chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case was linked to 2018SA292533 (same reporter). This case involves an Elderly patient above 65 years who received a dose of FLUZONE HIGH DOSE (lot number not reported) via unknown route in unknown administration site but it was from last year (expired vaccine used). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of potential medication error due to expired vaccine used. It was reported that the patient did not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
reports feeling faint, alert  with no loss of LOC, pale and mild diaphoresis. cool cloth applied and reported did not eat lunch prior to apt. water and snack provided. Symptoms resolved in few minutes left for home with parent without difficulty
t102.9 & high pitched cry 5PM 27FEB95; given APAP T dec to 101.0; given APAP & DPH; no ER visit;
Information has been received from a medical assistant(also reported as office manager) referring to a 15 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 01-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. ; Sender's Comments: US-009507513-1704USA014784:
Information has been received from a female registered nurse of unknown age (was also the patient) referring to herself. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot #, expiration date and route not reported). On an unknown date, the patient experienced pneumonia after receiving PNEUMOVAX 23. The outcome of the event was unknown. The causality between the event and PNEUMOVAX 23 was not provided. Upon internal review, the event of pneumonia was considered to be medically significant. Additional information is not expected as there was no consent to contact the reporter.
pt described that had a raised red itchy rash on abdo that started approx 24 hrs p/1st dose; dx immune complex hypersensitivity;
Cellulitis; Pain; Swelling; Heat at the injection site; A spontaneous report was received from a consumer who was also a 68-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced cellulitis at the injection site.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Aspirin, Metformin, Vivo, Thyroxine, Metoprolol, Omeprazole, Singulair, Oxygen, B12 Injection, Flaxseed Oil, Cocu10, Libutrin, Evox, Alogliptin, calcium Citrate and Vitamin B/C/D nonspecific.  The patient received both of two planned doses of mRNA-1273 first dose (Batch number: 027620A) on 19-Jan-2021 and second dose (Batch Number 002A219A) on 24Feb2021 intramuscularly in the hip for prophylaxis of COVID-19 infection.    On unspecified dates, following second dose the patient developed cellulitis with heat, pain and swelling at the injection site, the swelling was 6 inhes by 2 inches in size. Treatment for the event included Keflex and heat pad.  The action taken is not applicable.  The outcome of the events were considered resolving.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
swelling occurred p/vax lasted up to 3wk;SC induration @ site of vax inj on rt thigh of 2.0 x 2.5cm, no warm, red or tender;
pt recv vax 8MAY to lt arm & w/in 1min swelling @ inj  site w/raised border devel 1 hive;actual size;ice pack applied directly to site for 10min;pt observed in clinic for 30min;breathing nl;more redness or swelling @ site;
No additional AEs reported; GARDASIL 9 was administered following temperature excursion.; This spontaneous report was received from a nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-MAY-2023, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, 1 dose, lot #W014513, expiration date: 26-JAN-2025, administered as prophylaxis (strength, dosage regimen, anatomical location, and route of administration were not provided) (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 52.86 degrees Fahrenheit (F) for 96 hours (reported as "worst case scenario") without previous excursions. No adverse events were reported.  This is one of five case received from the same reporter. ; Sender's Comments:  US-009507513-2305USA005550: US-009507513-2305USA005725: US-009507513-2305USA005688:
Coughing, rapid heart beat about 180, temp approx 99+, wheezing, difficulty breathing.
Within 1 minute of receiving the shot, rapid heart rate, extreme dizziness, confusion, change in vision, numbness in right hand.
This spontaneous report was received from a healthcare worker regarding to an unspecified number of patients of unknown demographics. No concurrent condition and historical medication was reported. On an unspecified dates since 03-FEB-2015, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # K007979, expiration date 03-JUN-2016, lot # K021487, expiration date 03-NOV-2016 and lot # L001335, expiration date 13-JAN-2017, subcutaneous. No concomitant medication was reported. No adverse effect was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Soreness up to 5 days after the vaccine * Itchy rash, swelling, bump under skin at injection sight, which began 7 days after receiving the vaccine
Patient started to feel dizzy. Dizziness lasted for about 5 minutes. Gave patient water and she was fine afterwards. Told patient to call 911 if she doesn't feel well tonight.
Person Contracted COVID; Person Contracted COVID; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Jan2021 (Batch/Lot Number: EL3249) as dose 1, single (age at vaccination: 24 years old) for covid-19 immunisation. Medical history included penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient contracted covid on Jul2021. The event resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included COVID-19 test: positive   on Jul2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Case number PHEH2015US002659 is an initial spontaneous report from a consumer (patient) received on 04 Feb 2015. This report refers to a 55-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 004071A) intramuscularly in Oct 2013. On 12 Oct 2013, he experienced severe fatigue and a pulsating pain in his abdomen. It was diagnosed as appendix cancer and a surgery was performed to treat it. The outcome of the events reported as not recovered as of 04 Feb 2015. The seriousness and causality of the events were not reported.
