sore throat. Additionally, pain in the anterio-lateral side of the neck when moving, pain in moving arm that radiates to left breast.
pt had flu like symptoms, fever chills etc right off. Today he started with a rash over his face and neck and hot also. pt is calling dr just to make sure rash doesn't need any medication besides benadryl. Pt also was taking bactrim and stopped 4/12/21
Patient's left arm is swollen from the site of the KINRIX about 3 inches in diameter, redness reaches to elbow. Site is hot to the touch. The site affected is the site of the KINRIX.
Pfizer-BioNtech COVID-19 Vaccine EUA: patient hospitalized with acute hypoxemic respiratory failure due to COVID-19. Received remdesivir, steroids, and supplemental oxygen. Discharged to home medically stable.
TESTED POSITIVE AFTER BOTH DOSES ; 12/22/2020, 1/12/2021
After her 2nd shot she felt something trickle down her arm; Possible underdose; A spontaneous report  was received from a healthcare professional concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced events like Vaccine under dose and Vaccination complication.  The patient's medical history not provided. The patient's concomitant not provided  On 13th FEB 2021, the patient received their second of two planned doses of mRNA-1273 intramuscularly in the anatomical location  for prophylaxis of COVID-19 infection.   The patient experienced onset of events of After her 2nd shot she felt something trickle down her arm, possible under dose, and Side effects from the 2nd vaccine were much less than the first.  Treatment was not provided.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the reported events was unknown.; Reporter's Comments: This report refers to a case of Vaccine underdose and exposure via skin for nRNA-1273 with no associated AEs.
I was tired and a few days later I continued to be tired. I was also nauseated and anything I was eating or drinking I threw up. I was so tired and nauseated I couldn't get out of bed. 04/26/2021 I called my doctor and they couldn't get me in for blood work until the 04/27 because of concern for fatigue. Had the blood work done 04/27/2021 and later that night I had this horrible pain in my side and it felt like someone was stabbing me. I was literally so tired that I went back to bed and the pain never went away. 04/28/2021 called my doctor and he was out on vacation and they sent me to urgent care, and there, they thought I had Appendicitis and they sent me to the ER. I told the ER that urgent care thought I had Appendicitis and it was close to 4 hours of waiting and I went back to my car to sit and they said I had to come back in or go home. I went home that day. Next morning 04/29 I called my doctor's office and they sent me for an appendix scan and it didn't indicate appendicitis. They told me to take Tylenol and hope for the pain to go away. 05/03/2021 I woke up coughing up blood and went to a different ER locally and they found a pulmonary embolism and pneumonia on top of that in my right lung. They checked for embolisms in my legs and didn't find any, and they kept me over night. They gave me injections in the stomach and medicine for the Pneumonia. Sent me to PCP with a recommendation for a Hematologist but the Hematologist. Recommended to see a Pulmonologist, I was out of work and healing for several months and I didn't go back for part time until October. I could not breathe at the time and coughing constantly and I was so tired. I'm doing much better now. GI Doctor for GI problems post vaccination. Lactose Intolerance and no can longer tolerate sugars. Never had these problems before. Prescribed an Inhaler for daily use.
This spontaneous report was received from a medical assistant and refers to a 15 month-old (age reported also as 2 years), female patient who did not have any known drug reactions or allergies. There was no information about the patient's concomitant therapy or medical history provided. The patient did not have any illnesses at the time of vaccination. On 18-NOV-2015 at 14:15 (reported also as 2:15 pm), the patient was vaccinated with improperly stored dose of VARIVAX lot # L013068 in the right thigh for prophylaxis (dose, route of administration and expiration date were not reported). The vaccination was in privates doctor's office and administered VARIVAX was purchase with public funds. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion the administered VARIVAX experienced were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004106: US-009507513-1702USA004107: US-009507513-1702USA004108: US-009507513-1702USA004109: US-009507513-1702USA004110: US-009507513-1702USA004103: US-009507513-1702USA004102: US-009507513-1611USA008278: US-009507513-1702USA004105.
