chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was asked all pre-screening questions, no contra-indication. he was vaccinated with 0.1ml of jynneos/BN, wheal was not pbtain on first try, patient was vaccinated a second time 2 inches away from initial site a wheal was obtain.  ( this is a second report , unsure if first report went through)
Initial case was received on 07 May 2010 from a healthcare professional. A 19 year old female patient vaccines received included: a left deltoid intramuscular injection of IPOL (lot number B0475-2) on 21 April 2010; a left deltoid intramuscular injection of TYPHIM VI (lot number E-0214-1) and a left deltoid intramuscular injection of IMOVAX (lot number D0792-1) on 22 April 2010; a left deltoid intramuscular injection of IMOVAX (lot number D0869-1) on 29 April 2010. She had received a left deltoid intramuscular injection of  "IXARIO" (Novartis lot number JEV08E10B) on 14 April 2010. The patient's concomitant medications included CELEXA, ATIVAN and BCP-TRINESSA. She had allergies to red dye and sulfa. She had no illness at the time of the vaccinations. On 15 April 2010 the patient experienced a cough and sore throat until 21 April 2010. The cough and sore throat were treated with a Z PAK. On 05 May 2010 the patient experienced a fever of 105 F with mildly enlarged glands in the neck, which as of this report were getting better, but not resolved. On an unspecified date a CBC and monospot tests were normal. Follow-up information was received on 01 June 2010 from a healthcare professional. The IMOVAX injections were given for pre-exposure. The third dose of IMOVAX (lot number D0792-1) was completed on 13 May 2010. The patient completed "JE IXARIO" (lot number JEV08F12B) on 12 May 2010. The fever and mildly enlarged lymph glands resolved spontaneously by 10 May 2010 and no further treatment was needed. Documents held by sender: None.
From 1am-4am on the 19th I threw up 3 times. On 2/20 at 9:30am hives appeared on my bilateral lower legs, feet, arms, and hands. Irritation and itching.
got sick years ago when had the last one; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case from a consumer via Social media from the .  This case involves an Adult patient who experienced got sick years ago when had the last one (illness), while the patient received INFLUENZA VACCINE [INFLUENZA VACCINE].  Medical history, medical treatment, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, after started vaccine, the patient reported that no shot here and got sick years ago when had the last one (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data was provided.  Final diagnosis was illness.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for illness.
Tight throat. Abnormal swelling at injection site left upper arm. Felt out of it/lethargic.
administered 2 expired doses of IMOVAX to a patient; Initial information received on 21-Dec-2021 regarding an unsolicited non-valid non-serious case from other health professional.  This case involves a male (unknown age) patient who was vaccinated with the  two expired dose of suspect RABIES (HDC) VACCINE [IMOVAX RABIES] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 10-Dec-2021, the patient received a dose of suspect RABIES (HDC) VACCINE (lot T1B492M and expiry date: 07-Dec-2021) (Frequency: Once) via intramuscular route in arm site for prophylactic vaccination.  On 14-Dec-2021, he also received a dose of the same vaccine (lot T1B492M and expiry date: 07-Dec-2021) (Frequency: Once) via intramuscular route in arm site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt. is a 65 y.o. yo female with a past medical history significant of hypertension presents to the emergency department with concerns of weakness.  Patient states that she went to take a bath Tuesday night, and was found to still be in the bathtub tonight around 1800.  Supplemental history provided by patient's daughter, who found her in the bathtub.  When patient's daughter arrived, patient thought that she had only been in the bathtub for a couple hours.  Patient states that she had a doctor's appointment on Tuesday and received her influenza and tetanus vaccine at that time.  She denies any new medications, drugs or alcohol.  They are unsure of head trauma, but patient's daughter states that she was laying on the opposite end of the bathtub that she normally lays on.  Patient denies any headaches, vision changes, numbness or tingling.  The did note that she was having difficulty walking due to weakness.  She can take a few steps, and then would rely on someone close by to help.  They did give her some food and water prior to calling EMS, which she tolerated without difficulty.  Patient denies any musculoskeletal pain or neck pain.  Pt. is a 65 y.o. female with history of HTN, HLD, T2DM, chronic diastolic heart failure, CKD 3A, TIA 2021 who presented 10/12/2023 with bilateral lower extremity weakness and rhabdomyolysis secondary to immobility.  In the ED, patient was hypertensive 171/88. WBC 11, troponin 3, CK 6326 elevated, CRP 5.3 elevated, ESR 86 elevated, TSH 0.29 low.  CT head no acute process, stable right occipital encephalomalacia and generalized volume loss with chronic changes. Received 500ml normal saline bolus.  Admitted to general medicine.  WBCs normalized.  Creatinine kinase down trended to 2298.  Vascular ultrasound of lower extremities bilaterally showed no DVT.  Patient received B12 injections due to low B12.  Patient's weakness improved.  Patient's blood pressure medications were held to prevent AKI in context of rhabdomyolysis slowly reintroduced.  Recommend to monitor patient's blood pressure and adjust medications accordingly.  Other chronic medical problems stable and managed with home medications.  Discharged in stable condition.