1st shot: no problems. 2nd shot developed full body muscle ache and joint pain. Flu-like pain without being sick. Beginning about 48 hrs after shot. Muscle ache lasted about a week, but both elbows have remained painful. I have diminished gripping, lifting, and pull strength in my hands where there was no problem before vaccination. Exertion with hands and arms intensifies elbow pain. Had hoped it would eventually subside but it has not. 2nd symptom is a dryness on the inside of my upper/lower lip causing skin to drag or stick to front teeth. Have needed to use my tongue to moisten area. This was not needed before.
2 small blisters on roof of mouth 56 hrs. after injection of ZOSTAVAX. Symptoms resolved 5 days after breakout. No temperature.
Initial report received on 24 January 2014 and follow up information received on 28 January 2014 from an investigator participating in a study. A 33-year-old female subject had worsening of asthma on 10 December 2013 i.e. 146 days after receiving fifth intramuscular dose of IMOVAX rabies in the left deltoid on 17 July 2013 (batch number not reported). The subject received first dose of IMOVAX rabies on 19 June 2013, second dose on 22 June 2013, third dose on 27 June 2013 and fourth dose on 03 July 2013. The subject had medical history of migraine headaches, asthma and anemia. The subject had concomitant therapies with SINGULAIR from unknown date in 2000 Per OS, 10 mg, QD indicated in asthma, Multivitamins from unknown date in 2003, Per OS 2 Tabs QD indicated in anemia and Ibuprofen from unknown date in 2003, Per OS 800 mg PRN indicated in Migraine. The subject reported on 24 January 2014 at 09:00am that on 10 December 2013, she was admitted at the hospital due to a severe asthma attack. Medical records will be requested today for more details. Lab investigations were unknown as the medical records were pending to receive. The corrective treatment details were not reported because medical records were pending to receive to provide requested information. The event of worsening of asthma resolved on 15 December 2013 and the subject was discharged from the hospital on the same day i.e. on 15 December 2013. The event of worsening of asthma was not related to the study vaccine or to the trial procedure. The serious adverse event did not lead to termination of the subject from the study. List of documents held by sender: None. Unblinding information received on 31 January 2014. Follow up information received on 03 March 2014: It was reported that the records were requested on 24 January 2014, 05 February 2014 and 27 February 2014. The records were not available for date of service and no records would be provided. This case is linked with 2014SA012490 (SAE# 1: multiple traumatic fractures secondary to motor vehicle accident from 07 October 2013 to 10 October 2013).
he got dtap/hep B/IPV combo vaccine on 7/16 and the morning after developed new tics/ movements where he extends his head, clenches his hands. lasts a few seconds. occurs every couple minutes. no prior tics like this before although had a "sniffing tic" before.
Case number PHEH2014US018319 is an initial spontaneous report received from a nurse on 11 SEP 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. On 10 SEP 2014, he was vaccinated with FLUCELVAX 2014/2015 (batch number: 014021A) via intramuscular route. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a patient of an unknown age and gender 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 an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2021-163756 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-JUN-2021. No new information in Follow up document; Sender's Comments:  MOD-2021-163756:reporter case
Pain swelling/hardness, redness, of injection site approximately 2 inches in diameter when first noticed >1 week after injection.  Contacted primary care physicians and instructed to take ibuprofen and use topical hrdrocortisone.  Size increased  to 3 inches the following day and experienced some chillls.  No fever.
In addition to common symptoms listed on the CDC website ( soreness in arm, muscle and body aches, fatigue) I experienced tingling and numbness in hands and feet, and tingling in the face. It got progressively worse over the next few days, and started getting better each day after Sunday 4/11/20. I went to my doctor?s office yesterday, and since he was not available, I saw the nurse practitioner. She checked me out and did a needle test as well. She said that although this is not listed on the common side effects, that it appears to be a side effect. She said since I am getting better each day, it will likely resolve itself in a week or two. She feels that my nerves are inflamed. I was not prescribed anything, and since I do take a dose of gabapentin each day, this should help.
Minor soreness for a short while at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Minor soreness for a short while at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Blood pressure high (Have high blood pressure, but well controlled).    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Minor soreness for a short while at the injection site). At the time of the report, VACCINATION SITE PAIN (Minor soreness for a short while at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 121/72 Blood pressure is good, 121/72.         No concomitant medication information provided.  Patient had unspecified test which all case back negative.   Patient had two regular Moderna shots. Patient's doctor said patient was probably immunocompromised.   No treatment information provided.   This case was linked to MOD-2022-472171, MOD-2022-472076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Feb-2022: Follow up received included event.
