chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received a booster dose in error instead of a 3rd additional dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received a booster dose in error instead of a 3rd additional dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown, Unknown and Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Received a booster dose in error instead of a 3rd additional dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Received a booster dose in error instead of a 3rd additional dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The caller reported that the patient is immunosuppressed and received dose 1and 2 at the 28 day interval and 6 months later he received a booster dose in error instead of a 3rd additional dose.  No treatment medication was reported.  No Concomitant medication was reported.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA (lot#, expiry date, dosing details, anatomical location, were unknown) for prophylaxis. Previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009095: US-009507513-1708USA009095.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted outside in parking lot, hitting her head. Attended to by EMS, vitals within normal limits and went home.
This case was reported by a physician and described the occurrence of swelling arm in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). In September 2009 the subject received unspecified dose of BOOSTRIX (unknown arm). On 29 September 2009, 8 days after vaccination with BOOSTRIX, the subject experienced swelling in her arm. The physician did not have any information about the subject only that she was vaccinated 9 days ago; and yesterday, 8 days after vaccination, the subject had swelling in her arm. The physician reported that today the subject's arm was less swollen than the day before. No further information from the physician was provided. At the time of reporting the arm swelling was improved. The physician also reported a case of injection site pain, see A0810008A.
general body aches, chills first- went to bed- then body shaking-during night had nausea, more of body issues and felt hot- took Tylenol PM-apparently passed out coming from bathroom.  took one Tylenol and one Ibuprofen. stayed in bed until late morning. tried to hydrate but probably not enough. stayed up most of day- late afternoon chills returned and temperature 100.1 - took 2 Tylenol. went to bed 8:00- woke during night sweating and nightclothes drenched. got up this morning - 02/07- feeling better- some body aches and fatigue which could be from inactivity.
red, itchy, swollen, painful arm . gave the pt ibuprofen and hydrocortisone cream
Menstrual cycle and symptoms unusual - spotting/premenstrual bleeding, full period for first time since using IUD, breast swelling and pain
Approx. 10 minutes, post vax, pt was noted to have subcutaneous swelling and itching of upper eyelids, bilateral wheezing, shortness of breath and palpebral edema. He was give epinephrine X's 2, O2 at 2 LPM and IV obtained-KVO. Transferred to hospital and admitted to Pediatrics for further treatment and observation. Given albuterol updraft X 1 and every 4 hours, if needed; IV Solu-Medrol and every 6 hours, if needed; Benadryl X 1 and po every 6 hours, if needed. Diagnosed with anaphylactic shock. Per F/U 6/4/02: EpiPen JR to be applied IM in case of recurrence of wheezing or SOB. The pt has been given 2 injection, 1 for school and 1 for home. The family has been advised not to feed him with eggs. Also, prophylactic immunization needs to be reviewed in order to prevent a similar reaction. The pt will be scheduled for echocardiogram due to heart murmur. F/U appt. on 3/24/00. Final DX: Anaphylactic reaction and heart murmur.
Initial mild pain. The pain did not subside and continued to increase for six months. NSAIDs were unsuccessful at controlling the pain. Slow improvement through physical therapy.  One year later, the pain is mild but still substantially reduced range of motion.
He is falling asleep all the time and continues to get worse, not better; He is falling asleep all the time and continues to get worse, not better; Freezing cold all the time; feeling horrible; walking feebling at times; He has lost at least 10#, and lost three inches in waist,; stomach is bloated; he shuffles his feet-like his legs are stiff; balance is worse than ever; balance is worse than ever; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Freezing cold all the time) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOTHERMIA (Freezing cold all the time) (seriousness criterion medically significant), VACCINATION COMPLICATION (feeling horrible), GAIT DISTURBANCE (walking feebling at times), WEIGHT DECREASED (He has lost at least 10#, and lost three inches in waist,), ABDOMINAL DISTENSION (stomach is bloated), MUSCULOSKELETAL STIFFNESS (he shuffles his feet-like his legs are stiff), BALANCE DISORDER (balance is worse than ever), CONDITION AGGRAVATED (balance is worse than ever), DECREASED APPETITE (no appetite), SOMNOLENCE (He is falling asleep all the time and continues to get worse, not better) and CONDITION AGGRAVATED (He is falling asleep all the time and continues to get worse, not better). At the time of the report, HYPOTHERMIA (Freezing cold all the time), VACCINATION COMPLICATION (feeling horrible), GAIT DISTURBANCE (walking feebling at times), WEIGHT DECREASED (He has lost at least 10#, and lost three inches in waist,), ABDOMINAL DISTENSION (stomach is bloated), MUSCULOSKELETAL STIFFNESS (he shuffles his feet-like his legs are stiff), BALANCE DISORDER (balance is worse than ever), CONDITION AGGRAVATED (balance is worse than ever), DECREASED APPETITE (no appetite) and CONDITION AGGRAVATED (He is falling asleep all the time and continues to get worse, not better) outcome was unknown and SOMNOLENCE (He is falling asleep all the time and continues to get worse, not better) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Stool analysis: negative negative (Negative) Stool sample was negative for blood.         No concomitant medications were reported.  Treatment information was not provided.  Very limited information regarding the events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-125899 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
injection site soreness; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular at the right arm on 16Dec2020 11:00 at single dose for Covid-19 immunization in a hospital facility. Medical history included allergies to latex. The patient has no covid prior vaccination. The patient was not pregnant. Concomitant medications was none. The patient has no other vaccine in four weeks. The patient experienced injection site soreness on unspecified date. The patient did not receive treatment due to the event. The patient was not covid tested post vaccination. The reporter considered the event non-serious; which did not result in death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating and no congenital anomaly/birth defect.  Follow-up activities are possible, information on the batch number has been requested.
