chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The night after receiving the vaccine, I started having tinnitus/It has been ringing in my ear; headache gets so bad it makes my ears hurt; It is disabling, I cant focus it is constant; headache gets so bad it makes my ears hurt; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (The night after receiving the vaccine, I started having tinnitus/It has been ringing in my ear), EAR PAIN (headache gets so bad it makes my ears hurt), DISTURBANCE IN ATTENTION (It is disabling, I cant focus it is constant) and HEADACHE (headache gets so bad it makes my ears hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (The night after receiving the vaccine, I started having tinnitus/It has been ringing in my ear), EAR PAIN (headache gets so bad it makes my ears hurt), DISTURBANCE IN ATTENTION (It is disabling, I cant focus it is constant) and HEADACHE (headache gets so bad it makes my ears hurt). At the time of the report, TINNITUS (The night after receiving the vaccine, I started having tinnitus/It has been ringing in my ear), EAR PAIN (headache gets so bad it makes my ears hurt), DISTURBANCE IN ATTENTION (It is disabling, I cant focus it is constant) and HEADACHE (headache gets so bad it makes my ears hurt) 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.   No treatment medications were reported.
Patient had a rash around her neck that appeared 1 day after administration and lasted for 2 days. She took Benadryl to relieve the itchiness/ redness.
Information has been received from a Nurse Practitioner (N.P.) concerning a 73 year old female patient who "last year" was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). It was reported that the patient experienced a breakthrough case of shingles after receiving ZOSTAVAX (Merck) about a year ago. It was reported that the patient had not recovered at the time of the report. The patient sought unspecified medical attention. Follow up information was received from a Nurse Practitioner (N.P.) who reported that on 23-FEB-2009 a 73 year old female patient at 08:43 developed a severe case of shingles on her left chest wall 10 months after receiving ZOSTAVAX (Merck). There was no illness at time of vaccination. It was reported that the patient recovered on 05-MAR-2009. Additional information is not expected.
Fever of 99, aches subsided 3/30 early am. Headaches continue thru the day 3/30 and back ache, 6pm noticed arm looks like bee sting- red, puffy, tight to the touch.  Pain. Slight red rash. 2 inches x 2 inches.
26 y/o male ADMS is referred to the FBVHC from WAMC Allergy department for persistent leucopenia since receipt of multiple vaccines. 3/18/09-records received-office visite 3/9/09- C/O tendonitis, plantar warts, carbuncle on plantar surface. Leukopenia after participation in VHC smallpox study in 1/09. No complaints.
Mild Syncope(Dizzy/Warm) over about  a 5 minute period  Treatmet= Supine/removed layers of Clothing, Elevated Legs/ Water)
quadracel administered to 2 years age child with no reported adverse event; Initial information received on 14-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 2-year-old male patient of whom  was reported administered DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] to 2 years age child with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE for Immunisation.  On 12-Apr-2022, the patient received 0.5ml total dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE, strength: standard (Lot Number: C5970AA, Expiration Date: 02-Feb-2024) via intramuscular route in the left thigh for Immunization and it was administered to 2 years age child with no reported adverse event (product administered to patient of inappropriate age; latency: same day).  It was reported, Nurse asking for guidance moving forward. This situation is reported as a medication error due to administering dose outside of approved age indication.   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  At time of reporting, the outcome was Unknown.  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 the 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.
Facial rash, sore throat, body aches - T - 91'. (Allergic reaction)
started Rabies vaccine in 2016. She did not continue it; Initial information received on 05-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a female patient (age not reported) who started RABIES (HDC) VACCINE [IMOVAX RABIES] (number not reported via unknown route in unknown administration site) on an unknown date of 2016 and the patient did not continue it later with the other doses.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It is an actual medication error case due to missed dose.  It was unknown whether the patient had any adverse event 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.  List of documents held by sender: none.
Patient with 3 Pfizer COVID vaccinations who admitted to hospital with complications of COVID and positive COVID PCR.  Provider d/c note below:  "74-year-old male with a history of chronic obstructive pulmonary disease on chronic home oxygen (2L), hypertrophic cardiomyopathy with EF 55%, type 2 diabetes, hypertension, BPH, gout who presented to the emergency department with shortness of breath for the previous 3 days associated with worsening cough and white sputum production.  In the emergency department, patient appeared to be in respiratory distress, wheezing was noted on physical exam, he was not noted to be hypoxic at that time.  He was placed on CPAP with improvement of symptomatology, he was transferred to Hospital for further evaluation.  COVID test was ordered, and he was positive.  He was started on remdesivir, Decadron, and Lovenox, his home inhalers were otherwise continued.   During hospitalization, patient's symptoms continue to improve with steroids and remdesivir.  Apart from intermittent CPAP at night, patient was otherwise on no more than 3 L of oxygen during his stay.  He was restarted on his azithromycin, as this appears to have been a home medication longer-term.  On day of discharge, patient was walking around comfortably on his home oxygen.  Patient felt comfortable going home.  Physical therapy recommended home with assist.  He will be discharged home in stable medical condition"
Pt came to office today 4/27/2010 for follow up of (L) upper arm cellulitis from PNEUMOVAX injection. Treated with Azithromycin 250 mg (Z Pak). Reaction 10-12cm area.
