chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Medium, Systemic: Fever-Severe, Systemic: LIPS TURNED BLUE-Mild, Systemic: Shakiness-Medium, Additional Details: STARTED ABOUT 6 HOURS AFTER THE VACCINE AND LASTED THROUGH THE NIGHT AND STARTED DECREASING THE NEXT DAY
Information has been received from a cardiologist concerning a 15 year old female with no reported medical history who on 15-NOV-2007 was vaccinated with her first dose GARDASIL (lot number, route and site of administration not reported) and tolerated it well. On 29-JAN-2008 she received her second dose of GARDASIL intramuscularly into the upper arm (lot number not reported). Concomitant suspect therapy included REVAXIS intramuscularly on the same (lot number and site of administration not reported), and a third dose of ENGERIX-B (lot number, route and site of administration not reported) 29-JAN-2008. Other concomitant therapy included cortisone. On 29-JAN-2008 the patient experienced a memory disturbance shortly after the vaccination which lasted a short time. On 22-FEB-2008 the patient developed a rash at the site of injection. On 25-FEB-2008 the patient complained of arthritis with hot a swollen joints. The symptoms improved with treatment of cortisone. Rheumatism and mononucleosis and sarcoidosis were excluded. On 25-FEB-2008 the patient's serum C-reactive proteins were increased to 28 mg/dl (normal range is <0, 6 mg/dl). Under treatment with cortisone the patient developed generalised exanthema. At the time of reporting the symptoms were still ongoing. Arthritis, injection site rash, generalised exanthema, and memory disturbance were considered to be an other important medical events. This case has been upgraded to serious. Other business partner numbers included E200802351. No further information is available.
Painful and swollen lymph nodes; Painful and swollen lymph nodes; Headache; Vivid dreams; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: EN6203), dose 2 via an unspecified route of administration, administered in arm left on 26Feb2021 12:15 at age of 30 years old as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included thyroid nodules. The patient's concomitant medications were none. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. There was no covid tested post vaccination. The patient previously took first dose of bnt162b2 (lot number: EM9809) on 05Feb2021 11:15 in left arm for Covid-19 immunization. The patient experienced painful and swollen lymph nodes on left side, vivid dreams, headache, all on 27Feb2021 07:00. No treatment was received for adverse events. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Patient states that she developed redness, swelling and a pustular head at the site of her last HPV9 injection, which was on August 6, 2018. Since that times she has had a tender lump at the site. Over the last month she noticed that it is grown, swollen, developed a pustular head. About a week ago she noticed that it has opened and was draining purulent fluid. Draining has since stopped and her skin is now soft and non-tender.
experienced great pain in her neck and head; experienced great pain in her neck and head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN taken for hypertension.  The following information was reported: NECK PAIN (non-serious), HEADACHE (non-serious) all with onset 14May2021, outcome "recovered" (May2021) and all described as "experienced great pain in her neck and head".  Additional information: It was reported that, Caller mentioned that she received her 1st dose of the vaccine on 14May2021 and experienced great pain in her neck and head but was over that now. She was asking when she could take her hypertension medications again, if she could take it normally or at another time. She was taking Olmesartan 40 mg and a Combination pill with 37 mg of medication and a water pill. She does not know the name of the pill with 2 medicines in it. She does not have the other dosage for the pill with 2 medicines in it. She'd have to look through her paperwork to get that information. She was reading the Olmesartan from a pharmacy bottle and the print is difficult to see. This report was not related to a study or program. It was reported that patient received other products. She declines to file safety report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.) and NO ADVERSE EVENT (No adverse event) in an adult male patient 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 11-Jan-2023, 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 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again.).    This case contains information for the 47th of 100 adult male patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  Nurse reported that an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again. The 100 adult male patients were involved.  Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
tested positive for COVID; fever 102; chills; body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for COVID), PYREXIA (fever 102), CHILLS (chills) and MYALGIA (body aches) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced COVID-19 (tested positive for COVID), PYREXIA (fever 102), CHILLS (chills) and MYALGIA (body aches). At the time of the report, COVID-19 (tested positive for COVID), PYREXIA (fever 102), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 102 (High) 102. On 12-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. The patient received antibody treatment on 16-Apr-2021.
Patient's age was different than actual age. Patient was 11 during time of shot but had stated that her age was 12.
4 year boy with mother. Had vaccine - kinrix to Lt Deltoid area, IM, 0.5mL, on 6/8/21.  And MMRV - Rt deltoid same time.  Next day (D1) - had temp 100F, and vomited X1. Had Tylenol and was ok. Following day (D2- 6/10) - swelling at local site and redness, mom gave Tylenol, which helped him. Today- D3- area of redness, near 4X5 cm, lt deltoid area, no swelling/no pain/tender. No fever. He continued to use hand with no issues. no issues on Rt arm. He is alert and playful. Rest of systemic exam-N
Rash to right thigh about site of administration, fever on day 1, no further fever, no treatment other than clinical monitoring.