Patient received modern vaccine.  Was told to wait for signs for allergic reaction. While he was waiting he became dizzy.  He tried to get up thinking he would feel better. He had signs of syncope.    Female that was accompanying tried to stop him from falling but could not hold him and fell to ground.  I was walking back from isle after helping a customer when I saw him already fallen to ground.  Female picked him up and put him on chair. I stayed with him the entire time.  He was  talking and alert. Intern had already called 911.  I put cool compress behind neck.  I asked if he felt ok. He said he was ok just nervous .He kept apologizing and seemed more embarrassed. I assured him that it happens to some people and nothing to be sorry about. His pulse was good and was talking to us the entire time. He also drank some water. EMT arrived took vitals which were all fine.  They suggested he go get  head scan since he hit his head when he fell. He agreed and walked out with EMT.
Feeling ill / Malaise; Sick in bed all day; Lot of pain that she described as flu-like; Fatigue; Sore arm; Not sleeping well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MALAISE (Feeling ill / Malaise), ILLNESS (Sick in bed all day), INFLUENZA LIKE ILLNESS (Lot of pain that she described as flu-like) and INSOMNIA (Not sleeping well) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046a21a and 029a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included MULTIVITAMINS [VITAMINS NOS], SELEGILINE (EMSAM) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Not sleeping well). On 03-Apr-2021, the patient experienced MALAISE (Feeling ill / Malaise), ILLNESS (Sick in bed all day), INFLUENZA LIKE ILLNESS (Lot of pain that she described as flu-like) and FATIGUE (Fatigue). On 03-Apr-2021, ILLNESS (Sick in bed all day) had resolved. On 04-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, MALAISE (Feeling ill / Malaise), INFLUENZA LIKE ILLNESS (Lot of pain that she described as flu-like), INSOMNIA (Not sleeping well) and FATIGUE (Fatigue) outcome was unknown. Not Provided          The patient believes the vaccine triggered her immune system to experience a fight or flight response. She states her immune system doesn't cope well with viruses. Patient states she would be hesitant to take ever take the vaccine again. Treatment details included Aspirin to cope with the pain.
Constant Ringing the the ears since the 2nd shot that has not been resolved; I had a ear hearing test which did not show nerve damage; I also developed a cough, sinus infection, fluid in right ear, very clogged sinuses and ears.  Treatment  Prednisone 20 mg tablet; Augmentine.  I could not continue these medicines because they made me so sick .  I went to Crouse Hospital ER due to anxiety and was put on Alprazolam .25 mg tablet
They discovered after they had given him the booster dose that he had not had either dose of the primary series; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (They discovered after they had given him the booster dose that he had not had either dose of the primary series) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced INCORRECT DOSE ADMINISTERED (They discovered after they had given him the booster dose that he had not had either dose of the primary series). On 05-Nov-2021, INCORRECT DOSE ADMINISTERED (They discovered after they had given him the booster dose that he had not had either dose of the primary series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  It was reported that the patient had a recent case of COVID-19 and thought that he just needed the booster.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up received contains no new information. On 13-Nov-2021: Follow-up received contains no new information.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 69 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL8982), in right arm, on 01Mar2021 as dose 2, single (Lot number: EN6202), in right arm and on 27Sep2021 as dose 3 (booster), single (Lot number: 301458A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "VACCINATION FAILURE " and "COVID-19 ".
