chrisvoncsefalvay/vaers-outcomes huggingface dataset:
other zoster related injuries; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 24-MAY-2017, the pt was administered zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions, by a healthcare provider. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician and other healthcare providers for shingles and other zoster related injuries. At the time of the report, the outcome of the events of shingles and other zoster-related injuries was unknown. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).
10 days after injection, chronic urticaria. For date... one year, 8 mo.
A non-serious spontaneous report of fever has been received from a consumer in the United States concerning a four year-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Medical history and concomitant medications were not reported. On 17 Aug 2009 at 9:30 am, the patient received FluMist. At the time of reporting on 17 Aug 2009, the patient had a fever of 102.2. The outcome of the event was not reported.
Single 0.65 ml dose of SQ ZOSTAVAX given in (L) arm. Vaccine completed, patient reported feeling nauseated and dizzy. Provider had patient remain seated with daughter. Daughter left to get cold drink, patient fell down to floor. Provider roused patient to consciousness, had pt. remain lying down, 911 called. Minor abrasions bandaged, pulse taken.
This report is related to a deviation from recommended CDC COVID vaccine dosing guidelines; the patient has not suffered any adverse events as of the time of this report.  The patient received her first dose of Pfizer on 12/12/2021. She did not receive the second dose in her primary Pfizer series. The mother of the child requested that the patient receive Moderna today and restart her primary series with Moderna rather than Pfizer, as Moderna has higher efficacy and was not available for her child's age group at the time of her first vaccination. She is making this request due to a desire for the increased efficacy of Moderna compared to Pfizer.  Discussed with medical director, decision made to allow mother of child to restart patient's primary series with Moderna. Discussed with mother of child that this is a deviation from the CDC recommendations and, as a result, there is limited data on effectiveness or risks when changing from the standard schedule. Mother of child acknowledges the above, and decides to proceed with Moderna vaccination today.
Less than 24 hours after 2nd shot extreme itching.  From then to now left elbow very hard to bend without extreme pain.  Have a hard time holding items now.
red welts about an inch near injection location; itching; sorenes, and achiness; muscle ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (red welts about an inch near injection location), PRURITUS (itching), PAIN (sorenes, and achiness), MYALGIA (muscle ache) and FATIGUE (fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (red welts about an inch near injection location), PRURITUS (itching), PAIN (sorenes, and achiness), MYALGIA (muscle ache) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE REACTION (red welts about an inch near injection location), PRURITUS (itching), PAIN (sorenes, and achiness), MYALGIA (muscle ache) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO concomitant medications provided by the reporter. Treatment medication includes Tylenol.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Outcome of events updated.
This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent condutions, drug reactions, allergies and concomitant medications were not reported. On 29-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On 30-JAN-2019, the patient was vaccinated with the second dose of GARDASIL 9, longer than the recommended scheduling (inappropriate schedule of product administration). No adverse effects were reported.
Both vaccines have caused severe pain in elbows all around the elbow. Where it hurts to lift them at all.; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for himself. A 56-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at Right arm on 23Dec2020 10:30 at single dose, then received the second dose of BNT162B2 (lot number: EL1284), via an unspecified route of administration at Right arm on 13Jan2021 at single dose, both for covid-19 immunization. The COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. Medical history included Epilepsy, Heart disease, quad bypass. The patient's concomitant therapy reported as Yes (patient received other medications in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced both vaccines have caused severe pain in elbows all around the elbow, where it hurts to lift them at all on 14Dec2020 16:00. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: unknown results on 13Jan2021. The outcome of the event was not recovered.
48 hours - Fever. Sore leg - couple weeks. Inconsolable crying - 24 hours. Personality change - ongoing (never cried or fussed before, is unhappy a lot of the time now).
Passed out; Felt weak; Sweaty; Could not walk; Arm still sore at the left arm injection site; A spontaneous report was received from a consumer, who was an 80-year-old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out, felt weak, sweaty, couldn't walk, and arm still sore at the left arm injection site.   The patient's medical history was not provided. Concomitant product use was not reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient woke up real sweaty at 3 am. She got up and went to the bathroom and passed out. The patient reported that she fell on the commode then got to the floor because she felt weak and could not walk. Once she regained her strength, she returned to bed.   On 07 Jan 2021, the patient reported that her arm was still sore at the injection site and continued to feel weak. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The events, passed out, sweaty, and couldn't walk were considered resolved on 06 Jan 2021. The outcome of the events, felt weak and arm still sore at the left arm injection site, were considered not resolved.; Reporter's Comments: This case concerns an 80-year-old female patient  with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of Loss of consciousness, the non-serious listed event of Injection site pain, and the non-serious unlisted events of Asthenia, Hyperhidrosis, and Gait disturbance.  Based on the current available information and temporal association between the use of the product and the onset of the events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
This case was received on 27 May 2011 from MILVAX under MILVAX tracking number FDA-15 (No VAERS). A male patient in his twenties had received in 2011 a ACAM2000 (lot number and exact date of administration not reported), and 11 days post vaccination presented to the ER (emergency room) with mild upper chest pain for two days, especially with deep breath. On examination he was found to have shortness of breath, some coughing and body temperature changes. He was hospitalized for two days (dates not reported). Laboratory and diagnostic findings included: EKG, CXR (chest x-ray) and chest CT negative; elevated enzymes; elevated Troponin I (11 days post vaccination 0.44 and 12 days post vaccination 0.58); Fibrin D-dimer (12 days post vaccination 0.62 (0.00-0.59). Treatment medications included: ZOFRAN, TORADOL, ASA, Nitropaste, LOVENOX and MOTRIN. The patient's chest pain resolved and was diagnosed with myocarditis or pericarditis. The patient was released without limitations. Note: Although the manufacturer was not reported in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.