Improper storage of product in use; ADMINISTERED RECALLED VACCINE; No other AE information given at this time; This spontaneous report was received from a medical assistant (also reported as certified medical assistant) referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 19-OCT-2020, the patient was vaccinated with incorrectly stored (no details of storing were provided) pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), which was recalled, a dose was 0.5 milliliter, lot # S036495 was confirmed to be valid, expiration date 13-SEP-2021 (concentration, number of administered dose, route and anatomical location of administration were not reported), for prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA010843: US-009507513-2010USA010890: US-009507513-2010USA010905: US-009507513-2010USA011114: US-009507513-2010USA011126: US-009507513-2010USA011133: US-009507513-2010USA011194: US-009507513-2010USA011201: US-009507513-2010USA011364: US-009507513-2010USA011379: US-009507513-2010USA011790: US-009507513-2010USA012196: US-009507513-2011USA001141: US-009507513-2011USA001174:
Woke up on Tuesday 2/16/21  feeling normal, by 8:30 am symptoms of dry mouth, scratchy throat, achy all over, neck tightness and pain (more on left side), runny nose, minimal drainage.  Left work around 9:30 am, received rapid COVID test which was negative.   Symptoms continued at the same level through this morning 2/18/21  around 6 am  at the start of my day.
At approximately 2300 I started to feel very tired and my head started to ache.  At approximately 0000, I started experiencing chills and body aches.  I took my temperature and I had a fever of 101.6.  I drank fluids and took acetaminophen for my fever and body aches.  I woke up the next day  at 0800, no fever but still experiencing body aches and lethargic.  Injection site was also red and hot to touch.  I developed red spots that were itchy.
Neurological events; This case was reported by a other health professional via sales rep and described the occurrence of neurological symptom in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season. On an unknown date, less than 2 months after receiving FluLaval Tetra 2019-2020 season, the patient experienced neurological symptom. On an unknown date, the outcome of the neurological symptom was unknown.   It was unknown if the reporter considered the neurological symptom to be related to FluLaval Tetra 2019-2020 season.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter called to report adverse event due to unable to access database. The healthcare professional administered 10,000 vials of Flulaval vaccines to all employees.  The one of the patient developed neurological event. The reporter unable to provide patient details.  The healthcare professional reached out to the local health department. This matter went up to leadership at the healthcare professional. The reporter informed to medical Liason for that area and had been made aware. The reporter consented to follow up. This is 1 of the 3 linked cases reported by the same reporter.
10/14/2010 mild other Client called clinic stating she had hives. Advised to return to clinic. Had hives to trunk, arms and.
Information has been received from a registered nurse concerning a 44 year old female who on 16-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #655291/0985F). On 16-NOV-2007, the patient experienced an injection site reaction with swelling, pain and redness. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 5/10/2022 -- RECURRENCE OF SAME SYMPTOMS
Information received from school, unable to complete form in its entirety. Information from missing data report states: unknown lot number DR office no longer open.
This is a spontaneous report from a non-contactable 43-year-old female Nurse (patient, self-reported). A 43-year-old non-pregnant female received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; reason was misplaced/discarded and Expiration Date: unknown), unspecified dose via an unspecified route of administration in left arm, on 03Feb2021 13:30 (age at the time of vaccination was 43 years) as single for COVID-19 immunization in the hospital. The patient's medical history and concomitant medications were not reported. The patient did not receive other medications within 2 weeks of vaccination. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 03Feb2021 at 19:00, the patient experienced fatigue, sense of heaviness and sluggishness, headache, and dull throbbing pain in right lower anterior leg unrelieved by massage or rest. No treatment medications were reported. The reported assessed events as non-serious. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's relevant medical history, drug history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # 36301, expiry date: 01-DEC-2017 (strength, dose, route of administration were not provided). There were no concomitant medications reported. The administered vaccine underwent a temperature excursion of 32.1 degree Fahrenheit for 7 hours. The patient did not experience any adverse events. It was unknown if any tests were done. Lot number 36301 is an invalid lot number for GARDASIL 9. Additional information has been requested.