12/29/2020 I was not able to left at all. This lasted for three days.  It is mobile after the three days.  12/30/2020 I woke up in the night, went to the bathroom, go very hot and light headed and passed out. I hit my head on the floor, I crawled to the bed. I had fever for three days there after, and felt back to normal.
death (pt was found dead in the bathroom by husband, prev to this no complaints) no tx; no evaluation post mortem, data gather from conversation w/husband
swollen tender left upper arm (site of injection) fever 103.2 degrees, malaise, body aches
Information has been received on 31-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 23-APR-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical center as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 08-AUG-2014, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. The patient was prescribed famciclovir and hydrocodone for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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.
Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) 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 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received their first dose and reported that their arm was sore.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-118436 (Patient Link).
General feelings of anxiety and malaise that lead to reoccurring hallucinations similar to a psychotropic drug experience. The anxiety and experience then manifest itself in extreme nauseau and diarrhea and leads critical of dehydration.
Patient  received Covid-19 Pfizer vaccine at nursing facility from a RPH. Patient remarked she had gotten a prior dose but did not have her CDC card indicating who the manufacturer was. Upon investigation it was confirmed by RN at facility that patient had received 1 dose of the Moderna Covid-19 Vaccine at her last facility. Patient was fine following injection to time of this report. Patient's doctor was notified and patient will not receive any more Covid-19 Vaccines.
Vaccines given at 2 PM 9/15/03. Awoke day after vaccine with severe pain left posterior chest, auscultation left posterior chest some inspiratory pleural rubs. None on right, no N/V dyspnea, skin W&D, color good. T 98.4. B/P 100/70. P 80. R 16. Advised Ibuprofen 400mg q 4 hours. Return if needed.
Bullous pemphigoid developed with months of the vaccinations. No other change in medication, diet, lotions, soaps, ointments occurred during this time. Blood tests were taken by dermatologist and diagnosis was confirmed. Prednisone and minocycline began in September after other remedies were attempted prior to the bloodwork diagnosis.  Covid vaccines were given 1/29/2021 and 2/18/2021 in upper arms.
Very tired, even now on day 3. The day after the vacinne he felt awful, but most concerning is racing heart and chest pains. On day 3 after vaccinne, chest pains continuing any time he does moderate activity and he is a young, healthy, active child that never had chest pains before
whelps all over body worse on arm where inj was given;intense itching;rx w/DPH & claritin by MD;inj given on 24SEP98;sx were gone on 26SEP98 PM;
Hypernatremia - resolved Hypokalemia - resolved Diabetes insipidus Fatigue BMP on admission shows Na 153, K 2.7 Na 144, K 4.1 11/3 Pt has documented history of diabetes insipidus- follows with Dr with endocrine, treated with DDAVP - Resume home DDAVP - Replace potassium  - Trend BMP - Pt received D5W, now stopped - Encourage PO fluid intake - Endocrine consulted - suggested DI possibly related to AML but unclear etiology - Recommend outpatient follow up with endocrinology   Pancytopenia due to chemotherapy AML Getting chemo, last treatment 10/10/22 Restart pancytopenia prophylaxis, acyclovir, diflucan, levaquin was held while inpt as pt was tx with zosyn, will restart levaquin upon discharge for 5 day course Venetoclax held in setting of pancytopenia, will defer to heme/onc when to restart   Multifocal pneumonia COVID-19 infection Suspect pneumonia likely viral due to COVID Symptoms started 10/29, tested positive on admission, SORA CXR 10/31/22 shows ill defined consolidative opacities in right hemithorax, specifically in right upper lung zone and also subtle left retrocardiac opacity Currently on vanc and zosyn (started 10/31) MRSA probe negative and blood cultures pending Sputum cultures not collected Procal elevated ID recommended supportive care at this time for COVID-19 infection as long as SORA   HTN Tachycardia-resolved Patient not on BP meds at home Patient denies pain, does not appear agitated Amlodipine 10 mg daily, coreg 6.25mg BID, hydralazine PRN while inpt Will decrease norvasc to 5mg daily, continue coreg 6.25mg BID, until pt has appointment with PCP and can manage as appropriate   GERD Resume home prilosec 40mg   History of MSSA bacteremia Pt was recently treated with IV vanc and discharged on abx outpatient, pt was supposed to have antibiotics last until 11/4 Blood cultures negative MRSA probe negative Pt completes course of vancomycin tomorrow
Information has been received from a registered nurse (RN) concerning a 14-year-old female with asthma who was vaccinated with her second dose of varicella virus vaccine live (VARIVAX) on 25-MAY-2007. Concomitant therapy included a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). On 27-MAY-2007 the patient developed a rash on her arms and legs that resembled "dried mosquito bites". The rash was itchy. Unspecified medical attention was sought. The outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Pt recv vax on 10/10/98; 12 hr post vax pt exp fever, chills, hot & cold flu sx, stomach pains