I had no reaction to vaccine. I just got CVID-19 about two months after my vaccination. I was tired and felt like I had a cold. I had chest congestion and in the head. It was more upper respiratory. Like a typical cold. I spent the next day in bed because of the tiredness. I took a home test and tested positive on 12/29/2022. I called my medical provider and they recommended we take PAXLOVID. Within 24 hours I felt much better. I'm feeling fine now.
My arm was sore for approximately a month. I could not sleep on it, it was so sore it would wake me up. I believe that this was due to me being a breast cancer survivor and had lymph nodes removed in 2005. I mentioned the lasting pain to the nurse during my second shot and why I thought my arm was still sore and she agreed.
SKIN CHANGES ON BILATERAL UPPER ARMS AND CHEST.  LIGHTENING OF SKIN IN CIRCLES. FEVER,SORE ARM,MUSCLE ACHES
Arthritis pain in various joints, severe, much of the time, over the past year. More severe for the past 5 months. Also, numbness and tingling, especially in hands and arms. Presently taking Celebrex.
Within 3 hours: lethargy, refusing to drink or eat, tired. Not playful. Then next day all day Saturday temp of 102+, Motrin and Tylenol given. Back of throat tonsils are HUGE, pt not eating or drinking well. swollen throat. No energy, sleeping often. Sunday same symptoms, slight improvement in energy however tonsils still huge, I am afraid of narrowed airway therefore seeing doctor today at 11am.
pt recvd vax 29JUN93 & JUL93 mom noticed that daughter was losing hair; mom reported that pt hair was much thinner & estimated that process was ongoing for about 1 to 2 months; MD felt pt's condition may have been telogen effluvium;
I developed shortness of breath when I was walking. On Memorial Day it became severe. I went to the emergency department; I was admitted to the hospital with acute sandal embolism. During the admission at Hospital, I was treated with heparin and an ultrasound showed clot in my right leg. I was treated with 4-5 days with heparin. I was discharged on anti clotting medication. I failed outpatient treatment. I developed another clot a month later in my right leg again.  About a month later I was in the hospital again, I was continuing to have discomforted in my right leg. I had another ultrasound they found a new clot the others had resolved. I was treated again with heparin for 4-5 days. I was discharged 3 weeks ago. I was discharged on lovenox and I am still currently taking. They are trying to get me stabilized on warfarin. I also had an IVC filter this last admission as well.
Within 12 hours of administration I had nausea, fatigue, and body aches; afebrile. Within 36 hours of administration I had pleuritic chest pain (sharp in character, substernal; worse with respiration, coughing, and supine position). The pleuritic chest pain was relieved partially with aspirin 325 mg and Ibuprofen 600 mg and upright, leaning forward position. Pericarditis highly suspected and self-treated with Ibuprofen 600 mg BID. Symptoms improved by 10/27/17 by 2:00 pm, however, NSAIDs were continued and symptoms continued to resolve.
24 hrs p/vax pt devel pimples appeared then large red, hot, painful area; 48 hrs p/placed on DPH, 72 hrs later swelling worse (CBC nl);
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 13:30 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes; "Rhinitis" (unspecified if ongoing), notes: Non-allergic rhinitis. Concomitant medication(s) included: CETIRIZINE; DIPHENHYDRAMINE; FLUNISOLIDE. The following information was reported: MYALGIA (non-serious) with onset 13Apr2021, outcome "recovering", described as "Myalgia"; HEADACHE (non-serious) with onset 13Apr2021, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 13Apr2021, outcome "recovering", described as "Tiredness"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 13Apr2021 13:30, outcome "unknown" and all described as "My nursing 8 month old infant developed symptoms of Upper Respiratory disease (nasal discharge, cough) the evening of the date I received my first dose". Therapeutic measures were not taken as a result of myalgia, headache, fatigue. Additional Information: Patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202101083251 maternal/child.
Patient developed paroxysmal atrial fibrillation. Upon date of death- pt husband reported SOB, incontinence, gasping for air, slumped forward and died upon 911 arrival.
Client stated that approximately 45 minutes after leaving the office, her neck started to get itchy.  When she got home and looked in the mirror her neck was beet red, rashy and itchy. Client stated it was very itchy. Client stated that at about 8pm she took Benadryl and again at midnight. Client stated that the Benadryl helped with itchiness. The next morning (4/27/2021) the itchiness and redness was gone. Client stated that were the rash was her skin is really dry.
