chrisvoncsefalvay/vaers-outcomes huggingface dataset:
permanent lifetime diseases, triggered by a vaccine; This case was reported by a consumer via media and described the occurrence of chronic disease in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chronic disease. On an unknown date, the outcome of the chronic disease was not recovered/not resolved.   The reporter considered the chronic disease to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was living with permanent lifetime diseases that were triggered by a vaccine. The patient stated that it would have been better to have taken the chances without getting it. The patient stated that was right down scary what was happening. The patient wished that he/ she had been informed of potential side effects. The patient also stated to help us all.
DTaP given right leg intramuscular, no reaction after 10 minutes, but next day mother called and said site of immunization was red, hot, and swollen.  Per doctor patient mother notified to us MOTRIN, ice by 10 minutes 2-3 times a day, and to continue antibiotics for ears.
Saturday 7/20/19: woke up with sore throat in the morning and fatigue  Sunday 7/21/19: still sore throat, fatigue lessened  Monday 7/22/19: still sore, no fatigue  Tuesday 7/23/19: no sore throat  Wednesday (today) 7/24/19: has red sores/bumps on back of tongue, top of mouth, throat
no symptoms as of 05/19 or 05/20/2021 when noted error that had administered Moderna to 16 year old. I have spoken with his legal guardian on both days and advised of the mistake/error and she reports that he has not had any issues and is not concerned that had received Moderna and requested that schedule his second dose and have done so for 05/27/2021.
Pt was not immune to varicella and never had varicella containing vaccine. Pharmacist and medical director ordered Shingrix to be given to the client in lien of varicella. RN dispensed as ordered.
After injection, injection site had redness and swelling. It is getting better, but is still bruised like, sun burn like skin after 20 days of injection. Also, pt feels muscle weakness and is still tired.
I experienced a breakthrough case of COVID-19 with coughing, tiredness and shortness of breath.
This was a vaccine administration error in which a 13 year old patient inadvertently received a third dose of Pfizer covid vaccine. There were duplicate records for the patient in the system. The patient received their first dose of Pfizer covid vaccine on 5/17/21 and their second dose on 6/7/21. Not knowing they had already received their second dose at school, another dose was given on 11/22/2021. The error was discovered when the mother handed over the CDC card for documentation. The patient was monitored for 30 minutes after vaccination and experienced no symptoms during that time. This happened today.
Pt came in on 5/30, a huge area on her arm is red, swollen and she said has a lump. I advised her to take some benadryl and watch the size of the reaction.
3 days /p immun. infant only able to move fingers of left arm, no tone in arm. Immun. given in Right thigh/buttocks.  Mononeuropathy left upper extremity.
The client previously received two doses of Moderna Covid vaccine. Today, I gave her a third Covid vaccine due to an immunocompromising condtion, however it was the Pfizer vaccine, not Moderna. It was given at the proper time interval.
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 67-year-old male patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 22-NOV-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # S012245, the expiration date: 09-FEB-2021 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. # 1909USA001561, 2003USA005392, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407 and 2003USA005409.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S012245; expirationdate: 09-FEB-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005392: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005409:
patient received a dose of Flublok QIV instead of Fluzone QIV, no AE; a 17 year old patient received a dose of Flublok QIV instead of Fluzone QIV, no AE; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from other health-care professional.  This case involves a 17 years old male patient who was vaccinated with a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1934 Exp. Date 30-Jun-2020) via intramuscular route in the right upper arm instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 05-Nov-2019.  The patient's medical history was not reported.  Concomitant medications included MENINGOCOCCAL VACCINE (MENACTRA) for Immunisation .  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event reported at the time of reporting.  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 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.
Started my period in the evening the same day vaccine was administered. It was two weeks early. My periods are regular and last for three days with light flow. I have had heavy flow for eight days. I am still bleeding. In addition I had severe vertigo and mild fever for five days after receiving the vaccine beginning on day two and ending on day 6. I could not move my head without significant spinning sensation. The vertigo has now subsided. I have never experienced vertigo in my life. It was debilitating. Thankfully it has subsided. My mother who is 74 also experienced vertigo after both her first and second Covid vaccination - Pfizer. She still has vertigo in the mornings three months after the second vaccine.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 15-OCT-2012, the patient was administered an incorrectly stored dose of ZOSTAVAX, lot# 0468AE, expiration date: 04-APR-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Patient received a dose of 0.3ml IM Gray Vial Pfizer COVID-19 vaccine from an extremely busy, understaffed retail pharmacy. Patient's only reaction is mild, soreness at the injection site at 6PM on 4/2/2022.
sore arm, chills,  dizzy for  two days.  blood pressure was low, not sure if someone who is taking blood pressure medicine, should take their B/P  at the same time, taking a vaccine.