Patient reported neck pain, chest tighness approximately 15 minutes after receiving second COVID-19 vaccine (Moderna) dose. VS stable BP 146/95, HR 70, O2 sats 99%. Referred to ED staff/provider (physically located in same building) for further evaluation and management due to complaints of neck and chest pain. Walked with patient over to ED location and ED nurse assumed care for patient.
significant nausea and abdominal pain, that lasted 3 days, followed by severe severe headaches making me feel unable to think and nearly cried on days 6-12,  headaches sometimes still occur, also odd bruise to right size of chin that is not improving, about the size of a quarter.
CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever and chills was not reported. This report was non-serious.
Patient was administered the vaccine at approx 3:30pm. She then waited in the immediate vicinity for 30 minutes due to an anaphylactic reaction to shellfish in the past.  She felt fine and went grocery shopping after the 30 minute wait. Shortly after 4:30pm pt. was in the check out lane and began feeling light headed.  She sat down and store staff immediately phoned 911.  Pharmacist was notified and went to the scene. Patient was conscious, coherent, pale, cool and clammy feeling, with normal respiration.  She had a strong pulse, BP 110/64. EMS arrived within 10 minutes and took over. Blood sugar was checked as patient stated she had not eaten since earlier that morning - it was 127.  EMT told pharmacist that the patient refused further medical treatment and was released from their care.
Pfizer-BioNTech COVID-19 Vaccine EUA. Sweating, lightheaded
PATIENT TESTED POSITIVE FOR COVID-19 ON 8/27/2021; EXPIRED ON 10/3/2021
Mom notice bump 02/22/10 and swollen on leg as well redness. On the R thigh.
Pt. reports 2 hr. after administration fever at 102 F and chills, whole body ache, swelling, soreness, redness at site of administration which continued for one week. Then resolved.
LIGHT-HEADEDNESS; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced light-headedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light-headedness. This report was non-serious.
Patients INR was elevated after vaccine. Only change in diet/treatment. Patient had fist dose on 3.1.21 patient returned to office on 3.1.21 and had an elevated INR reading. Could be related also could not.
Staring spells, stopped talking, stopped pointing diarrhea, allergic shiners.
Info has been received from a physician's office employee concerning an adult male who on 10/30/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #6075M-invalid). On approx 10/30/2002 the pt developed swelling, redness, and soreness on the arm where he received the shot. The pt sought unspecified medical attention. It was also reported that another adult male pt had a similar experience (WAES #0306USA02770). Additional info has been requested.
Patient has shortness of breath the evening after receiving FLUZONE HD. She considered ER visit, but s/s subsided < 24 hrs.
patient received the diluent portion of Menveo without reconstitution; patient received the diluent portion of Menveo without reconstitution; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA911A, expiry date 31-MAR-2024) for prophylaxis.   On 14-SEP-2023, the patient received Menveo. On 14-SEP-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received the diluent portion of Menveo without reconstitution) and inappropriate dose of vaccine administered (Verbatim: patient received the diluent portion of Menveo without reconstitution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-SEP-2023 The pharmacist called in to request information about how to proceed after a patient received the diluent portion of Menveo without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (death, medically significant), outcome "fatal", described as "8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions". The patient underwent the following laboratory tests and procedures: oxygen saturation: ranged 60-80%. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200376657 same reporter/drug, different event with similar event. Reported Cause(s) of Death: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions.
This is a spontaneous report from a contactable nurse who reported for a patient. A 69-year-old female patient received PREVNAR 13 (lot # G98134, expiration date: FEB2015) intramuscularly on 08NOV2013 DTP on an unknown date.  Relevant medical history included reflux disease, hyperlipidemia and anxiety, all  since an unknown date. Relevant concomitant medication included ATIVAN, CRESTOR, nortriptyline, and NEXIUM; all at an unknown dose and frequency since an unknown date for an unknown indication. It was reported that the patient had extreme diaphoresis, hypotension, and nausea; all since an unknown date in NOV2013. Relevant laboratory data was none. Therapeutic measures taken in response to the events were unknown. Patient was recovered from the reported events on an unknown date in NOV2013.  Follow-up (09JAN2014): Follow-up attempts completed. No further information expected.
Information has been received from a medical assistant concerning a female who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot# 667995/1150Z, expiration date on 4-MAR-2012). Subsequently the patient experienced cellulitis and fever after administration of PNEUMOVAX 23 may have been hospitalized for two days (name of hospital was unknown). The patient was treated with antibiotics. She did not have the patient's chart so she could not provide patient specific information. She was requesting a lot check. A lot check has been initiated. The health care professional contacted during telephone follow up could not supply the following information: patient name, date of birth, date of vaccination, date of event, recovery, status, and hospital name. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. This is one of several reports received from the same source. Additional information has been requested.