Fever,  chills, body aches,  swollen glands under arms neck and head then a rash on front of legs that burned
Had one episode of severe shortness of breath while taking hot shower next morning; hands also went completely numb; Swelling at injection sight; severe bruising; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 27Mar2021 at 15:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient had no know allergies. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 10:00 the patient experienced swelling at injection sight, severe bruising, had one episode of severe shortness of breath while taking hot shower next morning and hands also went completely numb. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling at injection sight, severe bruising, had one episode of severe shortness of breath while taking hot shower next morning and hands also went completely numb was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: ew0172) and as dose 3 (booster), single (Lot number: en6200) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive; Negative, notes: negative test on the day previously. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient did not received any other medication in 2weeks. The patient received COVID 19 Treatment, (Paxlovid) from 06Jun2022 to 11Jun2022 for the treatment of COVID-19. Patient tested positive and symptoms returned after a negative test on the day previously.  No follow-up attempts are possible. No further information is expected.
Terrible headache, then started running fever for the past 2 days at night which I missed 2 days of work.  With my first dose in January I got a headache but nothing like this one, and with the  second dose nothing happened,  With this booster it was much worse headache started about 20 minutes after getting the injection and then the fever started that night, I am starting to feel better today so I think it may be over, but was not expecting this to happen at all.
About 9 pm on day of vaccine started feeling nauseous with some muscular aches. Increasingly more uncomfortable and By 9:45 began vomiting, accompanied by chills, sweats, weakness, headache, neck ache and severe muscular pain all over as well as joint pain. These conditions persisted fit about an hour. Once my stomach emptied I had no further vomiting but all other conditions persisted throughout the night. Next morning still nauseous and severe head and neck pain. Called my dr who said I could take Tylenol. Did so at 11 am. Helped head and neck pain a bit and allowed me to sleep most of day. Still very weak with muscle aches . Only tea and some pieces of bread to eat. Next day 2/19 took third dose Tylenol. Still confined to bed, slight headache, extreme fatigue and muscle aches. Still no appetite so sipping water and tea.
This spontaneous report as received from a female patient of unknown age, reporting on herself. On an unknown date the patient was vaccinated with GARDASIL dose 1 and 2 (route, dosage, and lot number unknown). The patient explained that she is currently 1 week past her recommended date for receiving her third shot of GARDASIL. The patient was unsure of the specific dates that she received her first and second doses. No adverse event reported. Additional information has been requested.
Per EMS,  patient stated he was light-headed. HR 46, BP 90/48, SPO2 93%, pale and diaphoretic at initial assessment, 5-lead EKG all sinus rhythm. Patient rested in his own car, reassessed in 15 minutes. BP 130/80, HR 68, SPO2 100%, color WNL. He declined transportation. EMS recommended followup with his primary doctor.
Telephone call from client's mother stating around 5:00 PM the evening of the receipt of the vaccine the child began to cry and c/o his arm hurting. This was during the mother's physician visit, and upon returning to their home, she took the child's temperature. Temperature at 6:30 PM was 103 F. At this time, the child was crying more intensely and c/o left arm pain. Child also c/o headache and dizziness. Mother states his c/o of arm pain was unusually painful the night of the vaccine. This continued throughout the evening; the child's pediatrician's office was closed and local Urgent Care Centers were closing. The mother took the child to the emergency room. Assessment was conducted, stated no anaphylaxis, no throat swelling, no dyspnea. Mother states the following day, January 4, 2019, the symptoms had resolved. She contacted the child's pediatrician as instructed by the ER physician. Related the events to his PMD who indicated he considered this an allergic reaction, he was making a note on the child's chart, and the child can never have the flu vaccine again. The mother had consulted the VIS and understood a temperature of 103 would be considered a severe reaction to the vaccine. States child has had flu vaccine in the past without issue.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Collapsed about 1 minute after receiving shot for about 30 seconds. Called 911 and paramedics arrived. He was able to walk out without assitance.
pt recv vax when pt 3.5wk preg & sought unspecified medical attention;pt exp preg induced HTN & no proteinuria;9/23/98 pt delivered a premature (37 wk) female baby vaginally;
24 HOURS AFTER ADMINISTRATION PATIENT DEVELOPED A FEVER AND FLU LIKE SYMPTOMS. 48 HOURS AFTER ADMINISTRATION PATIENT BEGAN TO DEVELOP RASH THAT SPREAD FROM SHOULDER TO ELBOW. SEEN IN URGENT CARE AND DIAGNOSED WITH MILD CASE OF SHINGLES.
bumpy red raised rash at the injection site; itchy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (bumpy red raised rash at the injection site) and VACCINATION SITE PRURITUS (itchy at the injection site) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was reported.     On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced RASH PAPULAR (bumpy red raised rash at the injection site) and VACCINATION SITE PRURITUS (itchy at the injection site). At the time of the report, RASH PAPULAR (bumpy red raised rash at the injection site) and VACCINATION SITE PRURITUS (itchy at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were not reported.
New onset right arm pain 3-4 weeks s/p covid injection at the site of original injection. Pain has persisted for one week and continues