chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and a 68-year-old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-SEP-2012, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 02-MAR-2017, the patient was treated by a certified medical assistant (CMA) at a health clinic for the following injury resulting from the patient's ZOSTAVAX use: Herpes zoster. The patient claims damages including: injury to herself and economic losses. The outcome of Herpes zoster was unknown. Causality assessment for Herpes zoster was considered as related to ZOSTAVAX. Additional information has been requested.
On the day of injection I had fatigue, dizziness and headaches.  About six days after my arm is red, hot and itches at the injection site. My right arm is sore all over with quarter sized red hot bump at injection site.
A mother reported that he 18 month old son received his first injection of Prevnar, as well as Hib, DtaP and Polio on 4/18/00. Later that day, he developed an injection site reaction characterized by hardness, warmth and redness the size of a softball. The reporter also indicated that her son experienced hoarseness, congestion and a runny nose draining a thick green discharge. Additional information received on 5/18/00 from the physician indicated that the pt developed an injection site reaction at the site of the Acel-Imune administration. The reporter also indicated that the pt has an allergy to Omnicef.
HOT, RED, SWOLLEN AREA FROM SHOULDER TO BELOW DELTOID  MUSCLE.  SEEN BY PHYSICIAN 9/9/09.  ENCOURAGED TO DO ICE COMPRESSES, MOVE ARM 7 SHOULDER JOINT.  TYLENOL FOR DISCOMFORT.    Previously reported under # E-31657  with error on report stating vaccines were purchased with private funds.  These vaccines were sent through the VFC program.    Patient has insurance that does not cover immunizations.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 16-FEB-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Busted blood vessel in lower left eye.  There is a bright red spot under pupil.
Information has been received from a physician concerning a 24 month old male patient with no past medical history who on 26MAR2002 was vaccinated subcutaneously in the right leg with a 0.5ml dose of varicella vaccine live. There was no concomitant medication or vaccinations. On 01APR2003, the patient developed vesicular lesions on a red base on the right anterior hip and thigh int he L2 distribution, spreading  to the groin and penis. Unspecified medical attention was sought, but no therapy was required.  On approximately 17APR2003, the patient was seen by the physician and the lesions had dried out. The patient was sent to the dermatologist, but there had been no report and it was unknown if the lesions were scraped. The reporter indicated that the adverse experience required no treatment, the adverse experience abated and the patient recovered. The reporter also mentioned two other patients that had adverse experiences following vaccination with varicella virus vaccine live. Additional information has been requested.
Narrative: Patient was an 85 yo on hospice with h/o: Anxiety/Depression/Dementia with behavioral disturbances/Sleep-wake schedule disorder/Coronary artery disease/CHEST PAIN/Benign essential hypertension/Hyperlipidemia/Postural hypotension/ Atrial fibrillation/Stented artery/history of fall/seizures. Was receiving all medications from hospice at time of death. Goals of care were to live day by day.
Became dizzy in post vaccination 15 minutes.  Waited 45 minutes and called for ride home.  Was feeling better
Patient received vaccine 10/19/2018, was counseled on injection site reactions usually self resolving within 3 days time with SHINGRIX and given VIS prior to administration. Patient phoned pharmacy 10/20/2018 to inquire if the vaccine can cause shingles but not to report any reaction. Patient phoned pharmacy at 05:30 PM 10/21/2018 to report inject site pain and rash as well as a "burning" radiating throughout lower bilateral lumbar region. Advised to seek medical attention if OTC antihistamine/pain reliever were not working as patient was not present for consultation to see reaction. Attempted to phone her doctor, but was Sunday so office was closed. Patient went to Hospital 10/22/2018 - no intervention needed and no medications were prescribed. Patient reported to pharmacy afterward and showed reporting/administering pharmacist the injection site which looked to be consistent with detailing in VIS and manufacturer packaging. Lumbar pain had also resolved.
Donor stated whole arm was sore for 48 hours and donor stated she was lethargic for 12 hours after injection.
