chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Engerix B pediatric administered to adult patient; Engerix B pediatric administered to adult patient; This case was reported by a nurse and described the occurrence of accidental underdose in a 21-year-old male patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date 24th January 2024) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 ug. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.       Additional Information: GSK Receipt Date: 05 DEC 2022 Reporter's comment: The nurse reported that the patient received pediatric dose Engerix B pediatric by accident. No harm reported. Additional supportive information: As adult patient received the pediatric dose of Engerix B which led to accidental underdose and adult use of a child product. This case has been linked with US2022158132, US2022158095 same reporter different patient.; Sender's Comments:  US-GSK-US2022158132:Same reporter US-GSK-US2022158095:Same reporter
Information has been received from a physician concerning a 13 year old male patient with a history of mumps who was vaccinated with the first dose of MMR II on 07-AUG-1997 and the second dose on 04-OCT-2000.  On 27-NOV-2009, the patient had an onset of mumps (diagnosed on 10-DEC-2009).  The patient had a fever of 102F.  On 10-DEC-2009, the first blood work was performed, but the results were not reported, the patient was diagnosed with left parotitis.  It was unknown if the patient sought medical attention.  At the time of the report, the patient's outcome was unknown.  Follow-up information has been received from the physician concerning the patient who on 18-JAN-2010 had an onset of mumps.  The patient had no sign/symptoms.  On 19-JAN-2010, the first blood work was performed, and the results showed IgM < 1:10, IgG 7.57, serum amylase 44.  The patient was diagnosed with left parotitis on 19-JAN-2010.  It was unknown if the patient sought medical attention.  It was reported that the patient had exposure to class fellow with mumps.  The patient did not receive the third dose of MMR II and the second blood work.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Patient is fully vaccinated. Patient is COVID + at ED visit on 12/30/2021. 49-year-old female presents to the ED due to substernal chest pain/abdominal burning sensation that radiates to the back as well as left shoulder spasms ongoing for the past 2 days but worsened today and became unbearable so came to ED for pain relief and further workup. Patient denies any fever, chills, nausea, vomiting, shortness of breath, diarrhea, constipation, urinary symptoms. BP 135/82  | Pulse 73  | Temp 98 °F (36.7 °C) | Resp 13  | Ht 157.5 cm (5' 2")  | Wt 77.1 kg (170 lb)  | SpO2 97%  | BMI 31.09 kg/m² CXR: No evidence of an acute process. Normal EKG. Treatment: fluid, toradol, decadron.  Discharged from ED stable.
Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain and a feeling of something eating away in my bones, chills, bruised/swollen/pain in left arm (injection spot), fever, fatigue, headache, light cough for 5 straight days. Not able to do normal activities. Took Tylenol and ice pack to alleviate fever. The day after injection, body fell so weak that my body acquired another viral infection (very unusual). No shortness of breath. Eating/drinking/appetite fine. No loss of taste/smell.  I am exactly 1 week from the injection. No fever, just light headache. Able to resume normal activities but gets fatigued fairly quickly (after 3 hours). I am very active and work out 2 hours every day, but may not be able to do strenuous activity/exercise for some time...  I was symptomatic covid last year in April 2019. This was very similar experience but an extremely debilitating, more intense version of the covid that I had.  ***I am unsure if I should proceed with the second dose due to a very severe reaction to the first dose***
Area of swelling redness warmth around site of injection left arm and left leg top of thigh.
This spontaneous report as received from a medical assistant refers to a 65 year old female patient. No information about medical history, drug reactions and allergies was specified. On 17-SEP-2014, the patient was vaccinated with temperature excursion supported PNEUMOVAX 23 injection (lot # K004542, expiry date: 19-AUG-2015, dose 0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects reported by patient. There was no product quality complaint. The outcome is unknown. This is one of the seven reports received from the same reporter MARRs # 1410USA002854, 1410USA005576, 1410USA005583, 1410USA005584, 1410USA005585 and 1410USA005587). Additional information has been requested.
Initial unsolicited report received from consumer on 29-Aug-2017. This case involves 70-year-old (reported as 71 years old) male patient who was vaccinated with a dose of FLUZONE HD (Batch number, expiration date, dose was not reported) via intramuscular route in left deltoid on 28 Aug 2017. The patient's medical history revealed that patient had hypertension. Illness at time of vaccination were reported as none. Concomitant medications were not reported. On 28 Aug 2017, same day following the vaccination, the patient experienced cheeks were becoming puffy or swollen. Once he arrived home on same day, he noticed his swollen cheeks were also red. It was reported that, in morning he notes that the symptoms have remained the same. Patient had no other symptoms to report. Lab data reported as none. Corrective treatment were not reported. It was reported that, the patient was not recovered from events. List of documents held by sender: none.
the patient reported that the last dose they had (which was the second in the series of ) was taken sometime in the "summer of 2019"; No additional AE information reported; This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.   On an unknown date and then on an unspecified date in June 2019 (also reported as "sometime in the summer of 2019") the patient was administered with the first and the second doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, exact doses, exact frequencies, routes of administration, anatomical injection sites, lot numbers and expiration dates were not reported) as prophylaxis. However, the patient had not received the third dose yet (inappropriate schedule of product administration).  No additional adverse event information reported.