The vial was first punctured on 21NOV2022 at 11:46AM and patient administered vaccine on 22NOV2022 Around 9:16 AM.; No adverse event; Received expired Bivalent booster beyond 12  hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster beyond 12  hours post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 21NOV2022 at 11:46AM and patient administered vaccine on 22NOV2022 Around 9:16 AM.) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 vaccination.     Specific product reported Yes, specific product known from information provided.     On 22-Nov-2022 at 9:16 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Nov-2022 at 9:16 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster beyond 12  hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 21NOV2022 at 11:46AM and patient administered vaccine on 22NOV2022 Around 9:16 AM.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster beyond 12  hours post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 21NOV2022 at 11:46AM and patient administered vaccine on 22NOV2022 Around 9:16 AM.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster beyond 12  hours post puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 21NOV2022 at 11:46AM and patient administered vaccine on 22NOV2022 Around 9:16 AM.).    No concomitant medication was provided. It was reported that, vaccine vial was in an amber vial to protect from light. Vial size was 10 dose vial. The vial was initially stored in the refrigerator was 18Nov2022 at around 7AM. The vial was first punctured on 21Nov2022 at 11:46AM. The vial was stored at room temperature in amber vial with a cap post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius, 46 degree to 77 degree F) 21.5 hours.  No treatment medication was provided.
Initial misuse report received from a Healthcare professional on 07 August 2013. A child was administered only the DTaP/IPV component of PENTACEL. No other information was provided. No adverse event was reported. List of documents held by sender: none.
This spontaneous report as received from a registered pharmacist refers to a 66 year old female patient with Crohn's disease and hypertension. On 05-OCT-2013, the patient was vaccinated with ZOSTAVAX (VIAL 19400PFU) lot # J004267, expiration date: 12-JUL-2013, 0.65 ml, subcutaneous route. Concomitant medications included "blood pressure medications". On 05-OCT-2013, within 24 hours after onset of therapy, her arm was swollen, red and hot from shoulder to elbow. On 06-OCT-2013, two days after injection, a blister developed over the injection site with "a burgundy core" in a lesion that was about 2 inches across. For two days, the patient had tiny bubble blisters on the skin of her arm which "seemed to merge" at the injection site (also reported as not recovered). In October 2013, the blisters were full of liquid, but did not open. The blister over the injection site became 4 inches in diameter and was full of an orange-red fluid that would move with gravity. The blisters dried up and the skin began to slough. The blister over the injection site broke open and the skin underneath was red and dry. At the time of this report, the injection site had still a hard knot about the size of a marble which continued to be painful. The patient had seen her physician via email and phone consultations. The physician wanted to prescribe a "Z-pack", but the patient refused so the physician recommended BENADRYL. No laboratory diagnostics studies were performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Within a week, my right arm began itching and hurting periodically. At first, there was redness at the injection site about the size of a penny and warm to the touch. The next day, it was the size of a quarter and still warm to the touch. Then, the redness grew to about the size of a half-dollar and was still warm to the touch so I returned to the place I had the vaccine to have the nurse, look at it.  She had the manager, over the clinic look at.   The told me it was a common reaction to the Moderna vaccine and that I didn't need to be concerned about getting the second vaccine on 9-7-21.  I went to see my own Internal Medicine doctor, about it that day, but was only able to see the nurse. I reminded them I had a similar reaction to Pneumovax. The nurse at my internal medicine doctor's office measured it to be about 4.1 centimeters. She gave me Tylenol to take and told me to use an icepack for it.  She had me return the next day to make sure it had not grown any more. I had the doctor also looked at it because I also had a nodule or something that could be felt under the skin next to the injection site. He said he felt it was unrelated to the redness area and vaccine itself. He said it was a sebaceous cyst. He advised me to go ahead with the second vaccine. He did not feel this would indicate a possible more severe reaction to the second vaccine.
Hives 20-30 minutes after giving MMR, DTaP< and IPV- Mother gave Benadryl with relief. No respiratory distress. Lips swollen.
10/27 received my first booster, had fever and achiness for 3 days after.  Then I was fine. On 11/15/21 began running a low grade fever (99.5-100) with tiredness which lasted till 11/23.  Called my PCP and was advised fever was probably a virus and to let it run it's course.  Second booster on 4/8 with fever and achiness for 3 days. Then fine till 4/26/22, began running low grade fever with tiredness again which lasted till 5/16/22.  We had moved so saw new PCP 5/9/22 who felt it was a reaction to vaccine. She administered Prevnar 20 that day. This may account for the additional days of low grade fever.  She felt it was my body's reaction due to Fibromyalgia and did not administer a COVID test. I am feeling fine at this time.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/31/21 2nd dose02/21/21 Diagnosed covid positive:09/03/21 Symptom onset:09/01/21 Exposure: Symptoms:cough fatigue,muscleaches,runny nose
The patient received a 3rd dose of Moderna from a vial that had been expired for 11 days. The patient stated that they did similar to prior doses where they felt an immune response.