Patient died on March 27, 2021. Coroner ruled it Acute Asthma Exacerbation. Because it was only a short time after his shot, his family wants to rule that out as a possible cause of death.
Patient woke up in the middle of the night the same day she received the vaccine and noticed pain and burning on her upper left leg. She saw her doctor the next day who diagnosed her with shingles. The outbreak spread to the back of her knee in the meantime. She was prescribed ointment and medication to treat shingles.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Prednisone, reaction(s): "allergies Prednisone", notes: Known allergies Prednisone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Antiviral details for COVID-19 Treatment included Paxlovid, Treatment start date: 08Sep2022, Lot number: Geo809. The patient did not receive other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
1/15-1/16 -localized arm pain from injection 1/22 - felt ill, nauseous & lethargic & arm pain returned 1/23 - woke with big red baseball sized lump & arm pain 1/24 - red lump becomes warm to touch, itches, I run low grade temp throughout  1/25 - redness begins to spread down arm, itches gets hot to touch  & arm registers 104 temp with no contact thermometer 1/29 - call doctor for appt, go in for same day Appt. Site infected, doctor says I have Cellulitis & I start to take antibiotics. Doctor marked arm 1/30-2/1- feel run down, dizzy, lightheaded & lethargic. Redness spreads a bit more, but antibiotics helping 2/1 -2/3- redness slowly gets better, but I feel very lethargic & run down, dizzy, lightheaded & body feels heavy. I take two sick days from work.
No adverse event; Vaccines administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date).    No concomitant medications were reported. It was reported that as per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24C and Min: -23C. It was reported that Moderna COVID-19 Vaccine with Lot number: 060H21A was received on 27-Dec-2020 with expiration date as 28-Mar-2022 but the Date of administration was 11-Apr-2022 with doses of 13. Treatment information was not provided. This is case is for Patient 10 of 13 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-728240 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728240:Master Case(Patient 1)
Leg pain; Back Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain) and BACK PAIN (Back Pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia, Lymphoma, Pancreatic cancer and Heart valve disorders.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Leg pain) and BACK PAIN (Back Pain). At the time of the report, PAIN IN EXTREMITY (Leg pain) and BACK PAIN (Back Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included pain killers. No Concomitant medication were reported. Patient states that her Doctor warned her she would probably have pain due to her history of multiple Cancer.   This case was linked to MOD-2021-121825, MOD-2021-121825 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional information received on 11-MAY-2021 and does not contain any new information.
1. Moderate headache 2 hrs after fir 8 hours. 2.  Significant fatigue 36 hours.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity ("it feels like something in my left arm is being stretched at; it hurts"), pain descending to elbow and arm rash in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 044B21A) for COVID-19 immunization. No medical history reported. On Apr 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 27, 2021, patient experienced pain in extremity ("it feels like something in my left arm is being stretched at; it hurts"). On Apr 28, 2021, patient experienced arm rash. On Apr 29, 2021, patient experienced pain descending to elbow. On Apr 28, 2021, arm rash resolved. At the time of the report, pain in extremity ("it feels like something in my left arm is being stretched at; it hurts") and pain descending to elbow resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Pt stated she had hives and itching on the back of her neck and upper back on the night of the vaccine administration. She had a headache that started 2 days after administration.  Pt was taking tylenol for the headache and was going to try benadryl cream for the neck and itching. Hives were no longer present on Thursday when pt came into office however, there were still some areas of redness.
Patient developed a rash, redness, swelling to injection site. Patient applied ice and anti-itch cream to affected area x 2 weeks. Patient called PCP and was prescribed Prednisone and after five days reaction has cleared.
This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender. The nurse reported that the office has been administering ZOSTAVAX (lot # not reported) subcutaneously in the back of the upper arm (triceps) rather than the deltoid. No adverse event was reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
10/21/13:  Client called and reported rash at sites where vaccines were received.  Has improved.  Denies difficulty breathing or rash on other parts of body.  Per client, improving but rash remains.
Information has been received from a physician concerning a male with a history of shingles who was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that the patient developed a mild case of shingles after vaccination.  At the time of report the patient was not recovered.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Received 1st dose of Pfizer Covid Vaccine and started becoming increasingly manic within about an hour. Complained of stomach discomfort. Became increasingly anxious and manic and was only able to sleep for two hours (received at 4pm, slept from 12am to 2am). Awake and manic the day following. Complained of stomach pain. Eating normally with no other symptoms. Started complaining of being cold and chills. Applied rotating heated blankets until he feel asleep about 10pm. Woke up at 2am. Manic and anxious. Stomach started swelling more and becoming rigid.  Gave him Miralax. No change in swelling. Increased stomach pain. Gave him a suppository. Immediate small bowel movement. After two more hours and no change in swelling, gave a second suppository. Immediate small bowel movement. Stomach becoming distended and complaining of increased pain. Took him to the ER. Pain amplified on the way. Admitted to PICU after EKG in ER. Quickly declined and went into respiratory failure. Right lung had no air exchange and left lung collapsed. Myocarditis, pleural effusion, kidney damage and new onset Type I diabetes. Unexplained pneumonia. No growth from fluid in lung.