Dizziness with injection for about 15 minutes. Fatigue set in at about 1400 and then it felt like my skin was crawling all over. Face began to swell and itch. Took Benadryl woke up in the morning still swollen and with blisters. Went to urgent care told it is Shingles.
Back pain; Leg pain; Lethargic; Pain in hip; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in a 64-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) injection for Rheumatoid arthritis.    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) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported.  The treatment information was not provided.  The action taken with mRNA 1273 with the events was considered as not applicable.
SSHL (Sudden Sensorineural Hearing Loss) in right ear resulting in complete and permanent deafness
PATIENT CITED DIZZINESS STARTING EVENING OF VACCINE AND CONTINUING INTO MORNING NEXT DAY; NO OTHER SYMPTOMS EXPERIENCED AT THIS TIMW
This spontaneous report was received from a pharmacist and refers to a 64 year old non-pregnant female patient. The patient did not have any pertinent medical history and drug reactions or allergies. The patient did not have any concomitant medications. On 14-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, anatomical location, lot # and expiration date were not reported) subcutaneously. On 21-AUG-2016, the patient developed 2 inch, round, red area at the injection site injection and, on the same day, called the pharmacy back to report that. There was no treatment for the adverse event given. No laboratory tests were performed. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Systemic: Fainting/Unresponsive-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Weakness-Mild, Additional details: Patient fainted shortly after receiving the vaccine. She lost color to her face and said she felt weak. The patient sat and was given water. She quickly regained color to her face. After sitting about 15 minutes, she stated she felt much better. They left shortly after. The patient's mother called shortly after the incident and was very upset the child was not initially instructed to wait 15 minutes in the store. I apologized and told her this should have been communicated to them.
May 18 I received my first Covid Moderna Vaccination.  4 hours later when I went to urinate there was blood on the toilet paper. It only lasted about 3-4 minutes.  2 hours after that I went to the bathroom again to urinate and it burned really bad.  I called my doctor and was able to see her the next morning ( May 19)  She sent my urine in for a culture and it came back as a Urinary Tract Infection. She treated me with Cipro for 3 days. She felt that I should see my GYN regarding the bleeding and felt that it is Post Menopausal Bleeding. I saw my GYN on June 7. She did a Pap Smear and it came back normal but it showed that I have a Bacterial Vaginitis infection and treated me with Metronidazole Vaginal Gel for 5 days. Today June 14 is my last day for that. But when I went to the bathroom to urinate there was some blood again on the toilet paper. I don't know if all this is a coincidence or if this is a reaction to the vaccination. My doctor doesn't think it is a reaction but I want to make sure since I was fine till I was vaccinated. I am concerned because I had no sign of the bleeding or the burning before I got the vaccination. I am also concerned because my next vaccination is tomorrow June 15. If I don't get the second one then is the 1st one not going to be valid. If I do get the second one could I have a worse problem with bleeding and UTI? Due to the bleeding I have to have a vaginal ultrasound and depending on the results I might have to have an endometrial biopsy.
Discharge Provider: MD Primary Care Provider:  DO Admission Date: 9/6/2022 Discharge Date: 09/08/2022  PRESENTING PROBLEM: Hypoxia Acute COVID-19 COVID-19 virus infection Generalized weakness   HOSPITAL COURSE: Patient is a 102 y.o. female with past medical history significant for HTN, HLD, and osteoporosis presented to the emergency department for generalized weakness and mild upper respiratory infection symptoms.  She is found to be COVID positive.  She had mild ambulatory hypoxia but SPO2 stable at rest on RA.  X-ray with no acute cardiopulmonary process in labs essentially unremarkable.  Was given dose of Decadron and admitted to internal medicine service.  She had no further hypoxia at rest or with ambulation so steroids were not continued.  She received 2 doses of Remdesivir.  PT recommended home with assist and HHC which was arranged.  Patient discharged home in stable condition
Patient called stating she had her 2nd Moderna vaccine on 03-29-2021.  She was recently diagnosed with Focal Sensory Seizures.  She states that she started having seizures last evening and continues to have them today.  Pt states she can not get her physician on the phone even after numerous tries.  I advised to have someone other than herself drive her to the emergency room.
Post vax, complained of feeling warm, headache, stomach ache, fatigue and a red rash, 5cm x 3cm, on right forearm. No local site redness, swelling. Temperature 99, pulse 76, respirations 18 and BP 90/60. at 13:00, felt better and went home at 14:00
Severe body aches, fever, fatigue, and arm pain, much worse than after 2nd shot. Diarrhea began 1/8/2022 and is ongoing. Today is Day 3 of symptoms; I was sick for only 1 day after the 2nd shot.  Treating with Tylenol and Immodium. I have had no (zero) contact with other people since I got the booster.
