chrisvoncsefalvay/vaers-outcomes huggingface dataset:
presentation to the ED on 4/17 with intractable HA & dizziness x3 days.  Pt with MS.  Normal & nonfocal neurologic exam.  Given her use of Coumadin with described severe headache, head CT was obtained.  This did not reveal any acute pathology.  Patient was treated with a combination of IV fluids, IV Reglan, IV Benadryl, oral Valium, scopolamine patch, IV Haldol, IV magnesium, IV Decadron for combined dizziness and headache.  She reported complete resolution of headache thereafter.  She was able to ambulate midway through her emergency department visit but later reported intractable dizziness for which she felt uncomfortable being discharged.  As such, general medicine was contacted for observation admission to obtain MRI to rule out posterior infarct and continue treatment for her intractable dizziness.  MRI obtained 4/18 with and without contrast showed no evidence of acute infarct and no evidence of active demyelinating lesions.  Findings compatible with known history of multiple sclerosis with supratentorial demyelination.  There was no of opacified right maxillary sinus for which she will continue Flonase.  Patient was seen by physical therapy who felt she was safe for discharge as she was able to ambulate independently without persistent dizziness.  PT and Care Management arranged for in-home physical therapy 3-5 times per week.  Prescriptions for Antivert and Zofran provided for presumed peripheral vertigo.  Did discuss the possibility of current symptoms being related to Janssen COVID 19 vaccination on March 25th, although I did convey this seemed unlikely to patient and her brother.  Patient is to follow up with her primary care doctor and was provided strict return precautions.  in 4/20/21 phone call f/u with RN Care Manager pt reports ongoing dizziness, headaches including new onset diarrhea.  PCP informed
Complain arm pain with erythema and induration at site of injection 5 cm diameter.
Patients Left deltoid where the vaccine was administered got very red splotchy hive-like rash, slightly itchy.  The rash to the injection site did not appear until 4/3/22.  Mom gave him Benadryl and applied over the counter hydrocortisone cream.  Resolving.
Bexsero was given to 13 year old patient who was supposed to be given HPV vaccine; This non-serious case was reported by a nurse and described the occurrence of wrong vaccine administered in a 13-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 08-AUG-2023, the patient received Bexsero. On 08-AUG-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero was given to 13 year old patient who was supposed to be given HPV vaccine). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-AUG-2023 Nurse reported to supervisor and supervisor was seeking information on what to do if Bexsero was given at younger age than recommended. The patient received Bexsero instead of HPV vaccine, which led to wrong vaccine administered. The reporter consented to follow up.
Dull and frequent headaches; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medication within two weeks of vaccination. Patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 30Mar2021, the patient experienced dull and frequent headaches for the past couple of weeks. The patient did not receive any treatment for the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The. The clinical outcome of the event of dull and frequent headaches was not recovered at the time of this report.    No follow-up attempts are needed; No further information is expected.
Moderate edema, redness, pain, and warmth at injection site. Symptoms also included fever, chills, and congestion with cough.
developed a 1.5cm blister at the site of injection; Initial information was received on 22-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 years old and unknown gender patient who developed a 1.5cm blister at the site of injection after receiving diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine (Suspension for injection) (lot U7656AA, Expiry date : 08-Mar-2025,strength was unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunization).  On an unknown date the patient developed a 1.5cm blister at the site of injection (vaccination site vesicles) (latency : 1 day) following the administration of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS and ipv VACCINE (Quadracel) was not applicable.  It was not reported if the patient received a corrective treatment for the event (developed a 1.5cm blister at the site of injection).  At time of reporting, the outcome was Unknown for the event developed a 1.5cm blister at the site of injection.
Excruciating pain; Immobilized shoulder arm; Administered in my shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, injected limb mobility decreased and product administered at inappropriate site. The patient was treated with ambiguous medication nos (Cortisone (Nos)). On an unknown date, the outcome of the pain, injected limb mobility decreased and product administered at inappropriate site were unknown.   It was unknown if the reporter considered the pain and injected limb mobility decreased to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient received Shingrix vaccine mis administered in his/her shoulder causing excruciating pain and immobilized shoulder arm, which led to product administered at inappropriate site. The patient went to orthopedic doctor and got a cortisone shot that was helping. The patient wanted to know as how to know if this shot was protecting his/her.
Symptoms of minor Bell's Palsy:  right side facial droop, R-eye extreme watering, R-ear pain, R-side headache.  To MD 2 days after symptoms to confirm Bell's Palsy.  Head CT was done to rule out acute stroke.  Started on Medrol 4mg Dose pack and also Valacyclovir 1gm 3 times a day x 7 days.
swelling; Stomach ache; Arm pain; Fever (101°F); headache; sore; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever (101°F)) and HEADACHE (headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN for Cholesterol high.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced SWELLING (swelling), ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever (101°F)), HEADACHE (headache) and MYALGIA (sore). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (swelling), ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever (101°F)), HEADACHE (headache) and MYALGIA (sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Body temperature: 101 (High) 101 Degrees F.