C/O N/V/D x 1 day. Had covid few days ago.Had cough which is better. No CP,SOB,LOC,seizures
High fever (102°), chills, extreme arm soreness, back & joint pain, severe headache, fatigue, feel terrible, sweating, out of breath when on feet, weakness
I received the vaccine 05/17/2021. The next day I began bleeding vaginally. I bled for about 3-4 days and then it stopped like I was having my menstrual. I started bleeding again in Aug and that lasted until December continuously. In Nov 2021 I had a vaginal probe ultrasound. Now in March 9,2022 I underwent a DNC. Showed I had cancer. On May 3 2022 I had a robotic hysterectomy. During hysterotomy they remove 4 sentinel lymph nodes. Cancer was stage 1A and did not spread into lymph nodes. Tumor was 2.2 cn.
received liquid component of menveo; received liquid component of menveo; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA643A, expiry date 30th November 2022) for prophylaxis.   On 15th June 2022, the patient received Menveo. On 15th June 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-June-2022 Reporter's Comments: The patient received only the liquid component of the menveo vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received only the liquid component of the Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
100.0- 103.8 fever (oral) from 10 hours post vaccine to 36 hours post vaccine. At 16 hours post vaccine, vomiting in sleep. 4 episodes of vomiting in 2 hours. Unable to keep liquids or food down for 20 hours. Chills, headache, fatigue, muscle aches, nausea , commuting, abdominal pain.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 14-MAR-2016, the patient was vaccinated with improperly stored PROQUAD (Merck) lot#L024123, expiry date: 30-DEC-2016 (dosing details, route and strength were not reported). It was reported that the vaccine was exposed to the temperature of 6F for a time frame of 15 hours. Previous temperature excursion was reported as 7F for 24 hours on 16-MAR-2016 and 10F for 24 hours on 11-MAR-2016. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
sweating; exhausted; Arm really sore; crappy with aches; fever; joints killing me; headache; This spontaneous case was reported by an other health professional and describes the occurrence of PAIN IN EXTREMITY (Arm really sore), PAIN (crappy with aches), HYPERHIDROSIS (sweating), PYREXIA (fever) and ARTHRALGIA (joints killing me) in a 48-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm really sore), PAIN (crappy with aches), PYREXIA (fever), ARTHRALGIA (joints killing me) and HEADACHE (headache). On 06-Feb-2021, the patient experienced HYPERHIDROSIS (sweating) and FATIGUE (exhausted). At the time of the report, PAIN IN EXTREMITY (Arm really sore), PAIN (crappy with aches), HYPERHIDROSIS (sweating), PYREXIA (fever), ARTHRALGIA (joints killing me), HEADACHE (headache) and FATIGUE (exhausted) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. No Treatment for the event was provided.   This case was linked to MOD-2020-001482 (Patient Link).
Pt seen initially 6 months after vaccination with complaint of worsening generalized anxiety disorder, fatigue and 70-80lb unintentional weight loss with 40lbs occurring in 3m prior to our first visit. At that time pt was started on SSRI for anxiety and labs were ordered for w/u of unintentional weight loss. found to have persistent leukocytosis. had work up for chronic infection, leukemia/lymphoma which were all negative. pt was evaluated by heme/onc without definitive dx. Pt's anxiety improved somewhat with tx however she developed weakness in R > L leg and b/l forearms. Had additional w/u by neurology and was told that her symptoms were likely related to moderna vaccine
This spontaneous report was received from a healthcare worker regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 01-JUL-2014, later than recommendation dosing schedule the patient was vaccinated with PNEUMOVAX 23 lot # L033707, expiration date- 18-MAY-2017, dose 1 and on 13-JAN-2016, 2 dose (inappropriate schedule of drug administration). No adverse event was reported. The outcome of the event was unknown. Additional information has been requested.