On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 27-week-old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 03-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.; Sender's Comments:  US-009507513-1903USA013366:
Patient recieved a Tdap vaccine on 11/19/13 and a second Tdap vaccine was administered on 12/18/13.
About two minutes after the injection of the second (HPV) vaccine, I began to feel dizzy and hear ringing in my ears. I experienced tunnel vision and felt like I could pass out at any moment. I also broke out in a sweat and felt very hot all over my body.  I felt nauseous and like I needed to vomit, but I did not. I let the nurse know that I wasn?t feeling well, and she instructed me to sit down and left the room to retrieve a glass of water. When she came back in the room, she gave me a wet towel to dab my forehead and a cup of water. She then instructed me to lay down on the examination table with my back slightly raised above my legs. Within a few minutes the feeling passed, and I felt well enough to leave. I had not eaten anything prior to the injection.
Slightly swollen, red, hot to the touch, redness in the arm. Pt referred to md to check if infected, ice or ibuprofen for swelling.
Initial unsolicited case received from a consumer, who is also the patient, on 16 February 2015. Another similar event was reported for the patient's husband, captured in case number 2015SA020528. A 58-year-old female patient, with a history of asthma, egg allergy, dairy allergy, and latex allergy, received an intramuscular left deltoid injection of FLUZONE QIV, (lot number not reported) in September 2014. On 13 February 2015, i.e. 5 months post-vaccination, the patient was seen in a clinic and diagnosed with the Flu. Per the reporter, no testing was performed. The event was treated with TAMIFLU and TYLENOL, and remained ongoing. Follow-up information was received from a consumer who is the patient on 03 March 2015. The responsible physician's contact information was provided. The patient began to experience chills, fever, joint pain on 12 February 2015 in the evening. The symptoms progressed until she went to a clinic on 13 February 2015. The adverse event onset was reported as starting on 13 February 2015. Laboratory tests were not performed "due to previous night's diagnosis of her husband and symptoms." The patient was not ill at the time of vaccination and she did not have any other vaccinations within four weeks prior. She did not experience any adverse events after vaccination in the past. The patient has seasonal allergies, animal allergies and dust allergies. The patient outcome is recovered on an unreported date. Follow-up information was received on 17 March 2015 from a physician. The patient's date of recovery is uncertain. No labs were done. The patient was not seen at the facility of the reporter for this event. No further information was available at the time of this report. Documents held by sender: None. Followup information received from a Physician on 6 April 2015. It was reported that patient's concomitant medications were none at the time of vaccination and medical history includes previous vaccination with FLUZONE QIV (at least 2 doses). The batch number of the vaccination was reported as U199AB.
Patient initially used J&J vaccine with no adverse effects. She developed hives about 6 weeks after mRNA booster. After three months working with her internist, she was referred to an allergist. She was told that the allergist has seen similar cases "almost every day" related to the mRNA covid boosters and recommended Xolair shots but could not say if or when they would be effective. Patient conferred with her internist and decided that the possible positive outcome did not overcome the potential for no relief or adverse response. Patient now on regimen of 2 Zyrtec twice a day plus refrigerated Sarna Sensistive, unable to wear clothes or sleep more than three hours at a time.
reaction to moderna vaccine due to allergy to shelfish; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (reaction to moderna vaccine due to allergy to shelfish) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney disorder.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (reaction to moderna vaccine due to allergy to shelfish). At the time of the report, HYPERSENSITIVITY (reaction to moderna vaccine due to allergy to shelfish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant as well as treatment information was provided.  Patient was also received Pfizer covid vaccine on an unknown date.
Approx 7 days after first vaccination developed an itchy, warm, semi-hard red rash approx one inch in diameter, but since then growing top approx 3 inches in diameter today, 12 days after vaccination of first dose.