Infant died on 1/19/99. Autopsy report states cause of death to be traumatic head injuries, homicide. Death certificate states: craniocerebral trauma.
While at the vaccination facility, pt states that "as soon as the needle went into his arm he felt a warm sensation in his whole body". He was then monitored for additional time. During that time, he was monitored and his heart rate became elevated, and continued to go up and down. After 30 minutes he was released home but pt states he continued to experience persistent fluctuations in heart rate. The following day, he presented to the Onsite clinic and after a quick evaluation was referred urgently to the ER. At the ER a battery of tests were performed including multiple EKGs, cardiac enzymes, echocardiogram and pt was found to have myocarditis. He was stabilized and referred to cardiology. His last Stress test done November 19, 2021 was normal. He had an additional follow up appointment with   cardiologist, on February 8, 2022.
From 8:30p 4/10/21 to 2am 4/11/21 I experienced nausea with vomiting and diarrhea.
pt recv vax & wife reports became ill Saturday evening by 3AM Sunday temp 104;took APAP;Monday AM temp was still elevated took motrin;was unable to eat & was very weak;
No adverse event; Accidentally administered dose of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Accidentally administered dose of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 14-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Accidentally administered dose of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Accidentally administered dose of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent) 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 ACCIDENTAL UNDERDOSE (Accidentally administered dose of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent).    No concomitant medications were reported.  It was reported that the HCP (Healthcare professional) accidentally administered doses of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent. Patient did not reported any adverse events after the vaccine was administered.  No treatment information was reported.
First day about 4-5 hours after: severe chills and headache Day 2: woke up in morning with left eye completely swollen, both ears swollen, congestion, and productive cough
@ 300pm same day began running T.T inc during noc.Mom gave Panadol & sponged pt-@ 600am 9Jul91 T inc to 104.2AX, @ 745 pt sz 30 sec & repeated X2-Pt taken to MD immed. Lt deltoid red & edematous.
Pt came to pharmacy in person 12PM 10/27/14 to report adverse events. Pt had extreme fatigue for 2 days immediately following vaccine admin (10/23 thru 10/24). Pt denied nausea, vomiting, rash, edema. Fatigue resolved within 48 hours. Also, pt has extended bruising on left bicep. Vaccine given in left deltoid.
Developed a rash erythematous and mildly painful and pruritic on right upper arm. Discomfort noted on 2/5/21 and noticed on 2/8/21
About 10 hours after receiving my vaccine- I became extremely ill. I had migraines, fever of 101, chills, nausea, tightness of chest, abdominal pain, difficulty with my stool / bowl movements, and body aches.  I could not move, and most effects subsided after laying in bed for two/three days straight. However, continuing up to today (three weeks later) I have still had tightness of chest/throat, bowl difficulties, and abdominal pain. I also noticed that for the past 2/3 weeks I have also had blood spotting with clots alongside my abdominal pain. It has not yet subsided.
Patient received both vaccinations, exited the vaccination room and then immediately began complaining that she was feeling lightheaded. She was very flushed and appeared to be in distress. She re-entered the vaccination room where she appeared to have significant back pain and continued lightheadedness. She was able to lie down more comfortably on the floor and rested while EMS was contacted. She complained of some chest pain and stated she had chest pain prior to the administrations of the vaccines. EMS arrived within 15 minutes, assessed the patient and transported her to the local hospital.
Swelling; Injection site pain; Headache; Fatigue; Muscle pain; Joint pain; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Swelling), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache), FATIGUE (Fatigue) and MYALGIA (Muscle pain) in a 72-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Faint (falling in the night, Both were faint episodes).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, SWELLING (Swelling), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.            No concomitant medications were reported. It was reported that the patient had minor side effects after vaccination. She was concerned regarding fainting as an event of Moderna vaccine. No treatment details were reported.     This case was linked to MOD-2022-572773, MOD-2022-572766 (Patient Link).   Reporter did not allow further contact
Fever-Temp 101- 103 degrees, swelling in upper rt arm with tenderness -pain rated 8 on scale 1-10. States she can not lift arm due to pain.
This spontaneous report as received from a Registered Nurse via field representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # K004281, exp. date 22-MAR-2015 (strength, dose, frequency and route were not provided). On an unknown date the patient experienced cellulitis, after receiving PNEUMOVAX 23. No further demographics were provided for the patient. Many of the fields in this report were marked, "Unspecified by reporter", because the reporter did not have specific information to provide. The outcome of cellulitis  was unknown. The patient sought medical attention and visited the office on an unspecified date. Additional information has been requested.