Loss of appetite; tiredness; itching at injection site; diarrhea; and difficultywalking 1st day after vaccine.; This is a spontaneous report from a contactable consumer, the patient. An 86-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW018S) via an unspecified route of administration in the left arm on 27May2021 at 11:15 as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension and stenosis in L-5. The patient had no known allergies to medications, food or other products. Concomitant medications included metformin (MANUFACTURER UNKNOWN), glipizide (GLUCOTROL) and acetylsalicylic acid (BABY ASPIRIN) all from an unknown date for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWONO) via an unspecified route of administration in the left arm on 06May2021 at 11:15 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. On 28May2021, the patient experienced loss of appetite, tiredness itching at injection site, diarrhea, and difficulty walking 1st day after vaccine. Each subsequent day ambulation improved, then normal for patient. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included home therapies. The clinical outcomes of the events loss of appetite, tiredness itching at injection site, diarrhea, and difficulty walking were recovered on unknown date in 2021.  No follow-up attempts are needed. No further information is expected
Patient reported extreme left arm pain affecting range of motion starting day after injection. Pain lasted four days after injection. Denies left arm pain or limited range of motion in left arm beginning 11/22/2021.
CLIENT RECEIVED DOSE 1 ON 12/8/2021. INTERVAL BETWEEN DOSE #1 AND DOSE #2 TOO SHORT, NOT AUTHORIZED INTERVAL.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 3:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 3:56 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 38.84 Years.   Concomitant products were not provided.   On 14-Feb-2021, Excursion time was 09:00 AM, temperature was 32,  10:00 AM, temperature was 32, 11:00 AM, temperature was 32, 02:00 PM, temperature was 35, 03:00 PM, temperature was 35, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 21-Mar-2021, Excursion time was 09:00 AM, temperature was 34,  10:00 AM, temperature was 32, 11:00 AM, temperature was 34, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 16-Mar-2021, vial was moved to clinic on 21-Mar-2021. 10 vials were sent to clinic. Vaccine BUD date was 15-Apr-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.   Temperature recordings were taken using a traceable temperature monitor at every hour.   After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.   Treatment medications were not reported.
Initial misuse report received from a healthcare professional on 30-Aug-2013. The case was received on 21-Mar-2014 at agency. This is an invalid case as individual patient identifiers are not reported. A patient had received a dose of PENTACEL on an unknown date. The nurse called last night after hours and is calling back to report change that now that the MA mixed the ACTHIB powder with sterile water instead of what was previously reported as DTaP/IPV mixed with sterile water. No adverse event was reported. (No information was provided regarding the patients). List of documents held by sender: none.
Diagnosed as mesenteric panniculitis; Acute abdominal pain; Labelled drug-drug interaction medication error; This case was reported by a pharmacist via sales rep and described the occurrence of mesenteric panniculitis in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number TB2PK, expiry date unknown) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUBLOK) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Shingrix and FLUBLOK. On 7th October 2019, unknown after receiving Shingrix, the patient experienced labeled drug-drug interaction medication error. In October 2019, the patient experienced mesenteric panniculitis (serious criteria hospitalization) and abdominal pain (serious criteria hospitalization). On an unknown date, the outcome of the mesenteric panniculitis, abdominal pain and labeled drug-drug interaction medication error were unknown.   It was unknown if the reporter considered the mesenteric panniculitis and abdominal pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and Flublok on left deltoid at same time which led to  labeled drug-drug interaction medication error. The patient experienced acute abdominal pain that was subsequently diagnosed as mesenteric panniculitis (aka sclerosing mesenteritis). For the condition, patient was admitted to the hospital, treated, and discharged. Additional information not available at time of report.  The reporter consented to follow up.
Approximately 1 week after my Janssen COVID19 vaccine, I started to experience lower right side abdominal pain and went to the ER. Unfortunately I was misdiagnosed and did not find out it was appendicitis until after it had already perforated and had a severe infection. I underwent an open appendectomy and recovered.
Initial report received from a health care professional (nurse) on 16 Sep 2010: This child was vaccinated with only the MenA conjugate component of MENVEO (batch number 100022) 0.5 ml, intramuscularly that was reconstituted with sterile water instead of the MenCWY liquid conjugate. The child did not receive the MenCWY component. No adverse event had occurred following this administration.
Patient reporting swelling, redness, pain, and itching in the arm injection was given. Patient self medicated with Benadryl and Ibuprofen.