Felt terrible; Migraines; Felt like had flu; Temperature drops; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt terrible), MIGRAINE (Migraines), INFLUENZA LIKE ILLNESS (Felt like had flu), BODY TEMPERATURE DECREASED (Temperature drops) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Previously administered products included for Product used for unknown indication: NIACIN, DILAUDID and CODEINE. Past adverse reactions to the above products included Drug allergy with CODEINE, DILAUDID and NIACIN. Concurrent medical conditions included Drug allergy (Dilaudid, manifested by stop breathing), Drug allergy (Niacin, manifested by stop breathing) and Drug allergy (Codeine, manifested by stop breathing).   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2022, received fourth 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) Solution for injection in pre-filled pen, Citrate Free. On 15-May-2022, the patient experienced FEELING ABNORMAL (Felt terrible), MIGRAINE (Migraines), INFLUENZA LIKE ILLNESS (Felt like had flu), BODY TEMPERATURE DECREASED (Temperature drops), PYREXIA (Fever) and MYALGIA (Body aches). On 15-May-2022, FEELING ABNORMAL (Felt terrible), MIGRAINE (Migraines), INFLUENZA LIKE ILLNESS (Felt like had flu), BODY TEMPERATURE DECREASED (Temperature drops), PYREXIA (Fever) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, Body temperature: temperature drops (Low) Temperature drops.         No concomitant medications were reported. The patient received 2nd booster on 15-May-2022. The reporter causality for the events Felt terrible, Migraine, Felt like had flu, Fever, Body aches and Temperature drops with Humira was reported as no reasonable possibility. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.
Headache, dizziness, double vision. Progressed to body aches, nausea and extreme fatigue over the next day.
After a few hours my injection arm around the injection felt numb and hard. I started to feel very fatigued, chills, aches, I took 2 Aleve and went to bed. The following morning still felt the same fatigued, achy, chills, laid down for a bit then felt with. a bit more energy. After a couple of hours feeling very tired, chilled, achy just want to lay down.
PART OF THE VACCINE CONTENT SPILLED OUT BECAUSE THE SYRINGE WAS NOT FIRM; THE AMOUNT OF VACCINE ADMINISTERED WAS UNKNOWN; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-OCT-2021, the patient experienced part of the vaccine content spilled out because the syringe was not firm. On 23-OCT-2021, the patient experienced and the amount of vaccine administered was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the and the amount of vaccine administered was unknown and part of the vaccine content spilled out because the syringe was not firm was not reported. This report was non-serious.
6:00pm 7/27/18-felt feverish with chills, headaches and body aches. Morning of 7/30/18-almost golf ball size swelling with redness. Started taking TYLENOL. (24 hours total). Morning of 7/31/18-symptoms and reactions gone.
Chills, headache, stomach ache, pain in calves, no energy  Just out of it. No appetite, Lasted from Monday til Thursday. Had to work during this. Loss of concentration  & forgetful.
A 53 year old female experienced pain in the back, wrist, head and joints after being treated with RabAvert. She received 3 doses of RabAvert and human rabies immune globulin after she had close contact with a rabid human pt who died of rabies. The pt, a respiratory therapist, administered therapy to the rabid pt. After the 3rd vax, she experienced sharp back pain behind the lungs area which woke her up from her sleep; the intensity of the pain brought her to tears. The pain migrated to the rest of her back, wrist and head. Her joint pain was severe, but the pain was not limited to the joints. The pt also experienced numbness in her hands. After the pain subsided, itching was substituted for the pain. She also experienced heightened irritability during this episode.
Pt received TDAP and MENACTRA in (R) deltoid on 7-25-13. Mom called the next day. She reported the patient's arm was very swollen at the injection site and the skin was tight. Pt was seen in ER, treated with Prednisone.
Swelling in anteriorlateral left thigh at the injection sight that measures 15 cm x 5.5 cm. on 12/20/18 at initial follow-up. Area has since begun to spread into groin area to the inner thigh. Patient was started on antibiotics on 12/20/18 and seen in office for follow-up on 12/21/18.
Patient developed Bells Palsy, facial paralysis, severe headache, blurry vision, mouth twitch and severe abdominal pain.
Pain on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain on the Injection Site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain on the Injection Site). On 28-Feb-2021, VACCINATION SITE PAIN (Pain on the Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication nor treatment provided.
Vomiting from 2AM to 8AM (8 x in 6 hrs), lethargic x 12-24 hrs; fever resolved post 8 hrs, following vomit (101) remained lethargic 24 hrs;
Slight fever (99.4), fatigue, minor pain at injection site, minor ear ache
COVID pneumonia diagnosed 9/11/2021.  Patient expired 11/2/2021
By 7 pm horrible pain at injection site. Could hardly move it. Hard and swollen, red from elbow to shoulder. It was so swollen that couldn't rest hand down; the arm was about 3 inches thicker than other arm due to swelling. Had fever, chills, legs jumping, felt horrible. Sister had similar problems so gave her BENADRYL and double her current antibiotics dosage. Pt's sister and brother in law got same shot 50 miles away. Sister got same horrible reaction and had to take BENADRYL and antibiotics. Her doctor said it could be the same batch. It took about 10 days for symptoms to go away. Had cough and problems breathing. 10/4 went to scheduled cardiologist visit and arm was still red and swollen. Swelling went down very slowly. Received HD vaccine 2 years prior with no problem.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided. This case belongs to 169 of 190 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case