Initial unsolicited report received from a consumer (Patient's daughter) via other company (Pfizer) on 30 December 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA vaccine (batch number, route and site of administration were not reported) and also received a dose of PREVNAR 13, manufacturer: Pfizer (batch number, route and site of administration were not reported) (on same day) on an unspecified date in the 'last month'. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced double pneumonia, water around his heart, kidney failure, had been sick for over 30 days. It was reported that, the patient was hospitalized since he experienced the adverse events. Laboratory data and corrective treatment were not reported. The patient was not recovered from the events. List of documents held by sender: none.
Pt. states 06/14/2021 started feeling nauseous, fatigued, and sever vomiting.  06/14/2021 Online visit with primary, advised use Zofran, rest. Subsided with 3 days. 06/25/2021 started feeling unwell again, nauseous and fatigued. Online visit 06/28/2021 prescribed more Zofran and rest.
Severe pain in low back unable to move, muscular weakness, bradycardia. It started Monday June 7 of the vaccine with physical exhaustion since the afternoon, in the evening my low back hurt a lot on the right side, the next day it was very difficult to walk, Wednesday I went to urgent care as I could no longer walk nor standup. They injected ketorolac and dexamethasone. They sent me prescriptions of diclofenac, tizadine, and prednisone. Of which did not have any effect, I could not move until the next Monday the following week, with a lot of pain. Monday they did an ultrasound and found strong inflammation English ganglions and armpits. I am still in studies and in slow recovery.
Right Shoulder pain ranging from moderate to severe.  Right shoulder weakness and inability to abduct or flex shoulder.  Seen in ER.  Treated with motrin and percocet.  Seen by neurologist on 11/30 and diagnosed with Brachial Neuritis. 12/03/09 PCP records received for DOS 11/20/09 (Work physical). Received Tdap and flu vaccine. 12/09/09 Neurology records received for DOS 11/30/09. Pt. presented c/o pain and weakness in right upper extremity; onset 3 days post vaccination. Physical therapy recommended. DX: Post vaccinal brachial neuritis
Breakthrough bleeding while on birth control; Daughter also had swollen lymph nodes, under her arm; Exposure to Sars-CoV-2 at work; This is a spontaneous report from a contactable consumer (patient mother). A female patient of an age 27 (unspecified age units) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Patient concomitant medications included unspecified birth control pills; start date and stop date were not reported. This report was not related to a study or programme. Reason for no lot number of Covid-19 vaccine was stated as Caller unwilling to complete the report. The patient experienced breakthrough bleeding while on birth control, also had swollen lymph nodes, under her arm, exposure to sars-cov-2 at work on an unspecified date. Caller reported that patient received the Pfizer-Biontech Covid19 vaccine. Then, 2 weeks afterward, she had breakthrough bleeding, even though she was taking birth control pills. Daughter also had swollen lymph nodes, under her arm. In response, reporter was informed that no information was available from the clinical trials regarding effects on menstruation. Lymphadenopathy was a commonly reported AE. Caller reports that patient was a pharmacist and fully vaccinated with the Pfizer-Biontech Covid19 vaccine, recently had an exposure to Sars-CoV-2 at work. All the technicians that she worked with got Sars-CoV-2, and since she was vaccinated, she did not get it. Caller stated that was good news, it must work. In response, provided efficacy data from the fact sheet. Caller stated that patient had both doses of the Covid-19 vaccine. And was on birth control and experienced breakthrough bleeding, swollen lymph nodes. When caller was asked if she would be willing to complete a safety report on the patient, the caller replied that it was up to the patient to report her experience. Caller reported that the patient was a pharmacist, and she did not want to impede on her privacy. Caller reported that the patient went to the doctor for the lymph node thing and the patient's physician instructed the patient to just put a warm compress on her lymph nodes and that the swelling was just from irritation. Caller reported that her physician when told of the patients swollen lymph nodes said, "no we are seeing that". The events were reported as not serious. Clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I had lower right leg pain. I could not wake up stairs or do normal actives. I could not wake very well. I went to the Emergency Room (Hospital). They just did a physical exam. They think it is tendonitis. It is slowly getting better.
shortness of breath and rapid heart rate that would not resolve in greater than 20 minutes of observing and oxygen
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's current conditions or medical history were reported. On 08-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX vial, 0.65 ml subcutaneous injection (lot number and expiration date not reported) that underwent a temperature excursion. No adverse effect reported. Additional information is not expected as the reporter did not wanted follow up contact.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 12-MAR-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted herpes zoster. On or about 31-JUL-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as zoster dermatitis. The patient has been prescribed VALTREX and prednisone for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
14DEC91 AM lt arm @ inject site very tender, swollen; 9PM lg flat itchy welts esp on lt shoulder & shoulder blade but scattered over body; t99; treated w/DPH;
patient experienced nausea, sweating, paleness immediately after injection. shortly afterward he had tingling in arms and legs. blood pressure 108/73 pulse 56, after about 5 minutes blood pressure 123/74 pulse 72, given ice pack on back of neck, apple juice, monitored for 30 plus minutes, released to parent after symptoms resolved
fever 102 degrees, chills, sweats, nausea and vomiting, swollen red vaccination site 10 cm across
patient reports left arm itching/rash/raised area at injection site. Patient reports axillary lymph nodes swollen that started at 6am this morning 1/21/2021
Woke up with swelling of upper lip Friday morning, 3 days after receiving shot. Also experiencing fatigue and headsches.