Within a couple of hours patient had a headache and swelling at the injection site. The following day a rash developed on her torso with itching.
Acute onset (R) shoulder pain describes as "burning" from (R) neck to (R) forearm. (R) upper arm muscle weakness. Pain aggravated by movement. Occurring over 3d & persisting x 3.5 wks. (R) upper arm strength & pain improving since Aug 15, 2012. Tx: SKELAXIN 800mg QID PRN. Ibuprofen 600-800mg PRN. (R) arm exercises.
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 7/2/2022 CANCER METASTATIC TO UNSPECIFIED LUNG  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/2/2022 CANCER METASTATIC TO UNSPECIFIED LUNG  HYPOXIA 6/26/2022 CANCER METASTATIC TO UNSPECIFIED LUNG  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 7/2/2022 ABNL WEIGHT LOSS  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/2/2022 ABNL WEIGHT LOSS  HYPOXIA 6/26/2022 ABNL WEIGHT LOSS  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 7/2/2022 ABDOMINAL PAIN  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/2/2022 ABDOMINAL PAIN  HYPOXIA 6/26/2022 ABDOMINAL PAIN  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 7/2/2022 CANCER PAIN MGMT  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/2/2022 CANCER PAIN MGMT  HYPOXIA 6/26/2022 CANCER PAIN MGMT  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 7/2/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/2/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE  HYPOXIA 6/26/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE  ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 7/2/2022 ABNL WEIGHT LOSS  ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/2/2022 ABNL WEIGHT LOSS  HYPOXIA 6/26/2022 ABNL WEIGHT LOSS
Hard knot behind left ear, and down neck; pain; swelling left neck in front of and behind ear and lower neck; pain in left jaw; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, in right arm on 12Feb2021 12:30 (at the age of 72 years old) (Lot Number: EN6201) as dose 2, single for COVID-19 immunisation. Medical history included hyperthyroid. Patient did not receive any other vaccine in four weeks. Patient was not tested covid prior vaccination. Known allergies was NSAIDS. Concomitant medications included levothyroxine sodium (SYNTHROID). Patient historical vaccine included received first dose of bnt162b2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration in arm right (at the age of 72-years-old) on 22Jan2021 12:45PM (Lot number: El1283) as dose 1, single for COVID-19 immunisation. On 12Feb2021 at 12:50 the patient reported that "About 20 minutes after the injection had pain and swelling left neck in front of and behind ear and lower neck, pain in left jaw. Hard knot behind left ear, and down neck. Painful when touched. Patient was not tested covid post vaccination. No therapeutic measures were taken as a result of events. The outcome of the events was resolved on an unspecified date in 2021.   Follow-up attempts completed. No further information expected.
I found a rash on my upper body next morning (chest, arms, some on back) with minor itching.  Called Dr. office who recommended Allegra in am and continue my Clarinex in pm.  Rash got better next day but itching increased.  Rash is gone today but still has itching.
shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced HERPES ZOSTER (shingles) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (shingles) 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  No concomitant medication reported.  The patient was taking valacyclovir, gabapentin and hydrocodone for the treatment of shingles.
While giving a Pfizer Covid vaccine today, a patient appeared to be fine but after a few minutes suddenly passed out and had a short 3-4 second seizure on the ground. He did hit his head and appeared to be hypoxic. We called 911 immediately and informed store management. The paramedics asked him to walk off on his own power, but they did offer to escort the family to Hospital which I believe was accepted. His mother and sister were present too.
4-5 hours after vaccine - slight nausea  8-10 hours after vaccine - heavy head/headache/slightly feverish 18-24 + hours after vaccine - headache/feverish/weak body/pain at injection site
On day 5 I began to have pain in my lungs, later my head started hurting and my lungs got tighter.  I took a nap and woke feeling the same.  I was very tired and slept for 12 hours that night.  Next morning, day 6, a rash began on my chest and spread throughout the day, until it covered my entire torso and both arms.  I took benadryl that night and by day 7, the rash began to subside leaving me very itchy for another day.
My office note 5/2/19: Had Shingrix  7 days ago - no local reaction. That night had belching. 6 days ago had nausea - did not eat breakfast. Felt hot and cold - left work. Then developed nausea, vomiting, and diarrhea with hives which started in groin, then abdomen, arms and legs. Took diphenhydramine and put oregano oil on feet. Hives resolved within hours and nausea and vomiting resolved also. OK until 2 days ago - at 1 pm had sudden severe diarrhea, then recurrent vomiting. Developed itching of hands, felt hot and cold, then recurrent urticaria on legs, trunk, arms, and face. Seen in ER, had labs. Got IV steroid, ondansetron, oral diphenhydramine. Hives and facial swelling cleared within hours and nausea and vomiting resolved.  No shortness of breath, dysphagia,  or stridor. Took prednisone 50 mg yesterday and today. Now feels back to normal - no further urticaria.
Patient returned to ED after recieved Td. Complaints of right arm pain, spasms, and fever.
Vasovagal Syncope  (vagal nerve hypersensitivity) weakness in legs, nausea, passing out when having bowel movement.