Body aches Loss of mental clarity - extreme confusion lasting for the first 5 days Very extreme headaches lasting for 9 days, then recurring on Apr 27 for another 7 days Intolerance to heat or temperatures above 72F lasting 30 days Positional dizziness lasting 30 days
Felt dizzy & light headed.  @ 14:28 BP 170/90, HR 90, BP 142/70 Sat O 98%, @ 15:06 BP 130/78, @15:08 BP 140/72 Osat. 98%
Elevated blood sugar levels; Tenderness at site of injection; Body ache from head to toe; A spontaneous report was received from a consumer who was a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced elevated blood sugar levels, body ache from head to toe and tenderness at the site of injection.  The patient's medical history included Type 1 Diabetes Mellitus, insulin dependent. Concomitant medications reported were rosuvastatin, losartan, levothyroxine and insulin.  On 7 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 8 Mar 2021, the patient experienced elevated blood sugar levels.  She reported that she was requiring triple the amount of her usual insulin dose.  She felt her situation was very dangerous.  Also, she reported tenderness at the site of injection and a body ache from head to toe.  Treatment included Insulin for the elevated blood glucose and ice for the tender injection site.  The patient received both scheduled doses of mRNA-1273, therefore, action taken with mRNA-1273 in response to the events was not applicable.   The outcomes of events, elevated blood sugar levels, body ache from head to toe and  tenderness at the site of injection, were considered unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with history of diabetes, confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid, start date 16Apr2023 and stop date 21Apr2023.  Clinical course: Patient did not had any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Got my 2nd does thursday afternoon, Friday I had a fever of 101.3, chills, headache,  very weak and tired. I took tylenol and was feeling better on Saturday. Woke up Sunday with a sore throat, red/swollen and this has lingered into today (Monday), throat feeling worse.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Social drinks, 3-4 drinks a week-no alcohol durning pregnancies stop date - 2021) in 2006, Nicotine dependence (Got up to 3 packs a week Nicotine (cigarettes/cigars/vaporized)) from 2003 to 2011 and Pregnancy (Live, Full-term birth) on 17-May-2017. Concurrent medical conditions included Asthma (exacerbated by any respiratory infection, not chronic condition). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from an unknown date to 29-Jan-2021 and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) from 04-Feb-2021 to an unknown date for Allergy, PARACETAMOL (TYLENOL) for Pain, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 04-Feb-2021 to an unknown date for Supplementation therapy, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Dec-2020 and the estimated date of delivery was 30-Sep-2021. On 28-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 28-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Pregnancy test: positive (Positive) Positive. On 05-Mar-2021, Ultrasound foetal: inconclusive (Inconclusive) ultrasound - 10 week establish there was a fetus..         Genetic blood test was scheduled on 25-Apr-2021. Ultrasound was scheduled on 21-May-2021.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information received on 06-May-2021 contains information regarding the historical conditions, laboratory data, concomitant medications, pregnancy details of the patient.
C/O sharp severe pain at injection site which then moved all over upper arms, neck, shoulders, ribs, states her stomach seems "loose" like she has no control over the muscles. Temp of 101, very tired.
Began experiencing left sided weakness, Evaluated in ER, Medivac'd to other facility for stroke
Mother reported that patient had a seizure in the car after leaving the office. Mother reported that seizure lasted for 3-5 seconds. Nurse assessed patient in the passenger seat of the car in the facility parking lot- patient was pale and calmy to touch. Patient reported feeling nausea. Patient was alert and oriented x3. Instructed patient's mother to take child to ER if not feeling any better and to follow up with primary care physician on 08-21-08.
Jan 2, 2021 patient received his first dose of the Monderna Vaccine at the County Health Department. He woke up on Janurary 3rd with a bloated somach, severe pain and nausea. He was in the ER at 6:00 am. diagnosed with acute pancreatititis (he did not drink alchol) He conditon declined during the month of Januray as he remained in he hospital gradually being moved to higer levels of care. On January 28 he endured open surgery to remove the gallbladder. On Januray 29 he passed.   Doctors belive only slight chance his condition was caused by vaccine.
first dose > 35 days ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago). On 13-Apr-2021, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is in another country and hence could not take her second dose. She was asked to take the second dose of Pfizer vaccine on 14-SEP-2021 and she has to start over.  Concomitant medications were not provide  No treatment medications were provided
is very sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (is very sick) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced VACCINATION COMPLICATION (is very sick). At the time of the report, VACCINATION COMPLICATION (is very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Her arm was painful for a week/arm killed me for a week; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Her arm was painful for a week/arm killed me for a week) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included Taste loss (Lost sense of taste) in March 2020, Sore throat (Terrible sore throat) in March 2020 and Feeling abnormal (felt funny electric shocks in her body) in March 2020. Concurrent medical conditions included Perfume sensitivity and Seasonal allergy.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her arm was painful for a week/arm killed me for a week). In February 2021, PAIN IN EXTREMITY (Her arm was painful for a week/arm killed me for a week) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications were reported.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  No treatment details were reported.   This case was linked to MOD-2022-660536, MOD-2022-660535 (Patient Link).