Patient thought he was to receive covid bivalent booster, but was given flu shot. He received his flu shot 1 week earlier than this event. No actual adverse effects reported
chills, fever, general aches; started noc of inject; lasted from Monday noc through following Sunday (arm hot to touch feeling very heavy, weak, sweating, cold/chills; labored breathing;
Pt was jittery, nauseous, and started to discolor (pale) at the face.  Pt had severe pain and needed to lay down.  After pt was given apple juice, he felt better.
Administered TDAP vaccine prior to 20 weeks of gestation.  Pt was 16 weeks at time of vaccine was given.
Rash on back, hands, feet 24 hrs p/inject; fever 100;
Nausea; headache; soreness at injection point; fever; runny nose; This is a spontaneous report from a contactable Consumer (patient). A 16-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN5318, Expiration date not reported), via an unspecified route of administration in arm left on 27Jan2021 (at the age 16-year-old), as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3249, Expiration date not reported), via an unspecified route of administration in arm right on 06Jan2021, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks before vaccination. The patient experienced nausea, headache, soreness at injection point, fever and runny nose on 27Jan2021. The patient did not receive any treatment for the events. The outcome of the events was reported as recovering  Follow-up attempts are completed. No further information is expected.
Patient developed osteomyelitis with subperiosteal abscess of the right distal thigh. Blood culture and abscess culture were positive for MRSA.
Pain in shoulder; limited range of motion. Treated at MD's office; MD noted that shot was given in tendon; Prescribed meloxicam 15mg for pain.
Sick; big rashes on both of his arms; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable consumer (Spouse) reported for a male patient (Husband). A male patient with unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Not reported) dose 2 via an unspecified route of administration on unspecified date in Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: not reported on unspecified date in Jan2021 for covid-19 immunisation. On unknown date in Mar2021 the patient experienced big ra Reporters on both of his arms and on an unknown date he was sick. Reporter husband received the Pfizer Covid vaccine in January and February, and something is going on with his skin. Reporter doesn't know how to explain it, but he has these big ole' ra Reporters on both of his arms. Reporter mentions her husband has been using hydrocortisone. The patient received treatment for the events with hydrocortisone. The outcome of the events was unknown.  Information on the lot/batch number has been requested.   F/U (PRD/SRD 30Aug2021): Follow-up activities closed: Batch/lot number not available.
Prior to receiving the 2 dose vaccine I had not had my period in over 7 months. Since receiving the vaccine I have had 3 very irregular and heavy periods. I recently became aware that there seems to be a link between the vaccine and menstruation becoming irregular or heavy. I thought I would report it.
Immediately after receiving vaccine patient stated she felt light headed and nauseous and laid down. mom then stated that it was because she was sick when she came in and was probably from that. We let her lie down for the post observation time, and then we had her sit up for several minutes. after the post observation time was up she was able to get up and leave.
Developed redness and swelling at injection site next day 9/17/09 then fever 103. Instructed per phone conversation with Advil and Benadryl. Went to ER 9/19/09 and treated Keflex 500 qid Benadryl 25-50 q 4-6 hour. Seen at physician office 9/21/09 Keflex 500 qid X 3 additional days. Diagnosed with Cellulitis.
Information has been received from a nurse concerning a 5 year old female who on 14-SEP-2005 was vaccinated with the first dose of MMR II. On 15-JUL-2009, the patient received the second dose of MMR II (0.5ml, SC, lot# 663100/1672X). On 27-JUL-2009, the patient experienced parotitis. The patient was treated with supportive care including TYLENOL with CODEINE and cold packs. At the time of the report the patient had not recovered. Follow-up information has been received from the registered nurse concerning a 5 year old female who on 15-JUL-2009 at 15:00, was vaccinated with the second dose of MMR II (SC, 0.5ml, lot# 663100/1672X) in her right thigh. On 26-JUL-2009, the patient experienced sore throat, marked right parotid swelling approximately 6x5 cm to inferior ear and posterior auricular area. On 04-AUG-2009, the patient recovered. No further information is available.
flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix at the minute clinic. The patient experienced flu- like symptoms, which was lasted for 1 week. The patient mentioned that, a case was legal. The reporter consented to follow up. For tolerance to next dose, refer case US2019072365.
I had my 2nd Shingrix vaccine 3 days ago / now feeling much better; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 2nd dose of Shingrix. In June 2021, less than a week after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovering/resolving.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself/himself. The age at vaccination was not reported. The patient had received dose of Shingrix vaccine 3 days ago and was now feeling much better. The patient was asking if it was safe to have an intense gym workout today (day of reporting) and do he/she need rest following the vaccine for a specific period. Follow up was not possible as no contact details were provided.
Felt nauseas initially and later felt low fever, head and body ache, tiredness for next couple of days. Not feeling completely well for 5 days. Occasional nausea once in  awhile. (This occurred with third dose. I did  not have a bad reaction with first or  second dose).
pt recvd vax; same day as dose, exp low grade fever,v, d;no tx;low grade fever lasted 24 hrs;v & d lasted 2-3 days;