There was no adverse reaction. Parent was contacted and made aware of situation. No signs or symptoms have been reported at this time.
This spontaneous report as received from a health care worker refers to a 13 month old female patient. The patient's medical history was not reported. On 04-APR-2014 the patient was vaccinated with her original M-M-R II (lot # J006953, Expiry date :04-JUN-2015) (Dose/Frequency: 1 injection, Therapy Route: Intramuscular). Concomitant medications were none. On 16-MAY-2014 the patient was vaccinated with second dose of M-M-R II. It was reported that the patient received the second dose of M-M-R II earlier than what was indicated. It was reported that the patient did not have any noticeable adverse reaction to the M-M-R II injection while in the office. The outcome of received second dose M-M-R II earlier that what was indicated and did not have any noticeable adverse reaction was unknown. The patient did not sought medical attention. Additional information has been requested.
Initial unsolicited report received from the literature on 01 June 2016. This case is linked to cases 2016SA108588, 2016SA108560, 2016SA108575 (same literature). The following is verbatim from the article: Background. Many adult immunization schedules recommend that tetanus and diphtheria vaccination be performed every 10 years. In light of current epidemiological trends of disease incidence and rates of vaccine-associated adverse events, the 10-year revaccination schedule has come into question. Methods. We performed cross-sectional analysis of serum antibody titers in 546 adult subjects stratified by age or sex. All serological results were converted to international units after calibration with international serum standards. Results. Approximately 97 percent of the population was seropositive to tetanus and diphtheria as defined by a protective serum antibody titer of .0.01 IU/mL. Mean antibody titers were 3.6 and 0.35 IU/mL against tetanus and diphtheria, respectively. Antibody responses to tetanus declined with an estimated half-life of 14 years (95 percent confidence interval, 11.17 years), whereas antibody responses to diphtheria were more long-lived and declined with an estimated half-life of 27 years (18.51 years). Mathematical models combining antibody magnitude and duration predict that 95 percent of the population will remain protected against tetanus and diphtheria for 30 years without requiring further booster vaccination. Conclusions. These studies demonstrate that durable levels of protective antitoxin immunity exist in the majority of vaccinated individuals. Together, this suggests that it may no longer be necessary to administer booster vaccinations every 10 years and that the current adult vaccination schedule for tetanus and diphtheria should be revisited. This case involves an 80-year old patient (gender not reported) who was vaccinated with a dose of TDAP (lot number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications was not reported. On an unknown date, unspecified timeframe after vaccination, the patient lacked immunity to both toxins (diphtheria and Tetanus). Serum antibody titers were performed (results not provided). Other laboratory data and corrective treatment was not reported. The outcome of the event was not reported. Documents held by sender: none.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On 21st April 2018, the patient received the 1st dose of SHINGRIX. On 21st April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injected limb mobility decreased, injection site pain and weakness of arms. On 22nd April 2018, the patient experienced fever. On an unknown date, the outcome of the injection site swelling, fever, injected limb mobility decreased, injection site pain and weakness of arms were recovered/resolved. It was unknown if the reporter considered the injection site swelling, fever, injected limb mobility decreased, injection site pain and weakness of arms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the nurse for herself. The age at vaccination was not reported. The patient experienced swelling and pain at the injection site. In addition, her whole arm where she received the injection was weak because she could not move it. The next day after receiving SHINGRIX, the patient experienced fever and had to miss two days of work. The patient denied permission to contact their physician.
This spontaneous report as received from a registered nurse refers to a 53 years old female patient (also a registered nurse) with no drug reactions or allergies and no pertinent medical history. The patient was vaccinated with MMR II on an unknown date (dose, route and lot# not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient had titers drawn and had negative mumps titer and positive titers for rubella and measles. The patient visited the office. No treatment was given for the event. The patient did not remember if she had MMR II but assumed she did since she did not remember getting rubella or measles disease and had positive titers for rubella and measles. The outcome of negative mumps titer was unknown. The relatedness for negative mumps titer was unknown for MMR II. Additional information has been requested.
The pt may have had a mild Guillain-Barre. He was weak and couldn't squat. He recovered without any paralysis or neuro-sensory changes.
patient called the day after  complaining of soreness and a scab forming about the size of a pencil eraser.  After a follow up call on 9/28 the patient reports that the pain is gone but there is a crystalline scab where the injection was given.