After shots were given, client asked to be picked up, mother did so, when mother picked her up she then went limp and bent backward. Mother states she awoke fast. Client was then offered water and crackers.
Large swelling (larger than golf ball, smaller than a tennis ball) in Right Axillary. No redness. Some tenderness. Right deltoid appropriately sore.
took only first dose of shingrix and second dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received first dose on 02-AUG-2021 with batch number 9ZJ25 and expiry date 23-JAN-2023).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: took only first dose of shingrix and second dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The pharmacist reported that the patient received the first dose of Shingrix and the second dose had not been received yet.  The reporter asked if the series should restart. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. VAERS details provided corresponding to the 1st dose and the case was an incomplete course of vaccination
No additional Adverse Events (AEs); Varivax and MMR II that underwent multiple temerature excursions and were administered; This spontaneous report was received from a medical assistant referring to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or past medical history provided.  On 07-MAY-2021, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # T020652, expiration date: 16-JUN-2022 (dose, route of administration and anatomical location were not reported), and of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA (recombinant human albumin)) (M-M-R II) injection lot # S035352, expiration date: 05-NOV-2021 (dose, route of administration and anatomical location were not reported). Both vaccines were administered as prophylaxis. Both vaccines underwent multiple temperature excursions: -14.03 Celsius degree (C) for 1 hour 15 minutes 0 seconds; -14.9 C for 0 hours 9 minutes 0 seconds; -10.3 C for 1 hour 0 minutes 0 seconds; -6.3 C for 2 hours 0 minutes 0 seconds. Prior temperature excursion was reported as -14.03 C for 1 hour 15 minutes 0 seconds; -14.9 C for 0 hours 9 minutes 0 seconds. Data logger was used to capture the temperature excursion. No additional adverse events were reported.
10/4/21 - Mom called office once returning home after receiving vaccines, reporting child having hives all over body. Denied swelling, cyanosis, or difficulty breathing at that time. Mom was then instructed to take child to urgent care. Per notes, child was seen and was not noted to have any difficulty breathing, swelling, or signs of distress. Was noted to have hives on trunk and extremities. Child was given dose of Benadryl and 5-day course of oral steroids. Per notes, Epi-pen not administered.  10/7/21 Child then started with  nonbilious vomiting and non-bloody diarrhea along with fever. Mom independently took child to ER to be evaluated. Per ER notes, some hives remained on trunk but noted to be improving. MD denied any signs of distress or swelling of face, lips, mouth reported. Child monitored and given dose of Zofran. Respiratory PCR done and resulted negative, including COVID negative. Child diagnosed with teething vs AGE likely. Child discharged home and instructed to follow up with PCP or return to ER for worsening.
09/14/22 presents to ED for "fatigue, abnormal labs". PMHx of "BPH, glaucoma, essential hypertension, history of prostate cancer, prediabetes, osteoarthritis"
feeling nauseous; having diarrhea; running fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAUSEA (feeling nauseous), DIARRHOEA (having diarrhea) and PYREXIA (running fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included PREGABALIN (LYRICA), OMEPRAZOLE, DULOXETINE HYDROCHLORIDE (CYMBALTA) and CELECOXIB (CELEBREX) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced NAUSEA (feeling nauseous), DIARRHOEA (having diarrhea) and PYREXIA (running fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ONDANSETRON at an unspecified dose and frequency and DICYCLOMINE HYDROCHLORIDE at an unspecified dose and frequency. At the time of the report, NAUSEA (feeling nauseous), DIARRHOEA (having diarrhea) and PYREXIA (running fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient received his flu shot on 10/4/18 and about 2 hours later started with left deltoid pain. This was a bit more severe than typical pain he has experienced after receiving an immunization in the past. There was no redness or bruising. The pain has persisted since then and he called to be seen as it is now 3-1/2 weeks. There is mild pain at rest 2/10 and pain is worse with any right shoulder movement. He has difficulty cleaning in the shower, getting his shirt on and off and similar movements. At times he has felt severe sharp pains in the arm. No numbness or tingling. Otherwise he feels unremarkable. He denies any fever. He has not had any reactions to immunizations in the past right upper deltoid no visible deformity, no erythema or ecchymosis. Limited right shoulder ROM. Mild tenderness to deep palpation. ASSESSMENT AND PLAN: Adverse effect of vaccine, initial encounter; Acute pain of right shoulder; Limited range of motion (ROM) of shoulder. The location of the immunization administration appears to be correct. No evidence of cellulitis. Will have him try prednisone 20 mg twice daily ×2 days, 20 mg once daily ×2 days, 10 mg daily ×2 days. Recheck on Monday. Follow-up in about 6 days (around 11/5/2018) for recheck arm.