Mom reported 3/4 hives appeared on trunk and SOB on 2/28/03. Did not treat but advised to come to office; unable to on 3/4/03 but wanted to see MD on 3/5/03. Appt. scheduled; no hives present, no SOB and no swelling on 3/5/03.
Vomiting, bloody diarrhea x 1, lethargy.  9/30/08 Reviewed hospital medical records of 8/24-8/29/08. FINAL DX: ileocolic intussusception, exp lap w/attempted manual reduction; resection of distal ileum & right colon with primary anastomosis. Records reveal patient experienced vomiting, diarrhea & lethargy.  Initially admitted for IV hydration.  Surgical consult done.  8/29/08 Reviewed partial medical records for 8/24/08 admit as patient remains hospitalized at this time. FINAL DX: Records reveal patient seen in out of state hospital due to vomiting & diarrhea after found playing with bottle of alcohol sanitizer although it did not appear that he had swallowed any. Symptoms began approx 2.5 hours after incident.  Became lethargic while hospitalized for observation & continued w/vomiting & diarrhea, occasionally blood tinged.  Surgery consult obtained & initially dx w/severe gastroenteritis.  When enema (+) for IS & unable to reduce, taken to OR for exploratory lap w/attempted manual reduction os IS & then resection of distal ileum & right colon w/primary anastomosis.
given pfizer vaccine on 10/26/21 in the evening. within a couple of hours developed shortness of breath and chest tightness like an asthma exacerbation. called her office on 10/27/21.
Her left arm as very week needing help from other arm to use it in the morning.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Her left arm as very week needing help from other arm to use it in the morning.) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20a and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Her left arm as very week needing help from other arm to use it in the morning.). At the time of the report, MUSCULAR WEAKNESS (Her left arm as very week needing help from other arm to use it in the morning.) outcome was unknown.            No concomitant medications were provided. No treatments were provided.
Red at injection site; Arm is swollen at injection site; Arm itches like crazy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE SWELLING (Arm is swollen at injection site) and INJECTION SITE PRURITUS (Arm itches like crazy at injection site) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DOXYCYCLINE HYDROCHLORIDE (DOXICYCLINE [DOXYCYCLINE HYDROCHLORIDE]), AZITHROMYCIN and EUCALYPTUS GLOBULUS OIL, MENTHOL, PROPYLENE GLYCOL (ICE COOL GEL) for an unknown indication.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE SWELLING (Arm is swollen at injection site) and INJECTION SITE PRURITUS (Arm itches like crazy at injection site). At the time of the report, INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE SWELLING (Arm is swollen at injection site) and INJECTION SITE PRURITUS (Arm itches like crazy at injection site) outcome was unknown.            No treatment medication was reported.
Pt recvd measles vax on 22AUG91 & the following day pt exp h/a which lasted for 2 to 3 days; No further details were provided;
hives; A spontaneous report was received from a consumer, concerning a Male of 64 years age, who received Moderna's COVID-19 vaccine and experienced  the hives after taking the vaccine. The patient's medical history was not provided. Concomitant product use was provided by the reporter that metformin has taken and received treatment 10mg steroid orally and then IM On 4jan2021 date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown)  to the Left arm via IM route for COVID-19 infection prophylaxis. And later 2 days after vaccination  started getting hives and lasted the whole weeks, big patches from 6 to 12Jan2021 Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, Hives was considered to be  resolved at the time of this report.
The young man that received the J&J vaccine was not 18. He was 17 years, 11 months and 19 days old. He was 12 days away from being 18 at the time of vaccination. Notified young man via phone, On Follow up he reports that he is doing fine. Is just "sore" but doesn't know if that was related to the J&J vaccine or the start of his College football practice/season. Denies concerns.
Chills, body ache, fever for approximately 30 hours beginning at 5PM the day of the shot  and ending around 9PM the following day No treatment was necessary
Vertigo while exercising (yoga) became apparent 10/2.  Spinning while looking down or up or any quick movement.  Not severe but persistent through today.  I have had vertigo before, approximately 8 years ago and very infrequently since then, maybe 2 or 3 times.
Pt was given 0.5 ml FLUZONE, but is only 2 yrs old and only required 0.25 ml.